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 pressure are controlled using a foot pedal control switch.

The Lipokit is a sterile, single-use, manual device consisting of a cannula, and tissue collection container (the 50cc AFT Syringe) that relies on the centrifuge 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 reinjection. 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 a various sizes ranging from 2.5 -- 4.0mm 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 though 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) submission for a medical device (Lipokit with disposable 50cc AFT Syringe). This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving specific performance criteria through a study with the level of detail requested.

Therefore, many of the requested details related to acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, expert qualifications, and MRMC studies are not available in this document. This document focuses on demonstrating that the modified device is substantially equivalent to a previously cleared device, primarily by showing that the only change is the addition of a transformer to adapt to different voltage input.

Here's a breakdown of the information that can be extracted and what is not available:

1. Table of acceptance criteria and reported device performance:

Acceptance Criteria (Implied by Equivalence)	Reported Device Performance
Electrical Safety: Compliance with IEC 60601-1:1998, Am1:91, Am2:95	Demonstrated compliance. (Specific test results not provided, only statement of compliance.)
Electromagnetic Compatibility (EMC): Compliance with IEC 60601-1-2:2007 (Edition 3)	Demonstrated compliance. (Specific test results not provided, only statement of compliance.)
Functional Equivalence: Same indications for use, operating principle, design, materials, shelf life, packaging, and sterilization.	Confirmed to be the same as the cleared predicate device (K083455) after modification (addition of transformer).
No change to technical specifications: Safety System, System performance, Environmental requirements, Transportation and Storage condition, User Interface, Hardware, Accessories, Alarms, Accuracy and Controls, Protection against Mechanical Hazard, Protection against Electrical Hazard, Protection against excessive temperature or other hazards, Manufacturing Location and processes.	Confirmed to be the same as the unmodified device.

2. Sample size used for the test set and data provenance:

Not Applicable / Not Available. This document describes a modification to an already cleared device, not a de novo device requiring a new clinical performance study with a test set of data. The "test set" here refers to device-level testing for electrical safety and EMC, not a clinical data set.

3. Number of experts used to establish the ground truth for the test set and qualifications of those experts:

Not Available. No clinical ground truth or expert review process is described in this document, as it's not a clinical performance study. The "ground truth" for the electrical safety and EMC testing would be the international standards themselves.

4. Adjudication method for the test set:

Not Available. Not applicable for the type of testing described (electrical safety, EMC).

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:

No. This device is a Lipokit system for fat transfer, not an AI-powered diagnostic or assistive tool. MRMC studies are not relevant to this device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not Applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

For the electrical safety and EMC testing, the "ground truth" is adherence to the specified international standards: IEC 60601-1:1998, Am1:91, Am2:95 and IEC 60601-1-2:2007.

8. The sample size for the training set:

Not Applicable / Not Available. There is no "training set" in the context of this device or the type of submission. This is not an AI/machine learning device.

9. How the ground truth for the training set was established:

Not Applicable / Not Available. As above, no training set data.

Summary of the Study Proving Acceptance Criteria:

The "study" proving the device meets the acceptance criteria is primarily a technical assessment affirming that the modified device remains substantially equivalent to its predicate device (K083455), with the only change being an electrical transformer.

Rationale: The submission argues that since the only modification is the addition of a transformer to change voltage input (220V to 120V) without altering the energy source or other hardware, the device's fundamental characteristics and performance remain unchanged.
Specific Tests Conducted: The modified Lipokit was tested for:
- Electrical safety in accordance with IEC 60601-1:1998, Am1:91, Am2:95.
- Electromagnetic compatibility (EMC) in accordance with IEC 60601-1-2:2007 (Edition 3).
Conclusion: The manufacturer concluded that the modified device is substantially equivalent to the cleared predicate device due to identical indications for use, operating principle, design, materials, shelf life, packaging, and sterilization processes, with the electrical safety and EMC tests confirming regulatory compliance for the modified electrical input. The FDA concurred with this determination, issuing the 510(k) clearance.

Summary

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Lipokit with disposable 50cc AFT Syringe Special 510(k) Notification

DEC 7 2012

510(k) Summary

This 510(k) Summary is in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990. The content of this 510(k) summary is provided in conformance with 21 CFR Part 807.92.

