The Lipose Fat Transfer System is a single-use disposable kit used in aspiration, harvesting, filtering, and transferring of autologus fat. The Lipose Fat Transfer System simplifies the collection and transfer autologous fat used in body contouring. The materials that comprise the Lipose Fat Transfer System are used routinely in similar devices and the predicate devices.

AI/ML Overview

The provided text is a 510(k) summary for the Lipose Fat Transfer System. This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than presenting a performance study with specific acceptance criteria and results.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets those criteria cannot be extracted from the provided text. The document states that the device is "substantially equivalent in intended use/technological characteristics and/or method of operation" to listed predicate devices.

Here's a breakdown of why the information is not present in the provided text:

No Acceptance Criteria or Performance Study: A 510(k) submission primarily establishes that a new device is as safe and effective as a legally marketed predicate device. It doesn't typically require a new clinical or performance study with defined acceptance criteria for the new device itself, unless the technological characteristics or intended use are significantly different from the predicate.
Focus on Substantial Equivalence: The summary explicitly states: "Based on the intended use, materials, and technological characteristics information provided in this notification, the subject device has been shown to be substantially equivalent to the currently marketed predicate devices." This means the basis for market clearance is similarity to existing devices, not a new performance evaluation against predefined metrics.
No Mention of Data Provenance, Experts, Ground Truth, or Sample Sizes for Performance: Since no specific performance study is detailed, there's no mention of sample sizes for test sets, data provenance, the number or qualifications of experts establishing ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or how ground truth was established for training sets.

In summary, the provided document does not contain the information needed to fill out the requested table or answer the questions related to acceptance criteria and a performance study.

Summary

{0}------------------------------------------------

Lipose Fat Transfer System

510(k) Notification

5. 510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

Date Prepared: December 4, 2008

510(k) number: _______________________________________________________________________________________________________________________________________________________________

DEC 0 4 2008

Applicant Information:

Lipose Corp. 280 Railroad Ave., Suite 200 Greenwich, CT 06830

Device Information:

Trade Name: Classification: Product Code: Classification Name: Lipose Fat Transfer System Class II 21CFR 878.5040 muu Liposuction Cannula

Physical Description:

Intended Use:

The Lipose Fat Transfer System is intended to be used in the aspiration, harvesting, filtering and reinjecting of autologous fat. Equivalent Device:

The subject device is substantially equivalent in intended use/technological characteristics and/or method of operation to:

Tissu-Trans™ Syringe (K050797) .
Tulip Disposable Cannulas (K060089) .
Cytori AFT System (K072587) .
Genesis Biosystems, Lipivage™ Fat Harvest, Wash and Transfer System (K# . unknown)

{1}------------------------------------------------

60818

Summary:

Based on the intended use, materials, and technological characteristics information provided in this notification, the subject device has been shown to be substantially equivalent to the currently marketed predicate devices.

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/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. In the center of the circle is an abstract image of an eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

EC 0 4 2008

Lipose Corporation % Mr. Alan Curtis, RAC 2647 Lin Gate Court Pleasanton, California 94566

Re: K081848

Trade/Device Name: Lipose Fat Transfer System Regulation Number: 21 CFR 878.5040 Regulation Name: Suction lipoplasty system Regulatory Class: II Product Code: MUU Dated: October 23, 2008 Received: October 24, 2008

Dear Mr. Curtis:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

{3}------------------------------------------------

Page 2 - Mr. Alan Curtis

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark M. Mulkerson

Mark N. Melkerson Director Division of General. Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

.081848/52 y

Lipose Fat Transfer System

510(k) Notification

4. INDICATIONS FOR USE STATEMENT

510(k) Number (if known): _

Device Name:

Lipose Fat Transfer System

Indications for Use:

The Lipose Fat Transfer System is intended to be used in the aspiration, harvesting, filtering and reinjecting of autologous fat.

Prescription Use 12 (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)

Page 1 of 1

(Division Sign-Off (Division of General, Restorative, and Neurological Devices

510(k) Number:

Confidential

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.