(47 days)
Not Found
No
The summary describes a standard suction pump/aspirator and makes no mention of AI, ML, or any related technologies.
Yes
The device is described as "for aesthetic body contouring" and "for the removal of fat/ adipose (Suction Lipoplasty)", which are therapeutic procedures.
No
Explanation: The device is described as a powered suction pump/aspirator for the removal of fat, soft tissue, and general surgical waste, which is a therapeutic function, not a diagnostic one. Its intended use is for "aesthetic body contouring" via liposuction.
No
The device description clearly states it is a "powered suction pump/ aspirator which uses an electrically (AC) driven vacuum pump," indicating it is a hardware device.
Based on the provided information, the LS Liposuction Aspirator is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is "for aesthetic body contouring" and the removal of fat, soft tissue, and general surgical waste. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a powered suction pump/aspirator used to generate negative pressure for removal of materials from the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue samples) outside of the body to provide information about a person's health. The description of the LS Liposuction Aspirator does not involve the analysis of specimens in this manner.
Therefore, the LS Liposuction Aspirator is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The LS Liposuction Aspirator is for aesthetic body contouring.
Product codes
MUU, QPB
Device Description
The LS Liposuction Aspirator is a powered suction pump/ aspirator which uses an electrically (AC) driven vacuum pump generating a negative pressure for the removal of fat/ adipose (Suction Lipoplasty), soft 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)
K854844, K980392, K981215, K032802
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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
Medical Device Resource Corp. Mel Kimsey President 23392 Connecticut St. Hayward, California 94545
June 8, 2021
Re: K081593
Trade/Device Name: Power Aspirator, Model Ls2 Or Ls2dp Regulation Number: 21 CFR 878.5040 Regulation Name: Suction lipoplasty system Regulatory Class: Class II Product Code: QPB
Dear Mel Kimsey:
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 July 23, 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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right.
Food and Druq Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 3 2008
Medical Device Resource Corporation % Mr. Mel Kimsev President 23392 Connecticut Street Hayward, California 94545
Re: K081593
Trade/Device Name: LS Liposuction Aspirator Pump Regulation Number: 21 CFR 878.5040 Regulation Name: Suction lipoplasty system Regulatory Class: II Product Code: MUU Dated: May 22, 2008 Received: June 6, 2008
Dear Mr. Kimsey:
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. Mel Kimsey
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 M Millman
- Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
Ko81593 510K Number:
Device Name: LS Liposuction Aspirator Pump
Indications For Use: The LS Liposuction Aspirator is for acsthetic body contouring.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number
Prescription Use
Over-the-Counter Use
Division Sign-off Division of General, Restorative and Neurological Devices
510(k) Number LOK15
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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
KO81593 The assigned 510(k) number is:
1. Submitter Information:
Prepared: May 12th, 2008 Contact Person: Melbourne Kimsey II, President Est. Reg. #: 2938001 Medical Device Resource Corporation 23392 Connecticut Street, Hayward, CA 94545 510.732.9950 T / 510.785.8182 F
2. Name of Device:
LS Liposuction Aspirator
Proprietary Name:
LS2 Liposuction Aspirator
Common Name:
Aspirator Pump, Powered Suction Pump, Power Aspirator, Liposuction Aspirator
3. Classification:
Suction Lipoplasty System, Class II - 21 CFR § 878.5040 (2008) Aspirator, Apparatus, Suction, Operating Room, Wall Vacuum Powered, Class II - 21 CFR § 878.6740 (2008) Aspirator, Apparatus, Suction, Ward Use, Portable, AC-Powered, Class II - 21 CFR § 878.4780 (2008)
4. Product Code: MUU
ട. Substantial Equivalence:
The LS Liposuction Aspirator(s) are believed to be substantially equivalent to the aspiration devices listed below in terms of intended use, design, operating principles, materials, performance, with a change of intended use:
M.D. Resource: K854844 Byron Medical: K980392 Byron Medical: K981215 HK: K032802
6. Device Description:
The LS Liposuction Aspirator is a powered suction pump/ aspirator which uses an electrically (AC) driven vacuum pump generating a negative pressure for the removal of fat/ adipose (Suction Lipoplasty), soft tissue, and general surgical waste.