510(k) SUMMARY from the FDA
From the FDA website: fda.gov
You can get a copy of it from the above site if you have Adobe Acrobat Reader. (FDA site seems to be down on this holiday weekend). This is the majority of it.
.......This summary is provided in accordance with the Safe Medical Devices Act of 1990 (SMDA), ai U.S.C. 360c(i)(3) and FDA'S implementing regulations, 21 C.F.R. 807.92..............
4.0 Device Description
The Colormate III (Colormate III or CM III) is a computer assisted noninvasive transcutaneous bilirubinometer which, through colorimetric technology, illuminates the skin of newborn babies and measures the yellow content of the skin color. The incremental changes of these color readings measured over time are compared to the newborn's baseline readings. These data are then automatically processed to provide a numerical index of estimated bilirubin count in mg/dl that has been shown to correlate with total serum bilirubin within a clinically useful range. The Colormate III like other colorimeters, generates a set of tristimulus color coordinates for each measurement. It then performs a series of algorithms to produce final measurement results.
5.0 Indications for Use & Intended Use
5.1 Indications For Use
The Colormate III is to be used as an aid to the physician in monitoring the status of newborn babies for the development of hyperbilirubinemia. Following the physician's examination within the first hours after birth, newborn babies are initially measured and periodically monitored by the Colormate III for incremental changes in the yellow content of the skin color as compared to the baseline Colormate III measurements. Babies with Colormate III test results indicative of hyperbilirubinemia are to be re-evaluated by the attending physician for appropriate patient management.
5.2 Intended Use
The Colormate III is a computer assisted non-invasive transcutaneous bilirubinometer which, through colorimetric technology, illuminates the skin of newborn babies and measures the yellow content of the skin color. The incremental changes of these color readings measured over time are compared to the newborn's baseline Colormate III readings. These data are then automatically processed to provide a numerical index of predicted bilirubin count in mg/dl that has been shown to correlate with total serum bilirubin concentration within a clinically useful range.
6.0 Substantial Equivalence
The Colormate III is "substantially equivalent" (as defined in 21 U.S.C. S 360c(i)) in principle, performance, and safety and effectiveness to at least two legally marketed predicate devices. The first predicate device, the Unistat Bilirubinometer manufactured by Leica, Inc.(K922770), is a bilirubinometer which operates by measuring the absorption of visible light through a sample of unreacted serum. The absorption at several wavelengths determines the level of bilirubin present in the sample. The second device, the Ingram Icterometer, commercially distributed preenactment (marketed since 1950's) by Cascade Health Care Products, Salem, Oregon, is a noninvasive aid used as a color reference by the physician during his/her visual assessment of the newborn's skin for jaundice or yellowing. The yellow color of the subcutaneous tissue is matched to a corresponding "yellow hue" stripe for a reference score.
The Colormate III and predicate devices can be used as aids in monitoring the development of hyperbilirubinemia in the newborn.
Further, the Colormate III has comparable technological characteristics to those of the predicate devices. The underlying principles of the Colormate III and the predicate devices are the same in that the Colormate III and the predicate devices base their measurements on the unique absorbance characteristics of bilirubin in the visible spectrum. That is, the level of bilirubin (whether intravascular or extravascular) is easily detected by its characteristic absorption of visible light. Bilirubin strongly absorbs light in the wavelengths between approximately 400 to 540 nm. These correspond to the green, blue and violet portions of the visible spectrum. Therefore, an increase in bilirubin is seen as a direct absorption of these colors in transmitted or reflected light or as a relative increase in the complementary color of yellow. This latter effect is seen in the yellowing (jaundice) of the infant's skin during hyperbilirubinemia.
The Colormate III, like the predicate Unistat Bilirubinometer, directly measures the bilirubin concentration via its absorption of visible light. The Colormate III measures the interstitial subcutaneous concentration and the Unistat measures the intravascular concentration.
The Colormate III and the noninvasive predicate device, as well as the visual assessment by the physician, operate on the principle that increasing levels of serum bilirubin during hyperbilirubinemia results in corresponding increases in the level of interstitial bilirubin. The painted stripes of precisely graded yellow hues in the Ingram Icterometer provide the physician with a visual aid to gauge the depth of jaundice in the newborns and estimate the serum bilirubin levels. The Colormate III expands on this concept. The Colormate III replaces the human eye with a colorimeter having more accuracy and precision and provides the physician with a numerical index of estimated serum bilirubin in mg/dl.
