STRAIGHT FIRE HOLMIUM LASER FIBER

K082928 · Boston Scientific Corp · GEX · Oct 16, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K082928
• Device Name: STRAIGHT FIRE HOLMIUM LASER FIBER
• Applicant: Boston Scientific Corp
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Oct 16, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The Straight Fire Holmium Laser Fiber is intended for use in laser-based surgical applications, including, but not limited to endoscopic, laparascopic and open surgical procedures involving vaporization, ablation and fragmentation of calculi (urinary and biliary) and surgical procedures involving vaporization, ablation, coagulation, hemostasis, excision, resection and incision of soft and cartilaginous tissue. The Straight Fire Holmium Laser Fiber is designed for use with holmium (Ho:YAG) lasers with a standard SMA 905 connector that have been cleared for surgical use.

Device Story

Fiber optic laser energy delivery device; consists of silica core fiber jacketed with ETFE; features SMA 905 connector and polished, flat output tip. Used as integral component of cleared Ho:YAG laser systems. Operated by surgeons in endoscopic, laparoscopic, or open surgical settings. Transmits laser energy from external source to target tissue/calculi. Enables vaporization, ablation, coagulation, hemostasis, excision, resection, and incision. Benefits patient by facilitating minimally invasive surgical interventions.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Silica core fiber; ETFE jacket; SMA 905 connector; polished flat output tip. Passive energy delivery device. No software or electronic components.

Indications for Use

Indicated for patients requiring endoscopic, laparoscopic, or open surgical procedures involving vaporization, ablation, and fragmentation of urinary and biliary calculi, or vaporization, ablation, coagulation, hemostasis, excision, resection, and incision of soft and cartilaginous tissue.

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

• AccuFlexTM Laser Lithotripsy Fibers (K050108)
• SlimLineEZ™ Fiber Device (K011703)

Submission Summary (Full Text)

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#### Boston Scientific Corporation

## 510(k) Summary for Straight Fire Holmium Laser Fiber

#### A. Sponsor

Boston Scientific Corporation Urology and Women's Health Division 100 Boston Scientific Way Marlborough, MA 01756

### B. Contact

Lauren B. Anderson Specialist, Regulatory Affairs 508-683-4707

or Donna Gardner Director, Regulatory Affairs 508-683-4398

#### C. Device Name

| Trade name: | To Be Determined<br>*Although the Trade Name is to be determined, for<br>purposes of this submission the proposed device will be<br>referred to as the Straight Fire Holmium Laser Fiber |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common/usual name: | Laser Instrument, Surgical, Powered |
| Classification Name: | GEX - Laser surgical instrument for use in general and<br>plastic surgery and in dermatology<br>21 CFR 878.4810, Class II |

#### D. Predicate Device(s)

| Trade name: | AccuFlexTM Laser Lithotripsy Fibers |
|-------------------------|----------------------------------------------------------------------------------------------|
| Common/usual name: | Laser Instrument, Surgical, Powered |
| Classification Name: | GEX - Laser surgical instrument for use in general and<br>plastic surgery and in dermatology |
| | 21 CFR 878.4810, Class II |
| Premarket Notification: | InnovaQuartz, Inc., K050108 |

and

SlimLineEZ™ Fiber Device Trade name: Common/usual name: Laser Instrument, Surgical, Powered Classification Name: GEX - Laser surgical instrument for use in general and plastic surgery and in dermatology 21 CFR 878.4810, Class II Premarket Notification: Lumenis, K011703

Traditional 510(k) Straight Fire Holmium Laser Fiber August 25, 2008

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Boston Scientific Corporation

## E. Device Description

The Straight Fire Holmium Laser Fiber is a fiber optic laser energy delivery device consisting of a silica core fiber jacketed with ethelylene tetraflouroethylene (ETFE) and a SMA 905 connector. It is equipped with a polished, flat output tip. This fiber may be used in a variety of laser based surgical cases as an integral part of laser systems.

For use with Ho:YAG laser systems with a standard SMA 905 connector that have been cleared for surgical use. Recommended Ho: YAG lasers are Dornier and New Star.

## F. Intended Use

The Straight Fire Holmium Laser Fiber is intended for use in laser-based surgical applications, including, but not limited to endoscopic, laparascopic and open surgical procedures involving vaporization, ablation and fragmentation of calculi (urinary and biliary) and surgical procedures involving vaporization, ablation, coagulation, hemostasis, excision, resection and incision of soft and cartilaginous tissue.

The Straight Fire Holmium Laser Fiber is designed for use with holmium (Ho:YAG) lasers with a standard SMA 905 connector that have been cleared for surgical use.

# G. Technological Characteristics

The Straight Fire Holmium Laser Fiber has the same technological characteristics (i.e. SMA 905 connector, length of fiber optic cable, and strain relief) as the predicate devices.

#### H. Substantial Equivalence

Utilizing FDA's Guidance for Industry and FDA Staff "Format for Traditional and Abbreviated 510(k)s" a direct comparison of key characteristics demonstrates that the proposed laser fiber is substantially equivalent to the predicate device in terms of intended use, technological characteristics, and performance characteristics. The Straight Fire Holmium Laser Fiber is as safe, as effective, and performs as well as the predicate devices.

Traditional 510(k) Straight Fire Holmium Laser Fiber August 25, 2008

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white.

OCT 1 6 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Boston Scientific Corporation % Intertek Testing Services Kachi C. Enyinna Staff Engineer - Medical Devices 2307 East Aurora Road Twinsburg, Ohio 44087 .

Re: K082928

Trade/Device Name: Undetermined Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: September 30, 2008 Received: October 1, 2008

Dear Kachi Enyinna:

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

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Page 2 -- Kachi C. Enyinna

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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 vours.

Mark N Millerson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Boston Scientific Corporation

## Indications for Use Statement

510(k) Number (if Known): K082923

Device Name: Undetermined

#### Indications For Use:

The Straight Fire Holmium Laser Fiber is indicated for use in laser-based surgical applications, including, but not limited to endoscopic, laparascopic and open surgical procedures involving vaporization, ablation and fragmentation of calculi (urinary and biliary) and surgical procedures involving vaporization, ablation, coagulation, hemostasis, excision, resection and incision of soft and cartilaginous tissue.

The Straight Fire Holmium Laser Fiber is designed for use with holmium (Ho:YAG) lasers with a standard SMA-905 connector that have been cleared for surgical use.

Prescription Use X (21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE

Hilke Olds for mixer

Division of General, Restorative. and Neurological Devices

Traditional 510(k) Straight Fire Holmium Laser Fiber August 25, 2008

510(k) Number K082928