DYONICS VARICOSE VEIN ABLATION BLADE

K990723 · Smith & Nephew, Inc. · GEI · Oct 5, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K990723
• Device Name: DYONICS VARICOSE VEIN ABLATION BLADE
• Applicant: Smith & Nephew, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Oct 5, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Dyonics Varicose Vein Ablation Blade (proprietary name TBD) is indicated for use in ambulatory phlebectomy procedures for the resection and ablation of varicose veins.

Device Story

The Dyonics Varicose Vein Ablation Blade is a surgical instrument used in ambulatory phlebectomy procedures. The device utilizes suction to draw target varicose vein tissue into a cutting window; a rotating inner blade then shears the tissue. The surgeon controls the location and extent of resection through manual placement and rotary activation of the blade. Used in a clinical setting by a surgeon, the device provides precise tissue removal, facilitating the ablation of varicose veins.

Clinical Evidence

No clinical data provided; substantial equivalence is supported by clinical experience.

Technological Characteristics

Constructed of surgical stainless steel. Operates via mechanical rotary shearing action with integrated suction. Form factor is a blade assembly designed for tissue resection.

Indications for Use

Indicated for patients undergoing ambulatory phlebectomy procedures for the resection and ablation of varicose veins.

Regulatory Classification

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.

Predicate Devices

• Medicon Ambulatory Phlebectomy Hook

Submission Summary (Full Text)

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OCT 5 1399

K990723

Smith & Nephew, Inc. ascomb Road, Andover, MA 01810 U.S.A. hone: 978-749-1000 ax - 978-749-1599

510(k) Summary March 3, 1999 Smith & Nephew, Inc., Endoscopy Division Dyonics Varicose Vein Ablation Blade

# th - Nephew

Endoscopy Division

#### Substantial Equivalence:

The Dyonics Varicose Vein Ablation Blade is substantially eqivalent in intended use and procedural outcomes to the conventional phlebectomy hook as supported by the clinical experience submitted with this Premarket Notification Submission. Patient contacting materials for both devices are surgical stainless steel.

#### Predicate Device:

The predicate device for the intended use described in this submission is the Medicon Ambulatory Phlebectomy Hook.

#### Summary of Device Function:

The design of the blades offers required precision for varicose vein ablation by controlling the location and extent of tissue resection. Target tissue is drawn into the cutting window of the blade under suction while the rotating inner blade shears off the tissue. The location and extent of tissue removal is completely controlled by surgeon placement and rotary activation of the blade.

### Intended Use of Device:

The Dyonics Varicose Vein Ablation Blade (proprietary name TBD) is indicated for use in ambulatory phlebectomy procedures for the resection and ablation of varicose veins.

Debmah J. Coss

Deborah J. Connors Senior Regulatory Affairs Specialist

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 5 1999

Ms. Deborah J. Connors Principal Regulatory Affairs Specialist Smith & Nephew, Inc. Endoscopy Division 160 Dascomb Road Andover, Massachusetts 01810

Re: K990723

Trade Name: Dyonics Varicose Vein Ablation Blade Regulatory Class: II Product Code : GEI Dated: June 30, 1999 Received: July 6, 1999

Dear Ms. Connors:

This letter corrects our substantially equivalent letter of October 5, 1999, regarding the Product Code.

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent to 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). 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 (Premarket Approval) 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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#### Page 2 - Ms. Deborah J. Connors

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594- 4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note that the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at their toll free number [phone] or at [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number : K 99 0723

Device Name : Dyonics Varicose Vein Ablation Blade

Indications for Use :

The Dyonics Varicose Vein Ablation Blade (proprietary name TBD) is indicated for use in ambulatory phlebectomy procedures for the resection and ablation of varicose veins.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use L OR (Per 21 CFR 801.109) (Optional Format 1-2-96)

Over-the-Counter

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Division Sign-Off

(Division Sign-Om)
Division of General Restorative Devices
510(k) Number K490723

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