Ranfac Fat Aspiration Transfer Syringe (FATS) Procedure Pack, Ranfac Fat Aspiration Transfer Syringe (FATS) Containment Vessel

K150156 · Ranfac, Corp. · MUU · Oct 19, 2015 · General, Plastic Surgery

Device Facts

• Record ID: K150156
• Device Name: Ranfac Fat Aspiration Transfer Syringe (FATS) Procedure Pack, Ranfac Fat Aspiration Transfer Syringe (FATS) Containment Vessel
• Applicant: Ranfac, Corp.
• Product Code: MUU · General, Plastic Surgery
• Decision Date: Oct 19, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5040
• Device Class: Class 2

Intended Use

The Ranfac FATS Procedure Pack is used in medical procedures involving the harvesting and transferring of autologous adipose tissue. The FATS Procedure Pack is for concentrating adipose tissue harvested with a legally marketed lipoplasty system. The device is intended for use in the following surgical specialties when the concentration of harvested adipose is desired: Neurosurgery, gastrointestinal surgery, urological surgery, plastic & reconstructive surgery, general surgery, orthopedic surgery, gynecological surgery, thoracic surgery, laparoscopic surgery, arthroscopic surgery.

Device Story

Device facilitates sterile processing and transfer of harvested autologous adipose tissue. System includes centrifugation syringes, transfer syringes, luer fittings, and a reusable containment vessel. Principle of operation: density-gradient separation via centrifugation. User aspirates fat into syringe; removes plunger/handle to shorten profile; places in generic centrifuge (1250 g-force for 4 minutes). Concentrated adipose tissue is transferred to injection syringe via luer-lock fittings. Used in clinical/surgical settings by healthcare providers. Benefits patient by providing concentrated autologous tissue for surgical applications.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including fluid transfer performance, centrifugation testing, and simulated use. Biocompatibility testing performed per ANSI/AAMI/ISO 10993-1:2009.

Technological Characteristics

Components: polypropylene syringe barrel, plunger with elastomer seal, luer fittings. Centrifugation: 1250 g-force for 4 minutes. Sterilization: Ethylene-Oxide (EtO). Conformance: ISO 7886-1:1993 (sterile hypodermic syringes). Single-use disposables.

Indications for Use

Indicated for patients undergoing medical procedures requiring the harvesting and concentration of autologous adipose tissue across various surgical specialties including neurosurgery, gastrointestinal, urological, plastic/reconstructive, general, orthopedic, gynecological, thoracic, laparoscopic, and arthroscopic surgery.

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

• Harvest AdiPrep System (K121005)

Submission Summary (Full Text)

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

October 19, 2015

Ranfac Corporation Mr. Christopher P. Whelan Senior Vice President - Quality 30 Doherty Avenue Avon, Massachusetts 02322

Re: K150156

Trade/Device Name: Ranfac Fat Aspiration Transfer Syringe (FATS) Procedure Pack Regulation Number: 21 CFR 878.5040 Regulation Name: Suction lipoplasty system Regulatory Class: Class II Product Code: MUU Dated: September 11, 2015 Received: September 14, 2015

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 [SELECT ONE: Part 801 [or, for IVDs only] Parts 801 and

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809]); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.

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/Resourcesfor You/Industry/default.htm. 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/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 yours,

# 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

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# Indications for Use

510(k) Number (if known) K150156

### Device Name

Ranfac Fat Aspiration Transfer Syringe (FATS) Procedure Pack

### Indications for Use (Describe)

The Ranfac FATS Procedure Pack is used in medical procedures involving the harvesting of autologous adipose tissue. The FATS Procedure Pack is for concentrating adipose tissue harvested with a legally marketed lipoplasty system. The device is intended for use in the following surgical specialties when the concentration of harvested adipose is desired: Neurosurgery, gastrointestinal surgery, urological surgery, plastic & reconstructive surgery, orthopedic surgery, gynecological surgery, thoracic surgery, laparoscopic surgery, arthroscopic surgery.

