The Bili-Tx is a phototherapy light that delivers a narrow band of high-intensity blue light emitting diodes (LEDs) to provide treatment for neonatal jaundice (hyperbilirubinemia). The blue LEDs emit light in the range of 400-550 nm (peak wavelength 450-470 nm). This range corresponds to the spectral absorption of light by bilirubin, and is thus considered effective for the degradation of bilirubin'. The blue LEDs used by the Bili-Tx do not emit significant energy in the ultraviolet (UV) region of the spectrum or infrared (IR) region of the spectrum, so there is no concern about UV or IR exposure and excessive warming of the neonate due to use of the device.

The Bili-Tx has two different treatment options for providing phototherapy, which includes: phototherapy by fiber optic light panel that directly contacts the neonate's body and phototherapy by overhead light that is positioned over the neonate. The same Bili-Tx light source is used to provide phototherapy light for both options.

In the fiber optic light panel treatment option, the Bili-Tx consists of the light source, fiber optic cable bundle used to transmit the light from the light source to the light panel, fiber optic light panel, and disposable fiber optic light panel cover. There are two styles of fiber optic light panels that may be used, which include a longer light panel that wraps around the neonate and a shorter light panel that the neonate's body rests on.

The Bili-Tx uses the same fiber optic light panels, including the permanently attached fiber optic cable bundle, and disposable fiber optic light panel covers that were cleared with the Wallaby 3 in K991627.

This treatment option does not require protective eyeshades to be worn by the neonate receiving phototherapy as the light panel is focused by the clinician/caregiver providing therapy.

In the overhead light treatment option, the Bili-Tx consists of the light source and a standard intravenous (IV) pole and bracket used to support the light source over the neonate. The Bili-Tx light source used in the overhead light option is the same light source used in the fiber optic light panel option. As with all overhead phototherapy lights, protective eyeshades must be used to protect the neonate's eyes from excessive light exposure.

AI/ML Overview

The provided text describes a 510(k) submission for a medical device called Bili-Tx, a neonatal phototherapy device. This type of submission relies on demonstrating substantial equivalence to predicate devices rather than proving safety and efficacy through extensive clinical studies with specific acceptance criteria in the same way a PMA (Pre-Market Approval) would.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and MRMC studies is largely not applicable to this 510(k) document. The focus of this submission is on design verification testing and demonstrating that the device is as safe and effective as previously cleared devices.

Here's a breakdown based on the provided text, highlighting what is (and isn't) present:

1. Table of acceptance criteria and reported device performance:

Not Applicable in the traditional sense for this 510(k). The submission states: "The functionality of the design of the device was verified through design verification testing. The safety of the design will be assured by the completion of IEC 60601-1-2 testing. Efficacy of therapy is established through peer reviewed clinical literature."
This implies that the acceptance criteria would be related to meeting the performance specifications of the design verification tests and compliance with the IEC standard. However, the specific quantitative acceptance criteria or detailed results of these tests are not provided in this summary. The "reported device performance" is not explicitly quantified here beyond stating its intended function (delivers high-intensity blue light, 400-550 nm, peak 450-470 nm).

2. Sample size used for the test set and the data provenance:

Not Applicable/Not provided. No clinical "test set" with a sample size as typically understood for clinical efficacy studies is mentioned. The testing described is design verification and compliance testing (IEC 60601-1-2), which doesn't typically involve human subjects or a specified "test set" in the context of diagnostic or treatment efficacy.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable/Not provided. As there's no clinical "test set" described for which ground truth would be established, this information is not relevant to this submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not Applicable/Not provided.

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:

Not Applicable. This device is a phototherapy unit, not an AI-powered diagnostic or treatment assistance tool. MRMC studies are not relevant to this type of device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not Applicable. This is a hardware device for phototherapy, not an algorithm, so "standalone" performance in this context is not relevant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Not Applicable in the context of clinical efficacy data. The "efficacy of therapy is established through peer reviewed clinical literature." This implies that the scientific community's understanding of phototherapy for hyperbilirubinemia, supported by existing research (e.g., the Vreman et al. paper cited), serves as the "ground truth" for the treatment principle. For the device itself, the ground truth would be compliance with engineering specifications and safety standards.

8. The sample size for the training set:

Not Applicable/Not provided. There is no "training set" for an algorithm, as this is a hardware device.

9. How the ground truth for the training set was established:

Not Applicable/Not provided. (See point 8).

