(105 days)
No
The summary describes a mechanical system for processing fat tissue and does not mention any AI or ML components or functionalities.
No
The device is described as harvesting, filtering, and transferring autologous fat tissue for reinjecting back into the same patient for aesthetic body contouring. This falls under cosmetic or reconstructive procedures rather than treating a disease or condition, which is typically the purpose of a therapeutic device.
No
Explanation: The device is described as a system for harvesting, filtering, and transferring autologous fat tissue for reinjecting, which is a therapeutic or surgical procedure, not a diagnostic one.
No
The device description explicitly states it is a "sterile, single use, closed-loop tubing and bag system" consisting of "collection bags, tubing and syringe adaptors," which are all physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "harvesting, filtering and transferring of autologous fat tissue for reinjecting back into the same patient for aesthetic body contouring." This describes a surgical procedure involving the patient's own tissue, not a diagnostic test performed on samples outside the body.
- Device Description: The description details a "closed-loop tubing and bag system intended for delivering adipose tissue back to the same patient." This aligns with a surgical or procedural device, not a diagnostic one.
- Lack of Diagnostic Elements: There is no mention of analyzing samples, detecting substances, or providing diagnostic information about a patient's health condition.
IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely for processing and transferring tissue for a therapeutic/aesthetic purpose.
N/A
Intended Use / Indications for Use
The Cytori PureGraft 250/PURE System is indicated for use in the harvesting, filtering and transferring of autologous fat tissue for reinjecting back into the same patient for body contouring.
The Cytori PureGraft 250/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.
Product codes
MUU
Device Description
The Cytori PureGraft 250/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. Cytori PureGraft 250/PURE consists of collection bags, tubing and syringe adaptors that all have unique connectors and fittings to assure proper assembly. The Cytori PureGraft 250/PURE System is composed of the following components: PureGraft 250mL Bag, 1.5L Waste Bag with Connection Tubing, Inlet Tubing with Spike, Luer-lock Syringe Adaptor, Toomey Syringe Adaptor.
The PureGraft 250mL Bag is a sterile, single-use, 500mL capacity mixing bag measuring approximately 10" x 6" and consists of 2 filters layered between a polyvinyl chloride (PVC) outer shell and 3 ports on the bottom of the bag. Each port is labeled and unique in design to assure the proper connection is made and to alleviate confusion. The "drain" port contains a male luer fitting, the "inlet" port contains a female swable luer fitting, and the "tissue" port contains a mark fitting and more fitting. The "tissue" port and the "inlet" port are designed as one-way valves to assure that the contents within the PureGraft 250mL Bag are not accidently spilled from the bag. The PureGraft 250mL Bag contains two (2) filters that are continuous within the bag. The first filter is a 1,000 micron filter mesh and the second filter is a 74 micron filter. All materials are medical grade and DEHP free.
The Waste Bag is a sterile, single use, 1.5 liter bag measuring approximately 11" x 8" with a 1/8" inch drain tube measuring 48 inch 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 250mL Bag. All materials are medical grade and DEHP free.
The Inlet Tubing set is a sterile, single use, 1/8" inch tubing approximately 66 inches in length with a spike for puncturing an IV bag at one end, a male luer at the other and a "Y" port with a one-way luer valve. The Inlet Tubing set is provided with a pinch clamp on the exterior of the tubing to control the flow of fluids. The male luer mates with the female swabable luer fitting on the "inlet" port of the PureGraft 250mL Bag. All materials are medical grade and DEHP free.
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 0 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.
The Toomey Syringe Adapter 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 Toomey-style irrigation syringe. The male end of the Toomey Syringe Adapter is designed to mate (press fit) with the tapered end of the Luer-Lock Syringe Adaptor 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 250mL Bag which allows for the transfer of tissue from a Toomey style syringe into the PureGraft 250mL Bag.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Mechanical testing of the Cytori PureGraft 250/PURE System demonstrates that the device is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
.K092923/52
JAN - 6 2010
510(k) Summary
Cytori PureGraft 250/PURE System
Page 1 of 4
ADMINISTRATIVE INFORMATION
Manufacturer Name:
Cytori Therapeutics, Inc. 3020 Callan Road San Diego, CA 92121
Official Contact:
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 Cytori PureGraft 250/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 Cytori PureGraft 250/PURE System is indicated for use in the harvesting, filtering and transferring of autologous fat tissue for reinjecting back into the same patient for body contouring.
esthentc
1
DEVICE DESCRIPTION
Design Characteristics
The Cytori PureGraft 250/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. Cytori PureGraft 250/PURE consists of collection bags, tubing and syringe adaptors that all have unique connectors and fittings to assure proper assembly. The Cytori PureGraft 250/PURE System is composed of the following components:
| Components | Quantity |
|---|---|
| PureGraft 250mL Bag | 1 |
| 1.5L Waste Bag with Connection Tubing | 1 |
| Inlet Tubing with Spike | 1 |
| Luer-lock Syringe Adaptor | 2 |
| Toomey Syringe Adaptor | 12 |
The PureGraft 250mL/PURE System may be used in conjunction with an Easel Rack to hold the PureGraft 250 Bag and a Squeegee that applies pressure to the exterior of the PureGraft 250mL Bag to facilitate the movement of excess away from the tissue and into the Waste Bag.
