STRATO/INFUSAID PERIPORT INFUSION SET 41770,41771

K960391 · Strato/Infusaid, Inc. · FPA · Jul 3, 1996 · General Hospital

Device Facts

• Record ID: K960391
• Device Name: STRATO/INFUSAID PERIPORT INFUSION SET 41770,41771
• Applicant: Strato/Infusaid, Inc.
• Product Code: FPA · General Hospital
• Decision Date: Jul 3, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Strato/Infusaid PeriPort Infusion Set is indicated for the infusion of drugs and fluids into the Strato/Infusaid PeriPort Peripheral Access Device.

Device Story

Device provides straight needle access to Strato/Infusaid PeriPort System for infusion of drugs/fluids into vascular access system. Used in clinical settings by healthcare professionals. Device facilitates delivery of therapeutic agents to patient via implanted peripheral access port.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Infusion set for vascular access; features straight needle and specific wing design. Mechanical device; no energy source or software.

Indications for Use

Indicated for patients requiring infusion of drugs and fluids into the Strato/Infusaid PeriPort Peripheral Access Device.

Regulatory Classification

Identification

An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.

Special Controls

*Classification.* Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.

Predicate Devices

• Strato/Infusaid LifePort Infusion Set (Model No. LPS 3004, LPS 3005, LPS 3006, LPS 3007, LPS 3008, LPS 3009, LPS 3017, LPS 3023, LPS 3025)
• Strato/Infusaid Infuse-a-Port Winged Infusion Set (Model Nos. 41129-1, 41129-2, 41129-3, 41129-4, 41129-5)

Submission Summary (Full Text)

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PREMARKET NOTIFICATION

# VII. 510(k) Summary of Safety and Effectiveness

K960391

## General Information

Manufacturer: Strato/Infusaid Inc.
1400 Providence Highway
Norwood, MA 02167
JUL - 3 1996

Contact Person: Craig M. Audet
Director, Worldwide Regulatory Affairs
Telephone #[phone]

Date Prepared: January 25, 1996

## Device Name

Proprietary Name: Strato/Infusaid PeriPort Infusion Set
Model Nos. 41770, 41771

Classification Name: Infusion Set, Administration, Intravascular

## Predicate Devices

Strato/Infusaid LifePort Infusion Set
Model No. LPS 3004, LPS 3005, LPS 3006, LPS 3007, LPS 3008, LPS 3009, LPS 3017, LPS 3023, LPS 3025

Strato/Infusaid Infuse-a-Port Winged Infusion Set
Model Nos. 41129-1, 41129-2, 41129-3, 41129-4, 41129-5

## Product Description

The Strato/Infusaid PeriPort Infusion Set is a device designed to provide straight needle access to the Strato/Infusaid PeriPort System for the infusion of drugs and fluids into the vascular access system.

## Indications for Use

The Strato/Infusaid PeriPort Infusion Set is indicated for the infusion of drugs and fluids into the Strato/Infusaid PeriPort Peripheral Access Device.

PeriPort Infusion Set
STRATO/INFUSAID
RA001
Page 45

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PREMARKET NOTIFICATION

## Substantial Equivalence

The subject Strato/Infusaid PeriPort Infusion Set is substantially equivalent to the commercially available Strato/Infusaid LifePort Infusion Set and the Strato/Infusaid Infuse-a-Port Winged Infusion Set.

The Strato/Infusaid PeriPort Infusion Set has the same indications, contraindications and design principles as the commercially available (substantially equivalent device), the Strato/Infusaid LifePort Infusion Set. The difference between the infusion sets is the wing design and straight vs. 90° needle.

The Strato/Infusaid PeriPort Infusion Set has the same indications, contraindications and design principles as the commercially available (substantially equivalent device), the Strato/Infusaid Infuse-a-Port Winged Infusion Set. The difference between the infusion sets is the straight vs. 90° needle

PeriPort Infusion Set
STRATO/INFUSAID
RA001
Page 46