The AdiPrep™ Adipose Transfer System is used in medical procedures involving the harvesting and transferring of autologous adipose tissue. The AdiPrep system is used 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 tissue is desired.
• Neurosurgery
• Gastrointestinal Surgery
• Urological Surgery
• Plastic and Reconstructive Surgery
• General surgery

Orthopedic Surgery .
. Gynecological Surgery
Thoracic Surgery .
Laparoscopic Surgery .
Arthroscopic Surgery ●

Device Description

The Harvest AdiPrep Adipose Transfer System consists of a disposable process pack to be utilized with the SmartPReP2 centrifuge. The process pack is a sterile (EtO) single use disposable pack used for the aspiration, harvesting, and transferring of autologous adipose tissue. It is intended for the concentration of aspirated adipose tissue for subsequent transfer during the same procedure.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Harvest AdiPrep™ Adipose Transfer System based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary primarily focuses on demonstrating substantial equivalence to predicate devices rather than pre-defined acceptance criteria with specific thresholds for the new device. The performance is presented as a comparison to predicate devices.

Feature / Criteria (Implied)	Harvest AdiPrep™ Adipose Transfer System (This submission)	Predicate Viafill System (K081848)	Predicate Vortech™ Adipose Transfer System (K100114)
Autologous Adipose Product
Nucleated Cell Count (x10³/ml of Product)	Mean 1.823	Mean 1.848	Actual results not available; claimed substantially equivalent to Viafill.
Nucleated Cell Viability (%)	Mean 83.5	Mean 82.4	Actual results not available; claimed substantially equivalent to Viafill.
Processing Capabilities / Volume	Volume = 5 mL to 25 mL	Volume = 5 mL to 20 mL	Volume = 180 mL
Processing Capabilities / g-force	Centrifuge to spin for approx. 4 minutes at 1250 g-force.	Centrifuge to spin for 2 minutes at 50 g-force.	4 1/2 minute centrifugation process, g-force unknown.

Acceptance Criteria for Substantial Equivalence: The primary acceptance criterion here is demonstrating that the Harvest AdiPrep system performs comparably to the legally marketed predicate devices, specifically in terms of nucleated cell count and viability of the autologous adipose product. The stated results show very similar mean values for both nucleated cell count and viability between the AdiPrep system and the Viafill predicate, supporting the claim of substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated as a number of patients or samples. The document mentions "Clinical testing was performed to determine substantial equivalence to the predicate device."
Data Provenance: Not specified (e.g., country of origin). The study appears to be retrospective or prospective, as it involved clinical testing to generate data for comparison. It is likely prospective as it's directly testing the new device.

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

There is no mention of "experts" or "ground truth" in the context of human expert review. The study focuses on direct biological measures (cell count and viability) of the processed adipose tissue, which are objective laboratory measurements, not subjective interpretations by experts.

4. Adjudication Method for the Test Set

Not applicable. There was no expert review or adjudication process as the study involved objective laboratory measurements of device output.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. The device is a medical processing system for adipose tissue, not an imaging or diagnostic device that requires human interpretation. Therefore, there is no mention of human readers or AI assistance.

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

The device itself is a standalone system for processing adipose tissue. The "clinical testing" performed evaluated the output of this standalone system (nucleated cell count and viability). There is no "algorithm" or AI component involved in this device, so the terminology of "standalone algorithm performance" does not directly apply. However, the performance reported is the standalone output of the device itself.

7. The Type of Ground Truth Used

The "ground truth" here is established through objective laboratory measurements of the processed autologous adipose tissue, specifically:

Nucleated Cell Count
Nucleated Cell Viability

8. The Sample Size for the Training Set

There is no mention of a "training set" in this context. The device is a mechanical/biological processing system, not an AI or machine learning algorithm that requires a training set. The clinical testing mentioned is for verification and validation, not model training.

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

Not applicable, as there is no training set for this type of device.

