TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) SET

K132334 · Cook, Inc. · LJS · Aug 16, 2013 · General Hospital

Device Facts

• Record ID: K132334
• Device Name: TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) SET
• Applicant: Cook, Inc.
• Product Code: LJS · General Hospital
• Decision Date: Aug 16, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5970
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Turbo-Ject Peripherally Inserted Central Venous Catheter (PICC) Sets and Trays are intended 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 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 Turbo-Ject PICC may not exceed 325 psi and the flow rate may not exceed the maximum flow rate indicated.

Device Story

Turbo-Ject PICC is a radiopaque polyurethane peripherally inserted central venous catheter; used for venous pressure monitoring, blood sampling, drug/fluid administration, and power-injected contrast delivery in CT studies. Device features a 1 Fr minimal taper design to facilitate insertion; available in 4.0 Fr single and double lumen configurations. Inserted via Peel-Away introducer or over-the-wire technique. Operated by clinicians in clinical settings. Output is the delivery of contrast media or fluids; enables diagnostic imaging and therapeutic administration. Benefits include ease of insertion and compatibility with high-pressure contrast injection.

Clinical Evidence

Bench testing only. Testing included tensile testing (ISO 10555-1:1995, >10 N), dynamic pressure testing, static failure pressure testing, liquid leakage testing, and air leakage testing. Results confirmed performance met design requirements and supported substantial equivalence.

Technological Characteristics

Radiopaque polyurethane catheter; 4.0 Fr single and double lumen; 1 Fr minimal taper design. Supplied sterile for single use. Includes obturator, Peel-Away introducer, entry needles, wire guide, and convenience components. No software or electronic components.

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 media delivery during CT studies. Contraindicated for power injector pressure settings exceeding 325 psi or flow rates exceeding device-specific maximums.

Regulatory Classification

Identification

A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.

Special Controls

*Classification.* Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”

Predicate Devices

• Turbo-Ject® PICC (K072625)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo for Cook Medical. The word "COOK" is in large, bold, white letters on a black background. The word "MEDICAL" is in smaller, white letters below the word "COOK". There is a registered trademark symbol next to the word "COOK".

COOK INCORPORATED
750 DANIELS WAY, P.O. BOX 489
BLOOMINGTON, IN 47402-0489 0.5.A.
PHONE: [phone] τOLL FREE: 800.457.4500
WWW.COOKMEDICAL.COM

### 510(k) SUMMARY - K132334 Turbo-Ject® Peripherally Inserted Central Venous Catheter Set 21 CFR \$807.92 Date Prepared: August 01, 2013

### Submitted By:

Applicant: Contact: Applicant Address:

Contact Phone Number: Contact Fax Number:

Cook Incorporated Erum B. Nasir or Sean Spence, RAC Cook Incorporated 750 Daniels Way Bloomington, IN 47404 [phone] x102607 or x105127 [phone]

**AUG 16 2013**

## Device Information:

Trade name: Common name: Classification Name: Regulation: Product Code:

Turbo-Ject® Peripherally Inserted Central Venous Catheter Set PICC Set Percutaneous, Implanted, Long-Term Intravascular Catheter 21 CFR 8880.5970 LIS

## Intended Use:

Turbo-Ject Peripherally Inserted Central Venous Catheter (PICC) Sets and Trays are intended 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 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 Turbo-Ject PICC may not exceed 325 psi and the flow rate may not exceed the maximum flow rate indicated.

# Predicate Device:

The Turbo-Ject® PICC Sets, subject of this submission, are a modification to the 4.0 Fr devices from the Cook Incorporated Turbo-Ject® PICC (K072625), which was cleared for commercial distribution on December 13, 2007.

