(90 days)
Not Found
Not Found
No
The summary does not mention AI, ML, image processing, or any other indicators of AI/ML technology. The device description is for a phacoemulsification system, which is a standard surgical device.
Yes
The device is described as a "Fragmentation System" used for "Vitreoretinal Procedures (Ultrasonic emulsification and removal of cataracts)," indicating it's intended to treat a medical condition.
No
This device is described as a "Fragmentation System" used for "Vitreoretinal Procedures (Ultrasonic emulsification and removal of cataracts)," which indicates it is used for treatment or surgical intervention, not for diagnosing a condition.
No
The device description explicitly states "Fibra-Sonics Phaco III and IIIP Fragmentation System," which strongly suggests a hardware system for ultrasonic emulsification and removal of cataracts, 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 is "Vitreoretinal Procedures (Ultrasonic emulsification and removal of cataracts)". This describes a surgical procedure performed directly on a patient's eye, not a test performed on a sample taken from the body.
- Device Description: The device is a "Fibra-Sonics Phaco III and IIIP Fragmentation System". Phacoemulsification systems are used in cataract surgery to break up and remove the cloudy lens. This is a surgical instrument, not a diagnostic test.
- Lack of IVD Indicators: The information does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a disease or condition based on sample analysis.
- Mentioning any kind of laboratory testing or analysis.
Therefore, the Fibra-Sonics Phaco III and IIIP Fragmentation System is a surgical device used for treatment, not an in vitro diagnostic device used for diagnosis.
N/A
Intended Use / Indications for Use
Vitreoretinal Procedures (Ultrasonic emulsification and removal of cataracts)
Product codes
86 HQC
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
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): 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.
Not Found
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, a symbol often associated with medicine and healthcare.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 16 1999
Mr. Robert Brohm Director of Quality Systems and Regulatory Affairs FIBRA-SONICS, INC. 5312 North Elston Ave. Chicago, IL 60630
Re: K984143 Trade Name: FIBRA - SONICS PHACO III or IIIP Fragmentation Systems Regulatory Class: II Product Code: 86 HQC Dated: November 16, 1998 Received: November 18, 1998
Dear Mr.Brohm:
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 .
1
Page 2 - Mr. Robert Brohm
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 Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Device Name: Fibra-Sonics Phaco III and IIIP Fragmentation System
Indications For Use:
Vitreoretinal Procedures (Ultrasonic emulsification and removal of cataracts)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
iusha K. Diske hi ilotas
or
(Division Sign-Off) Division of Ophthalmic Devices 510(k) Number_K934143
Prescription Use V (Per 21 CFR 801.109) Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________