ENDOBEAM HOLMIUM LASER FIBERS

K120926 · C.R. Bard, Inc. · GEX · Jul 27, 2012 · General, Plastic Surgery

Device Facts

• Record ID: K120926
• Device Name: ENDOBEAM HOLMIUM LASER FIBERS
• Applicant: C.R. Bard, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jul 27, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The EndoBeam™ Holmium Laser Fibers are indicated for a variety of surgical uses including open, laparoscopic or endoscopic ablation, incision, excision, vaporization, and coagulation of soft and cartilaginous tissue and in surgical procedures involving vaporization, ablation, and fragmentation of calculi. The delivery system may be used in surgical specialty or procedures for which compatible Holmium and Nd:YAG lasers have received regulatory clearance. Refer to the applicable laser system user manual for complete information regarding applications, contraindications, precautions and warnings when using this fiber.

Device Story

EndoBeam™ Holmium Laser Fibers are fiber optic delivery devices for Ho:YAG (2140nm) and Nd:YAG (1064nm) laser energy. Components include SMA 905 connector, strain relief, silica core/clad fiber, and ETFE jacket; reusable models include protective sheath. Used in OR/clinic settings by surgeons for soft/cartilaginous tissue procedures and calculi fragmentation. Device acts as passive conduit for laser energy from external laser system to surgical site. Output is forward-directed laser beam used for tissue interaction. Clinical benefit derived from precise tissue ablation/coagulation/fragmentation capabilities of compatible laser systems.

Clinical Evidence

Bench testing only. Included visual, functional, and tensile strength testing per internal methods and IEC 61754-22. Biocompatibility testing conducted per ISO 10993-1:2009 and FDA Bluebook Memorandum G95-1.

Technological Characteristics

Fiber optic delivery system; silica core/cladding; hard-fluoropolymer coating; ETFE jacket; SMA 905 connector; polished flat output tip. Core diameters: 200, 272, 365, 365 reduced buffer, 550, 1000 microns. Lengths: 2.5m or 3.0m. Sterilization: Ethylene Oxide (EtO). Connectivity: Passive fiber optic interface to external laser source. Standards: IEC 61754-22 (connectors), ISO 10993-1 (biocompatibility).

Indications for Use

Indicated for patients requiring surgical ablation, incision, excision, vaporization, or coagulation of soft and cartilaginous tissue, and vaporization, ablation, or fragmentation of calculi via open, laparoscopic, or endoscopic procedures. Compatible with cleared Ho:YAG and Nd:YAG laser systems.

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

• Laser Peripherals Holmium Bare Fibers (K972272)
• Laser Peripherals Reusable Holmium Fiber (K011207)
• SureFlex™ Laser Fiber (K050108)
• SlimLineEZ™ Fiber Delivery Device (K011703)

Submission Summary (Full Text)

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K120924

Section 4: 510(k) Summary 510/k) Premarket Notification: EndoBeam™ Holmium Laser Fibers, Page 1 of 2

JUL 2 7 2012

Bard Medical Division C.R. Bard Inc. 8195 Industrial Blvd. Covington, GA 30014

# RAIRD | MEDICAL

#### 510(k) Summary Section 4:

The following information is provided as required by 21 CFR §807.92 for the EndoBeam™ Holmium Laser Fiber 510(k) premarket notification. In response to the Safe Medical Devices Act of 1990, the following is a summary of the safety and effectiveness information upon which the substantial equivalence determination is based.

| BARD Medical Division |
|-----------------------|
| C. R. BARD, Inc. |
| 8195 Industrial Blvd. |
| Covington, GA 30014 |

Contact:

Sponsor:

Terri Morris Regulatory Affairs Specialist Bard Medical Division C. R. Bard, Inc. Ph: 770-784-6994 Fax: [phone] E-mail: [e-mail]

Date Prepared:

February 29, 2012

Subject Device:

Trade Name: EndoBeam™ Holmium Laser Fibers Common/Usual Name: Holmium Laser Fiber Classification Name: Powered Laser Surgical Instrument Regulation: 21 CFR §878.4810 Classification: II Product Code: GEX

Predicate Device(s): The EndoBeam™ Holmium Laser Fiber is substantially equivalent with respect to the following predicate devices:

| Product | Company | 510(k) Number |
|---------------------------------------------|------------------------------------------------------------|---------------|
| Laser Peripherals Holmium Bare Fibers | Laser Peripherals LLC | K972272 |
| Laser Peripherals Reusable Holmium<br>Fiber | Laser Peripherals LLC | K011207 |
| SureFlex™ Laser Fiber | InnovaQuartz (a subsidiary of<br>American Medical Systems) | K050108 |
| SlimLineEZ™ Fiber Delivery Device | Lumenis | K011703 |

