The Intravenous Power Injector Extension Set is intended to allow for the aspiration, injection or gravity/pump flow of fluids and may be used with low pressure power injectors having a maximum pressure setting of 325 psi and maximum flow rate of 10 ml/second. When used with a low pressure power injector, the Intravenous Power Injector Extension Set must be secured with other devices rated for pressures up to 325 psi with a luer lock connection.

Device Description

The Intravenous Power Injector Extension Set is an IV extension set intended for the aspiration and/or delivery of fluids and may be used with power injectors having a maximum pressure setting of 325 psi and maximum flow rate of 10 ml/second.

The Intravenous Power Injector Extension Set consists of polyvinyl chloride (PVC) tubing with non-DEHP plasticizer, configured with a male luer with hex lock hub on its distal end and a female luer lock on its proximal end. A slide clamp is positioned over the tubing to obstruct the fluid flow when needed by sliding the tubing into the narrow portion of the slide clamp.

The Intravenous Power Injector Extension Set is available in a configuration with and without a needle-free valve. The configuration with the valve allows access to the fluid delivery pathway without the use of a needle while maintaing a closed system for the fluid path. The valve is attached to the female luer lock.

The Intravenous Power Injector Extension Set is provided sterile for single use only. It is packaged with a commercially available skin protectant prep pad and a commercially available StatLock® stabilization device.

AI/ML Overview

The provided text describes a medical device, the "Intravenous Power Injector Extension Set," and its substantial equivalence to predicate devices, but it does not contain the specific details required to complete all sections of your request. This document is a 510(k) summary, which focuses on demonstrating substantial equivalence, primarily through performance bench testing rather than complex clinical studies involving human patients, AI, or expert adjudication.

Here's a breakdown of what can be extracted and what cannot, based on the provided text:

Acceptance Criteria and Study Details (Limited Information Available):

Acceptance Criteria (Inferred)	Reported Device Performance (Inferred from "adequate")
Functionality (e.g., fluid flow, pressure resistance)	Deemed "adequate for its intended use"
Integrity (e.g., no leaks, structural soundness)	Deemed "adequate for its intended use"
Safety (e.g., biocompatibility not explicitly stated but implied)	Deemed "adequate for its intended use"

Study Details:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The document mentions "performance (bench) testing." Bench testing typically involves a certain number of units of the device. However, the specific sample sizes for these tests are not provided in the 510(k) summary.
- Data provenance is not specified beyond "Bard Medical Division C. R. Bard, Inc. 8195 Industrial Blvd. Covington, Georgia 30014 USA." This implies the testing was conducted by the manufacturer, likely in the US, but whether it's prospective or retrospective isn't relevant for bench testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- This question is not applicable to this type of device and study. The testing described is "performance (bench) testing" for a physical medical device (an IV extension set). Ground truth for such a device would be established through a pass/fail criteria based on engineering specifications and regulatory standards, not through expert opinion on clinical findings.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This is not applicable. Adjudication methods are relevant for studies involving subjective assessments or disagreements in clinical interpretations (e.g., imaging studies). Bench testing involves objective measurements against predefined specifications.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. This type of study is completely irrelevant for an intravenous extension set. The device is a physical product, not an AI or diagnostic tool that assists human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, this is not applicable. The device is not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For this device, the "ground truth" for the performance testing would be engineering specifications and regulatory standards for characteristics like pressure resistance, flow rates, luer lock integrity, and material compatibility. This is inferred from the mention of "Accepted scientific methods, such as performance (bench) testing, do exist for assessing the effect of the differences in characteristics."
The sample size for the training set:
- This is not applicable. There is no "training set" as this is not an AI device or a model being trained.
How the ground truth for the training set was established:
- This is not applicable for the same reason as above.

Summary

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K090134

APR 2 1 2009

510(k) SUMMARY

This 510(k) summary is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.87

Establishment Registration Number:

Address of Manufacturer:

Contact Person:

Date Prepared:

Trade or Proprietary Name:

Common or Usual Name:

Classification Name:

Predicate Device Identification:

1018223

Bard Medical Division C. R. Bard, Inc. 8195 Industrial Blvd. Covington, Georgia 30014 USA Phone: (770) 784-6774 Fax: (770) 784-6340

Scott Pease Senior Manager, Regulatory Affairs

April 2, 2009

Intravenous Power Injector Extension Set

Set, Administration, Intravenous

Intravascular administration set (21 CFR 880.5440)

Product code: FPA

Class II

IV Administration Sets (extension set) with Needleless Access Device (K980992)

SmartSite® Needle-Free Valve Administration Set (K061285)

Device Description:

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the tubing to obstruct the fluid flow when needed by sliding the tubing into the narrow portion of the slide clamp.

Intended Use

Technological Characteristics and Comparison to Predicate Devices

The differences in technological characteristics (e.g., design specifications) between the subject and predicate devices do not raise new types of safety or effectiveness questions. Accepted scientific methods, such as performance (bench) testing, do exist for assessing the effect of the differences in characteristics.

Performance Data

The results of performance testing demonstrated that the functionality, integrity, and safety of the Intravenous Power Injector Extension Set are adequate for its intended use and supports a determination of substantial equivalence.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with outstretched arms, representing care and protection. To the left of the figure is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Scott Pease Senior Manager, Regulatory Affairs C.R. Bard, Incorporated Bard Medical Division 8195 Industrial Boulevard Covington, Georgia 30014

APR 2 1 2009

Re: K090134

Trade/Device Name: Intravenous Power Injector Extension Set Regulation Number: 21 CFR 880.5440 Regulatory Class: II Product Code: FPA Dated: April 3, 2009 Received: April 6, 2009

Dear Mr. Pease:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2- Mr. Pease

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0100. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Anthony D. Martin for

Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K090134 (To be assigned by FDA)

Device Name: Intravenous Power Injector Extension Set

Indications for Use:

Prescription Use: X (21 CFR 801 Subpart D)

AND/OR

Over-the-Counter Use: (21 CFR 807 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K090134

Page 1 of 1

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.