(251 days)
Not Found
No
The description mentions "a series of algorithms" but does not use terms like AI, ML, DNN, or describe any learning process from data to improve performance. The studies described are for validation and calibration, not for training a machine learning model.
No
The device is used for monitoring the status of newborn babies for hyperbilirubinemia, and provides a numerical index of estimated bilirubin count. It does not provide treatment or direct therapy.
Yes
The device is marketed and described as an aid to the physician in monitoring the status of newborn babies for the development of hyperbilirubinemia, and it provides a numerical index of estimated bilirubin count to correlate with total serum bilirubin within a clinically useful range. These functions are indicative of a diagnostic device.
No
The device description explicitly states that the Colormate III™ "illuminates the skin of newborn babies and measures the yellow content of the skin color" using "colorimetric technology." This indicates the presence of hardware components for light emission and detection, making it a hardware device with integrated software for data processing.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- Colormate III Method: The Colormate III is a noninvasive device that measures the yellow content of the skin color directly on the newborn baby. It does not analyze a sample taken from the body.
Therefore, based on the provided information, the Colormate III is a non-invasive diagnostic device, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes
MQM
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Colorimetric technology (measures yellow content of skin color)
Anatomical Site
Skin of newborn babies (not specifically stated, but inferred from the description)
Indicated Patient Age Range
Newborn babies
Intended User / Care Setting
Physician / Not Found
Description of the training set, sample size, data source, and annotation protocol
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.
Description of the test set, sample size, data source, and annotation protocol
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 study involved a sequence of 1317 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
§ 862.1113 Bilirubin (total and unbound) in the neonate test system.
(a)
Identification. A bilirubin (total and unbound) in the neonate test system is a device intended to measure the levels of bilirubin (total and unbound) in the blood (serum) of newborn infants to aid in indicating the risk of bilirubin encephalopathy (kernicterus).(b)
Classification. Class I.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads, representing the department's focus on health, human services, and science. The eagle is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" printed around it.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUL 2 4 1997
Thomas M. Tsakeris President Devices & Diagnostics Consulting Group 16809 Briardale Road Rockville, Maryland 20855
Re : K964590 Colormate™ Regulatory Class: II Product Code: MQM Dated: May 23, 1997 Received: May 23, 1997
Dear Mr. Tsakeris:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Requlations.
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Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Aitman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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APPENDIX F
(510 (K)) Summary
JUL 2 4 1997
510 (k) SUMMARY Colormate III™ November 14, 1996
This summary is provided in accordance with the Safe Medical Inis Bammary ID 1990 (SMDA), ai U.S.C. §360c(i)(3) and FDA's Devices Act of instally, 21 C.F.R. 807.92.
Submitter of 510(k) 1.0
Chromatics Color Sciences International, Inc. 5 East 80th Street New York, New York 10021-0109
Ms. Darby S. Macfarlane, CEO Attention:
212-717-6544 Telephone: 212-717-6675 Facsimile:
2.0 Name of Device
Trade/Proprietary Name 2.1
Colormate III™
Common/Usual Name 2.2
Transcutaneous Bilirubinometer (Colorimeter)
2.3 Classification Name
ੈ
Bilirubin (total and unbound) in the neonate test system (21 CFR 862.1113) ﺴﻤﺎ .
Reason for Submitting the 510(k) 3.0
This 510(k) is being submitted to notify FDA of Chromatics Color Sciences International's (CCSI) desire to commercially distribute for the first time the Colormate III.
4.0 Device Description
Colormate III™ (Colormate III or CM III) is a computer The 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
3
The Colormate III, like other colorimeters, generates a ranqe. set of tristimulus color coordinates for each measurement. It then performs a series of algorithms to produce final measurement results.
Indications for Use & Intended Use 5.0
Indications For Use 5.1
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 to be re-evaluated by the attending physician for are appropriate patient management.
Intended Use 5.2
computer assisted non-invasive Colormate III is a The 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 pilirubin concentration within a clinically useful range.
Substantial Equivalence 6.0
The Colormate III is "substantially equivalent" (as defined in 21 U.S.C. § 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 several wavelengths determines the level absorption at ot 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.
4
The Colormate III and predicate devices can be used as aids in monitoring the development of hyperbilirubinemia in the newborn.
the Colormate III has comparable technological Further, 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 Bilirubin strongly absorbs light in the wavelenqths light. between approximately 400 to 540 nm. These correspond to the blue and violet portions of the visible spectrum. qreen, 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 biligubin. 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 highly correlated (r = 0.90, p