MEGABEAM FIBER OPTIC DELIVERY SYSTEM WITH ADDITIONAL TIPS & HANDPIECE

K113709 · Biolitec Medical Devices, Inc. · GEX · Jan 20, 2012 · General, Plastic Surgery

Device Facts

• Record ID: K113709
• Device Name: MEGABEAM FIBER OPTIC DELIVERY SYSTEM WITH ADDITIONAL TIPS & HANDPIECE
• Applicant: Biolitec Medical Devices, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jan 20, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MegaBeam Fiber Optic Delivery System with Additional Tips & Handpiece 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

MegaBeam Fiber Optic Delivery System functions as an accessory to surgical laser systems. Device delivers laser energy to target tissue to perform vaporization, coagulation, incision, and excision. System includes fiber optic delivery components, handpiece, and various tips. Operated by clinicians in surgical settings. Output is laser energy directed at tissue; clinical effect depends on host laser parameters. Benefits include enabling precise tissue interaction for various surgical applications. This submission adds specific flat/bare fiber optic sizes (230µ, 365µ, 400µ, 550µ) to existing product line.

Clinical Evidence

No clinical data. Performance is established and documented on soft tissue; no specific performance testing included in this submission.

Technological Characteristics

Fiber optic delivery system for surgical lasers. Includes handpiece and various tips. Available in fiber sizes 230µ, 365µ, 400µ, and 550µ. Passive accessory device; no energy source or software.

Indications for Use

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

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 Fiber Optic Delivery System with Additional Tips & Handpiece (K946336)
• MegaBeam Fiber Optic Delivery System with Additional Tips & Handpiece (K923953)
• MegaBeam Fiber Optic Delivery System with Additional Tips & Handpiece (K943445)

Submission Summary (Full Text)

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K 113709 113

## 510(k) Summary MegaBeam Fiber Optic Delivery System with Additional Tips & Handpiece

## 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 Fiber Optic Delivery System with Additional Tips & Handpiece Biolitec Medical Devices, Inc. 515 Shaker Road East Longmeadow, Massachusetts 01028

Classification Name

ਾਂ
ਪ੍ਰ

Surgical laser accessory

## Predicate Devices

MegaBeam Fiber Optic Delivery System with Additional Tips & Handpiece, (K946336, K923953 and K943445)

## Intended Use/Indication for Use

The MegaBeam Fiber Optic Delivery System with Additional Tips & Handpiece 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 Fiber Optic Delivery System with Additional Tips & Handpiece for Biolitec Medical Devices, Inc. contains the identical same components and design as the device cleared under K946336, K923953 and K943445 for Biolitec Inc. There are no differences in technology and as such does not raise any new questions on safety or efficacy. Additional flat/ bare (no tips) fiber optic sizes of 230µ, 365µ, 400µ and 550u are included for clearance in this submission.

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113 709 2/2

## Performance Data

ﺔ ﺍﻟﻤ

Since the performance of the MegaBeam Fiber Optic Delivery System with Additional Tips & Handpiece is well established and documented on soft tissue no performance testing is being specifically included in this submission.

#### Substantial Equivalence

The MegaBeam Fiber Optic Delivery System with Additional Tips & Handpiece is as safe and effective for these Indications for Use as the MegaBeam Fiber Optic Delivery System with Additional Tips & Handpiece. Thus, the MegaBeam Fiber Optic Delivery System with Additional Tips & Handpiece 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 with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the bird symbol.

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

Biolitec Medical Devices, Incorporated % Harry Hayes, Ph.D. Regulatory Consultant 515 Shaker Road East Longmeadow, Massachusetts 01028

JAN 2 0 2012

Re: K113709

· Trade/Device Name: MegaBeam Fiber Optic Delivery System with Additional Tips and Handpiece 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: December 16, 2011 Received: December 19, 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.

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 – Harry Haves, Ph.D.

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 (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 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,

s,

erson

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 Fiber Optic Delivery System with Additional Tips & Handpiece.

The MegaBeam Fiber Optic Delivery System with Indications for Use: Additional Tips & Handpiece 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.

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

Nail R.P. Oden for mxm

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

510(k) Number. K113709.

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

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