MENTOR ULTRASOUND-ASSISTED TISSUE REMOVAL SYSTEM

K983065 · Mentor Corp. · LFL · Dec 1, 1998 · SU

Device Facts

• Record ID: K983065
• Device Name: MENTOR ULTRASOUND-ASSISTED TISSUE REMOVAL SYSTEM
• Applicant: Mentor Corp.
• Product Code: LFL · SU
• Decision Date: Dec 1, 1998
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

The Mentor Ultrasound-Assisted Tissue Removal System is indicated for the liquefication and aspiration of soft tissues in General Surgery, Plastic and Reconstructive Surgery and Gynecological Surgery applications.

Device Story

Solid probe accessory for Mentor Ultrasound-Assisted Tissue Removal System (TRS); used for liquefication and aspiration of soft tissues. Device consists of Titanium 6Al-4V probe with spherical tip; available in 3mm, 4mm, 5mm diameters and 4cm to 45cm lengths. Connects to existing ultrasonic handpiece via threaded screw-fit. Operates at 27 kHz frequency with 130 micron peak-to-peak amplitude. Used by surgeons in clinical settings to facilitate tissue removal. Benefits include mechanical compatibility with existing TRS infrastructure for soft tissue procedures.

Clinical Evidence

Bench testing only. Comparison of physical and operational characteristics (frequency, amplitude, material, dimensions) against predicate devices confirms equivalence.

Technological Characteristics

Material: Titanium 6Al-4V. Sensing/Actuation: Ultrasonic vibration. Energy: Ultrasonic generator (27 kHz). Dimensions: 3-5 mm diameter, 4-45 cm length. Connectivity: Mechanical attachment to handpiece. Sterilization: Steam autoclave.

Indications for Use

Indicated for liquefication and aspiration of soft tissues in patients undergoing General, Plastic, Reconstructive, or Gynecological surgery.

Predicate Devices

• Mentor TRS Hollow Cannula (K970471)
• SMEI Sculpture ultrasonic aspiration system (K971609)

Submission Summary (Full Text)

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K 983065

1 1998 DEC

## 510(k) SUMMARY

Date:

November 23, 1998

Submitter:

Donna A. Crawford Manager, Corporate Regulatory Affairs Mentor Corporation 5425 Hollister Avenue Santa Barbara, CA 93111 Phone: [phone] Fax: [phone]

Trade or Proprietary Name:

Solid probe (accessory to Mentor® Ultrasound-Assisted Tissue Removal System)

Common or usual name: Solid probe

### Description and Intended Use of Device:

The Mentor Ultrasound-Assisted Tissue Removal System (TRS) consists of the following components: ultrasonic generator, infiltrator, aspirator, ultrasonic handpiece, foot pedal(s), hollow cannulae and cannulae sheaths, system cart, irrigation tubing set, infiltration tubing set, and aspiration tubing set. The Mentor (TRS) is indicated for the liquefication and aspiration of soft tissues in General Surgery, Plastic and Reconstructive Surgery and Gynecological Surgery applications.

The purpose of this 510(k) notification is to add a solid probe as an accessory to the Mentor TRS. The solid probe is composed of Titanium 6Al-4V and will be available in three diameters (3 mm, 4 mm, and 5 mm) in lengths of 4 cm to 45 cm. The probe is connected to the handpiece with a threaded screw-fit. The tip has a spherical shape.

#### Substantial Equivalence:

The solid probe is substantially equivalent to the hollow cannula currently used with the Mentor TRS which was cleared under 510(k) K970471, as follows:

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| | Mentor TRS Hollow Cannula<br>510(k) K970471 | Mentor TRS Solid Probe |
|----------------------------------|---------------------------------------------|------------------------|
| Operating Frequency<br>(typical) | 27 kHz | 27 kHz |
| Amplitude (maximum) | 130 $\mu$ peak-to-peak | 130 $\mu$ peak-to-peak |
| Attachment Method | Threaded screw fit | Threaded screw fit |
| Material | Titanium 6Al-4V | Titanium 6Al-4V |
| Outside diameter (O.D.) | 3 mm, 4 mm, 5 mm | 3 mm, 4 mm, 5 mm |
| Length | 4 to 45 cm | 4 to 45 cm |
| Inner diameter (I.D.) | 1.98 mm, 2.26 mm, 2.54 mm | Not Applicable |
| Tip Shape | Bullet and spherical | Spherical |
| Sterilization Method | Steam autoclave | Steam autoclave |

The Mentor solid probe is also substantially equivalent to other solid probes currently on the market, such as the solid probe used with the SMEI Sculpture ultrasonic aspiration system which received clearance under 510(k) K971609. Both are made of solid titanium and are used in the same manner for the same intended use. The Mentor solid probe has a spherical tip, while the SMEI Sculpture probe does not.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

1 1998 DEC

Ms. Donna A. Crawford Manager, Corporate Regulatory Affairs Mentor Corporation 5425 Hollister Avenue Santa Barbara, California 93111

Re: K983065

Trade Name: Mentor Ultrasound-Assisted Tissue Removal System Regulatory Class: II Product Code: LFL Dated: September 1, 1998 Received: September 2, 1998

Dear Ms. Crawford:

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 (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 - Ms. Donna A. Crawford

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 yours,

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Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation

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510(k) Number (if known): K983065

Device Name: Mentor® Solid Probe (accessory to Mentor Ultrasound-Assisted Tissue Removal System)

Indications For Use:

The Mentor Ultrasound-Assisted Tissue Removal System is indicated for the liquefication and aspiration of soft tissues in General Surgery, Plastic and Reconstructive Surgery and Gynecological Surgery applications.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

(Division Sign-Um
Division of General Restorative Devices
510(k) Number. K983065

Prescription Use (Per 21 CFR 801.109)

OR

Over-The Counter Use