Summary

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K121005 page 1/4

510(k) SUMMARY

510(k) Summary of Safety and Effectiveness
Date Summary Prepared:	September 18, 2012
Applicant/Sponsor:	Harvest Technologies Corporation40 Grissom Road, Suite 100Plymouth, MA 02360
Phone Number:	508-732-7541
Fax Number:	508-732-0400
Contact Person:	Susan Finneran - Director Regulatory Affairs
Device Trade Name:	Harvest AdiPrep™ Adipose Transfer System
Common name:	Fat Concentration System
Classification Name:	Lipoplasty System, Class II(21 CFR 878.5040, Suction Lipoplasty System,Product Code MUU)
Legally Marketed Devicesto Which SubstantialEquivalence Is Claimed:	K081848, Viafill System, Lipose Corporation and,K100114, Vortech Adipose Transfer System, Biomet Biologics,Inc.
Device Description:	The Harvest AdiPrep Adipose Transfer System consists of adisposable process pack to be utilized with the SmartPReP2centrifuge. The process pack is a sterile (EtO) singleuse disposable pack used for the aspiration, harvesting, andtransferring of autologous adipose tissue. It is intended for theconcentration of aspirated adipose tissue for subsequent transferduring the same procedure.
Indications for Use:	The AdiPrep™ Adipose Transfer System is used in medicalprocedures involving the harvesting and transferring of autologousadipose tissue. The AdiPrep system is used for concentratingadipose tissue harvested with a legally marketed lipoplasty system.The AdiPrep™ Adipose Transfer System is intended for use in thefollowing surgical specialties when the concentration of harvestedadipose tissue is desired.• Neurosurgery• Gastrointestinal Surgery• Urological Surgery• Plastic and Reconstructive Surgery• General surgery

Orthopedic Surgery .

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. Gynecological Surgery
Thoracic Surgery .
Laparoscopic Surgery .
Arthroscopic Surgery ●

Substantial Equivalence:

The device system has been cleared by the FDA by the 510(k) Premarket Notification process. This submission describes this new adipose concentration system as compared to the predicate devices.

Technological Characteristics:

Based on the intended use, design, materials, and technological characteristics presented in this premarket notification as summarized in Table 1 below, the Harvest AdiPrep Adipose Transfer System has been shown to be substantially equivalent to the currently marketed predicate devices. Biocompatibility testing was conducted as per ISO 10993 to demonstrate that the materials used in the manufacture of the the AdiPrep Adipose Transfer System are suitable for the intended use.

Clinical Testing:

Clinical testing was performed to determine substantial equivalence to the predicate device. The testing included verification that the output of the AdiPrep Adipose Transfer System is substantially equivalent to the predicate Viafill System (Lipose Corp.) and the Vortech Adipose Transfer System (Biomet Biologics). The results indicated the devices were functional within their intended use. A summary of the results appears in Table 1 below.

