JAUNDICE METER, MODEL JM 103

K042522 · Draeger Medical Infant Care, Inc. · MQM · Jul 6, 2005 · Clinical Chemistry

Device Facts

• Record ID: K042522
• Device Name: JAUNDICE METER, MODEL JM 103
• Applicant: Draeger Medical Infant Care, Inc.
• Product Code: MQM · Clinical Chemistry
• Decision Date: Jul 6, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1113
• Device Class: Class 1
• Attributes: Pediatric

Intended Use

The Jaundice Meter (JM-103) is a non-invasive transcutaneous bilirubinometer. The unit provides a measurement of yellowness of subcutaneous tissue which has been shown to correlate with serum bilirubin in newborn infants. The device is intended for use in hospitals, clinics or doctor's offices under a physician's direction to assist clinicians in monitoring of newborn infants. The device is not intended as a standalone for diagnosis of hyperbilirubinemia. The device is intended to be used in conjunction with other clinical signs and laboratory measurements. Newborn infants whose JM-103 Jaundice Meter test results are indicative of hyperbilirubinemia should be evaluated by their physician(s) for appropriate patient management. Results should be confirmed by other methods, such as serum bilirubin, prior to treatment determinations. The JM 103 is a prescription Medical Device. The JM 103 is not intended for home use. The JM 103 may only be used at the sternum measurement site for Physician's office applications.

Device Story

JM-103 Jaundice Meter provides non-invasive transcutaneous bilirubin measurements in newborns; correlates yellowness of subcutaneous tissue with serum bilirubin levels. Used in hospitals, clinics, and physician offices by clinicians. Device serves as screening tool for monitoring; not for standalone diagnosis or treatment decisions. Clinicians use output to determine need for serum bilirubin testing. Benefits include reduced need for invasive blood draws for routine monitoring. No hardware or software modifications from predicate.

Clinical Evidence

No new clinical data provided; device is identical to previously cleared predicate.

Technological Characteristics

Transcutaneous bilirubinometer; non-invasive optical sensing. Displays results in mg/dL or µmol/L. Prescription-only device; not for home use. Sternum measurement site required for physician office applications.

Indications for Use

Indicated for non-invasive transcutaneous bilirubin monitoring in newborn infants to assist clinicians in assessing hyperbilirubinemia. Not for standalone diagnosis; results must be confirmed by serum bilirubin testing prior to treatment. Contraindicated for home use.

Regulatory Classification

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).

Predicate Devices

• JM-103 Jaundice Meter (K021622)

Submission Summary (Full Text)

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#### 510(k) Summary of Safety and Effectiveness Section I

K 04252 2

Applicant:

Draeger Air Shields Infant Care Inc. 330 Jacksonville Road Hatboro, Pa. 19040 Registration No: 2510954

JUL 6 - 2005

Contact Person:

Thomas McIntosh Ph 215-682-8634 Fax [phone]

Device trade/proprietary name:

Minolta Draeger Air Shields JM 103

Device common / usual/ classification name:

Jaundice Meter

Classification:

Clinical Chemistry Test Systems 21 CFR 862.113 Bilirubin in the Neonatal Test System, MQM, Class I

Performance Standards:

None applicable

Predicate Device:

K021622 JM 103 Jaundice Meter

## Device Description

The JM-103 Jaundice Meter is designed to provide a transcutaneous measurement of bilirubin displayed in Mg/dl or umol/L. This measurement is intended as a screening tool to determine when a serum bilirubin measurement should be taken, or, sequential bilirubin measurements over time to provide indication of change. This device is not intended for determinations of whether treatment is indicated. The determination of treatment must be based on a serum bilirubin measurement.

## Description of Modifications:

No modification to hardware, software, or procedures for use were implemented for this submission on the JM 103 Device previously cleared by the FDA as a medical device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three lines representing its body and wings. The eagle faces right and is positioned within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL 6 - 2005

Mr. Thomas McIntosh Regulatory Affairs Draeger Air Shields Infant Care, Inc. 330 Jacksonville Road Hatboro, PA 19040

Re: k042522

> 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: I Product Code: MQM Dated: March 24, 2005 Received: April 11, 2005

Dear Mr. McIntosh:

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).

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#### 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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Carol C. Benem

Carol C. Benson, M.A. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K042522

Device Name: JM 103 Jaundice Meter

A.1 Indication for Use Statement

The Jaundice Meter (JM-103) is a non-invasive transcutaneous bilirubinometer. It The Jaunulce Meter (SM-105) is a non-firsten o newborn infants. The unit provides a measures yellowness of ouboutano sus as a shown to correlate with serum bilirubin in newborn infants.

The device is intended for use in hospitals, clinics or doctor's offices under a The device is Internation for assist clinicians in monitoring of newborn infants. The device is not intended as a standalone for diagnosis of inflants. The deviloc is not internation with other clinical signs and laboratory measurements.

Newborn infants whose JM-103 Jaundice Meter test results are indicative of Newbom inflants whose on: 100 Saated by their physician(s) for appropriate patient hyperbilliubinemia should be evaluation by their projects should be confirmed by other mathods, such as serum bilirubin, prior to treatment determinations.

The JM 103 is a prescription Medical Device The JM 103 is not intended for home use. The JM 103 is not intended for nome assi
The JM 103 may only be used at the sternum measurement site for Physician's office applications.

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 5 of 40

Keal Sumpf
**Division Sign-Off**

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k)_K______________________________________________________________________________________________________________________________________________________________________