(171 days)
No
The summary describes a mechanical system for processing adipose tissue using a centrifuge and disposable pack. There is no mention of AI/ML terms, image processing, or data-driven performance metrics typically associated with AI/ML devices.
Yes
The device is used for processing autologous adipose tissue for transfer, which is a therapeutic intervention, indicated across various surgical specialties.
No
The device is used for processing and concentrating adipose tissue for transfer, not for diagnosing medical conditions.
No
The device description explicitly states it consists of a "disposable process pack" and is utilized with a "SmartPReP2 centrifuge," indicating it is a hardware-based system with a disposable component.
Based on the provided information, the AdiPrep™ Adipose Transfer System is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states the system is for "harvesting and transferring of autologous adipose tissue" and "concentrating adipose tissue harvested with a legally marketed lipoplasty system." This describes a process performed on the patient's tissue within the body or for re-introduction into the body, not for analyzing a sample outside the body to diagnose a condition.
- Device Description: The description focuses on the physical components and their function in processing adipose tissue for transfer. It doesn't mention any components or processes related to analyzing biological samples for diagnostic purposes.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue samples for analysis, etc.)
- Detecting or measuring specific analytes (proteins, genes, metabolites, etc.)
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition.
The AdiPrep system is a medical device used in surgical procedures to prepare tissue for therapeutic purposes (transfer), not for diagnostic testing.
N/A
Intended Use / Indications for Use
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
Product codes
MUU
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Autologous Adipose Product
Nucleated Cell Count (x10³/ml of Product): Mean 1.823
Nucleated Cell Viability (%): Mean 83.5
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
K121005 page 1/4
510(k) SUMMARY
| 510(k) Summary of Safety and Effectiveness | |
|---|---|
| Date Summary Prepared: | September 18, 2012 |
| Applicant/Sponsor: | Harvest Technologies Corporation |
| 40 Grissom Road, Suite 100 | |
| Plymouth, 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 Devices | |
| to Which Substantial | |
| Equivalence 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 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. | |
| Indications for Use: | 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 .
1
- . 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.
2
K12.1005 Page 3/4
| DEVICES | |||
|---|---|---|---|
| FEATURES | AdiPrep Adipose Transfer | ||
| System | |||
| (This submission) | Lipose Fat Transfer System, | ||
| K081848, (Predicate device) | Biomet Vortech™ Adipose Transfer | ||
| System (VATS), K100114, (Predicate | |||
| device) | |||
| Indications for | |||
| Use (IFU) | 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 | The Lipose Fat Transfer | ||
| System is intended to be used | |||
| in the aspiration, harvesting, | |||
| and reinjecting of autologous | |||
| fat. | The Vortech™ Adipose Transfer System | ||
| (VATS) is used in medical procedures | |||
| involving the harvesting and transferring of | |||
| autologous fat tissue. The VATS System is | |||
| used for concentrating fat harvested with a | |||
| legally marketed lipoplasty system. The | |||
| VATS System is intended for use in the | |||
| following surgical specialties when the | |||
| concentration 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 Transfer | |||
| System | |||
| (This submission) | Lipose Fat Transfer System, | ||
| K081848, (Predicate device) | Biomet Vortech™ Adipose Transfer | ||
| System (VATS), K100114, (Predicate | |||
| device) | |||
| Processing Pack: | |||
| -Materials | Components-syringes with | ||
| removable plunger, centrifuge | |||
| tubes with filter, aspiration & | |||
| fat injection cannula, fat | |||
| injection syringes, skin | |||
| puncture needles, and oil | |||
| extraction syringe & needle. | |||
| Cannula & syringes composed | |||
| of medical grade plastics. | Components-syringes with | ||
| removable plunger, centrifuge | |||
| tubes with filter, aspiration & | |||
| fat injection cannula, fat | |||
| injection syringes, skin | |||
| puncture needles, and oil | |||
| extraction syringe & needle. | The materials used in the Fat Concentrator, | ||
| syringes, and accessories consist of medical | |||
| grade polymers, elastomers, and stainless steel | |||
| suitable for use in medical devices. All | |||
| components are packaged, labeled and | |||
| sterilized as indicated by the manufacturer | |||
| labeling. | |||
| -Fill volumes | |||
| (mL) | Volume = 5 mL to 25 mL | Volume = 5 mL to 20 mL | Volume = 180 mL |
| -Sterilization | |||
| Method | Ethylene-Oxide Gas (EtO) | Gamma Radiation | Gamma Radiation |
| Autologous | |||
| Adipose | |||
| Product* | |||
| Nucleated Cell | |||
| Count (x10³/ml of | |||
| Product) | Mean 1.823 | ||
| Mean 83.5 | Mean 1.848 | ||
| Mean 82.4 | Actual results are not available, however, in | ||
| K100114, Biomet reported that testing "by | |||
| direct comparison included verification that | |||
| the output of the Vortech™ Adipose Transfer | |||
| System (VATS) is substantially equivalent to | |||
| the Viafill™ System (Lipose Corp.), the | |||
| predicate device. Test results for both percent | |||
| -Nucleated Cell | |||
| Viability (%) | volume reduction and percent cell viability | ||
| show that the VATS System is substantially | |||
| equivalent to the Viafill System." | |||
| Processing | |||
| Capabilities | |||
| Volume | Volume = 5 mL to 25 mL | Volume = 5 mL to 20 mL | Volume = 180 mL |
| Low-g-force | Centrifuge to spin for | ||
| approximately 4 minutes at | |||
| 1250 g-force. | Centrifuge to spin for 2 minutes | ||
| at 50 g-force. | 4 ½ minute centrifugation process , g-force | ||
| unknown. | |||
| Laboratory | |||
| Centrifuge | SmartPReP2 Centrifuge is a | ||
| general purpose laboratory | |||
| centrifuge for clinical use. | Viafill™ System centrifuge is a | ||
| general purpose laboratory | |||
| centrifuge. | The VATS reusable portable tabletop base | ||
| unit is similar to a general purpose laboratory | |||
| centrifuge. |
Table 1: SUBSTANTIAL EQUIVALENCE COMPARISON CHART
b
c
.
1
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.
.
.
.
.
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3
K121005/Page 4/4
4
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
5
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
6
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