SOLOPAK SIDEKICK INFUSION PUMP AND ADMINISTATION SET

K962663 · Solopak Medical Products, Inc. · MEB · Oct 4, 1996 · General Hospital

Device Facts

• Record ID: K962663
• Device Name: SOLOPAK SIDEKICK INFUSION PUMP AND ADMINISTATION SET
• Applicant: Solopak Medical Products, Inc.
• Product Code: MEB · General Hospital
• Decision Date: Oct 4, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SoloPak® Sidekick Infusion Pump and Administration Set is intended to be used for the general use infusion of small volumes (50 - 100 ml).

Device Story

Ambulatory infusion pump and single-use administration set; delivers small volumes (50-100 ml) of medication. Reusable pump; sterile, non-pyrogenic single-use administration set. Operation involves mechanical delivery of medication. Used in clinical or home settings for controlled fluid administration. Accuracy within ±15%. Benefits include portable, controlled medication delivery.

Clinical Evidence

Bench testing only. Administration sets tested for delivery accuracy (±15%), sterility (AAMI guidelines to 10^-6 SAL), and pyrogenicity (LAL testing per USP guidelines).

Technological Characteristics

Reusable infusion pump; single-use administration set. Materials identical to legally marketed predicate devices. Sterilization of administration set per AAMI guidelines. LAL testing per USP guidelines.

Indications for Use

Indicated for general infusion of small volumes (50-100 ml) of medication.

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

• I-Flow VIVUS 50 and VIVUS 100 (K915646)

Submission Summary (Full Text)

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Douglas Medical Products
A SoloPak® Company
K962663
OCT - 4 1996

June 10, 1996

To Whom it may concern:

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act and CFR 807.92:

Trade Name - SoloPak® Sidekick Infusion Pump and Administration Set
Common Name - Ambulatory Infusor/Infusion Pump and Infusion Set
Classification Name - Infusion Pump with Administration Set

The SoloPak® Sidekick Infusion Pump and Administration Set is intended to be used for the general use infusion of small volumes (50 - 100 ml). The infusion pump is reusable, however the administration set is intended for single use. The infusion sets have been tested and have been found to accurately deliver medication within ±15%.

The SoloPak® Sidekick Infusion Pump is individually packaged and can be cleaned and reused for multiple infusions. The Administration Set is sterile, non-pyrogenic, and packaged in a tyvek/polyethylene pouch. It is a single use set. The materials used to manufacture the SoloPak Sidekick Infusion Pump and Administration Set are the same as those used in currently legally marketed products with the same intended uses. The indicated use of the SoloPak® Sidekick Infusion Pump and Administration Set are the same as the predicate device named in this submission. The named predicate device in this submission is the I-Flow VIVUS 50 and VIVUS 100 marketed under 510(k) #K915646. The SoloPak® Sidekick Administration Set is sterilized per AAMI guidelines to a 10 _6 sterility assurance level. Each production lot is LAL tested per USP guidelines.

Based on the fact that the SoloPak® Sidekick Infusion Pump and Administration Set utilize the same design, materials, and manufacturing processes as the named predicate device, they are safe and effective when used as intended.

Sincerely,

Ron Haselhorst
Director of RA/QA
Douglas Medical Products Corporation
A SoloPak® Company

1840 Industrial Drive, Suite 200, Libertyville, IL 60048 • Telephone: [phone] • Telefax: 708-949-7388