(143 days)
The PSI Model 1200 ambulatory infusion pump is a multifunction pump designed to manage a wide variety of intravenous fluid profiles.
The PSI Model 1200 is a small portable ambulatory infusion pump intended for hospital, clinic and home care use. It uses dedicated disposables and related accessories.
I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets those criteria. The text describes a 510(k) summary for the "Model 1200 Ambulatory Infusion Pump" and focuses on establishing its substantial equivalency to existing legally marketed devices. It details the device's description, intended use, and technological characteristics, but it does not include performance metrics, study designs, sample sizes, expert qualifications, or ground truth methodologies that would be needed to answer your request.
Therefore, I cannot provide a response with the requested information based on the input given.
{0}------------------------------------------------
AUG 2 3 1996
APPENDIX F
Image /page/0/Figure/3 description: The image shows a document with the title "Patient Solutions Inc." at the top. Below the title, the text "MODEL 1200" is displayed in a larger font. At the bottom of the document, the text "510(k) Summary" is present.
ZLAI
{1}------------------------------------------------
Image /page/1/Picture/0 description: The image shows a logo for Patient Solutions Inc. The logo features a stylized letter "P" formed by interconnected loops, with the company name "Patient Solutions Inc." printed to the right of the letter. A dotted line extends from the right side of the "P" to the right edge of the image.
13220 Evening Creek Dr. So. Suite #114 San Diego, CA 92128 619-679-3840 FAX 619-679-3844
510(k) SUMMARY
| Submitter's Name: | Patient Solutions Inc. (PSI) |
|---|---|
| Address: | 13220 Evening Creek Dr. So.Suite #114San Diego, California 92128 |
| Phone: | (619) 679-3840 |
| Contact: | Tom Kane |
| Date of Summary: | April 1, 1996 |
| Name of Device: | Model 1200 Ambulatory Infusion Pump |
Legally Marketed Device to Which Substantially Equivalency Is Claimed:
Sabratek 6060 Homerun and Abbott Aim
Description of Device:
The PSI Model 1200 is a small portable ambulatory infusion pump intended for hospital, clinic and home care use. It uses dedicated disposables and related accessories.
Intended Use:
The PSI Model 1200 ambulatory infusion pump is a multifunction pump designed to manage a wide variety of intravenous fluid profiles.
Technological Characteristics
The PSI, Sabratek and Abbott ambulatory infusion pumps all have the same general design and incorporate similar technologies, materials, and components.
The primary function of the PSI Model 1200 is the same as the Sabratek 6060 and Abbott Aim, to administer fluids to a patient. The technological characteristics of the devices are the same and raise no new questions of safety and effectiveness. PSI concludes that the PSI Model 1200 is substantially equivalent to the Sabratek 6060 and Abbott Aim in providing infusion fluid therapy for the same clinical purposes that require the use of an ambulatory infusion pump.
§ 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).