The principles of operation and technology incorporated in the Cannulae and Needles are equivalent to fluid, soft tissue, and exudate removal and infusion instruments generally used for aspiration and infusion, utilizing a hollow Stainless Steal tube with multiple tip, handle and attachment connectors that are in a reusable and disposable configuration.

AI/ML Overview

I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets such criteria. The document is a 510(k) premarket notification for Lipoplasty/Liposuction Aspiration and Tumescent Infusion Cannulae and Needles, indicating that the device is substantially equivalent to a previously marketed device. It does not include performance data, study designs, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and a study's results based on the provided text.

Summary

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June 8, 2021

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services seal on the left and the FDA acronym and name on the right. The FDA acronym is in blue, and the name "U.S. Food & Drug Administration" is in a slightly lighter blue.

Byron Medical Steve Bollinger Vice President Research And Development 3280 E. Hemisphere Loop Suite 100 Tucson, Arizona 85706

Re: K981172

Trade/Device Name: Lipoplasty/ Liposuction Aspiration And Tumescent Infusion Cannulae And Needles Regulation Number: 21 CFR 878.5040 Regulation Name: Suction lipoplasty system Regulatory Class: Class II Product Code: QPB

Dear Steve Bollinger:

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 June 30, 1998. 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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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are rendered in black and white. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 3 0 1998

Mr. Steve Bollinger · Vice President Research and Development Byron Medical, Inc. 3280 East Hemisphere Loop, Suite 100 Tucson, Arizona 85706

Re: K981172

Trade Name: Lipoplasty/Liposuction Aspration and Tumescent Infusion Regulatory Class: II Product Code: MUU Dated: March 31, 1998 Received: April 1, 1998

Dear Mr. Bollinger:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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.

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Page 2 - Mr. Steve Bollinger

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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11981172 510(k) Number (if known):

Device Name:

Lipoplasty / Liposuction Aspiration and Tumescent Infusion Cannulae and Needles

Indications for Use:

The Aspiration and Infusion Cannulae and Needles indications for use are 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)

Padoel

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K981172

Prescription Use X
(Per 21 CFR 801.109

Over-The Counter Use _

(Optional Format 1-2-96)

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Byron Medical Confidential - TRADE SECRET

510(k) SUMMARY

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

The assigned 510(k) number is:	K981172
Submitted by:	Steve BollingerV.P. Research and DevelopmentByron Medical, Inc.3280 East Hemisphere LoopTucson, AZ 85706
	Telephone #: (520) 573-0857Facsimile #: (520) 746-1757
Date Prepared:	31 March 1998

Establishment Registration Number: Byron Medical is located at 3280 East Hemisphere
Loop, Tucson, AZ 85706. We are registered with th
Food and Drug Administration as Establishment
Number 2025576.

Suction Lipoplasty System	21 CFR § 878..5040 (05 Jan 1998)
	Manual Surgical Instruments for Gen. Use21 CFR § 878.4800 (1994)
Common/Usual Name:	Aspiration and Infiltration Cannula/Needles
Proprietary Name:	Lipoplasty/Liposuction Aspiration andTumescent Infiltration Cannulae/Needles(Cannulae and Needles)
Indication for Use:	Aesthetic Body Contouring

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Byron Medical Confidential - TRADE SECRET

510(k) SUMMARY (cont.)

Device Description: The principles of operation and technology incorporated in the Cannulae and Needles are equivalent to fluid, soft tissue, and exudate removal and infusion instruments generally used for aspiration and infusion, utilizing a hollow Stainless Steal tube with multiple tip, handle and attachment connectors that are in a reusable and disposable configuration. The principles of operation and technology Substantial Equivalence Claim: incorporated in the Cannulae and Needles are virtually exactly the same as other Aspiration and Infiltration cannulae and needle devices which are classified as Class I devices, vet with the function or intended use for aesthetic body contouring by means of aspiration and infiltration which the FDA has founded to be substantially equivalent to these devices with an additional intended use of aesthetic body contouring in accordance with Section 878.5040 Suction Lipoplasty System. In terms of safety, effectiveness, and intended use. Byron Medical's Cannulae and Needles are substantially equivalent to the following commercially distributed devices: Product: Suction Cannulae and Needles

Manufacturer: Byron Medical, Inc. 510(k) Number: K861878 Substantial Equivalence Date: 01 July 1986 Substantial Equivalence Letter is presented in Exhibit M.

Infusion Cannulae and Needles Product: Manufacturer: Byron Medical, Inc. 510(k) Number: Class | Exempt Substantial Equivalence Date: N/A

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.