MEGABEAM REUSABLE FIBER OPTIC DELIVERY SYSTEM

K113688 · Biolitec Medical Devices, Inc. · GEX · Mar 13, 2012 · General, Plastic Surgery

Device Facts

• Record ID: K113688
• Device Name: MEGABEAM REUSABLE FIBER OPTIC DELIVERY SYSTEM
• Applicant: Biolitec Medical Devices, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Mar 13, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

TheMegaBeam Reusable Fiber Optic Delivery System is intended for use as an accessory to any surgical laser system to vaporize, coagulate, incise and excise tissue for any application for which the lasers are cleared.

Device Story

The MegaBeam Reusable Fiber Optic Delivery System functions as a passive accessory to surgical laser systems. It delivers laser energy to a target site to perform tissue vaporization, coagulation, incision, and excision. The device is intended for use by clinicians in surgical settings where laser procedures are performed. It does not contain active electronic components or software; it serves solely as a conduit for laser light transmission. The device benefits patients by enabling precise surgical interventions consistent with the capabilities of the connected laser system.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Fiber optic delivery system designed as a surgical laser accessory. The device utilizes identical components and design specifications as the predicate device (K980838). It is a passive mechanical accessory with no electronic or software components.

Indications for Use

Indicated for use as an accessory to surgical laser systems for the vaporization, coagulation, incision, and excision of tissue in any application for which the host laser is cleared.

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 Reusable Fiber Optic Delivery System (K980838)

Submission Summary (Full Text)

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MAR. 1 3 2012

## 510(k) Summarv MegaBeam Reusable Fiber Optic Deliverv System

K113688

## 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: December 14, 2011

# Name of Device and Name/Address of Sponsor

MegaBeam Reusable Fiber Optic Delivery System Biolitec Medical Devices, Inc. 515 Shaker Road East Longmeadow, Massachusetts 01028

Classification Name

Surgical laser accessory

#### Predicate Devices

MegaBeam Reusable Fiber Optic Delivery System, (K980838)

#### Intended Use/Indication for Use

TheMegaBeam Reusable Fiber Optic Delivery System is intended for use as an accessory to any surgical laser system to vaporize, coagulate, incise and excise tissue for any application for which the lasers are cleared.

#### Technological Characteristics

The MegaBeam Reusable Fiber Optic Delivery System for Biolitec Medical Devices, Inc. contains the identical same components and design as the device cleared under K980838 for Biolitec Inc. There are no differences in technology and as such does not raise any new questions on safety or efficacy.

#### Performance Data

Since the performance of the MagaBeam Reusable Fiber Optic Delivery System is well established and documented on soft tissue no performance testing is being specifically included in this submission.

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#### Substantial Equivalence

The MegaBeam Reusable Fiber Optic Delivery System is as safe and effective for these Indications for Use as the Biolitec Inc MegaBeam Reusable Fiber Optic Delivery System. Thus, the MegaBeam Reusable 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 features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.

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

Biolitec Medical Devices, Inc. % Mr. Harry Hayes 515 Shaker Road East Longmeadow, Massachusetts 01028

MAR 1 3 2012

Re: K113688 Trade/Device Name: MegaBeam Reusable Fiber 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: II Product Code: GEX Dated: December 14, 2011 Received: December 15, 2011

Dear Mr. 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.

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. Harry Hayes

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 (OS) 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/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 toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark N. Melasky

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):_____________________________________________________________________________________________________________________________________________________

# Device Name: MegaBeam Reusable Fiber Optic Delivery System

Indications for Use:

The MegaBeam Reusable Fiber Optic Delivery System is intended for use as an accessory to any surgical laser system to vaporize, coagulate, incise and excise tissue for any application for which the lasers are cleared.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R.P. Snyder for mxm

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

510(k) Number K 113688

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

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