(176 days)
Not Found
No
The device description focuses on the hardware components and basic control functions of a laser system, with no mention of AI or ML capabilities for image processing, data analysis, or automated decision-making. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
Yes
The device is intended for the "treatment of reflux of the saphenous veins associated with varicose veins and varicosities," which is a therapeutic purpose.
No
The device description indicates it is a "Laser Surgery System" used to "cure varices" and deliver "laser light to soft tissue during general surgery procedures," which are therapeutic applications, not diagnostic.
No
The device description clearly outlines hardware components such as a CPU, LCD monitor, Cooling Systems, laser controller, Fiber optic pullback device, and foot pedal switch, indicating it is a physical laser system, not software only.
Based on the provided information, the ATOVEN device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the ATOVEN is a diode laser system designed for the delivery of laser light to soft tissue during general surgery procedures, specifically for the treatment of reflux of saphenous veins. This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The description details a laser surgery system that uses optical energy to treat varices. This is a physical intervention, not a test performed on samples taken from the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue samples) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the human body to provide information about a person's health. The ATOVEN is a surgical device used for treatment.
N/A
Intended Use / Indications for Use
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
Product codes
GEX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
saphenous veins, soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
K110364 LiteBeam+1470 Dornier MedTech
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
| 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
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
1
6. 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.
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
2
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
3
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
4
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)
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
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'
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