The MED-Fibers, surgical fiber optic laser delivery device, Endo-ENT fibers, Side Fire Laser delivery fibers and Endo Probes including Aspirating Endo Probes are intended for delivery of laser light to soft tissue in the contact and non-contact mode during surgical procedures including via endoscopes and cystoscopes. The MED-Fibers surgical fiber optic laser delivery device is intended for use with any cleared surgical laser with a SMA 905 or SMA 905 compatible connectors. In addition cleared lasers with SMA 906 connectors.

The MED-Fibers surgical fiber optic laser delivery devices are indicated for use in general surgery 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.

MED-Fibers, surgical fiber optic laser delivery devices is also intended as an aid for otologic procedures, for use in incision, excision, coagulation and vaporization of soft and fibrous tissue including osseous tissue. MED-Fibers surgical fiber optic delivery devices are also intended for intraocular photocoagulation with or without simultaneous aspirating as an adjunct to vitrectomy surgery. Specific indications include the treatment of proliferative vitreoretinopathy, Tractional retinal detachments, proliferative diabetic retinopathy and various vascular tumors. MED-Fibers surgical fiber optic delivery device 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 (532nm - 2100nm) with peak and continuous power from 1 - 300 Watt. MED-Fibers surgical laser fibers is indicated for use in general surgery, urology, gastroenterology, gynecology, dermatology, vascular surgery, neurosurgery, plastic surgery, ENT/otolaryngology, endovenous occlusion of the greater saphenous vein in the patient with superficial vein reflux and laser assisted lipolysis with an approved compatible laser marketed for use in the desired application.

Device Description

MED-Fibers surgical laser delivery system fibers contains the same components and the same technological characteristics as the predicate devices. The fiber core and cladding or fibers with no cladding are made from silica which is the same material used in all the predicate devices. As mentioned, the optical fiber is made out of silica with a coaxially mounted protective sheath. The fiber distal tip can be several configurations and the fiber can be used with hand pieces. MED-Fibers surgical laser delivery system fibers has no differences in technology and as such does not raise any new questions on safety or efficacy. Various core diameter sizes (200, 272, 365, 550, 600, 800 and 1000 microns) are offered.

AI/ML Overview

The device described, MED-Fibers Surgical Laser Fibers, is a fiber optic laser delivery system intended for various surgical applications. Based on the provided 510(k) summary, specific acceptance criteria and a detailed study proving the device meets them are not provided.

Instead, the submission relies on substantial equivalence to predicate devices. The key argument for safety and effectiveness is that the MED-Fibers surgical laser delivery system operates in the same manner and has the same technical characteristics as established predicate devices, and therefore does not raise new questions of safety or efficacy.

Here's an analysis of the information requested, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not explicitly stated in terms of quantitative metrics or thresholds. The implicit acceptance criterion is "substantial equivalence" to predicate devices, meaning it performs comparably and safely.	The device "operates in the same manner as the predicate devices and performs with no difference as compared with the predicate devices." (Qualitative statement)

2. Sample Size Used for the Test Set and Data Provenance

Performance data from specific test sets is not provided. The submission states, "The performance of the MED-Fibers surgical laser fiber delivery systems is well established and documented so no performance testing is included." This implies a reliance on the historical performance of similar predicate devices rather than a new independent study with a specific test set.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable, as no new performance testing with a specific test set requiring ground truth establishment was conducted or reported.

4. Adjudication Method for the Test Set

Not applicable, as no new performance testing with a specific test set or associated adjudication was conducted or reported.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or mentioned. The submission focuses on substantial equivalence based on technical characteristics and intended use, not on comparing human reader performance with and without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone performance study was not conducted or mentioned. This device is a physical laser delivery system, not an algorithm or AI.

7. The Type of Ground Truth Used

Not applicable, as no new performance testing was conducted. The "ground truth" for this type of submission is typically derived from the well-established safe and effective use of the predicate devices in clinical practice by qualified medical professionals.

8. The Sample Size for the Training Set

Not applicable. This is a medical device (laser fiber delivery system), not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set is relevant for this device.

Summary of the Study and Evidence Presented:

The submission for the MED-Fibers Surgical Laser Fibers is a 510(k) premarket notification based on the concept of substantial equivalence. Rather than presenting a new clinical or performance study with defined acceptance criteria and data, the manufacturer asserts that their device is substantially equivalent to several legally marketed predicate devices.

The justification for this substantial equivalence is rooted in:

Identical intended use/indications for use.
Same technological characteristics: The device uses the same materials (silica for fiber core and cladding) and operates in the same manner as predicate devices.
No new questions of safety or efficacy: Because the technology is deemed identical and well-established, no new risks or performance concerns are raised.

Therefore, the "study that proves the device meets the acceptance criteria" is implicitly the FDA's review and concurrence that the device's technical characteristics and intended use align sufficiently with predicate devices that have a history of safe and effective use. The acceptance criteria are, in essence, the FDA's regulatory requirements for establishing substantial equivalence for this specific class of device.

