(269 days)
Not Found
No
The device description and performance studies focus on mechanical components and biological compatibility, with no mention of AI or ML.
No.
The device facilitates the processing of autologous adipose tissue by concentrating it, but it does not directly treat or diagnose a disease or condition itself.
No
The device is described as a system for "concentrating adipose tissue" and "sterile processing and transfer of the collected adipose tissue." Its function is to prepare tissue for medical procedures, not to diagnose a condition or disease.
No
The device description explicitly lists physical components such as sterile syringes, luer fittings, and a centrifugation syringe containment vessel, indicating it is a hardware-based medical device.
Based on the provided text, the Ranfac FATS Procedure Pack is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "harvesting of autologous adipose tissue" and "concentrating adipose tissue harvested with a legally marketed lipoplasty system." This describes a surgical procedure involving the patient's own tissue, not a diagnostic test performed on a sample in vitro (outside the body) to diagnose a disease or condition.
- Device Description: The components listed (syringes, luer fittings, centrifugation vessel) are consistent with tools used for processing tissue during a surgical procedure, not for performing a diagnostic test.
- Lack of Diagnostic Language: The text does not mention any diagnostic purpose, analysis of biological markers, or interpretation of results for diagnostic purposes.
IVD devices are typically used to examine specimens such as blood, urine, or tissue samples in vitro to provide information for diagnosis, monitoring, or screening. The Ranfac FATS Procedure Pack is used to process tissue from the patient for re-implantation or other therapeutic uses, which falls under the category of a surgical or procedural device, not an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes
MUU
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.
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
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.
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.
Key Metrics
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized depiction of a human figure in profile, with three overlapping faces representing the department's focus on health and human well-being. The logo is in black and white.
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
1
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
2
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):
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
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
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
4
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 | |
| 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. | The AdiPrep Adipose Transfer System is used in
medical procedures involving the harvesting and
transferring of autologous adipose tissue. The
AdiPrep system is for concentrating adipose
tissue harvested with a legally marketed
lipoplasty system. The AdiPrep Adipose
Transfer System 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. |
| Components | Syringe with removable plunger, aspiration &
fat injection syringes and accessory caps and
luer fittings. | Syringe with removable plunger, aspiration & fat
injection syringes, accessory caps and luer
fittings, skin puncture needles, and oil extraction
syringe & needle. |
Table 5.1 Comparison of the Proposed Ranfac FATS System to the Predicate Harvest AdiPrep Adipose Transfer System
K150156/S001 RAI #2
5
510(k) Summary (Page 3 of 4)
| Ranfac FATS (This Submission) | Harvest AdiPrep (K121005) | |
|---|---|---|
| Centrifugation | ||
| Syringe | Modified standard hypodermic syringe with a | |
| polypropylene barrel with printed graduations, | ||
| and a plunger composed of a polypropylene body | ||
| supporting an elastomer seal (i.e., plunger tip). | ||
| The plunger is removed prior to centrifugation to | ||
| allow the syringe to fit within the centrifuge. | ||
| The FATS centrifugation syringe has a second | ||
| gasket that serves as a barrier to help maintain | ||
| vacuum pressure within the syringe during | ||
| centrifugation and minimizes exposure of the | ||
| syringe contents with air. | Modified standard hypodermic syringe with a | |
| Cyclo Olefin Polymer (COP) barrel with printed | ||
| graduations, and a plunger composed of a | ||
| polypropylene or ABS body supporting a | ||
| silicone seal (i.e., plunger tip). The plunger is | ||
| removed prior to centrifugation to allow the | ||
| syringe to fit within the centrifuge. | ||
| The AdiPrep centrifugation syringe has a lipid | ||
| barrier which provides isolation of oils and lipids | ||
| from adipose tissue and minimizes exposure of | ||
| the concentrated adipose tissue with air. | ||
| The centrifugation syringe has a male luer-lock | ||
| which is attached to a female-female luer lock to | ||
| transfer the concentrated fat to an injection | ||
| syringe. | The centrifugation syringe has a male luer-lock | |
| which is attached to a female-female luer lock to | ||
| transfer the concentrated fat to an injection | ||
| syringe. | ||
| Fill volumes | Volume = 5ml to 25ml | Volume = 5ml to 25ml |
| Principle of | ||
| Operation | Fat is aspirated into syringe (i.e., centrifugation | |
| syringe) that has a removable handle. Shortened | ||
| profile of syringe after removing the handle | ||
| allows the syringe to fit in a standard centrifuge. | ||
| Fat and supernatant material are separated via | ||
| density-gradient separation. | Fat is aspirated into syringe (i.e., centrifugation | |
| syringe) that has a removable handle. Shortened | ||
| profile of syringe after removing the handle | ||
| allows the syringe to fit in a standard | ||
| centrifuge. Fat and supernatant material are | ||
| separated via density-gradient separation. | ||
| Centrifugation | ||
| Protocol | 1250 g-force 4 minutes | 1250 g-force 4 minutes |
| Centrifuge | Generic centrifuge that has appropriate sized | |
| bucket. | Dedicated standard swinging bucket centrifuge | |
| Sterilization Method | ||
| 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.
6
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.