(459 days)
P810007
Not Found
No
The description focuses on optical measurement and spectral analysis, with no mention of AI/ML terms or data-driven algorithms.
No
The device is a diagnostic tool designed to measure the level of jaundice (icterus) in infants, providing an index that helps medical practitioners decide if further serum bilirubin tests are needed. It does not provide any therapeutic treatment.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states, "The JM-102 Jaundice Meter is a diagnostic device..." and describes its purpose in identifying infants who should receive a serum bilirubin test, which is a diagnostic function.
No
The device description explicitly states it is a "hand-held non-invasive device" and lists hardware components such as a "hand-held meter with digital display," "charger," "calibration checker," and "carrying case." It also describes a physical process involving a "fiberoptic probe," "flash lamp," and "optical wave guide."
Based on the provided information, the JM-102 Jaundice Meter is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- JM-102 Function: The JM-102 Jaundice Meter is a non-invasive device that measures the level of jaundice by analyzing light reflected off the infant's skin. It does not involve the collection or analysis of any biological specimens from the body.
Therefore, while it is a diagnostic device used to assess a medical condition, it falls under the category of a non-invasive diagnostic device rather than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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.
Specific action levels have not been developed which apply to infants of less than 36 weeks of gestational age.
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
Product codes
MOM
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin (in infants)
Indicated Patient Age Range
Infants
Intended User / Care Setting
Medical practitioner
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
A clinical study showed a high degree of correlation between readings on infants taken with the JM-101 and JM-102.
Key Metrics
Not Found
Predicate Device(s)
P810007
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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.
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.
C. INTENDED USE
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.
Specific action levels have not been developed which apply to infants of less than 36 weeks of gestational age.
000090
1
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.
2
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.
3
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, 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
4
STATEMENT OF INDICATIONS FOR USE
510(k) Number (if known):
JM-102 Jaundice Meter_________________________________________________________________________________________________________________________________________________________ Device Name:
Indications For Use:
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
(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
OR
Prescription Use
(Per 21 CFR 801.109)
Over-The-Counter Use _
000093