The SetPoint® Endovascular Temperature Probe is indicated for use with the SetPoint Endovascular Temperature Management System to measure core body temperature.

Device Description

The SetPoint Endovascular Temperature Probe consists of a sheath containing two 400-series equivalent thermistors on separate and independent circuits. This Probe is intended for endovascular placement similar to other venous catheters with temperature measurement capability, including the Arrow International Inc. Multi-Lumen Central Venous Catheter (K904404). The outer sheath is Pebax and has a soft, straight Pebax tip. The Endovascular Probe is heparin-coated for hemocompatibility. It is compatible with a 4 Fr. introducer with Touhy-Borst hemostasis valve. The intended use is to measure a patient's core body temperature via venous blood temperature. The Endovascular Probe is for single use only. It is provided sterile and packaged in a polyethylene/Tyvek pouch. Sterilization is by gamma irradiation.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Radiant Medical SetPoint Endovascular Temperature Probe based on the provided document:

This document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive de novo clinical outcome studies. Therefore, the information regarding in-depth clinical studies, expert-based ground truth, and specific acceptance criteria as might be seen for AI/ML devices, is limited.

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Functionality	Tested in accordance with BS EN ISO 10555. (Specific performance metrics or thresholds are not provided in this document).
Biocompatibility	Tested in accordance with ISO 10993. (Specific performance metrics or thresholds are not provided in this document).
Electrical Safety	The SetPoint Controller (which the probe is used with) was tested for electrical safety in accordance with EN 60601, as previously reported in K012512. (Specific performance metrics or thresholds are not provided for the probe itself in this document).

Note: The document states the device "performs with similar safety and effectiveness" to predicate devices, but it does not define explicit numerical acceptance criteria or provide specific numerical results for the probe's temperature measurement accuracy, precision, or other performance characteristics.

1. Sample size used for the test set and the data provenance

Sample Size: Not explicitly stated for specific performance tests. The document mentions tests for functionality and biocompatibility, but not the number of probes or samples used in these tests.
Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). These were likely bench and lab tests, not human subject clinical trials with specific patient data provenance.

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

This type of information is not applicable to the regulatory submission for this device. The tests mentioned (functionality, biocompatibility, electrical safety) are typically engineering and laboratory-based assessments, not dependent on expert consensus or clinical interpretation for ground truth.

3. Adjudication method for the test set

Not applicable. As the tests described are engineering and laboratory tests, an adjudication method as would be applied to subjective clinical assessments is not relevant.

4. 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

No. This is not an AI/ML device, and no MRMC comparative effectiveness study was performed or described. This type of study is specifically for evaluating the impact of AI on human interpretation.

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

No. This is a hardware device (temperature probe), not an algorithm. Standalone performance as defined for AI algorithms is not applicable.

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

The ground truth for functionality would have been established by reference standards or highly accurate calibrated measurement devices (e.g., a known temperature bath for temperature accuracy, or standard test blocks for mechanical properties).
For biocompatibility, the ground truth is established by adherence to ISO 10993 standards and their specified chemical/biological assays, rather than expert consensus on clinical images or pathology.

7. The sample size for the training set

Not applicable. This is a traditional medical device (temperature probe) and does not involve AI/ML algorithms or a "training set" in the context of machine learning.

8. How the ground truth for the training set was established

Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Radiant Medical. The logo consists of a circular graphic on the left, followed by the word "Radiant" in a bold, serif typeface. Below "Radiant" is the word "MEDICAL" in a smaller, sans-serif font. The circular graphic appears to contain an abstract design, possibly representing a human figure or energy flow.

MAR 2 5 2003

250 Chesapeake Drive Redwood City 0) 363.8000 (650) 363-7400

510[k] Summary of Safety and Effectiveness

Submitter Information

Company:	Radiant Medical, Inc.250 Chesapeake DriveRedwood City, CA 94063(650) 363-8000
Contact Person:	Andrew CleelandSr. Vice President of Regulatory, Clinical and Quality Affairs
Summary Date:

Name and Classification

Proprietary Name:	SetPoint® Endovascular Temperature Probe
Classification Name:	Percutaneous catheter (DQY) [21 CFR 870.1250]
Class:	II

Predicate Devices

a) SetPoint® Catheter and SetPoint General Purpose Temperature Probe, components of the SetPoint Endovascular Temperature Management System (K012512)
b) The Arrow International Inc. Multi-Lumen Central Venous Catheter (K904404).

Indication for Use

The SetPoint Endovascular Temperature Probe is indicated for use with the SetPoint Endovascular Temperature Management System to measure core body temperature.

Description of Device

The SetPoint Endovascular Temperature Probe consists of a sheath containing two 400-series equivalent thermistors on separate and independent circuits. This Probe

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Image /page/1/Picture/0 description: The image shows the logo for Radiant Medical. The logo consists of a circular graphic on the left, which contains a stylized image of a human figure. To the right of the graphic is the word "Radiant" in a serif font, with the word "MEDICAL" in smaller, sans-serif letters below it.

250 Chesapeake Drive
Redwood City
Cal: 94063
Tel. .0) 363.8000
Fax. +1 (650) 363.2400

is intended for endovascular placement similar to other venous catheters with temperature measurement capability, including the Arrow International Inc. Multi-Lumen Central Venous Catheter (K904404). The outer sheath is Pebax and has a soft, straight Pebax tip. The Endovascular Probe is heparin-coated for hemocompatibility. It is compatible with a 4 Fr. introducer with Touhy-Borst hemostasis valve. The intended use is to measure a patient's core body temperature via venous blood temperature.

The Endovascular Probe is for single use only. It is provided sterile and packaged in a polyethylene/Tyvek pouch. Sterilization is by gamma irradiation.

Summary of Technological Characteristics

The SetPoint Endovascular Temperature Probe measures venous blood temperature via endovascular access in the femoral vein. Patient temperature is measured by the SetPoint Controller via the 400 series-equivalent thermistors in the probe.

Performance Test

The SetPoint Endovascular Temperature Probe has been tested for functionality in accordance with BS EN ISO 10555 and for biocompatibility in accordance to ISO 10993. The SetPoint Controller has been tested for electrical safety in accordance to EN 60601, as previously reported in K012512.

Conclusion

Based upon the successful performance tests and the comparison to the predicate devices, the SetPoint Endovascular Temperature Probe performs with similar safety and effectiveness.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 5 2003

Radiant Medical, Inc. c/o Mr. Andrew Cleeland 250 Chesapeake Drive Redwood City, CA 94063

Re: K024327

SetPoint® Endovascular Temperature Probe Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: December 23, 2002 Received: December 26, 2002

Dear Mr. Cleeland:

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 - Mr. Andrew Cleeland

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 (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. 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 (301) 594-4646. 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) you may obtain. 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,

l. WQelchTull

ram D. Zuckerman, Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Statement of Indications for Use

Temperature Follar

The SetPoint Endovascular Temperature Probe is indicated for use with the SetPoint Endovascular Temperature Management System to measure core body temperature.

N. Deaton

Prescription Use Only

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).