SMITH & NEPHEW TUMESCENT CATHETER INVERSION SYSTEM, MODEL 7210023

K041453 · Smith & Nephew, Inc. · DWQ · Jul 22, 2004 · Cardiovascular

Device Facts

• Record ID: K041453
• Device Name: SMITH & NEPHEW TUMESCENT CATHETER INVERSION SYSTEM, MODEL 7210023
• Applicant: Smith & Nephew, Inc.
• Product Code: DWQ · Cardiovascular
• Decision Date: Jul 22, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4885
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Smith & Nephew Tumescent Catheter Inversion System is intended to provide a system for removal of incompetent greater saphenous veins.

Device Story

The Smith & Nephew Tumescent Catheter Inversion System is a surgical instrument used for the removal of incompetent greater saphenous veins. The system facilitates the mechanical stripping of the vein and provides the capability to simultaneously flush the resulting tunnel with tumescent solution. It is intended for use by physicians in a clinical or surgical setting. By enabling vein removal and local infusion of tumescent solution, the device assists in the management of venous insufficiency, potentially reducing post-operative complications associated with the vein stripping procedure.

Clinical Evidence

Bench testing only. The device was tested and found to be in compliance with ISO 10993-1 for biocompatibility and applicable sterilization standards. No clinical data was provided.

Technological Characteristics

Mechanical vein stripping system. Materials comply with ISO 10993-1 biocompatibility standards. Sterilization is performed according to applicable industry standards. The device is a manual surgical instrument.

Indications for Use

Indicated for the removal of incompetent greater saphenous veins in patients requiring vein stripping procedures.

Regulatory Classification

Identification

An external vein stripper is an extravascular device used to remove a section of a vein.

Predicate Devices

• Codman® Disposable Vein Stripper

Submission Summary (Full Text)

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K041453

JUL 22 2004

Endoscopy Shoith & Nephow, Inc 150 Minuteman Road Andever, MA 01810

UUUL (177 (1977) 149 1599 Fax w smilh-nephew.com

# >> We are smith&nephew

### SECTION IV

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

as required by the Safe Medical Devices Act of 1990 and codified in 21 CFR 807.92 upon which the substantial equivalence is based.

Date Prepared: May 28, 2004

### A. Submitter's Name:

Smith & Nephew, Inc., Endoscopy Division 150 Minuteman Road Andover, MA 01810

### B. Company Contact:

Karen Provencher Regulatory Affairs Specialist Phone: [phone] Fax: [phone]

#### C. Device Name

| Trade Name: | Smith & Nephew Tumescent Catheter Inversion System |
|----------------------|----------------------------------------------------|
| Common Name: | External Vein Stripper |
| Classification Name: | External Vein Stripper |

#### D. Predicate Devices

The Smith & Nephew Tumescent Catheter Inversion System is substantially equivalent in intended use and fundamental scientific technology to the following

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legally marketed device in commercial distribution: Codman® Disposable Vein Stripper (pre-amendment device).

#### Description of Device E.

The Smith & Nephew Tumescent Catheter Inversion System provides a system for removal of incompetent greater saphenous veins. The system also provides the capability to flush the tunnel left behind from the removal of the vein with tumescent solution.

#### F. Intended Use

The Smith & Nephew Tumescent Catheter Inversion System is intended to provide a system for removal of incompetent greater saphenous veins.

### G. Companson of Technological Characteristics

The Smith & Nephew Tumescent Catheter Inversion System is substantially equivalent in design, materials, function and intended use to the following device cleared for commercial distribution: Codman® Disposable Vein Stripper - legally marketed preamendment device.

### H. Summary Performance Data

There are no known performance standards or special controls promulgated under section 514 of the Act for this device has been tested and found to be in compliance with ISO 10993-1 and at the time of commercialization will be in compliance with applicable sterilization standards. This device has been tested and found to be safe and effective for its intended use.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 22 2004

Smith & Nephew, Inc. c/o Ms. Karen Provencher Regulatory Affairs Specialist 150 Minuteman Road Andover, MA 01810

Re: K041453

Tumescent Catheter Inversion System Regulation Number: 21 CFR 870.4885 Regulation Name: External Vein Stripper Regulatory Class: Class II (two) Product Code: DWQ Dated: May 28, 2004 Received: June 1, 2004

Dear Ms. Provencher:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Karen Provencher

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I four of action and i termination 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 begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally premaince nevice 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 [phone]. 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 [phone] or [phone] or at its Internet address

(501) : //www.fda.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Duna R. Holmes

Bran
Direc

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):

(041453

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

The Smith & Nephew Tumescent Catheter Inversion System is intended to provide a system for removal of incompetent greater saphenous veins.

Prescription Use _ ✔ (Per 21 CFR 801.109)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Duana R. Kirchner

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number K041453