The Puregraft® 850/PURE System is indicated for use in the harvesting, filtering and transferring of autologous fat tissue for reinjecting back into the same patient for aesthetic body contouring.

Device Description

The Puregraft® 850/PURE System is a sterile, single use, closed-loop tubing and bag system intended for delivering adipose tissue back to the same patient for cosmetic and reconstructive surgery applications. The Puregraft 850/PURE System consists of collection bags, tubing and syringe adaptors that all have unique connectors and fittings to assure proper assembly. The Puregraft® 850/PURE System is composed of the following components: Puregraft® 850 Bag, Puregraft® 850 Drain Bag, Tissue Access Port Adapter (TAPA), and Luer Lock Syringe Adapter. In addition to the Puregraft® Assemblies described above, the Puregran® 850/PURE System is used in combination with the following Class I hand-held manual instruments provided by Cytori Therapeutics: Easel and Slider.

AI/ML Overview

This document describes the Puregraft® 850/PURE System, a device for harvesting, filtering, and transferring autologous fat tissue. The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting new clinical study data with specific acceptance criteria and performance metrics in the format requested.

Therefore, much of the requested information cannot be extracted directly from the provided text. The document is a 510(k) summary, which typically focuses on demonstrating equivalence to a previously cleared device, not on presenting novel clinical trial results.

Here's an attempt to address your request based on the available information, with clear notations where information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (What was measured)	Reported Device Performance (Result)
Mechanical Performance (e.g., tensile strength, pressure, drop testing)	"Nonclinical testing was performed on the Puregraft® 850/PURE System and Puregraft® 250/PURE System predicate device that included... bench top testing such as tensile strength, pressure, and drop testing." The tests demonstrated that "the Puregraft® 850/PURE System is substantially equivalent to the Puregraft® 250/PURE System predicate device." Specific numerical acceptance criteria or performance values are not provided.
Biological Performance Verification	"Nonclinical testing... included biological performance verification..." Specific biological acceptance criteria (e.g., cell viability, sterility, endotoxin levels post-filtration) or results are not provided. The conclusion is that the new device is "substantially equivalent" to the predicate.
Material Composition (DEHP-free, Medical Grade)	"All materials are medical grade and DEHP free." (For Puregraft® 850 Bag and Drain Bag). "The Puregraft® 850/PURE System is fabricated from medical grade, DEHP free materials." This acts as an implicit acceptance criterion, which the device meets.
Sterility (Gamma Irradiation)	"The Puregraft® 850/PURE System is sterilized with gamma irradiation." This acts as an implicit acceptance criterion, which the device meets. No specific sterility assurance level (SAL) is mentioned.

2. Sample Size for Test Set and Data Provenance

Sample Size for Test Set: Not explicitly stated as a separate "test set" for a clinical study. The nonclinical testing mentioned was "bench top testing" comparing the new device to a predicate. The number of units tested for mechanical and biological verification is not specified.
Data Provenance: The testing was "nonclinical" and involved "bench top testing." It's internal testing conducted by the manufacturer, Cytori Therapeutics, Inc., based in San Diego, California, USA. It is retrospective in the sense that it's comparing against an existing predicate, but the specific testing conducted for this submission would be prospective for the purpose of demonstrating equivalence.

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

This information is not applicable and not provided because the study described is a nonclinical, bench-top comparison demonstrating substantial equivalence, not a clinical study involving human outcomes or expert assessment of diagnostic accuracy. There was no "ground truth" established by experts in the context of diagnostic performance.

4. Adjudication Method for the Test Set

Not applicable and not provided. As it was nonclinical bench testing, there was no need for adjudication by experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

Not applicable and not provided. This device is a medical instrument for fat tissue processing, not an AI-powered diagnostic or decision-support system involving human readers. Therefore, an MRMC study comparing human performance with and without AI assistance is irrelevant to this submission.

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

Not applicable and not provided. This device is a physical system, not a software algorithm.

7. The Type of Ground Truth Used

For the nonclinical testing described, the "ground truth" would be engineering specifications and the performance of the predicate device. For example, for tensile strength, the "ground truth" would be a defined breaking point or acceptable range. For biological performance, it would be adherence to established standards or the comparable performance of the predicate device. Specific quantitative metrics for this "ground truth" against which the new device was measured are not detailed in the summary.

