ACCUMAX

K093691 · Boston Scientific Corp · GEX · Dec 11, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K093691
• Device Name: ACCUMAX
• Applicant: Boston Scientific Corp
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Dec 11, 2009
• 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 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.

Device Story

AccuMax Straight Fire Holmium Laser Fiber is a fiber optic delivery system for Ho:YAG laser energy. Device connects to cleared holmium lasers via standard SMA-905 connector. Used by surgeons in endoscopic, laparoscopic, or open surgical settings. Fiber transmits laser energy to target site for vaporization, ablation, fragmentation of calculi, or soft/cartilaginous tissue management (coagulation, hemostasis, excision, resection, incision). Device facilitates precise energy delivery to anatomical targets, enabling minimally invasive surgical interventions. Benefits include effective tissue/calculi management through established laser surgical techniques.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Fiber optic delivery system; utilizes standard SMA-905 connector for compatibility with Ho:YAG surgical lasers. Designed for transmission of laser energy for tissue and calculi interaction. No electronic components or software.

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.

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

Boston Scientific Corporation % Intertek Testing Services NA, Inc. Mr. Daniel W. Lehtonen 2307 East Aurora Road, Unit B7 Twinsburg, Ohio 44087

DEC 1 1 2009

Re: K093691

Trade/Device Name: AccuMax™ Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: November 24, 2009 Received: November 30, 2009

Dear Mr. Lehtonen:

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 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

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Page 2 - Mr. Daniel W. Lehtonen

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 (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm 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.fda.gov/cdrh/mdr/ 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 toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

incerely yours,

ark N. Melkerson

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 Straight Fire Holmium Laser Fiber

Boston Scientific Corporation

## ATTACHMENT 1

Indications for Use Statement To be determined. 510(k) Number Device Name AccuMaxTM Indications The Straight Fire Holmium Laser Fiber is indicated for use in For Use 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)

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Concurrence of CDRH, Office of Deyice Evaluation (ODE) R8 Uni - +4 (Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number: K093691

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