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

| <span> <span style="font-size: 12px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|--------------------------------------------------------------------------------------------------------|
| <span> <span style="font-size: 12px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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# 510(k) Summary (Page 1 of 4)

The contents of this 510(k) summary have been provided in conformance with 21 CFR §807.92 "Content and Format of a 510(k) Summary".

#### Submitter/Sponsor 1.

Ranfac Corp. 30 Doherty Avenue Avon MA 02322 FDA Registration Number 1211566 Telephone Number/Fax: [phone] ext. 106/508-584-8588 Contact Person: Christopher P. Whelan Date Prepared: December 30, 2014

### 2. Device Name

Trade Name: Ranfac Fat Aspiration Transfer Syringe (FATS) Procedure Pack Common or Usual Name: Fat Transfer Syringe Procedure Pack Classification Name: Suction Lipoplasty System 21 CFR §878.5040, Procode MUU Classification: Class II

#### 3. Predicate Device:

| Trade Name | 510(k) | Company |
|------------------------|---------|----------------------|
| Harvest AdiPrep System | K121005 | Harvest Technologies |

### 4. Device Description

The Ranfac Fat Aspirate Transfer System (FATS) is designed to allow for sterile processing and transfer of the collected adipose tissue. The device consists of a procedure pack including the following components: two sterile centrifugation syringes, two each 30 mL and 20 mL sterile syringes for adipose tissue aspirate transfer, and other luer fittings as accessories to be used to transfer into and from the centrifugation syringe. Additionally, a non-sterile, reusable centrifugation syringe Containment Vessel is provided as a separate accessory which allows the centrifugation syringe to fit within a commercially available centrifuge.

### K150156/S001 RAI #2

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### 510(k) Summary (Page 2 of 4)

#### 5. Indications For Use

The Ranfac FATS Procedure Pack is used in medical procedures involving the harvesting and transferring of autologous adipose tissue. The FATS Procedure Pack is for concentrating adipose tissue harvested with a legally marketed lipoplasty system. The device is intended for use in the following surgical specialties when the concentration of harvested adipose is desired: Neurosurgery, gastrointestinal surgery, urological surgery, plastic & reconstructive surgery, general surgery, orthopedic surgery, gynecological surgery, thoracic surgery, laparoscopic surgery, arthroscopic surgery.

#### Comparison of the Technological Characteristics With the Predicate Devices: 6.

As compared with the predicate device, and as shown below, the Ranfac FATS device has the same indications for use, and has similar technological and operational characteristics when compared with the predicate device.

| | Ranfac FATS (This Submission) | Harvest AdiPrep (K121005) |
|--------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Ranfac FATS Procedure Pack is used in<br>medical procedures involving the harvesting<br>and transferring of autologous adipose tissue.<br>The FATS Procedure Pack is for concentrating<br>adipose tissue harvested with a legally<br>marketed lipoplasty system. The device is<br>intended for use in the following surgical<br>specialties when the concentration of harvested<br>adipose is desired:<br><br>Neurosurgery, gastrointestinal surgery,<br>urological surgery, plastic & reconstructive<br>surgery, general surgery, orthopedic surgery,<br>gynecological surgery, thoracic surgery,<br>laparoscopic surgery, arthroscopic surgery. | The AdiPrep Adipose Transfer System is used in<br>medical procedures involving the harvesting and<br>transferring of autologous adipose tissue. The<br>AdiPrep system is for concentrating adipose<br>tissue harvested with a legally marketed<br>lipoplasty system. The AdiPrep Adipose<br>Transfer System is intended for use in the<br>following surgical specialties when the<br>concentration of harvested adipose is desired:<br><br>Neurosurgery, gastrointestinal surgery,<br>urological surgery, plastic & reconstructive<br>surgery, general surgery, orthopedic surgery,<br>gynecological surgery, thoracic surgery,<br>laparoscopic surgery, arthroscopic surgery. |
| Components | Syringe with removable plunger, aspiration &<br>fat injection syringes and accessory caps and<br>luer fittings. | Syringe with removable plunger, aspiration & fat<br>injection syringes, accessory caps and luer<br>fittings, skin puncture needles, and oil extraction<br>syringe & needle. |

