MODEL 1200 ABMULATORY INFUSION PUMP

K961263 · Patient Solutions, Inc. · FRN · Aug 23, 1996 · General Hospital

Device Facts

• Record ID: K961263
• Device Name: MODEL 1200 ABMULATORY INFUSION PUMP
• Applicant: Patient Solutions, Inc.
• Product Code: FRN · General Hospital
• Decision Date: Aug 23, 1996
• Decision: ST
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PSI Model 1200 ambulatory infusion pump is a multifunction pump designed to manage a wide variety of intravenous fluid profiles.

Device Story

Model 1200 ambulatory infusion pump; portable device for hospital, clinic, or home care use. Administers intravenous fluids via dedicated disposables and accessories. Operated by clinicians or patients to manage various fluid profiles. Provides controlled fluid delivery; supports clinical decision-making by ensuring accurate infusion therapy. Benefits patient through mobility and consistent fluid management.

Technological Characteristics

Portable ambulatory infusion pump; uses dedicated disposables and accessories. Design, materials, and components similar to predicate devices.

Indications for Use

Indicated for patients requiring intravenous fluid therapy managed by an ambulatory infusion pump in hospital, clinic, or home care settings.

Regulatory Classification

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.

Predicate Devices

• Sabratek 6060 Homerun
• Abbott Aim

Submission Summary (Full Text)

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AUG 23 1996
K941263

# APPENDIX F

Patient Solutions Inc.

# MODEL 1200

510(k) Summary

261

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13220 Evening Creek Dr. So. Suite #114 San Diego, CA 92128 619-679-3840 FAX [phone]

# 510(k) SUMMARY

Submitter's Name: Patient Solutions Inc.(PSI)

Address: 13220 Evening Creek Dr. So. Suite #114 San Diego, California 92128

Phone: [phone]

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.

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