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

Device 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.

AI/ML Overview

This document is a 510(k) summary for a medical device called the "Strato/Infusaid PeriPort Infusion Set." It focuses on establishing substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study with detailed statistical analysis.

Therefore, many of the requested pieces of information are not applicable or not provided in this type of regulatory submission. This is a common characteristic of 510(k) summaries for Class II devices where a new device is shown to be as safe and effective as a legally marketed predicate device.

Here's a breakdown of the information that can be extracted or inferred, and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

This document does not provide a table of acceptance criteria and reported device performance in the way a clinical study report would. The primary "performance" being demonstrated here is substantial equivalence to existing devices, implying that its performance will be similar.

Acceptance Criteria (Implicit by substantial equivalence):

The device performs its intended function (infusion of drugs and fluids).
The device is as safe and effective as the predicate devices.
The design principles, indications, and contraindications are sufficiently similar to predicate devices.

Reported Device Performance (Implicit by substantial equivalence):

The Strato/Infusaid PeriPort Infusion Set is expected to perform infusion safely and effectively into the Strato/Infusaid PeriPort Peripheral Access Device, similar to how the predicate devices perform their intended functions.
Functional differences are limited to "wing design and straight vs. 90° needle" compared to the LifePort set, and "straight vs. 90° needle" compared to the Infuse-a-Port Winged set. These differences are presented as minor and not impacting fundamental performance or safety.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not Applicable / Not Provided. This document does not describe a clinical study with a "test set" in the context of AI/machine learning or a traditional clinical trial. The basis of the submission is a comparison to predicate devices, not empirical testing data from a new study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not Applicable / Not Provided. No "ground truth" was established by experts for a test set in the context of this 510(k) submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not Applicable / Not Provided. No "adjudication method" was used as there was no test set requiring expert review.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not Applicable. This device is an infusion set, not an AI-powered diagnostic or assistive tool. No MRMC study or AI assistance is relevant here.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not Applicable. As above, this is an infusion set, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not Applicable. No "ground truth" was established in the context of this type of regulatory submission. The "truth" being established is that the device is substantially equivalent to legally marketed predicate devices, which implicitly means they are safe and effective.

8. The sample size for the training set:

Not Applicable / Not Provided. No "training set" is relevant for this device.

9. How the ground truth for the training set was established:

Not Applicable / Not Provided. No "training set" or "ground truth" establishment for training is relevant for this device.

Summary of what the document does provide:

Device Name: Strato/Infusaid PeriPort Infusion Set (Model Nos. 41770, 41771)
Manufacturer: Strato/Infusaid Inc.
Intended Use: "infusion of drugs and fluids into the Strato/Infusaid PeriPort Peripheral Access Device."
Basis for Equivalence: Comparison to predicate devices:
- Strato/Infusaid LifePort Infusion Set (Model Nos. LPS 3004-3009, 3017, 3023, 3025)
- Strato/Infusaid Infuse-a-Port Winged Infusion Set (Model Nos. 41129-1 to 41129-5)
Claim of Equivalence: The subject device has "the same indications, contraindications and design principles" as the predicate devices.
Differences from Predicates (and why they don't impact equivalence):
- Vs. LifePort: "the wing design and straight vs. 90° needle."
- Vs. Infuse-a-Port: "the straight vs. 90° needle." These are presented as non-substantial design variations.

Summary

{0}------------------------------------------------

510(k) Summary of Safety and Effectiveness VII.

K96039|

3 1000

General Information

Manufacturer:	Strato/Infusaid Inc.1400 Providence HighwayNorwood, MA 02167
Contact Person:	Craig M. AudetDirector, Worldwide Regulatory AffairsTelephone #(617) 255-6765
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

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.

RA001

{1}------------------------------------------------

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 priciples 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

Regulation Number and Section

§ 880.5440 Intravascular administration set.

(a)
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.(b)
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.