MicroFrance® Wormald Vascular Clamps enable a surgeon to suture the vessel defect, allowing the clamps to be released and therefore flow to be maintained. The stainless steel clamps are rotatable, allowing for proper orientation of the jaw tip as well as the handle. The device functions by clamping the jaw around the vessel to isolate the operative area. The degree of closure is adjusted by a ratcheting handle.

AI/ML Overview

The provided document is a 510(k) summary for the MicroFrance® Wormald Vascular Clamp and describes a device that is substantially equivalent to a predicate device, not an AI/ML powered medical device. Therefore, much of the requested information (e.g., sample size, ground truth, expert qualifications, MRMC studies, standalone performance, training set details) is not applicable or cannot be extracted from this type of regulatory submission. This document focuses on demonstrating equivalence to an existing device through comparison of features and non-clinical bench testing.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify quantitative acceptance criteria in the typical sense of performance metrics (e.g., sensitivity, specificity, accuracy). Instead, the demonstration of equivalence relies on showing that the new device has similar characteristics and performs according to specifications.

Feature / Criterion	Acceptance Criteria (Implied by Substantial Equivalence)	Reported Device Performance (MicroFrance® Wormald Vascular Clamps)
Indications for Use	Similar to predicate device (Wexler Vascular Clamp Series)	"MicroFrance® Wormald Vascular Clamps are indicated for use for temporary or partial occlusion of blood vessels during surgical procedures." (Identical to predicate)
Principles of Operation	Similar to predicate device	"Clamp jaw applied around the vessel to isolate the operative area. The degree of closure is adjusted by a ratcheting handle." (Identical to predicate)
Materials	Similar to predicate device	"Stainless Steel" (Predicate also uses Stainless Steel, but also Titanium)
Device Design (Jaw tips, orientations, handle)	Similar to predicate device	"Variety of jaw tips and orientations, ratchet lock on handle, ring handle, integrated flush port, rotatable shaft" (Similar to predicate's "Variety of jaw tips and orientations, ratchet lock on handle, ring handle," with additional features of "integrated flush port, rotatable shaft" which are considered minor differences not affecting substantial equivalence.)
Sterility	Similar to predicate device	"Non-sterile" (Identical to predicate)
Reusable	Similar to predicate device	"Yes" (Identical to predicate)
Functionality (Ratchet Mechanism, Jaw Movement)	Perform according to specifications and allow varying degrees of pressure; rotation, opening, and closure of jaws consistently; ensure clamp and jaw plating consistency	"Bench testing provided evidence that the proposed MicroFrance® Wormald Vascular Clamps performs according to specifications. The ratchet mechanism on each device allows the surgeon to apply varying degrees of pressure on the vessel. The nature of the tests comprised of three sections for each instrument type. It tested rotation, opening and closure of the jaws as well as testing of the clamps and jaw plating to ensure consistency." (Meets implied functional requirements)

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

Sample Size: Not explicitly stated as a number of devices or clinical cases. The "bench testing" refers to mechanical tests on the instruments themselves. The document states "three sections for each instrument type," implying a set of tests performed on each specific clamp design.
Data Provenance: Bench testing, likely conducted internally by the manufacturer (Medtronic Xomed, Inc.). The document does not mention data from other countries or a retrospective/prospective study design in the context of device performance testing.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable as the study is bench testing of a mechanical device, not an AI/ML algorithm or a study requiring expert clinical interpretation to establish ground truth.

4. Adjudication Method for the Test Set

This information is not applicable as the study is bench testing of a mechanical device.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging AI/ML devices where human readers' performance with and without AI assistance is evaluated. This document describes a surgical instrument.

6. If a Standalone Study (algorithm only without human-in-the-loop performance) was done

No, a standalone performance study in the context of an AI algorithm was not done. The "bench testing" refers to mechanical performance evaluation of the clamp itself.

7. The Type of Ground Truth Used

Engineering specifications and functional requirements. For mechanical devices, the "ground truth" is typically defined by engineering design specifications, material properties, and functional performance criteria (e.g., maximum force, consistency of movement, integrity of components). The testing confirmed the device "performs according to specifications."

8. The Sample Size for the Training Set

This information is not applicable as there is no AI/ML algorithm being trained in this context.

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

This information is not applicable as there is no AI/ML algorithm or training set.

