The provided text describes a 510(k) premarket notification for the "Chase Thoracic Catheter." This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than performing extensive novel clinical studies with detailed acceptance criteria and performance metrics.

Therefore, many of the requested elements (like a table of acceptance criteria, sample sizes for test sets, expert consensus, MRMC studies, standalone performance, and training set details) are not applicable or not provided in this document, as they are typically required for de novo submissions or PMA applications for novel devices.

Here's a breakdown of the information that is available and what is not:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Substantial Equivalence to Predicate Device (Sherwood Medical Thoracic Catheter K760351)	Demonstrated: The device is stated to be "substantially equivalent" in materials, fit, form, and functional characteristics.
Materials: Identical to predicate device.	Validated: "All material are identical to the predicate device."
Sterilization: Ethylene Oxide sterilization cycle.	Validated: "Validated 100% Ethylene Oxide sterilization cycle (Overkill Method) SAL 10⁻⁶."
Functional Characteristics: Non-differentiable from predicate device.	Validated: "All functional characteristics...are non-differentiable as compared with the predicate because both devices have the exact same fit, form, and material composition."
Package Integrity: Pass burst test.	Validated: "Tyvek/Polymylar passed burst test per ASTM F I 140-88."
Shipping & Distribution Testing: Pass vibration and drop tests.	Validated: "Per National Safe Transit Ass. vibration and drop tests."
Accelerated Aging: 2-year shelf life.	Validated: "Two year shelf life."

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

Not applicable / Not provided. The submission focuses on substantial equivalence based on material and functional comparison to a predicate device and engineering testing, not a clinical test set with patient data for performance evaluation in the way a diagnostic AI would.
For functional and engineering tests: The sample sizes for tests like sterilization validation, package integrity, and shipping tests are not specified.
Data Provenance: Not applicable in the context of device performance, as no clinical data or patient data is mentioned.

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

Not applicable / Not provided. This device is a Class I thoracic catheter, and the submission is a 510(k) based on substantial equivalence. It does not involve a "ground truth" derived from expert consensus for diagnostic AI performance. The "ground truth" here is compliance with engineering standards and direct comparison of physical properties with the predicate.

4. Adjudication Method for the Test Set

Not applicable / Not provided. No clinical test set with human readers or AI output requiring adjudication is described or performed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. An MRMC study was not done. This type of study is relevant for evaluating the impact of an AI diagnostic aid on human reader performance, which is not the scope of this 510(k) for a physical medical device.

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

No. This is a physical medical device, not an algorithm or AI. Standalone algorithm performance is not applicable.

7. The Type of Ground Truth Used

The "ground truth" for this submission is primarily:
- Predicate Device Specifications: The "Sherwood Medical Thoracic Catheter (K760351)" serves as the primary ground truth for substantial equivalence in terms of materials, fit, form, and function.
- Engineering Standards and Test Methods: Standards like ASTM F I 140-88 (for burst test) and National Safe Transit Ass. (for vibration and drop tests) provide the "ground truth" for physical and packaging performance.
- Sterilization Standards: The "Overkill Method" leading to an SAL 10⁻⁶ is the ground truth for sterilization efficacy.

8. The Sample Size for the Training Set

Not applicable / Not provided. This is a physical device, not an AI model. There is no concept of a "training set" in this context.

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

Not applicable / Not provided. As there is no training set, this question is not relevant to this submission.

Summary

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SUMMARY OF SAFETY AND EFFECTIVENESS

CHASE THORACIC CATHETER

I. General Information Thoracic Catheter A. Generic Name: SEP - 8 1997 B. Trade Name of Device: Chase Thoracic Catheter C. Applicant's Name and Address: CHASE MEDICAL INC. , Richardson, TX Not assigned D. Pre-market Notification Number: II. Indication for Use: The Chase Thoracic Catheter is indicated for use during and after open-heart surgery to drain fluid from the pericardium. Device Description 【】. The Chase Thoracic Catheter is a polyvinyl chloride tube with precut holes at the distal tip. Class I device IV. Device Classification: Safety and Effectiveness: V. This device is substantially equivalent to the Sherwood Substantial Equivalence: Medical Thoracic Catheter (K760351). VI. Other Safety and Effectiveness Data: Materials: All material are identical to the predicate device. Validated 100% Ethylene Oxide sterilization cycle (Overkill Method) SAL 10° Sterilization:

Functional Testing

All functional characteristics of the Chase Thoracic Catheter 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 I 140-88

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 Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines beneath them. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

SEP = 8 1997

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

Re: K971023 Chase Thoracic Catheter Requlatory 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 to 895. A substantially equivalent determination assumes compliance 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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4639. 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

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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CHASE MEDICAL, INC.

THORACIC CATHETER

Intended Use:

The Thoracic Catheter is indicated for use during and after open-heart surgery to drain fluid from the pericardium.

(Division Sign-Off) I con of Cardiovascular Respiratory, and Neurological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________

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).