FIBEROPTIC LASER DELIVERY SYSTEM

K120810 · Fiberoptic Fabrications, Inc. · GEX · Jun 28, 2012 · General, Plastic Surgery

Device Facts

• Record ID: K120810
• Device Name: FIBEROPTIC LASER DELIVERY SYSTEM
• Applicant: Fiberoptic Fabrications, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jun 28, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The fiber optic laser delivery system is intended for delivery of laser light to soft tissue in the contact and non-contact mode during surgical procedures, including via endoscopes. The fiber optic laser delivery system is intended for use with any cleared surgical laser with an SMA 905 or SMA 905 compatible connector It is indicated for use in general surgical applications for: incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in a contact or non contact mode. It is also indicated for use in open or closed endoscopic applications where incision, excision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors or lesions, tissue vaporization, hemostasis and or coagulation may be indicated. It is also indicated for use in lithotripsy with a compatible laser cleared for the desired application. It is indicated for use with Argon, KTP/532, Ho:YAG, Nd:YAG, 1.44YAG, and Diode Lasers (635-1900nm) with peak and continuous power from 1-200W. Core size 230um- 45W, 365um- 113W, 400um-135W, 600um- 200W, 800um-200W, and 1000um-200W.

Device Story

Fiber optic laser delivery system; delivers laser light to soft tissue in contact/non-contact modes; used in surgical procedures including endoscopy. Input: laser energy from external cleared surgical laser (SMA 905 connector). Output: focused laser light at distal tip for tissue interaction. Device consists of quartz glass fiber core with protective sheath; distal tips available in various configurations (flat, orb, cone, chisel, radial). Used in clinical settings by physicians. Benefits: enables precise tissue management (incision, ablation, hemostasis) via laser energy.

Clinical Evidence

Bench testing only; performance is well-established and documented as equivalent to predicate devices.

Technological Characteristics

Quartz glass fiber core with coaxially mounted protective sheath; SMA 905 or compatible connector; distal tip configurations include flat, orb, cone, chisel, and radial; sterile; compatible with 635-1900nm lasers; power handling 1-200W depending on core size (230um-1000um).

Indications for Use

Indicated for soft tissue incision, excision, vaporization, ablation, hemostasis, or coagulation in general surgery and endoscopic procedures; lithotripsy; compatible with Argon, KTP/532, Ho:YAG, Nd:YAG, 1.44YAG, and Diode lasers (635-1900nm).

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

• CeramOptec, Inc MegaBeam Fiber Optic Laser Delivery Systems (K934008, K943445, K943444, K943526, K943527, K941909)
• Biolitec Radial Emitting shaped fiber optic delivery system (K110080)

Submission Summary (Full Text)

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120810

JUN 2 8 2012

# 510(k) SUMMARY

# Fiberoptic Fabrications Inc.'s Fiberoptic Laser Delivery System

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

Fiberoptic Fabrications, Inc. 495 Main Street Wilbraham, MA 01095 [phone] Phone: Facsimile: [phone]

Carol J.Morello,VMD Contact Person:

Date Prepared: June 5, 2012

# Name of Device and Name/Address of Sponsor

Fiberoptic Fabrications Fiber optic Laser Delivery System

Fiberoptic Fabrications, Inc. 495 Main Street Wilbraham, MA 01095

#### Common or Usual Name

Fiber optic laser delivery system

## Classification Name

Surgical laser accessory

#### Predicate Devices

CeramOptec, Inc MegaBeam Fiber Optic Laser Delivery Systems (K934008,K943445,K943444,K943526,K943527,K941909) Biolitec Radial Emitting shaped fiber optic delivery system (K110080).