Summary

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K112662 page 1 of 2

JAN 2 0 2012

510(k) SUMMARY SUMMARY OF SAFETY AND EFFECTIVENESS FOR MicroFrance® Wormald Vascular Clamps

510(k) Owner:	Medtronic Xomed, Inc6743 Southpoint Drive NorthJacksonville, Florida 32216-0980 USA904-296-9600904-296-2386 (FAX)
Contact Person:	Marsha SeetaramRegulatory Affairs SpecialistMedtronic Xomed, Inc
Date Prepared:	September 9, 2011
Trade Name:	MicroFrance® Wormald Vascular Clamp
Common Name:	Vascular clamp
Classification Name:	Vascular clamp21CFR 870.4450, Pro Code DXC, Class II
Predicate Device:	Wexler Vascular Clamp SeriesK110148 (Cleared 04/19/2011)
Device Description:	MicroFrance® Wormald Vascular Clamps enable a surgeon tosuture the vessel defect, allowing the clamps to be releasedand therefore flow to be maintained. The stainless steelclamps are rotatable, allowing for proper orientation of thejaw tip as well as the handle. The device functions byclamping the jaw around the vessel to isolate the operativearea. The degree of closure is adjusted by a ratcheting handle.
Statement of Intended Use:	MicroFrance® Wormald Vascular Clamps are indicated foruse for temporary or partial occlusion of blood vessels duringsurgical procedures.
Conclusion from Data:	The data provided in this 510(k) Notification demonstratesthat the proposed MicroFrance® Wormald Vascular Clampsare substantially equivalent to the predicate device since it hassimilar indications for use, principles of operation, materialsand device design. The MicroFrance® Wormald VascularClamps are as safe, as effective, and performs as well as the

predicate device.

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K112662 page 2 of 2

Substantial Equivalence

The MicroFrance® Wormald Vascular Clamps have similar indications for use, principles of operation, materials and device design as the predicate device; Wexler Vascular Clamp Series [Table 1]. FDA originally cleared the predicate device under K110148 on April 19, 2011. K110148 510(k) summary is included in Appendix I.

Feature	MicroFrance® WormaldVascular Clamps	Wexler Vascular ClampSeries
Manufacturer	Medtronic XomedInstrumentation	Wexler Surgical Supplies,Inc.
510k Clearance	Subject of submission	K110148
Procode & Class	DXC and Class II	DXC and Class II
Intended Use	MicroFrance® WormaldVascular Clamps are indicatedfor use for temporary or partialocclusion of blood vesselsduring surgical procedures.	The Wexler Vascular ClampSeries is indicated for use fortemporary or partial occlusionof blood vessels duringsurgical procedures.
Various sizes,configurations	Yes	Yes
Principle ofOperation	Clamp jaw applied around thevessel to isolate the operativearea. The degree of closure isadjusted by a ratchetinghandle.	Clamp jaw applied around thevessel to isolate the operativearea. The degree of closure isadjusted by a ratchetinghandle.
Design	Variety of jaw tips andorientations, ratchet lock onhandle, ring handle, integratedflush port, rotatable shaft	Variety of jaw tips andorientations, ratchet lock onhandle, ring handle
Material	Stainless Steel	Stainless Steel orTitanium
Sterility	Non-sterile	Non-sterile
Reusable	Yes	Yes

Table 1: Comparison to Legally Marketed Device

Summary of Non-Clinical Testing

Bench testing provided evidence that the proposed MicroFrance® Wormald Vascular Clamps performs according to specifications. The ratchet mechanism on each device allows the surgeon to apply varying degrees of pressure on the vessel. The nature of the tests comprised of three sections for each instrument type. It tested rotation, opening and closure of the jaws as well as testing of the clamps and jaw plating to ensure consistency.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle or bird symbol, with three curved lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the bird symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

JAN 2 0 2012

Medtronic USA, Inc. c/o Marsha Seetaram 6743 Southpoint Dr. N. Jacksonville, FL 32216-0980

Re: K112662

Trade Name: MicroFrance Wormald Vascular Clamp Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular clamp Regulatory Class: Class II (two) Product Code: DXC Dated: December 15, 2011 Received: December 16, 2011

Dear Ms. Seetaram:

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 application (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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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. Marsha Seetaram

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

M.A. Willoham.

for 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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INDICATIONS FOR USE

510(k) Number (if known):

Device Name: MicroFrance® Wormald Vascular Clamps

Indications for Use: MicroFrance® Wormald Vascular Clamps are indicated for use for temporary or partial occlusion of blood vessels during surgical procedures.

Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Val. A. Kllolien

(Division Sign-Off) Division of Čardiovascular Devices

510(k) Number_ K /12662

Medtronic Xomed, Inc. MicroFrance® Wormald Vascular Clamps Traditional 510(k), September 9, 2011

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K12662

Regulation Number and Section

§ 870.4450 Vascular clamp.

(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).