(154 days)
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Not Found
No
The summary describes a phacoemulsifier accessory for irrigation and aspiration, with no mention of AI, ML, image processing, or data-driven performance metrics typically associated with AI/ML devices.
No
The product is described as an accessory for a phacoemulsifier, used in phaco procedures, which are surgical procedures, not therapeutic applications.
No
This device is for use in phaco procedures, which are surgical, not diagnostic. It assists with irrigation and aspiration during surgery.
No
The summary describes a device indicated for use with a specific piece of hardware (Alcon Series 20,000 Legacy Phacoemulsifier) and its function relates to controlling irrigation and aspiration during a surgical procedure. This strongly suggests it is either a hardware component or software that directly controls hardware, not a standalone software-only medical device. The lack of a device description further prevents confirmation of it being software-only.
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 a surgical procedure (phacoemulsification) on a patient's eye. This is an in vivo procedure, meaning it's performed within a living organism.
- 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.
The device described is a surgical instrument used during eye surgery, not a diagnostic test performed on a sample outside the body.
N/A
Intended Use / Indications for Use
This product is indicated for use with the Alcon Series 20,000 Legacy Phacoemulsifier. It may be utilized in phaco procedures in which either combined or segregated automated irrigation and aspiration is deemed appropriate.
Product codes
86 MSR
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
Not Found
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)
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Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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 eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The eagle is facing to the right. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
TUT - a 1998
Don W. Haar QA/RA Manager Surgin Inc. 14762 Bentley Circle Tustin, CA 92680
Re: K980849 Trade Name: Surgin Kit Regulatory Class: II Product Code: 86 MSR Dated: June 22, 1998 Received: June 24, 1998
Dear Mr. Haar:
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. Don W. Haar
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 Roerl lorentbal
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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Surgin, Inc
14762 Bentley Circle Tustin, CA 92680 Tel: 714 832 6300
INDICATIONS FOR USE STATEMENT
510(k) Number (11known): N / A
Device Name: OPHTHALMIC KIT
Indications For Use:
This product is indicated for use with the Alcon Series 20,000 Legacy Phacoemulsifier. It may be utilized in phaco procedures in which either combined or segregated automated irrigation and aspiration is deemed appropriate.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrance of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) Division of Ophthalmic Devices 510(k) Number K980849 | |
|---|---|
| -- | ------------------------------------------------------------------------------------------------------------------------------------------------------ |
| Prescription Use (Per 21 CFR 801.109) | OR | Over-The-Counter Use | |
|---|---|---|---|
| --------------------------------------- | -------------------------------------------- | ---- | ---------------------- |
(Optional Format 1-2-96)