(320 days)
Not Found
No
The device description mentions a "dual path optical system" and software that "computes the estimated bilirubin concentration based on an established correlation coefficient." This describes a deterministic algorithm based on optical measurements and a pre-defined formula, not AI/ML. There is no mention of AI, ML, or related terms, nor any description of training or test sets typically associated with AI/ML development.
No
The device is a diagnostic tool used to monitor hyperbilirubinemia, not to treat it. It assists clinicians in determining the need for further evaluation, but does not directly provide therapy.
No
The device is explicitly stated as "not intended as a standalone for diagnosis of hyperbilirubinemia." It is used to "assist clinicians in monitoring the status of newborn infants" and its results "should be confirmed by other methods... prior to treatment determinations," indicating it is a screening or monitoring tool rather than a diagnostic one.
No
The device description explicitly states it uses a "dual path optical system" to take measurements, which is a hardware component. The software then processes these hardware measurements.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the safety and compatibility of potential donors and recipients, or to monitor therapeutic measures.
- Device Function: The Jaundice Meter (JM-103) measures the yellowness of subcutaneous tissue on the body (transcutaneous). It does not examine specimens in vitro (outside the body).
- Intended Use: The intended use is to assist clinicians in monitoring newborn infants for hyperbilirubinemia by measuring a physical characteristic (yellowness) on the skin. While this measurement correlates with serum bilirubin (which is measured in vitro), the device itself is not performing an in vitro test.
Therefore, based on the provided information, the Jaundice Meter (JM-103) is a non-invasive medical device used for monitoring, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Jaundice Meter (JM-103) is a non-invasive transcutaneous bilirubinometer. It measures yellowness of subcutaneous tissue in newborn infants and displays a measured value which has been shown to correlate with serum bilirubin. The device is for use in the hospital to assist clinicians in monitoring the status of newborn infants for the development of hyperbilirubinemia. The device is not intended as a standalone for diagnosis of hyperbilirubinemia. It is to be used in conjunction with other clinical signs and laboratory measurements. Newborn infants whose Jaundice Meter (JM 103) test results are indicative of hyperbilirubinemia are evaluated by their doctor(s) for appropriate patient management. Bilirubin levels should be confirmed by other methods, such as serum bilirubin, prior to treatment determinations.
This device is not intended for home use.
This is a prescription device.
Product codes (comma separated list FDA assigned to the subject device)
MQM
Device Description
The JM 103 Jaundice Meter is designed to provide a non-invasive measurement of the yellowness of subcutaneous tissue. This measurement is converted to an estimated bilirubin concentration and displayed in units of mg/dL or umole/L. This measurement is taken using a dual path optical system. The measurements from each path are then subtracted to minimize the impact of skin pigmentation. The software in the device then computes the estimated bilirubin concentration based on an established correlation coefficient.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
subcutaneous tissue, forehead, sternum
Indicated Patient Age Range
newborn babies, newborn infants
Intended User / Care Setting
clinicians in the hospital
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical assessment of this device was performed to ensure that the device operated as intended. In addition, all aspects of the system features and functionality have been bench tested. Software development, validation and verification has been performed.
Clinical Assessment of this device was performed at two study sites to establish correlation between the JM 103 estimated bilirubin concentration and total serum bilirubin concentration. The study also demonstrates that the device can be used effectively across diverse populations.
Clinical Study Site A Forehead all: n=513, r=0.914, SD=1.29, y=1.05x-0.35
Clinical Study Site A Sternum all: n=513, r=0.946, SD=1.02, y=1.07x-0.74
Study Site B Forehead All: n=100, R=0.84, SD=2.14, y=1.07x-0.00
Study Site B Sternum All: n=100, R=0.89, SD=1.85, y=1.16x-0.43
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
JM 102 Jaundice Meter K972309
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Section I 510(k) Summary of Safety and Effectiveness
Applicant:
APR 0 1 2003
Hill-Rom Air Shields 330 Jacksonville Road Hatboro, Pa 19040
Registration No: 2510954
Contact Person:
Monica Ferrante Phone 215-682-8691 Fax 215-681-8689
Device trade/proprietary name:
Minolta Hill-Rom Air Shields JM 103
Device common/usual/classification name:
Jaundice Meter
Classification:
Clinical Chemistry Test Systems 21 CFR 862.1113 Bilirubin in the Neonatal Test System, MQM, Class I
Performance Standards:
None applicable
Predicate Device:
JM 102 Jaundice Meter K972309
Device Description:
The JM 103 Jaundice Meter is designed to provide a non-invasive measurement of the yellowness of subcutaneous tissue. This measurement is converted to an estimated bilirubin concentration and displayed in units of mg/dL or umole/L. This measurement is taken using a dual path optical system. The measurements from each path are then subtracted to minimize the impact of skin
1
pigmentation. The software in the device then computes the estimated bilirubin concentration based on an established correlation coefficient.
