(71 days)
Not Found
No
The description focuses on a standard powered suction pump and does not mention any AI/ML capabilities or related terms.
Yes
The intended use mentions "aesthetic body contouring" and "removal of fat/adipose (Suction Lipoplasty), soft tissue, and general surgical waste," which are medical procedures performed for therapeutic or aesthetic purposes.
No
The device description states its purpose is for the "removal of fat/adipose (Suction Lipoplasty), soft tissue, and general surgical waste," which indicates a therapeutic or procedural function, not a diagnostic one.
No
The device description explicitly states it is a "powered suction pump/ aspirator which uses an electrically (AC) driven vacuum pump," indicating it is a hardware device with a physical pump component, 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" and the removal of fat/adipose tissue and general surgical waste. This is a surgical procedure performed on the body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device is a "powered suction pump/ aspirator" that generates negative pressure for removal of tissue. This describes a surgical tool, not a device used to analyze biological samples.
- Lack of IVD Characteristics: 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 information for diagnosis, monitoring, or screening of diseases or conditions.
Therefore, the HK Liposuction Aspiration Pump is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The HK Liposuction Aspiration Pump is for aesthetic body contouring.
Product codes
QPB, MUU
Device Description
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.
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)
K980392, K981215, K895761, K832274
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services - USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The word "FDA" is in a larger, bolder font, while "U.S. FOOD & DRUG" is in a slightly smaller font, and "ADMINISTRATION" is in an even smaller font below.
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
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal is circular and contains the department's name around the perimeter. Inside the circle is a stylized image of an eagle with three lines above it, representing the department's mission to promote health and well-being.
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.
2
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
3
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
OR
Over-The-Counter Use
Miriam C. Provost
n of General, Restorative and Neurological Devic
510(k) Number K032802
4
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"
-
- Submitter Information:
HK Surgical, Inc. 2620 Temple Heights Dr. Oceanside, CA 92056 Ph: 800-909-0060 Fax: 949-369-9797
- Submitter Information:
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.
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- Intended Use: Aesthetic Body Contouring
- Signature of Applicant: Sally M. Bowdon
Sally M. Bowdon, General Manager