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Kizogies pg. 2 of

# Intended Use / Indications for Use

The fiber optic laser delivery system is intended for delivery of laser light to soft tissue in the contact and non-contact mode during surgical procedures, including via endoscopes. The fiber optic laser delivery system is intended for use with any cleared surgical laser with an SMA 905 or SMA 905 compatible connector It is indicated for use in general surgical applications for: incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in a contact or non contact mode. It is also indicated for use in open or closed endoscopic applications where incision, excision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors or lesions, tissue vaporization, hemostasis and or coagulation may be indicated. It is also indicated for use in lithotripsy with a compatible laser cleared for the desired application. It is indicated for use with Argon, KTP/532, Ho:YAG, Nd:YAG, 1.44YAG, and Diode Lasers (635-1900nm) with peak and continuous power from 1-200W. Core size 230um- 45W, 365um- 113W, 400um-135W, 600um- 200W, 800um-200W, and 1000um-200W.

## Technical Characteristics

The fiber optic laser delivery system contains the same components and design as the already cleared CeramOptec MegaBeam optical fibers and the Biolitec radial emitting shaped fiber optic delivery system. The optical fiber is composed of quartz fiber core with a coaxially mounted protective sheath. The fibers distal tip can be several configurations and the fiber can be used with handpieces. This is industry standard for delivery systems thus no questions of safety or efficacy are raised.

#### Performance Data

The performance of the fiber optic laser delivery systems is well established and documented so no performance testing is included. The fiber optic delivery systems operates in the same manner as the predicate devices and performs with no difference as compared with the predicate devices.

## Substantial Equivalence

The Fiberoptic Fabrications fiber optic laser delivery systems are as safe and effective for the indications for use as the CeramOptec fiber optic laser delivery systems and the Biolitec radial emitting shaped fiber optic delivery system previously cleared thus the Fiberoptic Fabrications fiber optic laser delivery systems are substantially equivalent.

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THAHD THEVILLANUQH ANTALI SITAO ARATH
THAHD EDWALAVUQA TATATATAAUS

| Intended Use | Fiberoptic Fabrications | | Fiberoptic Fabrications | CeramOptec MegaBeam fiber optic laser delivery systems K934008,K943445,K943444,K94 3526,K943527.K941909 | Biolitec radial emitting shaped fiber optic delivery K110080 | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|--|
| | Intended Use: The fiber optic<br>laser delivery system is<br>intended for delivery of laser<br>light to soft tissue in the<br>contact and non-contact mode<br>during surgical procedures,<br>including via endoscopes. The<br>fiber optic laser delivery<br>system is intended for use<br>with any cleared surgical<br>laser with an SMA 905 or<br>SMA 905 compatible<br>connector | CeramOptec MegaBeam fiber<br>optic laser delivery systems<br>K934008,K943445,K943444,K94<br>3526,K943527.K941909<br>The fiber optic laser delivery<br>system is intended for<br>delivery of laser light to soft<br>tissue in the contact and non-<br>contact mode during surgical<br>procedures, including via<br>endoscopes. The fiber optic<br>laser delivery system is<br>intended for use with any<br>surgical laser with an SMA<br>905 compatible connector. | Biolitec radial emitting shaped<br>fiber optic delivery<br>K110080<br>The fiber optic laser delivery<br>system is intended for<br>delivery of laser light to soft<br>tissue in the contact and non-<br>contact mode during surgical<br>procedures, including via<br>endoscopes. The fiber optic<br>laser delivery system is<br>intended for use with any<br>surgical laser with an SMA<br>905 compatible connector. | Indications for Use | | |
| It is indicated for use in general surgical applications for: incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in a contact or non contact mode. It is also indicated for use in open or closed endoscopic applications where incision, excision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors or lesions, tissue vaporization, hemostasis and or coagulation may be indicated. It is also indicated for use in lithotripsy with a compatible laser cleared for the desired application. It is indicated for use with Argon, KTP/532, Ho:YAG, Nd:YAG, 1.44YAG, and Diode Lasers (635- 1900nm) with peak and continuous power from 1- 200W. | It is indicated for use in general surgical applications for: incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), arthroscopy, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology, neurosurgery (peripheral nervous system), pulmonary surgery, cardiothoracic surgery, dental applications, endovenous occlusion of the greater saphenous vein, laser assisted lipolysis, and benign prostatic hyperplasia with a compatible laser cleared for use in the desired applications. It is also indicated for use in open or closed endoscopic applications where incision, excision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors or lesions, tissue vaporization, hemostasis and or coagulation may be indicated. It is also indicated for use in lithotripsy with a compatible laser cleared for the desired application | It is indicated for use in general surgical applications for: incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), arthroscopy, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology, neurosurgery (peripheral nervous system), pulmonary surgery, cardiothoracic surgery, dental applications, endovenous occlusion of the greater saphenous vein, laser assisted lipolysis, and benign prostatic hyperplasia with a compatible laser cleared for use in the desired applications. It is also indicated for use in open or closed endoscopic applications where incision, excision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors or lesions, tissue vaporization, hemostasis and or coagulation may be indicated. | | | | |

