(103 days)
The SmartGraft™ 30 system is intended to be used in medical procedures involving the harvesting, centrifugation and transferring of autologous adipose tissue. The SmartGraff™ 30 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™ 30 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™ 30 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.
Thislooks like a 510(k) summary for a medical device called the SmartGraft™ 30 System. The FDA has determined the device to be substantially equivalent to previously marketed devices. The document highlights the device's intended use in processing autologous adipose tissue and its technological characteristics.
The summary describes bench testing conducted to support the claim of substantial equivalence. However, it does not contain the detailed acceptance criteria or the specific study results in the format requested, particularly regarding statistical performance, sample sizes for training/test sets, expert ground truth establishment, or multi-reader multi-case studies.
Therefore, I cannot fulfill your request for the tables and specific details about acceptance criteria, reported performance, sample sizes, and ground truth establishment from the provided text. The document primarily focuses on regulatory approval based on substantial equivalence rather than detailed performance metrics.
What the document does provide concerning testing:
- Bench Testing: Two non-clinical studies were performed on the SmartGraft™ 30 system.
- Study 1: Usability and Operation: Evaluated the system's usability according to Instructions for Use and its ability to produce concentrated adipose tissue from lipoaspirate.
- Study 2: Nucleated Cell Viability: Investigated the viability of nucleated cells in concentrated adipose tissue produced by the SmartGraft™ 30 system compared to unprocessed adipose tissue.
- Result of Viability Study: The results indicated that the SmartGraft™ 30 system "does not adversely impact viability of the adipose tissue." It concludes that the "Impact of the SmartGraft™ 30 system on cell viability is then substantially equivalent to that of predicate devices."
- Ground Truth for Bench Testing: For the usability and operation study, the ground truth was likely based on successful operation according to the Instructions for Use and the production of concentrated adipose tissue. For the cell viability study, the ground truth was "unprocessed adipose tissue" for comparison.
- No information is provided regarding:
- Specific quantitative acceptance criteria (e.g., "X% accuracy," "Y cells/mL viable").
- Specific reported device performance in numerical terms.
- Sample sizes used for these tests.
- Data provenance (country of origin, retrospective/prospective).
- Number or qualifications of experts.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance (as this is a physical device, not an AI algorithm).
- Training set sample size or how its ground truth was established.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three stylized human profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 24, 2014
InGeneron Incorporated Ms. Anita Kadala Chief Executive Officer/General Counsel 8205 El Rio Houston, Texas 77054
Re: K141591
Trade/Device Name: SmartGraft™ 30 System Regulation Number: 21 CFR 878.5040 Regulation Name: Suction lipoplasty system Regulatory Class: Class II Product Code: MUU Dated: August 28, 2014 Received: September 3, 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
{1}------------------------------------------------
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
- Binita S. Ashar, M.D., M.B.A., F.A.C.S. for 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) K141591
Device Name SmartGraft™ 30 System
Indications for Use (Describe)
The SmartGraft™ 30 system is intended to be used in medical procedures involving the harvesting, centrifugation and transferring of autologous adipose tissue. The SmartGraff™ 30 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™ 30 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
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | X |
| 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."
B
{3}------------------------------------------------
Section 5: 510(k) Summary
510(k) Summary of Safety and Effectiveness
| Date Summary Prepared: | 10 June 2014Revised: 19 September 2014 |
|---|---|
| Applicant/Sponsor: | InGeneron, Inc.8205 El RioHouston, TX 77054 |
| Contact Person: | Anita Kadala – CEO/General CounselTel: 713-440-9900FAX: 713-715-5454Email: AKadala@ingeneron.com |
| Device Trade Name: | SmartGraft™ 30 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 SubstantialEquivalence is Claimed: | K100114 Vortech™ Adipose Transfer System, BiometBiologics, Inc. and,K121005 AdiPrep™ Adipose Transfer System fromHarvest Technologies Corp. |
|---|---|
| Device Description: | The SmartGraft™ 30 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. |
| Indications For Use: | The SmartGraft™ 30 System is intended to be used inmedical procedures involving the harvesting, centrifugationand transferring of autologous adipose tissue. TheSmartGraft™ 30 System is used for concentrating adiposetissue for aesthetic body contouring, and for tissue that hasbeen harvested with a legally marketed lipoplasty system. |
| The SmartGraft™ 30 System is intended for use in thefollowing surgical specialties when the concentration ofharvested 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 | |
| Substantial Equivalence: | The SmartGraft™ 30 System is believed to be substantiallyequivalent to the two referenced legally marketed predicatedevices in that it has the same intended use, same operatingprinciples and same function within the medical procedure,uses equivalent polymeric materials of construction, are allprovided as sterile single-use disposables. TheSmartGraft™ 30 device is sterilized using the samesterilization method as one referenced legally marketedpredicate device. Substantial equivalence to a legallymarketed predicate device in reference to biocompatibilityfor the intended use using was determined using arecognized standard. The SmartGraft™ 30 System andboth referenced legally marketed predicate devices areintended to be used for the same application across thesame range of surgical specialties. |
Image /page/3/Picture/5 description: The image shows the number 05-0002 in a bold, sans-serif font. The numbers are black and are displayed on a white background. The hyphen is centered between the two sets of numbers. The numbers are evenly spaced and are easy to read.
{4}------------------------------------------------
Technological Characteristics:
The SmartGraft™ 30 System is substantially equivalent to the two legally marketed predicate devices cited based on technological characteristics. The SmartGraft™ 30 and the two legally marketed predicates cited all are used in the concentration of adipose tissue harvested with legally
{5}------------------------------------------------
marketed lipoplasty systems. All three are single-use devices made of medical-grade polymer materials. The SmartGraft™ 30 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™ 30 device and one predicate device use gamma irradiation for sterilization, whereas the other predicate device utilizes EO gas 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™ 30 System is essentially identical to one of the predicate devices. Both of these volumes are smaller 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™ 30 and the two legally marketed predicate devices, and through two non-clinical studies involving only the SmartGraft™ 30 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™ 30 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™ 30 system does not adversely impact viability of the adipose tissue. Impact of the SmartGraft™ 30 system on cell viability is then substantially equivalent to that of predicate devices. A specification comparison between the SmartGraft™ 30 System and predicate devices was also 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™ 30 System performs to specification, and can be operated successfully with the Instructions for Use provided (Appendix 1 -Appendix 4).
§ 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.