FIBRA SONICS ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL 2100 USSTA

K980930 · Fibra Sonics, Inc. · LFL · Sep 22, 1998 · SU

Device Facts

• Record ID: K980930
• Device Name: FIBRA SONICS ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL 2100 USSTA
• Applicant: Fibra Sonics, Inc.
• Product Code: LFL · SU
• Decision Date: Sep 22, 1998
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended 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

Device Story

Fibra Sonics Ultrasonic Surgical Aspirator System Model 2100 USSTA; surgical device for soft tissue management. Operates via ultrasonic energy to fragment and emulsify tissue, followed by aspiration. Used by surgeons in clinical/OR settings across multiple specialties including neurosurgery and orthopedics. Provides controlled tissue removal; assists in surgical procedures requiring precise aspiration. Output is mechanical tissue removal; clinical benefit includes efficient soft tissue debulking.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological and intended use comparison to legally marketed predicates.

Technological Characteristics

Ultrasonic surgical aspirator system; utilizes ultrasonic energy for tissue fragmentation and emulsification; system includes aspiration capability. Technical specifications and material standards not detailed in provided text.

Indications for Use

Indicated for fragmentation, emulsification, and aspiration of soft tissues in neurosurgery, gastrointestinal, urological, plastic/reconstructive, gynecological, and orthopedic surgical procedures.

Submission Summary (Full Text)

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Public Health Service

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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.

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], 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

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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

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(Optional Format 1-2-96)

Indications for use statement.doc