(60 days)
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No
The summary describes a mechanical accessory for phacoemulsification and contains no mention of AI, ML, or related concepts.
No
The device is described as an accessory to neutralize vacuum surge during phacoemulsification, which suggests a supporting role in a medical procedure without directly providing therapy itself.
No
The device is described as an accessory device incorporated in the aspiration line to neutralize vacuum surge during phacoemulsification, which is a therapeutic function rather than a diagnostic one.
No
The intended use describes a physical accessory device ("incorporated in the aspiration line behind the handpiece") that neutralizes vacuum surge. This indicates a hardware component, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is an accessory for phacoemulsification, a surgical procedure performed in vivo (on a living organism). IVDs are used to examine specimens in vitro (outside the body).
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, diagnostic testing, or any other activity typically associated with IVDs.
Therefore, the ACM Module is a surgical accessory, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ACM Module is an accessory device incorporated in the aspiration line behind the handpiece to neutralize vacuum surge during phacoemulsification.
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): 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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§ 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 seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 4 1997
Mr. Richard Dirkson ------------Director of Regulatory/Quality Affairs Paradigm Medical Industries, Inc. 1772 West 2900 South Salt Lake City, UT 84119
Re: K971795 Trade Name: Automated Chamber Maintenance (ACM) Module Regulatory Class: II Product Code: 86 HQC Dated: May 13, 1997 Received: May 15, 1997
Dear Mr. Dirkson:
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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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. Richard Dirkson
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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STATEMENT OF INDICATION FOR USE
510(K) Number: Unknown ACM Module Device Name:
Indications for use: The ACM Module is an accessory device incorporated in the aspiration line behind the handpiece to neutralize vacuum surge during phacoemulsification.
Emenetta T. Beene
Division Sign-Off
Division of Ophthalmic Devices
510(k) Number K971795
Prescription Use
(Per 21 CFR 801.109)
(Per 21 CFR 801.109)