KINETIC CANNULA

K012042 · Reliance Medical Corp. · QPB · Sep 20, 2001 · General, Plastic Surgery

Device Facts

• Record ID: K012042
• Device Name: KINETIC CANNULA
• Applicant: Reliance Medical Corp.
• Product Code: QPB · General, Plastic Surgery
• Decision Date: Sep 20, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5040
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Reliance Medical Kinetic Cannula indications for use are the removal of tissue or fluid from the body during general surgical the removal of tissue of fliala lipoplasty for the purpose of aesthetic body contouring.

Device Story

Kinetic Cannula is a surgical instrument used for the removal of tissue or fluid during general surgery and lipoplasty procedures. Operated by a surgeon in a clinical or surgical setting, the device facilitates aesthetic body contouring. It functions as a mechanical tool for suction-assisted tissue extraction. The device is intended for prescription use.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on 510(k) regulatory review.

Technological Characteristics

Suction lipoplasty system cannula; mechanical surgical instrument; Class II device; regulated under 21 CFR 878.5040.

Indications for Use

Indicated for the removal of tissue or fluid from the body during general surgical procedures and lipoplasty for aesthetic body contouring.

Regulatory Classification

Identification

A suction lipoplasty system is a device intended for aesthetic body contouring. The device consists of a powered suction pump (containing a microbial filter on the exhaust and a microbial in-line filter in the connecting tubing between the collection bottle and the safety trap), collection bottle, cannula, and connecting tube. The microbial filters, tubing, collection bottle, and cannula must be capable of being changed between patients. The powered suction pump has a motor with a minimum of 1/3 horsepower, a variable vacuum range from 0 to 29.9 inches of mercury, vacuum control valves to regulate the vacuum with accompanying vacuum gauges, a single or double rotary vane (with or without oil), a single or double diaphragm, a single or double piston, and a safety trap.

Special Controls

*Classification.* Class II (special controls). Consensus standards and labeling restrictions.

Submission Summary (Full Text)

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Reliance Medical Corp. Robert Nicks 730 Independent Ave. Grand Junction, Colorado 81505

June 8, 2021

Re: K012042

Trade/Device Name: Kinetic Cannula Regulation Number: 21 CFR 878.5040 Regulation Name: Suction lipoplasty system Regulatory Class: Class II Product Code: QPB

Dear Robert Nicks:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated September 20, 2001. Specifically, FDA is updating this SE Letter because FDA has created a new product code to better categorize your device technology.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Cindy Chowdhury, OHT4: Office of Surgical and Infection Control Devices, 240-402-6647, [e-mail].

Sincerely.

## Cindy Chowdhury -S

Cindy Chowdhury, Ph.D., M.B.A. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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SEP 2 0 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Robert W. Nicks Document Regulation Manager Reliance Medical 730 Independent Avenue Grand Junction, Colorado 81505

Re: K012042

Trade/Device Name: Kinetic Cannula Regulation Number: 878.5040 Regulatory Class: II Product Code: MUU Dated: May 2, 2001 Received: June 29, 2001

Dear Mr. Nicks:

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 W. Nicks

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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Sus-Walk, up

Celia M. Witten, Ph.D., M.D. J Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

The Reliance Medical Kinetic Cannula indications for use are the removal of tissue or fluid from the body during general surgical the removal of tissue of fliala lipoplasty for the purpose of aesthetic body contouring.

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

OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

SN

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K012042

Prescription Use__ (Per 21 CFR 801.109)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)