The Lipokit with disposable 50cc AFT Syringe is composed of one centrifuge unit with a motor for suction and positive pressure; a 50cc AFT (autologous fat transfer) syringe with weight-mesh piston, a cannula and other ancillary parts. The vacuum and positive pressures are controlled using a foot pedal control switch.

The Lipokit is a sterile, single-use, manual device consisting of a cannula, and a tissue collection container (the 50cc AFT Syringe) that relies on the centrifying unit for its energy supply. The cannula is attached directly to the 50cc AFT Syringe which simplifies and reduces the steps needed in the collection, filtering and transfer of the autologous fat. In so doing, the harvested fat is less traumatized and risk of contamination is lowered because the fat never leaves the harvesting syringe until re-injection. The cannula is a hollow tube with an opening near the tip to communicate the centrifuge unit to the tissues and subsequently aspirate, harvest and filter subcutaneous fatty tissues from the patient into the collection container (the 50cc AFT Syringe).

The stainless steel cannula that contacts the patient is provided in various sizes ranging from 2.5 - 4.0 mm in diameter. The tip region of the cannula may have a single or multiple openings that range in size from 170mm to 260mm in length distributed uniformly or randomly throughout the end of the cannula.

The 50cc AFT Syringe is a polymeric 50cc volume luer-lock style, single-use syringe consisting of a polypropylene barrel with printed graduations and a weight-mesh piston composed of polycarbonate.

AI/ML Overview

The provided document is a 510(k) summary for the Medi-Khan USA, Inc. Lipokit with disposable 50cc AFT Syringe. It describes the device, its intended use, and argues for its substantial equivalence to previously cleared predicate devices.

Crucially, this document does not contain a study that proves the device meets specific acceptance criteria in the way a clinical trial or performance study would for a novel device. Instead, it relies on demonstrating "substantial equivalence" to existing, legally marketed devices.

Therefore, I cannot provide a table of acceptance criteria and reported device performance in the traditional sense, nor can I provide information on sample sizes, ground truth establishment, expert adjudication, or MRMC studies, as these types of studies were not conducted or reported in this submission for the purpose of establishing efficacy or performance against defined criteria.

The submission focuses on comparing the Lipokit's design and indications for use to three predicate devices:

Shippert Medical Tissu-Trans (K050797)
Cytori AFT System (K072587)
MaceneRoncel Lipoplasty System (K042261) (though later listed as Macropore Puricel Lipoplasty System (K042261))

The primary "acceptance criteria" here are implied to be that the device functions similarly to the predicate devices and meets general safety standards.

Here's a breakdown of what can be extracted from the document regarding the device's characteristics and the basis for its clearance, framed in the context of your request:

1. Table of Acceptance Criteria and Reported Device Performance

As noted, this document does not present acceptance criteria and performance data from a dedicated study for the Lipokit. Instead, its "performance" is demonstrated through substantial equivalence to predicate devices. The implied "acceptance criteria" revolve around the device's ability to perform the same functions as the predicates without raising new questions of safety or effectiveness.

