(194 days)
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Not Found
No
The provided text describes a surgical aspirator system and its intended uses, but contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
Yes
The device is described as an "Ultrasonic Surgical Aspirator System" used for "fragmentation, emulsification and aspiration of soft tissues" in various surgical areas. These actions directly treat or modify the body, indicating a therapeutic function.
No
The device is described as an "Ultrasonic Surgical Aspirator System" used for "fragmentation, emulsification and aspiration of soft tissues" in various surgical areas. This indicates it is a therapeutic/surgical device, not a diagnostic one.
No
The device is described as a "Fibra Sonics Ultrasonic Surgical Aspirator System" and is used for fragmentation, emulsification, and aspiration of soft tissues. This functionality inherently requires hardware components (ultrasonic transducer, aspiration system, etc.) and is not achievable with software alone. The lack of a device description doesn't negate the clear hardware-dependent nature of the intended use.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device's function as fragmenting, emulsifying, and aspirating soft tissues during surgical procedures. This is a direct intervention on the patient's body.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, tissue samples) outside of the body to provide information about a patient's health.
The description clearly indicates a surgical tool used on the patient, not a device used to analyze samples from the patient.
N/A
Intended Use / Indications for Use
The Fibra Sonics Ultrasonic Surgical Aspirator System has been designed for use in the fragmentation, emulsification and aspiration of soft tissues as used in the following surgical areas:
- (a) Neurosurgery
- (b) Gastrointestinal and affiliated organ surgery
- (c) Urological surgery
- (d) Plastic and reconstructive surgery
- (e) Gynecological procedures
- (f) Orthopedic Surgery
Product codes
LFL
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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N/A
0
Public Health Service
Image /page/0/Picture/2 description: The image shows a partial view of a logo, specifically the emblem of the U.S. Department of Health and Human Services (HHS). The emblem features a stylized depiction of an eagle's head with three overlapping lines representing the bird's feathers. The word "DEPARTMENT" is partially visible along the left edge of the image, indicating the full logo includes the department's name.
SEP 2 2 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Robert Brohm Director, Quality Assurance/Regulatory Affairs Fibra Sonics, Inc. 5312 North Elston Avenue Chicago, Illinois 60630
Re: K980930
Trade Name: Fibra Sonics Ultrasonic Surgical Aspirator System Model 2100 USSTA Regulatory Class: Unclassified Product Code: LFL Dated: June 29, 1998 Received: July 2, 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 legally marketed predicate 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) 594-4595. 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 vours.
fscellf
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number: K980930
Device Name: Model 2100 USSTA
Indications For Use:
The Fibra Sonics Ultrasonic Surgical Aspirator System has been designed for use in the fragmentation, emulsification and aspiration of soft tissues as used in the following surgical areas:
- (a) Neurosurgery
- (b) Gastrointestinal and affiliated organ surgery
- (c) Urological surgery
- (d) Plastic and reconstructive surgery
- (e) Gynecological procedures
- (f) Orthopedic Surgery
These indicated uses are equivalent to the predicate device. Appropriate warnings and cautions are indicated in the Operator's Manual.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
lly
Prescription Use
(Per 21 CFR 801.109)
or
Over-The-Counter Use
Page 7
(Optional Format 1-2-96)
Indications for use statement.doc