Table 5.1 Comparison of the Proposed Ranfac FATS System to the Predicate Harvest AdiPrep Adipose Transfer System

### K150156/S001 RAI #2

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# 510(k) Summary (Page 3 of 4)

| | Ranfac FATS (This Submission) | Harvest AdiPrep (K121005) |
|-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Centrifugation<br>Syringe | Modified standard hypodermic syringe with a<br>polypropylene barrel with printed graduations,<br>and a plunger composed of a polypropylene body<br>supporting an elastomer seal (i.e., plunger tip).<br>The plunger is removed prior to centrifugation to<br>allow the syringe to fit within the centrifuge.<br>The FATS centrifugation syringe has a second<br>gasket that serves as a barrier to help maintain<br>vacuum pressure within the syringe during<br>centrifugation and minimizes exposure of the<br>syringe contents with air. | Modified standard hypodermic syringe with a<br>Cyclo Olefin Polymer (COP) barrel with printed<br>graduations, and a plunger composed of a<br>polypropylene or ABS body supporting a<br>silicone seal (i.e., plunger tip). The plunger is<br>removed prior to centrifugation to allow the<br>syringe to fit within the centrifuge.<br>The AdiPrep centrifugation syringe has a lipid<br>barrier which provides isolation of oils and lipids<br>from adipose tissue and minimizes exposure of<br>the concentrated adipose tissue with air. |
| | The centrifugation syringe has a male luer-lock<br>which is attached to a female-female luer lock to<br>transfer the concentrated fat to an injection<br>syringe. | The centrifugation syringe has a male luer-lock<br>which is attached to a female-female luer lock to<br>transfer the concentrated fat to an injection<br>syringe. |
| Fill volumes | Volume = 5ml to 25ml | Volume = 5ml to 25ml |
| Principle of<br>Operation | Fat is aspirated into syringe (i.e., centrifugation<br>syringe) that has a removable handle. Shortened<br>profile of syringe after removing the handle<br>allows the syringe to fit in a standard centrifuge.<br>Fat and supernatant material are separated via<br>density-gradient separation. | Fat is aspirated into syringe (i.e., centrifugation<br>syringe) that has a removable handle. Shortened<br>profile of syringe after removing the handle<br>allows the syringe to fit in a standard<br>centrifuge. Fat and supernatant material are<br>separated via density-gradient separation. |
| Centrifugation<br>Protocol | 1250 g-force 4 minutes | 1250 g-force 4 minutes |
| Centrifuge | Generic centrifuge that has appropriate sized<br>bucket. | Dedicated standard swinging bucket centrifuge |
| Sterilization Method<br>of Procedure Pack | Ethylene-Oxide Gas (EtO) | Ethylene-Oxide Gas (EtO) |
| How Used | Single use only | Single use only |

# Table 5.1 Comparison of the Proposed Ranfac FATS System to the Predicate Harvest AdiPrep Adipose Transfer System

#### 7. Performance Data

Design verification tests were performed based on the risk analysis and product requirements, and the results of these tests demonstrate that the Ranfac FATS Procedure Pack is adequately designed for the intended use indicated. Design verification tests included fluid transfer into and from the process disposable, centrifugation tests, data to support conformance with applicable requirements of ISO 7886-1:1993 and simulated use.

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### 510(k) Summary (Page 4 of 4)

Biocompatibility testing have also been performed in compliance with ANSVAAMI/ISO 10993-1: 2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process and consistent with FDA's Blue Book Guidance G95 "Use of International Standard ISO 10993-1, Biological Evaluation of Medical Devices -Part 1: Evaluation and Testing. Results of this testing demonstrate that the materials used in the assembly of the FATS device are suitable for their intended use.

#### 8. Clinical Data

Not applicable

#### 9. Conclusion

Based on the similarities in indications for use, materials, design, principles of function, biocompatibility and sterilization between the Ranfac Fat Aspirate Transfer Syringe Procedure Pack, subject of this premarket notification and the predicate devices, the proposed subject device has been shown to be substantially equivalent to the predicate devices in accordance with Section 510(k) of the Federal Food, Drug and Cosmetic Act.