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 Description

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 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.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device accessory (Mentor® Solid Probe) and does not contain detailed information about acceptance criteria or specific study results that would typically be found in a clinical trial report or a more comprehensive validation study. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device.

However, based on the information provided, we can infer the "acceptance criteria" and "device performance" in terms of substantial equivalence to the predicate device.

Here's an attempt to answer your request based on the available text:

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission demonstrating substantial equivalence, the "acceptance criteria" are implicitly that the new device's characteristics are either identical to or do not raise new questions of safety and effectiveness compared to the predicate device. The "reported device performance" is the direct comparison of the new device's specifications to those of the predicate.

Characteristic	Acceptance Criteria (Predicate Device K970471)	Reported Device Performance (Mentor TRS Solid Probe)
Operating Frequency	27 kHz	27 kHz
Amplitude (maximum)	130 µ peak-to-peak	130 µ 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 (as it's a solid probe)
Tip Shape	Bullet and spherical	Spherical
Sterilization Method	Steam autoclave	Steam autoclave

The document also states: "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." This implies that the broad characteristics and intended use align with another predicate for solid probes.

2. Sample size used for the test set and the data provenance

The document does not describe a "test set" in the context of clinical or performance data for the solid probe. The "test" here refers to a comparison of the device's technical specifications to those of a predicate device. Therefore, there is no sample size for a test set, nor specific data provenance (e.g., country of origin, retrospective/prospective) as there wasn't a study involving human subjects or collected data for the new accessory's performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This 510(k) submission is for an accessory based on substantial equivalence to predicate devices, not a study requiring expert-established ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. There was no test set or adjudication process described for the solid probe accessory. The FDA reviewed the submission based on the provided technical specifications and comparison to predicate devices.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI-assisted device, and no MRMC study was conducted or described in the provided document.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical probe, an accessory, and does not involve algorithms or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable in the typical sense of clinical studies. The "ground truth" for this 510(k) submission is the specifications and performance of the legally marketed predicate devices, to which the new device (solid probe) is compared to demonstrate substantial equivalence.

8. The sample size for the training set

Not applicable. This is not an AI/ML device and does not involve training sets.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/ML device and does not involve training sets or associated ground truth establishment.

Summary

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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: 805-681-6000 Fax: 805-681-6004

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 Cannula510(k) K970471	Mentor TRS Solid Probe
Operating Frequency(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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Image /page/2/Picture/2 description: The image shows a logo for the Department of Health & Human Services. The logo features the department's name in a circular arrangement on the left side. To the right of the text is a symbol consisting of three curved lines, resembling a stylized human figure or abstract representation. The image is in black and white.

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 (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 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:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

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)

Over-The Counter Use

Regulation Number and Section

N/A