Ranfac Fat Aspiration Cannula

K162932 · Ranfac, Corp. · MUU · Jan 19, 2017 · General, Plastic Surgery

Device Facts

• Record ID: K162932
• Device Name: Ranfac Fat Aspiration Cannula
• Applicant: Ranfac, Corp.
• Product Code: MUU · General, Plastic Surgery
• Decision Date: Jan 19, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Ranfac Fat Aspiration Cannula are intended for use in aesthetic body contouring. If harvested fat is to be re-implanted, the harvested fat is only to be used without any additional manipulation.

Device Story

Ranfac Fat Aspiration Cannula are sterile, single-use, disposable stainless steel cannulas designed for aesthetic body contouring. The device features a closed distal end with side-wall fenestrations for fat aspiration and an ABS plastic handle compatible with Luer Lock syringes. Operated by clinicians in a clinical setting, the device is attached to a syringe to create suction. The cannula aspirates fat tissue through the side ports into the tubing. The harvested fat may be re-implanted without further manipulation. The device provides a mechanical means for fat removal, assisting the physician in body contouring procedures.

Clinical Evidence

Bench testing only. Performance was evaluated by comparing aspiration of distilled water, silicone fluid, and pure glycerin using the subject device versus the predicate and reference cannulas with 20cc and 30cc syringes. No clinical data was provided.

Technological Characteristics

Materials: ISO 9626 stainless steel with silicone coating; ABS plastic handle. Design: Hollow cannula, closed distal end, side ports. Dimensions: 11Ga, 13Ga, 14Ga; lengths 10cm-25cm. Energy: Manual suction via Luer Lock syringe. Sterilization: Ethylene Oxide. Connectivity: None.

Indications for Use

Indicated for aesthetic body contouring in patients requiring fat aspiration; if fat is re-implanted, it must be used without additional manipulation.

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 Cannulas (K060089)

Reference Devices

• Tulip Trivisonno Micro Harvester Cannula
• Tulip J. W. Little Harvester Cannula
• Tulip GEMS Carraway Harvester Cannula

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 19, 2017

Ranfac Corporation Mr. Christopher Whelan Senior Vice President 30 Doherty Avenue, P.O. Box 635 Avon, Massachusetts 02322

Re: K162932

Trade/Device Name: Ranfac Fat Aspiration Cannula Regulation Number: 21 CFR 878.5040 Regulation Name: Suction Lipoplasty System Regulatory Class: Class II Product Code: MUU Dated: October 18, 2016 Received: October 20, 2016

Dear Mr. Whelan:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

{1}------------------------------------------------

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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

David Krause -S

for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known) K162932

Device Name Ranfac Fat Aspiration Cannula

Indications for Use (Describe)

The Ranfac Fat Aspiration Cannula is intended for use in aesthetic body contouring.

If harvested fat is to be re-implanted, the harvested fat is only to be used without any additional manipulation.

Type of Use (Select one or both, as applicable)

| | <b>x</b> Prescription Use (Part 21 CFR 801 Subpart D) |
|--|-------------------------------------------------------|
| | Over-The-Counter Use (21 CFR 801 Subpart C) |

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

K162932 - Page 1 of 5

# 510k Summary

| Owner's Name and Address: | Ranfac Corp. |
|---------------------------|---------------------------------------------------|
| | 30 Doherty Avenue |
| | Avon, MA 02322-0635 |
| | FDA Registration Number 1211566 |
| Official Contact Person: | Christopher P. Whelan |
| | Senior Vice President |
| | Telephone: [phone] extension: 106 |
| | Facsimile: 508-584-8588 |
| | e-mail: [e-mail] |
| Date Summary Prepared: | December 13, 2016 |
| Device Trade Name: | Ranfac Fat Aspiration Cannula |
| Common Name: | Liposuction Cannula |
| Classification Name: | Suction lipoplasty system (MUU) |
| | 21 CFR § 878, General and Plastic Surgery Devices |
| | Subpart E Surgical devices, |
| | Sec. 878.5040 Suction lipoplasty system, Class II |

# Predicate Device:

| 510(k)<br>Number | Predicate Description | Manufactured By |
|------------------|---------------------------|-----------------|
| K060089 | Tulip Disposable Cannulas | Tulip Medical |

