The RPI heating elements are used to emit infrared radiant heat in an infant radiant warmer to maintain an infant's body temperature. The heating elements are identical to those supplied as original equipment as part of the infant radiant warmer.

Device Description

The RPI Replacement Heating Elements are intended to be used as replacement parts for the Hill-Rom Air Shields infant radiant warmers. The RPI heating elements are used to emit infrared radiant heat in an infant radiant warmer to maintain an infant's body temperature. The Replacement Heating Elements are available in different outputs (wattage) and terminations. The heating elements are provided nonsterile.

AI/ML Overview

This 510(k) summary (K020966) describes RPI Replacement Heating Elements, which are replacement parts for infant radiant warmers. The submission states that "No new technology, materials, or change in efficacy have been introduced by RPI in the manufacture of the RPI Replacement Heating Elements. The design, form, and materials of the probes are identical to their predicate devices." Therefore, the document leverages substantial equivalence to predicate devices rather than presenting a study where the device itself meets specific performance criteria.

As such, acceptance criteria and device performance as typically understood for new medical devices or software algorithms are not applicable or provided in this 510(k) submission.

Here's an breakdown based on the information provided and what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. The submission asserts substantial equivalence based on identical design, form, and materials to existing predicate devices. There are no performance metrics or acceptance criteria reported for the RPI Replacement Heating Elements themselves.

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

Not applicable, as no specific performance testing on a "test set" for the RPI Replacement Heating Elements is described. The basis for clearance is manufacturing the replacement parts to be identical to existing, already cleared components.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. There is no mention of expert involvement in establishing ground truth, as the device is a replacement part asserting identicality to existing parts.

4. Adjudication Method for the Test Set

Not applicable. No test set requiring expert adjudication is described.

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

Not applicable. This device is a heating element, not an interpretive system that would involve human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is a physical heating element, not a software algorithm.

7. Type of Ground Truth Used

Not applicable. No ground truth is established or used for performance evaluation of the RPI Replacement Heating Elements in this submission. The "ground truth" for regulatory clearance is the established performance and safety of the predicate devices to which these parts are identical.

8. Sample Size for the Training Set

Not applicable. This device is a physical replacement part, not an AI or machine learning algorithm requiring a training set.

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

Not applicable. As above, no training set or ground truth for algorithmic development is mentioned.

Summary of the K020966 Submission for RPI Replacement Heating Elements:

This 510(k) submission for RPI Replacement Heating Elements is a premarket notification asserting substantial equivalence to several predicate infant radiant warmer heating elements. The key argument for approval is that the RPI heating elements are identical in design, form, materials, and intended use to existing, legally marketed predicate devices.

The submission explicitly states:

"No new technology, materials, or change in efficacy have been introduced by RPI in the manufacture of the RPI Replacement Heating Elements."
"The design, form, and materials of the probes are identical to their predicate devices."
"The heating elements are identical to those supplied as original equipment as part of the infant radiant warmer."

Because the device is a replacement part claimed to be identical to already approved components, a detailed performance study with specific acceptance criteria, test sets, expert ground truth, or algorithm-specific metrics (like those relevant to AI/ML devices) is not presented or required for this type of submission. The 'proof' of meeting acceptance criteria is the demonstration of identicality to already approved predicate devices.

Summary

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TO20966

JUN 1 3 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 91313-5019

Phone Number: (818) 882-8611

Contact Person: Ira Lapides, President/CEO

Date Prepared:

March 19, 2002

II. DEVICE NAME AND CLASSIFICATION

Proprietary Name: RPI Replacement Heating Elements Common or Usual Name: Replacement Heating Elements Class II, 21 CFR 880.5130, Infant Radiant Warmers FMT Classification:

III. PREDICATE DEVICES

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

RPI Models AIH039 and AIH100; Infant Care System. Narco Air-Shields: K790137 .
RPI Models AIH040 and AIH094: Infant Intensive Care System, Free-Standing Infant Warmer, . Air-Shields Inc., Hatboro, PA 19040; K875270
RPI Model AIH097: Resuscitaire Radiant Warmer, Hill-Rom Air-Shields, Hatboro, PA 19040; . K003355 and K940951
. RPI Model AIH099: Stabilet Infant Radiant Warmer, Hill-Rom, Inc. Batesville, IN 47006; K94904
RPI Model AIH098: Stabilet Infant Radiant Warmer, Hill-Rom, Inc., Batesville, TN 47006: . K913945

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IV. DESCRIPTION

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The Replacement Heating Elements are available in different outputs (wattage) and terminations. The heating elements are provided nonsterile.

V. INTENDED USE

VI. TECHNOLOGICAL CHARACTERISTICS

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

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings or feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 3 2002

Mr. Ira Lapides President Replacement Parts Industries, Incorporated P.O. Box 5019 Chatsworth, California 91313-5019

Re: K020966

Trade/Device Name: RPI Replacement Heating Elements Regulation Number: 880.5130 Regulation Name: Infant Radiant Warmer Accessory Regulatory Class: II Product Code: FMT Dated: March 21, 2002 Received: March 25, 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 vour 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 of the Act or any Federal statutes and regulations administered by other Federal agencies.

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Page 2 - Mr. Lapides

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.qov/cdrh/dsma/dsmamain.html

Sincerely vours.

Susan Runne

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

Enclosure

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Include the following "Indications For Use" page that contains the applicant's name, name of the device and the intended use of the device. The information, data and labeling claims in the entire the 510(k) submission must support and agree with the "indications for use" statement. *For a new submission, do NOT fill in the 510(k) number blank.

INDICATIONS FOR USE

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

510(k) Number (if known): N/A* 14020966

Device Name: RPI Replacement Heating Elements

Indications For Use:

(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 Cuscinito

of Dental, Infection Contr ·neral Hospital De · Number _

Regulation Number and Section

§ 880.5130 Infant radiant warmer.

(a)
Identification. The infant radiant warmer is a device consisting of an infrared heating element intended to be placed over an infant to maintain the infant's body temperature by means of radiant heat. The device may also contain a temperature monitoring sensor, a heat output control mechanism, and an alarm system (infant temperature, manual mode if present, and failure alarms) to alert operators of a temperature condition over or under the set temperature, manual mode time limits, and device component failure, respectively. The device may be placed over a pediatric hospital bed or it may be built into the bed as a complete unit.(b)
Classification. Class II (Special Controls):(1) The Association for the Advancement of Medical Instrumentation (AAMI) Voluntary Standard for the Infant Radiant Warmer;
(2) A prescription statement in accordance with § 801.109 of this chapter (restricted to use by or upon the order of qualified practitioners as determined by the States); and
(3) Labeling for use only in health care facilities and only by persons with specific training and experience in the use of the device.