SPECTRUM TURBO-JECT PICC SET

K100974 · Cook Incorporated · FOZ · May 6, 2010 · General Hospital

Device Facts

• Record ID: K100974
• Device Name: SPECTRUM TURBO-JECT PICC SET
• Applicant: Cook Incorporated
• Product Code: FOZ · General Hospital
• Decision Date: May 6, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5200
• Device Class: Class 2

Intended Use

The Spectrum Turbo-JeCT PICC is indicated for short- or long-term use for venous pressure monitoring, blood sampling, administration of drugs and fluids, and for use with power injectors for delivery of contrast in CT studies. The catheter is impregnated with the antimicrobials minocycline and rifampin to help provide protection against catheter-related bloodstream infections (CRBSIs). The Spectrum Turbo-JeCT PICC is indicated for multiple injections of contrast media through a power injector. The maximum pressure limit setting for power injectors used with the Spectrum Turbo-JeCT PICC may not exceed 325 psi and the flow rate may not exceed the maximum flow rate indicated.

Device Story

Radiopaque polyurethane peripherally inserted central venous catheter (PICC); impregnated with minocycline and rifampin to reduce catheter-related bloodstream infections. Used for venous pressure monitoring, blood sampling, drug/fluid administration, and power-injected contrast delivery in CT imaging. Operated by clinicians in clinical settings. Device supports multiple contrast injections via power injector (max 325 psi). Clinicians use device to establish venous access; power injector integration facilitates diagnostic imaging. Benefits include reduced infection risk and capability for high-pressure contrast delivery.

Clinical Evidence

Bench testing only. Performance verified via tensile testing, flow rate, cyclic bending, zone of inhibition, elution profile, air/liquid leakage, burst pressure, cyclic pinch clamping, HPLC analysis, and stability testing.

Technological Characteristics

Radiopaque polyurethane catheter; impregnated with minocycline and rifampin. Available in 3 Fr single lumen and 6 Fr triple lumen configurations. Designed for power injection up to 325 psi. Non-electronic, mechanical device.

Indications for Use

Indicated for patients requiring short- or long-term venous access for pressure monitoring, blood sampling, drug/fluid administration, and power-injected contrast delivery during CT studies. Includes antimicrobial impregnation (minocycline/rifampin) for CRBSI protection.

Regulatory Classification

Identification

An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.

Predicate Devices

• Spectrum® Turbo-JeCT™ PICC Set (K081690)

Submission Summary (Full Text)

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Special 510(k): Device Modification Spectrum® TurboJeCT™ PICC Set COOK INCORPORATED 07 April 2010

KIO0974

## 510(k) SUMMARY

Submitted By:

Susanne Galin, RAC Regulatory Affairs Specialist Cook Incorporated 750 Daniels Way, P.O. Box 489 Bloomington, IN 47402 [phone] x 2296 April 2, 2010

Device:

| Trade Name: | Spectrum® Turbo-JeCT™ PICC Set |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------|
| Proposed Classification Name: | Percutaneous, Implanted, Short- and Long-Term<br>Intravascular Catheter<br>21 CFR §880.5200, Product Code FOZ, LJS |

### Indications for Use:

The Spectrum Turbo-JeCT PICC is indicated for short- or long-term use for yenous pressure monitoring, blood sampling, administration of drugs and for use with power injectors for delivery of contrast in CT studies. The catheter is impregnated with the antimicrobials minocycline and rifampin to help provide protection against catheter-related bloodstream infections (CRBSIs). The Spectrum Turbo-JeCT PICC is indicated for multiple injections of contrast media through a power injector. The maximum pressure limit setting for power injectors used with the Spectrum Turbo-JeCT PICC may not exceed 325 psi and the flow rate may not exceed the maximum flow rate indicated.

| Catheter Size | Maximum Flow Rate* | Injection Pressure<br>Limit Setting |
|----------------------|--------------------|-------------------------------------|
| 3 Fr Single Lumen | 2 mL/sec | 325 psi |
| 4 Fr Single Lumen | 4 mL/sec | 325 psi |
| 5 Fr Single Lumen | 7 mL/sec | 325 psi |
| 5 Fr Double Lumen | 5 mL/sec | 325 psi |
| 6 Fr Triple Lumen ** | 7 mL/sec | 325 psi |

*Flow rates achieved using room temperature Omnipaque 300® contrast and verified using a Medrad Stellant® CT injector system. Omnipaque 300 has a viscosity of 11.8 centipoise at room temperature (20 degrees C). A change in temperature or viscosity of the contrast medium used will result in a change in achievable flow rates. **Lumen #1 only.

