(160 days)
Not Found
No
The description focuses on ultrasonic energy for tissue liquefaction and aspiration, with manual controls and no mention of AI/ML terms or data processing.
Yes
The device is used for the liquefication and aspiration of soft tissues in surgical applications, which is a therapeutic intervention aimed at treating medical conditions.
No
Explanation: The device is indicated for the liquefication and aspiration of soft tissues, which are surgical procedures, not diagnostic ones. It performs tissue removal, not diagnosis.
No
The device description clearly outlines hardware components such as a handpiece with a piezoelectric transducer, a control module/ultrasonic generator, a titanium cannula, and a stainless steel sheath, indicating it is a hardware-based system with software control.
Based on the provided information, the Mentor Ultrasound Assisted Tissue Removal System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is the "ultrasonic liquefication and aspiration of soft tissue" during surgical procedures. This is a direct intervention on the patient's body for therapeutic or surgical purposes.
- Device Description: The description details a surgical device that uses ultrasonic energy to break down and remove tissue. It involves a handpiece, cannula, irrigation, and aspiration, all components of a surgical instrument.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body to provide information about a person's health status. The Mentor Ultrasound Assisted Tissue Removal System is a surgical tool used on the body during a procedure.
N/A
Intended Use / Indications for Use
The Mentor Tissue Removal System indications for use are the ultrasonic liquefication and aspiration of soft tissue.
The Mentor Ultrasound Assisted Tissue Removal System is indicated for use for the " . liquefication and aspiration of soft tissues in General Surgery, Plastic and Reconstructive Surgery and Gynecological Surgery applications.
Product codes (comma separated list FDA assigned to the subject device)
LFL
Device Description
The principles of operation and technology incorporated in the Mentor Tissue Removal System are equivalent to ultrasonic surgical aspirator systems which use ultrasonic energy to liquefy selected tissues. The Mentor TRS performs the functions of ultrasonic tissue liquefication, irrigation/infiltration and aspiration. The user interface consists of digital and bar displays of manually controlled parameters.
The system is controlled by the handpiece mounted switches or by traditional footpedal controls. The handpiece contains a piezoelectric transducer and connects by cable to the control module. The handpiece converts the electrical signal into ultrasonic mechanical vibrations which are amplified by the titanium cannula. The cannula may be used by itself or together with a stainless steel sheath which provides a path for irrigation. The irrigation and aspiration functions may be performed simultaneously or independently.
The Control Module/Ultrasonic Generator is designed to operate with the complete integrated Mentor Tissue Removal System or as a "stand alone" unit used in conjunction with existing aspiration and irrigation equipment.
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 applications.
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
Image /page/0/Picture/0 description: The image shows the logo for Mentor Corporation. The logo consists of a symbol resembling a four-pointed star with arrows at each point, followed by the word "MENTOR" in bold, uppercase letters. Below "MENTOR" is the word "CORPORATION" in smaller, uppercase letters.
JUL 17 159:
Executive Offices
5425 Hollister Avenue
Santa Barbara, CA 93111
(805) 681-6000
510(k) SUMMARY
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92
The assigned 510(k) number is: K970471
Submitted by: Clarke Scherff Director Regulatory Affairs/Quality Assurance Mentor Corporation 5425 Hollister Avenue Santa Barbara, CA 93111
Telephone: (805) 681-6000 FAX: (805) 681-6004
Date Prepared: February 6, 1997
Device Name
Proprietary Name: Mentor Ultrasound Assisted Tissue Removal System
Common Name: Ultrasonic Surgical Aspirator
Indication for Use
The Mentor Tissue Removal System indications for use are the ultrasonic liquefication and aspiration of soft tissue. ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ..............................................................................................................
Device Description
The principles of operation and technology incorporated in the Mentor Tissue Removal System are equivalent to ultrasonic surgical aspirator systems which use ultrasonic energy to liquefy selected tissues. The Mentor TRS performs the functions of ultrasonic tissue liquefication, irrigation/infiltration and aspiration. The user interface consists of digital and bar displays of manually controlled parameters.
1
510 Summary Page 2 of 2
The system is controlled by the handpiece mounted switches or by traditional footpedal controls. The handpiece contains a piezoelectric transducer and connects by cable to the control module. The handpiece converts the electrical signal into ultrasonic mechanical vibrations which are amplified by the titanium cannula. The cannula may be used by itself or together with a stainless steel sheath which provides a path for irrigation. The irrigation and aspiration functions may be performed simultaneously or independently.
The Control Module/Ultrasonic Generator is designed to operate with the complete integrated Mentor Tissue Removal System or as a "stand alone" unit used in conjunction with existing aspiration and irrigation equipment.
Substantial Equivalence Claim
The principles of operation and technology incorporated in the Mentor Tissue Removal System are similar to other surgical devices with suction, ultrasound and irrigation functions which FDA has found to be substantially equivalent to pre-amendment devices as outlined in the following table:
. . . . .
Table 1
| Manufacturer | Product | 510(k) Number |
|---|---|---|
| Morwel Corporation | Ultra-Safe Ultrasonic | |
| Aspiration System | K962525 | |
| Valleylab | Valleylab CUSA System | K910696 |
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with three lines forming its body and head. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Clarke Scherff Vice President Quality and Regulatory Assurance Mentor Corporation 5425 Hollister Avenue Santa Barbara, California 93111
JUL 17 1997
Re: K970471
Trade Name: Mentor Ultrasound Assisted Tissue Removal System Regulatory Class: II Product Code: LFL Dated: May 16, 1997 Received: May 19, 1997
Dear Mr. Scherff:
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 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.
3
Page 2 - Mr. Clarke Schreff
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/dsmamain.html".
Sincerely yours.
to all
Salli M. White, Ph.D., M.P.
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
4
510(k) Number (if known): K970471
Device Name: MENTOR Ultrasound Assisted Tissue Removal System
Indications For Use:
The Mentor Ultrasound Assisted Tissue Removal System is indicated for use 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)
to colle 8
neral Restorative D
Prescription Use (Per 21 CFR 801.109)
OR
Over-The Counter Use
(Optional Format 1-2-96)
0000008