Diotech Laser Fibers (400um, 600um) is indicated for endovascular coagulation of the great saphenous vein in patients with superficial vein reflux, for the treatment of varicose veins and varicosties associated with superficial reflux of the great saphenous vein, and for the treatment of incompetence and reflux of superficial veins of the lower extremity. The Diotech Laser Fibers (400um, 600um) may be used with CW laser with wavelength range 810-1470mm, a power range 5-15W, using an SMA905 connector.

Device Description

Diotech Laser Fiber is free- beam delivery device that transits laser energy into intended direction. Fiber length is 2.9mters. And catheter tube length is 0.85meters. Catheter tube marked on per 10mm. This device can be connected with SMA905 connector and deliver to 810~1470m. This device can be connected with cleared surgical use laser diode. This device is single use only and sterilized by EO gas.

AI/ML Overview

This document is a 510(k) premarket notification for the Diotech Laser Fiber, seeking substantial equivalence to a predicate device. It primarily focuses on comparing the new device's technical characteristics and intended use to a previously cleared device. Therefore, it does not contain the detailed clinical study information typically found in a post-market study or a full PMA application.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the typical sense of quantitative thresholds for clinical performance. Instead, it relies on demonstrating substantial equivalence to a predicate device (AngioDynamics, Inc. NeverTouch 600mm Fiber) based on intended use, technological characteristics, and performance. The performance section mentions "bench tests," but only broadly states they demonstrated safety, effectiveness, and substantial equivalence. No specific quantitative performance metrics are provided for the Diotech Laser Fiber (e.g., success rates, complication rates).

The table below summarizes the comparison of key characteristics, implying that "performance" for this submission is met by being similar to the predicate.

Feature	Acceptance Criteria (Implied: Substantially Equivalent to Predicate)	Reported Device Performance (Diotech Laser Fiber)	Predicate Device (AngioDynamics, Inc. NeverTouch 600 um Fiber)
Intended Use	Same as predicate	Endovascular coagulation of great saphenous vein for superficial vein reflux, varicose veins, etc.	Same as predicate
510(k) Number	N/A	K140458	K071959
Diameter of Optical Fiber	Within comparable range of predicate	0.6 mm (DRF-A600-1, DBF-A600-1), 0.4 mm (DBF-A400-1)	0.6 mm
Diameter of Glass Tube	Comparable to predicate	1.1 mm	0.905 mm
Length of Glass Tube	Comparable to predicate	10 mm	5.8 mm
Catheter Total Length	Comparable to predicate	85 cm	80 cm & 90 cm
Catheter Operation Length	Comparable to predicate	82 cm	83 cm
Hub (Catheter)	Similar to predicate	5 cm	Similar
Outer Inlet (Catheter)	Similar to predicate	1.5 cm	Similar
Optic Fiber Material	Same as predicate	Silica	Silica
Connector Material	Comparable to predicate	Stainless steel	Stainless steel & Plastic
Catheter Hub Material	Acceptable material	PP	Unknown
Catheter Outer Inlet Material	Acceptable material	Polycarbonate	Unknown
Catheter Tube Material	Same as predicate	PE	PE
Fiber transmission angle	Within acceptable range for intended use	70~80°	30~50°
Wavelength range	Same as predicate	810~1470nm	810~1470nm
Maximum output power	Adequate for intended use (implied, not directly compared)	15W	Unknown
Single Use	Same as predicate	Single use	Single use
Biocompatibility	Meets ISO10993	ISO10993	ISO10993
Sterility	EO gas sterilized	EO gas sterilized	EO gas sterilized

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

The document mentions "Bench tests were performed," but does not specify any sample size for these tests. There is no information regarding the data provenance (country of origin, retrospective or prospective) as it was a bench study, not a clinical trial.

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)

This information is not provided in the document as it describes bench testing, not clinical studies involving expert interpretation or ground truth establishment in a clinical context.

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

This information is not applicable and not provided as there was no clinical study with expert adjudication described.

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

No MRMC comparative effectiveness study was done or reported in this document. This submission is for a medical device (laser fiber) and not an AI-powered diagnostic or assistive tool.

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

This information is not applicable and not provided as the device is a physical medical instrument (laser fiber), not an algorithm or software.

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

The document mentions "Bench tests," which typically involve engineering assessments and material characterization. The "ground truth" for these tests would be the established scientific and engineering principles and standards (e.g., ISO10993 for biocompatibility) against which the device's physical properties and performance characteristics are measured. No clinical ground truth (like pathology or outcomes data) is mentioned as no clinical study was presented.

8. The sample size for the training set

The document describes bench testing and a comparison to a predicate device, not a machine learning model or algorithm. Therefore, there is no concept of a "training set" for this submission, and no sample size is applicable or provided.

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

As there is no training set for a machine learning model, this information is not applicable and not provided.

Summary

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

Image /page/0/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 stylized symbol. The symbol consists of a series of overlapping human profiles, creating an abstract representation of people. The profiles are arranged in a way that suggests movement or progress.

