The BiliChek Non-Invasive Bilirubin Analyzer is a computer assisted non-invasive transcutaneous bilirubinometer which is intended as an index to predict serum bilirubin levels in neonates less than eight days old, without regard to gender, gestational age, race, or bodyweight. The BiliChek provides a numerical measurement of predicted bilirubin count in mg/dL within a clinically beneficial range that has been correlated with total serum bilirubin concentration measured by High Pressure Liquid Chromatography (HPLC). The device is used in the hospital or institutional environment to assist clinicians in monitoring the status of neonates for the development of hyperbilirubinemia. Neonates whose BiliChek test results are indicative of hyperbilirubinemia are evaluated by their physician(s) for appropriate patient management.

Device Description

The Bilichek consists of the BiliChek hand-held unit, the BiliCal Individual calibration tips, a charger base, and rechargeable battery packs. The BiliChek hand-held unit contains a light source, a fiberoptic probe, a microspectrometer, and a microprocessor control circuit within an 8.5 x 2x 4 inch assembly. The hand-held unit is battery powered and is controlled by an internal microprocessor. Operator interface with the microprocessor is achieved through three buttons and a liquid crystal display (LCD). The buttons are used to select different set-up options. The measurement is initiated when the operator presses the Trigger button on the bottom of the unit. The LCD window on the device displays the calculated bilirubin value, date and time, battery status, and permits the unit set-up parameters to be programmed. The BiliCal disposable tips protect the fiber-optic probe, ensure a hygienic contact with the patient, provide a means for calibration of the BiliChek, and serve as a positioning aid. The disposable tip includes a removable target with calibration material which is used in the initial calibration of the device prior to use on each patient. Before a measurement is taken, the BiliChek runs a baseline reference calibration scan which measures the removable target on the tip. After calibration, the target is removed from the tip to expose an optically clear window through which measurements are made. Sensors in the BiliChek detect when the tip is correctly installed and the depression of the tip under pressure when it is applied to the patient. Two rechargeable nickel-cadmium battery packs are supplied with the system. The battery pack is inserted in the bottom of the BiliChek Hand-held Unit. The BiliChek Hand-Held Unit includes status indicators which indicate if the battery is low or dead. When fully charged, each battery pack provides sufficient power to conduct 100 measurements. The Bilichek battery charger includes two charging wells, one for the Bilichek and the other for the spare battery pack. The charger is provided power from a 110 volt power supply.

AI/ML Overview

The SpectRx BiliChek Non-Invasive Bilirubin Analyzer underwent clinical testing to demonstrate its ability to non-invasively measure bilirubin levels in neonates.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the BiliChek device are not explicitly quantified with specific thresholds (e.g., a certain correlation coefficient or error margin) in the provided text. However, the reported performance states that the clinical testing demonstrated a "statistically and clinically significant correlation" between the BiliChek's measurements and serum bilirubin levels as indicated by HPLC.

Acceptance Criterion (Implicit)	Reported Device Performance
Ability to non-invasively measure bilirubin levels	Demonstrated in clinical testing.
Correlation with serum bilirubin levels (HPLC)	"Statistically and clinically significant correlation" between BiliChek and serum bilirubin levels measured by HPLC.
Performance across various demographic factors	"No significant differences in the performance of the BiliChek attributed to race, sex, gestational age at delivery, bodyweight, or presence in the NICU."
Safety (absence of adverse events)	"No injuries or deaths that occurred while the device was being used or any adverse effects reported from use of the device."
Intended Use Fulfillment (predict serum bilirubin, aid monitoring)	The device "is intended as an index to predict serum bilirubin levels" and "provides a numerical measurement of predicted bilirubin count... that has been correlated with total serum bilirubin concentration measured by High Pressure Liquid Chromatography (HPLC)." It is used "to assist clinicians in monitoring the status of neonates for the development of hyperbilirubinemia."

2. Sample Size and Data Provenance for the Test Set

Sample Size: The document does not explicitly state the total number of neonates included in the clinical test set.
Data Provenance: The country of origin of the data is not specified. The study was prospective in nature, as it involved "clinical testing... conducted to demonstrate the ability of the BiliChek device to non-invasively measure the bilirubin levels of infants... prior to the use of phototherapy or any related therapeutic intervention." This suggests real-time measurement on actual patients before interventions.