{1}------------------------------------------------

| | Turbo-Ject PICC: K072625<br>(Predicate - 4.0 Fr only) | Turbo-Ject PICC Set<br>(Subject Devices) |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|
| Classification | 21 CFR §880.5970, LJS: Percutaneous,<br>Implanted, Long-Term Intravascular Catheter | Identical |
| Intended Use | Intended for short- or long-term use for venous<br>pressure monitoring, blood sampling,<br>administration of drugs and fluids, and for use<br>with power injectors for delivery of contrast in<br>CT studies. The maximum pressure limit<br>setting for Power Injectors used with the<br>Turbo-Ject PICC may not exceed 325 psi and<br>the flow rate may not exceed the maximum<br>flow rated indicated. | Identical |
| Catheter Shaft Material | Polyurethane | Polyurethane |
| French Size / Length (cm) | 4.0 / 60 | Identical |
| Number of Lumens | 4.0 Fr - Single lumen<br>4.0 Fr - Double lumen | Identical |
| Flow Rate | 4.0 Fr Single lumen - 4 mL/sec<br>4.0 Fr Double lumen - 3 mL/sec | 4.0 Fr Single lumen - 5 mL/sec<br>4.0 Fr Double lumen - 3 mL/sec |
| Max Pressure Rating | 325 psi | Identical |
| Taper | 2 Fr size | 1 Fr size |
| Inside Diameter (inch) | 4.0 Fr Single lumen - 0.030<br>4.0 Fr Double lumen - 0.015/0.035* | 4.0 Fr Single lumen - 0.037<br>4.0 Fr Double lumen -0.022/0.038* |
| Outside Diameter (inch) | 4.0 Fr Single lumen - 0.053<br>4.0 Fr Double lumen - 0.053 | 4.0 Fr Single lumen - 0.055<br>4.0 Fr Double lumen - 0.055 |
| Primary set components | Obturator, Peel-Away® introducer, entry<br>needles, wire guide, injection caps, syringe,<br>scalpel, and securement device | Identical |

#### Table 1: Comparison to Predicate

*height/width

### Device Description:

The proposed Turbo-Ject® PICCs are radiopaque polyurethane peripherally inserted central venous catheters for short- or long-term use, and can be inserted through a Peel-Away introducer, or over-the-wire. The proposed devices are minimally tapered 4.0 Fr single and double lumen catheters. A taper is a design element meant to help "wedge" the catheter into the tract by having a transition from a larger Fr size to the labeled Fr size. The proposed minimal taper design provides the same wedge feature only a △1 Fr versus Δ2 Fr from the manifold to the labeled Fr size of the catheter. The primary advantage of the 1 Fr size minimal taper is ease of insertion.

The set components may include the PICC, obturator, Peel-Away® introducer, entry needles, wire guide and other convenience components. The set is supplied sterile and is intended for one-time use.

{2}------------------------------------------------

#### Test Data:

The following tests were performed to demonstrate that the proposed Turbo-Ject® PICC Set met applicable design and performance requirements and support a determination of substantial equivalence.

- Tensile Testing In conformance with ISO 10555-1:1995, testing demonstrated that the . peak load value was greater than 10 N.
- Dynamic Pressure Testing Testing demonstrated that the catheters did not fail during . simulated use. Testing revealed the proposed 4.0 Fr single lumen device labeling could be modified to a maximum flow rate of 5 mL/sec from the 4 mL/sec in the predicate labeling.
- Static Failure Pressure Testing demonstrated that static failure pressure was at or above I the acceptance criterion.
- Liquid Leakage Testing Testing demonstrated that the catheter did not leak liquid. ■
- Air Leakage Testing Testing demonstrated that the catheter did not exhibit air leakage. .

### Conclusions Drawn from the Tests:

The results of these tests provide reasonable assurance that the Turbo-Ject® PICC Set is as safe and effective as the predicate devices and support a determination of substantial equivalence.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a stylized symbol. The symbol resembles an abstract human form or a stylized eagle. The logo is presented in black and white.

Food and Drug Administration 0903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 16th 2013

Cook. Incorporated C/O Mr. Sean Spence Regulatory Affairs Team Lead 750 Daniels Way P.O. Box 489 BLOOMINGTON IN 47402-0489

Re: K132334

Trade/Device Name: Turbo-Ject® Peripherally Inserted Central Venous Catheter Set PICC Set Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: July 25, 2013 Received: July 26, 2013

Dear Mr. Spence:

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.

{4}------------------------------------------------

Page 2 - Mr. Spence

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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,

Mary S. Runner -S

Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Cook Incorporated Special SIO(k) Premarket Notification - K 132334 Turbo-Ject® PICC Set August 1, 2013

510(k) Number (if known): K132334

Device Name: Turbo-Ject® PICC Set

Indications for Use:

Turbo-Ject Peripherally Inserted Central Venous Catheter (PICC) Sets and Trays are intended 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 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 Turbo-Ject PICC may not exceed 325 psi and the flow rate may not exceed the maximum flow rate indicated.

Prescription Use _ X (Per 21 CFR 801 Subpart D)

.

OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) 、1000年の1000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

Image /page/5/Picture/11 description: The image contains some text on the right side. The text says "Richard C. Chapman 2013.08.16 13:39:33 -04". The text appears to be a name, date, and time. The rest of the image is blurry and hard to make out.

Richard C. Chapman 13:39:33 -04'00'

510(k) Number: K132334