8. The Sample Size for the Training Set

Not applicable and not provided. This is not an AI/ML device that requires a training set.

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

Not applicable and not provided. This is not an AI/ML device that requires a training set or ground truth for training.

Summary

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MAR - 7 2012 K 113255
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510(k) Summary
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Puregraft® 850/PURE System

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ADMINISTRATIVE INFORMATION

Manufacturer Name:

Official Contact:

Cytori Therapeutics, Inc. 3020 Callan Road San Diego, CA 92121

Kenneth K. Kleinhenz Vice President Regulatory Affairs and Quality Assurance

Telephone (858) 458-0900 Fax (858) 458-0994

DEVICE NAME

Classification Name: Trade/Proprietary Name:

Suction Lipoplasty System Puregraft® 850/PURE System

ESTABLISHMENT REGISTRATION NUMBER 3002642958

DEVICE CLASSIFICATION AND PRODUCT CODE

As shown in 21 CFR 878.5040, Suction Lipoplasty Systems are defined as devices consisting of collection bottles, cannulas, and connecting tubing for use in aesthetic body contouring procedures. Suction Lipoplasty Systems are classified as Class II. They have been assigned Product Code MUU.

INDICATIONS FOR USE

The Puregraft® 850/PURE System is indicated for use in the harvesting, filtering and transferring of autologous fat tissue for reinjecting back into the same patient for aesthetic body contouring.

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DEVICE DESCRIPTION

Design Characteristics

Component	Description	Quantity
1	Puregraft® 850 Bag	1
2	Puregraft® 850 Drain Bag	1
3	Tissue Access Port Adapter (TAPA)	12
4	Luer Lock Syringe Adapter	2

In addition to the Puregraft® Assemblies described above, the Puregran® 850/PURE System is used in combination with the following Class I hand-held manual instruments provided by Cytori Therapeutics:

Instruments Used in Conjunction with the Puregraft® 850/PURE System
InstrumentName	Configuration	Function	Quantity
Easel	Anodized Aluminum Stand	Supports Puregraft® 850 Bag	1
Slider	Hand-held Anodized SliderTool	Externally compresses Puregraft® 850Bag to force liquid through filter andinto Puregraft® Drain Bag.	1

Puregraft® 850 Bag

The Puregraft® 850 Bag is a sterile, single-use, 1275mL capacity mixing bag measuring approximately 12" x 9" and consists of 2 filters layered between a polyvinyl chloride (PVC) outer shell and 4 ports on Each port is labeled and uniquely designed to assure the proper connection is the bottom of the bag. made and to alleviate confusion. The "auxiliary" port contains a female bore connector, and the "drain" port contains a male bore connector fitting. The "inlet" port contains a female swabable luer fitting, and the "tissue" port contains a Toomey syringe adapter female fitting. The "tissue" port and the "inlet" port are designed as one-way valves to assure that the contents within the Puregraft® 850 Bag are not accidently spilled from the bag. The Puregraft 850 Bag contains two (2) filters that are continuous within the bag. The first filter is an 800 micron filter mesh and the second filter is a 74 micron filter mesh. All materials are medical grade and DEHP free.

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510(k) Summary

Puregraft® 850/PURE System

Puregraft®850 Drain Bag

The Puregraft® 850 Drain Bag is a sterile, single use, 5 liter bag measuring approximately 11," x 8° with a 0.125 inch drain tube measuring 48 inches in length. The drain tube is provided with a pinch clamp on the exterior of the tubing to control the ingress and egress of fluids to and from the Waste Bag. The attached drain tubing contains a luer lock fitting that mates with the male luer lock on the "drain" port of the Puregraft® 850 Bag. All materials are medical grade and DEHP free.

Luer-Lock Syringe Adapter

The Luer-Lock Syringe Adapter is a sterile, single use, female cylinder measuring approximately 1.5" in length consisting of a swabable luer adaptor on one end and a tapered bore on the opposite end. The swabable female luer mates with a luer-type syringe tip and the tapered bore mates (press fit) with the male end of a Toomey Syringe Adapter and allows for the transfer of material from a Toomey style syringe into a luer style syringe.