Omnipaque 300® is a registered trademark of Amersham Health, New Jersey.

MAY - 6 2010

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Special 510(k): Device Modification Spectrum® TurboJeCTTM PICC Set COOK INCORPORATED 07 April 2010

Predicate Devices:

Spectrum® Turbo-JeCT™ PICC Set, 510(k) number K081690

## Device Description:

The Spectrum Turbo-JeCT PICC catheters are radiopaque polyurethane peripherally inserted central venous catheters impregnated with the antimicrobials minocycline and rifampin for short- or long-term use. The devices are currently available in the following configurations: 4 Fr single lumen, 5 Fr single lumen, 5 Fr double lumen. The proposed devices add two additional configurations, more specifically, a 3 Fr single lumen catheter and a 6 Fr triple lumen catheter.

## Substantial Equivalence:

The Spectrum Turbo-JeCT PICC Sets in 3 Fr and 6 Fr sizes are identical to the predicate Spectrum Turbo-JeCT PICC Sets in 4 Fr and 5 Fr sizes (cleared under premarket notification 510(k) number K081680) in terms of intended use, technological characteristics, drugs used for impregnation, impregnation process, and material which support a determination of substantial equivalence.

## Test Data:

The following tests were presented to demonstrate that the Spectrum Turbo-JeCT PICC Set meets applicable design and performance requirements.

- Tensile Testing .
- Flow Rate .
- Cyclic Bending .
- Zone of Inhibition .
- Elution Profile �
- Air and Liquid Leakage .
- Burst Pressure .
- Cyclic Pinch Clamping .
- . HPLC Analysis
- Stability Testing ●

The results of these tests provide reasonable assurance that the device is safe and effective for its intended use.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle with three stripes representing the three levels of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Ms. Susanne Galin, RAC Regulatory Affairs Specialist Cook, Incorporated 750 Daniels Way, P.O. Box 489 Bloomington, Indiana 47402

MAY - 6 2010

Re: K100974

Trade/Device Name: Spectrum® Turbo-JeCT™ Peripherally Inserted Central Venous Catheter (PICC) Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ, LJS Dated: April 7, 2010 Received: April 8, 2010

Dear Ms. Galin:

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 note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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- Ms. Galin

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Susan Rurres

Anthony D. Watson, B.S., M.S., M.B.A. 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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Special 510(k): Device Modification Spectrum® TurboJeCTTM PICC Set COOK INCORPORATED 07 April 2010

### Indications for Use

510(k) Number (if known):

K100974

## Device Name:

Spectrum® Turbo-JeCT™ Peripherally Inserted Central Venous Catheter (PICC)

## Indications for Use:

The Spectrum Turbo-JeCT PICC is indicated for short- or long-term use for venous pressure monitoring, blood sampling, administration of drugs and fluids, and for use with power injectors for delivery of contrast in CT studies. The catheter is impregnated with the antimicrobials minocycline and rifampin to help provide protection against catheter-related bloodstream infections (CRBSIs). The Spectrum Turbo-JeCT PICC is indicated for multiple injections of contrast media through a power injector. The maximum pressure limit setting for power injectors used with the Spectrum Turbo-JeCT PICC may not exceed 325 psi and the flow rate may not exceed the maximum flow rate indicated.

| Catheter Size | Maximum Flow Rate* | Injection Pressure<br>Limit Setting |
|---------------------|--------------------|-------------------------------------|
| 3 Fr Single Lumen | 2 mL/sec | 325 psi |
| 4 Fr Single Lumen | 4 mL/sec | 325 psi |
| 5 Fr Single Lumen | 7 mL/sec | 325 psi |
| 5 Fr Double Lumen | 5 mL/sec | 325 psi |
| 6 Fr Triple Lumen** | 7 mL/sec | 325 psi |

*Flow rates achieved using room temperature Omnipaque 300® contrast and verified using a Medrad Stellant® CT injector system. Omnipague 300 has a viscosity of 11.8 centipoise at room temperature (20 degrees C). A change in temperature or viscosity of the contrast medium used will result in a change in achievable flow rates.

**Lumen #1 only.

Omnipaque 300® is a registered trademark of Amersham Health, New Jersey.

Prescription Use XX (Per 21 CFR 801.109)

Over-the-Counter Use

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER

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Sumalatha

Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

| 510(k) Number: | K1004 |
|----------------|-------|
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