K120819 Par

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Kizozic

4 વદ્યદ ద్రా

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| | Fiberoptic Fabrications | CeramOptec MegaBeam fiber<br>optic laser delivery systems<br>K934008,K943445,K943444,K94<br>3526,K943527.K941909 | Biolitec radial emitting shaped<br>fiber optic delivery<br>K110080 |
|----------------------|-------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|
| Delivery Systems | | | |
| Fiber<br>Material | Flexible fiber<br>Quartz glass | Flexible fiber<br>Quartz glass | Flexible fiber<br>Quartz glass |
| Core diameter | 200-1000um | 200 - 1000um | 600 |
| Proximal end | SMA 905 connector or SMA 905<br>compatible connector | SMA 905 connector<br>HGM connector or other | SMA 905 connector<br>HGM or other |
| Sterile | Sterile | Sterile | Sterile |
| Distal End | Shaped fibers, side fibers, hand<br>pieces. Shaped fibers<br>include:flat, orb, cone, chisel, or<br>radial. | Shaped fibers, side fibers, hand<br>pieces. Shaped fibers<br>include:flat, orb, cone, or chisel | Side fibers |
| Max | Core size: 230um<br>365um<br>400um<br>600um<br>800um<br>1000um | 45W<br>113W<br>135W<br>200W<br>200W<br>200W | Up to 25W<br>N/A<br>N/A<br>200W<br>200W<br>200W |
| Recommended<br>Power | | Up to 25W<br>N/A<br>N/A<br>200W<br>200W<br>200W | |

ર જુદ રિ

199.

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3.

. . . .

izeole

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

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

JUN 2 8 2012

Fiberoptic Fabrications, Incorporated % Ms. Carol J. Morello, VMD 495 Main Street Wilbraham, Massachusetts 01095

Re: K120810

Trade/Device Name: Fiber optic laser 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: May 28, 2012 Received: June 05, 2012

Dear Ms. Morello:

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

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### Page 2 - Ms. Carol J. Morello

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.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm

Sincerely yours

for Dabo
Nor. Car. 1.

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): K120810

## Device Name: Fiber optic laser delivery system

The fiber optic laser delivery system is intended for delivery of laser light to soft tissue in the contact and non-contact mode during surgical procedures, including via endoscopes. The fiber optic laser delivery system is intended for use with any cleared surgical laser with an SMA 905 or SMA 905 compatible connector It is indicated for use in general surgical applications for: incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in a contact or non contact mode. It is also indicated for use in open or closed endoscopic applications where incision, excision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors or lesions, tissue vaporization, hemostasis and or coagulation may be indicated. It is also indicated for use in lithotripsy with a compatible laser cleared for the desired application. It is indicated for use with Argon, KTP/532, Ho:YAG, Nd:YAG, 1.44YAG, and Diode Lasers (635-1900nm) with recommended peak and continuous power from 1-200W based upon fiber diameter. Core size 230um- 45W, 365um- 113W, 400um-135W, 600um- 200W, 800um-200W, and 1000um-200W.

Prescription Use _ X (Part 21 C.F.R. 801 Subpart D) AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Division of Surgical, Orthopedic,
and Restorative Devices

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