Powered Suction Pump(s)/Aspirator(s) which use an electrically (AC) driven vacuum pump generating a negative pressure for the removal of fat/adipose, soft tissue, and general surgical waste. The Psi-Tec Aspirator 2 also has the capability to capture the waste air "exhaust" (that creates the negative pressure) in an enclosed container. This now, contained and pressurized air, can then be utilized for driving other devices requiring the use of pressurized air.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device (Psi-Tec Liposuction Aspirator), which means it focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting new clinical study data with acceptance criteria.

Therefore, the provided text does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets them.

Here's why and what kind of information you would typically find in a document that does address your request:

510(k) Notifications: These submissions aim to show that a new device is as safe and effective as another legally marketed device (the predicate device). This is usually done by demonstrating similar technological characteristics and indications for use, often through performance testing that is not a full-blown clinical study with acceptance criteria as you've described.
Premarket Approval (PMA) Applications (or De Novo submissions for novel devices): These types of FDA submissions would typically include detailed clinical study data, acceptance criteria, and comprehensive reports proving the device's safety and effectiveness.

Based only on the provided text, I can infer the following, but cannot provide the detailed information you requested:

Device Name: Psi-Tec Liposuction Aspirator
Indications for Use: Aesthetic Body Contouring (stated on page 3 and 5)
Predicate Device: Psi-Tec Aspirator(s) (K880392, Substantial Equivalence Date: 05 March 1998)
Nature of the Submission: 510(k) summary, aiming to demonstrate substantial equivalence, not to present novel clinical trial data.

To answer your specific questions, I would need a different type of document, such as a summary of a clinical trial report or a performance data section from a PMA application.

Summary

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June 8, 2021

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

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

Re: K981215

Trade/Device Name: Psi-Tec Liposuction Aspirator Regulation Number: 21 CFR 878.5040 Regulation Name: Suction lipoplasty system Regulatory Class: Class II Product Code: OPB

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 July 1, 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/2 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" around the perimeter. Inside the circle is a stylized symbol resembling a caduceus, with three curved lines representing snakes or streams.

JUL - 1 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Steve Bollinger ·Vice President. Research and Development Byron Medical 3280 East Hemisphere Loop Suite 100 Tucson, Arizona 85708

Re: K981215 Trade Name: PSI-Tec Liposuction Aspirator Regulatory Class: II Product Code: MUU Dated: April 1, 1998 Received: April 2, 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.

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Page2 - Mr. Steve Bollinger

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.

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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K981215 510(k) Number (if known): __

Device Name: The PSI-TEC Liposuction Aspirator(s)

Indications for Use:

..............................................................................................................................................................................

he PSI-TEC Liposuction Aspirator(s) indications for use is for esthetic body contouring.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEÈDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

pcaillef

(Division Sign-Off) Division of General Restorative Devices 510(k) Numbe 981215

Prescription Use
X
(Per 21 CFR 801.109

Over-The Counter Use _

(Optional Format 1-2-96)

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JUL - 1 1998

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

1981215

The assigned 510(k) number is:

Submitted by:

Steve Bollinger V.P. Research and Development Byron Medical, Inc. 3280 East Hemisphere Loop Tucson, AZ 85706

Telephone #: (520) 573-0857 Facsimile #: (520) 746-1757

Date Prepared:

01 April, 1998

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

Classification Name:

Suction Lipoplasty System Class II 21 CFR § 878.5040 (1998)

Aspirator, Apparatus, Suction, Operating Class II Room, Wall Vacuum Powered 21 CFR § 880.6740 (1997)

Aspirator, Apparatus, Suction, Ward Use. Class II Portable, AC -Powered 21 CFR § 878.4780 (1997)

Powered Suction Pump

Psi-Tec Liposuction Aspirator

Common/Usual Name:

Proprietary Name:

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Byron Medical Confidential - TRADE SECRET

510(k) SUMMARY (cont.)

Indication for Use:

Device Description:

Aesthetic Body Contouring.

Substantial Equivalence Claim:

The PSI-TEC Liposuction Aspirator(s) are IDENTICAL to the following legally-marketed devices ("Predicate Devices") in terms of safety, effectiveness, with a change of intended use:

Product: Psi-Tec Aspirator(s) Manufacturer: Byron Medical 3280 East Hemisphere Loop Tucson, AZ 85706 510(k) Number: K880392 Substantial Equivalence Date: 05 March 1998

-end of summarv-

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.