(83 days)
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No
The summary provides a basic description of an electrically powered ophthalmic device for vitreous removal and does not mention any AI or ML components, image processing, or performance studies related to algorithmic analysis.
Yes
The device is intended to remove vitreous matter from the vitreous cavity, which is a therapeutic intervention.
No
The device is described as an ophthalmic device intended to remove vitreous matter, indicating a therapeutic or interventional function, not a diagnostic one. There is no mention of it detecting, analyzing, or identifying a condition.
No
The description explicitly states the device is an "electrically powered ophthalmic device," which implies hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "remove vitreous matter from the vitreous cavity." This is a surgical procedure performed directly on the patient's body.
- Device Description: The description reinforces the intended use as an electrically powered ophthalmic device for removing vitreous matter.
- Lack of IVD Characteristics: There is no mention of analyzing samples (like blood, urine, tissue, etc.) in vitro (outside the body) to provide diagnostic information. IVDs are used to diagnose diseases or conditions based on the analysis of these samples.
Therefore, this device is an ophthalmic surgical device, not an IVD.
N/A
Intended Use / Indications for Use
An electrically powered ophthalmic device intended to remove vitreous matter from the vitreous cavity
Product codes
HQE
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
vitreous cavity
Indicated Patient Age Range
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Intended User / Care Setting
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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)
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Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 886.4150 Vitreous aspiration and cutting instrument.
(a)
Identification. A vitreous aspiration and cutting instrument is an electrically powered device, which may use ultrasound, intended to remove vitreous matter from the vitreous cavity or remove a crystalline lens.(b)
Classification. Class II (special controls). The device, when it is phacofragmentation unit replacement tubing, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
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Image /page/0/Picture/1 description: The image shows a circular logo. The logo contains an abstract image of a bird in the center. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the bird in a circular fashion.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 7 2003
Howard Instruments, Inc. c/o Jack Howard President 4749 Appletree Lane Tuscaloosa, AL 35405-5747
Re: K030948
Trade/Device Name: VMate TM Vitreous Cutting System Regulation Number: 21 CFR 886.4150 Regulation Name: Vitreous Aspiration and Cutting Instrument Regulatory Class: Class II Product Code: HQE Dated: March 17, 2003 Received: March 26, 2003
Dear Mr. Jack Howard:
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.
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 comply 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 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.
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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), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,
A. Ralph Rosenthal
A. Ralph Rosenthal, M.D Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
Device Name: VMate™ Vitreous Cutting System
Indication for use:
An electrically powered ophthalmic device intended to remove vitreous matter from the vitreous cavity
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | ✓ |
|---|---|
| Per 21 CFR 801.109 | |
| OR | |
| Over-The-Counter Use __________ |
| signature | |
|---|---|
| Division of Ophthalmic Ear, | |
| and Throat Devises |
| 510(k) Number | K030948 |
|---|---|
| --------------- | --------- |