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 Description

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.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called the "Fiberoptic Laser Delivery System." This document is a premarket notification to the FDA, demonstrating substantial equivalence to already legally marketed predicate devices, rather than a study proving the device meets acceptance criteria through performance testing.

Therefore, many of the requested categories for acceptance criteria and study details are not applicable or explicitly stated as not performed in this type of submission. The submission relies on the established performance of the predicate devices for substantial equivalence.

Here's the information that can be extracted or deduced from the provided text, with clarifications where the requested information is not available:

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

The submission does not present specific acceptance criteria with quantitative performance values for the new device, nor does it report new performance data as a study was not conducted. Instead, it claims substantial equivalence to predicate devices. The "performance" is implicitly deemed acceptable if it matches that of the predicate devices.

Feature / Characteristic	Acceptance Criteria (from Predicate Device)	Reported Device Performance (Fiberoptic Fabrications)
Intended Use	Delivery of laser light to soft tissue in contact and non-contact mode during surgical procedures, including via endoscopes. Intended for use with any cleared surgical laser with an SMA 905 or SMA 905 compatible connector. Indicated for general surgical applications (incision, excision, vaporization, ablation, hemostasis, coagulation), endoscopic applications (incision, excision, dissection, tumor/lesion removal, tissue vaporization, hemostasis, coagulation), and lithotripsy with compatible lasers. Specified compatible lasers (Argon, KTP/532, Ho:YAG, Nd:YAG, 1.44YAG, Diode Lasers (635-1900nm)) with peak and continuous power from 1-200W, and specific core size power ratings.	Matches predicate device's intended use and indications.
Fiber Material	Flexible fiber, Quartz glass	Flexible fiber, Quartz glass
Core Diameter	200 - 1000 µm	200 - 1000 µm
Proximal End	SMA 905 connector or SMA 905 compatible connector, HGM connector or other	SMA 905 connector or SMA 905 compatible connector
Sterility	Sterile	Sterile
Distal End	Shaped fibers, side fibers, hand pieces (flat, orb, cone, chisel, radial)	Shaped fibers, side fibers, hand pieces (flat, orb, cone, chisel, or radial)
Maximum Recommended Power	Core size-specific (e.g., 230um-45W, 365um-113W, 400um-135W, 600um-200W, 800um-200W, 1000um-200W)	Core size-specific (e.g., 230um-45W, 365um-113W, 400um-135W, 600um-200W, 800um-200W, 1000um-200W)

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

Sample Size: Not applicable. No performance testing on a test set for the new device was conducted or reported.
Data Provenance: Not applicable. The submission relies on the established performance of predicate devices, not new data from a test set.

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. No new test set was created, and thus no experts were used to establish ground truth for this submission. The "ground truth" for the device's acceptable performance is derived from the established safety and effectiveness of the predicate devices.

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

Not applicable. No test set was used.

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 device is a laser delivery system, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted.

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

Not applicable. This device is a physical medical instrument, not an algorithm.

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

The "ground truth" in this context is the established safety and effectiveness of the legally marketed predicate devices (CeramOptec MegaBeam Fiber Optic Laser Delivery Systems and Biolitec Radial Emitting shaped fiber optic delivery system). This is based on their regulatory clearances and presumably, their own prior performance data and clinical use.

8. The sample size for the training set

Not applicable. This is a physical device, not a machine learning algorithm. No training set was used.

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

Not applicable. No training set was used.

Summary

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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 (413) 374-4303 Phone: Facsimile: (413) 599-1640

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

Technical Characteristics

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 opticlaser delivery system isintended for delivery of laserlight to soft tissue in thecontact and non-contact modeduring surgical procedures,including via endoscopes. Thefiber optic laser deliverysystem is intended for usewith any cleared surgicallaser with an SMA 905 orSMA 905 compatibleconnector	CeramOptec MegaBeam fiberoptic laser delivery systemsK934008,K943445,K943444,K943526,K943527.K941909The fiber optic laser deliverysystem is intended fordelivery of laser light to softtissue in the contact and non-contact mode during surgicalprocedures, including viaendoscopes. The fiber opticlaser delivery system isintended for use with anysurgical laser with an SMA905 compatible connector.	Biolitec radial emitting shapedfiber optic deliveryK110080The fiber optic laser deliverysystem is intended fordelivery of laser light to softtissue in the contact and non-contact mode during surgicalprocedures, including viaendoscopes. The fiber opticlaser delivery system isintended for use with anysurgical laser with an SMA905 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 fiberoptic laser delivery systemsK934008,K943445,K943444,K943526,K943527.K941909	Biolitec radial emitting shapedfiber optic deliveryK110080
Delivery Systems
FiberMaterial	Flexible fiberQuartz glass	Flexible fiberQuartz glass	Flexible fiberQuartz glass
Core diameter	200-1000um	200 - 1000um	600
Proximal end	SMA 905 connector or SMA 905compatible connector	SMA 905 connectorHGM connector or other	SMA 905 connectorHGM or other
Sterile	Sterile	Sterile	Sterile
Distal End	Shaped fibers, side fibers, handpieces. Shaped fibersinclude:flat, orb, cone, chisel, orradial.	Shaped fibers, side fibers, handpieces. Shaped fibersinclude:flat, orb, cone, or chisel	Side fibers
Max	Core size: 230um365um400um600um800um1000um	45W113W135W200W200W200W	Up to 25WN/AN/A200W200W200W
RecommendedPower		Up to 25WN/AN/A200W200W200W

ર જુદ રિ

. . . .

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

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

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510(k) Number	K120810
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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.