TULIP DISPOSABLE CANNULAS

K060089 · Cell Bio-Systems, Inc. · QPB · Apr 27, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K060089
• Device Name: TULIP DISPOSABLE CANNULAS
• Applicant: Cell Bio-Systems, Inc.
• Product Code: QPB · General, Plastic Surgery
• Decision Date: Apr 27, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Tulip Disposable Cannulas are stainless steel, hydrophilic-coated cannulas designed for aesthetic body contouring. Devices connect to syringes via Luer Lock or hub adaptors for use with syringe aspirators or re-injectors. An infiltrator configuration is available for pre-lipoplasty solution administration. Cannulas are single-use, sterile (e-beam), and available in various diameters, lengths, and tip configurations. Used by clinicians in surgical settings to perform liposuction or fat transfer. The device facilitates the physical removal or injection of adipose tissue, aiding in body contouring procedures.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, material, and intended use comparisons to legally marketed predicate devices.

Technological Characteristics

Materials: stainless steel with hydrophilic coating. Form factor: various diameters, lengths, and tip configurations. Connectivity: Luer Lock or hub adaptor for syringe connection. Sterilization: e-beam. Function: manual suction/infiltration tool.

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

• Byron Medical, Inc. Lipoplasty/Liposuction Aspiration and Tumescent Infiltration Cannulae/Needles (K981172)
• Richter LTDA. Richter Lipoplasty Cannulas and Accessories (K990602)

Submission Summary (Full Text)

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Cell Bio-Systems, Inc. Christine Emanuel President 1205 De La Vina Street Santa Barbara, California 93101

June 8, 2021

Re: K060089

Trade/Device Name: Tulip Disposable Cannulas 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 April 27, 2006. 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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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three bars extending from its head, representing health, services, and people. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 7 2006

Cell Bio-Systems, Inc. c/o Tecsa Technical Services Ms. Christine Emanuel Regulatory Consultant 1205 De La Vina Street Santa Barbara, California 93101

Re: K060089

Trade/Device Name: Tulip Disposable Cannulas Regulation Number: 21 CFR 878.5040 Regulation Name: Suction lipoplasty system Regulatory Class: II Product Code: MUU Dated: March 22, 2006 Received: March 23, 2006

Dear Ms. Emmanuel:

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 such 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 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

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Page 2 - Ms. Christine Emanuel

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/dsma/dsmamain.html

Sincerely yours,
Mark N. Melkerson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K060089

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

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

Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)

D/OR
Over-The
(21 CFR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark H. Milliman

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## 510(k) SUMMARY

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

| Submitted by: | Cell Bio-Systems, Inc.<br>438 Camino del Rio. So., Suite 219<br>San Diego, CA 92108<br>Phone: [phone]<br>Ed Semanik, Production<br>email: [e-mail]<br>Fax: [phone]<br><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]<br>Email: [e-mail] | APR 27 2006 |
|-------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Date Prepared: | April 21, 2006 | |
| Device Name: | | |
| Proprietary Name: | Tulip Disposable Cannulas | |
| Common Name: | Liposuction Cannulas | |
| Classification: | Class II, MUU, 21 CFR 878.5040 | |

Identification of Predicate Devices

- Byron Medical, Inc. Lipoplasty/Liposuction Aspiration and Tumescent Infiltration . Cannulae/Needles, 510(k) number K981172,
- Richter LTDA. Richter Lipoplasty Cannulas and Accessories, Richter LTDA, Sao . Pualo, SP-Brazil, CEP 05047-001; 510(k) number K990602

Device Description:

The Tulip Disposable Cannulas are coated stainless steel cannulas designed for connection to syringes (Luer Lock® tip type or hub adaptor). The cannulas are designed to be used with a syringe aspirator or syringe re-injector. There is also an infiltrator configuration available, to administer a solution to surgery sites prelipoplasty. The cannulas are made of hydrophilic coated stainless steel, and are available in various diameters, lengths and tip configurations.

The Tulip Disposable Cannulas are single-use disposables, supplied sterile (e beam),

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The Tulip Disposable Cannula is intended for use in aesthetic body Indication for Use: contouring.

## Technological Characteristics

The design, use, and materials of the Tulip Disposable Cannulas and their predicate devices are equivalent, in that all these cannulas are designed to be used for aesthetic body contouring and are fabricated out of stainless steel. Tulip Cannulas are all provided with a hydrophilic coating. The Byron cannulas provide the option of a PTFE or hydrophilic Slik-Tip coating to their users and the Richter cannulas provide the option of PTFE coating to their users. No new technology or change in indications for use have been introduced by Cell Bio-Systems in the manufacture of the Disposable Cannulas. For these reasons, Cell Bio-Systems considers the use of the Tulip Disposable Cannulas to be substantially equivalent to their predicate devices