The Cook Vascular VITAL-JECT Power Injectable Safety Infusion Set is intended to be used to administer solutions and medications into vascular implant ports. When used with a power Injectable vascular implant port, the Cook Vascular Safety Infusion Set is indicated for power injection of contract media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/s using contrast with a maximum viscosity of 11.8cP.

In addition, to minimize the risk of accidental needle stick after use, the attached safety guard fully encapsulates the needle when manually activated during withdrawal.

Device Description

The Cook Vascular VITAL-JECT Power Injectable Safety Infusion Set is intended to administer solutions and medications into vascular implant ports. In addition, to minimize the risk of accidental needle stick after use, the attached safety guard fully encapsulates the needle when manually activated during withdrawal.

When used with a power Injectable vascular implant port, the Cook Vascular Safety Infusion Set is indicated for power injection of contract media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/s using contrast with a maximum viscosity of 11.8cP.

The device consists of a protector cap, female luer lock, PVC tubing, two each 4 inch tubing length, a pinch clamp, with a needle free y-site, a butterfly wing, a safety needle guard, an AISI 304 (19 ga) stainless steel needle and a needle sheath.

The components and the processes use to manufacture these solution administration sets are the same as the currently legally marketed by Command Medical, K033515 HuberPRO™ Safety Huber Infusion Set.

Cook Vascular, Inc. will label and sterilize the final product. The proposed device is manufactured exactly the same as the currently marketed device. (K033515)

AI/ML Overview

Here's an analysis of the provided text, outlining the acceptance criteria and study details for the Cook Vascular VITAL-JECT™ Power Injectable Safety Infusion Set:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state quantitative acceptance criteria with specific pass/fail thresholds for each test. Instead, it describes general conclusions about performance. The key performance aspect highlighted is the ability to withstand power injection.

Acceptance Criteria Category (Derived)	Stated Acceptance Criteria (Implied)	Reported Device Performance
Power Injection Capability	The device should be capable of being power injected at specified parameters.	"The Vital-Ject infusion set is capable of being power injected at the establish 5mL/s with a given media viscosity of 11.8cP."
Dynamic Failure Flow Test	Reliable design and performance under specified testing parameters.	Results contributed to the conclusion that the device can handle power injection. (No specific numerical result or failure threshold provided in the summary.)
Instantaneous Burst Test	Reliable design and performance under specified testing parameters.	Results contributed to the conclusion that the device can handle power injection. (No specific numerical result or failure threshold provided in the summary.)
Static Pressure Test	Reliable design and performance under specified testing parameters.	Results contributed to the conclusion that the device can handle power injection. (No specific numerical result or failure threshold provided in the summary.)
Life Cycle Power Injection Test	Reliable design and performance under specified testing parameters.	Results contributed to the conclusion that the device can handle power injection. (No specific numerical result or failure threshold provided in the summary.)
Sterilization (Bioburden)	Bioburden should be within specification, below alert levels.	Average Bioburden level for all nine samples was 149 cfu/device, which is far below the 300 cfu alert limit. One sample measured 1126 cfu/device, which was above the alert level, but the overall conclusion was acceptable.
Sterilization (ETO Residuals)	EO residual levels should be acceptable.	Test results indicated acceptable results.
Sterilization (Endotoxin)	Endotoxin levels should be acceptable.	Test results indicated acceptable results.
Sterilization (Sterility)	Sterility should be achieved.	Test results indicated acceptable results.
Safety Feature (Needle Stick)	The safety guard should fully encapsulate the needle to minimize accidental needle stick.	The device description states: "the attached safety guard fully encapsulates the needle when manually activated during withdrawal" to minimize risk. The study summary does not include specific testing or performance data related to the effectiveness of the needle stick prevention feature.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size for Test Set:
- For the performance tests (Dynamic Failure Flow, Instantaneous Burst, Static Pressure, Life Cycle Power Injection Tests), a specific sample size is not explicitly stated in the provided summary.
- For Bioburden testing, nine individual infusion sets were tested.
Data Provenance: The data appears to be prospective testing conducted by Cook Vascular, Inc. or its contractors. The country of origin is implicitly the USA, where Cook Vascular, Inc. is based and the submission was made to the FDA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Not applicable for this type of device and study. The testing described involves engineering and microbiological performance metrics, not clinical interpretation by experts to establish a "ground truth." The ground truth is objective performance characteristics measured through laboratory testing.

4. Adjudication Method for the Test Set:

Not applicable. This study involves objective laboratory tests with measurable outcomes, not subjective assessments requiring adjudication by multiple experts.

5. 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. This document describes a 510(k) submission for a physical medical device (infusion set), not an AI/software-as-a-medical-device. Therefore, no MRMC study or AI-related comparative effectiveness was performed or applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

No. As mentioned, this is not an AI/algorithm-based device.

7. The Type of Ground Truth Used:

The "ground truth" for the performance tests (flow, pressure, burst, life cycle) are engineering specifications and physical measurements designed to assess the device's functional integrity under intended use conditions.
The "ground truth" for sterilization tests (Bioburden, Endotoxin, EO Residuals, Sterility) are established microbiological and chemical standards for medical device sterilization.