3. Number of Experts and Qualifications for Ground Truth

The document does not mention the use of experts to establish ground truth in the traditional sense of consensus reading. The ground truth was established by laboratory measurement using HPLC.

4. Adjudication Method for the Test Set

No adjudication method involving experts is mentioned, as the ground truth was derived from laboratory measurements (HPLC).

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly described or performed. The study focused on the performance of the device against a gold standard (HPLC), not on comparing human readers with and without AI assistance.

6. Standalone (Algorithm Only) Performance

Yes, a standalone performance study was performed. The clinical testing described measures the performance of the BiliChek device directly against serum bilirubin levels obtained through HPLC, without the intervention of a human interpreter or decision-maker in the measurement process itself. The BiliChek "provides a numerical measurement of predicted bilirubin count in mg/dL."

7. Type of Ground Truth Used

The ground truth used was High Performance Liquid Chromatography (HPLC) measurements of total serum bilirubin concentration. This is a laboratory-based, objective measurement.

8. Sample Size for the Training Set

The document does not specify a separate training set or its sample size. The description of the performance testing focuses on clinical validation of the device, which typically implies a test set rather than a training set for model development (though the device itself likely underwent internal development and calibration).

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

Since a dedicated training set is not explicitly mentioned, the method for establishing its ground truth is also not described. If an internal training set was used during device development, it is highly probable that ground truth would have been established through a reference method like HPLC, similar to the clinical test set.

Summary

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4 2000 FEB

510(k) Premarket Notification Summary for SpectRx BiliChek Non-Invasive Bilirubin Analyzer

1. SPONSOR

SpectRx, Inc. 6025A Unity Drive Norcross GA 30071

Mr. Keith D. Ignotz Contact Person: 770-242-8723 Telephone:

Date Prepared: December 29, 1999

2. DEVICE NAME

Proprietary Name:	BiliChek Non-invasive Bilirubin Analyzer
Common/Usual Name:	Non-invasive bilirubin analyzer
Classification Name:	Bilirubin (total and unbound) in the neonate test system(21 CFR 862.1113)

3. PREDICATE DEVICES

Respironics BiliChek Non-invasive Bilirubin Analyzer (K983071) Chromatics III (K964590) Leica Unistat Bilirubinometer (K922770).

DEVICE DESCRIPTION 4.

The hand-held unit is battery powered and is controlled by an internal microprocessor. Operator interface with the microprocessor is achieved through three buttons and a liquid crystal display (LCD). The buttons are used to select different set-up options. The measurement is initiated when the operator presses

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the Trigger button on the bottom of the unit. The LCD window on the device displays the calculated bilirubin value, date and time, battery status, and permits the unit set-up parameters to be programmed.

The BiliCal disposable tips protect the fiber-optic probe, ensure a hygienic contact with the patient, provide a means for calibration of the BiliChek, and serve as a positioning aid. The disposable tip includes a removable target with calibration material which is used in the initial calibration of the device prior to use on each patient. Before a measurement is taken, the BiliChek runs a baseline reference calibration scan which measures the removable target on the tip. After calibration, the target is removed from the tip to expose an optically clear window through which measurements are made. Sensors in the BiliChek detect when the tip is correctly installed and the depression of the tip under pressure when it is applied to the patient.

Two rechargeable nickel-cadmium battery packs are supplied with the system. The battery pack is inserted in the bottom of the BiliChek Hand-held Unit. The BiliChek Hand-Held Unit includes status indicators which indicate if the battery is low or dead. When fully charged, each battery pack provides sufficient power to conduct 100 measurements. The Bilichek battery charger includes two charging wells, one for the Bilichek and the other for the spare battery pack. The charger is provided power from a 110 volt power supply.

INTENDED USE ર્ડ.

The Bilichek Non-Invasive Bilirubin Analyzer is a computer assisted noninvasive transcutaneous bilirubinometer which is intended as an index to predict serum bilirubin levels in neonates less than eight days old, without regard to gender, gestational age, race, or bodyweight. The Bilichek provides a numerical measurement of predicted bilirubin count in mg/dL within a clinically beneficial range that has been correlated with total serum bilirubin concentration measured by High Pressure Liquid Chromatography (HPLC). The device is used in the hospital or institutional environment to assist clinicians in monitoring the status of neonates for the development of hyperbilirubinemia. Neonates whose Bilichek test results are indicative of hyperbilirubinemia are evaluated by their physician(s) for appropriate patient management

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TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.

