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.

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.

AI/ML Overview

This document is a 510(k) Pre-market Notification for the SyntrFuge System, a medical device used for processing autologous adipose tissue. The information provided outlines the system's design, indications for use, and a comparison to a predicate device to demonstrate substantial equivalence, rather than a study proving the device meets specific performance acceptance criteria for a diagnostic AI device.

Therefore, many of the requested elements for an AI device study (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, effect size for human readers) are not applicable to this type of device and submission.

However, based on the provided text, I can infer and extract the relevant information for the acceptance criteria and the type of "study" (which is more accurately described as "performance testing" and "comparison") that proves the device meets those criteria, specifically concerning the Nucleated Cell Viability.

Here's the breakdown:

Acceptance Criteria and Reported Device Performance

The core performance metric mentioned for the device's function is centered around the viability of the concentrated adipose tissue.

Acceptance Criteria Category	Acceptance Criteria	Reported Device Performance
Biocompatibility	Meets ISO 10993-1:2018 standards (non-cytotoxic, non-sensitizing, non-irritant, non-pyrogenic, no systemic toxicity effects).	"Test results demonstrated that the SyntrFuge System is non-cytotoxic, non-sensitizing, non-irritant, non-pyrogenic and has no systemic toxicity effects." (Implies it met this criterion)
Product Specification Requirements	Meets established product specification requirements.	"The SyntrFuge™ System has undergone verification testing to ensure it meets product specification requirements. Verification testing consisted of the following: SyntrFuge System Design Verification Testing, Cleaning Validation, Cell Viability, Distribution Simulation and Packaging Integrity Testing, Usability Testing, Sterilization Validation and Shelf-Life Testing. All testing met specifications." (Overall confirmation)
Nucleated Cell Viability	Comparable to the predicate device (AdiPrep™ Adipose Transfer System).	SyntrFuge™ System: Mean = 87.8% AdiPrep™ Adipose (Predicate): Mean = 83.5% (Demonstrates a higher mean viability than the predicate, satisfying comparability or superiority)
Intended Use Capability	Functions as intended (harvesting, concentrating, transferring autologous adipose tissue).	"Bench test results allowed us to conclude that the SyntrFuge System meets its intended use."

Additional Information Not Applicable to an AI Device (as requested, but noting their irrelevance here):

Sample size used for the test set and the data provenance: Not specified for "cell viability" or other performance tests, as this is a mechanical device rather than an AI model. This is physical product testing, not a data-driven study.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for cell viability would be established through laboratory assays, not expert interpretation.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable to laboratory performance testing of a physical device.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is not an AI device assisting human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For "Cell Viability," the ground truth would be established through laboratory-based cell counting and viability assays (e.g., trypan blue exclusion, flow cytometry). For other performance tests, it would be engineering specifications and validated test methods.
The sample size for the training set: Not applicable, as this is not an AI device requiring a training set.
How the ground truth for the training set was established: Not applicable, as this is not an AI device requiring a training set or ground truth in that context.

Summary

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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.

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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

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Indications for Use

510(k) Number (if known)

K203800

Device Name

SyntrFuge™ System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
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K203800 – 510(k) Summary

Submitter	Syntr Health Technologies, Inc.5270 California Ave., Suite #300Irvine, CA 92617, U.S.Establishment Reg. No. – 3017791237
Contact	Ahmed ZobiChief Executive OfficerPhone 949 732-4298E-Mail azobi@syntrtech.com
Official Correspondent	Nevine ErianRegulatory ConsultantBQC Consulting, LLC24341 Barbados Dr.Dana Point, CA 92629Phone (949) 370-7155Fax (949) 240-8829E-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

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Device Description

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 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.

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

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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™ AdiposeTransfer System(Predicate)
Classification & RegulationNumber	System, Suction,Lipoplasty21 CFR 878.5040	System, Suction,Lipoplasty21 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.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™ AdiposeTransfer System(Predicate)
Technological Attribute
Processing Pack Components	3 AdipoSets, comprisedeach of an AdipoChip and2 AdipoChambers	Harvest AdiPrep ProcessDisposable unit,centrifuge tubes withfilter, aspiration & fatinjection cannula, fatinjection syringes, skinpuncture needles, andoil extraction syringe &needle.
Material Type	AdipoChip &AdipoChamberscomposed of medicalgrade resin.	Cannula & syringescomposed of medicalgrade 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 CentrifugeSystem	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 AdiposeTissue	Concentrated AdiposeTissue
Nucleated Cell Viability (%)	Mean = 87.8%	Mean = 83.5%
For Adipose Transfer	Yes	Yes
Environment of Use	Sterile Setting	Sterile Setting

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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

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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.

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.