Tissue Access Port Adapter (TAPA)

The Tissue Access Port Adapter (TAPA) is a sterile, single use, male / female cylinder measuring approximately 1.5" in length and 0.75mm in diameter at the female end and 0.25" on the male end. The female end has a tapered bore of approximately 0.5" and is designed to mate (press fit) with a Toomeystyle irrigation syringe. The male end of the Tissue Access Port Adapter is designed to mate (press fit) with the tapered end of the Luer-Lock Syringe Adapter which allows for the transfer of material from a Toomey style syringe to a luer style syringe. The male end of the Toomey Syringe Adapter is also designed to fit into the Tissue Inlet Port of the Puregraft® 850 Bag which allows for the transfer of tissue from a Toomey style syringe into the Puregraft® 850 Bag.

Material Composition

The Puregraft® 850/PURE System is fabricated from medical grade, DEHP free materials.

Sterility

The Puregraft® 850/PURE System is sterilized with gamma irradiation.

In Vitro Testing

Mechanical testing of the Puregraft® 850/PURE System demonstrates that the device is substantially equivalent to the predicate devices.

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510(k) Summary

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EQUIVALENCE TO MARKETED PRODUCT

The Puregraft® 850/PURE System shares indications and design principles with the following predicate device which has been determined by FDA to be substantially equivalent to a premarket device: the Cytori Puregraft® 250/PURE System (K092923); a Class II medical device that has been cleared for marketing in the United States under K092923.

Indications for Use

The Puregraft® 850/PURE System and the predicate devices are substantially equivalent with respect to their indications for use, as they are all indicated for the same surgical procedures of harvesting, filtering and transferring of autologous fat tissue for reinjecting back into the same patient.

Design and Materials

The design and materials of the Puregraft® 850/PURE System and the predicate device are substantially equivalent, as they are both single-use, polymer constructed, manually operated systems that receive adipose tissue, filter the adipose tissue, and temporarily hold the adipose tissue until it is removed or placed into a syringe that delivers / re-injects the adipose tissue back into the same patient during the same surgical procedure. The Puregraft® 850/PURE System is substantially equivalent to the predicate device as they both consist of a polymeric housing chamber with a filter unit within the chamber. The predicate device also shares design principles of accepting adipose tissue from the patient and subsequently transport the adipose tissue through a polymeric collection chamber/bag that contains a filtering mechanism of various pore sizes that restricts the movement of adipose tissue and only allows fluids and small debris to pass through the filter and become deposited into a waste container. The Puregraft® 850/PURE System is also substantially equivalent to the predicate device as they both have substantially equivalent tissue volume capacities.

Nonclinical Summary

As a means to confirm the substantial equivalence between the Puregraft® 250/PURE System and the Puregraft® 850/PURE System, nonclinical testing was performed on the Puregraft® 850/PURE System and Puregraft® 250/PURE System predicate device that included biological performance verification and bench top testing such as tensile strength, pressure, and drop testing. The nonclinical testing demonstrates that the Puregraft® 850/PURE System is substantially equivalent to the Puregraft® 250/PURE System predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized image of an eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

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

Cytori Therapeutics, Inc. % Mr. Kenneth K. Kleinhenz VP. Regulatory Affairs & Quality Assurance 3020 Callan Road San Diego, California 92121

Re: K113255

Trade/Device Name: Puregraft® 850/PURE System Regulation Number: 21 CFR 878.5040 Regulation Name: Suction lipoplasty system Regulatory Class: II Product Code: MUU Dated: February 16, 2012 Received: February 17, 2012

Dear Mr Kleinhenz:

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

MAR - 7 2012

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Page 2 - Mr. Kenneth K. Kleinhenz

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/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 Small Manufacturers, International and Consumer Assistance 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.

Sincerely yours.

Mark N. Melkerson

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

Enclosure

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Indications for Use

Device Name: Puregraft® 850/PURE System

Indications for Use:

The Puregraft® 850/PURE System is indicated for use in the harvesting, filtering and transferring of autologous fat tissue for reinjecting back into the same patient for aesthetic body contouring.

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

Over-The-Counter Use _ (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)

Daniel Knaebel MXIV
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Surgical, Orti

510(k) Number K113255

Page 1 of 1

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.