(266 days)
Not Found
No
The summary describes a passive laser fiber for delivering energy and does not mention any computational or analytical capabilities that would suggest AI/ML.
Yes.
The device is used for endovascular coagulation and treatment of varicose veins and superficial vein reflux, which are therapeutic interventions.
No
The device is described as a "free-beam delivery device that transmits laser energy" for "endovascular coagulation" and treatment of varicose veins, indicating it is a therapeutic device, not a diagnostic one.
No
The device description clearly states it is a "free-beam delivery device" consisting of "optic fiber" and a "connector," which are physical hardware components designed to transmit laser energy.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used for "endovascular coagulation of the great saphenous vein" and "treatment of varicose veins and varicosities associated with superficial reflux." This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device is described as a "free-beam delivery device that transits laser energy into intended direction." It's a tool for delivering laser energy for treatment.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with such specimens.
Therefore, the ATOVEN-Reusable Laser Fiber is a surgical device used for therapeutic purposes, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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 810-1470 mm, a power range 5-15W, using an SMA905 connector.
Product codes
GEX
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 8101470;m. This device can be connected with cleared surgical use laser diode.1470 m that have been cleared for surgical use diode laser. Outer diameter of fiber cable is 0.6mm and length is 2900 mm.
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
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
great saphenous vein, superficial veins of the lower extremity.
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
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.
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
Key Metrics
Not Found
Predicate Device(s)
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The symbol is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The logo is simple and recognizable, and it is used to represent the U.S. Department of Health & Human Services.
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
1
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)
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.
| 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
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- Company : Diotech Co.
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- Address : 301, Nakdong-daero, Saha-gu, Busan, Korea
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- Device : ATOVEN-Reusable Laser Fiber
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- Phone Number : +82-51-292-6237
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- Fax Number : +82-51-292-6258
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- Homepage: http://www.diotech21.com
2. Device Information
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- Trade Name : ATOVEN-Reusable Laser Fiber (Model name : DLF147-7)
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- Common Name : Diode Laser
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- Regulation Name : Laser surgical instrument for use in general and plastic surgery and in dermatology
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- Product code : GEX
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- Regulation number : 878.4810
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- Class of device : Class II
3. The legally marketed device to which we are claiming equivalence K140458, K140366
4. Description of device
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.
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 8101470nm, a power range 515W, using an SMA905 connector.
6. Technological Characteristics
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.
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 8101470nm and K140366's wavelength range is 5322200nm. 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.