Summary of Relevant Information from the Document:

Acceptance Criteria (Implied):
- Successful completion of design verification testing (specifics not detailed).
- Compliance with IEC 60601-1-2 safety standards.
- Mitigation of all identified hazards as per the Risk Traceability Matrix.
Study Proving Acceptance Criteria Met:
- Design Verification Testing: "The functionality of the design of the device was verified through design verification testing." (Details of testing or results not provided in summary).
- Safety Testing: "The safety of the design will be assured by the completion of IEC 60601-1-2 testing." (Completion is promised, results not provided).
- Efficacy: "Efficacy of therapy is established through peer reviewed clinical literature." (The submission relies on existing scientific knowledge about phototherapy for hyperbilirubinemia, evidenced by the citation provided: Vreman HJ, et al. Light-emitting diodes: a novel light source for phototherapy. Pediatric Research. 1998; 44(5):804-809).
Data Provenance for Design/Safety: Likely internal lab testing by Respironics, Inc.
Ground Truth for Efficacy (General Principle): Peer-reviewed clinical literature on the effectiveness of blue light phototherapy for hyperbilirubinemia.

In conclusion, this 510(k) submission demonstrates a "modified design" of a previously cleared device, relying on substantial equivalence to predicates and engineering/safety testing, rather than presenting new clinical study data with detailed acceptance criteria for a novel therapeutic or diagnostic claim.

Summary

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Traditional 510(k) Tab 5 - 510(k) summary

MAY 1 8 2007

Bili-Tx

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RESPIRONICS

Date of Submission

17 January 2007

Official Contact / Address of Manufacturing facility

Zita A. Yurko Manager, Regulatory Affairs Respironics Inc. 1001 Murry Ridge Lane Murrysville, PA 15668

Phone: 724-387-4120 Fax: 724-387-4216 Zita. Yurko@Respironics.com

Proprietary Name
Common/Usual Name Neonatal Phototherapy Device

Bili-Tx

Class II

21 CFR 880.5700

General Hospital

Modified design

Device Classification Name Unit, Neonatal Phototherapy
Classification Reference

Appropriate Classification Panel

Product Code

Classification

Predicate Devices

rBi Respironics, Inc. Wallaby 3 (K991627) Natus Medical, Inc. neoBLUE cozy LED Phototherapy System (K051869) Natus Medical, Inc. Blue Light Phototherapy Unit (K022196)

Reason for submission

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Substantial Equivalence

This premarket notification submission demonstrates that the Respironics, Inc. Bili-Tx is substantially equivalent to the combination of the Respironics, Inc. Wallaby 3 (K991627), the Natus Medical, Inc. neoBLUE cozy LED Phototherapy System (K051869), and the Natus Medical, Inc. Blue Light Phototherapy Unit (K022196).

The functionality of the design of the device was verified through design verification testing. The safety of the design will be assured by the completion of IEC 60601-1-2 testing. Efficacy of therapy is established through peer reviewed clinical literature. The Risk Traceability Matrix provided in the Risk Analysis assures that all hazards identified by the risk analysis are successfully mitigated.

Intended Use

The Bili-Tx is intended to treat hyperbilirubinemia through phototherapy in a home or hospital/institutional environment.

Device Description

1 Vreman HJ, et al. Light-emitting diodes: a novel light source for phototherapy. Pediatric Research. 1998; 44(5):804-809.

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This treatment option does not require protective eyeshades to be worn by the neonate receiving phototherapy as the light panel is focused by the clinician/caregiver providing therapy.

Phototherapy through Overhead Light

(End of Tab.)

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MAY 1 8 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Zita A. Yurko Director, Regulatory Affairs Respironics, Incorporated, Sleep & Home Respiratory Group 1001 Murry Ridge Lane Murrysville, Pennsylvania 15668

Re: K070180

Trade/Device Name: Bili-Tx Regulation Number: 880.5700 Regulation Name: Neonatal Phototherapy Unit Regulatory Class: II Product Code: LBI Dated: April 25, 2007 Received: April 26, 2007

Dear Ms. Yurko:

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 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.

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Page 2 - Ms. Yurko

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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Chiu Lin, Ph.D.

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): H (7018

Device Name:

Indications for Use:

The Bili-Tx is intended to treat hyperbilirubinemia through phototherapy in a home or hospital/institutional environment.

Prescription Use ____________________________________________________________________________________________________________________________________________________________

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Stall
Bernadw & Annie Lu 5/18/07

sion of Anesthesiology, General Hospital,
ction Control, Dental Devices
510(k) Number: K070186

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).