(216 days)
The IMED Ambulatory Infusion System is intended for use in a health care facility as well as home health care setting to pump standard IV fluids, medications, blood and blood products into a patient in a controlled manner.
The IMED Ambulatory Infusion System is comprised of a cassette assembly and the pump. The system uses a rotary peristaltic pumping action which physically pumps fluid to the patient when used in conjunction with the dedicated administration sets. Various confiqurations of the IV administration sets are available. The IMED Ambulatory Infusion System incorporate the following features:
- Battery status Indicator; provides estimated remaining battery run time.
- Ease of Use; provides operator queries, visual and audio alarms.
- Flow Rates; range of 0.1-999 mL/hr
- Free Flow Protection; administration set-based protection.
- Occlusion Pressure; provides multiple detection options.
- Secondary Infusion; provides dual rate sequential piggyback infusions.
- Tamper-resistant Mode; provides the ability to lockout kevpad.
- Volume-To Be-Infused; range of 0.1-9999 mL.
This document describes an "IMED Ambulatory Infusion System" (pump and associated administration sets) and its equivalence to predicate devices, but it does not contain the specific detailed information typically found in a study proving a device meets acceptance criteria.
The provided text focuses on:
- Device Description and Intended Use: What the device is and what it's for.
- Predicate Devices: Identifying existing devices it's claimed to be substantially equivalent to.
- Technological Aspects and Equivalence Claim: Stating that its technology and materials are equivalent and that performance data supports this.
- Biocompatibility: Mentioning compliance with biocompatibility standards for the administration sets.
However, the key elements requested in your prompt (acceptance criteria table, specific study details like sample size, ground truth, expert qualifications, etc.) are not present in this document.
The document states: "The performance data resulting from the comparative functional testing also support the substantial equivalence claim to the predicate device." and "The conclusion drawn from the Performance Data demonstrates that the IMED Ambulatory Infusion Pump and Administration Sets are equivalent to legally marketed devices and that they perform as well as or better than the predicate devices."
This indicates that such a study was conducted, but the details of that study are not provided in this summary document.
Therefore, I cannot fulfill your request for the specific details of the acceptance criteria and the study that proves the device meets them based on the provided text. The requested information like sample size, ground truth establishment, expert qualifications, etc., is simply not included in this "Safety and Effectiveness Summary."
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IMED Corporation
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Telex 00005-3989 1619
249061 IMED UR
FAX (619) 693-9434
Image /page/0/Picture/5 description: The image shows a combination of a symbol and a series of numbers. On the left side of the image, there is a symbol that looks like a grid with some additional markings. To the right of the symbol, there is a sequence of numbers and a letter, which reads 'K953896'.
Image /page/0/Picture/6 description: The image shows the word "imed" in a bold, sans-serif font. The letters are all connected and in black. The letters are all lowercase.
MAR 20 996
SAFETY AND EFFECTIVENESS SUMMARY
(Page one)
1.0 SUBMITTER INFORMATION
IMED Corporation 9775 Businesspark Ave. San Diego, CA 92131-1699
Contact Person: Ahmad Sajadi, Manager, Regulatory Affairs
2.0 DEVICE NAME
| Trade Name: | The IMED Ambulatory Infusion Pump and AdministrationSets |
|---|---|
| Common Names: | Infusion PumpIntravascular Administration Sets |
| Classification Names: | Infusion Pumps (21 CFR 880.5725),Class IIIV Administration Sets (21 CFR 880.5440),Class II |
3.0 PREDICATE DEVICE
The IMED Ambulatory Infusion Pump is substantially equivalent to the CADD series of ambulatory infusion pumps (CADD-PCA®, CADD-TPN™, and CADD-PLUS®). These devices are currently being marketed by Pharmacia Deltec (St. Paul, MN). Some features of the IMED Ambulatory Infusion Pump are equivalent to the Gemini PC-2TX Infusion Pump/Controller. The IMED Ambulatory Administration Sets are substantially equivalent to the Gemini series of IV Administration Sets. The Gemini devices have been reviewed by FDA and are currently being marketed by IMED Corporation (San Diego, CA).
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SAFETY AND EFFECTIVENESS SUMMARY (Page two)
4.0 DESCRIPTION OF THE SUBJECT DEVICE
The IMED Ambulatory Infusion System is comprised of a cassette assembly and the pump. The system uses a rotary peristaltic pumping action which physically pumps fluid to the patient when used in conjunction with the dedicated administration sets. Various confiqurations of the IV administration sets are available. The IMED Ambulatory Infusion System incorporate the following features:
- Battery status Indicator; provides estimated remaining battery run time. 18
- Ease of Use; provides operator queries, visual and audio alarms. 育
- 食 Flow Rates; range of 0.1-999 mL/hr
- 费 Free Flow Protection; administration set-based protection.
- ★ Occlusion Pressure; provides multiple detection options.
- 食 Secondary Infusion; provides dual rate sequential piggyback infusions.
- 食 Tamper-resistant Mode; provides the ability to lockout kevpad.
- ★ Volume-To Be-Infused; range of 0.1-9999 mL.
5.0 INTENDED USE OF THE SUBJECT DEVICE
The IMED Ambulatory Infusion System is intended for use in a health care facility as well as home health care setting to pump standard IV fluids, medications, blood and blood products into a patient in a controlled manner. The system is electrically powered, with back up battery power available, and uses rotary peristaltic pumping action to infuse fluids. The IMED Ambulatory Infusion System is capable of detecting air-in-line and occlusions.
6.0 TECHNOLOGICAL ASPECTS OF THE SUBJECT DEVICE
The technological aspects of the IMED Ambulatory Infusion Pump and Administration Sets are substantially equivalent to the technological aspects of the CADD series of infusion pumps and IMED Gemini Administration Sets. This is supported by the comparison of the design and component materials of both systems. The performance data resulting from the comparative functional testing also support the substantial equivalence claim to the predicate device. The IMED Ambulatory System complies with the applicable safety and/or performance standards.
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IMED Corporation
Telex FAX (E19) 693-9434 249061 IMED UR Diego, CA 9213 1699 (619) 566-9000
SAFETY AND EFFECTIVENESS SUMMARY
(Page three)
TECHNOLOGICAL ASPECTS (CONT'D)
The IMED Ambulatory Administration Sets are equivalent to the Gemini Administration Sets. The materials are equivalent in that per the device category definition in the Tripartite Biocompatibility Guidance For Medical Devices and ISO 10993; Biological Testing of Medical and Dental Materials and Devices, Part 1, Guidance on Selection of Tests (as modified by FDA effective 1 July 1995), both are "Externally Communicating Devices for Blood Path Indirect and Short-term Contact Duration." Consequently all materials must meet the same testing criteria as outlined in the above referenced documents. Biocompatibility data to support this claim is provided.
The conclusion drawn from the Performance Data demonstrates that the IMED Ambulatory Infusion Pump and Administration Sets are equivalent to legally marketed devices and that they perform as well as or better than the predicate devices.
7.0 CERTIFICATION
I hereby certify that to the best of my knowledge all information contained in this Premarket Notification is truthful and accurate and that no material fact has been omitted.
Ahmad S. Syarif.
Date:
August 15, 1995
Ahmad Sajadi Manager, Regulatory Affairs
659
§ 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).