(56 days)
The Radiant Medical Endocatheter Temperature Probe is indicated for use with the SetPoint/Reprieve Endovascular Temperature Management System to measure core body temperature.
The Endocatheter Temperature Probe consists of a sheath containing two thermistors on separate and independent circuits. This Probe is intended for placement into the inferior vena cava through the guidewire lumen of the catheter. The outer sheath is Pebax and has a soft, straight Pebax tip. The Endocatheter Probe is heparin-coated for hemocompatibility. The intended use is to measure a patient's core body temperature via venous blood temperature. The Endocatheter Probe is for single use only. It is provided sterile and packaged in a Tyvek/polyethylene pouch. Sterilization is by gamma irradiation.
Here's an analysis of the provided text regarding the Endocatheter Temperature Probe, structured to address your specific questions about acceptance criteria and the supporting study:
The provided document does not contain a detailed study report with specific acceptance criteria or performance metrics typical of clinical trials for efficacy. Instead, it describes a 510(k) premarket notification which focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel clinical effectiveness or setting new performance benchmarks.
Therefore, many of your specific questions cannot be fully answered from this document. However, I will extract what is available and indicate when information is not present.
Acceptance Criteria and Study Details for the Endocatheter Temperature Probe (K042388):
The submission primarily relies on demonstrating that the device is substantially equivalent to a legally marketed predicate device (Radiant Medical Endovascular Temperature Probe, K024327). This means the "acceptance criteria" are largely centered on meeting existing standards and showing comparable functionality and safety to the predicate, rather than achieving specific quantitative performance targets against a clinical gold standard.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of a 510(k) summary, specific numerical acceptance criteria for performance (e.g., accuracy +/- X degrees with Y% confidence) and corresponding reported device performance values are not explicitly stated in this document in a tabular format. The "acceptance criteria" are implied by the performance tests conducted and the comparison to the predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functionality | Successful completion of performance verification tests in accordance with BS EN ISO 10555. |
| Biocompatibility | Successful completion of biocompatibility tests in accordance with ISO 10993. |
| Safety and Effectiveness | Performs with safety and effectiveness equivalent to the predicate device (Radiant Medical Endovascular Temperature Probe, K024327). |
| Core Body Temperature Measurement | Measures patient's core body temperature via venous blood temperature. |
| Probe Design/Materials | Sheath: Pebax; Tip: soft, straight Pebax; Heparin-coated. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for the Test Set: Not specified. The document mentions "performance verification tests" but does not detail the number of units tested or if any human subject testing was part of this verification.
- Data Provenance: The tests were conducted internally by Radiant Medical, Inc. The document does not specify country of origin for any human data (if collected) or indicate if the study was retrospective or prospective. It implies bench testing and potentially in vitro or animal studies for biocompatibility.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable/Not specified. This type of information (expert review for ground truth) is typically relevant for diagnostic imaging devices or devices where subjective expert assessment is critical. For a temperature probe, "ground truth" would likely be established against a highly accurate reference thermometer in a controlled environment, not via expert consensus.
4. Adjudication Method for the Test Set
Not applicable/Not specified. Adjudication methods (like 2+1 or 3+1) are used to resolve discrepancies in expert interpretations, which is not relevant for a device like a temperature probe that measures a biophysical parameter.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
No, a MRMC comparative effectiveness study was not done. This type of study is typically for diagnostic devices where human readers interpret medical images or data. The Endocatheter Temperature Probe is a measurement device.
6. Standalone Performance Study (Algorithm only without human-in-the-loop)
Yes, in essence, standalone performance testing was done. The "Performance Test" section states: "The Endocatheter Temperature Probe has been tested for functionality in accordance with BS EN ISO 10555 and for biocompatibility in accordance to ISO 10993." These are standards for catheter functionality and biocompatibility, implying the device's technical performance was assessed on its own. Specific numerical results are not provided in this summary.
7. Type of Ground Truth Used
The type of ground truth used would have been against reference standards for temperature measurement (e.g., highly accurate laboratory thermometers) for functionality testing, and standard laboratory methods for assessing material biocompatibility. It would not typically involve "expert consensus," "pathology," or "outcomes data" in the traditional sense for a device like this during premarket submission.
8. Sample Size for the Training Set
Not applicable. This device is a largely electromechanical temperature probe, not an AI or machine learning algorithm. Therefore, there is no "training set" in the context of data science. The device's design and manufacturing processes are validated, not "trained."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set.