Aspect of Equivalence / "Acceptance Criteria" (Implied from 510(k) Process)	Reported Device Performance / Basis for Equivalence
Intended Use (ability to perform specific surgical procedures)	The Lipokit has the same indications for use as the predicate devices: tumescent injection, aspiration, harvesting, filtering, and transferring autologous fat tissue in plastic, reconstructive, general, dermatological, obstetrician & gynecological, and cosmetic surgery.
Technology/Design Principles (how the device achieves its intended use)	The Lipokit shares design principles with predicates: single-use, polymer-constructed, manually operated systems using manual or external vacuum sources to withdraw, hold, and/or inject fluids/tissues. Specifically, it's substantially equivalent to Tissu-Trans™ (K050797) in using a polypropylene piston syringe to collect and re-inject autologous fat.
Material Composition (safety of patient-contacting materials)	Components with direct patient contact are fabricated from surgical stainless steel, a commonly accepted material in medical devices. The 50cc AFT Syringe is polymeric (polypropylene barrel, polycarbonate piston).
Sterility (prevention of contamination)	The 50cc AFT Syringe is sterilized by ethylene oxide (EtO) gas, a common and accepted sterilization method for medical devices.
Mechanical Integrity/Functionality (device robustness under use)	"Mechanical testing of Lipokit demonstrates that the device is substantially equivalent to the predicate devices." (No specific test results or criteria are provided, but this statement implies internal verification of functional design.)
Reduced Traumatization/Contamination Risk (process efficiency/safety)	The design (cannula attached directly to the 50cc AFT Syringe) "simplifies and reduces the steps needed in the collection, filtering and transfer of the autologous fat." This is stated to result in "less traumatized" fat and lower contamination risk because "the fat never leaves the harvesting syringe until re-injection," similar to Tissu-Trans™.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not applicable. This submission relies on a comparison to predicate devices, not on a test set from a performance study of the Lipokit itself to establish efficacy. The "mechanical testing" mentioned is general and details (like sample size) are not provided.
Data Provenance: Not applicable in the context of a clinical test set. The data presented is descriptive of the device and comparative analysis against legally marketed devices regulated by the FDA (presumably in the USA).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. There was no "test set" and thus no ground truth established by experts in the context of a performance study for the Lipokit's efficacy. The FDA's review process, however, involves internal experts assessing the submission for substantial equivalence.

4. Adjudication Method for the Test Set

Not applicable. No test set requiring expert adjudication was conducted or described.

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

Not applicable. This device is a mechanical system for fat transfer, not an AI-assisted diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a mechanical system, not an algorithm.

7. The Type of Ground Truth Used

Not applicable in the context of a clinical performance study. The "ground truth" for the submission is the regulatory precedent set by the predicate devices and the demonstration that the Lipokit is sufficiently similar in function, safety, and intended use.

8. The Sample Size for the Training Set

Not applicable. This device is a mechanical system and does not involve AI or algorithms that require a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. This device is a mechanical system and does not involve AI or algorithms that require a training set.

In summary, the provided document is a regulatory submission for 510(k) clearance based on substantial equivalence, not a detailed report of a clinical efficacy study with performance metrics against predefined acceptance criteria. The "study" for this device was a comparative analysis against predicate devices, focusing on design, materials, intended use, and general safety considerations (like sterility and mechanical integrity).

Summary

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Suite # 400, 6033 West Century Boulevard, Los Angeles, CA 90045, USA Tel. (310) 649-7570 Fax (310) 649-7569

510(k) Summary (21 CFR 807.92(c))

ADMINISTRATIVE INFORMATION

Manufacturer Name:	Medi-Khan USA, Inc.6033 West Century BoulevardSuite 403Los Angeles, California 90045		MAY 18 2005
Contact Person:	Peter Jung, Vice President & C.O.O.Tel.: (310) 649-7570Fax: (310) 649-7569E-mail: peter2275@gmail.com
Official Correspondent:	CALISO Consulting, LLCJulie Santiago, Sr. Consultant1516 Oak Street, Suite 312Alameda, CA 94501(510) 864-0463

Establishment Registration Number: 3007134825

Date prepared: October 23, 2008

DEVICE CLASSIFICATION AND PRODUCT CODE

As shown in 21 CFR 878.5040 Suction Lipoplasty Systems are defined as devices consisting of collection bottles, cannulas, and connecting tubing for use in aesthetic body contouring procedures. Suction Lipoplasty Systems are classified as Class II. They have been assigned Product Code MUJ.

INTENDED USE

The Lipokit is used in the tumescent injection, aspiration, harvesting, filtering and transferring of autologous fat tissue.

The Lipokit is intended for use in the following surgical specialties when the aspiration of soft tissue is desired:

Plastic and Reconstructive Surgery .
General Surgery .
Dermatological Surgery .
o Obstetrician & Gynecological Surgery
. Cosmetic Surgery

The Lipokit is indicated for use when harvesting of highly concentrated pure fatty tissues for aesthetic body and facial contouring is desired.

