The JM-102 Jaundice Meter is a diagnostic device intended for use on infants suspected of having jaundice to provide an objective index of icterus. This index can be used by a medical practitioner to identify infants who should be given a serum bilirubin test and to identify those infants who do not need a serum test.

The JM-102 Jaundice Meter provides an objective index of icterus in infants and when used in conjunction with other clinical signs and/or laboratory measurements, can assist the physician in making clinical decisions regarding the need for serum bilirubin measurements medior therep

Device Description

The Air-Shields JM-102 Jaundice Meter is a hand-held non-invasive device for the measurement of the level of jaundice in an infant. The system consists of the hand-held meter with digital display, the charger for recharging the NiCd battery pack in the device, a calibration checker, and a carrying case. The device measures the yellowish tint in jaundiced skin by analyzing the light reflected off the skin. The fiberoptic probe on top of the device is held against the infant's skin and an internal flash lamp sends a pulse of light through the outer part of an optical wave guide to the skin where the light is reflected back through the inner part of the optical wave guide and to the spectral analysis section of the device.

AI/ML Overview

This 510(k) summary for the JM-102 Jaundice Meter outlines the device's substantial equivalence to a predicate device (JM-101) rather than establishing new performance acceptance criteria for an innovative device. Therefore, the information provided focuses on demonstrating equivalence through comparison, not on proving the device meets novel acceptance criteria in a standalone study.

Here's an analysis based on the provided text, addressing the requested points:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission, the "acceptance criteria" are implicitly equivalence to the predicate device in terms of spectral response and clinical correlation.

Acceptance Criteria (Implicit)	Reported Device Performance
Spectral responses of green and blue pathways are the same as the predicate device (JM-101).	Testing with a spectrophotometer has demonstrated that the spectral responses are the same.
High degree of correlation between readings from JM-101 and JM-102 on infants.	A clinical study showed a high degree of correlation between readings on infants taken with the JM-101 and JM-102. (No specific correlation coefficient or statistical measure is provided in this summary.)

2. Sample Size Used for the Test Set and Data Provenance

The document states: "In addition, a clinical study showed a high degree of correlation between readings on infants taken with the JM-101 and JM-102."

Sample Size for Test Set: Not specified. The summary only mentions "a clinical study" without detailing the number of infants.
Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Number of Experts: Not applicable. The study's purpose was to compare the JM-102 with the JM-101, not to establish a new ground truth using expert consensus. The "ground truth" (or reference standard) would have been the readings from the predicate device (JM-101).
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. The study was a comparison between two devices, not an assessment requiring adjudication of interpretations.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study: No, an MRMC study was not described. The study compared two devices, not the effect of AI assistance on human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Standalone Study: Yes, in effect. The "clinical study" described compared the performance of the JM-102 independently (as a device) against the JM-101. It was not a human-in-the-loop assessment.

7. Type of Ground Truth Used

Type of Ground Truth: The "ground truth" for the comparison was the measurements obtained from the predicate device, the JM-101 Jaundice Meter.

8. Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This device is a measurement instrument, not an AI/machine learning algorithm that requires a training set in the conventional sense. Its "training" or development would have involved engineering design and calibration, not data-driven model training.

9. How the Ground Truth for the Training Set Was Established

How Ground Truth for Training Set Was Established: Not applicable, as it's not an AI/ML algorithm requiring a training set. The engineering specifications and calibration of the device would have been established through validated measurement standards.

Summary

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SEP 2 2 1998

972309

510(k) Summary

JM-102 Jaundice Meter

Common/Classification Name: Jaundice Meter Air-Shields 330 Jacksonville Road Hatboro, PA 19040

Contact: Marci Goldfinger, Prepared: June 19, 1997

LEGALLY MARKETED PREDICATE DEVICES A.

The JM-102 Jaundice Meter is substantially equivalent to an earlier model of the same device, the JM-101 (P810007).

DEVICE DESCRIPTION B.

C. INTENDED USE

Specific action levels have not been developed which apply to infants of less than 36 weeks of gestational age.

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D. SUBSTANTIAL EQUIVALENCE SUMMARY

The JM-102 has the same indications statement as the predicate device and it has the same technological characteristics. The descriptive characteristics may not be sufficient to ensure equivalence, but performance data are available and they demonstrate equivalence (see Section F, below). Therefore, the decision algorithm brings us to a decision of substantial equivalence.

TECHNOLOGICAL CHARACTERISTICS ய்

See Section B, above.

F. TESTING

The only modification to the device which could affect the performance of the device is the spectral response of the green and blue pathways. Testing with a spectrophotometer has demonstrated that the spectral responses are the same.

In addition, a clinical study showed a high degree of correlation between readings on infants taken with the JM-101 and JM-102.

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Image /page/2/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus with three intertwined snakes and a staff. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the caduceus. The seal is black and white.

SEP 2 2 1998

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

T. Whit Athey, Ph.D. . Senior Consultant C.L. McIntosh & Associates, Inc. 12300 Twinbrook Parkway, Suite 625 Rockville, Maryland 20852

Re : K972309 JM-102 Jaundice Meter Regulatory Class: I Product Code: MOM Dated: July 17, 1997 Received: July 17, 1997

Dear Dr. Athey:

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 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 (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. ਖੇ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements 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 regulations.

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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, prease 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 Gutman

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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STATEMENT OF INDICATIONS FOR USE

510(k) Number (if known):

JM-102 Jaundice Meter_________________________________________________________________________________________________________________________________________________________ Device Name:

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Clinical Laboratory Devices

510(k) Number kc 972309

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use _

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Regulation Number and Section

§ 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.