3TM MYOCARDIAL NEEDLE-TEMPERATURE PROBE

K020365 · 3t Medical Systems, LLC · KRI · May 3, 2002 · Cardiovascular

Device Facts

• Record ID: K020365
• Device Name: 3TM MYOCARDIAL NEEDLE-TEMPERATURE PROBE
• Applicant: 3t Medical Systems, LLC
• Product Code: KRI · Cardiovascular
• Decision Date: May 3, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4200
• Device Class: Class 1

Intended Use

The 3T Myocardial Needle Temperature Probes are indicated for use in the routine monitoring of temperature during open-heart surgery and is intended for insertion into the myocardium.

Device Story

3T Disposable Myocardial Needle Temperature Probe is a sterile, single-use device designed for intraoperative temperature monitoring. Device consists of a needle-style probe inserted directly into the myocardium during open-heart surgery. Operates by sensing myocardial temperature and transmitting data to compatible external monitoring equipment. Used by surgeons or perfusionists in the operating room environment. Provides real-time thermal data to assist clinicians in managing patient temperature during cardiopulmonary bypass or cardiac procedures. Benefits include accurate, localized myocardial temperature assessment to help prevent thermal injury or monitor cardioplegia delivery efficacy.

Clinical Evidence

Bench testing only.

Technological Characteristics

Needle-style temperature probe; disposable; sterile; designed for myocardial insertion. Connects to standard cardiopulmonary bypass monitoring equipment. No complex software or active electronic processing components described.

Indications for Use

Indicated for temperature monitoring during open-heart surgery via myocardial insertion. No specific age or gender restrictions provided.

Regulatory Classification

Identification

Cardiopulmonary bypass accessory equipment is a device that has no contact with blood and that is used in the cardiopulmonary bypass circuit to support, adjoin, or connect components, or to aid in the setup of the extracorporeal line, e.g., an oxygenator mounting bracket or system-priming equipment.

Special Controls

*Classification.* (1) Class I. The device is classified as class I if it does not involve an electrical connection to the patient. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 870.9.(2) Class II (special controls). The device is classified as class II if it involves an electrical connection to the patient. The special controls are as follows: (i) The performance standard under part 898 of this chapter, and (ii) The guidance document entitled “Guidance on the Performance Standard for Electrode Lead Wires and Patient Cables.” The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 870.9.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 0 3 2002

Mr. Robert P. Eaton Manager 3T Medical Systems, LLC 12553 South Wamblee Valley Road Conifer, Colorado 80433

Re: K020365

Trade Name: 3T™ Disposable Myocardial Needle Temperature Probe Regulation Number: 21 CFR 870.4200 Regulation Name: Accessory Equipment, Cardiopulmonary Bypass Regulatory Class: Class II (two) Product Code: KRI Dated: January 30, 2002 Received: February 4, 2002

## Dear Mr. Eaton:

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. Robert P. Eaton

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 (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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Daula Tuller

Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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3T Medical Systems, LLC (Regulatory Office) 12553 South Wamblee Valley Road Conifer, Colorado 80433

## INDICATIONS FOR USE STATEMENT

510 (k) Number: K020365

Device Name: 3T Disposable Myocardial Needle Temperature Probe

Indications For Use: The 3T Myocardial Needle Temperature Probes are indicated for use in the routine monitoring of temperature during open-heart surgery and is intended for insertion into the myocardium.

Division of Cardiovascular & Respiratory Devices
510(k) Number K020365

Prescription Use
(Per 21 CFR 801.109)