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.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the "LS Liposuction Aspirator Pump" (later referred to as "Power Aspirator, Model Ls2 Or Ls2dp"). The FDA determined the device is substantially equivalent to legally marketed predicate devices.

Based on the provided text, there is no specific study that proves the device meets detailed acceptance criteria in terms of performance metrics. The 510(k) submission process focuses on demonstrating substantial equivalence to a predicate device, not necessarily on new, extensive performance studies with specific acceptance criteria that would typically be seen for novel AI/software devices. However, we can infer some aspects relevant to device performance and regulatory approval:

Here's an attempt to answer your questions based on the available information:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Inferred from 510(k) Process)	Reported Device Performance (Inferred from 510(k) Submission)
Intended Use Equivalence: The device's intended use should be similar to that of legally marketed predicate devices.	Intended Use: Aesthetic Body Contouring (stated in document). This matches or is substantially equivalent to predicate devices.
Design Equivalence: The fundamental design and operating principles should be similar to predicate devices.	Design & Operating Principles: "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." This design is considered substantially equivalent to predicate devices (M.D. Resource: K854844, Byron Medical: K980392, Byron Medical: K981215, HK: K032802).
Material Equivalence: Materials used should be similar or demonstrably safe and effective as predicate devices.	Materials: Stated as having similar materials to predicate devices. (Specific materials are not detailed in this summary).
Performance Equivalence: The device should perform in a manner similar to predicate devices for its intended use.	Performance: Expected to provide similar suction capabilities for lipoplasty, soft tissue, and general surgical waste removal as predicate devices. (No specific quantitative performance metrics are provided in this summary, but the claim of substantial equivalence implies acceptable performance).
Safety: Device components and operation should meet general safety standards.	This is generally assumed for any medical device seeking FDA clearance. No specific safety tests are described in this summary, but the clearance implies safety has been addressed in the full 510(k) submission.
Effectiveness: Device should be effective for its intended use.	Effectiveness is implied by substantial equivalence to devices already on the market and cleared for the same indications.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The provided document is a 510(k) clearance letter and a summary of the 510(k) submission. For mechanical devices like a liposuction aspirator pump, the "test set" and "data provenance" as you might understand them for AI/software are not applicable in the same way.

Sample Size for Test Set: Not applicable. Performance testing for such devices typically involves engineering tests (e.g., vacuum pressure, flow rates, durability) rather than clinical studies with "test sets" of patients in the context of an AI device.
Data Provenance: Not applicable. The 510(k) relies on comparison to predicate devices, not on a dataset of patient outcomes.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This type of information would be relevant for devices that interpret medical images or signals and require expert consensus for ground truth. This is a mechanical device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. See point 3.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI-assisted device, nor does it involve human readers interpreting cases.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithm or AI device. It's a powered suction pump.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. The "ground truth" for this device would be its ability to generate and maintain a negative pressure and safely remove substances as intended, typically verified through engineering performance specifications and safety testing, not clinical ground truth in the AI sense.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. See point 8.

Summary

{0}------------------------------------------------

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

{3}------------------------------------------------

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

{4}------------------------------------------------

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:

7. Intended Use: Aesthetic Body Contouring

Regulation Number and Section

§ 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.