8. The Sample Size for the Training Set:

Not applicable. There is no "training set" as this is not an AI/machine learning device. The design, components, and manufacturing processes leverage those of a previously cleared predicate device (K033515 HuberPRO™ Safety Huber Infusion Set), which serves as a benchmark for substantial equivalence rather than a training set in the AI sense.

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

Not applicable. As there is no training set, there's no ground truth established for one. The basis for safety and effectiveness is substantial equivalence to a predicate device, supported by the described physical and microbiological testing.

Summary

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K083.482

510(k) Summary

Submitted by:

Jim Ferguson Quality Systems Manager Cook Vascular, Incorporated 1186 Montgomery Lane Vandergrift. Pa 15690 724-845-8621, XT 2227 April 10, 2006

Device:

Trade name:	Cook Vascular VITAL-JECT TM Power Injectable Safety Infusion Set
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Intravascular Administration Set, 880.5440 Proposed Classification:

Predicate Devices:

The Cook Vascular VITAL-JECT™ Power Injectable Safety Infusion Set is similar in terms of intended use, and exactly the same as materials of construction and technology characteristics to the predicate devices that have been found substantially equivalent.

Device Description:

Substantial Equivalence:

The components and the processes used to manufacture these solution administration sets are the exact same as the currently legally marketed by Command Medical, HuberPRO™ Safety Huber Infusion Set. (K033515). The packaged Infusion set will be supplied from Command Medical and Cook Vascular will label, sterilize and market the product.

● Cook Vascular, Inc. ● 510(k) Premarket Submission ● VITAL-JECT™ Power Injectable Safety Infusion Set ● Confidential

APR - 2 2009

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Test Data:

The Cook Vascular, Inc. VITAL-JECT™ Power Injectable Safety Infusion Set was subjected to the flowing tests to assure reliable design and performance under the specified testing parameters. These tests were comprised of:

Dynamic Failure Flow Test 1.
1. Instantaneous Burst Test
Static Pressure Test 3.
1. Life Cycle Power Injection Test

An analysis of the test results lead to the conclusion that the Vital-Ject infusion set is capable of being power injected at the establish 5mL/s with a given media viscosity of 11.8cP.

The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a VITAL-JECT™ Power Injectable Safety Infusion Set

Sterilization Information:

The infusion sets were validated to a standard 100% ETO Cook sterilization cycle with the Infusion Port Universal Tray set. Bioburden Testing, Endotoxin Testing, EO residual testing, and sterility testing was performed. EO Residual testing and sterility testing was performed on the Infusion Port body (model IP-S6110) which has been determined to provide the greatest challenge when testing for EO residuals and sterility. The test results for Endotoxin testing. EO Residual testing and sterility testing all indicated acceptable results. Bioburden testing on the infusion sets using combination membrane filtration and 3-layer pour plates was used. All individual tested infusion sets were within specification with the exception of one. The cfuldevice for this sample measured 1126. This result is above the alert level of 300 colony forming units per device. The other eight test samples cfu level ranged from 3 to 56 cfuldevice. The average Bioburden level for all nine samples is 149 cfu with is far below the 300 cfu alert limit. In addition, the sterilization validation and Endotoxin results for the Infusion sets indicate that the established sterilization process is capable of producing acceptable results.

Based on the fact the Cook Vascular, Inc. VITAL-JECT Power Injectable Safety Infusion Set utilizes the same design, components and manufacturing processes as currently legally marketed products, the Cook Vascular, Inc. VITAL-JECT Power Injectable Safety Infusion Set is safe and effective when used as intended.

• Cook Vascular, Inc. • 510(k) Premarket Submission • VITAL-JECT™ Power Injectable Safety Infusion Set • Confidential

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Device Description

Cook Vascular, Inc. will label and sterilize the final product. The proposed device is manufactured exactly the same as the currently marketed device. (K033515)

Drawings are included in Attachment B.

Functional Features

A comparison of features and specifications of the Cook Vascular, Inc. VITAL-JECT™ Power Injectable Safety Infusion Set are included on page 7.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image is a seal for the Department of Health & Human Services in the USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. In the center of the seal is an abstract emblem that resembles an eagle or other bird in flight. The emblem is stylized and composed of curved lines, giving it a modern and symbolic appearance.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 2 2009

Mr. Jim Ferguson, Jr. Cook Vascular Incorporated 1186 Montgomery Lane Vandergrift, Pennsylvania 15690

K083482 Re:

Trade/Device Name: Cook Vascular VITAL-JECT™ Power Injectable Safety Infusion Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: March 12, 2009 Received: March 17, 2009

Dear Mr. Ferguson:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition. FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 -- Mr. Ferguson

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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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 regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,

Cinthan O.nne for

Ginette Y. Michaud, M.D. 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 Statement

1083482

510(k) Number: Device Name: Cook Vascular, Inc. Vital-Ject Power Injectable Safety Infusion Set Indications for Use:

In addition, to minimize the risk of accidental needle stick after use, the attached safety guard fully encapsulates the needle when manually activated during withdrawal.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Anesthesiology, General Hospital
infection Control, Dental Devices

510(k) Number:	K083482
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Prescription Use X	OR Over-The-Counter Use __
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· Cook Vascular, Inc. · 510(k) Premarket Submission · Power Injectable Infusion Set · Confidential ·

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.