ACCUTRAC

K110686 · Boston Scientific Corp · GEX · Mar 28, 2011 · General, Plastic Surgery

Device Facts

• Record ID: K110686
• Device Name: ACCUTRAC
• Applicant: Boston Scientific Corp
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Mar 28, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The AccuTrac Laser Fibers are intended for use in laser-based surgical applications, including, but not limited to, endoscopic, laparoscopic 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 AccuTrac Laser Fibers are designed for use with Ho:YAG lasers with a standard SMA-905 connector that have been cleared for surgical use.

Device Story

AccuTrac Laser Fiber is a fiber optic delivery device for Ho:YAG laser energy; consists of SMA-905 connector, strain relief, and silica core fiber jacketed with ETFE. Features a polished, reinforced ball-shaped 'TracTip' for energy delivery. Used in endoscopic, laparoscopic, or open surgical procedures; operated by surgeons. Device connects to cleared Ho:YAG laser systems to perform tissue vaporization, ablation, coagulation, hemostasis, excision, resection, incision, and calculi fragmentation. Output is laser energy delivered to the surgical site; assists surgeons in precise tissue management and stone treatment. Benefits include effective energy delivery for various urological and surgical applications.

Clinical Evidence

Bench testing only. Testing included tip fracture resistance, scope compatibility, power rating/output efficiency, and aiming beam testing. Samples were evaluated at T=0 and T=13 months (accelerated aging) to validate the distal ball tip design change. Results demonstrated equivalence to predicate devices.

Technological Characteristics

Fiber optic laser delivery device; silica core fiber with ETFE jacket; SMA-905 connector; reinforced ball-shaped distal tip. Compatible with Ho:YAG laser systems. No electronic components or software.

Indications for Use

Indicated for patients requiring laser-based surgical procedures including vaporization, ablation, and fragmentation of urinary and biliary calculi, and vaporization, ablation, coagulation, hemostasis, excision, resection, and incision of soft and cartilaginous tissue. Used in endoscopic, laparoscopic, and open surgical procedures.

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

• AccuMax (Straight Fire Holmium Laser Fiber) (K082928)
• Flexiva (Modified Straight Fire Laser Fiber) (K100078)

Submission Summary (Full Text)

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# Boston Scientific

## 510(k) Summary for AccuTrac Laser Fiber

## A. Sponsor

MAR 2 8 2011

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

## B. Contact

Lauren Anderson Senior Specialist, Regulatory Affairs 508-683-4707 [e-mail]

or

Nichole Riek Manager, Regulatory Affairs 508-683-4175 [e-mail]

## C. Device Name

AccuTracTM 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

## D. Predicate Device(s)

AccuMax™ (Straight Fire Holmium Laser Fiber) 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: Boston Scientific, K082928

And

FlexivaTM (Modified Straight Fire Laser Fiber) 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: Boston Scientific, K100078

## E. Device Description

The AccuTrac Laser Fibers are fiber optic laser energy delivery devices consisting of a SMA-905 connector, strain relief, and a silica core fiber jacketed

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with ethylene tetrafluoroethylene (ETFE). The AccuTrac fibers are equipped with a polished and reinforced ball-shaped TracTip. These fibers 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. Please refer to the laser system User Manual for complete information regarding applications, contraindications, precautions and warnings.

#### F. Intended Use

The AccuTrac Laser Fibers are 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 AccuTrac Laser Fibers are 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 AccuTrac Laser Fiber has the same technological characteristics (i.e. SMA 905 connector, length of fiber optic cable, and strain relief) as the predicate devices. It is equipped with a polished and reinforced ball-shaped output tip, whereas the predicate devices have a polished flat tip.

#### H. Substantial Equivalence

A direct comparison of key characteristics demonstrates that the proposed laser fiber is substantially equivalent to the predicate devices in terms of intended use, technological characteristics, and performance characteristics. The AccuTrac Laser Fiber is as safe, as effective, and performs as well as the predicate devices.

### I. Performance Testing (Bench and User Evaluation)

Boston Scientific has conducted performance testing with samples aged at T=0 and T=13 months accelerated aging in support of the distal ball tip design change. The following testing was completed to evaluate the effects of the design change:

- Tip Fracture Resistance .
- . Scope Testing
- Power Rating/Output Efficiency Testing .
- Aiming Beam Testing .

The results of the performance testing demonstrate equivalence of the AccuTrac to the predicate AccuMax and Flexiva laser fibers. The AccuTrac fibers are considered safe and effective for their intended use.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Boston Scientific Corporation % Ms. Lauren B. Anderson Senior Regulatory Affairs Specialist 100 Boston Scientific Way, M21 Marlborough, Massachusetts 01752

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Re: K110686 Trade/Device Name: AccuTrac™ Laser Fiber 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: March 24, 2011 Received: March 25, 2011
Dear Ms. Anderson:

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 10 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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Page 2 - Ms. Lauren B. Anderson

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 liast 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 forth in the quality systems (QS) regulation (2) CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 100-100.

If you desire specific advice for your device on our labeling regulation (21 CFR Pan 801), please go to http://www.fda.gov/AboutFDA/Centers0ffices/CDRH/CDRHOffices/ucm115809.html 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.ida.gov/MedicalDevices/Safety/ReportaProblem/default.htm 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 tolli inc [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Aling B. n h
for

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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Special 510(k) Premarket Notification AccuTrac Laser Fiber

## Indications for Use Statement

510(k) Number To be determined.

Device Name

AccuTracTM Laser Fiber

Indications For Use

The AccuTrac Laser Fibers are intended for use in laser-based surgical applications, including, but not limited to, endoscopic, laparoscopic 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 AccuTrac Laser Fibers are designed for use with 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)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Nifel Coder for mxm
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number