(40 days)
Not Found
No
The device description explicitly states it is a "mechanical device that requires no external power" and there is no mention of AI, ML, or any computational processing.
Yes
The device is described as delivering fixed boluses of medication upon demand by the patient or healthcare provider for various routes of administration, which directly relates to treating or alleviating symptoms.
No
Explanation: The device is described as an accessory for delivering fixed boluses of medication. Its purpose is to administer treatment, not to diagnose a condition or disease.
No
The device description explicitly states it consists of plastic housing, medication reservoir, bolus button activator, and wrist bands, and is a mechanical device. These are hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This includes tests for diagnosis, monitoring, screening, and prognosis.
- Device Function: The Paragon Bolus Accessory Set is a mechanical device designed to deliver medication to a patient. It is used for administering substances into the body, not for analyzing substances from the body.
- Intended Use: The intended use clearly states "to deliver fixed boluses of medication upon demand by the patient or healthcare provider." This is a therapeutic function, not a diagnostic one.
Therefore, the function and intended use of the Paragon Bolus Accessory Set fall outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Bolus Accessory is intended to deliver fixed boluses of medication upon demand by the patient or healthcare provider. The routes of administration intravenous, epidural, intramuscular and subcutaneous. The Bolus Accessory is not intended for continuous delivery. The Bolus Accessory is single patient use only. The Bolus Accessory is suitable for use as an ambulatory device and is intended for use in the hospital, home environment or alternative care sites. No testing has been conducted to determine the efficacy of Bolus Accessory for the delivery of blood, blood products, lipids or fat emulsions. The Bolus Accessory is not intended for the delivery of blood, blood products, lipids or fat emulsions.
Product codes (comma separated list FDA assigned to the subject device)
80 FPA
Device Description
The Bolus Accessory may connect to any Paragon administration set to deliver fixed boluses of medication upon demand by the patient or healthcare provider. The Bolus Accessory consists of plastic housing, medication reservoir, bolus button activator and wrist bands. The bolus button allows patient controlled administration of medication as needed. The Bolus Accessory is available in 0.5 ml bolus volume. All fluid path components of the Bolus Accessory are in conformance with ISO 10993 Part 1. The Bolus Accessory is a mechanical device that requires no external power.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
patient or healthcare provider / hospital, home environment or alternative care sites.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Data: Testing occurred at standard operating conditions. All models performed within the specified accuracy when tested at nominal conditions. Standard Operating Conditions: Bolus Volume: 0.5 ml; Refill Time: variable; Priming/Residual Volume:
§ 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
Image /page/0/Picture/0 description: The image shows the date 2/9/99 at the top left. Below the date is the I-FLOW logo, which is a rounded rectangle with the words "I-FLOW" inside. Underneath the logo, the words "I-FLOW CORPORATION" are printed in a smaller, sans-serif font. The logo has a registered trademark symbol.
20202 Windrow Rd. Lake Forest, CA 92630 (800) 448-3569 (714) 206-2700 Fax (714) 206-2600
SUMMARY OF SAFETY AND EFFECTIVENESS
December 30, 1998
Trade Name: Paragon Bolus Accessory Set
Common Name: Bolus Accessory
Classification Name: Set, Administration, Intravascular
All questions and/or comments concerning this document should be made to:
Robert J. Bard, Esq., R.A.C. Vice President of Regulatory and Legal Affairs
I-Flow Corporation 20202 Windrow Drive Lake Forest, CA 92630
Telephone: 949.206.2700 Fax: 949.206.2600
1
GENERAL INFORMATION 1.0
Purpose of Submission 1.1
- This submission is intended to notify the Federal Food and Drug 1.1.1 Administration that I-Flow Corporation intends to market an accessory device for the Paragon Infusion System (K923875), originally identified as the SideKick 50 Plus and SideKick 100 Plus. This new accessory will be known as the Paragon Bolus Accessory Set, hereafter identified as the Bolus Accessory. No change will be made to the existing Paragon pump or administration sets.
- Trade Name: Paragon Bolus Accessory Set 1.1.2
- Common Name: Bolus Accessory Set 1.1.3
- Classification Name: Set. Administration, Intravascular 1.1.4
- Product Code: 80 FPA 1.1.5
- Device Classification: Class II, 880.5440 1.1.6
- Classification Panel: General Hospital and Personal Use Device 1.1.7
Statement of Equivalence 1.2
- The Bolus Accessory is substantially equivalent to Patient Control Module 1.2.1 (K884505) marketed by Baxter Healthcare Corporation and the I-Flow Bolus Dispenser (K935811).
2.0 PHYSICAL SPECIFICATIONS AND DESCRIPTIONS
Description of the Bolus Accessory 2.1
Wherever the Paragon pump and administration set are mentioned, they may be replaced by any constant 6 psi pressure system.
- The Bolus Accessory may connect to any Paragon administration set to 2.1.1 deliver fixed boluses of medication upon demand by the patient or healthcare provider.
- 2.1.2 The Bolus Accessory consists of plastic housing, medication reservoir, bolus button activator and wrist bands.
- The bolus button allows patient controlled administration of medication as 2.1.3 needed.
Product Configuration 2.2
- The Bolus Accessory is available in 0.5 ml bolus volume. 2.2.1
2.3 Components and Materials
- All fluid path components of the Bolus Accessory are in conformance with 2.3.1 ISO 10993 Part 1.
2.4 Power Requirements
- 2.4.1 The Bolus Accessory is a mechanical device that requires no external power.
2
:
OPERATIONAL SPECIFICATIONS AND DESCRIPTIONS 3.0
Standard Operating Conditions: 3.1
| Bolus Volume: | 0.5 ml |
|---|---|
| Refill Time: | variable |
| Priming/Residual Volume: |