ATOVEN-Reusable Laser Fiber is indicated for endovascular coagulation 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 ATOVEN-Reusable Laser Fiber may be used with CW laser with wavelength range 810-1470 mm, a power range 5-15W, using an SMA905 connector.

Device Description

ATOVEN-Reusable Laser Fiber is free-beam delivery device that transits laser energy into intended direction. Fiber length is 2.9mters. This device can be connected with SMA905 connector and deliver to 810~1470;m. This device can be connected with cleared surgical use laser diode.

ATOVEN-Reusable Laser Fiber consists of optic fiber. The optic fiber also consists of connector, optical fiber. Fiber cable is made of the optical fiber that delivers the laser beam. 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.

The fiber core and cladding for the subject device are made from silica which is the same material used in the predicate device. This device can be connected with SMA905 connector.

AI/ML Overview

This document is a 510(k) summary for the ATOVEN-Reusable Laser Fiber, a medical device used for endovascular coagulation of varicose veins. It doesn't contain the typical acceptance criteria and study design found in a clinical trial for an AI/CADe device. Instead, it details bench tests and biocompatibility tests conducted to demonstrate substantial equivalence to predicate devices.

Therefore, many of the requested fields cannot be directly extracted from this document, as they pertain to clinical performance studies of AI algorithms, which are not relevant to this type of device submission.

Here's a breakdown of what can be extracted and what cannot, based on the provided text:

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

The document lists various bench tests and biocompatibility tests performed. It states "The tests demonstrated that the device is as safe, as effective and performs in a substantially equivalent manner to the predicate device." However, it does not provide specific numerical acceptance criteria or quantitative performance results in a table format. The performance is broadly stated as meeting the standard for substantial equivalence.

Types of Tests Performed (Not acceptance criteria/performance in a table):

Test Type	Specific Tests Performed	Reported Device Performance
Bench Tests	Radiopacity, flexural strength, drop out, breakdown, appearance, dimension, laser transfer efficiency test, integrity test, fiber transmission angle tip test, simulated clinical environment test, fiber transmission angle test (with glass and without glass), Dimension comparison test.	"The tests demonstrated that the device is as safe, as effective and performs in a substantially equivalent manner to the predicate device."
Biocompatibility	Hemolysis, cytotoxicity, intracutaneous reactivity, maximization, pyrogen, and acute systemic toxicity.	"The tests demonstrated that the device is as safe, as effective and performs in a substantially equivalent manner to the predicate device."

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

This document details bench tests and biocompatibility tests, not clinical studies with a test set of patient data. Therefore, information about a "test set" in the context of patient data, sample size for such a set, and data provenance (country, retrospective/prospective) is not applicable and not provided.

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 applicable and not provided as there was no clinical test set requiring expert ground truth establishment for an AI/CADe device.

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

This information is not applicable and not provided for the same reason as above.

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

There was no MRMC comparative effectiveness study and thus no effect size for human readers with/without AI assistance, as this is not an AI/CADe device.

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

This is not an AI algorithm, so no standalone algorithm performance study was done.

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

Ground truth in the context of an AI/CADe device is not applicable. For the physical device, the "ground truth" for the bench and biocompatibility tests would be established by validated measurement standards and laboratory procedures.

8. The sample size for the training set

This is not an AI device, so there is no concept of a "training set" in the machine learning sense. The device is evaluated based on its physical properties and biocompatibility.

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

This is not applicable as there is no training set for an AI model.

Summary

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

June 9, 2016

Diotech Co. % Mr. Peter Chung Official Correspondent Plus Global 300 Atwood Street Pittsburgh, Pennsylvania 15213

Re: K152667

Trade/Device Name: ATOVEN-Reusable 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: March 4, 2016 Received: March 11, 2016

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 ; medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality

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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, please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Post-market Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education 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,

Jennifer R. Stevenson -S

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

Enclosure

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Indications for Use

510(k) Number (if known) K152667

Device Name ATOVEN Reusable Laser Fiber

Indications for Use (Describe)

The ATOVEN-Reusable Laser Fiber may be used with CW laser with wavelength range 810-1470 mm, a power range 5-15W, using an SMA905 connector.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summarv (K152667)

[as required by 807.92(c)]

1. Applicant Information

1. Company : Diotech Co.
1. Address : 301, Nakdong-daero, Saha-gu, Busan, Korea
1. Device : ATOVEN-Reusable Laser Fiber
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 : ATOVEN-Reusable Laser Fiber (Model name : DLF147-7)
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 K140458, K140366

4. Description of device

5. Intended Use

ATOVEN-Reusable Laser Fiber is indicated for endovascular coagulation 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 ATOVEN-Reusable Laser Fiber may be used with CW laser with wavelength range 810~~1470nm, a power range 5~~15W, using an SMA905 connector.

6. Technological Characteristics

The fiber core and cladding for the subject device are made from silica which is the same material used in the predicate device. This device can be connected with SMA905 connector.

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.

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Bench test

Radiopacity, flexural strength, drop out, breakdown, appearance, dimension, laser transfer efficiency test, integrity test, fiber transmission angle tip test, simulated clinical evironment test, fiber transmission angle test (with glass and without glass) and Dimension comparison test

Biocompatibility test

Hemolysis, cytotoxicity, intracutaneous reactivity, maximization, pyrogen and acute systemic toxicity

8. Predicate device comparison table

Predicate device - Diotech Laser Fibers (K140458)

The ATOVEN-Reusable Laser Fiber have a identical intended use to the Diotech Laser Fibers in that they are indicated for endovascular coagulation 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.

And raw material, dimension, structure and components are identical. The different is ATOVEN-Reusable Laser Fiber is not single use and this device is reusable.

Predicate device - Hogue Surgical EndlessFiber Reusable Surgical Laser Fiber (K140366)

The ATOVEN-Reusable Laser Fiber is similar intended use to the Reusable Surgical Laser Fiber for patient vein. These devices are using identical connector SMA905 and have similar raw material, dimension, structure and components. The wavelength range is similar that proposed device's wavelength range is 810~~1470nm and K140366's wavelength range is 532~~2200nm. These devices are reusable.

9. Conclusion

The Device is investigated for function and effectiveness to compare the operation of function between ATOVEN-Reusable 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 ATOVEN-Reusable 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.