(406 days)
The Model P7000 is intended to be used for intravenous administration of drugs, blood, and blood products. This device is also indicated for epidural applications. The final DFU will contain all necessary precautions and recommendations for safe epidural application. The specific purpose for the P7000 is to offer users a fully featured variable pressure syringe pump suitable for critical care applications.
The P7000 is a variable pressure syringe pump suitable for critical care applications.< This instrument functions with a range of standard, single use, disposable. Iuer-lock svringes of various types and accepts syringe sizes of 5, 10, 20, 30, 50, and 100ml. The P7000 is a microprocessor controlled device designed to use standard, single use, disposable extension sets with luer-lock connectors, of type designed for use on the P7000 syringe pump. The pump can be used with either dedicated or nondedicated syringe extension sets. The dedicated sets include a pressure sensing disc which can be used for additional features. Or, non-dedicated sets (standard sets) can be utilized for standard syringe pump needs.
The provided document is a 510(k) Premarket Notification for the ALARIS Medical Systems Model P7000 Variable Pressure Syringe Pump. This document is a regulatory submission for a medical device and does not contain the type of study data and acceptance criteria information typically associated with AI/ML-based diagnostic devices. It primarily focuses on demonstrating substantial equivalence to a predicate device.
Therefore, I cannot extract the requested information regarding acceptance criteria and study details for device performance as it is not present in this document. The document describes the device, its intended use, and states its technological characteristics are similar to a predicate device (Baxter Corporation Auto Syringe AS40A Infusion Pump, K940147). This equivalence is the basis for its approval, not a separate performance study with specific metrics.
{0}------------------------------------------------
3
Model P7000 Variable Pressure Syringe Pump 510(k) Premarket Notification
SUMMARY OF SAFETY AND EFFECTIVENESS
- ALARIS Medical Systems, Inc. SUBMITTER'S NAME: 1. 10221 Wateridge Circle San Diego, CA 92121-2733 (619) 458-7563 (619) 458-6223 FAX CONTACT PERSON: Renée L. Fluet Sr. Regulatory Affairs Specialist November 17, 1997 DATE PREPARED: Variable Pressure Syringe 2. Proprietary Name: DEVICE NAME: Pump Syringe Pump Common Name: Classification Name: Infusion Pump Baxter Corporation, Auto Syringe AS40A Infusion PREDICATE DEVICE: 3. Pump, K940147 DEVICE DESCRIPTION: The P7000 is a variable pressure syringe pump 4. suitable for critical care applications.< This instrument functions with a range of standard, single use, disposable. Iuer-lock svringes of various types and accepts syringe sizes of 5, 10, 20, 30, 50, and 100ml. The P7000 is a microprocessor controlled device designed to use standard, single use, disposable extension sets with luer-lock connectors, of type designed for use on the P7000 syringe pump. The pump can be used with either dedicated or nondedicated syringe extension sets. The dedicated sets include a pressure sensing disc which can be used for additional features. Or, non-dedicated sets (standard sets) can be utilized for standard syringe pump needs. The P7000 Syringe Pump is intended to be used ട. INTENDED USE: for intravenous and epidural administration of drugs and fluids.
3
{1}------------------------------------------------
SUMMARY OF SAFETY AND EFFECTIVENESS (continued)
6. TECHNOLOGICAL CHARACTERISTICS:
The P7000 is similar to the Baxter Corporation Auto Syringe AS40A Infusion Pump, K940147. Both devices have the same intended use, general design and incorporate similar technologies, software, materials, electronics, energy sources, and mechanical components.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines forming the snake and staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus. The seal is black and white and has a simple, clean design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 29 1998
Ms. Renee L. Fluet Senior Regulatory Affairs Specialist ALARIS™ Medical Systems, Incorporated Corporate Office 10221 Wateridge Circle San Diego, California 92121-2733
Re : K974332 Variable Pressure Syringe Pump Trade Name: Requlatory Class: II Product Code: FRN October 30, 1998 Dated: November 2, 1998 Received:
Dear Ms. Fluet:
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 reqistration, 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 requlations 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 requlation (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 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
{3}------------------------------------------------
Page 2 - Ms. Fluet
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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 requlation (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 qeneral 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/dsma/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
thy A. Ulatow Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Model P7000 Variable Pressure Syringe Pump 510(k) Premarket Notification
INDICATIONS FOR USE
Page 1 of 1
510(k) Number (if known):
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: MODEL P7000 VARIABLE PRESSURE SYRINGE PUMP
The Model P7000 is intended to be used for intravenous administration of drugs, blood, and blood products. This device is also indicated for epidural applications. The final DFU will contain all necessary precautions and recommendations for safe epidural application.
ALARIS Medical Systems' policy is to not indicate specific drugs and/or fluids except in cases when a device is designed specifically or solely for a particular drug or fluid. Consistent with this policy, we would contraindicate drugs and/or fluids as appropriate for the P7000. No such contraindications have been identified.
The specific purpose for the P7000 is to offer users a fully featured variable pressure syringe pump suitable for critical care applications.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
Use
(Per 21 CFR 801.109)
OR Over-The-Counter
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number
§ 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).