(156 days)
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No
The document describes a simple infusion set and makes no mention of AI or ML.
No.
The device description and intended use specify that it is for the infusion of drugs and fluids into a peripheral access device, which is a method of drug delivery rather than a direct therapeutic action of the device itself.
No
The device is used for the infusion of drugs and fluids, not for diagnosis.
No
The device description clearly indicates it is a physical infusion set designed for accessing a vascular access system, not a software product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "infusion of drugs and fluids into the Strato/Infusaid PeriPort Peripheral Access Device." This describes a device used for delivering substances into the body, not for testing samples from the body.
- Device Description: The description reinforces this by stating it provides "straight needle access...for the infusion of drugs and fluids into the vascular access system." Again, this is about delivery, not diagnosis.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely for the delivery of substances.
N/A
Intended Use / 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.
Product codes
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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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
0
510(k) Summary of Safety and Effectiveness VII.
K96039|
3 1000
General Information
| Manufacturer: | Strato/Infusaid Inc.
1400 Providence Highway
Norwood, MA 02167 |
|-------------------|---------------------------------------------------------------------------------------|
| Contact Person: | Craig M. Audet
Director, Worldwide Regulatory Affairs
Telephone #(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
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.
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