OPTICAL INTEGRITY GENERAL SHAPED FIBER

K022338 · Optical Integrity, Inc. · GEX · Oct 16, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K022338
• Device Name: OPTICAL INTEGRITY GENERAL SHAPED FIBER
• Applicant: Optical Integrity, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Oct 16, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Optical Integrity 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, cystoscopes, 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 Optical Integrity General Shaped Fiber is indicated for use in medicine and surgery in the following medical specialties: Urology . Plastic Surgery . Radiology . Dermatology . . Pulmonology Gastroenterology . Gynecology . ENT . Lithotripsy ● General and Vascular Surgery ● Arthroscopy ● . Podiatry Orthopedics . Neurosurgery

Device Story

Optical Integrity General Shaped (GS) Fiber is a 3-meter silica fiber optic laser delivery system; clad in fluorinated doped silica; buffered with fluorinated acrylate; features shaped tip. Device functions as integral component of laser surgical systems; delivers laser energy for soft tissue vaporization, cutting, ablation, and coagulation. Used in OR or clinical settings by physicians across multiple surgical specialties. Includes internal quartz sleeve reflector to protect laser focusing lens from back splatter; secondary memory cladding to assist endoscope steering. Device enables contact or non-contact surgery; facilitates precision tissue interaction; benefits patients by providing versatile, compatible delivery mechanism for various endoscopic and open surgical procedures.

Clinical Evidence

Bench testing only.

Technological Characteristics

3-meter silica fiber; fluorinated doped silica cladding; fluorinated acrylate buffer; shaped tip. Features internal quartz sleeve reflector and secondary memory cladding. Laser surgical instrument accessory; non-electronic/mechanical delivery system.

Indications for Use

Indicated for soft tissue vaporization, cutting, ablation, and coagulation in patients requiring surgical intervention across specialties including Urology, Plastic Surgery, Radiology, Dermatology, Pulmonology, Gastroenterology, Gynecology, ENT, Lithotripsy, General/Vascular Surgery, Arthroscopy, Podiatry, Orthopedics, and Neurosurgery. 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

• Wave Form Manufacturing Prolase General Shaped Fiber (K020673)
• 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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K022338

# ATTACHMENT 6 - 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Optical Integrity General Shaped Fiber

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

Optical Integrity, Inc. 8317 Front Beach Road, Suite 21 Panama City Beach, FL 32407 Contact: Joe D. Brown

Phone: [phone] Facsimile: 850-233-3658 Email: [e-mail]

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

Trade Name: Optical Integrity General Shaped Fiber Classification Name: Laser Surgical Instrument Accessories

#### Predicate Devices

Wave Form Manufacturing Prolase General Shaped Fiber (K020673) InnovaOuartz General Shaped Fiber (K954904), single use InnovaQuartz General Shaped Fiber (K994010), reuse Dornier Medilas H Fibers (K001243) Lumenis Slimline Fibers (K990947)

#### Device Description

The Optical Integrity General Shaped (GS) 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 GS fiber may be used for a wide variety of surgical procedures.

#### Indications for Use

The Optical Integrity 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, arthroscopes, cystoscopes, cystoscopes, gastroscopes, and colonoscopes, or for contact or non-contact surgery with or without handpieces for use in coagulation, incision/excision, ablation and vaporization of soft tissue.

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

#### Technological Characteristics and Performance Data

Design changes made to the Optical Integrity GS 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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Public Health Service

OCT 1 6 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Optical Integrity, Inc. Joe D. Brown President 8317 Front Beach Road, Suite 21 Panama City Beach, Florida 32407-4893

Re: K022338

Trade/Device Name: Optical Integrity General Shaped Fiber Regulation Number: 878.4810 Regulation Name: Laser Surgical Instrument Accessories Regulatory Class: Class II Product Code: GEX Dated: July 15, 2002 Received: July 18, 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 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.

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 D. 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" (21 CFR 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,

Stypt Rlurdu
Célia 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:

K022-338

Device Name: Optical Integrity General Shaped Fibers

Indications for Use:

The Optical Integrity 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, cystoscopes, 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 Optical Integrity General Shaped Fiber is indicated for use in medicine and surgery in the following medical specialties:

- Urology .
- Plastic Surgery .
- Radiology .
- Dermatology .
- . Pulmonology
- Gastroenterology .
- Gynecology .
- ENT .
- Lithotripsy ●
- General and Vascular Surgery ●
- Arthroscopy ●
- . Podiatry
- Orthopedics .
- Neurosurgery

Concurrence of CDRH, Office of Evaluation (ODE)

or Over-the-Counter Use Prescription Use

Stupt Rlurdu

ion of General, Restorative and Neurological Devices

510(k) Number_KOZZ338