The HK Liposuction Pump 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 FDA document is a 510(k) premarket notification for a medical device and, as such, does not contain the detailed study information typically found in a clinical trial report or a journal publication. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting and evaluating specific acceptance criteria and detailed study results from a de novo clinical study.

Therefore, the requested information components (Acceptance Criteria, Reported Device Performance, Sample Sizes, Expert Qualifications, Adjudication Methods, MRMC Studies, Standalone Performance, Ground Truth Type and Establishment for Training Set) cannot be extracted from the provided text.

The document confirms the following about the device and its regulatory clearance:

Device Name: HK Liposuction Aspiration Pump (also referred to as HK Liposuction Aspirator, Model Ap-III & Ap230-iii)
Intended Use: Aesthetic Body Contouring (Stated in the "Indications for Use Statement" and "510(k) Summary")
Regulatory Class: Class II
Regulation Number: 21 CFR 878.5040
Regulation Name: Suction Lipoplasty System
Product Code: MUU (later updated to QPB in 2021 as an administrative change)
Clearance Type: 510(k) Substantial Equivalence
Predicate Devices: Byron Medical K980392, Byron Medical K981215, Kolster Methods K895761, Wells Johnson K832274

The clearance is based on the claim that the device is "substantially equivalent ... in terms of intended use, design, operating principles, materials and performance" to the listed predicate devices. The document does not describe a clinical study with specific acceptance criteria that a new device must meet. Substantial equivalence typically relies on non-clinical performance testing and comparison to predicates, which are not detailed in this public 510(k) summary.

Summary

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June 8, 2021

Hk Surgical, Inc. Sally Bowdon General Manager 2620a Temple Heights Dr. Oceanside, California 92675

Re: K032802

Trade/Device Name: Hk Liposuction Aspirator, Model Ap-III & Ap230-iii Regulation Number: 21 CFR 878.5040 Regulation Name: Suction lipoplasty system Regulatory Class: Class II Product Code: QPB

Dear Sally Bowdon:

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 November 19, 2003. 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

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 9 2003

Ms. Sally Bowman General Manager HK Surgical, Inc. 2620 Temple Heights Drive Oceanside, California 92056

Re: K032802

Trade/Device Name: HK Liposuction Aspiration Pump Regulation Number: 21 CFR 878.5040 Regulation Name: Suction Lipoplasty System Regulatory Class: II Product Code: MUU Dated: September 3, 2003 Received: September 9, 2003

Dear Ms. Bowman:

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.

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Page 2 - Ms. Sally Bowman

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 (301) 594-4659. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

for Celia M. Witten, Ph.D., M.D. 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

510K Number: _ KO32802

Device Name: HK Liposuction Aspiration Pump

Indications For Use:

The HK Liposuction Aspiration Pump is for aesthetic 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

Miriam C. Provost

n of General, Restorative and Neurological Devic

510(k) Number K032802

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NOV 1 9 2003

510(k) Summary

"This summary of 510(k) safety and effectiveness is being submitterd in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92."

The assigned 510(k) number is K032002"

1. Submitter Information:
  HK Surgical, Inc. 2620 Temple Heights Dr. Oceanside, CA 92056 Ph: 800-909-0060 Fax: 949-369-9797

Contact Person: Mrs. Sally Bowdon General Manager

Name of Device: 2. Proprietary Name: HK Liposuction Aspirator III w/tubing Common Name: Aspirator Pump, Liposuction Aspirator, Powered Suction Pump
Classification: Suction Lipoplasty System, Class II 3. 21 CFR § 878.5040 (1998)
Product Code: MUU 4.
Substantial Equivalence: The HK Aspiration Pump Model AP-III and AP230-III is believed to be న. substantially equivalent to the aspiration devices listed below in terms of intended use, design, operating principles, materials and performance.

Byron Medical K980392 Byron Medical K981215 Kolster Methods K895761 Wells Johnson K832274

Device Description: The HK Liposuction Pump is a powered suction pump/ aspirator 6. 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.
1. Intended Use: Aesthetic Body Contouring

Signature of Applicant: Sally M. Bowdon

Sally M. Bowdon, General Manager

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.