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 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.

AI/ML Overview

This document describes the 510(k) summary for the Cook Turbo-Ject® Peripherally Inserted Central Venous Catheter Set (K132334). The submission primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device (K072625) through design modifications and performance testing, rather than a clinical study involving human readers or extensive ground truth establishment.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes performance testing to support substantial equivalence. The "acceptance criteria" are implied by conformance to standards and successful test outcomes.

Acceptance Criteria (Implied)	Reported Device Performance
Peak load value greater than 10 N (per ISO 10555-1:1995)	Testing demonstrated that the peak load value was greater than 10 N.
Catheters did not fail during simulated dynamic pressure use	Testing demonstrated that the catheters did not fail during simulated use.
Static failure pressure was at or above the acceptance criterion	Testing demonstrated that static failure pressure was at or above the acceptance criterion.
Catheter did not leak liquid	Testing demonstrated that the catheter did not leak liquid.
Catheter did not exhibit air leakage	Testing demonstrated that the catheter did not exhibit air leakage.
(Implied) Flow Rate Acceptance for 4.0 Fr Single Lumen	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, indicating it met or exceeded the predicate's performance for this parameter.

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

The document primarily describes bench testing for physical and mechanical properties of the device.

Sample Size: The document does not specify the exact number of units or samples used for each test (e.g., how many catheters were tested for tensile strength).
Data Provenance: The data provenance is from laboratory bench testing of the manufactured device. There is no information regarding country of origin for data or whether it's retrospective or prospective, as this is laboratory testing, not clinical data.

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

Not applicable. This submission relies on engineering and laboratory performance testing, not expert-adjudicated clinical data requiring ground truth establishment by healthcare professionals for diagnostic accuracy.

4. Adjudication Method for the Test Set

Not applicable. As this is bench testing of physical properties, there is no adjudication method in the context of clinical interpretation or diagnostic performance. Test results are objective measurements against predefined criteria.

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

Not applicable. This is a submission for a medical device (PICC catheter), not an artificial intelligence (AI) or imaging diagnostic device. Therefore, no MRMC study or AI-assisted assessment of human readers was conducted.

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

Not applicable. This is a physical medical device; there is no algorithm or standalone performance to evaluate.

7. The Type of Ground Truth Used

The "ground truth" for the performance tests described would be the physical and mechanical properties of the catheter as measured in a controlled laboratory environment against established engineering and international performance standards (e.g., ISO 10555-1:1995).

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device, so there is no "training set."

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

Not applicable. As there is no training set, there is no ground truth establishment for it.

Summary

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COOK INCORPORATED
750 DANIELS WAY, P.O. BOX 489
BLOOMINGTON, IN 47402-0489 0.5.A.
PHONE: 812.339.2235 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 (812) 335-3575 x102607 or x105127 (812) 332-0281

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:

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.

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	Turbo-Ject PICC: K072625(Predicate - 4.0 Fr only)	Turbo-Ject PICC Set(Subject Devices)
Classification	21 CFR §880.5970, LJS: Percutaneous,Implanted, Long-Term Intravascular Catheter	Identical
Intended Use	Intended for short- or long-term use for venouspressure monitoring, blood sampling,administration of drugs and fluids, and for usewith power injectors for delivery of contrast inCT studies. The maximum pressure limitsetting for Power Injectors used with theTurbo-Ject PICC may not exceed 325 psi andthe flow rate may not exceed the maximumflow rated indicated.	Identical
Catheter Shaft Material	Polyurethane	Polyurethane
French Size / Length (cm)	4.0 / 60	Identical
Number of Lumens	4.0 Fr - Single lumen4.0 Fr - Double lumen	Identical
Flow Rate	4.0 Fr Single lumen - 4 mL/sec4.0 Fr Double lumen - 3 mL/sec	4.0 Fr Single lumen - 5 mL/sec4.0 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 - 0.0304.0 Fr Double lumen - 0.015/0.035*	4.0 Fr Single lumen - 0.0374.0 Fr Double lumen -0.022/0.038*
Outside Diameter (inch)	4.0 Fr Single lumen - 0.0534.0 Fr Double lumen - 0.053	4.0 Fr Single lumen - 0.0554.0 Fr Double lumen - 0.055
Primary set components	Obturator, Peel-Away® introducer, entryneedles, wire guide, injection caps, syringe,scalpel, and securement device	Identical

Table 1: Comparison to Predicate

*height/width

Device Description:

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.

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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.

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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.

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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

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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:

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

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

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

510(k) Number: K132334

Regulation Number and Section

§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.

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