Summary Takeaway:
This document is a 510(k) summary for a temperature probe. The primary goal of a 510(k) is to demonstrate substantial equivalence to a predicate device, focusing on safety and effectiveness without requiring new clinical trials to prove efficacy. Therefore, the details requested about clinical study designs, expert reviews, and AI-related metrics are largely absent, as they are not typically part of a 510(k) submission for this class of device. The "studies" mentioned are performance verification tests against established national/international standards (BS EN ISO 10555, ISO 10993).
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250 Chesapeake Drive Redwood City, CA 94063-4745
tel. 650.363.8000 toll. 888.867.5179 fax. 650.363.2400
510|k] Summary of Safety and Effectiveness
OCT 2 8 2004
Submitter Information
| Company: | Radiant Medical, Inc.250 Chesapeake DriveRedwood City, CA 94063(650) 363-8000 |
|---|---|
| Contact Person: | Andrew CleelandSenior Vice President of Regulatory & Clinical Affairs |
| Summary Date: | August 31, 2004 |
Name and Classification
| Proprietary Name: | Endocatheter Temperature Probe |
|---|---|
| Classification Name: | Percutaneous catheter (DQY) [21 CFR 870.1250] |
| Class: | II |
Predicate Device
- a) Radiant Medical Endovascular Temperature Probe (K024327)
Indication for Use
The Radiant Medical Endocatheter Temperature Probe is indicated for use with the Radiant Medical Endovascular Temperature Management System to measure core body temperature.
Description of Device
The Endocatheter Temperature Probe consists of a sheath containing two thermistors on separate and independent circuits. This Probe is intended for
Image /page/0/Picture/17 description: The image shows the logo for Radiant Medical. The logo consists of a stylized graphic above the company name. The graphic is a series of curved lines that resemble a stylized vine or abstract design. Below the graphic is the word "Radiant" in a serif font, with the word "MEDICAL" in smaller, sans-serif letters underneath.
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Image /page/1/Picture/0 description: The image shows the logo for Radiant Medical. The logo features a stylized graphic above the text. The text "Radiant" is in a larger font size than the text "MEDICAL" which is placed directly below it.
250 Chesapeake Drive Redwood City, CA 94063-4745 tel. 650.363.8000 toll. 888.867.5179 fax. 650.363.2400 www.radiantmedical.com
placement into the inferior vena cava through the guidewire lumen of the catheter. The outer sheath is Pebax and has a soft, straight Pebax tip. The Endocatheter Probe is heparin-coated for hemocompatibility. The intended use is to measure a patient's core body temperature via venous blood temperature.
The Endocatheter Probe is for single use only. It is provided sterile and packaged in a Tyvek/polyethylene pouch. Sterilization is by gamma irradiation.
Summary of Technological Characteristics
The Endocatheter Temperature Probe measures blood temperature in the inferior vena cava. Patient temperature is measured by the SetPoint/Reprieve Controller via the thermistors in the probe.
Performance Test
The Endocatheter Temperature Probe has been tested for functionality in accordance with BS EN ISO 10555 and for biocompatibility in accordance to ISO 10993.
Conclusion
Based upon the successful completion of performance verification tests and the comparison to the predicate devices, the Radiant Medical Endovascular Temperature Probe performs with safety and effectiveness equivalent to the predicate device.
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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three stripes on its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 8 2004
Mr. Andrew Cleeland Senior Vice President of Regulatory & Clinical Affairs Radiant Medical, Inc. 250 Chesapeake Drive Redwood Citv. CA 94063
Re: K042388
Trade/Device Name: Endocatheter Temperature Probe Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: II Product Code: DOY Dated: August 31, 2004 Received: September 2, 2004
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.
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
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Page 2 - Mr. Andrew Cleeland
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) 276-0120. 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/dsma/dsmamain.html
Sincerely yours.
Duna R. Kirchner
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K042388
Radiant Medical Endocatheter Temperature Probe Device Name: The Radiant Medical Endocatheter Temperature Probe is Indications For Use: indicated for use with the SetPoint/Reprieve Endovascular Temperature Management System to measure core body temperature.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dinnar R. Lo. Jones
Onlision Sign-Off) Trasion of Cardiovascular Devices
510:x) Number_K042388
Page 1 of
§ 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).