The Chase Temperature Probe consist of a 15mm stainless steel needle connected to 8 ft. of cable with a dual prong plug.
The Chase Temperature Probe consist of a 15mm, .032 O.D. stainless steel needle. The needle is attached to a cable support and eight feet of insulated twin lead cable. The rable ends in a dual prong connector plug.

AI/ML Overview

The device is the Chase Temperature Probe, indicated for use during open-heart surgery to monitor myocardial temperature.

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Functional Characteristics	Non-differentiable compared to the predicate device (Webster Labs Temperature Probe, K813271) due to similar fit, form, and function.
Material Composition	Identical to the predicate device.
Sterilization	Validated 100% Ethylene Oxide sterilization cycle (Overkill Method) SAL 10⁻⁶.
Package Integrity	Tyvek/Polymylar passed burst test per ASTM F 1 40-88.
Shipping & Distribution Testing	Passed National Safe Transit Ass. vibration and drop tests.
Accelerated Aging	Two-year shelf life established.

Study Details

The provided document describes the substantial equivalence of the Chase Temperature Probe to a predicate device, rather than a standalone clinical study with specific performance metrics against defined acceptance criteria in the traditional sense. The "study" here is a comparative one against a predicate device.

Sample size used for the test set and the data provenance: Not applicable. The "testing" primarily involved comparing functional characteristics, materials, and performing engineering tests (sterilization, package integrity, shipping, aging) on the device itself. No patient data or test set in the context of clinical performance data is mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth in a clinical sense with expert consensus is not described for this type of device and submission.
Adjudication method for the test set: Not applicable.
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: Not applicable. This device is a temperature probe, not an AI-powered diagnostic tool.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a medical instrument, not an algorithm.
The type of ground truth used: For functional characteristics, the "ground truth" was established by comparison to the predicate device's fit, form, and function. For sterilization, packaging, shipping, and aging, the ground truth was based on adherence to established standards and validation methods (e.g., SAL 10⁻⁶, ASTM F 1 40-88).
The sample size for the training set: Not applicable, as this is not an AI/machine learning device.
How the ground truth for the training set was established: Not applicable.

Summary

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SUMMARY OF SAFETY AND EFFECTIVENESS

chase temperature probe

I.	General Information	OCT 28 1997
----	---------------------	-------------

A. Generic Name:	Temperature Probe
B. Trade Name of Device:	Chase Temperature Probe
C. Applicant's Name and Address:	CHASE MEDICAL INC., Richardson, TX
D. Pre-market Notification Number:	Not assigned

II.	Indication for Use:
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The Temperature Probe is indicated for use during open-heart surgery to monitor myocardial temperature.

III.	Device Description
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The Chase Temperature Probe consist of a 15mm stainless steel needle connected to 8 ft. of cable with a dual prong plug.

IV.	Device Classification:	Class I device
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V.	Safety and Effectiveness:
----	---------------------------

Substantial Equivalence: This device is substantially equivalent to the Webster Labs Temperature Probe (K813271).

VI.	Other Safety and Effectiveness Data:
Materials:	All material are identical to the predicate device.
Sterilization:	Validated 100% Ethylene Oxide sterilization cycle (Overkill Method) SAL 10⁻⁶

Functional Testing

All functional characteristics of the Chase Temperature Probe are non-differentiable as compared with the predicate because both devices have similar fit, form, and function.

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SUMMARY OF SAFETY AND EFFECTIVENESS

Package Integrity:

Tyvek/Polymylar passed burst test per ASTM F 1 40-88

Per National Safe Transit Ass. vibration and

Shipping & Distribution Testing:

Accelerated Aging:

: .. .. Two year shelf life

drop tests

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure, with the head and upper body represented by a series of curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Bert Davis President Chase Medical Inc. 1876 Firman Drive Richardson, Texas 75081

OCT 2 8 1997

Re: K971013 Chase Temperature Probe Regulatory Class: II (Two) Product Code: DTN Dated: Auqust 25, 1997 August 25, 1997 Received:

Dear Mr. Davis:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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, qood 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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Page 2 - Mr. Bert Davis

This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its -----toll-free number (800) 638-2041 or (301) 443-6597 or at its internet ............. address "http://www.fda.gov/cdrh/dsmamain.html."

Sincerely yours,

Thomas J. Callahan, Ph.D.

Thomas J. Callahan Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Temperature trobe DIN II -

Page

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

CHASE MEDICAL, INC.

TEMPERATURE PROBE

Description:

Clinical:

During open-heart surgery, the patient's heart is temporarily stopped to allow the surgeon a bloodless, still surface in order to complete the surgical repair. The pocess of stopping the heart is often achieved by infusing into the heart a solution containing various are propper which act to stop and preserve the heart. This solution is often cooled proof to infusion into the heart. The cooled solution lowers the temperature of the heart. The Chase Temperature Probe monitors the temperature of the heart.

Product:

The Chase Temperature Probe consist of a 15mm, .032 O.D. stainless steel needle. The needle is attached to a cable support and eight feet of insulated twin lead cable. The rable ends in a dual prong connector plug.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ben E. Lempereur

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number K971013

Prescription Use______________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)

Over-The-Counter Use_

(Optional Format 1-2-96)

Regulation Number and Section

§ 870.4400 Cardiopulmonary bypass blood reservoir.

(a)
Identification. A cardiopulmonary bypass blood reservoir is a device used in conjunction with short-term extracorporeal circulation devices to hold a reserve supply of blood in the bypass circulation.(b)
Classification. Class II (special controls), except that a reservoir that contains a defoamer or filter is classified into the same class as the defoamer or filter. The device, when it is a cardiopulmonary bypass blood reservoir that does not contain defoamers or blood filters, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.