{4}------------------------------------------------

| Instrument | Ranfac Fat Aspiration Cannula | Tulip Disposable Cannulas |
|--------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K162932 | K060089 |
| Intended Use | The Ranfac Fat Aspiration Cannula are<br>intended for use in aesthetic body<br>contouring. If harvested fat is to be re-<br>implanted, the harvested fat is only to be<br>used without any additional manipulation. | The Tulip Disposable Cannulas are<br>intended for use in aesthetic body<br>contouring. |
| Design | Sterile, Disposable | Sterile, Disposable |
| Performance<br>Characteristics | Cannula designed to be attached to<br>a Luer Lock type syringe.<br>Cannula available in several<br>diameters, lengths and tip<br>configurations. | Cannulas are designed to be used<br>with a syringe or syringe adaptor.<br>They are available in various<br>diameters, lengths and tip<br>configurations. |
| Cannula<br>Configuration | Hollow Cannula, with Closed End<br>and Side Ports | Hollow Cannula, with Closed End<br>and Side Ports |
| Ga. Size | 11Ga., 13Ga. & 14Ga. | 11Ga., 13Ga. & 14Ga. |
| Length | 10cm, 12cm, 15cm, 20cm & 25cm | 10cm, 12cm, 15cm, 20cm & 25cm |
| Sterilization | Supplied Sterile<br>(Ethylene Oxide) | Supplied Sterile<br>(Ethylene Oxide) |
| Materials:<br>Cannula<br>Handle<br>Cannula | Plastic (ABS)<br><br>ISO 9626 Stainless Steel with<br>silicone coating | Plastic<br><br>ISO 9626 Stainless Steel with<br>hydrophilic coating |

The materials used in the devices compare in this way:

# Background

The Ranfac Fat Aspiration Cannula are stainless steel cannula designed for connection to Luer Lock syringes or similar Luer Lock devices for aspiration. The cannula are made of stainless

{5}------------------------------------------------

steel, is silicone coated and are available in various diameters, lengths and tip configurations.

The Ranfac Fat Aspiration Cannula are single-use disposables, supplied sterile (Ethylene Oxide), and are packaged in a Tyvek® pouch.

Device Description: The Ranfac Fat Aspiration Cannula consist of silicone coated stainless steel tubing that is closed on the distal end and has fenestrations in the side wall to allow fat to be aspirated into the tubing. There is a Luer Lock compatible handle made of ABS plastic, molded to the cannula.

| Intended Use: | The Ranfac Fat Aspiration Cannula are intended for<br>use in aesthetic body contouring. If harvested fat is<br>to be re-implanted, the harvested fat is only to be<br>used without any additional manipulation. |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological Characteristics: | The design, use and materials of the Ranfac Fat<br>Aspiration Cannula and the predicate device are<br>equivalent, in that all of the cannula are designed to<br>be used for aesthetic body contouring and are<br>fabricated of stainless steel. No new technology or<br>change in indications for Use has been introduced<br>by Ranfac Corp. in the manufacture of the Ranfac<br>Fat Aspiration Cannula. |

{6}------------------------------------------------

### Performance Testing:

Non-clinical Data:

Performance testing was conducted to demonstrate that the aspiration performance of the Ranfac Fat Aspiration Cannula was substantially equivalent to The Tulip Disposable Cannula. Testing performed:

- . Aspiration of Distilled Water using the Ranfac Fat Aspiration Cannula with 30cc & 20cc svringes.
- . Aspiration of Distilled Water using the Tulip Trivisonno Micro Harvester Cannula with 20cc & 30cc syringes.
- Aspiration of Distilled Water using the Tulip J. W. Little Harvester Cannula with 20cc & . 30cc syringes.
- Aspiration of Distilled Water using the Tulip GEMS Carraway Harvester Cannula with ● 20cc & 30cc syringes.
- . Aspiration of Silicone, Dow Corning 200 Fluid using the Ranfac Fat Aspiration Cannula with 30cc & 20cc syringes.
- . Aspiration of Silicone, Dow Corning 200 Fluid using the Tulip Trivisonno Micro Harvester Cannula with 20cc & 30cc syringes.
- Aspiration of Silicone, Dow Corning 200 Fluid using the Tulip J. W. Little Harvester . Cannula with 20cc & 30cc syringes.
- Aspiration of Silicone, Dow Corning 200 Fluid using the Tulip GEMS Carraway . Harvester Cannula with 20cc & 30cc syringes.
- Aspiration of Pure Glycerin using the Ranfac Fat Aspiration Cannula with 30cc & 20cc . syringes.
- Aspiration of Pure Glycerin using the Tulip Trivisonno Micro Harvester Cannula with . 20cc & 30cc syringes.
- Aspiration of Pure Glycerin using the Tulip J. W. Little Harvester Cannula with 20cc & . 30cc syringes.
- Aspiration of Pure Glycerin using the Tulip GEMS Carraway Harvester Cannula with . 20cc & 30cc syringes.

{7}------------------------------------------------

### Conclusion:

Based on the similarities in materials, design, manufacturing, principles of function, biocompatibility and sterilization between the Ranfac Fat Aspiration Cannula, subject of this premarket notification and the predicate device, we consider the Ranfac Fat Aspiration Cannula to be substantially equivalent to the predicate device under the Federal Food, Drug and Cosmetic Act.