7.0 Performance Data
The performance testing provided demonstrates that the Colormate III is statistically significantly more accurate and precise than visual assessment alone and can aid the physician in monitoring hyperbilirubinemia in the newborn. Further, these data demonstrate that the Colormate III interstitial readings are highly correlated (r = 0.90, p<0.0l) with serum or intravascular bilirubin readings within a clinically useful range.
A series of reproducibility studies were conducted using the Colormate III. Measurements were made using (A) a standard calibration tile, (B) adult subjects and (C) newborn babies with varying degrees of jaundice. The coefficients of variation (CV) for the tristimulus color coordinates calculated by the Colormate III and used in its numerical index are below 3%.
Prior to undertaking a pivotal clinical trial to evaluate the Colormate III's performance, two phases of studies were conducted to validate the clinical approach and test criteria and determine calibration algorithms for subsequent validation.
A clinical study was conducted to compare (1) the performance of the Colormate III using colorimetric measurement technology to estimate serum bilirubin concentration (BRC) from the yellow content of the color of the skin and (2) the ability of the physician to visually assess the same yellow color of the skin and make a clinical estimate of the BRC. Neonates enrolled in the study underwent the usual course of physical examination (including a visual assessment of the yellowness of the skin for bilirubinemia), monitoring and care. Colormate III skin color measurements, employing a number of anatomical sites on an infant, were made concurrently with serum bilirubin blood tests and physicians' visual estimates.
The trial involved a sequence of1317 newborns. The study included a mix of the following races: 487 (37%) Caucasians, 298 (23%) Blacks, 427 (32%) Hispanics, 82 (6%) Orientals and 20 (2%) others. One Thousand Thirty-seven (1037) babies were normal (i.e., did not develop hyperbilirubinemia) and, therefore, did not undergo blood serum tests. One Hundred Nine (109) babies did not have initial measurements made within acceptable time frames. The remaining 171 premature and full term newborns with 360 concurrent Colormate III measurements, clinical visual estimates and blood serum tests demonstrated that the Colormate III was better correlated (p<0.05) with serum bilirubin concentration (r = .90) than was the clinicians' visual assessment (r = 67).
The estimation of bias between the Colormate III test and comparative serum did not exceed 1.6 my/do in the clinically useful range of 4.0 to 17.0 my/do (less than 1 my/do from 7 to 17 my/do). In addition, the correlation of Colormate In with serum readings was relatively unaffected by race (Caucasian r = .91, Black r = .88, Hispanic r = .89, Oriental r = .91).
Additionally, the relative sensitivities of the visual measurement and the Colormate III results to serum values were computed and compared using a contingency table approach to data presentation and a cutoff of12.0 mg/dl of bilirubin as an acceptable level of clinical concern. The clinicians' visual assessment agreed above the cutoff of 12.0 with serum only 6l% of the time while the Colormate III agreement (sensitivity of the Colormate Ill) was over 89% in the same patients. The sensitivity of the Colormate III was statistically significantly better than that for the visual assessment, in their correlation to serum values above and below the accepted level of clinical concern of 12.0 mg/dl, p<.05. Further, exactly the same conclusions were reached when higher or lower levels were examined (e.g., 8.0 or 14.0). Sensitivity calculations again demonstrated significantly higher sensitivity for the Colormate III than that for the visual assessment.
In conclusion, the Colormate III performance was superior to visual examination in estimating the true level of serum bilirubin, in addition to an excellent correlation to serum bilirubin throughout a clinically useful range.
Device Name: Colormate III(tm)
Indications for use:
The Colormate III is to be used as an aid to the physician in monitoring the status of newborn babies for the development of hyperbilirubinemia. Following the physician's examination within the first hours of birth, newborn babies are initially measured and periodically monitored by the Colormate III for incremental changes in the yellow content of the skin color as compared to the baseline Colormate III measurements. Babies with Colormate III test results indicative of hyperbilirubinemia are to be re-evaluated by the attending physician for appropriate patient management.
Intended Use:
The Colormate III is a computer assisted non-invasive transcutaneous bilirubinometer which, through colorimetric technology, illuminates the skin of newborn babies and measures the yellow content of the skin color. The incremental changes of these color readings measured over time are compared to the newborn's baseline Colormate III readings. These data are then automatically processed to provide a numerical index of predicted bilirubin count in mg/dl that has been shown to correlate with total serum bilirubin concentration within a clinically useful range.
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