I. Sponsor's Information

Name:Address:Phone:Fax:	Medi-Khan USA, Inc.705 S Ave 61, Los Angeles, CA 90042(323)259-5000(323)259-5005
Contact Person:	Peter Jung, Vice President & C.O.OTel: (323) 259-5000Fax: (323) 259-5005Email: peter2275@gmail.com
Official Correspondent:	Kachi Enyinna,Principal Consultant510K Technology Group, LLC399 Massachusetts Avenue, Suite 2Boston, MA 02115(240) 994-4242
Establishment Reg. No.:	3007134825
Date Prepared:	June 8, 2012

II. Device Name

Trade Name: Lipokit with disposable 50cc AFT Syringe, model LK-101 Suction Lipoplasty System Common Name: System, Suction, Lipoplasty Classification Name: Classification Number: 878.5040 Product Code: MUU General and Plastic Surgery Classification Panel:

III. Predicate Device

Lipokit with disposable 50cc AFT Syringe (K083455)

K121703
lofy

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Lipokit with disposable 50cc AFT Syringe Special 510(k) Notification

Indications for Use rv.

ﻣﺮ ــ ﺭ

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 specialities 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.

v. Device Description

Design Characteristics

The Lipokit is a sterile, single-use, manual device consisting of a cannula, and tissue collection container (the 50cc AFT Syringe) that relies on the centrifuge unit for its The cannula is attached directly to the 50cc AFT Syringe which energy supply. simplifies and reduces the steps needed in the collection, filtering and transfer of the In so doing, the harvested fat is less traumatized and risk of autologous fat. contamination is lowered because the fat never leaves the harvesting syringe until reinjection. 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 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.

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112 1703

3,544

Material Composition

No change in material composition. The components of Lipokit that have direct patient contact are fabricated from surgical stainless steel.

Sterility

ﻤﺴ ﻣ

Sterility requirements as approved in the original device has not changed for the modified device. The 50cc AFT Syringe is sterilized by ethylene oxide (EtO) gas.

Design and Materials

The design and materials of the modified Lipokit with disposable 50cc AFT Syringe remains the same as the legally cleared Lipokit with disposable 50cc AFT Syringe. The only change to the design of the cleared Lipokit is the addition of a transformer to step down the voltage input of the Lipokit from 220V/60Hz to 120V/60Hz. The engery source has not been modified and remains the same as the cleared Lipokit. Other than the change in voltage input requirement for the Lipokit, there are no other changes to the design, material, intended use or fundamental scientific technology.

Technological Characteristics

There are no changes in the technological characteristics to the previously cleared Lipokit with disposable 50cc AFT Syringe. The Lipokit with disposable 50cc AFT Syringe incorporates changes pertaining only to the addition of the transformer to step down the voltage of the Lipokit from 220V/60Hz to 120V/60Hz for use in U.S. market. There were no hardware changes made in the machine to accommodate this modification. The following technical specifications of the modified device remain the same as the unmodified device:

· Safety System
· System performance
· Environmental requirements
· Transportation and Storage condition
· User Interface
· Hardware
· Accessories
· Alarms
· Accuracy and Controls
· Protection against Mechnical Hazard
· Protection against Electrical Hazard
· Protection against excessive temperature or other hazards
· Manufacturing Location and manufacturing processes (assembly, fabrication, testing, shipping, installation and service).

VI. Performance Data

Based on the Risk Analysis, the modified Lipokit was tested for electrical safety and electromagenetic compatiblity in accordance to IEC 60601-1:1998, Am1:91, Am2:95 and

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Lipokit with disposable 50cc AFT Syringe Special 510(k) Notification

IEC 60601-1-2:2007, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic Compatibility - Requirements and tests (Edition 3).

VII. Equivalence to Market Product

The modified Lipokit with disposable 50cc AFT Syringe has the same indicated use, same operating principle, same design, same materials, shelf life and is packaged and sterilized using the same material and processes as the cleared Lipokit (K083455).

In summary, the modified Lipokit described in this submission are, in our opinion, substantially equivalent to the cleared Lipokit with disposable 50cc AFT Syringe.

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a caduceus, with flowing lines representing movement or connection.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

December 7, 2012

Medi-Khan USA, Inc. % 510K Technology Group, LLC Mr. Kachi Enyinna 399 Massachusetts Avenue, #2 Boston, Massachusetts 02115

Re: K121703

Trade/Device Name: Lipokit with disposable 50cc AFT Syringe Regulation Number: 21 CFR 878.5040 Regulation Name: Suction lipoplasty system Regulatory Class: Class II Product Code: MUU Dated: November 15, 2012 Received: November 20, 2012

Dear Mr. Enyinna:

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

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Page 2 - Mr. Kachi Enyinna

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/CDRHOffices/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Peter D. Rumm -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Lipokit with disposable 50cc AFT Syringe Special 510(k) Notification

Indications for Use Statement

510(k) Number (if known): K121703

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 the 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 __ X (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)

David Krause

(Division Sign-Off) Division of Surgical Devices 510(k) Number: K121703

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.