RPI replacement phototherapy bulbs are designed to be used as replacement light bulbs for use wi various phototherapy units and infant radiant warmers.

Device Description

The RPI Replacement phototherapy lights are intended to be used as replacement parts for various Hill-Rom Air Shields phototherapy units and infant radiant warmers. The replacement phototherapy lights are available in different wattage and other specifications. The lights are provided nonsterile.

AI/ML Overview

This document describes an application for a 510(k) premarket notification for "RPI Replacement phototherapy lights/bulbs". The application asserts substantial equivalence to existing predicate devices.

Summary of Acceptance Criteria and Device Performance:

Acceptance Criteria Category	Reported Device Performance
Design, Form, and Materials	Identical to predicate devices.
Technology	No new technology, materials, or change in efficacy introduced.
Intended Use	Designed to be used as replacement light bulbs for various phototherapy units and infant radiant warmers (same as predicate).
Sterility	Provided nonsterile (same as predicate).
Wattage/Specifications	Available in different wattage and other specifications (implying ability to match predicate specifications).

Study Information:

The provided document does not describe a clinical study or performance study in the traditional sense, as would be conducted for a novel medical device or software. Instead, it is a 510(k) Premarket Notification applying for substantial equivalence for replacement parts.

Here's why a typical "study" as requested isn't present:

Nature of the Device: The device is a "replacement phototherapy bulb" – essentially a consumable part for existing approved medical devices (phototherapy units and infant radiant warmers).
Basis for Approval: The manufacturer is claiming substantial equivalence to already legally marketed predicate devices. This means they are asserting their replacement bulbs are as safe and effective as the original bulbs they are designed to replace, without introducing new performance or safety characteristics.
Lack of Novelty: The document explicitly states: "No new technology, materials, or change in efficacy have been introduced by RPI in the manufacture of the RPI Replacement phototherapy bulbs. The design, form, and materials of the lights are identical to their predicate devices."

Therefore, based on the provided text, the following information cannot be extracted:

Sample size used for the test set and the data provenance: Not applicable, as no dedicated "test set" and corresponding performance data are provided for this type of substantial equivalence claim.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no independent ground truth evaluation was conducted for a novel device.
Adjudication method for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used: Not applicable in the context of a performance study for a novel device feature. The "ground truth" here is the established safety and efficacy of the predicate devices.
The sample size for the training set: Not applicable, as this is not an AI/ML device requiring a training set.
How the ground truth for the training set was established: Not applicable.

In essence, the "study" for this 510(k) application is the demonstration and assertion of identical design, materials, and intended use as the legally marketed predicate devices, rather than a clinical or performance trial for a new medical technology. The FDA's issuance of a "substantial equivalence determination" (K021531) indicates they agreed with this assessment based on the documentation provided by RPI.

Summary

{0}------------------------------------------------

MAY 3 1 2002

510(k) SUMMARY

This 510(k) summary is being submitted in accordance with the requirements of SMDA and21CFR $ 807.92

I. NAME OF SUBMITTER

RPI

Replacement Parts Industries, Inc. P.O. Box 5019 Chatsworth, California 913-5019

Phone Number: (818) 882-8611

Contact Person: Ira Lapides, President/CEO

Date Prepared:

May 6, 2002

II. DEVICE NAME AND CLASSIFICATION

RPI Replacement phototherapy lights Proprietary Name: Replacement phototherapy lights Common or Usual Name: Class II, 21 CFR 880.5700, Unit, Neonatal Phototherapy LBI Classification:

III. PREDICATE DEVICES

The RPI replacement phototherapy lights are substantially equivalent in design and indications for use to the following devices currently in commercial distribution:

Infant Intensive Care System, Free-Standing Infant Warmer, Air-Shields Inc., Hatboro, PA . 19040; K875270
Phototherapy System PTM78, Air-Shields, Inc., Hatboro, PA 19040; K840454 ●
Duo-Light Phototherapy Unit, Air-Shields, Inc., Hatboro, PA 19040; K971256 .
Resuscitaire Radiant Warmer, Hill-Rom Air-Shields, Hatboro, PA 19040; K003335 and . K940951

IV. DESCRIPTION

The RPI Replacement phototherapy lights are intended to be used as replacement parts for various Hill-Rom Air Shields phototherapy units and infant radiant warmers.

{1}------------------------------------------------

The replacement phototherapy lights are available in different wattage and other specifications. The lights are provided nonsterile.

V. INTENDED USE

RPI replacement phototherapy lights are designed to be used as replacement light lights for use with various phototherapy units and infant radiant warmers

VI. TECHNOLOGICAL CHARACTERISTICS

No new technology, materials, or change in efficacy have been introduced by RPI in the manufacture of the RPI Replacement phototherapy bulbs. The design, form, and materials of the lights are identical to their predicate devices. All devices are provided nonsterile to the user.

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 31 2002

Mr. Ira Lapides President Replacement Parts Industries, Incorporated P. O. Box 5019 Chatsworth, California 91315-5019

Re: K021531

Trade/Device Name: RPI Replacement Phototherapy Bulbs Regulation Number: 880.5700 and 880.5130 Regulation Name: Neonatal Phototherapy Unit Regulatory Class: II Product Code: LBI and FMT Dated: May 8, 2002 Received: May 10,2002

Dear Mr. Lapides:

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.

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

{3}------------------------------------------------

Page 2 - Mr. Lapides

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely vours,

Oas L/on

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Applicant: Replacement Parts Industries, Inc. (RPI, Inc.)

510(k) Number (if known): N/A* .

K021S31.

Device Name: RPI Replacement phototherapy bulbs

Indications For Use:

RPI replacement phototherapy bulbs are designed to be used as replacement light bulbs for use wi various phototherapy units and infant radiant warmers.

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

Concurrence of CDRH Office of Device Evaluation (ODE)

Prescription Use Per 21 CFR 801.109

Over-the-Counter

Patricia Cescente

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number _

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).