Summary

{0}------------------------------------------------

510 (k) SUMMARY

This 510(k) summary of safety and effectiveness is submitted in accordance with all of the requirements

and follows Office of Device Evaluation guidance concerning the organization of a 510 (k) summary.

MED-Fibers Fiber Optic Laser Delivery System

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

MED-Fibers, Inc. 2675 E. Bartlett Place Chandler, AZ 85249 Phone: (480) 516 8454 (480) 621 6040 Fax:

Dr. Armin Kaus, Ph.D. Contact Person:

December 14, 2012 Date Prepared:

Name of Device and Name of Sponsor

MED-Fibers Surgical Laser Fibers

MED-Fibers, Inc. 2675 E. Bartlett Place Chandler, AZ 85249

Common or Usual Name

Nd:YAG-, Ho:YAG-, KTP- and Diode Laser -- Fiber Optic Laser Delivery Systems

Classification Name

Surgical Laser Accessory Regulation: 21 CFR §878.4810 Classification: II Product Code: GEX

12 | 122

{1}------------------------------------------------

124203 Page ② of ③

Predicate Devices

Laser Peripherals Bare Fibers	(K972272)
Laser Peripherals Reusable Bare Fibers	(K011207)
FiberTech (LEONI) Bare Fibers (single and reusable)	(K050738)
Lumenis SlimLineEZ Fiber Delivery Device	(K011703)
InnovaQuartz (AMS) Sure Flex Laser Fiber	(K050108)
CeramOptec MegaBeam Fiber Laser Delivery SystemsK943444, K943526, K943527, K941909	(K934008, K943445)
BioLitec Radial Emitting shaped Fiber Optic delivery System	(K110080)
BioLitec MegaBeam Endo-ENT-Probe	(K113858)
BioLitec MegaBeam Endocular- and Aspirating Endo Probe	(K113792)
BARD Medical Holmium Laser Fibers	(K120926)
Fiberoptic Fabrications Laser Delivery System	(K120810)
Cynosure SideLaze800 Side Fire Firing Laser delivery device	(K121127)

Intended Use / Indications of Use

{2}------------------------------------------------

s Page 3 of 3

and lesions, complete or partial resection of internal organs, tumors or lesions, tissue vaporization, hemostasis and or coagulation may be indicated.

Technical Characteristics

Performance Data

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

122

{3}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized, curved shapes that resemble ribbons or banners. The overall design is simple and recognizable, representing the department's role in health and human services.

Public Health Service

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

Med-Fibers, Incorporated % Armin Kaus, Ph.D. President/Chief Executive Officer 2675 East Bartlett Place Chandler, Arizona 85249

January 17, 2013

Re: K124003 Trade/Device Name: MED-Fibers Surgical 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: December 20, 2012 Received: December 26, 2012

Dear Dr. Kaus:

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 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

{4}------------------------------------------------

Page 2 -- Armin Kaus, Ph.D.

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/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Peter D. Rumm -S

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

Enclosure

{5}------------------------------------------------

K2400}

Indication of Use Statement

5IO(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ K

Device Name: MED-Fibers Surgical Laser Fibers

The MED-Fibers, surgical fiber optic laser delively device, Endo-ENT fibers, Side Fire Laser delivery fibers and Endo Probes including Aspirating Endo Probes are intended for delivery of laser light to soft tissue in the contact and non-contact mode during surgical procedures including via endoscopes and cystoscopes. The MED-Fibers surgical fiber optic laser delivery device is intended for use with any cleared surgical laser with a SMA 905 connector. In addition cleared lasers with SMA 906 comlectors. The MED-Fibers surgical fiber optic laser delivery devices are indicated for use in general surgery applications for: incision, 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. (Diode Laser 532nm-2100nm)

MED-Fibers, surgical fiber optic laser delivery devices is also intended as an aid for otologic procedures, for use in incision, excision, coagulation and vaporization of soft and fibrous tissue including osseous tissue (Diode Laser 532nm- 2100nm). MED-Fibers surgical fiber optic delivery devices are also intended for intraocular photocoagulation with or without simultaneous aspirating/irrigating as an adjunct to vitrectomy surgery. (Diode Laser 532nm-2100nm), Specific indications include the treatment of proliferative vitreoretinopathy, Tractional retinal detachments, proliferative diabetic retinopathy and various (Diode Laser 532nm-2100mm) MED-Fibers surgical fiber optic delivery device 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, 1.44YAG and Diode Lasers (532nm-2100m) with peak and continuous power from 1 - 300 Watt. MED-Fibers surgical laser fibers is indicated for use in general surgery, urology, gastroenterology, demlatology, vascular surgery, neurosurgery, plastic surgery, ENT/otolaryngology, endovenous occlusion of the greater saphenous vein in the patient with superficial vein reflux and laser assisted lipolysis with an approved compatible laser marketed for use in the desired application.

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)

Neil R Ogden 2013.01.16 15:45:09-05'00'

(Division Sign-Off)

Division of Surgical Devices

510(k) Number

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.