RADIAL-EMITTING SHAPED FIBER OPTIC DELIVERY SYSTEM

K110080 · Biolitec, Inc. · GEX · Feb 24, 2011 · General, Plastic Surgery

Device Facts

• Record ID: K110080
• Device Name: RADIAL-EMITTING SHAPED FIBER OPTIC DELIVERY SYSTEM
• Applicant: Biolitec, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Feb 24, 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, 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 contact or non-contact, open or closed endoscopic procedures; enables incision, ablation, cutting, vaporization, hemostasis, and coagulation; operated by physicians in clinical settings; output is laser energy; clinical benefit includes precise tissue interaction for surgical applications; endovenous occlusion; and lipolysis.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Fiber optic delivery system; SMA 905 compatible connector; radial-emitting design; passive accessory for surgical lasers.

Indications for Use

Indicated for soft tissue incision, excision, ablation, cutting, vaporization, hemostasis, and coagulation in 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

• Megabeam Radial Fiber (K924258)
• Ceralas F 1060 nm & 1320nm (K953851)
• Ceralas 980nm & 1470nm diode laser family (K100726, K101712, K102755)

Submission Summary (Full Text)

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# 510(k) Summary K110080 - Radial-Emitting Shaped Fiber Optic Delivery System

## Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared Biolitec, Inc.

515 Shaker Road East Longmeadow, Massachusetts 01028 [phone] Phone: Facsimile: [phone]

Contact Person: Harry Hayes, Ph.D. - Regulatory Consultant Date prepared: January 10, 2011

## Name of Device and Name/Address of Sponsor

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

#### Classification Name

Surgical laser accessory

#### Predicate Devices

Megabeam Radial Fiber (K924258) for Nd: YAG lasers. Ceralas F 1060 nm & 1320nm (K953851). Ceralas 980nm & 1470nm diode laser family, (K100726, K101712, K102755).

#### 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, 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 contains the same basic components and design as the cleared Megabeam Radial fiber and theCeralas diode laser family is substantially similar in performance and technology to the cleared Nd: YAG laser. Any minor differences in technology do not raise any new questions on safety or efficacy.

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#### 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 Indication for Use as the Megabeam Radial-Emitting Shaped Fiber Optic Delivery System. The Ceralas diode laser family has the same intended uses, indications, technological characteristics, and principles of operation as its predicate Nd: Y AG devices. Thus, the Ceralas diode laser family is substantially equivalent to its predicate device.

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

Biolitec, Inc. % Ms. Nancy Foley 515 Shaker Road East Longmeadow, Massachusetts 01028

# FEB 2 4 2011

Re: K110080

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: January 10, 2011 Reccived: January 11, 2011

Dear Ms. Foley:

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 - Ms. Nancy Foley

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/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,

A. is. R.h.
for.

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: Radial-Emitting Shaped Fiber Optic Delivery System

Indications 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.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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

| 510(k) Number | K110080 |
|---------------|---------|
|---------------|---------|

| Prescription Use | <div> <span style="text-decoration: underline;">✓</span> </div> |
|-------------------------|-----------------------------------------------------------------|
| (Per 21 C.F.R. 801.109) | |

OR

| 510(l) Number | |
|---------------|--|
|---------------|--|

Orthopedic, devices

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