(155 days)
Not Found
No
The summary describes a basic infiltration pump and explicitly states "Not Found" for mentions of AI, DNN, or ML, as well as information typically associated with AI/ML device submissions (training/test sets, performance metrics).
No
The device is described for "aesthetic body contouring" and functions as an infiltration pump for lipoplasty, which is generally considered a cosmetic procedure rather than a therapeutic medical treatment addressing disease or injury.
No
Explanation: The intended use of the device is for "aesthetic body contouring," which is a treatment rather than a diagnostic purpose. The description also identifies it as an "infiltration pump."
No
The device description explicitly states it is an "electrically powered infiltration/peristaltic pump," which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "For aesthetic body contouring." This is a procedure performed on the human body, not a test performed on samples taken from the body.
- Device Description: The device is an "infiltration/peristaltic pump" used as part of a "Lipoplasty System." This describes a surgical or procedural device, not a device used for analyzing biological samples.
- Lack of IVD Indicators: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information about a patient's health status
IVD devices are specifically designed to perform tests on samples taken from the body to provide information for diagnosis, monitoring, or screening. This device's function is to infiltrate fluids into the body during a cosmetic procedure.
N/A
Intended Use / Indications for Use
For aesthetic body contouring.
Product codes
QPB, MUU
Device Description
The Liposat Basic infiltration pump is one of the components that make up the Möller Medical Lipoplasty System. Like the original Liposat infiltration pump, the Liposat Basic is an electrically powered infiltration/peristaltic pump.
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
Not Found
Key Metrics
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, followed by the words "U.S. FOOD & DRUG" in a larger font. Below that is the word "ADMINISTRATION".
Moeller Medical Gmbh & Co. Kg Bill Kelley Contact Person 23832 Via Monte Coto De Caza, California 92679-4001 June 8, 2021
Re: K072793
Trade/Device Name: Liposat Basic (infiltration Pump), Model 92-007 688 Regulation Number: 21 CFR 878.5040 Regulation Name: Suction lipoplasty system Regulatory Class: Class II Product Code: QPB
Dear Bill Kelley:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated March 4, 2008. Specifically, FDA is updating this SE Letter because FDA has created a new product code to better categorize your device technology.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Cindy Chowdhury, OHT4: Office of Surgical and Infection Control Devices, 240-402-6647, Cindy.Chowdhury@fda.hhs.gov.
Sincerely,
Cindy Chowdhury -S
Cindy Chowdhury, Ph.D., M.B.A. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 4 2008
Moeller Medical GmbH & Co. KG % Moeller Medical Mr. Bill Kelley 23832 Via Monte Coto De Caza, California 92679-4001
Re: K072793
Trade/Device Name: Suction Lipoplasty System (containing the Liposat Basic infiltration pump) Regulation Number: 21 CFR 878.5040 Regulation Name: Suction lipoplasty system Regulatory Class: II Product Code: MUU Dated: February 6, 2008 Received: February 11, 2008
Dear Mr. Kelley:
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
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Page 2 - Mr. Bill Kelley
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,
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 N. Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
5. Indications for Use Statement
Indications for Use
272793
510(k) Number (if known):
Device Name:
Suction Lipoplasty System (containing the Liposat Basic infiltration pump)
Indications for Use:
For aesthetic body contouring.
Prescription Use ಳ (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)
Mark A. Milken
Page 1 of 1
Division of General, Restorative, and Neurological Devices
(Division Sign-Of
Number K072793
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4
-
- 510(k) Summary or 510(k) Statement
MAR - 4 2008
- 510(k) Summary or 510(k) Statement
510(k) Summary
"This summary of 510(k) safety and effectiveness is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92."
"The assigned 510(k) number is K072793
Submitter Information: 1.
Möller Medical GmbH & Co. KG Wasserkuppenstrasse 29-31 D36043 Fulda Germany
Contact person:
Bill Kelley 23832 Via Monte Coto de Caza, CA 92679-4001 Phone: (949) 292-8477 (509) 479-4840 Fax:
2. Name of Device:
| Common Name: | Suction Lipoplasty System |
|---|---|
| Proprietary Name: | Liposat® Basic (infiltration pump), model # 92 007 688; is a |
| component of the Moller Medical Lipoplasty System. | |
| Classification: | Suction Lipoplasty System, Class II |
| 21 CFR § 878.5040 (1998) | |
| Product Code: | MUU |
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K072793 page2/i
న. Substantial Equivalence:
The original Liposat infiltration pump (model # 00 002 274), one of the components which make up the Möller Medical Suction Lipoplasty System, has been modified to make it easier to use. The modified version of the Liposat infiltration pump is called the Liposat Basic infiltration pump (model # 92 007 688), and is substantially equivalent to the original Liposat infusion pump in terms of intended use, design, operating principles, and materials.
Moller Medical 510(k): K053451 - Containing the original Liposat infiltration pump
6. Device Description:
The Liposat Basic infiltration pump is one of the components that make up the Möller Medical Lipoplasty System. Like the original Liposat infiltration pump, the Liposat Basic is an electrically powered infiltration/peristaltic pump.
-
- Intended Use:
Aesthetic Body Contouring
- Intended Use:
: Bee Kelley
Bill Kelley, Möller Medical
-
- Signature of Applicant: