BOLUS ACCESSORY SET

• K Number: K992072
• Device Name: BOLUS ACCESSORY SET
• Manufacturer: I-FLOW CORP.
• Date Cleared: 1999-09-15 ( 88 days)
• Product Code: FPA
• Regulation Number: 880.5440

Intended Use

The Bolus Accessory Set, in combination with a positive pressure, continuous flow infusion pump, is intended to deliver fixed boluses of medication upon demand by the patient or healthcare provider. Routes of administration include intravenous, epidural, intramuscular, subcutaneous, intra-operative (as the one the same and percutaneous.

Device Description

The Bolus Accessory may connect to any positive pressure, continuous flow rate infusion pump with an 8 to 17 psi pressure source 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.

Predicate Devices

K984638, K884505, K935811

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on mechanical components and fixed bolus delivery, with no mention of AI/ML terms or functionalities.

Therapeutic

Yes.
The device is intended to deliver medication, which is a therapeutic intervention, and it is described as an "accessory" to an "infusion pump," implying a role in patient treatment.

Diagnostic

No
The device is intended to deliver fixed boluses of medication, not to diagnose a medical condition. It's a delivery system for treatment, not a diagnostic tool.

SaMD (Software as a Medical Device)

No

The device description explicitly lists physical components such as plastic housing, medication reservoir, bolus button activator, and wrist bands, indicating it is a hardware device with accessories.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use is to deliver fixed boluses of medication to a patient. This is a therapeutic or drug delivery function, not a diagnostic one.
• Device Description: The description details a mechanical device for delivering medication, not for analyzing biological samples or providing diagnostic information.
• Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic results.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is entirely focused on administering medication.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Bolus Accessory, in combination with a positive pressure, continuous flow infusion pump. is intended to deliver fixed boluses of medication upon demand by the patient or healthcare provider. Routes of administration include intravenous, epidural, intramuscular, subcutaneous, percutaneous and intra-operative.
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 positive pressure, continuous flow rate infusion pump with an 8 to 17 psi pressure source 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 to operate.

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.
Test Solution: normal saline (0.9% NaCl)
Accuracy: bolus volume: ±10% at 95% confidence interval at the identified refill times.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Accuracy: bolus volume: ±10% at 95% confidence interval at the identified refill times.

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K984638, K884505, K935811

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

0

Image /page/0/Picture/0 description: The image shows the logo for I-FLOW Corporation. The logo consists of the text "I-FLOW" inside of a rounded rectangle. Below the logo, the text "I-FLOW CORPORATION" is printed in a simple sans-serif font.

20202 Windrow Drive Lake Forest, CA 92630 [phone] [phone] Fax [phone]

SEP 1 5 1999

K992072

SUMMARY OF SAFETY AND EFFECTIVENESS

June 17, 1999

Trade Name: 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: [phone] Fax: [phone]

1

GENERAL INFORMATION 1.0

1.1 Purpose of Submission

• This submission is intended to notify the Federal Food and Drug 1.1.1 Administration that I-Flow Corporation intends to market a new administration set called the Bolus Accessory Set, hereafter identified as the Bolus Accessory.
• Trade Name: Bolus Accessory Set 1.1.2
• Common Name: Bolus Accessory 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 the I-Flow Paragon 1.2.1 Bolus Accessory Set (K984638), the Patient Control Module (K884505) marketed by Baxter Healthcare Corporation and the I-Flow Bolus Dispenser (K935811).

PHYSICAL SPECIFICATIONS AND DESCRIPTIONS 2.0

Description of the Bolus Accessory 2.1

• The Bolus Accessory may connect to any positive pressure, continuous 2.1.1 flow rate infusion pump with an 8 to 17 psi pressure source to deliver fixed boluses of medication upon demand by the patient or healthcare provider.
• The Bolus Accessory consists of plastic housing, medication reservoir, 2.1.2 bolus button activator and wrist bands.
• The bolus button allows patient controlled administration of medication as 2.1.3 needed.

2.2 Product Configuration

• The Bolus Accessory is available in 0.5 ml bolus volume. 2.2.1

2.3 Components and Materials

• 2.3.1 All fluid path components of the Bolus Accessory are in conformance with ISO 10993 Part 1.

2.4 Power Requirements

• The Bolus Accessory is a mechanical device that requires no external 2.4.1 power to operate.

3.0 OPERATIONAL SPECIFICATIONS AND DESCRIPTIONS

3.1 Standard Operating Conditions:

Bolus Volume:	0.5 ml
Refill Time:	variable, determined by pressure source flow rate
Priming/Residual Volume: