(88 days)
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Not Found
No
The summary describes a temperature probe for monitoring during surgery and contains no mention of AI or ML.
No
The device is used for monitoring temperature during surgery, which is a supportive function rather than directly treating a disease or condition.
No.
The device's intended use is for "routine monitoring of temperature during open-heart surgery," which describes a monitoring function, not a diagnostic one. Diagnostic devices are used to identify the presence or nature of a disease or condition.
No
The device is described as "Myocardial Needle Temperature Probes" intended for insertion into the myocardium. This description clearly indicates a physical, hardware-based device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "routine monitoring of temperature during open-heart surgery" and "intended for insertion into the myocardium." This describes a device that is used directly on or within the patient's body to measure a physiological parameter (temperature).
- IVD Definition: In vitro diagnostics (IVDs) are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are performed outside of the living body (in vitro).
Since this device is inserted into the myocardium (a part of the heart) and used for direct temperature monitoring within the patient, it falls under the category of a medical device but not an IVD.
N/A
Intended Use / 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.
Product codes
KRI
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
myocardium
Indicated Patient Age Range
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Intended User / Care Setting
open-heart surgery
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 870.4200 Cardiopulmonary bypass accessory equipment.
(a)
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.(b)
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.
0
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 (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). 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,
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)