GIVEN ELECTROSURGICAL NEEDLE

K082584 · Tripps Court Enterprises, Inc. · GEI · Oct 28, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K082584
• Device Name: GIVEN ELECTROSURGICAL NEEDLE
• Applicant: Tripps Court Enterprises, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Oct 28, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Given Electrosurgical Needle is used to apply electrosurgical current directly into a spider vein located within the skin. The electrosurgical current destroys the spider vein.

Device Story

Single-patient-use needle electrode for monopolar electrosurgical handpieces; used to treat spider veins. Physician inserts needle into vein; applies electrosurgical current (1.5 to 1.75 Watts) to destroy vein; insulation protects surrounding tissue. Needle withdrawn after treatment. Biocompatible materials (Tungsten Carbide needle, Parylene-C insulation).

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Needle electrode for monopolar electrosurgical handpieces. Materials: Tungsten Carbide (needle), Parylene-C (insulation). Biocompatible. Single-patient use. Operates via electrosurgical current (1.5-1.75 Watts).

Indications for Use

Indicated for the destruction of spider veins located within the skin via the application of electrosurgical current.

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

• Stryker Leibinger Colorado MicroDissection Needle (K033232)
• Stryker Leibinger Colorado MicroDissection Needle (K000348)
• Stryker Leibinger Colorado MicroDissection Needle (K881763)

Submission Summary (Full Text)

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Kenna S. Given, M.D./Tripps Court Enterprises, Inc. K082584 - Given Electrosurgical Needle

CONFIDENTIAL Response to Additional Information

# Attachment 2 Revised - October 5, 2009

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### 510(k) Summarv

| Owner's Information: | Kenna S. Given, M.D.<br>748 Tripps Court<br>Augusta, GA 30909<br>Tel: [phone] Fax: [phone] |
|----------------------------------------|----------------------------------------------------------------------------------------------------------|
| Contact Person: | Julie Stephens, President/Consultant<br>Regulatory Resources Group, Inc. |
| 510(k) Number: | K082584 <span style="float:right;">OCT 2 8 2009</span> |
| Trade/Proprietary Name: | Given Electrosurgical Needle |
| Common Name: | Electrosurgical Instrument |
| Classification Name: | Electrosurgical Cutting & Coagulation Device and Accessories (21<br>CFR 878.4400) |
| Product Code: | GEI |
| Legally Marketed<br>Predicate Devices: | Stryker Leibinger Colorado MicroDissection Needle®<br>510(k) #s: K033232; K000348; K881763 |

### Device Description:

The Given Electrosurgical Needle is a single patient use needle electrode for use in monopolar electrosurgical handpieces. The skin which is usually anesthetized with a topical and/or injectable anesthetic. The monopolar generator is set at the cutting mode to 1.5 to 1.75 Watts. The needle is introduced into the vein located within the skin. The current is then applied with destruction of the vein while the insulation protects the surrounding tissue. The needle is withdrawn and additional veins are then treated in a similar fashion. The needle is made of Tungsten Carbide and the insulation is Parylene-C which are both biocompatible materials that have been used extensively in electrosurgical electrodes.

#### Intended Use:

The Given Electrosurgical Needle is used to apply electrosurgical current directly into a spider vein located within the skin. The electrosurgical current destroys the spider vein.

Similarities and Differences of the Proposed Devices to the Predicate Devices:

#### Similarities

The Given Electrosurqical Needle has the same basic technology characteristics for an electrosurgical electrode for use in monopolar electrosurgical handpieces. It is intended for precision cutting and cauterizing of soft tissue as the predicate devices, and the indications for use are the same except for the specific additions as noted below.

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K082584

Kenna S. Given, M.D./Tripps Court Enterprises, Inc. K082584 - Given Electrosurgical Needle

Response to Additional Information

## Attachment 2 Revised - October 5, 2009

## 510(k) Summary

Differences

The Given Electrosurgical Needle utilizes some of the exact materials as the predicate devices; however, all materials are known biocompatible materials that have been used in electrosurgical electrodes or electrosurgical instruments.

#### Conclusion:

The Given Electrosurgical Needle has the same principles of operation, and technological characteristics as the predicate device. The Given Electrosurgical Needle has determined a specific intended use from results of testing as presented in the submission.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

# OCT 2 8 2009

Tripps Court Enterprises, Inc. % Regulatory Resources Group, Inc. Ms. Julie Stephens 111 Laurel Ridge Drive Alpharetta, Georgia 30004

Re: K082584

Trade/Device Name: Given Electrosurgical Needle Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: October 5, 2009 Received: October 6, 2009

Dear Ms. Stephens:

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 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.

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

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Page 2 - Ms. Julie Stephens

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.

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/cdrh/mdr/ 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/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson

Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K082584

Device Name: Given Electrosurgical Needle

Indications For Use:

The Given Electrosurgical Needle is used to apply electrosurgical current directly into a spider vein located within the skin. The electrosurgical current destroys the spider vein.

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nilkeal for mkm
(Division Sign Off)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K082584

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