The Heartport™ Maze System: Cryoprobe Set is intended for use in minimally invasive cardiac surgery procedures, including the surgical treatment of cardiac arrhythmias. The cryoprobes are applied to tissue and frozen to cause a block of electrical conduction through tissue by way of an inflammatory response, or cryonecrosis. The Set includes probes of varied tip shapes to optimize access to the treatment site.

Device Description

The Heartport™ Maze System: Cryoprobe Set is specifically designed for introduction and use via a trocar or incision in minimally invasive cardiac surgery procedures. The Set includes probes of varied tip shapes to optimize access to the treatment site.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called the "Heartport™ Maze System: Cryoprobe Set." This type of document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

It is important to note that a 510(k) submission generally does not include studies demonstrating the device meets specific acceptance criteria in the way a clinical trial for a novel drug or a de novo device might. Instead, it focuses on demonstrating substantial equivalence to existing devices. Therefore, the information requested in your prompt regarding acceptance criteria, specific device performance metrics, sample sizes for test/training sets, expert adjudication, MRMC studies, and detailed ground truth provenance is not typically found within a 510(k) summary.

The document states that the device meets applicable sections of ASTM F 882-84, which is a standard for cryosurgical medical instruments. This is the closest it comes to "acceptance criteria" and "device performance" in the traditional sense you're asking for.

Here's an attempt to answer your questions based only on the provided text, with the understanding that many of your specific points are not addressed by this type of regulatory submission:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Implied)	Reported Device Performance
Meets applicable sections of ASTM F 882-84 Standard Performance and Safety Specification for Cryosurgical Medical Instruments.	Stated to meet the applicable sections of ASTM F 882-84. (No specific performance values are given).
Biocompatibility of materials.	"All materials used in the Heartport™ Maze System: Cryoprobe Set have established biocompatibility." (Based on similarity to predicate devices).
Substantially equivalent in intended use and/or method of operation to predicate devices.	The device is described as "substantially equivalent in intended use and operational characteristics" to predicate devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not provided. 510(k) summaries do not typically detail specific clinical or non-clinical test sets with sample sizes in this manner, beyond referencing compliance with standards. The "Performance" section for "Non-Clinical Test Results" only states that it meets a particular ASTM standard.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable/Not provided. This type of detail relates to clinical studies and ground truth establishment, which are not part of this 510(k) summary.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not provided. This is not relevant to a 510(k) submission for substantial equivalence.

5. 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

No. This device is a cryoprobe, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No. This device is a physical cryosurgical instrument for performing procedures, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not applicable/Not provided. For the non-clinical performance test, "ground truth" would be defined by the standards and test methods within ASTM F 882-84. The document does not elaborate on this.

8. The sample size for the training set

Not applicable/Not provided. This device is not an AI algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable/Not provided. This device is not an AI algorithm that requires a training set.

Summary of the Study (as described in the 510(k) Summary):

The "study" described in the 510(k) summary is a non-clinical evaluation to demonstrate that the Heartport™ Maze System: Cryoprobe Set is "substantially equivalent" to predicate devices (Frigitronics® CCS-200 Cardiac Cryosurgical System and Spembly Medical Cardiac Cryounit and Cryoprobes).

Performance: The device confirmed compliance with applicable sections of the ASTM F 882-84 Standard Performance and Safety Specification for Cryosurgical Medical Instruments. No specific test results or metrics are included, only the statement of compliance.
Biocompatibility: The materials used were evaluated and confirmed to have "established biocompatibility," likely based on their similarity to materials in the predicate devices.

This submission focuses on regulatory substantial equivalence rather than detailed clinical effectiveness data or specific performance metrics typical of studies for novel devices or algorithmic tools.

Summary

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Image /page/0/Picture/2 description: The image is a seal for the Department of Health & Human Services (HHS). The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with three human profiles incorporated into its design.

FEB 2 1 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Heartport c/o Ms. Marianne C. Drennan Regulatory Affairs Specialist 200 Chesapeake Drive Redwood City, CA 94063

Re: K970496

Trade Name: Heartport™ Maze System Cryoprobe Set Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical unit and accessories Regulatory Class: II (two) Product Code: OCL Dated: February 7, 1997 Received: February 10, 1997

Dear Ms. Drennan:

This letter corrects our substantially equivalent letter of May 9, 1997.

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 (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 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 - Ms. Marianne C. Drennan

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 continue 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

elgmll.

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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APPENDIX A. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

97049 The assigned 510(k) number is: _______________________________________________________________________________________________________________________________________________

Applicant Information:

MAY - 9 1997

Date Prepared:	February 7, 1997
Name:	Heartport, Inc.
Address:	200 Chesapeake DriveRedwood City, CA 94063
Contact Person:	Marianne C. DrennanRegulatory Affairs Specialist
Phone Number:	(415) 482-4405
Fax Number:	(415) 482-4346

Device Information:

Classification	Class II
Trade Name:	Heartport™ Maze System: Cryoprobe Set
Common Name:	Cryosurgical unit and accessories
Product Code:	GEH

Equivalent Devices:

The Heartport™ Maze System: Cryoprobe Set is substantially equivalent in intended use and/or method of operation to the following predicate devices:

Frigitronics® CCS-200 Cardiac Cryosurgical System 1.
ﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ 2. Spembly Medical - Cardiac Cryounit and associated Cardiac Cryoprobes

Intended Use:

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510(k) Summary of Safety and Effectiveness (continued)

Comparison To Predicate Devices:

The Heartport™ Maze System: Cryoprobe Set is equivalent in intended use and operational characteristics to the Frigitronics® Cryoprobes and the Spembly Medical Cardiac Cryoprobes. The Heartport™ Maze System: Cryoprobe Set is specifically designed for introduction and use via a trocar or incision in minimally invasive cardiac surgery procedures.

Non-Clinical Test Results:

Performance

Heartport™ Maze System: Cryoprobe Set meets the applicable sections of ASTM F 882 -84 Standard Performance and Safety Specification for Cryosurgical Medical Instruments.

Biocompatibility

The materials used to fabricate the Heartport™ Maze System: Cryoprobe Set are similar to the predicate devices. All materials used in the Heartport™ Maze System: Cryoprobe Set have established biocompatibility.

Summary:

Based on the intended use, product information, performance data and biocompatibility information provided in this premarket notification, the Heartport™ Maze System: Cryoprobe Set has been shown to be substantially equivalent to currently marketed predicate devices.

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.