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.

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.

AI/ML Overview

This document describes a 510(k) premarket notification for the Ranfac Fat Aspiration Transfer Syringe (FATS) Procedure Pack. The purpose of this notification is to demonstrate substantial equivalence to a legally marketed predicate device.

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state quantitative acceptance criteria in a table format for performance metrics like fat viability, purity, or recovery rate. Instead, it mentions that "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."

The "Performance Data" section lists the types of tests conducted:

Fluid transfer into and from the process disposable: This would likely involve ensuring efficient and sterile movement of fluids within the system.
Centrifugation tests: This would assess the device's ability to withstand centrifugation and effectively separate components.
Data to support conformance with applicable requirements of ISO 7886-1:1993: This standard relates to sterile hypodermic syringes for single use. Conformance would imply meeting specified dimensional, functional, and material requirements for syringes.
Simulated use: This testing would mimic the actual surgical procedure to confirm the device performs as expected.
Biocompatibility testing: Performed in compliance with ANSI/AAMI/ISO 10993-1: 2009, demonstrating that the materials are suitable for contact with human tissue.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample sizes used for the design verification tests. It mentions "tests" in plural, implying multiple units were tested, but no specific numbers are given.

The data provenance (country of origin, retrospective/prospective) is also not specified. Given this is a 510(k) submission, the tests were likely conducted by the manufacturer (Ranfac Corp., located in Avon, Massachusetts, USA) as part of their product development and regulatory submission process. It's prospective testing for this specific device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not applicable and not provided in the document. The performance tests described (fluid transfer, centrifugation, ISO compliance, biocompatibility, simulated use) are objective engineering and material science tests, not assessments requiring expert "ground truth" in a clinical diagnostic sense. There is no mention of experts establishing a ground truth for these tests.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the tests are objective engineering and material science evaluations, not subjective assessments requiring adjudication by experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states under "8. Clinical Data": "Not applicable." This type of study is typically associated with diagnostic imaging devices or algorithms that involve human interpretation and would measure the impact of an AI on human reader performance. This device is a surgical procedure pack, not a diagnostic or interpretation-assistive device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not applicable as the Ranfac FATS Procedure Pack is a physical medical device (a surgical procedure pack), not a software algorithm. Therefore, "standalone" performance in the context of an algorithm is not a relevant concept for this device. Its performance is evaluated through its physical and functional attributes.

7. The Type of Ground Truth Used

For the engineering and material tests, the "ground truth" would be the established specifications, standards (e.g., ISO 7886-1:1993), and risk analysis requirements that the device is designed to meet. For biocompatibility, the ground truth is defined by the ANSI/AAMI/ISO 10993-1 standard. There is no clinical "ground truth" in terms of pathology or outcomes data presented here, as it's a 510(k) submission for a device based on substantial equivalence, not a clinical trial demonstrating efficacy against a disease outcome.

8. The Sample Size for the Training Set

Not applicable. This device is a physical sterile procedure pack, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

Summary

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)

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

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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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: 508-588-4400 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

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 inmedical procedures involving the harvestingand transferring of autologous adipose tissue.The FATS Procedure Pack is for concentratingadipose tissue harvested with a legallymarketed lipoplasty system. The device isintended for use in the following surgicalspecialties when the concentration of harvestedadipose is desired:Neurosurgery, gastrointestinal surgery,urological surgery, plastic & reconstructivesurgery, general surgery, orthopedic surgery,gynecological surgery, thoracic surgery,laparoscopic surgery, arthroscopic surgery.	The AdiPrep Adipose Transfer System is used inmedical procedures involving the harvesting andtransferring of autologous adipose tissue. TheAdiPrep system is for concentrating adiposetissue harvested with a legally marketedlipoplasty system. The AdiPrep AdiposeTransfer System is intended for use in thefollowing surgical specialties when theconcentration of harvested adipose is desired:Neurosurgery, gastrointestinal surgery,urological surgery, plastic & reconstructivesurgery, general surgery, orthopedic surgery,gynecological surgery, thoracic surgery,laparoscopic surgery, arthroscopic surgery.
Components	Syringe with removable plunger, aspiration &fat injection syringes and accessory caps andluer fittings.	Syringe with removable plunger, aspiration & fatinjection syringes, accessory caps and luerfittings, skin puncture needles, and oil extractionsyringe & 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)
CentrifugationSyringe	Modified standard hypodermic syringe with apolypropylene barrel with printed graduations,and a plunger composed of a polypropylene bodysupporting an elastomer seal (i.e., plunger tip).The plunger is removed prior to centrifugation toallow the syringe to fit within the centrifuge.The FATS centrifugation syringe has a secondgasket that serves as a barrier to help maintainvacuum pressure within the syringe duringcentrifugation and minimizes exposure of thesyringe contents with air.	Modified standard hypodermic syringe with aCyclo Olefin Polymer (COP) barrel with printedgraduations, and a plunger composed of apolypropylene or ABS body supporting asilicone seal (i.e., plunger tip). The plunger isremoved prior to centrifugation to allow thesyringe to fit within the centrifuge.The AdiPrep centrifugation syringe has a lipidbarrier which provides isolation of oils and lipidsfrom adipose tissue and minimizes exposure ofthe concentrated adipose tissue with air.
	The centrifugation syringe has a male luer-lockwhich is attached to a female-female luer lock totransfer the concentrated fat to an injectionsyringe.	The centrifugation syringe has a male luer-lockwhich is attached to a female-female luer lock totransfer the concentrated fat to an injectionsyringe.
Fill volumes	Volume = 5ml to 25ml	Volume = 5ml to 25ml
Principle ofOperation	Fat is aspirated into syringe (i.e., centrifugationsyringe) that has a removable handle. Shortenedprofile of syringe after removing the handleallows the syringe to fit in a standard centrifuge.Fat and supernatant material are separated viadensity-gradient separation.	Fat is aspirated into syringe (i.e., centrifugationsyringe) that has a removable handle. Shortenedprofile of syringe after removing the handleallows the syringe to fit in a standardcentrifuge. Fat and supernatant material areseparated via density-gradient separation.
CentrifugationProtocol	1250 g-force 4 minutes	1250 g-force 4 minutes
Centrifuge	Generic centrifuge that has appropriate sizedbucket.	Dedicated standard swinging bucket centrifuge
Sterilization Methodof 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.

Regulation Number and Section

§ 878.5040 Suction lipoplasty system.

(a)
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 of1/3 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.(b)
Classification. Class II (special controls). Consensus standards and labeling restrictions.