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 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.

AI/ML Overview

This document describes the 510(k) premarket notification for the "EndoBeam™ Holmium Laser Fibers" (K120924/K120926). The information provided focuses on demonstrating substantial equivalence to predicate devices, rather than an AI/ML-based device requiring detailed performance metrics against a defined ground truth derived from expert consensus or pathology. Therefore, many of the requested fields are not applicable in this context.

Here's an analysis based on the provided text:

1. A table of acceptance criteria and the reported device performance

The submission focuses on demonstrating substantial equivalence by showing that the EndoBeam™ Holmium Laser Fibers have the same technological characteristics and intended use as predicate devices, and that nonclinical performance testing confirms their safety and effectiveness. The acceptance criteria are implicitly met by successful completion of these nonclinical tests and by showing equivalence to legally marketed devices.

Acceptance Criteria (Implied)	Reported Device Performance
Technological Characteristics Equivalence	The EndoBeam™ Holmium Laser Fibers have the same technological characteristics as the predicate devices: silica core/cladding, hard-fluoropolymer coating, and ETFE fiber jacket.
Intended Use Equivalence	The EndoBeam™ Holmium Laser Fibers have the same intended use as the predicate devices, indicated for a variety of surgical uses including ablation, incision, vaporization, and coagulation of soft/cartilaginous tissue and fragmentation of calculi.
Nonclinical Functional Performance (Safety & Effectiveness)	Nonclinical functional performance testing included visual, functional, and tensile strength testing carried out per internal test methods and IEC 61754-22.
Biocompatibility	Nonclinical biocompatibility testing was conducted in accordance with ISO 10993-1:2009 and FDA Bluebook Memorandum G95-1.
Substantial Equivalence to Predicate Devices	Nonclinical test data demonstrate that the device is safe and effective and is substantially equivalent to the legally marketed predicate devices (Laser Peripherals Holmium Bare Fibers (K972272), Laser Peripherals Reusable Holmium Fiber (K011207), SureFlex™ Laser Fiber (K050108), SlimLineEZ™ Fiber Delivery Device (K011703)).

Regarding the other requested information:

This 510(k) submission is for a physical medical device (holmium laser fibers) and does not involve AI or algorithms that would require a test set, ground truth established by experts, or training data in the typical sense of AI/ML performance evaluation. Therefore, the following points are not applicable to this submission.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable: This filing does not describe a software or AI/ML device that uses a test set of data for performance evaluation. The "performance data" refers to nonclinical functional and biocompatibility testing of the physical device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable: There is no "ground truth" establishment by experts in the context of an AI/ML system for this type of device submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable: No test set or expert adjudication is described for this device.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable: This is a physical laser fiber, not an AI-assisted diagnostic or treatment system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable: This is a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not Applicable: Ground truth for AI/ML performance is not relevant here. The "ground truth" for this device's safety and effectiveness is established through adherence to recognized standards (e.g., ISO 10993-1:2009, IEC 61754-22) and by demonstrating equivalence to predicate devices that have prior regulatory clearance and established safety records.

8. The sample size for the training set

Not Applicable: No training set is involved.

9. How the ground truth for the training set was established

Not Applicable: No training set with ground truth is involved.

Summary

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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: 770-385-4706 E-mail: terri.morris@crbard.com

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 HolmiumFiber	Laser Peripherals LLC	K011207
SureFlex™ Laser Fiber	InnovaQuartz (a subsidiary ofAmerican 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 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.

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 (800) 638-2041 or (301) 796-7100 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

Prescription Use: 风

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

Page 1 of

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
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.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.