MICROFRANCE(R) WORMALD VASCULAR CLAMP

K112662 · Medtronic Xomed, Inc. · DXC · Jan 20, 2012 · Cardiovascular

Device Facts

• Record ID: K112662
• Device Name: MICROFRANCE(R) WORMALD VASCULAR CLAMP
• Applicant: Medtronic Xomed, Inc.
• Product Code: DXC · Cardiovascular
• Decision Date: Jan 20, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

MicroFrance® Wormald Vascular Clamps are reusable stainless steel surgical instruments used to temporarily or partially occlude blood vessels to isolate operative areas during surgery. The device features a ratcheting handle to adjust the degree of jaw closure, ring handles, and a rotatable shaft for jaw tip orientation. It also includes an integrated flush port. Surgeons operate the device manually to clamp vessels, allowing for suture of vessel defects while maintaining blood flow. The device is non-sterile and intended for use in a clinical/surgical setting.

Clinical Evidence

Bench testing only. Testing evaluated rotation, jaw opening/closure, and jaw plating consistency to ensure performance according to specifications.

Technological Characteristics

Stainless steel construction; reusable; non-sterile; manual operation via ratcheting handle; features include rotatable shaft, ring handles, and integrated flush port.

Indications for Use

Indicated for temporary or partial occlusion of blood vessels during surgical procedures.

Regulatory Classification

Identification

A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.

Predicate Devices

• Wexler Vascular Clamp Series (K110148)

Submission Summary (Full Text)

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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, Inc<br>6743 Southpoint Drive North<br>Jacksonville, Florida 32216-0980 USA<br>904-296-9600<br>904-296-2386 (FAX) |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Marsha Seetaram<br>Regulatory Affairs Specialist<br>Medtronic Xomed, Inc |
| Date Prepared: | September 9, 2011 |
| Trade Name: | MicroFrance® Wormald Vascular Clamp |
| Common Name: | Vascular clamp |
| Classification Name: | Vascular clamp<br>21CFR 870.4450, Pro Code DXC, Class II |
| Predicate Device: | Wexler Vascular Clamp Series<br>K110148 (Cleared 04/19/2011) |
| Device Description: | MicroFrance® Wormald Vascular Clamps enable a surgeon to<br>suture the vessel defect, allowing the clamps to be released<br>and therefore flow to be maintained. The stainless steel<br>clamps are rotatable, allowing for proper orientation of the<br>jaw tip as well as the handle. The device functions by<br>clamping the jaw around the vessel to isolate the operative<br>area. The degree of closure is adjusted by a ratcheting handle. |
| Statement of Intended Use: | MicroFrance® Wormald Vascular Clamps are indicated for<br>use for temporary or partial occlusion of blood vessels during<br>surgical procedures. |
| Conclusion from Data: | The data provided in this 510(k) Notification demonstrates<br>that the proposed MicroFrance® Wormald Vascular Clamps<br>are substantially equivalent to the predicate device since it has<br>similar indications for use, principles of operation, materials<br>and device design. The MicroFrance® Wormald Vascular<br>Clamps 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® Wormald<br>Vascular Clamps | Wexler Vascular Clamp<br>Series |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Medtronic Xomed<br>Instrumentation | Wexler Surgical Supplies,<br>Inc. |
| 510k Clearance | Subject of submission | K110148 |
| Procode & Class | DXC and Class II | DXC and Class II |
| Intended Use | MicroFrance® Wormald<br>Vascular Clamps are indicated<br>for use for temporary or partial<br>occlusion of blood vessels<br>during surgical procedures. | The Wexler Vascular Clamp<br>Series is indicated for use for<br>temporary or partial occlusion<br>of blood vessels during<br>surgical procedures. |
| Various sizes,<br>configurations | Yes | Yes |
| Principle of<br>Operation | Clamp jaw applied around the<br>vessel to isolate the operative<br>area. The degree of closure is<br>adjusted by a ratcheting<br>handle. | Clamp jaw applied around the<br>vessel to isolate the operative<br>area. The degree of closure is<br>adjusted by a ratcheting<br>handle. |
| Design | Variety of jaw tips and<br>orientations, ratchet lock on<br>handle, ring handle, integrated<br>flush port, rotatable shaft | Variety of jaw tips and<br>orientations, ratchet lock on<br>handle, ring handle |
| Material | Stainless Steel | Stainless Steel or<br>Titanium |
| 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 [phone] or [phone] 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