The FLEX 10 Accessory is intended to be used with the AFx Microwave Ablation System for the surgical ablation of soft tissue, in addition to striated, cardiac and smooth muscles. The system is designed to ablate tissue by the induction of thermal necrosis in the targeted tissues.

Device Description

The FLEX 10 Accessory is a surgical ablation probe that directs the microwave energy developed by the AFx Microwave Generator into the target tissue. The FLEX 10 Accessory is a sterile, hand-held, single-use, surgical ablation device. The ablative microwave energy emanates from an antenna contained in the ablation sheath at the distal end of the device.

The FLEX 10 Accessory has a flexible 2 m long insulated coax cable that attaches the Probe to the Microwave Generator output cable. The flexible cable is attached to a 24 cm long hand grip, followed by a 15 cm section of stainless steel hypotube, followed by a highly flexible PTFE ablation sheath, which contains the movable microwave energy delivery antenna. The end of the ablation sheath is attached to a PEBAX positioning sheath and sutures to aid in the proper placement of the ablating sheath. Moving the sliding ring on the hand grip moves the antenna to discrete numbered locations in the ablating sheath. The position of the antenna within the ablating sheath is displayed to the user by the position indicator of the sliding ring on the hand grip.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called the "FLEX 10 Accessory for the AFx Microwave Ablation System." This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than establishing performance against specific acceptance criteria through a clinical study.

Therefore, the information required to populate most of the requested table and answer the study-related questions is not present in this document. This typically occurs because 510(k) clearances, especially for accessories to existing systems, often rely on bench testing and comparisons to established devices and their known performance, rather than new, extensive clinical trials with detailed statistical endpoints.

Here's a breakdown of what can and cannot be extracted:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not explicitly stated in terms of quantitative clinical performance metrics. Substantial equivalence is the primary "acceptance criteria" for 510(k) submission.	The document states that "The animal testing demonstrated the reliability of the sliding antenna concept."

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

Sample size for test set: Not applicable/Not provided. The document mentions "animal testing" but does not specify the number of animals or the details of the study design.
Data provenance: Not explicitly stated. Animal testing, typically pre-clinical, would precede human clinical data.

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. There is no mention of expert-established ground truth for a test set, as this isn't a diagnostic or imaging device study requiring such a process.

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

Not applicable/Not provided.

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, an MRMC comparative effectiveness study was not done. This device is an ablation probe, not an AI-assisted diagnostic tool.

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

Not applicable. This device is a physical surgical accessory; it does not operate as a standalone algorithm.

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

Not explicitly stated in detail for the "animal testing." The study objective was to demonstrate the "reliability of the sliding antenna concept," suggesting performance related to proper function and tissue ablation, which would likely be assessed through pathological examination of ablated tissue, but this is an inference.

8. The sample size for the training set

Not applicable. This is not a machine learning/AI device, so there is no "training set."

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

Not applicable.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the caduceus symbol.

FEB 2 1 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Afx, Inc. c/o Ms. Nancy Norris Program Director 47929 Fremont Boulevard Fremont, CA 94538

Re: K013946

Trade/Device Name: FLEX 10 Accessory for the Afix Microwave Ablation System Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgicual unit and accessories Regulatory Class: II (two) Product Code: OCL, NEY Dated: November 28, 2001 Received: November 29, 2 001

Dear Ms. Norris:

This letter corrects our substantially equivalent letter of February 27, 2002.

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. Nancy Norris

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.

eegmell.

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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AFx inc.

FLEX 10 Ablation Probe Accessory Premarket Notification 510(k)

INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

K 013946

Device Name:

FLEX 10 Ablation Probe Accessory for the AFx Microwave Ablation System

Indications for Use

Mark A. Mckinnon

Division Sign-Off) Orvision of General, Restorative and Neurological Devices 013946 (Division Sign-Cam Division of General. 1 451 and Neurological tren

210(!

510(k) Number

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

Concurrence of CDRH/Office of Device Evaluation (ODE)

Prescription Use \ (Per 21 CFR 801.109)

Over-the-Counter Use (Optional Format 1-2-96)

CONFIDENTIAL

Page 1-4

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SECTION 2 - 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS K 013946

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 8807.92

Contact Person Nancy Norris

FEB 2 7 2002

Program Manager AFx inc. 47929 Fremont Blvd Fremont, CA 94538 (510) 651-7430 (510) 651-7061 fax

Device Name

Trade Name: FLEX 10 Accessory for the AFx Microwave Ablation System Common Name: None Classification Name: Cryosurgical unit and accessories (21 CFR 878.4350);

Predicate Devices

AFx Microwave Ablation System and Accessories	K003978
CryoGen Cardiac Cryosurgery System	K974320
Heartport Maze System: Cryoprobe Set	K970496

Device Description

Indications for Use

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510(k) Summary - continued

Testing in Support of Substantial Equivalence Determination

The results of bench testing and biocompatibility testing support the substantial equivalence claims of the FLEX 10 Accessory for the AFx Microwave Ablation System in the above indication. The animal testing demonstrated the reliability of the sliding antenna concept.

Substantial Equivalence Conclusion

Substantial equivalence is based on the fact that the FLEX 10 Accessory for the AFx Microwave Ablation System has equivalent data-based intended uses as the predicate AFx Microwave Ablation System with its LYNX and FLEX Ablation Probe Accessories. There are no significant technological differences between the FLEX 10 and cleared microwave ablation probes. There are no new questions of safety or efficacy raised by the AFx Microwave Ablation System with any of its ablation probes vis -a-vis the predicate cryogenic ablation devices. Therefore, it can be concluded that the FLEX 10 Ablation Probe Accessory for the AFx Microwave Ablation System is substantially equivalent to the 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.