← Product Code [FPA](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPA) · K083482

# COOK VASCULAR VITAL-JECT POWER INJECTABLE SAFETY INFUSION SET (K083482)

_Cook Vascular, Inc. · FPA · Apr 2, 2009 · General Hospital · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPA/K083482

## Device Facts

- **Applicant:** Cook Vascular, Inc.
- **Product Code:** [FPA](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPA.md)
- **Decision Date:** Apr 2, 2009
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 880.5440
- **Device Class:** Class 2
- **Review Panel:** General Hospital
- **Attributes:** Therapeutic

## Indications for Use

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 Story

The VITAL-JECT is a safety infusion set for vascular implant ports; consists of protector cap, female luer lock, PVC tubing, pinch clamp, needle-free y-site, butterfly wing, safety needle guard, and 19 ga AISI 304 stainless steel needle. Used by clinicians to administer medications or power-inject contrast media. Safety guard manually activated during withdrawal to encapsulate needle, reducing accidental stick risk. Device performance validated for power injection up to 5 mL/s with 11.8 cP viscosity media. Benefits include safe vascular access and reduced sharps injury risk.

## Clinical Evidence

Bench testing only. Tests included dynamic failure flow, instantaneous burst, static pressure, and life cycle power injection. Sterilization validation performed via ETO cycle with bioburden, endotoxin, and EO residual testing.

## Technological Characteristics

Materials: AISI 304 stainless steel needle, PVC tubing. Components: protector cap, female luer lock, pinch clamp, needle-free y-site, butterfly wing, safety needle guard. Sterilization: 100% ETO. Connectivity: None (mechanical device).

## Regulatory 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.

## Special Controls

*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.

## Predicate Devices

- HuberPRO™ Safety Huber Infusion Set ([K033515](/device/K033515.md))

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
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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 <sup>TM</sup> Power Injectable Safety Infusion Set |
|-------------|-----------------------------------------------------------------------------|
|-------------|-----------------------------------------------------------------------------|

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:

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.

### 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.
- 2. Instantaneous Burst Test
- Static Pressure Test 3.
- 4. 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

12

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# Device Description

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)

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:

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.

(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 |
|----------------|---------|
|----------------|---------|

| Prescription Use <span></span> X | OR Over-The-Counter Use <span></span> __ |
|----------------------------------|------------------------------------------|
|----------------------------------|------------------------------------------|

· Cook Vascular, Inc. · 510(k) Premarket Submission · Power Injectable Infusion Set · Confidential ·

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**Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPA/K083482](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPA/K083482)

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