(154 days)
The ENT LaserVision is a device to be used in conjunction with the UN-L25 CO2 Laser in The ENI Laser Vision is a device to be used far computer membrane and Myringotomy .
Laser Otoscope, Device Model: ENT LaserVision
The provided text is a 510(k) premarket notification letter from the FDA to Union Medical USA regarding their ENT LaserVision device. This document primarily focuses on regulatory approval and does not contain the detailed information necessary to answer the questions about acceptance criteria and study design.
Specifically, the document states:
- It is a 510(k) review, which determines "substantial equivalence" to a legally marketed predicate device, rather than requiring new clinical efficacy or performance studies in the same way a PMA would.
- The device is a "Laser surgical instrument for use in general and plastic surgery and in dermatology" (K012071) and is classified as II.
- The "Indications for Use" for the ENT LaserVision are "to be used in conjunction with the UN-L25 CO2 Laser in The ENI Laser Vision is a device to be used far computer membrane and Myringotomy." This is a typo, and it likely intends to say "for tympanic membrane and Myringotomy".
Since this is a substantial equivalence determination, rigorous clinical trials with acceptance criteria, sample sizes, ground truth establishment, or expert reviews are typically not required as they would be for a PMA or novel device. The FDA's letter confirms substantial equivalence based on the information provided in Union Medical USA's 510(k) submission, which would compare the new device's technological characteristics and performance (e.g., laser power, wavelength, safety features) to a predicate device.
Therefore, I cannot extract the requested information from the provided text. The document does not describe a study that sets acceptance criteria or proves the device meets them in the way the questions imply for AI/diagnostic devices.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 0 3 2001
Ms. Annie Velez Director Union Medical USA 3750 NW 114th Avenue, Unit #5 Miami, Florida 33178
Re: K012071
Trade/Device Name: ENT LaserVision Regulation Number: 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX
Dated: August 30, 2001 Received: September 4, 2001
Dear Ms. Valez:
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 10 mos been and 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 or mply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of R Pat 801); accimig (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
{1}------------------------------------------------
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Susan Walker, us
Image /page/1/Picture/5 description: The image contains a black and white drawing of a symbol. The symbol appears to be a stylized letter, possibly a cursive 'C' or a similar character. The lines are thick and bold, and the symbol is positioned in the center of the frame. The background is plain white, which makes the symbol stand out.
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
INDICATION FOR USE STATEMENT
510(k) Number:
Device Name:
Laser Otoscope
Device Model:
ENT LaserVision
Indications for Use:
The ENT LaserVision is a device to be used in conjunction with the UN-L25 CO2 Laser in The ENI Laser Vision is a device to be used far computer membrane and Myringotomy .
Federal Law restricts the use of this device by or on the order of a qualified physician only.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Over the Counter Use _ Prescription Use _____________________________________________________________________________________________________________________________________________________________ OR
(Per 21 CFR 801.109)
Susa Walker
(Division Sign-Off) (Division Signi-On)
Division of General, Restorative
Division of General, Devices Division of General
Neurological Devices and Neurological Devices
510(k) Number K012071
§ 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.