RPI Skin or Air Temperature Probes are designed to be used as replacement temperature sensing probes for use with the temperature controller portion of Air Shields infant radiant warmers and infant incubators. The probes provide skin or air temperature feedback in order to maintain preselected temperature settings.

Device Description

The RPI Temperature Probes are intended to be used as replacement parts for Air Shields infant radiant warmers and infant incubators. The RPI Temperature Probes are used to monitor the patient's skin temperature or the unit's air temperature when used in conjunction with the infant radiant warmer or infant incubator. The probes are connected to a unit controller to automatically adjust the heater output of the unit to maintain a pre-selected skin or air temperature. Two of the probes are used in "baby-controlled mode" to monitor the skin temperature of the baby and one of the probes is designed to be used in "air controlled mode", to monitor the air temperature of the incubator or radiant warmer. One probe is a disposable skin temperature probe. The RPI Skin Temperature Probes have a thermistor tip which is attached to the infant's skin. A cable attaches the probe to the unit controller. The electrical flow resistance changes in response to changes in the skin temperature. This resistance change is converted into a temperature reading. The Skin Temperature Probe is available in three models, including a disposable probe and a reusable probe. The Air Temperature Probe has the same thermistor tip, which is attached to a cable connecting the probe to the controller. The Temperature Probes are provided nonsterile.

AI/ML Overview

The provided text is a 510(k) summary for RPI Replacement Temperature Probes. It does not contain information about acceptance criteria or a study proving device performance in the context of detailed performance metrics, test set characteristics, expert involvement, or statistical analysis.

A 510(k) submission generally focuses on demonstrating substantial equivalence to a predicate device, which in this case, involves showing similar design, materials, indications for use, and technological characteristics. Performance data, if present, would likely be limited to confirming that the device functions as expected and is comparable to the predicate.

Therefore, I cannot fulfill your request for:

A table of acceptance criteria and reported device performance: This detailed performance data is not included.
Sample size used for the test set and data provenance: No test set or related detailed evaluation is mentioned.
Number of experts used to establish ground truth and their qualifications: Not applicable, as detailed performance validation regarding ground truth is not described.
Adjudication method: Not applicable.
MRMC comparative effectiveness study: Not mentioned.
Standalone (algorithm only) performance: Not applicable as this is a physical medical device, not an algorithm.
Type of ground truth used: Not applicable.
Sample size for the training set: Not applicable (not an AI/ML device requiring a training set).
How the ground truth for the training set was established: Not applicable.

The document primarily focuses on:

Device Name: RPI Skin and Air Temperature Probes
Intended Use: To be used as replacement temperature sensing probes for use with the temperature controller portion of Air Shields infant radiant warmers and infant incubators. The probes provide temperature feedback to maintain pre-selected temperature settings.
Predicate Devices:
- Accutemp-Probe, Kentec Medical, Inc. (K970686)
- Hill-Rom ISOLETTE Infant Incubator; Hill-Rom Air-Shields (K001242)
- First Touch Disposables Temperature Probes, First Touch Disposables, Inc. (K950422)
Technological Characteristics: States that "No new technology, materials, or change in efficacy have been introduced by RPI in the manufacture of the RPI Temperature Probes. The design, form, and materials of the probes are equivalent to their predicate devices." This is the core argument for substantial equivalence, implying that since the predicate devices are already cleared, this device, being equivalent, meets the necessary "acceptance criteria" by extension.

Summary

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APR 1 2 2002

Ko206219

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:

January 4, 2002

II, DEVICE NAME AND CLASSIFICATION

RPI Skin and Air Temperature Probes Proprietary Name: Skin and Air Temperature Probes Common or Usual Name: Classification: Class II, 21 CFR 880.5130, Infant Radiant Warmers

III. PREDICATE DEVICES

The RPI Temperature Probes are substantially equivalent in design and indications for use to the following devices currently in commercial distribution:

Accutemp-Probe, Kentec Medical, Inc., 510(k) number K970686 .
Hill-Rom ISOLETTE Infant Incubator; Hill-Rom Air-Shields, Hatboro, PA 19040; . 510(k) number K001242
. First Touch Disposables Temperature Probes, First Touch Disposables, Inc., Wilmington, NC 28403; 510(k) number K950422

IV. DESCRIPTION

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or air temperatue. Two of the probes are used in "baby-controlled mode" to monitor the skin temperature of the baby and one of the probes is designed to be used in "air controlled mode", to monitor the air temperature of the incubator or radiant warmer. One probe is a disposable skin temperature probe.

The RPI Skin Temperature Probes have a thermistor tip which is attached to the infant's skin. A cable attaches the probe to the unit controller. The electrical flow resistance changes in response to changes in the skin temperature. This resistance change is converted into a temperature reading. The Skin Temperature Probe is available in three models, including a disposable probe and a reusable probe. The Air Temperature Probe has the same thermistor tip, which is attached to a cable connecting the probe to the controller. The Temperature Probes are provided nonsterile.

V. INTENDED USE

RPI Temperature Probes are designed to be used as replacement temperature sensing probes for use with the temperature controller portion of Air Shields infant radiant warmers and infant incubators. The probes provide temperature feedback in order to maintain pre-selected temperature settings.

VI. TECHNOLOGICAL CHARACTERISTICS

No new technology, materials, or change in efficacy have been introduced by RPI in the manufacture of the RPI Temperature Probes. The design, form, and materials of the probes are equivalent to their predicate devices in that all are designed to be used to sense temperature information when in the skin or air sensing modes and to feed this information to the incubator of the incubator or radiant warmer. All devices are provided nonsterile to the user. The RPI Temperature Probe and its predicate devices are available as reusable devices or as disposable devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 2 200

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

Re: K020219

Trade/Device Name: RPI Replacement Temperature Probes Regulation Number: 880.5130 Regulation Name: Infant Radiant Warmer Regulatory Class: II Product Code: FMT Dated: January 16, 2002 Received: January 22, 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 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.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Runner

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 Include 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.)

K020219 510(k) Number (if known): NH

Device Name: RPI Replacement Temperature Probes

Indications For Use:

RPI Skin or Air Temperature Probes are designed to be used as replacement temperature sensing rd i bith of The remperature controller portion of Air Shields infant radiant warmers and infant incubators. The probes provide skin or air temperature feedback in order to maintain preselected temperature settings.

(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

Susan Rans

(Division Sign-Off) (Division Sign-Onli)
Division of Dental, Infection Control, Division of Deman, Devices of 510(k) 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.