(34 days)
Not Found
No
The device description and performance studies focus on mechanical aspiration and collection of fat tissue, with no mention of AI or ML capabilities.
No.
The device is used for aspirating fat and collecting it, which is a procedural function, not a therapeutic one where it treats or cures a disease or condition.
No
The device is designed for aspirating and collecting fat, which is a procedural/surgical function, not a diagnostic one. Diagnostic devices are used to identify or analyze a medical condition.
No
The device description explicitly lists physical components such as a canister, tubing, funnel, and syringe, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "For use in aspirating subcutaneous fatty tissue including autologous fat collection." This describes a surgical or procedural use on the body, not a test performed on a sample outside the body to diagnose a condition.
- Device Description: The description details components for aspiration and collection of tissue, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue samples) for diagnostic purposes. The device is used to collect tissue, not to test it.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is purely for tissue collection.
N/A
Intended Use / Indications for Use
For use in aspirating subcutaneous fatty tissue including autologous fat collection.
Product codes
MUU, KYZ
Device Description
Device function:
- Contains port interfaces between: Canister to tubing & aspirator to canister.
- Sterile tubing to connect the interfaces
- Funnel to interface port to tubing.
- Syringe to collect fat.
Device design: - Contents subjected to sterility
Material used: Plastic Canister, Syringe, silicone tubing
Physical properties: Plastic & Silicone
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
subcutaneous fatty tissue
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
い・・・・・
Image /page/0/Picture/1 description: The image shows the logo for M.D. Resource. The logo consists of a symbol on the left and the text "M.D. RESOURCE" on the right. The symbol appears to be a stylized representation of a medical or scientific concept. The text "M.D. RESOURCE" is written in a bold, sans-serif font.
Food and Drug Administration Center for Device and Radiological Health HFZ-401 9200 Corporate Blvd Rockville, MD 20850
SEP - 1,2009
ﺎ
K092284 May 2
July 24th, 2009
Dear Sir/Madam,
Delineated below is the 510(k) Summary:
| Date prepared: | July 24th, 2009 | |
|---|---|---|
| 510(k) Owner / Preparer / Official Contact: | Melbourne | |
| Kimsey II | ||
| 23392 Connecticut Street | ||
| Hayward, Ca. 94545 | ||
| 510.909.7882 Mobile | ||
| 510.732.9950 Office | ||
| 510.785.8182 Fax | ||
| Manufacturer: | Medical Device Resource Corporation | |
| Trade Name: | LipiSystems AquaVage | |
| Common Name: | Sterile canister system | |
| Classification Name: | Suction Lipoplasty System, Class II - 21 CFR | |
| § 878.5040, Product Code: MUU | ||
| 21 CFR 880.6960 - Syringe, Class I (Sterile), Product | ||
| Code: KYZ | ||
| Legally marketed device: | K081593 - LS Liposuction Aspirator | |
| Description of Device: | Device function: | 1. Contains port interfaces |
| between: Canister to tubing & | ||
| aspirator to canister. |
- Sterile tubing to connect the
interfaces - Funnel to interface port to
tubing. - Syringe to collect fat. |
| | Device design: | 1. Contents subjected to
sterility |
| | Material used: | Plastic Canister, Syringe,
silicone tubing |
.
1
Image /page/1/Picture/0 description: The image shows a collection of small, dark, irregular shapes scattered across a white background. The shapes vary in size and density, with some appearing as isolated dots and others clustered together. The overall impression is one of randomness and contrast, with the dark shapes standing out against the bright background.
