(154 days)
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No
The summary does not mention AI, ML, or any related concepts like image processing or performance studies typically associated with AI/ML devices.
No
The device is described as an accessory (to be used in conjunction with a CO2 laser) for procedures like myringotomy, indicating it is an instrument used during therapy rather than a therapeutic device itself.
No
The "Intended Use / Indications for Use" states the device is 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", which are surgical procedures, not diagnostic ones.
No
The device description explicitly states "Laser Otoscope, Device Model: ENT LaserVision," which implies a hardware component (an otoscope with laser capabilities). The intended use also mentions being used "in conjunction with the UN-L25 CO2 Laser," further indicating a hardware dependency.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device used in conjunction with a CO2 laser for surgical procedures (computer membrane and Myringotomy). This is a therapeutic or surgical application, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as a "Laser Otoscope," which is a tool used for visualizing the ear canal and eardrum, often in conjunction with a laser for surgical procedures. This aligns with a surgical/therapeutic device, not a diagnostic one.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening based on sample analysis.
Therefore, the ENT LaserVision, as described, is a surgical/therapeutic device used in conjunction with a laser, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ENT LaserVision is a device to be used in conjunction with the UN-L25 CO2 Laser in Tympanostomy and Myringotomy.
Product codes
GEX
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
qualified physician
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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 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
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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