(256 days)
Not Found
No
The device description details a mechanical system for fat removal (pumps, cannulas, tubing) and explicitly states "Not Found" for mentions of AI, DNN, or ML, as well as for descriptions of training/test sets and performance studies typically associated with AI/ML devices.
No.
The 'Intended Use' states "For aesthetic body contouring," which is not typically considered a therapeutic purpose. The device's function is the removal of fat tissue, a cosmetic procedure.
No
Explanation: The device is described as an infiltration/peristaltic pump combined with an aspiration/vacuum pump for the removal of fat tissue and general surgical waste, primarily for aesthetic body contouring. Its function is to perform a medical procedure (fat removal), not to diagnose a condition or disease.
No
The device description clearly outlines hardware components including pumps, hand-pieces, tubing sets, and waste containers, indicating it is 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 aesthetic body contouring," which is a surgical procedure performed on a living patient.
- Device Description: The device is described as a system for removing fat tissue and general surgical waste, involving pumps, hand-pieces, tubing, and waste containers. This is consistent with surgical equipment used directly on a patient.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on samples taken from the body to provide diagnostic or other health-related information. This device's function is to physically remove tissue from the body during a surgical procedure.
N/A
Intended Use / Indications for Use
For aesthetic body contouring.
Product codes
QPB, MUU
Device Description
The Moller Medical Lipoplasty System is an electrically powered infiltration/peristalitic pump combined with an aspiration/vacuum pump and manual or vibrating cannula hand-piece, tubing sets and waste containers for the removal of fat tissue and general surgical waste.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K032802, K981172, K001803, K981922
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
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 text "U.S. FOOD & DRUG ADMINISTRATION" in a sans-serif font, also in blue.
Moeller Medical Gmbh & Co. Kg Bill Kelley 23832 Via Monte Coto De Caza, California 92679-4001
June 8, 2021
Re: K053451
Trade/Device Name: Liposat (infiltration Pump), Model 00 002 274; Vacusat (suction Unit), Model 00 002 252 (220 V), 00 002 318 (110 V); 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 August 25, 2006. 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 is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of a human figure, represented by three overlapping profiles, with flowing lines suggesting movement or connection. The figure is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 5 2006
Moeller Medical GmbH & Co. KG % Moeller Medical Mr. Bill Kelley 23832 Via Monte Coto De Caza, California 92679-4001
Re: K053451
Trade/Device Name: Suction Lipoplasty System Regulation Number: 21 CFR 878.5040 Regulation Name: Suction lipoplasty system Regulatory Class: II Product Code: MUU Dated: July 14, 2006 Received: July 28, 2006
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 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.
2
Page 2 – Mr. Bill Kelley
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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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.
Sabaye Puechum
for
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known):
Device Name:
Suction Lipoplasty System
Indications for Use:
For aesthetic body contouring.
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)
KO Barbara Bouchard
(Division Sign-Off) FOR MY
Page 1 of 1
Division of General, Restorative, and Neurological Devices
510(k) Number K053451
4
1/2
510(k) Summary
"This surrery of 510(k) safety and effectiveness is being submitted in accordance with the requireme of SMDA 1990 and 21 CFR § 807.92."
"The assiged 510(k) number is KOS3 45 1
1. Subentler Information:
Molt... Medical GmbH & Co. KG Was . I uppenstrasse 29-31 D360 | Fulda Germany
Commel person:
Bill I. cliey 238 - Via Monte Coton. Caza, CA 92679-4001 Phone (949) 292-8477 Fax: (509) 479-4840
- Name of Device: 2.
| Common Name: | Suction Lipoplasty System |
|---|---|
| Proprietary Name: | Liposat® (infiltration pump), model # 00 002 274. |
| Vacusat® (aspiration/suction pump), model # 00 002 252 (220 V) and model # 00 002 318 (110 V). |
Vibrasat® (vibration handpiece for the liposuction cannula), model # 00 002 246.
3. Classification:
Suction Lipoplasty System, Class II 21 CFR § 878.5040 (1998)
2
5
4. Product Code:
MUU
Substantial Equivalence: 5.
The Moller Medical Suction Lipoplasty System is substantially equivalent to the aspiration devices listed below in terms of intended use, design, operating principles, and materials.
HK Surgical, Inc .: Byron Medical, Inc .: MicroAire Surgical Instruments: K032802 K981172, K001803 K981922
Device Description: 6.
The Moller Medical Lipoplasty System is an electrically powered infiltration/peristalitic pump combined with an aspiration/vacuum pump and manual or vibrating cannula hand-piece, tubing sets and waste containers for the removal of fat tissue and general surgical waste.
7. Intended Use:
Aesthetic Body Contouring
8. Signature of Applicant:
Bill Kelley, Möller Medical