Turbo-Ject Peripherally Inserted Central Venous Catheter (PICC) Sets and Trays are intended for shortor 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 subject 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-thewire. The subject devices are minimally tapered 5.0 Fr single and double lumen catheters. 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

The provided text (K132883) describes the testing and acceptance criteria for the "Turbo-Ject® Peripherally Inserted Central Venous Catheter Set". This is a medical device, and the testing described here relates to its mechanical performance and safety, not an AI/ML-driven diagnostic or image analysis device. As such, many of the requested categories (e.g., number of experts, adjudication method, MRMC study, training set ground truth) are not applicable to this type of device and study.

However, I can extract the relevant information regarding the acceptance criteria and the performance studies as described in the document.

Summary of Device Acceptance Criteria and Performance Study for a Medical Device (Turbo-Ject® PICC Set):

The device is a non-AI/ML medical device (a catheter set). The acceptance criteria and testing focus on physical and mechanical performance to ensure safety and effectiveness, not diagnostic accuracy or human-AI interaction.

1. Table of Acceptance Criteria and Reported Device Performance:

Test	Acceptance Criterion	Reported Device Performance
Tensile Testing (ISO 10555-1:1995)	Peak load value greater than 10 N	Demonstrated that the peak load value was greater than 10 N
Dynamic Pressure Testing	Catheter did not fail during simulated use	Demonstrated that the catheter did not fail during simulated use
Static Failure Pressure	Static failure pressure at or above acceptance criterion	Demonstrated that static failure pressure was at or above the acceptance criterion
Liquid Leakage Testing	Catheter did not leak liquid	Demonstrated that the catheter did not leak liquid
Air Leakage Testing	Catheter did not exhibit air leakage	Demonstrated that the catheter did not exhibit air leakage

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

The document does not specify the exact sample sizes (number of units tested) for each mechanical test.
The data provenance is not explicitly stated in terms of country of origin for the data or whether it was retrospective or prospective. These are typically laboratory-based engineering tests conducted by the manufacturer (Cook Incorporated, U.S.A.).

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not Applicable. This is a mechanical device, not one requiring expert human interpretation for ground truth. Ground truth for these tests is established by physical measurement and engineering standards (e.g., ISO standards, pressure gauges, leakage detection methods).

4. Adjudication Method for the Test Set:

Not Applicable. As mentioned above, these are objective mechanical tests, not subjective assessments requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No. An MRMC study is relevant for AI/ML diagnostic devices where human readers interpret medical images. This device is a catheter set, and its performance is assessed through laboratory mechanical testing.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done:

Not Applicable. This is a physical medical device, not an algorithm. The "standalone" performance is the mechanical test results themselves.

7. The Type of Ground Truth Used:

The ground truth for these tests is based on engineering standards, physical measurements, and objective pass/fail criteria derived from the device's intended physical performance and safety requirements (e.g., a certain tensile strength, absence of leakage, ability to withstand pressure).

8. The Sample Size for the Training Set:

Not Applicable. This device development did not involve a "training set" in the context of machine learning. The design and manufacturing process would involve internal development and validation, but not a distinct machine learning training set.

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

Not Applicable. See point 8.

Summary

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K132883

Image /page/0/Picture/1 description: The image shows the logo for Cook Medical. The word "COOK" is in large, bold, white letters on a black background. Below "COOK" is the word "MEDICAL" in smaller, white letters. The logo is simple and professional.

COOK INCORPORATED
750 DANIELS WAY, P.O. BOX 489
BLOOMINGTON, IN 47402-0489 U.S.A.
MONE: 812.339.2235 TOU PREF: 800.457.4500
WWW.COOKMEDICAL.COM

510(k) SUMMARY Turbo-Ject® Peripherally Inserted Central Venous Catheter Set 21 CFR $807.92 Date Prepared: September 13, 2013

Submitted By:

Applicant: Contact: Applicant Address:

Contact Phone Number: Contact Fax Number:

Cook Incorporated Sean Spence, RAC Cook Incorporated 750 Daniels Way Bloomington, IN 47404 (812) 335-3575 x105127 (812) 332-0281

OCT 1 1 2013

Device Information:

Turbo-Ject® Peripherally Inserted Central Venous Catheter Set Trade name: Common name: PICC Set Classification Name: Percutaneous, implanted, long-term intravascular catheter 21 CFR §880.5970 Regulation: Product Code: ાં રાજ

Intended Use:

Predicate Devices:

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

Comparison to Predicate Device:

It has been demonstrated that the subject Turbo-Ject® PICC Sets are comparable to the predicate. Both are intended for short- or long-term use for venous pressure monitoring, administration of drugs and fluids, and for use with power injectors for delivery of contrast in CT studies. In addition. the subject devices and predicate are substantially equivalent in terms of design.

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Device Description:

Test Data:

The following tests were performed to demonstrate that the subject 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 catheter did not fail during simulated use.
. Static Failure Pressure - Testing demonstrated that static failure pressure was at or above the acceptance criterion.
. Liquid Leakage Testing - Testing demonstrated that the catheter did not leak liquid.
들 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.

COMPANY CONFIDENTIAL

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Public Health Service

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

October 11, 2013

Cook, Incorporated C/O Mr. Sean Spence, RAC 750 Daniels Way BLOOMINGTON IN 47404

Re: K132885

Trade/Device Name: Turbo-Jet® PICC Set Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: September 13, 2013 Received: September 16, 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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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/ReportalProblem/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 vours.

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 510(k) Premarket Notification Turbo-Ject® PICC Set September 2013

K 132885 510(k) Number (if known):

Device Name: Turbo-Ject® PICC Set

Indications for Use:

Turbo-Ject Peripherally Inserted Central Venous Catheter (PICC) Sets and Trays are intended for shortor 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 Iimit 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)

Over the Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Image /page/4/Picture/10 description: The image shows the logo of the Food and Drug Administration (FDA). The logo is a stylized version of the letters "FDA". The letters are made up of small, geometric shapes, giving the logo a textured appearance. The logo is black and white.

Richard C. Chapman 2013.10.11 15:56:55 -04'00'

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.”