KVO CHECK VALVE ACCESSORY, MODEL EV-0001

• K Number: K984441
• Device Name: KVO CHECK VALVE ACCESSORY, MODEL EV-0001
• Manufacturer: I-FLOW CORP.
• Date Cleared: 1999-02-22 ( 70 days)
• Product Code: FPA
• Regulation Number: 880.5440

Intended Use

The KVO Accessory is intended to allow fluid flow in one direction and stop, or check, fluid flow in the opposite direction. The KVO Accessory is intended to be used with the I-Flow One•Step KVO infusion pump.

Device Description

The KVO Accessory is simply the Supravalve Check Valve Assembly manufactured by Vernay Laboratories, Inc. The KVO Accessory housing consists of polycarbonate with a standard female luer lock connector on the inlet port and male luer connector with a locking rotating collar on the outlet port. The check valve consists of a one-piece, elastomeric duckbill which allows free flow with positive differential pressure. With negative differential pressure, backflow is checked.

Predicate Devices

K932740

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the mechanical function of a check valve and do not mention any AI or ML components.

Therapeutic

No

Explanation: The device is described as an accessory for an infusion pump, designed to manage fluid flow, not to treat a medical condition.

Diagnostic

No

Explanation: The device is described as an accessory for an infusion pump (check valve) designed to control fluid flow, not to diagnose medical conditions.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a physical check valve assembly made of polycarbonate and an elastomeric duckbill, which are hardware components.

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 clearly states that the device is for controlling fluid flow in an infusion pump. This is a therapeutic or delivery function, not a diagnostic one.
• Device Description: The description details a mechanical check valve for fluid control. There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information.
• Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
  • Analyzing biological specimens.
  • Detecting or measuring substances in biological samples.
  • Providing information for diagnosis, monitoring, or screening of diseases or conditions.

The device is a component used in a medical device (infusion pump) for controlling fluid delivery to a patient. This falls under the category of a therapeutic or delivery device, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The KVO Accessory is intended to allow fluid flow in one direction and stop, or check, fluid flow in the opposite direction. The KVO Accessory is intended to be used with the I-Flow One•Step KVO infusion pump.

Product codes

80 FPA

Device Description

The KVO Accessory is simply the Supravalve Check Valve Assembly manufactured by Vernay Laboratories, Inc. I-Flow Corporation intends to sterilize, package and label the Supravalve as the KVO Accessory for use with the I-Flow One•Step KVO infusion pump. The KVO Accessory housing consists of polycarbonate with a standard female luer lock connector on the inlet port and male luer connector with a locking rotating collar on the outlet port. The rotating collar facilitates easy assembly and a secure connection to the Y-site of the One•Step KVO. The female connector may attach to a needleless connector followed by a secondary medication line. The check valve consists of a one-piece, elastomeric duckbill which allows free flow with positive differential pressure. With negative differential pressure, backflow is checked. The check valve has a low cracking pressure to allow use of standard IV gravity drug bags as a secondary medication line.

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

Not Found

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)

Back Testing: Two tests were performed, both a high and low pressure, to determine backflow effects on the check valve. The first test air pressurized 20 samples of the check valve with a 10 psi backflow pressure. No leaks were observed. The second test was performed on 30 samples of the check valve with 8 inches H2O backflow for 4 hours. There were no backflow incidents observed. The check valve performed within specification during both high and low backpressure tests.

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

Not Found

Predicate Device(s)

K932740, B. Braun Low Pressure Check Valve, Medex, Inc. Check Valve

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

0

Image /page/0/Picture/0 description: The image shows the date 2/22/99 written in black ink at the top of the image. Below the date is the logo for I-FLOW, which is a rounded rectangle with the words "I-FLOW" inside. The "I" is separated from the word "FLOW" by a dot. The logo is in black and white.

I-FLOW CORPORATION 20202 Windrow Drive Lake Forest, CA 92630 [phone] [phone] Fax [phone]

K98 4441

SUMMARY OF SAFETY AND EFFECTIVENESS

December 10, 1998

Trade Name: KVO Check Valve Accessory

Common Name: Check Valve

Classification Name: Set, Administration, Intravascular

All questions and/or comments concerning this document should be made to:

Shane P. Noehre, RAC Regulatory Affairs Specialist

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 1.1.1 Administration that I-Flow Corporation intends to market an accessory component for the I-Flow One•Step KVO infusion pump (K932740).
• Trade Name: KVO Check Valve Accessory 1.1.2
• Common Name: Check Valve 1.1.3
• Classification Name: Set, Administration, Intravascular 1.1.4
• Classification Panel: General Hospital and Personal Use Device 1.1.5

1.2 Statement of Equivalence

• The KVO Check Valve Accessory, hereafter referred to as the KVO 1.2.1 Accessory, is simply the Supravalve Check Valve Assembly manufactured by Vernay Laboratories, Inc.
• The KVO Accessory is substantially equivalent to the B. Braun Low Pressure 1.2.2 Check Valve and Medex, Inc. Check Valve.

2.0 PHYSICAL SPECIFICATIONS AND DESCRIPTIONS

Description of the KVO Accessory 2.1

• The KVO Accessory is simply the Supravalve Check Valve Assembly 2.1.1 manufactured by Vernay Laboratories, Inc.
  • Vernay has over 50 years of experience designing and 2.1.1.1 manufacturing check valves.
  • The Supravalve Check Valve Assembly manufactured by Vernay 2.1.1.2 is sold as a component to medical device manufacturers.
  • I-Flow Corporation intends to sterilize, package and label the 2.1.1.3 Supravalve as the KVO Accessory for use with the I-Flow One•Step KVO infusion pump.
• The KVO Accessory housing consists of polycarbonate with a standard 2.1.2 female luer lock connector on the inlet port and male luer connector with a locking rotating collar on the outlet port.
  • The rotating collar facilitates easy assembly and a secure 2.1.2.1 connection to the Y-site of the One•Step KVO.
  • 2.1.2.2 The female connector may attach to a needleless connector followed by a secondary medication line.
• The check valve consists of a one-piece, elastomeric duckbill which allows 2.1.3 free flow with positive differential pressure. With negative differential pressure, backflow is checked.
  • The check valve has a low cracking pressure to allow use of 2.1.3.1 standard IV gravity drug bags as a secondary medication line.

2

2.2 Product Configuration

• The following KVO Accessory model will be available: 2.2.1
  • EV-0001: KVO Check Valve Accessory. 2.2.1.1
    • The check valve is manufactured by Vernay 2.2.1.1.1 Laboratories, model # 1300-233.

2.3 Power Requirements

• 2.3.1 The KVO Accessorv does not require any external power.

OPERATIONAL SPECIFICATIONS AND DESCRIPTIONS 3.0

3.1 Standard Operating Conditions:

| Priming/Residual Volume: | = 0.1 psi |
| Backpressure Withstand: |