LIPOSE DISPOSABLE CANNULA

K093067 · Lipose Corp. · QPB · Dec 29, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K093067
• Device Name: LIPOSE DISPOSABLE CANNULA
• Applicant: Lipose Corp.
• Product Code: QPB · General, Plastic Surgery
• Decision Date: Dec 29, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Lipose Disposable Cannula is intended for use in aesthetic body contouring.

Device Story

Lipose Disposable Cannulas are stainless steel cannulas used for aesthetic body contouring. Devices connect to syringe aspirators or re-injectors via Luer Lock or hub adaptors; infiltrator configurations allow pre-lipoplasty solution administration. Used by clinicians in surgical settings. Hydrophilic coating provides lubricious properties to facilitate tissue movement. Single-use, sterile, disposable design reduces cross-contamination risk compared to reusable alternatives. Output is physical tissue aspiration or fluid infiltration; clinical decision-making relies on surgeon manual technique and visual assessment of contouring results.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and design similarities to the predicate device.

Technological Characteristics

Hydrophilic-coated stainless steel cannulas. Available in various diameters, lengths, and tip configurations. Features Luer Lock connector or hub adaptor for syringe attachment. Supplied sterile via gamma radiation in PETG/Tyvek packaging. Single-use.

Indications for Use

Indicated for aesthetic body contouring in patients undergoing lipoplasty procedures.

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.

Predicate Devices

• Tulip Disposable Cannula (K060089)

Submission Summary (Full Text)

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June 9, 2021

Lipose Corp. Christine Emanuel President 1205 De La Vina Street Santa Barbara, California 93101

Re: K093067

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

Dear Christine Emanuel:

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 December 29, 2009. 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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

DEC 2 9 2009

Lipose Corporation % TECSA Technical Services, Inc. Ms. Christine Emanuel Regulatory Consultant 1205 De La Vina Street Santa Barbara, California 93101

Re: K093067

Trade/Device Name: Lipose Disposable Cannulas Regulation Number: 21 CFR 878-5040 Regulation Name: Suction lipoplasty system Regulatory Class: Class II Product Code: MUU Dated: September 09, 2009 Received: September 30, 2009

Dear Ms. Emanuel:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21

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CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.

Sincerely yours.

cerely yours,

F

Mark N. Melkerson Director Division of Surgical. Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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(K093067 V/

## Indications for Use

510(k) Number (if known): K093067

Device Name: Lipose Disposable Cannulas

Indications For Use:

The Lipose Disposable Cannula is intended for use in aesthetic body contouring.

Over-The-Counter Use _ _ _ _ _ (Part 21 CFR 801 Prescription Use AND/OR x Subpart D) (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dail Krone for MxM
(Division Sign-Off)

Division o Surgical. Orthopedic. and Restorative Device

510(k) Number K093067

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## LIPOSE CORP. DISPOSABLE CANNULA 510(k) Submission

DEC 2 9 2009

## Section 5: 510(k) Summary

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This 510(k) summary is being submitted in accordance with the requirements of SMDA and 21CFR § 807.92

| Submitted by: | Lipose Corp.<br>280 Railroad Ave., Suite 200<br>Greenwich, CT. 06830 USA<br>Phone: [phone]<br>Lee Miller, President<br>email: [e-mail]<br>Fax: [phone]<br>Contact Person for premarket notification:<br>Christine Emanuel, Regulatory Consultant<br>1205 De La Vina Street<br>Santa Barbara, CA 93101<br>Phone: [phone]<br>Fax: [phone] |
|-------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Email: [e-mail] |
| Date Prepared: | September 28, 2009 |
| Proprietary Name: | Lipose Disposable Cannulas |
| Common Name: | Liposuction Cannulas |
| Classification: | Class II, MUU, 21 CFR 878.5040 |
| Predicate Device: | Tulip Biomed (formerly Cell Bio-Systems, Inc., USA).<br>Tulip Disposable Cannula, 510(k) number K060089 |
| | Device Description: The Lipose Disposable Cannulas are<br>coated stainless steel cannulas designed for connection to<br>syringes (Luer Lock connector or hub adaptor). The<br>cannulas are designed to be used with a syringe aspirator or<br>syringe re-injector. There is also an infiltrator<br>configuration available, to administer a solution to surgery<br>sites pre-lipoplasty. The cannulas are made of hydrophilic<br>coated stainless steel, and are available in various<br>diameters, lengths and tip configurations. |
| | The Lipose Disposable Cannulas are single-use<br>disposables, supplied sterile (gamma radiation), packaged<br>in a PETG tray sealed with a labeled or pre-printed Tyvek<br>CONFIDENTIAL<br>000000 |

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### LIPOSE CORP. DISPOSABLE CANNULA 510(k) Submission

## lid.

Indication for Use:

The Lipose Disposable Cannula is intended for use in aesthetic : body contouring.

Technological Characteristics:

The design, use, and materials of the Lipose Disposable Cannulas and their predicate device are equivalent, in that all these cannulas are designed to be used for aesthetic body contouring and are fabricated out of stainless steel. Lipose Cannulas are all provided with a hydrophilic coating with lubricious properties as well, as are the Tulip Disposable Cannulas. No new technology or change in indications for use have been introduced by Lipose Corp. in the manufacture of the Disposable Cannulas. For these reasons, Lipose Corp. considers the use of the Lipose Disposable Cannulas to be substantially equivalent to their predicate device.

#### CONFIDENTIAL

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