(90 days)
Not Found
No
The document describes a mechanical system for tissue removal using ultrasound and does not mention any AI or ML components or functions.
Yes
The device is indicated for the liquefication and aspiration of soft tissues in surgical applications, which directly treats or modifies body function for therapeutic purposes.
No
The device is indicated for the liquefaction and aspiration of soft tissues, which are therapeutic actions, not diagnostic ones. It is an ultrasound-assisted tissue removal system.
No
The device description explicitly lists multiple hardware components, including an ultrasonic generator, handpiece, foot pedal, cannulae, and a system cart. The 510(k) is for adding a solid probe accessory, which is also a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "liquefication and aspiration of soft tissues" in surgical applications. This describes a procedure performed on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The components listed (ultrasonic generator, handpiece, cannulae, etc.) are all consistent with a surgical device used for tissue removal, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), reagents, or any processes typically associated with in vitro diagnostics.
In vitro diagnostics are tests performed on samples taken from the human body to provide information about a person's health. This device is a surgical tool used directly on the patient's tissues.
N/A
Intended Use / 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.
Product codes
LFL
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissues
Indicated Patient Age Range
Not Found
Intended User / Care Setting
General Surgery, Plastic and Reconstructive Surgery and Gynecological Surgery
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
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:
1
| | Mentor TRS Hollow Cannula
510(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.
2
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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.
3
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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4
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.
(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)
OR
Over-The Counter Use