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.

AI/ML Overview

The KVO Check Valve Accessory is designed to allow fluid flow in one direction and prevent backflow. The following information summarizes its acceptance criteria and the studies performed to demonstrate compliance.

1. Acceptance Criteria and Reported Device Performance

Criteria	Acceptance Limit	Reported Performance
Priming/Residual Volume	<= 0.5 ml	Not explicitly stated in the provided text, but implied to meet the specification.
Test Solution	0.9% NaCl	0.9% NaCl
Cracking Pressure	>= 0.1 psi	Not explicitly stated as a value, but described as "low cracking pressure to allow use of standard IV gravity drug bags" and that the "check valve performed within specification."
Backpressure Withstand	<= 10 psi	"No leaks were observed" at 10 psi. "No backflow incidents observed" at 8 inches H2O.
Sterilization Assurance Level (SAL)	10^-6	"Sterilization assurance level (SAL) of 10^-6"
Packaging Sterility Maintenance	Not specified	"maintain sterility in excess of three years"
Residual Levels (ETO Sterilization)	Ethylene Oxide: 25 ppm, Ethylene Chlorohydrin: 25 ppm, Ethylene Glycol: 250 ppm	"consistent with the FDA proposed rule" (implied to meet these levels)

2. Sample Sizes and Data Provenance for Test Set

Back Testing (high pressure): 20 samples of the check valve.
Back Testing (low pressure): 30 samples of the check valve.
Package Aging Tests: Not specified, but stated "results of bacterial dust challenge testing has determined that the pouches used to package the disposable KVO Accessory maintain sterility in excess of three years."
Data Provenance: The document does not specify the country of origin. The studies appear to be prospective, conducted specifically for this submission.

3. Number and Qualifications of Experts for Ground Truth (Test Set)

This device is a physical medical accessory (check valve), not a diagnostic or AI-driven device. Therefore, the concept of "experts establishing ground truth for a test set" with qualifications like "radiologist with 10 years of experience" is not applicable.
Performance validation relies on physical and biological testing against established engineering and regulatory standards rather than expert consensus on interpretive data.

4. Adjudication Method for the Test Set

Adjudication methods like 2+1 or 3+1 are typically used for subjective assessments by multiple human readers (e.g., in medical image analysis). Since this involves objective physical testing of a medical device, such adjudication methods are not relevant.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance, which is not applicable to this physical device.

6. Standalone (Algorithm Only) Performance

No, a standalone (algorithm only) performance study was not done. This device is a physical component, not an algorithm.

7. Type of Ground Truth Used

The ground truth used for the device's performance evaluation is based on objective physical and biological testing against predefined technical specifications and regulatory standards. This includes:
- Measurement of physical properties (e.g., priming volume, cracking pressure, backpressure withstand).
- Biological testing for biocompatibility (ISO 10993 Part 1) and sterility (ANSI/AAMI ST32-1991 / EN552 Method 1, ANSI/AAMI/ISO 11135-1994 / EN550).
- Chemical testing for residual levels after sterilization.
- Package testing to ensure sterility maintenance.

8. Sample Size for the Training Set

This information is not applicable. The KVO Check Valve Accessory is a physical device, and the concept of a "training set" is typically associated with machine learning or AI algorithms, which are not involved here.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable, as there is no training set for this type of device.

Summary

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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 (800) 448-3569 (949) 206-2700 Fax (949) 206-2600

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: 949.206.2700 Fax: 949.206.2600

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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.

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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:	<= 0.5 ml
Test Solution:	0.9% NaCl
Cracking Pressure:	>= 0.1 psi
Backpressure Withstand:	<= 10 psi

Back Testing: Two tests were performed, both a high and low pressure, to determine 3.2 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 3.2.1 backpressure tests.

3.3 Safety / Alarm Functions

3.3.1 The KVO Accessory will not be recommended for any application that exceeds the maximum internal pressure of the system.
3.3.2 If for any reason the patient needs to stop his or her infusions, each One•Step KVO infusion pump is supplied with a pinch clamp to stop the infusion.
3.3.3 This device contains no alarms or indicators for flow other than visual.

BIOLOGICAL SPECIFICATIONS 4.0

4.1 Biological testing is in conformance with ISO 10993 Part 1 for all fluid path components of the KVO Accessory.

5.0 CHEMICAL AND DRUG SPECIFICATIONS

5.1 Compatibility and Stability
- 5.1.1 There are no specific drugs referenced in the labeling for the KVO Accessory.

6.0 INTENDED USE

6.1 The KVO Accessory is intended to allow fluid flow in one direction and stop, or check, fluid flow in the opposite direction.
6.2 · The KVO Accessory is intended to be used with the I-Flow One•Step KVO infusion pump.
6.3 The KVO Accessory is single patient use only.