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Suite # 400, 6033 West Century Boulevard, Los Angeles, CA 90045, USA Tel. (310) 649-7570 Fax (310) 649-7569

DEVICE DESCRIPTION

Design Characteristics

The 50cc AFT Syringe is a polymeric 50cc volume luer-lock style, single-use syringe consisting of a polypropylene barrel with printed graduations and a weight-mesh piston composed of polycarbonate.

Material Composition

The components of Lipokit that have direct patient contact are fabricated from surgical stainless steel.

Sterilitv

The 50cc AFT Syringe is sterilized by ethylene oxide (EtO) gas

In Vitro Testina

Mechanical testing of Lipokit demonstrates that the device is substantially equivalent to the predicate devices.

EQUIVALENCE TO MARKET PRODUCT

The Lipokit with disposable 50cc AFT Syringe shares indications and design principles with the following predicate devices which have been determined by FDA to be substantially equivalent to premarket devices: Shippert Medical Tissu-Trans (K050797), Cytori AFT System (K072587) and MaceneRoncel Lipoplasty System (K042261); Class I and Class II Medical Devices that were cleared for Marketing in the United States under K050797, K072587 and K042261 respectively.

Indications for Use

The Lipokit with disposable 50cc AFT Syringe and the predicate devices are substantially equivalent with respect to their indications for use, as they are all indicated for the same surgical procedures of anni rating, harvesting, filtering, and transferring autologous tissues.

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Design and Materials

The design and materials of the Lipokit with disposable 50cc AFT Syringe and the predicate devices {Shippert Medical TissueTrans™ (K050797), Macropore Puricel Lipoplasty System (K042261) and Cytori AFT System (K072587)} are substantially equivalent, as they are all single-use polymer constructed, manually operated systems that utilize manual or external sources of vacuum to withdraw, hold, and/or inject fluids/tissues into the body. The Lipokit with disposable 50cc AFT Syringe is substantially equivalent to the Tissu-Trans™ (K050797) predicate device, as they both use a polypropylene piston syringe to collect the autologous fat as well as re-inject the fat into the patient at desired locations. Lipokit, like Tissu-Trans™ (K050797) decreases the number of steps a physician must take to process the fat for re-injection. The fat remains in a sterile field at all times with Lipokit, thus reducing the risk of infection.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with flowing lines, positioned to the right of a circular text element. The text within the circle reads "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" in capital letters. The logo is presented in black and white.

Public Health Service

MAY 18 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medi-Khan (USA), Inc. % CALISO Consulting, LLC Ms. Julie C. Santiago 1516 Oak Street, Suite 312 Alameda, California 94501

. « ஃ

Re: K083455

Trade/Device Name: Lipokit with disposable 50cc AFT Syringe Regulation Number: 21 CFR 878.5040 Regulation Name: Suction lipoplasty system Regulatory Class: II Product Code: MUU Dated: April 22, 2009 Received: April 22, 2009

Dear Ms. Santiago:

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 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 (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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at

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Page 2 - Ms. Julie C. Santiago

(240) 276-0115. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at (240) 276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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

F/2 O.h

Mark N. Melkerson 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):

Device Name: Lipokit with disposable 50cc AFT Syringe

Indications for Use:

The Lipokit is used in the tumescent injection, aspiration, harvesting, filtering and transferring of autologous fat tissue.

The Lipokit is intended for use in the following surgical specialties when the aspiration of soft tissue is desired:

Plastic and Reconstructive Surgery
General Surgery
Dermatological Surgery
Obstetrician & Gynecological Surgery
Cosmetic Surgery

The Lipokit is indicated for use when harvesting of highly concentrated pure fatty tissues for aesthetic body and facial contouring is desired.

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel Krone for luxury
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K083455

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.