SyntrFuge System

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July 2, 2021 Syntr Health Technologies, Inc. % Nevine Erian Regulatory Consultant BQC Consulting, LLC 24341 Barbados Dr. Dana Point, California 92629 Re: K203800 Trade/Device Name: SyntrFuge System Regulation Number: 21 CFR 878.5040 Regulation Name: Suction Lipoplasty System Regulatory Class: Class II Product Code: MUU Dated: May 11, 2021 Received: May 13, 2021 Dear Nevine Erian: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. {1}------------------------------------------------ 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. Cindy Chowdhury, Ph.D., M.B.A. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### Indications for Use 510(k) Number (if known) K203800 Device Name #### SyntrFuge™ System Indications for Use (Describe) The SyntrFuge™ System is a sterile medical device used in medical procedures involving the harvesting, concentrating and transferring of autologous adipose tissue harvested with a legally marketed lipoplasty system. The device is intended for use in the following surgical specialties when the transfer of harvested adipose tissue is desired: orthopedic surgery, arthroscopic surgery, neurosurgery, gastrointestinal, urological surgery, general surgery, gynecological surgery, laparoscopic surgery, and plastic and reconstructive surgery when aesthetic body contouring is desired. Only legally marketed accessory items, such as syringes, should be used with the system. If harvested fat is to be transferred, the harvested fat is only to be used without any additional manipulation. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| | <b>X</b> Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) | |-------------------------------------------------------|---------------------------------------------| |-------------------------------------------------------|---------------------------------------------| CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ***DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*** The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # K203800 – 510(k) Summary | Submitter | Syntr Health Technologies, Inc.<br>5270 California Ave., Suite #300<br>Irvine, CA 92617, U.S.<br>Establishment Reg. No. – 3017791237 | | | |------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|--| | Contact | Ahmed Zobi<br>Chief Executive Officer<br>Phone 949 732-4298<br>E-Mail azobi@syntrtech.com | | | | Official Correspondent | Nevine Erian<br>Regulatory Consultant<br>BQC Consulting, LLC<br>24341 Barbados Dr.<br>Dana Point, CA 92629<br>Phone (949) 370-7155<br>Fax (949) 240-8829<br>E-mail nevine@bqcconsulting.com | | | | Date Prepared | June 27, 2021 | | | | ■ | Trade/Device Name | SyntrFuge™ System | | | ■ | Common Name | Suction Lipoplasty System | | | ■ | Classification Name | System, Suction, Lipoplasty | | | ■ | Regulation Number | 21 CFR 878.5040 | | | ■ | Product Code | MUU | | ## Predicate Devices - AdiPrep™ Adipose Transfer System (Harvest Technologies Corp.) K121005— Predicate {4}------------------------------------------------ # Device Description The SyntrFuge System is a sterile single use disposable medical device, comprised of three AdipoSets. Each AdipoSet is comprised of two AdipoChambers and one AdipoChip, two AdipoChambers attach to the AdipoChip by luer connectors. The SyntrFuge™ System concentrates lipoaspirate, following a syringe vacuum liposuction method. The SyntrFuge System is utilized in medical procedures where reinjection of adipose tissue into the same individual during the same surgical procedure is needed. ## Indication for Use The SyntrFuge™ System is a sterile medical device used in medical procedures involving the harvesting, concentrating and transferring of autologous adipose tissue harvested with a legally marketed lipoplasty system. The device is intended for use in the following surgical specialties when the transfer of harvested adipose tissue is desired: orthopedic surgery, arthroscopic surgery, neurosurgery, gastrointestinal, urological surgery, general surgery, gynecological surgery, thoracic surgery, laparoscopic surgery, and plastic and reconstructive surgery when aesthetic body contouring is desired. Only