The SmartGraft™ 200 system is intended to be used in medical procedures involving the harvesting, centrifugation and transferring of autologous adipose tissue. The SmartGraft™ 200 system is used for concentrating adipose tissue for aesthetic body contouring, and for tissue that has been harvested with a legally marketed lipoplasty system.

The SmartGraft™ 200 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, and
· Arthroscopic Surgery

Device Description

The SmartGraft™ 200 System is a disposable process pack to be used with the InGeneron Tissue Processing Unit (centrifuge). The process pack is a collection of sterile single-use off-the-shelf and proprietary components used during the process of harvesting, centrifugation, 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

The provided text describes a 510(k) premarket notification for the SmartGraft™ 200 System. This submission focuses on demonstrating substantial equivalence to predicate devices, rather than proving device performance against specific acceptance criteria for AI/algorithm-based diagnostic tasks. Therefore, many of the requested elements for an AI study are not applicable or cannot be extracted from this document.

However, I can extract information related to the device description and the non-clinical studies performed to support substantial equivalence.

Here's a breakdown based on the provided text, indicating where information is not applicable (N/A) or not provided:

Device Description:

The SmartGraft™ 200 System is a disposable process pack used with the InGeneron Tissue Processing Unit (centrifuge). It is a collection of sterile, single-use, off-the-shelf and proprietary components.

Intended Use:

The system is intended for use in medical procedures involving the harvesting, centrifugation, and transferring of autologous adipose tissue. It is used for concentrating adipose tissue for aesthetic body contouring and for tissue harvested with a legally marketed lipoplasty system.

Surgical Specialties for Use:

Neurosurgery
Gastrointestinal Surgery
Urological Surgery
Plastic and Reconstructive Surgery
General Surgery
Orthopedic Surgery
Gynecological Surgery
Thoracic Surgery
Laparoscopic Surgery
Arthroscopic Surgery

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) for a physical device (lipoplasty system), not an AI algorithm, the concept of "acceptance criteria" for diagnostic performance metrics (like sensitivity, specificity, accuracy) is not directly applicable in the same way as for an AI diagnostic device. The "performance" here relates to functional performance, safety, and substantial equivalence to predicate devices.

Acceptance Criteria (Implicit from 510(k) Standards)	Reported Device Performance (Summary from Bench Testing)
Usability according to Instructions for Use	System performs to specification and can be operated successfully with provided Instructions for Use.
Operation to produce concentrated adipose tissue	System successfully produces concentrated adipose tissue from lipoaspirate.
Impact on nucleated cell viability	Does not adversely impact the viability of adipose tissue (compared to unprocessed tissue), indicating substantial equivalence to predicate devices' impact on cell viability.
Biocompatibility	Tested for biocompatibility to ISO 10993.
Sterilization effectiveness	Sterilized using standard methods (EO gas), similar to predicate devices.
Materials of construction	Uses equivalent polymeric materials of construction; made of medical-grade polymer materials.
Operating principle (low g-force centrifugation)	Utilizes low g-force centrifugation for short periods of time, consistent with predicate devices.
Volume of adipose tissue processed	Volume processed is essentially identical to one predicate device and larger than the other.

2. Sample size used for the test set and the data provenance:

Sample Size: The document does not specify a numerical sample size for the "two non-clinical studies" mentioned. It only refers to "lipoaspirate."
Data Provenance: N/A for country of origin as these were bench tests. The studies were non-clinical/bench testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Number of Experts: N/A. Ground truth in this context would likely be defined by calibrated instruments or standard laboratory protocols for measuring cell viability, not expert interpretation.
Qualifications of Experts: N/A.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

N/A. Adjudication methods are typically relevant for human interpretation of data in diagnostic tasks, which is not the primary focus of this device's evaluation.

5. 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:

N/A. This device is not an AI diagnostic tool and does not involve human readers interpreting images with or without AI assistance.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

N/A. This is a physical medical device, not a standalone AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For "nucleated cell viability," the ground truth would likely be established through standard laboratory assays and microscopy/cell counting techniques.
For "usability" and "operation," the ground truth would be successful completion of specified tasks and adherence to performance specifications.

8. The sample size for the training set:

N/A. This device is not an AI algorithm requiring a training set.

9. How the ground truth for the training set was established:

N/A. This device is not an AI algorithm requiring a training set.

Summary

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

October 28, 2014

InGeneron Incorporated Ms. Anita Kadala Chief Executive Officer/General Counsel 8205 El Rio Houston, Texas 77054

Re: K141713

Trade/Device Name: SmartGraft™ 200 System Regulation Number: 21 CFR 878.5040 Regulation Name: Suction lipoplasty system Regulatory Class: Class II Product Code: MUU Dated: October 7, 2014 Received: October 10, 2014

Dear Ms. Kadala:

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 (reporting of medical

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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.

for

Sincerely yours,

David Krause -S

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

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Indications for Use

510(k) Number (if known) K141713

Device Name SmartGraft™ 200

Indications for Use (Describe)

The SmartGraff™ 200 system is intended to be used in medical procedures involving the harvesting, centrifygation and transferring of autologous adipose tissue. The SmartGraft™ 200 system is used for concentrating adipose tissue for aesthetic body contouring, and for tissue that has been harvested with a legally marketed lipoplasty system.

