TWISTER SIDE FIRE OPTICAL FIBER DELIVERY SYSTEM

K112987 · Biolitec Medical Devices, Inc. · GEX · Dec 16, 2011 · General, Plastic Surgery

Device Facts

• Record ID: K112987
• Device Name: TWISTER SIDE FIRE OPTICAL FIBER DELIVERY SYSTEM
• Applicant: Biolitec Medical Devices, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Dec 16, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Twister™ Side Fire Fiber Optic Delivery System is a delivery accessory used to deliver optical energy and is indicated for use in general surgical applications in combination with any SMA-compatible laser system also indicated for the same applications. It is indicated for use in hemostasis, ablation and vaporization of soft or fibrous tissue in any surgical discipline in contact or non contact mode with a compatible laser marketed for the desired application. The system can be used with or without a standard viewing scope. It can be inserted through the working channel of a cystoscope. urethroscope, or any other viewing scope.

Device Story

Twister™ Side-Firing Fiber Optic Delivery System acts as a passive accessory for surgical laser systems; transmits optical energy from an external SMA-compatible laser source to target tissue. Device consists of a fiber optic delivery fiber; inserted through working channels of standard endoscopic viewing scopes (cystoscopes, urethroscopes) or used manually. Operated by surgeons in clinical/surgical settings. Facilitates hemostasis, ablation, and vaporization of soft or fibrous tissue via laser energy delivery. No active electronic components or software; purely mechanical delivery accessory. Benefits patient by enabling minimally invasive surgical access to internal tissue for precise laser-based treatment.

Clinical Evidence

No clinical data. Bench testing only; performance is established and documented for soft tissue applications.

Technological Characteristics

Fiber optic delivery system; SMA 905 compatible connector; side-firing configuration. Materials of construction are identical to the predicate Megabeam® system. Passive device; no energy source, software, or electronic components.

Indications for Use

Indicated for hemostasis, ablation, and vaporization of soft or fibrous tissue in any surgical discipline. Compatible with SMA 905 laser systems. Used in contact or non-contact mode, with or without viewing scopes (e.g., cystoscope, urethroscope).

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

• Megabeam® Lateral/ Side Fire Fiber Optic Delivery System (K940008, K941909, K943444, K943526, K943527, K060050)

Submission Summary (Full Text)

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# 12987

DEC 1 6 2011

## 510(k) Summary Twister™ Side-Firing Fiber Optic Delivery System

#### Submitter's Name. Address. Telephone Number, Contact Person and Date Prepared Biolitec Medical Devices, Inc. 515 Shaker Road East Longmeadow, Massachusetts 01028 [phone] Phone: Facsimile: [phone]

Contact Person: Harry Hayes, Ph.D. - Regulatory Consultant Date prepared: October 5, 2011

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

Twister™ Side-Firing Fiber Optic Delivery System Biolitec Medical Devices, Inc. 515 Shaker Road East Longmeadow, Massachusetts 01028

#### Classification Name

Surgical laser & accessories

## Predicate Devices

Megabeam® Lateral/ Side Fire Fiber Optic Delivery System, (K940008, K941909, K943444, K943526, K943527 and K060050)

## Intended Use/Indication for Use

The Twister™ Side Fire Fiber Optic Delivery System is a delivery accessory used to deliver optical energy and is indicated for use in general surgical applications in combination with any SMA-compatible laser system also indicated for the same applications. It is indicated for use in hemostasis, ablation and vaporization of soft or fibrous tissue in any surgical discipline in contact or non contact mode with a compatible laser marketed for the desired application. The system can be used with or without a standard viewing scope. It can be inserted through the working channel of a cystoscope. urethroscope, or any other viewing scope.

## Technological Characteristics

The Biolitec Medical Devices, Inc. Twister™ Side-Fire Fiber Optic Delivery System contains equivalent components and identical patient-contact materials as the cleared Biolitec Inc. Megabeam Lateral/ Side Fire Fiber Optic Delivery Systems.

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#### Performance Data

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Since the performance of the Twister™ Side-Fire Fiber Optic Delivery System is well established and documented on soft tissue no performance testing is being specifically included in this submission.

## Substantial Equivalence

The Twister™ Side-Fire Fiber Optic Delivery System is as safe and effective for these Indications for Use as the Biolitec Inc MegaBeam® Lateral/ Side Fire Fiber Optic Delivery System. Thus, the Twister™ Side Fire Fiber Optic Delivery System for Biolitec Medical Devices, Inc. is substantially equivalent to its predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol on the right side. To the left of the bird symbol, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

DEC 1 6 2011

Biolitec Medical Device, Incorporated % Genmarhay, BDA Harry Hayes, Ph.D. Regulatory Consultant . 1349 Main Road Grandville, Massachusetts 01034

Re: K112987

Trade/Device Name: Twister™ Side-Firing Optic Delivery System 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: October 5, 2011 Received: October 6, 2011

Dear Dr. Hayes:

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. 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.

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Page 2 - Harry Hayes, Ph.D.

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); medical device 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/MedicalDevices/Safety/ReportalProblem/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 toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDeviccs/ResourcesforYou/Industry/default.htm.

Sincerely yours,

fon Neth Lundi

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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Indications for Use Statement

510(k) Number (if known): k|12687

Device Name:

Twister™ Side-Firing Fiber Optic Delivery System

Indications for Use:

The Twister™ Side Firing Fiber Optic Delivery System is intended for use as a fiber optic delivery system in conjunction with any surgical laser with SMA 905 compatible connector. The Twister™ Side-Firing Fiber Optic Delivery System is indicated for hemostasis, ablation and vaporization of soft or fibrous tissue in any surgical discipline in contact or non contact mode with a compatible laser marketed for the desired application. The system can be used with or without a standard viewing scope. It can be inserted through the working channel of a cystoscope, urethroscope, or any other viewing scope.

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#### Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use V (Per 21 C.F.R. 801.109) OR

Over The Counter Use (Optional Format 1-2-96)

Nielae Ogden for mkm

Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K112987

GBDA/ BioELVeS-060710-02

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