PureGraft 250mL Bag
The PureGraft 250mL Bag is a sterile, single-use, 500mL capacity mixing bag measuring approximately 10" x 6" and consists of 2 filters layered between a polyvinyl chloride (PVC) outer shell and 3 ports on the bottom of the bag. Each port is labeled and unique in design to assure the proper connection is made and to alleviate confusion. The "drain" port contains a male luer fitting, the "inlet" port contains a female swable luer fitting, and the "tissue" port contains a mark fitting and more fitting. The "tissue" port and the "inlet" port are designed as one-way valves to assure that the contents within the PureGraft 250mL Bag are not accidently spilled from the bag. The PureGraft 250mL Bag contains two (2) filters that are continuous within the bag. The first filter is a 1,000 micron filter mesh and the second filter is a 74 micron filter. All materials are medical grade and DEHP free.
Waste Bag with Connection Tubing
The Waste Bag is a sterile, single use, 1.5 liter bag measuring approximately 11" x 8" with a 1/8" inch drain tube measuring 48 inch 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 250mL Bag. All materials are medical grade and DEHP free.
2
510(k) Summary
Inlet Tubing with Spike
The Inlet Tubing set is a sterile, single use, 1/8" inch tubing approximately 66 inches in length with a spike for puncturing an IV bag at one end, a male luer at the other and a "Y" port with a one-way luer valve. The Inlet Tubing set is provided with a pinch clamp on the exterior of the tubing to control the flow of fluids. The male luer mates with the female swabable luer fitting on the "inlet" port of the PureGraft 250mL 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 0 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.
Toomey Syringe Adapter
The Toomey Syringe Adapter 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 Toomey-style irrigation syringe. The male end of the Toomey Syringe Adapter is designed to mate (press fit) with the tapered end of the Luer-Lock Syringe Adaptor 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 250mL Bag which allows for the transfer of tissue from a Toomey style syringe into the PureGraft 250mL Bag.
Material Composition
The Cytori PureGraft 250/PURE System is fabricated from medical grade, DEHP free materials.
Sterility
The Cytori PureGraft 250/PURE System is sterilized with gamma irradiation.
In Vitro Testing
Mechanical testing of the Cytori PureGraft 250/PURE System demonstrates that the device is substantially equivalent to the predicate devices.
3
EQUIVALENCE TO MARKETED PRODUCT
The Cytori PureGraft 250/PURE System shares indications and design principles with the following predicate devices which have been determined by FDA to be substantially equivalent to premarket devices: the Cytori AFT System (K072587), the Shippert Medical Tissu-Trans (K050797), and the Lipose Fat Transfer System (K081848); Class II medical devices that were cleared for marketing in the United States under K072587, K050797, and K081848 respectively.
Indications for Use
The Cytori PureGraft 250/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 Cytori PureGraft 250/PURE System and the predicate devices are substantially equivalent, as they are all 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 Cytori PureGraft 250/PURE System is substantially equivalent to the predicate devices as they all consist of a polymeric housing chamber with a filter unit within the chamber. These predicate devices also share design principles of accepting adipose tissue from the patient and subsequently transport the adipose tissue through a tube into 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 Cytori PureGraft 250/PURE System is also substantially equivalent to the predicate devices as they all have substantially equivalent tissue volume capacities.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a bird in flight, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
JAN - 6 2010
Cytori Therapeutics, Inc. % Mr. Kenneth K. Kleinhenz VP of Regulatory Affairs & Quality Assurance 3020 Callan Road San Diego, California 92121
Re: K092923
Trade/Device Name: Cytori PureGraft 250/PURE System Regulation Number: 21 CFR 878.5040 Regulation Name: Suction lipoplasty system Regulatory Class: Class II Product Code: MUU Dated: January 4, 2010 Received: January 5, 2010
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.
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
5
Page 2 - Mr. Kenneth K. Kleinhenz
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 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/cdrh/mdr/ 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/cdrh/industry/support/index.html.
Sincerely yours,
Mark A. Millam
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
· Enclosure
6
Indications for Use
510(k) Number (if known):K092923
Device Name: Cytori PureGraft 250/PURE System
Indications For Use:
The Cytori PureGraft 250/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 Kane
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K092923
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