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6.4 No testing has been conducted to determine the efficacy of the KVO Accessory for the delivery of blood, blood products, lipids or fat emulsions. The KVO Accessory is not intended for the delivery of blood, blood products, lipids or fat emulsions.

7.0 LABELS AND LABELING

I-Flow Corporation believes the proposed labels and labeling, where appropriate, 7.1 meets the requirements of 21 CFR Part 801 as it relates to a determination of intended use and adequate directions for use.
7.2 The KVO Accessory Directions for Use labeling:
- 7.2.1 Provides comprehensive directions for preparation and use for the KVO Accessory.
- 7.2.2 Describes the intended use.
- 7.2.3 Contains caution information.
- 7.2.4 Contains the prescription statement required under 801.109 (b)(1).
- 7.2.5 Includes the specifications of the KVO Accessory.
7.3 Identification labels and labeling
- I-Flow has developed product identification labeling for the KVO Accessory. 7.3.1
7.4 Packaging labels
- 7.4.1 Contains the prescription statement required under 801.109(b)(1).

8.0 STANDARDS

8.1 There are currently no standards established for check valves.

9.0 PACKAGING

9.1 The KVO Accessory will be purchased in bulk, non-sterile and packaged by I-Flow.
9.2 Each KVO Accessory will be packaged separately in a Tyvek or Form/Fill/Seal pouch.
9.3 Packaging is suitable for either radiation or ETO sterilization.
9.4 Package aging tests have been conducted on the Tyvek pouch packaging material. The results of bacterial dust challenge testing has determined that the pouches used to package the disposable KVO Accessory maintain sterility in excess of three years.

STERILIZATION INFORMATION 10.0

The KVO Accessory shall be sterilized as follows:

10.1 The methods of sterilization are gamma radiation (Cobalt 60) or ETO gas.
10.2 Sterilization validation methodology is by ANSI/AAMI ST32-1991 / EN552 Method 1 for gamma radiation.
- 10.2.1 The gamma radiation dose validated for this product is 25 to 35 KGy (2.5 to 3.5 Mrad).
10.3 Sterilization validation methodology is by ANSI/AAMI/ISO 11135-1994 / EN550 for ETO gas sterilization.
- 10.3.1 For ETO sterilized product, the maximum levels of gas residuals for ethylene oxide, ethylene chlorohydrin and ethylene glycol are consistent with the FDA proposed rule, 43 FR 27482 (June 23, 1978).

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The maximum residual limits are 25 ppm for ethylene oxide, 25 ppm for 10.3.2 ethylene chlorohydrin, and 250 ppm for ethylene glycol.
The sterile product under review here will have a sterilization assurance level (SAL) of 10.4 10 6. Sterility testing is by spore strip for ETO. Under AAMI Method 1 for Gamma sterilized product, no sterility test is required.
The product is labeled pyrogen free and is tested for pyrogens using either the USP 10.5 Rabbit Pyrogen Test or LAL test methods.
- I-Flow products have been validated for LAL testing. 10.5.1
- Either method may be used as necessary. 10.5.2

11.0 COMPARISON TO LEGALLY MARKETED DEVICES

See Table 1 that follows this section for more specific information.

11.1 Intended Use
- The KVO Accessory, B. Braun Low Pressure Check Valve and Medex Check 11.1.1 Valve are intended:
  - To allow fluid flow in one direction and stop, or check, fluid flow in 11.1.1.1 the opposite direction.
  - The KVO Accessory is intended to be used with the I-Flow 11.1.1.2 One · Step KVO infusion pump.
11.2 Device Descriptions
- 11.2.1 The KVO Accessory
  - 11.2.1.1 The KVO Accessorv is simply the Supravalve Check Valve Assembly manufactured by Vernay Laboratories, Inc.
    - 11.2.1.1.1 Vernay has over 50 years of experience designing and manufacturing check valves.
    - 11.2.1.1.2 The Supravalve Check Valve Assembly manufactured by Vernay is sold as a component to medical device manufacturers.
    - 11.2.1.1.3 I-Flow Corporation intends to packaged, label and sterilize the Supravalve as the KVO Accessory for use with the 1-Flow One•Step KVO infusion pump.
  - 11.2.1.2 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.
    - 11.2.1.2.1 The rotating collar facilitates easy assembly and a secure connection to the Y-site of the One•Step KVO device.
    - 11.2.1.2.2 The female connector may attach to a needleless connector followed by a secondary medication line.
  - 11.2.1.3 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.