legally marketed accessory items, such as syringes, should be used with the system. If harvested fat is to be transferred, the harvested fat is only to be used without any additional manipulation. # Safety and Performance Testing ## Biocompatibility Testing The SyntrFuge System was tested and meets the biocompatibility requirements of ISO 10993-1:2018 – Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process. Test results demonstrated that the SyntrFuge System is non-cytotoxic, non-sensitizing, non-irritant, non-pyrogenic and has no systemic toxicity effects. #### Performance Testing The SyntrFuge™ System has undergone verification testing to ensure it meets product specification requirements. Verification testing consisted of the following: - 트 SyntrFuge System Design Verification Testing - Cleaning Validation - . Cell Viability {5}------------------------------------------------ - 트 Distribution Simulation and Packaging Integrity Testing - . Usability Testing - . Sterilization Validation and Shelf-Life Testing All testing met specifications. Bench test results allowed us to conclude that the SyntrFuge System meets its intended use. ## Substantial Equivalence The SyntrFuge System is substantially equivalent to the predicate device. ### Substantial Equivalence Comparison of the SyntrFuge System to the Predicate Device | Attribute | SyntrFuge™ System | AdiPrep™ Adipose<br>Transfer System<br>(Predicate) | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Classification & Regulation<br>Number | System, Suction,<br>Lipoplasty<br>21 CFR 878.5040 | System, Suction,<br>Lipoplasty<br>21 CFR 878.5040 | | Product Code | MUU | MUU | | Indications for use | | | | Used in medical procedures involving the harvesting, concentrating and transferring of autologous adipose tissue harvested with a legally marketed lipoplasty system. | Yes | Yes | | Intended for use in the following surgical specialities when concentration of harvested tissue is desired.<br>Orthopedic surgery Arthroscopic surgery Neurosurgery Gastrointestinal surgery Urological surgery General surgery Gynecological surgery Thoracic surgery Laparoscopic surgery Plastic and reconstructive surgery | Yes | Yes | | Attribute | SyntrFuge™ System | AdiPrep™ Adipose<br>Transfer System<br>(Predicate) | | Technological Attribute | | | | Processing Pack Components | 3 AdipoSets, comprised<br>each of an AdipoChip and<br>2 AdipoChambers | Harvest AdiPrep Process<br>Disposable unit,<br>centrifuge tubes with<br>filter, aspiration & fat<br>injection cannula, fat<br>injection syringes, skin<br>puncture needles, and<br>oil extraction syringe &<br>needle. | | Material Type | AdipoChip &<br>AdipoChambers<br>composed of medical<br>grade resin. | Cannula & syringes<br>composed of medical<br>grade plastics. | | Sterilization Method | Ethylene-Oxide (EO) | Ethylene-Oxide (EO) | | Sterility Assurance | SAL 10-6 | SAL 10-6 | | Design | AdipoSet/Chamber | Syringe | | Mode of Operation | Centrifugation | Centrifugation | | Processing Volume Capacity | 5mL to 15mL | 5 mL to 25 mL | | Uses Laboratory Centrifuge<br>System | Yes - SyntrFPU 360 | Yes - SmartPrep2 | | Disposable or Reusable | Single Use, Disposable | Single Use, Disposable | | Procedural Attribute | | | | Harvesting Method | Cannula | Cannula | | Tissue Washing Media | Sterile Saline | Sterile Saline | | Processing Output | Concentrated Adipose<br>Tissue | Concentrated Adipose<br>Tissue | | Nucleated Cell Viability (%) | Mean = 87.8% | Mean = 83.5% | | For Adipose Transfer | Yes | Yes | | Environment of Use | Sterile Setting | Sterile Setting | {6}------------------------------------------------ The differences in product configuration between the SyntrFuge System and the AdiPrep Adipose Transfer System do not impact safety and effectiveness, as the SyntrFuge System {7}------------------------------------------------ shares the same indications and achieves the same fat concentration as the predicate device. ## Conclusion Information provided in this application demonstrates that the SyntrFuge System is substantially equivalent to the predicate device. The SyntrFuge System has same indications for use and similar technological characteristics as the predicate device.