The SmartGraft™ 200 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, and
· 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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510(k) Summary

Date Summary Prepared: 07 October 2014
Applicant/Sponsor:	InGeneron, Inc.8205 El RioHouston, TX 77054
Contact Person:	Anita Kadala - CEO/General Counsel713-440-9900Tel:FAX: 713-715-5454Email: AKadala@ingeneron.com
Device Trade Name:	SmartGraft™ 200 System
Common Name:	Suction Lipoplasty System
Classification Name:	Suction Lipoplasty System, Class II
Regulation:	21 CFR 878.5040, Suction Lipoplasty System
Product Code:	MUU
Legally Marketed DevicesTo Which Substantial
Equivalence is Claimed:	K100114 Vortech™ Adipose Transfer System, BiometBiologics, Inc. and,K121005 AdiPrep™ Adipose Transfer System fromHarvest Technologies Corp.
Device Description:	The SmartGraft™ 200 System is a disposable process packto be used with the InGeneron Tissue Processing Unit(centrifuge). The process pack is a collection of sterilesingle-use off-the-shelf and proprietary components usedduring the process of harvesting, centrifugation, andtransferring of autologous adipose tissue. It is intended forthe concentration of aspirated adipose tissue for subsequenttransfer during the same procedure.
Indication For Use:	The SmartGraft™ 200 System is intended to be used inmedical procedures involving the harvesting, centrifugationand transferring of autologous adipose tissue. The

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SmartGraft™ 200 System is used for concentrating adipose tissue for aesthetic body contouring, and for tissue that has been harvested with a legally marketed lipoplasty system.

The SmartGraft™ 200 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

The SmartGraft™ 200 System is believed to be Substantial Equivalence: substantially equivalent to the two referenced legally marketed predicate devices in that it has the same intended use, same operating principles and same function within the medical procedure, uses equivalent polymeric materials of construction, are all provided as sterile single-use disposables. The SmartGraft™ 200 device is sterilized using the same sterilization method as one referenced legally marketed predicate device. Substantial equivalence to a legally marketed predicate device in reference to biocompatibility for the intended use was determined using a recognized standard. The SmartGraft™ 200 System and both referenced legally marketed predicate devices are intended to be used for the same application across the same range of surgical specialties.

Technological Characteristics:

The SmartGraft™ 200 System is substantially equivalent to the two legally marketed predicate devices cited based on technological characteristics. The SmartGraft™ 200 and the two legally marketed predicates cited all are used in the concentration of adipose tissue harvested with legally marketed lipoplasty systems. All three are single-use devices made of medical-grade polymer materials. The

0018

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SmartGraft™ 200 device and at least one other predicate are tested for biocompatibility to ISO 10993. All three are sterilized using standard sterilization methods for sterile single-use devices. The SmartGraft™ 200 device and one predicate device utilize EO gas sterilization, whereas the other predicate device uses gamma irradiation for sterilization. All three devices utilize a centrifuge-like device using relatively low g-force for short periods of time for concentration of adipose tissue for transfer. The volume of adipose tissue processed by the SmartGraft™ 200 System is essentially identical to one of the predicate devices. Both of these volumes are larger than the volume processed by the other predicate device.

Bench Testing: Determination of substantial equivalence was substantiated by a tabular specification comparison between the SmartGraft™ 200 and the two legally marketed predicate devices, and through two non-clinical studies involving only the SmartGraft™ 200 system. Both usability of the system according to Instructions for Use, and operation of the system to produce concentrated adipose tissue from lipoaspirate were tested. Concentrated adipose tissue produced using the SmartGraft™ 200 system was investigated further evaluating the nucleated cell viability of the concentrated adipose tissue compared to unprocessed adipose tissue. The results of the viability evaluation indicate that the SmartGraft™ 200 system does not adversely impact viability of the adipose tissue. Impact of the SmartGraft™ 200 system on cell viability is then substantially equivalent to that of predicate devices. A specification comparison between the SmartGraft™ 200 System and predicate devices was used to make a determination of substantial equivalence. The specification comparison shows that all three use low g-force centrifugation for a short period of time as an operating principle to obtain concentrated lipoaspirate. The Usability and Clinical Evaluation protocols and corresponding reports indicate that that the SmartGraft™ 200 System performs to specification, and can be operated successfully with the Instructions for Use provided.

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.