PSI-TEC ASPIRATOR

K980392 · Byron Medical · BTA · Mar 5, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K980392
• Device Name: PSI-TEC ASPIRATOR
• Applicant: Byron Medical
• Product Code: BTA · General, Plastic Surgery
• Decision Date: Mar 5, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4780
• Device Class: Class 2

Intended Use

The PSI-TEC Aspirator(s) indications for use are general surgical fluids, exudate, soft tissue, and general tissue removal from surgical sites.

Device Story

Psi-Tec Aspirator is an AC-powered vacuum pump device used in surgical settings to generate negative pressure for the evacuation of surgical waste, including fluids, exudate, and soft tissue. The device features a secondary capability to capture exhaust air from the vacuum process in an enclosed container; this pressurized air can then be utilized to power other auxiliary surgical devices. Operated by clinical staff in surgical environments, the device facilitates site clearance, potentially improving surgical visibility and procedural efficiency.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Electrically (AC) powered vacuum pump; generates negative pressure for suction; includes secondary pressurized air capture system for powering auxiliary devices. Class II device.

Indications for Use

Indicated for removal of general surgical fluids, exudate, soft tissue, and general tissue from surgical sites in patients undergoing surgery.

Regulatory Classification

Identification

A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.

Predicate Devices

• General Aspirator (Kolster Methods, K895761)
• Grams Aspirator (Grams Medical)
• Aspirator and Aspirator II (Wells Johnson Company)
• General Aspirator (Mentor Corporation)

Submission Summary (Full Text)

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#### K 980392 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:

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

> Telephone #: [phone] Facsimile #: [phone]

Date Prepared:

26 January, 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:

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

Room, Wall Vacuum Powered 21 CFR & 880.6740 (1997)

Aspirator, Apparatus, Suction, Operating Class II

Common/Usual Name:

Proprietary Name:

Aspirator, General

Psi-Tec Aspirator

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### Byron Medical Confidential - TRADE SECRET

### 510(k) SUMMARY (cont.)

Indication for Use:

Device Description:

General surgical fluids, exudate, soft tissue, and general tissue removal from surgical sites.

General aspirator(s), which use an electrically (AC) driven vacuum pump generating a negative pressure for evacuating 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.

#### Substantial Equivalence Claim:

The PSI-TEC Aspirator(s) are substantially equivalent to the following legally-marketed devices ("Predicate Devices") in terms of safety, effectiveness, and intended use:

Product: General Aspirator Manufacturer: Kolster Methods 510(k) Number: K895761 Substantial Equivalence Date: Unknown

Product: Manufacturer:

#### Grams Aspirator

Grams Medical 2443 Norse Ave, Costa Mesa, CA92627 510(k) Number: Unknown Substantial Equivalence Date: Unknown

Product: Manufacturer:

510(k) Number:

### Aspirator and Aspirator II

Wells Johnson Company 8075 E. Research Court, Suite 101 Tucson, AZ 85710 Unknown

Substantial Equivalence Date: Unknown

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# Byron Medical Confidential - TRADE SECRET

# 510(k) SUMMARY (cont.)

# Substantial Equivalence Claim (CONT.):

510(k) Number:

Product: Manufacturer:

General Aspirator Mentor Corporation 5425 Hollister Ave. Santa Barbara, CA 931111 Unknown

Substantial Equivalence Date: Unknown

-end of summary-

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

MAR - 5 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Steve Bollinger Vice President, Research and Development Byron Medical, Incorporated 3280 East Hemisphere Loop Tucson, Arizona 85706

Re : K980392 PSI-TEC Aspirators Trade Name: Requlatory Class: II Product Code: BTA and JCX Dated: January 26, 1998 Received: February 2, 1998

Dear Mr. Bollinger:

We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined these devices are substantially equivalent (for the indications for use stated in the enclosures) 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 devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major requlations affecting your devices can be found in the Code of Federal Requlations, 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 (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your devices 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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Page 2 - Mr. Bollinger

This letter will allow you to begin marketing your devices as described in your 510 k) premarket notification. The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in a classification for your devices and thus, permits your devices to proceed to the market.

If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your devices, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

C. Colin M. Witten, Ph. D., M.

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

Enclosures

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CONFIDENTIAL

510(k) Number (if known): _ _ k 980392

Device Name: The PSI-TEC Aspirator(s)

Indications for Use:

The PSI-TEC Aspirator(s) indications for use are general surgical fluids, exudate, soft tissue, and general tissue removal from surgical sites.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

General Res 510(k) Numbe

Prescription Use
(Per 21 CFR 801.109

Over-The Counter Use _ · ·

(Optional Format 1-2-96)

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