WAVE FORM MANUFACTURING PROLASE GENERAL SHAPED FIBER

K020673 · Wave Form Mfg., Inc. · GEX · May 30, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K020673
• Device Name: WAVE FORM MANUFACTURING PROLASE GENERAL SHAPED FIBER
• Applicant: Wave Form Mfg., Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: May 30, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Wave Form Manufacturing Prolase General Shaped Fiber is intended to be used in vaporization, cutting, ablation and coagulation of soft tissue in conjunction with or without endoscopic equipment including laparoscopes, hysteroscopes, arthroscopes, bronchoscopes, cystoscopes, ureteroscopes, gastroscopes and colonoscopes, or for contact or non-contact surgery with or without handpiece for use in coagulation, incision/excision, ablation and vaporization of soft tissue. The Wave Form Manufacturing Prolase General Shaped Fiber is indicated for use in medicine and surgery in the following medical specialties: Urology, Plastic Surgery, Radiology, Dermatology, Pulmonolgy, Gastroenterology, Gynecology, General and Vascular Surgery, Lithotripsy, Arthroscopy, Podiatry, Orthopedics, Neurosurgery, ENT.

Device Story

Fiber optic laser delivery system; 3-meter silica fiber; fluorinated doped silica cladding; fluorinated acrylate buffer; shaped tip. Integrates with laser systems for soft tissue surgery. Features internal quartz sleeve reflector to protect focusing lens from back splatter; secondary memory cladding to assist endoscope guidance. Used in OR/clinic settings by physicians across multiple specialties. Delivers laser energy to target tissue for vaporization, cutting, ablation, or coagulation. Benefits include precise tissue interaction and compatibility with various endoscopic tools.

Clinical Evidence

Bench testing only.

Technological Characteristics

Silica fiber (3m length), fluorinated doped silica cladding, fluorinated acrylate buffer, shaped tip. Includes internal quartz sleeve reflector and secondary memory cladding. Passive fiber optic delivery system; no energy source or software.

Indications for Use

Indicated for soft tissue vaporization, cutting, ablation, and coagulation in patients undergoing surgery across various specialties including Urology, Pulmonology, Arthroscopy, Podiatry, Orthopedics, Lithotripsy, ENT, Neurosurgery, Gastroenterology, Plastic Surgery, Dermatology, Radiology, Gynecology, and General/Vascular surgery. Used with or without endoscopic equipment or handpieces.

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

• InnovaQuartz General Shaped Fiber (K954904)
• InnovaQuartz General Shaped Fiber (K994010)
• Dornier Medilas H Fibers (K001243)
• Lumenis Slimline Fibers (K990947)

Submission Summary (Full Text)

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# MAY 3 0 2002

# CD20673 ATTACHMENT 6 - 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Wave Form Manufacturing Prolase General Shaped Fiber

# Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Wave Form Manufacturing, Inc. 8095 SW Nimbus Ave, Bldg. 12 Beaverton, Oregon 97008 Contact: Charles R. Watkins

Phone: [phone] Facsimile: 503-643-6314 Email: [e-mail] Date Prepared: February 28, 2002

#### Name of Device and Name/Address of Sponsor

Trade Name: Wave Form Manufacturing Prolase General Shaped Fiber Classification Name: Laser Surgical Instrument Accessories

## Predicate Devices

InnovaQuartz General Shaped Fiber (K954904), single use InnovaQuartz General Shaped Fiber (K994010), reuse Dornier Medilas H Fibers (K001243) Lumenis Slimline Fibers (K990947)

#### Device Description

The Wave Form Manufacturing Prolase General Shaped (PGS) Fiber is a fiber optic laser delivery system consisting of a 3 meter long silica fiber, clad in fluorinated doped silica, buffered with a fluorinated acrylate and a shaped tip. As an integral part of a laser system, the PGS fiber may be used for a wide variety of surgical procedures.

#### Indications for Use

The Wave Form Manufacturing Prolase General Shaped Fiber is intended to be used for vaporization, cutting, ablation and coagulation of soft tissue in conjunction with or without endoscopic equipment including laparoscopes, hysteroscopes, ureteroscopes, bronchoscopes, cystoscopes, gastroscopes, arthroscopes, colonoscopes, or for open surgery in contact or non-contact surgery with or without handpieces for use in coagulation, incision/excision, ablation and vaporization of soft tissue.

The Wave Form Manufacturing PGS Fiber is indicated for use in medicine and surgery in the following specialties: Urology, Pulmonology, Arthroscopy, Podiatry, Orthopedics, Lithotripsy, ENT Surgery, Neurosurgery, Gastroenterology, Plastic Surgery, Dermatology, Radiology, Gynecology, and General and Vascular Surgery.

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# Technological Characteristics and Performance Data

Design changes made to the Wave Form Manufacturing PGS Fiber are the addition of an internal proprietary quartz sleeve reflector which protects the laser focusing lens from back splatter of vaporized metal from the connector ferrule and the addition of an optical secondary memory cladding to help guide a steerable endoscope with the optical fiber.

Bench testing was performed to demonstrate that the device will perform as intended.

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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 & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Wave Form Manufacturing, Inc. c/o Mr. Joe Brown Optical Integrity 8317 Front Beach Road Panama City Beach, FL 32407

MAY 3 0 2002

Re: K020673

R02007-5
Trade/Device Name: Wave Form Manufacturing Prolase General Shaped Fibers Regulation Number: 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: February 28, 2002 Received: March 1, 2002

Dear Mr. Brown:

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 for associated in the 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). and Cosmotion (110) that the device, subject to the general controls provisions of the Act. The I ou may , and controls 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 If your de roo is exach 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); 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.

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### Page 2 – Mr. Joe Brown

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 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 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

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

Enclosure

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# PREMARKET NOTIFICATION

## INDICATIONS FOR USE STATEMENT

#### 510(k) Number: 020673

## Device Name: Wave Form Manufacturing Prolase General Shaped Fibers

#### Indications for Use:

The Wave Form Manufacturing Prolase General Shaped Fiber is intended to be used in vaporization, cutting, ablation and coagulation of soft tissue in conjunction with or without endoscopic equipment including laparoscopes, hysteroscopes, arthroscopes, bronchoscopes, cystoscopes, ureteroscopes, gastroscopes and colonoscopes, or for contact or non-contact surgery with or without handpiece for use in coagulation, incision/excision, ablation and vaporization of soft tissue.

The Wave Form Manufacturing Prolase General Shaped Fiber is indicated for use in medicine and surgery in the following medical specialties:

- Urology
- Plastic Surgery ●
- Radiology .
- Dermatology .
- Pulmonolgy .
- Gastroenterology ●
- Gynecology ●

- General and Vascular Surgery .
Lithotripsy

- Arthroscopy ●
- Podiatry .

.

Association

- Orthopedics
- Neurosurgery
- Plastic Surgery

- ENT
Concurrence of CDRH, Office of Evaluation (ODE)

Prescription Use

Or

Over-the-Counter Use

usiam C. Provost

n of General, Restorative and Neurological Devices

510(k) Number K620673