NOVATIP FAMILY OF LASER HANDPIECE TIPS

K971539 · Xanova Corp. · GEX · Jun 3, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K971539
• Device Name: NOVATIP FAMILY OF LASER HANDPIECE TIPS
• Applicant: Xanova Corp.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jun 3, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The intended use of the Xanova tips is to comprise the distal end element of a surgical CO2 laser beam delivery system for the incision, excision, ablation, or photocoagulation of soft tissue.

Device Story

Novatip NT family consists of disposable distal end tips for hollow fiber CO2 surgical laser delivery systems. Tips function as optical waveguides to direct laser energy for soft tissue vaporization, ablation, incision, or photocoagulation. Used in clinical settings (gynecology, dermatology, dentistry, general surgery, ENT, podiatry) by physicians. Device receives laser energy from the CO2 laser system and outputs a focused beam to the target tissue. Benefits include precise tissue interaction for various surgical procedures. Xanova tips are designed without toxic lead fluoride, unlike predicate devices.

Clinical Evidence

No clinical data were presented. Substantial equivalence is based on bench testing and technological comparison to the predicate device.

Technological Characteristics

Disposable hollow fiber laser handpiece tips. Operates as an optical waveguide for CO2 laser energy. Materials are similar to predicate but exclude lead fluoride. Maintains same mode structure, spot size, and power density as predicate. Non-electronic, passive optical component.

Indications for Use

Indicated for soft tissue incision, excision, ablation, or photocoagulation in gynecology (condyloma, neoplasia, cysts), dermatology (hemangioma, rhinophyma, warts, carcinoma, dermabrasion), dentistry/oral surgery (gingivectomy, frenum release, soft tissue tumors), general surgery (hemorrhoids, skin tags, cysts, ulcers, mastectomy, biopsy), otorhinolaryngology (lymphangioma, turbinectomy), and podiatry (warts, fungal nails, matrixectomy, neuroma).

Regulatory Classification

Identification

(1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.

Predicate Devices

• Luxar laser handpiece tips models LXT-C5, LXT-C10, LXT-005TSS, LXT-120ST, LXNS-T3 (K960475)

Submission Summary (Full Text)

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K771J39

Image /page/0/Picture/1 description: The image shows the logo for Xanova Corporation. The logo consists of a black square with a white starburst pattern inside, followed by the word "Xanova" in large, bold, black letters. Below the word "Xanova" is the word "CORPORATION" in smaller, sans-serif, black letters.

JUN - 3 1997

# 9.0 510(k) Summary

Page 1 of 2. -

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.

#### 1 . Submitter's name, address, telephone, and contact person:

Xanova Corporation 15018 N.E. 177th Drive Woodinville, WA 98072 206/481-6223 Michael Levy, President

2. Date summary prepared: April 11, 1997

3. Product trade or proprietary name: Novatip NT family of laser handpiece tips

4. Product common name: Laser Handpiece Tips

#### 5. Product classification name:

21CFR § 878.4810 Lasers in general and plastic surgery and in dermatology 21CFR § 874.4500 Lasers for use in ENT 21CFR § 884.4550 Gynecologic surgical laser

### 6. Legally marketed predicate devices used for equivalency:

Luxar laser handpiece tips models LXT-C5, LXT-C10, LXT-005TSS, LXT-120ST, LXNS-T3, as cleared under K960475 Luxar Modified CO2 Surgical Laser System

7 . Descriptions The Xanova Novatips constitute the disposable end element of the hollow fiber deliverv system of a CO2 surgical laser.

8. Statement of intended use: The intended use of the Xanova tips is identical to that of the Luxar tips, namely to constitute the disposable end element of the delivery system of the Luxar laser used for the vaporization, ablation, incision, or photocoagulation of soft tissue in the surgical specialties of gynecology, dermatology, dentistry and oral surgery, general surgery, otorhinolaryngology, and podiatry. No new indications were sought in the premarket notification and no clinical data were presented.

15018 N.E. 177th Drive

Woodinville, WA 98072

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Phone/Fax [phone]

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#### 9. Technological characteristics:

The Xanova tips function in the same manner, and according to the same optical principles as the predicate Luxar tips. The Xanova tips operate within the same range of spot size, power, and power density as the Luxar tips, and have similar transmission efficiencies. The output beam of the Xanova tips has the same mode structure as the output beam of the Luxar tips, and the effect on tissue is the same. The Xanova tips are constructed of materials that are also found in the Luxar tips, although these materials are incorporated in different ways in some cases. The Xanova tips however, do not use toxic lead fluoride, as do the Luxar tips. Xanova believes that the minor differences in performance and differences in construction techniques (where they exist) do not raise any new issues of safety and effectiveness.

Advisory: This information was prepared for the sole purpose of compliance with the Safe Medical Devices Act of 1990. It does not imply that the procedures described herein can be performed with the equipment described without substantial risk of personal injury or death to patients or operators due to operator error or in high-risk procedures.

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Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services USA. The seal is circular with the text "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

JUN - 3 1997

Mr. Michael Levy President Xanova Corporation 15018 N.E. 177th Drive Woodinville, Washington 98072

Re: K971539

> Trade Name: Novatip Family of Laser Handpiece Tips Regulatory Class: II Product Code: GEX Dated: April 11, 1997 Received: April 28, 1997

Dear Mr. Levy:

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 (for the indications for use stated in the enclosure) 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 Fractice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, 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 - Mr. Michael Levy

,

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note 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 its toll-free number [phone] or [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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KG)134

## 5.2 Intended Use and Indications for Use

The intended use of the Xanova tips is to comprise the distal end element of a surgical CO2 laser beam delivery system for the incision, excision, ablation, or photocoagulation of soft tissue.

Representative examples of indications for use in various specialties are listed below.

Gynecology-excision and vaporization of cervical, vulvar, and perineal condyloma; ablation. of vaginal and vulvar intraepithelial neoplasia; he pes vaporization of urethral caruncle; I&D Bartholin's and nubothian cysts.

Dermatology-port wine hemangioma removal, rhinophyma reduction; telangiectasia removal; wart removal; basal squamous cell carcinoma removal; blepharoplasty; xanthalasma removal; removal of neurofibromas, hemangiomas, nevi, and tricoeptiheliomas; dermabrasion for lentigos, keratoses, actinic keratosis and actinic chleilitis.

Dentistry/Oral Surgery-gingivectomy; frenum release; gingivoplasty; removal of soft tissue, cysts, and tumors.

General Surgery-hemorrhoid removal; skin tag vaporization; pilodidal cyst removal and repair; debridement of decubitus ulcers and stasis ulcers; mastectomy; breast biopsy; reduction mammoplasty; cytoreduction for metastatic disease; many dermatological procedures.

Otorhinolaryngology- - lymphangioma removal; turbinectomy.

Podiatry-plantar wart vaporization; fungal nail treatment; partial and complete matrixectomy; porokeratoma ablation; Morton's neuroma removal; ingrown toenail treatment.

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Prescription Use
(Per 21 CFR 801.109)

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