RADIAL-EMITTING SHAPED FIBER OPTIC DELIVERY SYSTEM

K112442 · Biolitec Medical Devices, Inc. · GEX · Sep 30, 2011 · General, Plastic Surgery

Device Facts

• Record ID: K112442
• Device Name: RADIAL-EMITTING SHAPED FIBER OPTIC DELIVERY SYSTEM
• Applicant: Biolitec Medical Devices, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Sep 30, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Radial Emitting Shaped Fiber Optic Delivery System, is intended for use as a fiber delivery system in conjunction with any surgical laser with an SMA 905 compatible connector. It is indicated for use in general surgical applications for incision, excision, ablation, cutting, vaporization, hemostasis, and coagulation of soft tissue contact or non-contact, open or closed endoscopic applications where incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, tissue vaporization, hemostasis and/or coagulation may be indicated. The fiber is indicated for use in general surgery, urology, gastroenterology, gynecology, dermatology, neurosurgery, plastic surgery, ENT/ otolaryngology, endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux and laser assisted lipolysis with a compatible laser marketed for use in the desired application.

Device Story

Fiber optic delivery system; connects to surgical lasers via SMA 905 connector; transmits laser energy to target soft tissue. Used in clinical settings (OR, endoscopic suites) by physicians. Enables incision, excision, ablation, coagulation, and vaporization of tissue; facilitates endovenous occlusion and laser-assisted lipolysis. Device acts as passive conduit for laser energy; clinical decision-making relies on physician control of laser parameters and fiber positioning. Benefits include precise tissue interaction and minimally invasive surgical access.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Fiber optic delivery system; SMA 905 compatible connector; passive optical component; no electronic or software components.

Indications for Use

Indicated for patients requiring soft tissue surgery (incision, excision, ablation, cutting, vaporization, hemostasis, coagulation) across general surgery, urology, gastroenterology, gynecology, dermatology, neurosurgery, plastic surgery, and ENT/otolaryngology. Also indicated for endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux and laser-assisted lipolysis.

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

• Radial-Emitting Shaped Fiber Optic Delivery System (K110080)

Submission Summary (Full Text)

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# SEP 3 0 2011

K112442..

## 510(k) Summary Radial-Emitting Shaped 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: August 16, 2011

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

Radial-Emitting Shaped Fiber Optic Delivery System Biolitec Medical Devices, Inc. 515 Shaker Road East Longmeadow, Massachusetts 01028

### Classification Name

Surgical laser accessory

### Predicate Devices

Radial-Emitting Shaped Fiber Optic Delivery System, (K110080)

#### Intended Use/Indication for Use

The Radial Emitting Shaped Fiber Optic Delivery System, is intended for use as a fiber delivery system in conjunction with any surgical laser with an SMA 905 compatible connector. It is indicated for use in general surgical applications for incision, excision, ablation, cutting, vaporization, hemostasis, and coagulation of soft tissue contact or non-contact, open or closed endoscopic applications where incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, tissue vaporization, hemostasis and/or coagulation may be indicated. The fiber is indicated for use in general surgery, urology, gastroenterology, gynecology, dermatology, neurosurgery, plastic surgery, ENT/ otolaryngology, endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux and laser assisted lipolysis with a compatible laser marketed for use in the desired application.

#### Technological Characteristics

The Radial Emitting Shaped Fiber Optic Delivery System for Biolitec Medical Devices. Inc. contains the identical same components and design as the device

GBDA/ BioMD-RF-DL-081611-04

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cleared under K110080 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 Radial-Emitting Shaped 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 Radial Emitting Shaped Fiber Optic Delivery System is as safe and effective for these Indications for Use as the Biolitec Inc Radial-Emitting Shaped Fiber Optic Delivery System. Thus, the Radial Emitting Shaped Fiber Optic Delivery System for Biolitec Medical Devices, Inc. is substantially equivalent to its predicate device.

. ·

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

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 depiction of a human figure with three flowing lines above it, all enclosed within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the perimeter of the circle.

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

Biolitec Medical Devices, Inc. % Harry Haves, Ph.D. 515 Shaker Road East Longmeadow, Massachusetts 01028

SEP 3 0 2011

Re: K112442

Trade/Device Name: Radial-Emitting Shaped 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: Class II Product Code: GEX Dated: August 16, 2011 Received: August 24, 2011

Dear Dr. Haves:

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

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Page 2 - Harry Haves, Ph.D.

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 (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/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. 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

< 11 2442 510(k) Number (if known):

:

## Device Name: Radial-Emitting Shaped Fiber Optic Delivery System

The Radial Emitting Shaped Fiber Optic Delivery Indications for Use: System, is intended for use as a fiber delivery system in conjunction with any surgical laser with an SMA 905 compatible connector. It is indicated for use in general surgical applications for incision, excision, ablation, cutting, vaporization, hemostasis, and coagulation of soft tissue contact or non-contact, open or closed endoscopic applications where incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, tissue vaporization, hemostasis and/or coagulation may be indicated. The fiber is indicated for use in general surgery, urology, gastroenterology, gynecology, dermatology, neurosurgery, plastic surgery, ENT/ otolaryngology, endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux and laser assisted lipolysis with a compatible laser marketed for use in the desired application.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil RP Sdl for men

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

510(k) Number K112442

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

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

GBDA/ BioMD-RF-DL-081611-04

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