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Section 4: 510(k) Summary

510(k) Premarket Notification: EndoBeam™ Holmium Laser Fibers, Page 2 of 2

Device Description: The EndoBeam™ Holmium Laser Fibers are free-beam delivery devices that transmit laser energy in a forward direction. The devices are either 2.5 meters (8.2 ft.) or 3.0 meters (9.8 ft) in length and are terminated with a laser specific connector on the proximal end. These delivery systems are capable of delivering Ho:YAG (2140nm) and Nd:YAG (1064nm). The devices are either single use or reusable and are supplied Ethylene Oxide (EtO) sterilized.

The Bard Holmium series of laser fibers are fiber optic laser energy delivery devices consisting of an SMA 905 connector, strain relief, and a silica core/silica clad fiber jacketed with ethylene tetrafluoroethylene (ETFE). The fibers are further equipped with a polished, flat output tip. These fibers may be used in a variety of laser-based surgical cases as an integral part of laser systems.

The line of reusable laser fibers will feature a protective sheath outside of the jacketed fiber and extending from the strain relief to the midpoint of the fiber length.

Intended Use: The EndoBeam™ Holmium Laser Fibers are indicated for a variety of surgical uses including open, laparoscopic or endoscopic ablation, incision, vaporization, and coagulation of soft and cartilaginous tissue and in surgical procedures involving vaporization, ablation, and fragmentation of calculi.

The delivery system may be used in surgical specialty or procedures for which compatible Holmium and Nd:YAG lasers have received regulatory clearance. Refer to the applicable laser system user manual for complete information regarding applications, contraindications, precautions and warnings when using this fiber.

Technological Characteristics: The EndoBeam™ Holmium Laser Fibers have the same technological characteristics as the predicate devices. The fiber core and cladding for the subject device are made from silica which is the same material used in all the predicate devices. Additionally, as with the predicate devices, the fiber coating of the subject device is constructed from hard-fluoropolymer and the fiber jacket is Ethylene Tetrafluoroethylene (ETFE). Various core diameter sizes (200, 272, 365, 365 reduced buffer, 550 and 1000 micron) are offered.

Performance Data: Nonclinical functional performance testing was conducted and included visual, functional and tensile strength testing carried out per internal test methods and per IEC 61754-22 - IEC Standard for Fiber Optic Connectors. Nonclinical biocompatibility testing in accordance with ISO 10993-1:2009, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process and FDA Bluebook Memorandum G95-1, Use of International Standard ISO 10993 "Biological Evaluation of Medical Devices Part 1: Evaluation of Testing" was conducted.

Substantial Equivalence: The EndoBeam™ Holmium Laser Fibers have the same intended use as the predicate devices. Nonclinical test data demonstrate that the device is safe and effective and is substantially equivalent to the legally marketed predicate devices.

CONFIDENTIAL

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the edge. In the center of the seal is an abstract image of an eagle.

#### Public Health Service

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

JUL 2 7 2012

C.R. Bard, Incorporated % Ms. Terri Morris Regulatory Affairs Specialist, Bard Medical Division 8195 Industrial Boulevard Covington, Georgia 30209

Re: K120926

Trade/Device Name: EndoBeam™ Holmium Laser Fibers 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: July 20, 2012 Received: July 23, 2012

Dear Ms. Morris:

We have reviewed vour 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- Ms. Terri Morris

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.

Erinal Keith

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Device Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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cations

510(k) Number:

Device Name:

Indications for Use:

# K120926

EndoBeam™ Holmium Laser Fibers

The EndoBeam™ Holmium Laser Fibers are indicated for a variety of surgical uses including open, laparoscopic or endoscopic ablation, incision, excision, vaporization, and coagulation of soft and cartilaginous tissue and in surgical procedures involving vaporization, ablation and fragmentation of calculi.

The delivery system may be used in surgical specialty or procedures for which compatible Holmium and Nd:YAG lasers have received regulatory clearance. Refer to the applicable laser system user manual for complete information regarding applications, contraindications, precautions and warnings when using this fiber.

Prescription Use: 风

or

Over the Counter Use

Part 21 CFR 801 Subpart D

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nil R.P. Ogale for mkm
(Division Sign. DM)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K120926

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