(111 days)
General surgical fluid irrigation and infiltration.
The Psi-Tec Syringe Infusion Pump and accessories indications for use are for General Fluid Irrigation/Infiltration.
The principles of operation and technology incorporated in the Psi-Tec Svringe Infusion Pump and accessories are to provide controlled fluid delivery by utilizing a disposable, pneumatically driven syringe cartridge attached to tubing, that can propel and monitor fluid volumes delivered into a surgical site by the system.
This document is a 510(k) summary for the Byron Medical Psi-Tec Syringe Infusion Pump. It does not contain information about acceptance criteria or a study proving the device meets said criteria.
Therefore, I cannot provide the requested information. The document focuses on establishing substantial equivalence to previously cleared devices for the purpose of market clearance, rather than presenting performance study data against specific acceptance criteria.
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JUN 1 6 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
The assigned 510(k) number is: K980738
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:
17 February 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. Irrigating Syringe Classification Name:
21 CFR § 880.6960 (1997)
Piston Syringe 21 CFR § 880.5860 (1997)
Infusion Pump 21 CFR § 880.5725 (1997)
Jet Lavage 21 CFR § 880.5475 (1997)
Syringe Irrigation/Infiltration Pump
Psi-Tec Syringe Infusion Pump
Common/Usual Name:
Proprietary Name:
Indication for Use:
General surgical fluid irrigation and infiltration.
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Byron Medical Confidential - TRADE SECRET
510(k) SUMMARY (cont.)
Device Description: The principles of operation and technology incorporated in the Psi-Tec Svringe Infusion Pump and accessories are to provide controlled fluid delivery by utilizing a disposable, pneumatically driven syringe cartridge attached to tubing, that can propel and monitor fluid volumes delivered into a surgical site by the system.
Substantial Equivalence Claim: The principles of operation and technology incorporated in the Byron Medical Psi-Tec Syringe Infusion Pump and accessories are similar to other irrigation devices, with the function to deliver fluid to a surgical site, which the FDA has founded to be substantially equivalent to pre-amendment devices as outlined below.
Product: Ackrad Fluid Connecting Set Manufacturer: Ackrad Laboratories, Inc. 510(k) Number: K820937 Substantial Equivalence Date: 26 April 1982 Substantial Equivalence Letter is presented in Exhibit N.
Product: Big Bag 3000 Pressure Infusor Manufacturer: Byron Medical, Inc. 510(k) Number: K973133 Substantial Equivalence Date: 12 September 1997 Substantial Equivalence Letter is presented as Exhibit O.
Product: Nezhat-Dorsey Hydro-Dissection Universal Bag Squeezer Manufacturer: Davol, Inc. 510(k) Number: K953574 Substantial Equivalence Date: 29 September 1995 Substantial Equivalence Letter is presented as Exhibit P.
-end of summary-
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized depiction of an eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 6 1998
Mr. Steve Bollinger ·V.P. Research and Development Byron Medical 3280 East Hemisphere Loop, Suite 100 Tucson, Arizona 85706
Re: K980738 Psi-Tec Syringe Pump Trade Name: Regulatory Class: II Product Code: FRN March 25, 1998 Dated: Received: March 31, 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 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). 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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 (FD ) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
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Page 2 - Mr. Bollinger
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.
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) 594-4692. 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" (21CFR 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.qov/cdrh/dsma/dsmamain.html".
:
:
Sincerely yours,
Timothy A. Ulatowski
hy A. Ulatowski Timot Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Elling Station Come Comer
Enclosure ... ....
విశ్వవం
లోనూ వైద్యశాల
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510(k) Number (if known): K980738
Device Name: Psi-Tec Syringe Infusion Pump and Accessories Indications for Use:
The Psi-Tec Syringe Infusion Pump and accessories indications for use are for General Fluid Irrigation/Infiltration.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Patricio Crescente
(Division Sign-Off) Division of Dental, Infection Control. and General Hospital Devices
510(k) Number 4980738
Prescription Use (Per 21 CFR 801.109
لقارة المقاومة المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخ
Over-The Counter Use
频
(Optional Format 1-2-96)
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).