(182 days)
Not Found
No
The device description and intended use focus on mechanical processes (centrifugation, aspiration, filtering) and do not mention any software, algorithms, or data processing that would indicate the use of AI or ML. The "Mentions AI, DNN, or ML" section also explicitly states "Not Found".
No.
The document describes the device's function as collecting, filtering, and transferring autologous fat tissue for contouring, which is a procedure rather than a therapeutic treatment in itself. The device facilitates a medical procedure but does not directly treat a disease or condition.
No
The device is described as harvesting, filtering, and transferring autologous fat tissue for surgical procedures, not for diagnosing conditions or diseases.
No
The device description explicitly details hardware components such as a centrifuge unit with a motor, a syringe, a cannula, and a foot pedal control switch. It also mentions electrical safety and electromagnetic compatibility testing, which are relevant to hardware devices.
Based on the provided information, the Lipokit is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological state, state of health, disease or congenital abnormality. This examination is performed outside of the living body (in vitro).
- Lipokit's Function: The Lipokit is used for the harvesting, filtering, and transferring of autologous fat tissue for surgical procedures like body and facial contouring. It is a surgical tool used on the patient's body to collect and prepare tissue for re-implantation.
- No Specimen Examination for Diagnosis: The Lipokit does not examine a specimen to provide diagnostic information about a patient's health or disease state. Its purpose is purely for tissue manipulation and transfer within a surgical context.
Therefore, the Lipokit falls under the category of a surgical device rather than an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
MUU
Device Description
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.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 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).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
.. .
・・
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.O
Tel: (323) 259-5000
Fax: (323) 259-5005
Email: peter2275@gmail.com |
| Official Correspondent: | Kachi Enyinna,
Principal Consultant
510K Technology Group, LLC
399 Massachusetts Avenue, Suite 2
Boston, 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
1
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 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 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 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.
2
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
3
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.
4
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
5
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
6
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