HILL-ROM AIR SHIELDS/MINOLTA JAUNDICE METER, MODEL JM-103

K021622 · Hill-Rom Air-Shields · MQM · Apr 1, 2003 · Clinical Chemistry

Device Facts

• Record ID: K021622
• Device Name: HILL-ROM AIR SHIELDS/MINOLTA JAUNDICE METER, MODEL JM-103
• Applicant: Hill-Rom Air-Shields
• Product Code: MQM · Clinical Chemistry
• Decision Date: Apr 1, 2003
• 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. 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.

Device Story

JM 103 Jaundice Meter provides non-invasive estimation of bilirubin concentration in newborns; measures yellowness of subcutaneous tissue. Device utilizes dual-path optical system to subtract skin pigmentation effects; software computes estimated bilirubin concentration using established correlation coefficient. Used in hospital settings by clinicians; output displayed in mg/dL or umole/L. Device serves as screening tool to assist monitoring; not for standalone diagnosis. Clinicians use output in conjunction with other clinical signs and laboratory tests to determine if further evaluation or treatment is required. Benefits include non-invasive monitoring, reducing need for frequent blood draws.

Clinical Evidence

Clinical studies conducted at two sites (Site A: n=513; Site B: n=100) to establish correlation between JM 103 estimated bilirubin and total serum bilirubin (TSB). Site A forehead correlation r=0.914 (SD=1.29); sternum r=0.946 (SD=1.02). Site B forehead correlation r=0.84 (SD=2.14); sternum r=0.89 (SD=1.85). Studies demonstrate effective performance across diverse populations.

Technological Characteristics

Dual-path optical system for transcutaneous bilirubin measurement. Software-based computation of bilirubin concentration using correlation coefficients. Form factor is a handheld jaundice meter. Intended for hospital use.

Indications for Use

Indicated for newborn infants in hospital settings to assist clinicians in monitoring for the development of hyperbilirubinemia. Not for home use. Not intended as a standalone diagnostic tool; results must be confirmed by other clinical signs and laboratory measurements (e.g., serum bilirubin) prior to treatment.

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 102 Jaundice Meter (K972309)

Submission Summary (Full Text)

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K021622

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 [phone] Fax [phone]

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

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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)

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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=

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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.

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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.

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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".

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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).

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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/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

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#### 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)