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K12.1005 Page 3/4

	DEVICES
FEATURES	AdiPrep Adipose TransferSystem(This submission)	Lipose Fat Transfer System,K081848, (Predicate device)	Biomet Vortech™ Adipose TransferSystem (VATS), K100114, (Predicatedevice)
Indications forUse (IFU)	The AdiPrep™ AdiposeTransfer System is used inmedical procedures involvingthe harvesting and transferringof autologous adipose tissue.The AdiPrep system is used forconcentrating adipose tissueharvested with a legallymarketed lipoplasty system.The AdiPrep™ AdiposeTransfer System is intended foruse in the following surgicalspecialties when theconcentration of harvestedadipose tissue is desired.Neurosurgery, GastrointestinalSurgery, Urological Surgery,Plastic and ReconstructiveSurgery, General Surgery,Orthopedic Surgery,Gynecological Surgery,Thoracic Surgery, LaparoscopicSurgery, Arthroscopic Surgery	The Lipose Fat TransferSystem is intended to be usedin the aspiration, harvesting,and reinjecting of autologousfat.	The Vortech™ Adipose Transfer System(VATS) is used in medical proceduresinvolving the harvesting and transferring ofautologous fat tissue. The VATS System isused for concentrating fat harvested with alegally marketed lipoplasty system. TheVATS System is intended for use in thefollowing surgical specialties when theconcentration of adipose tissue is desired.Neurosurgery Gastrointestinal and Affiliated Organ Surgery Urological Surgery Plastic and Reconstructive Surgery General Surgery Orthopedic Surgery Gynecological Surgery Thoracic Surgery Laparoscopic Surgery
FEATURES	DEVICES
	AdiPrep Adipose TransferSystem(This submission)	Lipose Fat Transfer System,K081848, (Predicate device)	Biomet Vortech™ Adipose TransferSystem (VATS), K100114, (Predicatedevice)
Processing Pack:-Materials	Components-syringes withremovable plunger, centrifugetubes with filter, aspiration &fat injection cannula, fatinjection syringes, skinpuncture needles, and oilextraction syringe & needle.Cannula & syringes composedof medical grade plastics.	Components-syringes withremovable plunger, centrifugetubes with filter, aspiration &fat injection cannula, fatinjection syringes, skinpuncture needles, and oilextraction syringe & needle.	The materials used in the Fat Concentrator,syringes, and accessories consist of medicalgrade polymers, elastomers, and stainless steelsuitable for use in medical devices. Allcomponents are packaged, labeled andsterilized as indicated by the manufacturerlabeling.
-Fill volumes(mL)	Volume = 5 mL to 25 mL	Volume = 5 mL to 20 mL	Volume = 180 mL
-SterilizationMethod	Ethylene-Oxide Gas (EtO)	Gamma Radiation	Gamma Radiation
AutologousAdiposeProduct*Nucleated CellCount (x10³/ml ofProduct)	Mean 1.823Mean 83.5	Mean 1.848Mean 82.4	Actual results are not available, however, inK100114, Biomet reported that testing "bydirect comparison included verification thatthe output of the Vortech™ Adipose TransferSystem (VATS) is substantially equivalent tothe Viafill™ System (Lipose Corp.), thepredicate device. Test results for both percent
-Nucleated CellViability (%)			volume reduction and percent cell viabilityshow that the VATS System is substantiallyequivalent to the Viafill System."
ProcessingCapabilities
Volume	Volume = 5 mL to 25 mL	Volume = 5 mL to 20 mL	Volume = 180 mL
Low-g-force	Centrifuge to spin forapproximately 4 minutes at1250 g-force.	Centrifuge to spin for 2 minutesat 50 g-force.	4 ½ minute centrifugation process , g-forceunknown.
LaboratoryCentrifuge	SmartPReP2 Centrifuge is ageneral purpose laboratorycentrifuge for clinical use.	Viafill™ System centrifuge is ageneral purpose laboratorycentrifuge.	The VATS reusable portable tabletop baseunit is similar to a general purpose laboratorycentrifuge.

Table 1: SUBSTANTIAL EQUIVALENCE COMPARISON CHART

b
c

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

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

SEP 2 1 2012

Harvest Technologies Corporation % Mr. Gabriel J. Muraca, Jr. Regulatory Affairs Manager 40 Grissom Road, Suite 100 Plymouth, Massachusetts 02360

Re: K121005

Trade/Device Name: AdiPrep™ Adipose Transfer System Regulation Number: 21 CFR 878.5040 Regulation Name: Suction lipoplasty system Regulatory Class: Class II Product Code: MUU Dated: August 29, 2012 Received: August 30, 2012

Dear Mr. Muraca:

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 Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Gabriel J. Muraca, Jr.

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/CDRH0ffices/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/dafault.htm.

Sincerely yours,

Mark N. Melkerson

Mark N. Melker 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

510(k) Number (if known): K121005

Device Name: AdiPrep™ Adipose Transfer System

Indications for Use:

The AdiPrepTM Adipose Transfer System is used in medical procedures involving the harvesting and transferring of autologous adipose tissue. The AdiPrep system is used 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 tissue is desired.

Neurosurgery .
Gastrointestinal Surgery t
Urological Surgery .
· Plastic and Reconstructive Surgery
General surgery ●
. Orthopedic Surgery
Gynecological Surgery .
Thoracic Surgery .
Laparoscopic Surgery
Arthroscopic Surgery

Prescription Use (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel Krene for MM
(Division Sign-Off)

Page of

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K121005

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.