ATOVEN is a diode laser system designed to delivery of laser light to soft tissue during general surgery procedures. This device intended for treatment of reflux of the saphenous veins associated with varicose veins and varicosities. Non-Contact mode
ATOVEN is a diode laser system designed to delivery of laser light to soft tissue during general surgery procedures. This device intended for treatment of reflux of the saphenous veins of thigh associated with varicose veins and variosities. Non-Contact mode

Device Description

ATOVEN Diode laser systems are Laser Surgery Systems that use optical energy radiated from semiconductor laser in order to cure varices. with Wave Length 1,470mm, and consists of CPU, LCD monitor, Cooling Systems, laser controller, Fiber optic pullback device included foot pedal switch. LED monitor are displaying various graphic to shows Operating Parameter, Mode, Time function, system status to user.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device (ATOVEN) and does not contain information about a study proving the device meets specific acceptance criteria.

Instead, it focuses on demonstrating substantial equivalence to a predicate device based on common intended use, function, technology, operational principles, and performance. The document explicitly states: "No clinical standards have been established for Diode Laser, but did Safety and Performance test in accordance with below Standard." followed by a list of non-clinical safety and performance standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-2-22, IEC60825_1).

Therefore, I cannot provide a table of acceptance criteria and reported device performance directly from this document, nor can I answer questions related to sample sizes, expert qualifications, or comparative effectiveness studies, as these types of studies were not conducted or reported for this submission.

Here's a breakdown of what can be extracted and addressed:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Non-Clinical, based on Standards)	Reported Device Performance
Safety and Performance Tests conducted in accordance with:
IEC 60601-1 Medical Electrical Equipment part 1 General Requirement for safety amend 2:1995	Not explicitly detailed, but implied compliance for substantial equivalence.
IEC 60601-1-2 Electromagnetic compatibility test ED 2007	Not explicitly detailed, but implied compliance for substantial equivalence.
IEC 60601-1-2-22: 1996 Particular requirement for the safety and Diagnostic of Therapeutic laser Equipment	Not explicitly detailed, but implied compliance for substantial equivalence.
IEC60825_1 Safety of laser products Part 1, section 2, Manufacturing requirement.	Not explicitly detailed, but implied compliance for substantial equivalence.

Note: The document only states that these tests were "did" (performed) and that the device is substantially equivalent, implying that it met the requirements of these standards. Specific numerical performance data or pass/fail criteria for each standard are not provided.

Regarding the other requested information:

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 / Not provided. The submission relies on non-clinical safety and performance tests to standards, not a clinical test set with a sample size of patients.
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 / Not provided. No clinical ground truth was established by experts for performance evaluation as part of this submission. The ground truth for proving safety and performance was adherence to the listed international safety standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided. No clinical test set or adjudication was performed.
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 / Not provided. This device is a diode laser system, not an AI-assisted diagnostic tool, and no MRMC study was conducted or reported.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable / Not provided. This is not an algorithm; it's a medical device (laser system). Its performance is inherent in its design and manufacturing, verified against safety standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the non-clinical tests, the "ground truth" was compliance with the specified international safety and performance standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-2-22, IEC 60825-1).
8. The sample size for the training set
- Not applicable / Not provided. There is no "training set" as this is not a machine learning or AI device.
9. How the ground truth for the training set was established
- Not applicable / Not provided. As there is no training set, this question is not relevant.

Summary

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	JUN 0 6 2014
	KJ33774
DIOTECH	ATOVEN

Summary of safety and effectiveness

In accordance with Section 513 (1) of the SMDA as defined in 21CFR part 807.3 this summary is submitted to obtain Pre-Market 510 (K) notification.

Prepared on May 28, 2014

1. Manufacturer

DIOTECH CO LTD will register after cleared #212, Ildongjiaenin, GeoJeong 4 dong, Saha gu, Busan, Rep of Korea Tel: 82 51 292 6236 F 82 51 292 6238

2. Submitter, Correspondent

Young Chi Bio-Med USA Inc. 111 Ellison Street, Paterson, NJ07505. U.S.A Tel: 973 278 5222 Fax 201 934 6030 e mail: biomedusa@msn.com

3. Name of Device

Trade name	:	ATOVEN
Classification name	:	Powered, Laser surgical instrument
Classification panel	:	General & Plastic Surgery
Common name	:	Diode laser system
Regulation	:	880.4810 Class II
Product Code	:	GEX

4. Legally marketed Predicate Device

K110364 LiteBeam+1470 Dornier MedTech

5. Intended use

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6. Device Description

LED monitor are displaying various graphic to shows Operating Parameter, Mode, Time function, system status to user.

7. Non-Clinical Data.

No clinical standards have been established for Diode Laser, but did Safety and Performance test in accordance with below Standard.

IEC 60601-1 Medical Electrical Equipment part 1 General Requirement for safety amend 2:1995 IEC 60601-1-2 Electromagnetic compatibility test ED 2007 IEC 60601-1-2-22: 1996 Particular requirement for the safety and Diagnostic of Therapeutic laser Equipment IEC60825_1 Safety of laser products Part 1, section 2, Manufacturing requirement.

8. Sterilization and Biocompatibility information

This submission does not included any fiber, catheters, Guide Wire etc. accordingly no need any Sterilization and Biocompatibility information.

9. Conclusion.

ATOVEN Diode laser system, in this submission, is substantially equivalent to several already cleared predicate device in respect to Intended use, Main function, Technology, Principal operation and performance.

So, it does not raise any additional concerns regarding safety and effectiveness.

Bio-Med USA will update and include in this summary any other information deemed seasonally necessary by the FDA

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Image /page/2/Picture/0 description: The image is a black and white circular logo for the U.S. Department of Health and Human Services. The logo features the department's symbol, which is a stylized representation of a human figure embracing a globe. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

June 6. 2014

Bio-Med USA Incorporated Mr. Young Chi President 111 Ellison Street Paterson, New Jersey 07505

Re: K133774

Trade/Device Name: ATOVEN 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 2, 2014 Received: May 8, 2014

Dear Mr. Chi:

We have reviewed your Scction 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 10 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

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Page 2 - Mr. Young Chi

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 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/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 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

David Krause -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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K133774

Device Name ATOVEN

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)

Neil R Ogden -S 2014.06.06 11:53:13 -04'00'

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 Drug 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."

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.