Interlectric Bili Blue F20T12/BBY and F40T12/BBY lamps are used in the treatment of Hyperbilirubinemia in newborn infants. The lamps are placed in commercially available luminaries that will concentrate the blue light energy.

Device Description

The Interlectric Bili Blue F20T12/BBY and F40T12/BBY devices are standard 2-foot and 4-foot T-12 fluorescent lamps that contain a phosphor composition that emits blue light energy in the range between 400 - 500 nanometers and produces no energy in the ultraviolet region of the spectrum.

AI/ML Overview

This document describes a 510(k) submission for Interlectric Bili Blue F20T12/BBY and F40T12/BBY fluorescent lamps, used for neonatal phototherapy. It is a submission for a new device that directly compares itself to a predicate device (Philips Special Blue) to establish substantial equivalence.

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance (New Device vs. Predicate Device)	Study Type Supporting Performance
Intended Use	Substantially equivalent for the treatment of Hyperbilirubinemia in newborn infants.	Comparison Testing
Spectral Output in effective range (400-500 nanometers)	Substantially equivalent.	Comparison Testing
Ultraviolet Radiation Safety	Substantially equivalent; produces no energy in the ultraviolet region of the spectrum.	Comparison Testing
Conformity to ANSI Specifications for Dimensional and Electrical Characteristics (ANSI C78.2-1978 and ANSI C78.1-1991)	Substantially equivalent.	Comparison Testing

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

The document does not specify a separate "test set" in the context of clinical data for a medical device. Instead, the evaluation focuses on comparison testing of the new lamps against the predicate lamps. The "sample" here refers to the actual manufactured lamps of the new device and the predicate device that underwent testing. The document does not provide the exact number of lamps tested.

The data provenance is not explicitly stated as "country of origin" or "retrospective/prospective" because this is a technical comparison of physical devices, not a clinical study involving human subjects or patient data. The testing would have been conducted on the manufactured lamps themselves.

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

This information is not applicable to this type of device submission. Since it's a technical comparison of light bulbs against a predicate device and ANSI standards, there isn't a "ground truth" established by medical experts for a "test set" of patient data. The ground truth would be the established ANSI standards and the technical specifications of the predicate device.

4. Adjudication Method for the Test Set

This is not applicable. There's no clinical "test set" requiring adjudication by experts. The comparison testing would involve objective measurements of physical properties (spectral output, UV radiation, dimensional/electrical characteristics) against defined standards and predicate device performance.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

This is not applicable. This device is a fluorescent lamp, not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or AI performance evaluation was conducted or is relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not applicable. This device is a physical light source, not an algorithm.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" in this context is based on:

Established Clinical Practice: The acceptance that "Phototherapy for treating Hyperbilirubinemia in newborn infants is a well-established clinical practice" and "Exposure to light from blue fluorescent lamps for such treatment was adopted in the United States back in the 1970's" serves as a foundational "ground truth" for the intended use.
Predicate Device Specifications: The performance characteristics (spectral output, UV safety, etc.) of the Philips Special Blue predicate device serve as a benchmark.
ANSI Specifications: Adherence to ANSI C78.2-1978 and ANSI C78.1-1991 for dimensional and electrical characteristics serves as a regulatory and industry "ground truth."

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" as this is not a machine learning or AI-based device.

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

This is not applicable for the same reason as point 8.

Summary

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1401 Lexington Ave Warren, PA. 16365

fax 814-723-6069

510(k) Summary as required by section 807.92(c)

Submitter Information

Interlectric Corporation 1401 Lexington Ave. Warren, PA. 16365 814-723-6061 fax 814-723-1074 Contact: Ken C Frazier

APR 2 4 2009

Reason for Submission: New Device

Summary prepared on December 28, 2008

Device Name

Trade Name: Bili Blue F20T12/BBY and F40T12/BBY Common Name: 2-foot and 4-foot T12 Blue fluorescent lamps Classification Name: Unit, Neonatal Phototherapy (21 CFR 880.5700, product code LBI)

Predicate Device

F40 and F20; Philips Special Blue; Philips Lighting Co., Division of Philips Electronics

Product Description

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KOSO192

Indications for Use

Technological Characteristics

Phototherapy for treating Hyperbilirubinemia in newborn infants is a well-established clinical practice. Exposure to light from blue fluorescent lamps for such treatment was adopted in the United States back in the 1970's. Comparison testing between the New Device and the Predicate Device demonstrates that the New Device lamps are substantially equivalent to the Predicate Device lamps with respect to:

-Intended Use (Treatment of Hyperbilirubinemia)
Spectral output in the effective range (400 500 nanometers)
Ultraviolet Radiation Safety
-Conformity to ANSI Specifications for Dimensional and Electrical Characteristics for fluorescent lamps (ANSI C78.2-1978 and ANSI C78.1-1991)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Ken C. Frazier Engineering Manager Interlectric Corporation 1401 Lexington Avenue Warren, Pennsylvania 16365

APR 2 4 2009

Re: K090192

Trade/Device Name: 2-Foot and 4-Foot T12 Blue Flourescent Lamps Trade Name: "Bili Blue F20T12/BBY and F40T12/BBY" Regulation Number: 21 CFR 880.5700 Regulation Name: Neonatal Phototherapy Unit Regulatory Class: II Product Code: LBI Dated: December 28, 2008 Received: January 27, 2009

Dear Mr. Frazier:

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 additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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

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Page 2- Mr. Frazier

and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours. finiter

Susan Runner, D.D.S., MA Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: 2-foot and 4-foot T12 Blue fluorescent lamps Trade Name: "Bili Blue F20T12/BBY and F40T12/BBY"

Indications for Use:

Prescription Use X (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)

KOSO 197

signature

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dentai Devices

510(k) Number:

Page 1 of _1

Regulation Number and Section

§ 880.5700 Neonatal phototherapy unit.

(a)
Identification. A neonatal phototherapy unit is a device used to treat or prevent hyperbilirubinemia (elevated serum bilirubin level). The device consists of one or more lamps that emit a specific spectral band of light, under which an infant is placed for therapy. This generic type of device may include supports for the patient and equipment and component parts.(b)
Classification. Class II (performance standards).