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The check valve has a low cracking pressure to 11.2.1.3.1 allow use of standard IV gravity drug bags as a secondary medication line.
The B. Braun Low Pressure Check Valve (model # S5401068) 11.2.2
- The B. Braun Check Valve is very similar to the KVO Accessory. 11.2.2.1
- Both the B. Braun Check Valve and the KVO Accessory consist of 11.2.2.2 polycarbonate housing with a standard female luer lock connector on the inlet port and male luer connector with a locking rotating collar on the outlet port.
- Both contain elastomeric check valves which allow free flow with 11.2.2.3 positive differential pressure and prevent backflow with negative differential pressure.
  - Both check valves have a low cracking pressure. 11.2.2.3.1
  - 11.2.2.3.2 The B. Braun check valve consists of a diaphragm (disk) as opposed to a duckbill as in the KVO Accessory.
The Medex, Inc. Check Valve (model # B1741-05) 11.2.3
- 11.2.3.1 The Medex Check Valve is very similar to the KVO Accessory.
- Both the Medex Check Valve and the KVO Accessory consist of 11.2.3.2 plastic housing with a standard female luer lock connector on the inlet port and male luer connector on the outlet port. The Medex Check Valve does not have a rotating collar on the outlet port.
- 11.2.3.3 Both contain elastomeric check valves which allow free flow with positive differential pressure and prevent backflow with negative differential pressure.
  - Both check valves have a low cracking pressure. 11.2.3.3.1
  - 11.2.3.3.2 Both check valves have a one-piece duckbill design made of silicone.

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Materials 11.2.4
- 11.2.4.1 The KVO Accessory and its predicate devices have similar materials. All fluid path materials of the KVO Accessory are in conformance with ISO 10993 Part 1.
11.3 Based upon the data presented in this section 11.0 and Table 1, I-Flow Corporation has determined that the KVO Accessory is substantially equivalent to the named predicate devices.

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Comparison Element	KVO Accessory(subject device)	SE' B. Braun LowPressure Check Valve	SE' Medex MedicalCheck Valve
Intended Use	To allow fluid flow in onedirection and stop, orcheck, fluid flow in theopposite direction. TheKVO Accessory isintended to be used withthe I-Flow One•Step KVOinfusion pump.	To allow fluid flow in onedirection and stop, orcheck, fluid flow in theopposite direction.	To allow fluid flow in onedirection and stop, orcheck, fluid flow in theopposite direction.
ReuseCapability	Disposable, single patientuse	Disposable, single patientuse	Disposable, single patientuse
Description	Female luer lock inlet port,male luer lock withrotating collar outlet port,duckbill check valve.	Female luer lock inlet port,male luer lock withrotating collar outlet port,diaphragm check valve.	Female luer lock inlet port,male luer lock outlet port,duckbill check valve.
PowerRequirements	None	None	None
Check Valve Mechanism	Elastomeric duckbill	Elastomeric diaphragm(disk)	Elastomeric duckbill
Fluid Path Components
Housing	Polycarbonate	Polycarbonate	Co-polyester
Check Valve	Silicone	Silicone	Silicone
Luer Caps	ABS, Polycarbonate orHigh Density Polyethylene
Packaging (sterile)	Tyvek Pouch orForm/Fill/Seal	Tyvek Pouch orForm/Fill/Seal	Tyvek Pouch orForm/Fill/Seal
Sterilization	Gamma or ETO	Gamma or ETO	Gamma or ETO
Product Code	80 FPA	80 FPA	80 FPA

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Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with three stripes forming its wings. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 2 1999

Shane P. Noehre, R.A.C. Regulatory Affairs Specialist I-Flow Corporation 20202 Window Drive Lake Forest, California 92630

K984441 Re: KVO Check Valve Accessory, Model EV-0001 Trade Name: Requlatory Class: II Product Code: FPA Dated: December 10, 1998 Received: December 14, 1998

Dear Mr. Noehre:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਕ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in Please note: this response to your the Federal Reqister. premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Noehre

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Direct Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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Image /page/10/Picture/0 description: The image shows the logo for I-FLOW Corporation. The logo consists of the words "I-FLOW" inside of a rounded rectangle. Below the logo are the words "I-FLOW" and "CORPORATION" stacked on top of each other.

20202 Windrow Drive Lake Forest, CA 92630 (800) 448-3569 (949) 206-2700 Fax (949) 206-2600

510(k) Number (if known): 119 8 44 1

Device Name: __ KVO Check Valve Accessory

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUED ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use -(Per 21 CFR 801.109)

OR Over-The-Counter Use
Patrica Cicenile

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number .

(Optional Format 1-2-96)

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.