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

August 26, 2014

Plus Global Mr. Peter Chung 300 Atwood Street Pittsburgh, Pennsylvania 15213

Re: K140458 Trade/Device Name: Diotech Laser Fiber 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 15, 2014 Received: July 28, 2014

Dear Mr. Chung:

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

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

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 yours,

David Krause -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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

Indications for Use

510(k) Number (if known) K140458

Device Name Diotech Laser Fibers

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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

1. Applicant Information

1. Company : Diotech Co.
1. Address : 301, Nakdong-daero, Saha-gu, Busan, Korea
1. Device : Diotech Laser Fibers
1. Phone Number : +82-51-292-6237
1. Fax Number : +82-51-292-6258
1. Homepage: http://www.diotech21.com

2. Device Information

1. Trade Name : Diotech Laser Fibers
1. Common Name : Diode Laser
1. Regulation Name : Laser surgical instrument for use in general and plastic surgery and in dermatology
1. Product code : GEX
1. Regulation number : 878.4810
1. Class of device : Class II

3. The legally marketed device to which we are claiming equivalence

1. 510(K) Number : K071959
1. Trade Name : AngioDynamics, Inc. NeverTouch 600 mm Fiber
1. Product Code : GEX

4. Description of device

5. Intended Use

Diotech Laser Fiber is indicated for endovascular cagulation of the great saphenous vein in patients with superficial vein reflux, for the treatment of varicose veins and varicosities associated with superficial reflux of the great saphenous vein, and for the treatment of incompetence and reflux of superficial veins of the lower extremity.

The Diotech Laser Fiber used with CW laser with wavelength range 810~~1470nm, a power range 5~~15W, using an SMA905 connector.

6. Technological Characteristics

Diotech laser fiber consists of two parts that are optic fiber and catheter. The optic fiber also consists of connector, optical fiber, and the tip part. Fiber cable is made of the optical fiber that delivers the laser beam, and tip part is made of glass that can deliver the laser beam diagonally. And the fiber may be used any laser wavelength between 810~1470 m that have been cleared for surgical use diode laser. Outer diameter of fiber cable is 0.6mm and length is 2900 mm.

Catheter has a function that let the fiber cable be inserted into blood vessel as vein through its inner path. The catheter tube also consist of three parts as hub, tube and outer Inlet. Hub is used to connect with syringe. Tube is used for way that fiber cable may go through inner hole of tube. Outer Inlet is entrance hole for fiber to go through into tube. Catheter tube length is 0.85meters(850mm). It was marked on per 10mm to check depth to insert. The fiber core and cladding for the subject device are made from silica which is the same material used in the

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

predicate device. This device can be connected with SMA905 connector. This device is single use only and sterilized by EO gas.

7. Performance

Bench tests were performed. Bench testing included biocompatibility. The tests demonstrated that the device is as safe, as effective and performs in a substantially equivalent manner to the predicate device.

8. Predicate device comparison table

Trade Name			Diotech laser fiber	AngioDynamics, Inc. NeverTouch 600 um Fiber
Intended use			This device is indicated for endovascularcoagulation of the great saphenous vein inpatients with superficial vein reflux, for thetreatment of varicose veins varicosities andassociated with superficial reflux of the greatsaphenous vein, and for the treatment ofincompetence and reflux of superficial veins ofthe lower extremity.	The AngioDynamics, Inc. NeverTouch 600gmFiber is indicated for endovascular coagulation ofthe great saphenous vein in patients with superficialvein reflux, for the treatment of varicose veinsvaricosities and associated with superficial refluxof the great saphenous vein, and for the treatmentof incompetence and reflux of superficial veins ofthe lower extremity.
510(k) Number			K140458	K071959
rediy	Design		.1mm0.6mm10mm
	Diameter of OpticalFiber		0.6 mm(DRF-A600-1, DBF-A600-1)0.4 mm(DBF-A400-1)	0.6 mm
	Diameter of Glass Tube		1.1 mm	0.905 mm
	Length of Glass Tube		10 mm	5.8 mm
ទេវាទប្រពុជ	Design
	Total Length		85 cm	80 cm & 90 cm
	Operation Length		82 cm	83 cm
	Hub		5 cm	Similar
	Outer Inlet		1.5 cm	Similar
	Fiber	Optic Fiber	Silica	Silica
sinə aid bitki növü. İstinadlar Rüspitaliya Şamaları Şahil Şamaları Şamaları Şamaları Şamaları Şamaları Şamaları Şamaları Şamaları Şamaları Şamaları Şamaları		Connector	Stainless steel	Stainless steel & Plastic
	Catheter	Hub	PP	Unknown
		Outer inlet	Polycarbonate	Unknown
		Tube	PE	PE
Fiber transmission angle			70~80°	30~50°
Wavelength range			810~1470nm	810~1470nm

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

Maximum output power	15W	Unknown
Single use	Single use	Single use
Biocompatibility	ISO10993	ISO10993
Sterility	EO gas sterilized	EO gas sterilized

9. Conclusion

The Device is investigated for function and effectiveness to compare the operation of function between Diotech laser fiber and predicate devices .

Comparison results demonstrate that the specifications and performance of the device are similar as functional and effective as the legally marketed predicate device.

Therefore, it is concluded that Diotech laser fiber is substantially equivalent to the legally marketed predicate device.

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.