MEGABEAM SIDEFIBER FIBER OPTIC DELIVERY SYSTEM

K060050 · Biolitec, Inc. · GEX · Jan 23, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K060050
• Device Name: MEGABEAM SIDEFIBER FIBER OPTIC DELIVERY SYSTEM
• Applicant: Biolitec, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jan 23, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Model SF-2100-H MegaBeam SideFiber Fiber Optic Delivery System is intended for use as a fiber optic delivery system in conjunction with any Ho:YAG (holmium) surgical laser with SMA 905 compatible connector. The MegaBeam SideFiber Fiber Optic Delivery System is indicated for hemostasis, ablation and vaporization of soft or fibrous tissued in discipline 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

MegaBeam SideFiber (Model SF-2100-H) is a fiber optic delivery system for Ho:YAG surgical lasers. It transmits laser energy to target tissue for hemostasis, ablation, and vaporization. The device features a quartz fiber core and a protective sheath with a distal metal tip. It is designed for insertion through the working channel of endoscopic viewing scopes (e.g., cystoscope, urethroscope). Operated by physicians in clinical or surgical settings, the device acts as a passive conduit for laser energy. It does not perform independent processing; clinical outcomes depend on the host laser system and physician control. Benefits include precise tissue interaction during endoscopic procedures.

Clinical Evidence

Bench testing only.

Technological Characteristics

Quartz fiber core; coaxially mounted protective sheath; distal metal tip; SMA 905 compatible connector; passive fiber optic delivery system.

Indications for Use

Indicated for hemostasis, ablation, and vaporization of soft or fibrous tissue in patients requiring surgical intervention via Ho:YAG laser, compatible with cystoscopes, urethroscopes, or other viewing scopes.

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

• Biolitec Inc MegaBeam Lateral Fire Fiber Optic Delivery System
• Lumenis DuoTome Side Firing Fiber
• Trimedyne VAPORMAX side firing fiber

Submission Summary (Full Text)

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### JAN 2 3 2006

#### Kobouso 510(k) SUMMARY

# Biolitec MegaBeam® SideFiber® Fiber Optic Delivery System

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Biolitec, Inc 515 Shaker Road EastLongmeadow, MA 01028

Phone: [phone] Facsimile: [phone]

Contact Person: Carol J. Morello, VMD

Date Prepared: January 6, 2006

#### Name of Device

MegaBeam SideFiber Fiber Optic Delivery System (Model SF-2100-H)

Common or Usual Name

Ho:YAG Fiber Optic Delivery System

Classification Name

Accessory to Laser Surgical Instruments

### Predicate Devices

Biolitec Inc MegaBeam Lateral Fire Fiber Optic Delivery System Lumenis DuoTome Side Firing Fiber Trimedyne VAPORMAX side firing fiber

# Intended Use / Indications for Use

The Model SF-2100-H MegaBeam SideFiber Fiber Optic Delivery System is intended for use as a fiber optic delivery system in conjunction with any Ho:YAG (holmium) surgical laser with SMA 905 compatible connector. The MegaBeam SideFiber Fiber Optic Delivery System is indicated for hemostasis, ablation and vaporization of soft or fibrous tissued in discipline 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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Kobooso

### Technological Characteristics

The SF-2100-H MegaBeam SideFiber Fiber Optic Delivery System consists of quartz fiber core and a coaxially mounted protective sheath with a metal tin at the distal end.

### Performance Data

Bench test data was provided in support of the 510(k) notice.

#### Substantial Equivalence

The SF-2100-H MegaBeam SideFiber Fiber Optic Delivery System is as safe and effective as the Biolitec MegaBeam Lateral Fiber (SideFiber) Fiber Optic Delivery System. The MegaBeam Lateral Fiber Optic Delivery System has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences between the MegaBeam Fiber Optic Delivery System and it 2 predicate devices raise no new issues of safety or effectiveness. Thus, the MegaBeam Fiber Optic Delivery System is substantially equivalent.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle faces right. Encircling the eagle is the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 3 2006

Biolitec, Inc. c/o Mr. Jonathan S. Kahan Hogan and Hartson, L.L.P. 555 13th Street, NW Washington, District of Columbia 20004-1109

Re: K060050

Roodo50
Trade/Device Name: MegaBeam SideFiber Fiber Optic Delivery System (Model SF-2100-H) 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: January 6, 2006 Received: January 6, 2006

#### Dear Mr. Kahan:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use suated in the Merce, 1976, the enactment date of the Medical Device Amendments, or to conimeres prior to May 20, 1978) 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). and Cosmetter Free) the device, subject to the general controls provisions of the Act. The r ou may, and every inions 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 such 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 cormply with all the Act's requirements, including, but not limited to: registration and listing

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#### Page 2 — Mr. Kahan

(21 CFR Part 807); labeling (21 CFR Part 801); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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,

Barbara Mielup

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### Indications for Use Statement

12660050 510(k) Number (if known):

Device Name:

Indications for Use:

The Model SF-2100-H MegaBeam SideFiber Fiber Optic Delivery System is intended for use as a fiber optic delivery system in conjunction with any Ho:YAG (holmium) surgical laser with SMA 905 compatible connector. The MegaBeam SideFiber Fiber Optic Delivery System is indicated for hemostasis, ablation and vaporization of soft or fibrous tissue in any surgical discipline 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.

Prescription Use X (Part 21 C.F.R. 801 Subpart D)

AND/OR

Over-The-Counter Use (21 C.F.R. 807 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Vorhare Budhur for mam

sion Sign-O Division of General, Restorative, and Neurological Devices

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**510(k) Number** *K060050*

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