Intended Use:
JM 103 is a non-invasive transcutaneous bilirubinometer. It measures yellowness of subcutaneous tissue in newborn babies and displays a measured value which has been shown to correlate with serum bilirubin. The device is for use in the hospital to assist clinicians in monitoring the status of newborn babies for the development of hyperbilirubinenmia. The device is not intended as a standalone for diagnosis of hyperbilirubinemia. It is to be used in conjunction with other clinical signs and laboratory measurements. Newborn infants whose JM 103 test results are indicative of hyperbilitubinemia are evaluated by their doctor(s) for appropriate patient management. Bilirubin levels should be confirmed by other methods (e.g., serum bilirubin) prior to treatment determinations.
Description of Modifications
The primary difference between the JM 102 and the JM 103 is that the JM 102 employed a single optical path for measurement and the JM 103 employs a dual optical path.
Performance Assessment
Non-Clinical assessment of this device was performed to ensure that the device operated as intended. In addition, all aspects of the system features and functionality have been bench tested. Software development, validation and verification has been performed.
Clinical Assessment of this device was performed at two study sites to establish correlation between the JM 103 estimated bilirubin concentration and total serum bilirubin concentration. The study also demonstrates that the device can be used effectively across diverse populations.
(attach graphs of total population for each site forehead and sternum – 4 charts)
2
Image /page/2/Figure/0 description: This image shows a scatter plot with a negative correlation. The x-axis is labeled "TSB" and ranges from 0 to 20, while the y-axis is labeled "103F(MP)" and ranges from 0 to 25. The plot shows data from a clinical study at Site A for the forehead, with a sample size of 513, a correlation coefficient of 0.914, a standard deviation of 1.29, and a regression equation of y=1.05x-0.35.
linical Study Site A Forhead all
r=0.914 SD=1.29 y=1.05x-0.35
n=
3
n=513 Site A Sternum all
SD=1.02 y=1.07x-0.74 Clinical Study | r=0.946
Image /page/3/Figure/1 description: This image is a scatter plot with a negative correlation. The x-axis is labeled "TSB" and ranges from 0 to 20. The y-axis is labeled "103S (MP)" and ranges from 0 to 25. The data points are clustered along a line that slopes downward from left to right, indicating that as TSB increases, 103S (MP) tends to decrease.
4
Image /page/4/Figure/0 description: This image is a scatter plot titled "Study Site B Forehead All n=100". The x-axis is labeled "TSB" and ranges from 0 to 20. The y-axis is labeled "JM-103" and ranges from 0 to 25. A line of best fit is plotted on the scatter plot, and the equation for the line is y=1.07x-0.00, with R=0.84 and SD=2.14.
5
Image /page/5/Figure/0 description: This image shows a scatter plot with a regression line. The x-axis is labeled TSB and ranges from 0 to 20, while the y-axis is labeled JM-103 and ranges from 0 to 25. The plot is titled "Study Site B Sternum All n=100 R=0.89 SD=1.85 y=1.16x-0.43".
6
Image /page/6/Picture/1 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle image.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Monica Ferrante Regulatory Affairs Hill-Rom® Air Shields 330 Jacksonville Road Hatboro, PA 19040
APR 0 1 2003
Re: K021622
Trade/Device Name: JM 103 Jaundice Meter Regulation Number: 21 CFR 862.1113 Regulation Name: Bilirubin (total and unbound) in the neonate test system Regulatory Class: Class I Product Code: MQM Dated: January 10, 2003 Received: January 13, 2003
Dear Ms. Ferrante:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
7
Page 2 -
This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Steven Gutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
8
SMDA Requirements Section A
A.1 Indication for Use Staternent
510(k) Number:
Device Name: JM 103 Jaundice Meter
Indications for Use:
The Jaundice Meter (JM-103) is a non-invasive transcutaneous bilirubinometer. It measures yellowness of subcutaneous tissue in newborn infants and displays a measured value which has been shown to correlate with serum bilirubin. The device is for use in the hospital to assist clinicians in monitoring the status of newborn infants for the development of hyperbilirubinemia. The device is not intended as a standalone for diagnosis of hyperbilirubinemia. It is to be used in conjunction with other clinical signs and laboratory measurements. Newborn infants whose Jaundice Meter (JM 103) test results are indicative of hyperbilirubinemia are evaluated by their doctor(s) for appropriate patient management. Bilirubin levels should be confirmed by other methods, such as serum bilirubin, prior to treatment determinations.
This device is not intended for home use.
This is a prescription device.
(Please do not write below this line continue on another page if needed) Concurrence of CDRH, Office of Device Evaluation (ODE)
tion Use
Han Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K021622
OB OVE
Prescription Use (Per 21 CFR 801.109) OR
Over-the-Counter Use
(Optional Format 1/2/96)