(43 days)
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No
The summary describes a surgical handpiece for cataract surgery and does not mention any AI or ML capabilities.
Yes
The device is used to disrupt and extract cataracts, which is a therapeutic intervention aimed at treating a medical condition.
No
The device is described as being used to "disrupt a cataract with ultrasound through emulsification and extract the cataract," which are therapeutic actions, not diagnostic ones.
No
The device description explicitly states "Odyssey Technologies P3 Universal Handpiece," which is a hardware component used in cataract surgery. The intended use also describes a physical process ("disrupt a cataract with ultrasound through emulsification and extract the cataract") that requires hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "For use in cataract surgery to disrupt a cataract with ultrasound through emulsification and extract the cataract." This describes a surgical procedure performed directly on a patient's body, not a test performed on a sample taken from the body (which is the definition of an in vitro diagnostic).
- Device Description: The device is a "P3 Universal Handpiece" used in cataract surgery. This further supports its use in a surgical setting.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information based on sample analysis
- Using reagents or assays
Therefore, the Odyssey Technologies P3 Universal Handpiece, as described, is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
For use in cataract surgery to disrupt a cataract with ultrasound through emulsification and extract the cataract.
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
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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)
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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 U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 29 1997
Mr. Glenn A. Dunki-Jacobs . Official Correspondent Odyssey Technologies 9327 Blackley Street Temple City, CA 91780
Re: K972253 -- --Trade Name: Odyssey Technologies P3 Universal Handpiece Regulatory Class: II Product Code: 86 HQC Dated: May 31, 1997 Received: June 16, 1997
Dear Mr. Dunki-Jacobs:
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 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. Glenn A. Dunki-Jacobs
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) 594-4613. 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/dsmamain.html".
Sincerely yours,
A Ralph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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ODYSSEY TECHNOLOGIES
26945 Cabot Road, Suite 113 Laguna Hills, CA 92653 Tel: 714.348.6912 - Fax: 714.348.6914
INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Device Name:
Odyssey Technologies P3 Universal . Handpiece
Indications For Use:
For use in cataract surgery to disrupt a cataract with ultrasound through emulsification and extract the cataract.
Dom/L Kaufmo
(Division Sign-Off) Division of Ophthalmic Devices 1972253 510(k) Number
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Prescription Use (Per 21 CFR 801.109)
Over-The-Counter Use
(Optional Format 1-2-96)