The SpectRx BiliChek Noninvasive Bilirubin Analyzer is identical to the Respironics BiliChek Noninvasive Bilirubin Analyzer which was cleared by FDA under 510(k) K983071. There are no technological differences between the devices since they are identical.

The BiliChek is substantially equivalent to the Chromatics Color Sciences International Colormate III (K964590) and to the Unistat Bilirubinometer (K922770). All of these devices have similar intended uses and technological characteristics. Each device measures the presence of hyperbilirubinemia in neonates, and each device bases its measurements on the absorbance characteristics of bilirubin in the visible spectrum.

7. PERFORMANCE TESTING

Testing of the SpectRx BiliChek included the following:

Materials used in the BiliChek were tested for a. Biocompatibility: biocompatibility and shown to be safe for use on intact skin.
b. Electrical safety testing. The BiliChek System was tested for compliance with IEC 601-1. The results show that the device complies with the requirements of IEC 601-1.
c. Electronic hardware testing: Functional testing of the printed circuit boards for the main board and charger board was performed and demonstrated that these boards meet their respective performance specifications.
d. BiliChek Battery and Temperature Testing: These tests verified that the BiliChek battery pack will operate the BiliChek for at least 100 measurements. In addition, the tests verified that the BiliChek meets specifications for operating over the specified temperature range of +5°C to +40°C.
Calibration Material Stability: The calibration material was exposed to e. elevated temperature for an extended period of time to simulate exposure to extreme environmental conditions and to accelerate aging. The material was found to be stable over the tested temperature range.
್ EMI/EMC Testing: Immunity and emissions testing was performed and demonstrates that the BiliChek System complies with the requirements of IEC 601-1-2 for immunity and EN55011 for emissions.

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Software testing: The software/firmware used in the BiliChek was tested in ಲ್ಲ. accordance with the software test plan and demonstrates that the software program meets the performance specifications.
h. Clinical testing: Clinical testing of the BiliChek was conducted to demonstrate the ability of the BiliChek device to non-invasively measure the bilirubin levels of infants less than eight days old prior to the use of phototherapy or any related therapeutic intervention. Bilirubin values measured by HPLC and with the BiliChek were compared to determine the accuracy of the BiliChek. The test results demonstrate a statistically and clinically significant correlation between the BiliChek and serum bilirubin levels as indicated by HPLC. There were no significant differences in the performance of the BiliChek attributed to race, sex, gestational age at delivery, bodyweight, or presence in the NICU. There were no injuries or deaths that occurred while the device was being used or any adverse effects reported from use of the device.

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS), USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" arranged around the perimeter. Inside the seal is a stylized symbol featuring three abstract human profiles facing to the right, with flowing lines suggesting movement or connection.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

FEB 4 2000

Mr. James R. Veale Vice President, Regulatory Services Medical Device Consultants, Inc. 49 Plain Street North Attleboro, Massachusetts 02760

Re: K994438

Trade Name: BiliChek Non-Invasive Bilirubin Analyzer Regulatory Class: I reserved Product Code: MQM Dated: December 29, 1999 Received: December 30, 1999

Dear Mr. Veale:

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 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). 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) 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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Page 2

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, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

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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K994438 510(k) Number (if known):

Device Name: BiliChek, Non-Invasive Bilirubin Analyzer

Indications For Use:

The BiliChek Non-Invasive Bilirubin Analyzer is a computer assisted non-invasive transcutaneous bilirubinometer which is intended as an index to predict serum bilirubin levels in neonates less than eight days old, without regard to gender, gestational age, race, or bodyweight. The BiliChek provides a numerical measurement of predicted bilirubin count in mg/dL within a clinically beneficial range that has been correlated with total serum bilirubin concentration measured by High Performance Liquid Chromatography (HPLC). The device is used in the hospital or institutional environment to assist clinicians in monitoring the status of neonates for the development of hyperbilirubinemia. Neonates whose BiliChek test results are indicative of hyperbilirubinemia are evaluated by their physician(s) for appropriate patient management.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Patricia Bernhart for S.J. Cooper
(Division Sign-Off)

ivision of Clinical Laboratory I evices 510(k) Number . 人 994438

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

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.