HOMEPUMP C-SERIES AND HOMEPUMP C-SERIES ONE-STEP KVO

• K Number: K991513
• Device Name: HOMEPUMP C-SERIES AND HOMEPUMP C-SERIES ONE-STEP KVO
• Manufacturer: I-FLOW CORP.
• Date Cleared: 1999-06-21 ( 52 days)
• Product Code: FPA APR
• Regulation Number: 880.5440

Intended Use

1. The Homepump C-Series is intended for continuous infusion of medications for general infusion use, including chemotherapy and pain management. Routes of administration include intravenous, subcutaneous, intramuscular and epidural. 2. The KVO model of the Homepump C-Series is intended for general purpose drug and/or diluent delivery at a sufficient flow rate to maintain a patient IV line open (i.e. keep vein open). The Y-site at the distal end of the administration set allows piggy back infusions. The routes of administration include intravenous, subcutaneous and intramuscular.

Device Description

The Homepump C-Series is an elastomeric infusion pump with an integrated administration set. The elastomeric membranes function as the fluid reservoir and the pressure source. The pressure that pumps the fluid comes from the strain energy of the elastomeric membranes which are forced to expand when the pump is filled. The incorporation of fixed diameter flow control tubing or glass orifice combined with the elastomeric pressure source produces the desired flow rate. Homepump C-Series models are available in fill volumes from 50 to 500 ml and flow rates from 0.5 to 10 ml/hr. The One•Step KVO models of the Homepump C-Series have an optional Y-site and optional check valve attached to the distal end of the administration set. The following accessories are available: carry case, E-clip and power ring.

Predicate Devices

K944692, K896907

Reference Devices

K944692, K896907

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on mechanical and fluid dynamics principles (elastomeric pressure, flow control tubing) and do not mention any computational or data-driven components indicative of AI/ML. The "Mentions AI, DNN, or ML" field is also explicitly marked as "Not Found".

Therapeutic

Yes.
The device is intended for the "continuous infusion of medications for general infusion use, including chemotherapy and pain management," which are therapeutic interventions.

Diagnostic

No

The device is an infusion pump for delivering medications; it does not diagnose medical conditions.

SaMD (Software as a Medical Device)

No

The device description clearly states it is an "elastomeric infusion pump with an integrated administration set," describing physical components like membranes, tubing, and orifices, indicating it is a hardware device.

IVD (In Vitro Diagnostic)

Based on the provided information, the Homepump C-Series is not an IVD (In Vitro Diagnostic) device.

Here's why:

• Intended Use: The intended use clearly states that the device is for the "continuous infusion of medications" and "general purpose drug and/or diluent delivery." This describes a device used to administer substances into the body, not to perform tests on samples taken from the body.
• Device Description: The description details an "elastomeric infusion pump" that delivers fluid based on pressure. This is consistent with a drug delivery system, not a diagnostic device.
• Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Homepump C-Series' function is to deliver substances to the body, which is a therapeutic or supportive function, not a diagnostic one.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

• 1. The Homepump C-Series is intended for continuous infusion of medications for general infusion use, including chemotherapy and pain management. Routes of administration include intravenous, subcutaneous, intramuscular and epidural.
• 2. The KVO model of the Homepump C-Series is intended for general purpose drug and/or diluent delivery at a sufficient flow rate to maintain a patient IV line open (i.e. keep vein open). The Y-site at the distal end of the administration set allows piggy back infusions. The routes of administration include intravenous, subcutaneous and intramuscular.

Product codes

FPA

Device Description

• The Homepump C-Series is an elastomeric infusion pump with an integrated administration set.
• The elastomeric membranes function as the fluid reservoir and the pressure source.
• The pressure that pumps the fluid comes from the strain energy of the elastomeric membranes which are forced to expand when the pump is filled.
• The incorporation of fixed diameter flow control tubing or glass orifice combined with the elastomeric pressure source produces the desired flow rate.
• Homepump C-Series models are available in fill volumes from 50 to 500 ml and flow rates from 0.5 to 10 ml/hr. The One•Step KVO models of the Homepump C-Series have an optional Y-site and optional check valve attached to the distal end of the administration set.
• The following accessories are available: carry case, E-clip and power ring.

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

ambulatory device and is intended for use in the 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)

Flow Rate and Pressure Performance Data: Testing occurred at standard operating conditions. All models produced an average flow rate and pressure within the ±10% accuracy claim.

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

Flow Rate Accuracy: ±10% at 95% confidence interval

Predicate Device(s)

K944692, K896907

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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

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K99/513

Image /page/0/Picture/1 description: The image shows the text "JUN 21 1999" at the top. Below that is the I-FLOW logo, which is a stylized version of the word "I-FLOW" inside of a rounded rectangle. The text "I-FLOW CORPORATION" is printed below the logo.

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

SUMMARY OF SAFETY AND EFFECTIVENESS

April 29, 1999

Trade Name: Homepump C-Series and Homepump C-Series One•Step KVO

Common Name: Elastomeric Infusion Pump

Classification Name: Pump, Infusion, Elastomeric

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

Purpose of Submission 1.1

• This submission is intended to notify the Federal Food and Drug Administration 1.1.1 that I-Flow Corporation is adding two new optional components to the Homepump C-Series (K944692).
  • Regulator (optional) 1.1.1.1
    • The optional requlator controls the decreasing 1.1.1.1.1 pressure (14 to 9 psi) of the Homepump C-Series to a fixed 6.0 psi.
  • Flow Indicator (optional) 1.1.1.2
    • An optional flow indicator component 1.1.1.2.1 incorporates a flow status column indicator with the glass orifice flow restrictor.

Note: The PainBuster Infusion Kit (K980558 and K982946), the On-Q Infusion Kit (K980558 and K982946) and the Nerve Block Infusion Kit (K984502) use the Homepump C-Series infusion pumps in their kits. Neither the regulator nor the flow indicator components change the intended use of the Homepump C-Series when used in the PainBuster, On-Q or Nerve Block Infusion Kits.

1.2 Statement of Equivalence

• The Homepump C-Series is substantially equivalent to the existing I-Flow 1.2.1 Homepump C-Series (K944692) and the 3M IV Flow Regulator (K896907).

2.0 PHYSICAL SPECIFICATIONS AND DESCRIPTONS

2.1 Description of Device

• The Homepump C-Series is an elastomeric infusion pump with an integrated 2.1.1 administration set.
• 2.1.2 The elastomeric membranes function as the fluid reservoir and the pressure source.
• 2.1.3 The pressure that pumps the fluid comes from the strain energy of the elastomeric membranes which are forced to expand when the pump is filled.
• 2.1.4 The incorporation of fixed diameter flow control tubing or glass orifice combined with the elastomeric pressure source produces the desired flow rate.

2.2 Product Configuration

• 2.2.1 Homepump C-Series models are available in fill volumes from 50 to 500 ml and flow rates from 0.5 to 10 ml/hr. The One•Step KVO models of the Homepump C-Series have an optional Y-site and optional check valve attached to the distal end of the administration set.
• 2.2.2 The following accessories are available: carry case, E-clip and power ring.

2.3 Components and Materials

All fluid path materials are in compliance with ISO 10993 Part 1.

2

2.4 Power Requirements

• The Homepump C-Series is a mechanical device that utilizes elastomeric 2.4.1 membranes for power. No additional external power is required.

OPERATIONAL SPECIFICATIONS AND DESCRIPTIONS 3.0

3.1 Standard Operating Conditions:

| Priming/Residual Volume: |