(257 days)
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
The VATS System includes a disposable fat concentrator, reusable portable tabletop base unit, and single-use piston syringes.
Here's a breakdown of the acceptance criteria and study information based on the provided text, using the requested format:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Percent volume reduction substantially equivalent to predicate device (Viafill™ System) | Test results show the VATS System is substantially equivalent to the Viafill™ System. |
| Percent cell viability substantially equivalent to predicate device (Viafill™ System) | Test results show the VATS System is substantially equivalent to the Viafill™ System. |
| Functional within intended use | Results indicated both devices (VATS and predicate) were functional within their intended use. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated. The document mentions "Non-clinical laboratory testing was performed" and "Test results for both percent volume reduction and percent cell viability show...". However, the specific number of tests or samples used for these comparisons is not provided.
- Data Provenance: The testing was non-clinical laboratory testing. The country of origin is not specified, but the applicant (Biomet Biologics, Inc.) is based in Warsaw, IN, USA, suggesting the testing likely occurred in the US. It was prospective testing as it was conducted to demonstrate substantial equivalence for this specific device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. The ground truth for this device was established through direct comparison to a predicate device's performance characteristics (percent volume reduction and cell viability) in a laboratory setting, not by expert consensus on clinical data.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. As this was non-clinical laboratory testing comparing performance against a predicate device, an adjudication method for a test set (like 2+1 or 3+1) is not relevant.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- MRMC Study: No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical Testing: None provided as a basis for substantial equivalence." The testing was non-clinical and focused on device performance parameters rather than human reader interpretation.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Standalone Performance: Yes, in a sense, the non-clinical testing represents a standalone evaluation of the device's performance in terms of its ability to concentrate fat and maintain cell viability, implicitly "without human-in-the-loop" once the device is operating. However, this is not an "algorithm" in the typical sense of AI, but rather a physical system.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth was established by the performance characteristics of the legally marketed predicate device (Cytori AFT System, K072587 and Lipose Fat Transfer System, K081848, specifically the Viafill™ System from Lipose Corp. for direct comparison). The ground truth was the established performance of these previously cleared devices in terms of percent volume reduction and percent cell viability.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This device is a physical system for fat concentration, not an AI/ML algorithm that requires a training set. The term "training set" doesn't apply in this context.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.
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510(k) Summary
Preparation Date:
October 16, 2009
SEP 2 9 2010
Applicant/Sponsor: Biomet Biologics, Inc., P.O. Box 587, Warsaw, IN 46581 Contact Person: Lonnie Witham Vortech™ Adipose Transfer System (VATS) Proprietary Name: Common Name: Fat Concentration System Classification Name: Suction Lipoplasty System MUU (21 CFR 878.5040)
Legally Marketed Devices To Which Substantial Equivalence Is Claimed:
K072587 Cytori AFT System, Cytori Therapeutics, Inc. K081848 Lipose Fat Transfer System, Lipose Corporation
Device Description:
The VATS System includes a disposable fat concentrator, reusable portable tabletop base unit, and single-use piston syringes.
Intended Use:
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 ø
- Laparoscopic Surgery �
- a
Summary of Technologies:
The manufacturing methods, components and materials used for the VATS System have been used in devices previous-cleared for commercial distribution.
Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial equivalence. The testing included verification that the output of the Vortech™ Adipose Transfer System (VATS) is substantially equivalent to the Viafill™ System (Lipose Corp.) predicate device by direct comparison. Test results for both percent volume reduction and percent cell viability show that the VATS System is substantially equivalent to the Viafili™ System, a currently marketed predicate device. The results indicated that both devices were functional within their intended use.
Clinical Testing: None provided as a basis for substantial equivalence.
All trademarks are property of Biomet, Inc.
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird-like figure with three wing-like shapes.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
SEP 2 9 2010
Biomet Biologics, LLC % Mr. Lonnie Witham Regulatory Affairs Consultant 56 East Bell Drive P.O. Box 587 Warsaw, Indiana 46581-0587
Re: K100114
Trade/Device Name: Vortech™ Adipose Transfer System (VATS) Regulation Number: 21 CFR 878.5040 Regulation Name: Suction lipoplasty system Regulatory Class: Class II Product Code: MUU Dated: August 30, 2010 Received: August 31, 2010
Dear Mr. Witham:
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.
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Page 2 - Mr. Lonnie Witham
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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/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/default.htm.
Sincerely vours.
For Patothm Des D.R
Mark N. Melkerson 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):
SEP 2 9 2010
Device Name:
Indications for Use: VortechTM Adipose Transfer System (VATS)
The Vortech™ Adipose Transfer System (VATS) is used in medical procedures involving the filtering and transferring of autologous fat tissue. The Vorted Adipose Tighster System (VATS) is used for concentrating faction with a legally marketed ipoplasty system. The Vortech™ Adipose Transfer System (VATS) is intended for use in the following surgical specialties when the concentration of adipose tissue is desired.
- Neurosurgery 9
- Gastrointestinal and Affiliated Organ Surgery 0
- ଡ Urological Surgery
- Plastic and Reconstructive Surgery
- General Surgery �
- Orthopedic Surgery 0
- Gynecological Surgery
- Thoracic Surgery
- Laparoscopic Surgery
Prescription Use X (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices
510(k) Number L/60/14
§ 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.