The provided documentation describes a 510(k) premarket notification for the CHASE Phrenic Nerve Pad. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting new clinical trials to establish de novo safety and effectiveness. Therefore, the information requested regarding acceptance criteria based on a study of the device's performance is not directly applicable in the way it would be for a novel device undergoing a formal effectiveness study.

However, I can extract the relevant information from the document to address your points in the context of a 510(k) submission, focusing on the comparisons made to the predicate device.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) device, "acceptance criteria" primarily relate to demonstrating that the new device is as safe and effective as the predicate. In this case, the criteria are based on equivalence to the predicate device, not on specific performance metrics established through clinical trials.

Acceptance Criterion (Basis for Equivalence)	Reported Device Performance (vs. Predicate)
Materials	All material are identical to the predicate device.
Sterilization	Validated 100% Ethylene Oxide sterilization cycle (Overkill Method) SAL 10⁻⁶
Functional Characteristics	Non-differentiable as compared with the predicate because both devices have the exact same fit, form, and material composition.
Package Integrity (Burst Test)	Tyvek/Polymylar passed burst test per ASTM F 140-88
Shipping & Distribution Testing	Per National Safe Transit Ass. vibration and drop tests
Accelerated Aging (Shelf Life)	Two year shelf life
Indications for Use	"Indicated for use during open-heart surgery to insulate the heart from the warmer organs and tissues of the body." (Identical to predicate)

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not applicable in the context of clinical "test sets" for effectiveness in a 510(k) for this type of device. The "testing" involved material comparisons, sterilization validation, and package/shipping tests.
Data Provenance: The document does not specify the country of origin for the data related to material testing, sterilization, or package integrity. Given it's a US submission, it's presumed to be in compliance with US standards. The data is retrospective in the sense that it relies on established standards and comparisons to an already marketed device (Medtronic/DLP Phrenic Nerve Pad, K890707).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Number of Experts: Not applicable. For a 510(k) cleared based on substantial equivalence to the design and materials of a predicate device, there is no "test set" in the sense of clinical data requiring expert human review or ground truth establishment.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable for the reasons stated above.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a Class I medical device (though later reclassified to Class II by FDA in the letter), and its 510(k) submission focused on demonstrating substantial equivalence based on material composition, fit, form, and function to a predicate device, not on human interpretive performance with or without AI assistance.
Effect Size: Not applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Standalone Performance: No, this device is a physical medical product, not an algorithm or AI system. Therefore, standalone algorithm performance testing is not applicable.

7. The Type of Ground Truth Used

Type of Ground Truth: The "ground truth" for this 510(k) submission is primarily the established safety and effectiveness of the predicate device (Medtronic/DLP Phrenic Nerve Pad, K890707) as demonstrated by its prior market clearance. For the specific tests conducted (materials, sterilization, packaging), the "ground truth" would be adherence to recognized standards (e.g., ASTM F 140-88 for burst test, SAL 10⁻⁶ for sterilization validation).

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This device is not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Ground Truth for Training Set: Not applicable as there is no training set for this type of medical device submission.

Summary

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K971021

AUG | 2 |997

SUMMARY OF SAFETY AND EFFECTIVENESS

CHASE PHRENIC NERVE PAD

I.	General Information
A.	Generic Name:	Phrenic Nerve Pad
B.	Trade Name of Device:	CHASE Phrenic Nerve Pad
C.	Applicant's Name and Address:	CHASE MEDICAL INC., Richardson, TX
D.	Pre-market Notification Number:	Not assigned

II. Indication for Use:

The CHASE Phrenic Nerve Pad is indicated for use during open-heart surgery to insulate the heart from the warmer organs and tissues of the body.

III. Device Description

The CHASE Phrenic Nerve Pad consists of a heart shaped, 1/8 inch, closed cell piece of foam with an 18 inch silicone tail.

IV. Device Classification: Class I device

V. Safety and Effectiveness:

Substantial Equivalence: This device is substantially equivalent to the Medtronic/DLP Phrenic Nerve Pad (K890707).

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 Phrenic Nerve Pad are non-differentiable as compared with the predicate because both devices have the exact same fit, form, and material composition.

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SUMMARY OF SAFETY AND EFFECTIVENESS

Package Integrity:

Shipping & Distribution Testing:

Accelerated Aging:

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

Per National Safe Transit Ass. vibration and drop tests

Two year shelf life

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and body. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circumference of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

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

AUG 1 2 1997

K971021 Re: Chase Phrenic Nerve Pad Regulatory Class: II (Two) Product Code: 74 DWF Dated: June 30, 1997 Received: June 30, 1997

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, 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 (Premarket Approval), 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 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirement, 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 assumptions. Failure to comply with the GMP regulation may result in 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 regulations.

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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 requlation (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. Callehan

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

Enclosure

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Page	of
510(k) Number (if known):	<971021/51
Device Name:
Indications For Use:

CHASE MEDICAL, INC.

PHRENIC NERVE PAD

Intended Use:

The Phrenic Nerve Pad is indicated for use during open-heart surgery to insulate the heart from the warmer organs and tissues of the body.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ben L. Esquibel

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

510(k) Number_________________________________________________________________________________________________________________________________________________________________

Prescription Use______________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109) Over-The-Counter Use_

(Optional Format 1-2-96)

Regulation Number and Section

§ 870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.

(a)
Identification. A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.(b)
Classification. Class II (performance standards).