(36 days)
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Not Found
No
The provided 510(k) summary contains no mention of AI, ML, image processing, or any other indicators of AI/ML technology. The intended use is a standard surgical procedure.
Yes
The device is intended for "Phacoemulsification of cataracts in the human eye," which is a medical procedure to treat a condition, thus making it a therapeutic device.
No
The stated intended use is "Phacoemulsification of cataracts in the human eye," which describes a surgical procedure to remove cataracts, not a process to diagnose them.
No
The intended use describes a surgical procedure (phacoemulsification) which inherently involves hardware (the phacoemulsification machine). The summary provides no information suggesting the device is solely software controlling or analyzing data from such hardware, and the lack of a device description prevents confirmation of a software-only nature.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Phacoemulsification of cataracts in the human eye." This describes a surgical procedure performed directly on the patient's body.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
This device is clearly a surgical instrument used for treatment, not a diagnostic test performed on a sample.
N/A
Intended Use / Indications for Use
Phacoemulsification of cataracts in the human eye.
Product codes
86 HQC
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
human eye
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 886.4670 Phacofragmentation system.
(a)
Identification. A phacofragmentation system is an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping human figures or birds in flight, creating a sense of movement and unity.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 7 1999
Mr. Wayne H Matelski C/O Arent Fox Surgical Design Corp. 1050 Connecticut Avenue, NW Washington, DC 20036-5339
Re: K991852 Trade Name: Ocusystem Art Advantage® Regulatory Class: II Product Code: 86 HQC Dated: May 28, 1999 Received: June 1, 1999
Dear Mr. Matelski:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations .
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Page 2 - Mr. Wayne H. Matelski
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-2018. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures: Indications for Use Paradigm Attachment Letter
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510(k) Nunber (if known): _ K991852
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
Phacoemulsification of cataracts in the human eye.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NERDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daryl L. Kaufman
Division of Ophthalmic Devices K991852 510(k) Number.
?rescription Use
Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Formal 1-2-96)