(31 days)
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.
This document is a 510(k) summary for a medical device called the "Psi-Tec Aspirator," submitted by Byron Medical, Inc. The purpose of a 510(k) summary is to demonstrate substantial equivalence to legally marketed predicate devices, not to provide detailed performance study results against specific acceptance criteria.
Therefore, the provided text does not contain the information requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or direct performance results.
The document primarily focuses on:
- Identification of the device: Psi-Tec Aspirator
- Manufacturer information: Byron Medical, Inc.
- Classification: Aspirator, Apparatus, Suction, Ward Use and Aspirator, Apparatus, Suction, Operating Room, Wall Vacuum Powered (Class II)
- Intended Use/Indications for Use: General surgical fluids, exudate, soft tissue, and general tissue removal from surgical sites.
- Device Description: Electrically (AC) driven vacuum pump generating negative pressure for evacuating surgical waste, with the Psi-Tec Aspirator 2 also capturing and pressurizing exhaust air for other devices.
- Substantial Equivalence Claim: Lists several predicate devices (General Aspirator by Kolster Methods, Grams Aspirator by Grams Medical, Aspirator and Aspirator II by Wells Johnson Company, General Aspirator by Mentor Corporation) to which the Psi-Tec Aspirator is claimed to be substantially equivalent.
- Approval Letter: A letter from the FDA indicating that the device is substantially equivalent and can be marketed.
In summary, none of the requested information regarding acceptance criteria or the specific study details (sample size, ground truth, experts, adjudication, MRMC, standalone performance) is present in the provided text. The 510(k) process for this type of device typically relies on demonstrating equivalence to predicate devices, often through performance testing that shows similar functional characteristics, rather than establishing de novo acceptance criteria and conducting extensive clinical efficacy trials with detailed statistical reporting as would be expected for a novel device or a device requiring de novo authorization.
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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 #: (520) 573-0857 Facsimile #: (520) 746-1757
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 (301) 594-4595. Additionally, for questions on the promotion and advertising of your devices, 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,
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)
!
§ 878.4780 Powered suction pump.
(a)
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.(b)
Classification. Class II.