K092284 page 4/2
| Physical properties: | Plastic & Silicone | |
|---|---|---|
| Intended Use of the Device: | For use in aspirating subcutaneous fatty tissue including | |
| autologous fat collection. | ||
| Patient population for which the device is | ||
| intended: | Patients who desire aesthetic body contouring and | |
| autologous fat collection | ||
| 510(k) Summary continued... | 11 | |
| Technological characteristics: | Same as predicate except canister is sterilized | |
| Determination of substantial equivalence: | SE to the predicate device was based on non-clinical | |
| data. Performance and function supported the | ||
| determination of SE. | ||
| Conclusions for safety, effectiveness, and | ||
| performance of the device: | Predicate device demonstrates safety/effectiveness. | |
| Conclusions have been drawn that the device is SE and | ||
| therefore safe & effective. The device performs better | ||
| than predicate due to addition of sterilized canister | ||
| system. |
Sincerely,
Melbourne Kimsey II President
'
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it. The symbol is placed to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA", which is arranged in a circular fashion. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center ~ WO66-G609 Silver Spring, MD 20993-0002
Medical Device Resource Corporation % Mr. Melbourne Kimsey II President 23392 Connecticut Street Hayward, California 94545
March 21, 2013
Re: K092284
K032264
Trade/Device Name: Lipisystems Aquavage Model AV2000 & 1200 Regulation Number: 21 CFR 878.5040 Regulation Name: Suction Lipoplasty System Regulatory Class: Class II Product Code: MUU, KYZ Dated: July 24, 2009 Received: August 7, 2009
Dear Mr. Kimsey:
This letter corrects our substantially equivalent letter of September 1, 2009.
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 3 iv(c) premaint is substantially equivalent (for the indications
referenced above and have determined the device is substantially equivalent in referenced above and have determined the devices marketed in interstate for use stated in the enclosure) to teany management date of the Medical Device Amendments on to
commerce prior to May 28, 1976, the enactment date of the Federal Food. Drue commerce prior to May 28, 1976, the enactions of the Frovisions of the Federal Food, Drug, devices that have been reclassified in accordance was are archarded approval (PMA). You may,
and Cosmetic Act (Act) that do not require approval of the Act. The ectoral and Cosmetic Act (Act) that do not require approvisions of the Act. The general
therefore, market the device, subject to the general control provisions of the general therefore, market the device, subject to the generals for annual registration, listing of devices, controls provisions of the Act include requirements for annual regions and adulteration.
good manufacturing practice, labeling, and prohibitions against misbranding and adult
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (see above) minorenas it eppations affecting your device can be
it may be subject to additional controls. Existing major regulation FDA may it may be subject to additional controls. Larsing major regor. of each as an addition, FDA may
found in the Code of Federal Regulations, Title 21, Parts 800 to 800 federal R found in the Code of Federal Regulations, This any .
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 Please be advised that FDA's issuance of a substance equires with other requirements of the Act
that FDA has made a determination that your device adderacies. You must that FDA has made a determination inal your areas by other Federal agencies. You must
or any Federal statutes and regulations administered by other Federal ion and listing or any Federal statutes and regulations and limited to: registration and listing (21
comply with all the Act's requirements, including, but not limited to: reporting of medic comply with all the Act's requirements, including be novements of medical
CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical CFR Part 807); labeling (21 CFR Part 801); incured device reporting (1)
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Mr. Melbourne Kimsey II
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (QD) regulation (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
s and the superior and the second of the column and CDRUCCRALLSS00 htm for If you desire specific advice for your devices/CDRHCORHOffices/ucm] I S809.htm for and go to mtp://www.loa.gov/Abouth DAVCCMcchions of Compliance. Also, please
the Center for Devices and Radiological Health's (CDRH's) natifiestion" (21CFR Part the Center for Devices and Radionaling by reference to premarket notification" (21 CFR Part note the regulation entitled, "Misoranding of reference to promation
807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
CFR Part 803), please go to of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the You may obtain other general information on your responsional as and its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address (800) 038-2041 of (501) 770 7700 7100 0100 00000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000
Sincerely yours, FOR Peter D. Rumm -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K092284
Lipisystems Aquavage Model AV2000 & 1200 Device Name:
For use in aspirating subcutaneous fatty tissue including autologous fat collection.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel Krome
(Division Sign-Off)
(Division Sign-(Division Sign-Sign-Sign-Orthopedic, and Restorative Devices
Page 1 of
510(k) Number: K092284.