The 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 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 Turbo-Ject® PICC catheters 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 currently marketed Turbo-Ject® PICCs are available in the following configurations: 4.0 Fr single lumen, 5.0 Fr single lumen, and 5.0 Fr double lumen. The currently marketed Spectrum® Turbo-Ject® PICCs are available in the following antimicrobial agent impregnated configurations: 3.0 Fr single lumen, 4.0 Fr single lumen, 5.0 Fr single lumen, 5.0 Fr double lumen, and 6.0 Fr triple lumen. The proposed devices add two additional non-impregnated configurations, a 3.0 Fr single lumen catheter and a 6.0 Fr triple lumen catheter.

AI/ML Overview

The provided text describes a Special 510(k) submission for a device modification, not a study evaluating an AI device or algorithm. Therefore, many of the requested categories (such as sample size for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and data provenance) are not applicable to this document.

The document focuses on demonstrating substantial equivalence for modifications to existing Peripherally Inserted Central Venous Catheters (PICCs) by Cook Incorporated. The "acceptance criteria" discussed are for the physical and functional performance of the medical device itself, not for the performance of an AI algorithm.

Here's a summary of the information that can be extracted relevant to acceptance criteria and device performance:

1. Table of Acceptance Criteria and Reported Device Performance

Test Type	Acceptance Criteria (Stated or Implied)	Reported Device Performance
Static Failure Pressure Testing	Pressures reached during proper clinical use (maximum pressure at maximum flow rate) are less than the static burst pressure of the catheter; catheter should not fracture or rupture.	Predetermined acceptance criteria met. (Implies the device did not fracture or rupture and clinical pressures were below burst pressure).
Flow Rate Testing	Pressure exerted at the maximum flow rate during proper clinical use should not fracture or rupture the catheter.	Predetermined acceptance criteria met. (Implies the device performed as expected without fracture/rupture at specified flow rates).
Tensile Strength Testing	Tensile strength during proper clinical use should not fracture or rupture the catheter. Conformance with BS EN ISO 10555-1:2009.	Predetermined acceptance criteria met. (Implies conformance to standard and no fracture/rupture under clinical tensile forces).
Biocompatibility Testing	Device is biocompatible. Conformance with BS EN ISO 10993-1:2009.	Predetermined acceptance criteria met. (Implies conformance to standard and biocompatibility).

Note on Flow Rates: The document also specifies performance for maximum flow rates and injection pressure limits, which are part of the device's functional performance:

Catheter Size	Maximum Flow Rate*	Injection Pressure Limit Setting	Device Performance (Achieved)
3.0 Fr Single Lumen	2 mL/sec	325 psi	2 mL/sec @ 325 psi
4.0 Fr Single Lumen	4 mL/sec	325 psi	4 mL/sec @ 325 psi
5.0 Fr Single Lumen	7 mL/sec	325 psi	7 mL/sec @ 325 psi
5.0 Fr Double Lumen	5 mL/sec	325 psi	5 mL/sec @ 325 psi
6.0 Fr Triple Lumen**	7 mL/sec	325 psi	7 mL/sec @ 325 psi
*Flow rates verified using room temperature Omnipaque 300® contrast and a Medrad Stellant® CT injector system.
**Lumen #1 only.

Information Not Applicable to this Document (as it's not an AI/algorithm study):

Sample size used for the test set and the data provenance: Not applicable. This document describes physical device testing, not data-driven algorithm validation.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for physical device testing is typically based on engineering standards and measurements, not expert consensus on images/data.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For this type of device, "ground truth" for the tests mentioned (Static Failure Pressure, Flow Rate, Tensile Strength, Biocompatibility) would be established by validated engineering tests and adherence to international standards (e.g., BS EN ISO 10555-1:2009 for tensile strength, BS EN ISO 10993-1:2009 for biocompatibility).
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary

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Special 510(k): Device Modification Turbo-Ject® Peripherally Inserted Central Venous Catheter (PICC) COOK INCORPORATED 6 June 2011

¹K111244

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JUN 1 4 2011

510(k) SUMMARY

Mironda Carpenter Submitted By: Regulatory Affairs Specialist Cook Incorporated 750 Daniels Way, P.O. Box 489 Bloomington, IN 47402 (812) 339-2235 x 2827 June 6, 2011

Device:

Trade Name:	Turbo-Ject® PICC Set
Proposed Classification Name:	Percutaneous, Implanted, Long-Term IntravascularCatheter
	21 CFR §880.5970, Product Code LJS

Indications for Use:

Catheter Size	Maximum FlowRate*	Injection Pressure LimitSetting
3.0 Fr Single Lumen	2 mL/sec	325 psi
4.0 Fr Single Lumen	4 mL/sec	325 psi
5.0 Fr Single Lumen	7 mL/sec	325 psi
5.0 Fr Double Lumen	5 mL/sec	325 psi
6.0 Fr Triple Lumen**	7 mL/sec	325 psi

*Flow rates achieved using room temperature Omnipaque 3000 contrast and verified using a Medrad Stellante 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 GE Healthcare.

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Special 510(k): Device Modification Turbo-Ject® Peripherally Inserted Central Venous Catheter (PICC) COOK INCORPORATED 6 June 2011

Predicate Devices:	Turbo-Ject® Peripherally Inserted Central Venous Catheter(PICC), 510(k) number K072625
	Spectrum® Turbo-Ject® Peripherally Inserted CentralVenous Catheter (PICC), 510(k) number K100974

Device Description:

Substantial Equivalence:

The proposed Turbo-Ject® PICC is similar to many devices in commercial distribution 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 Turbo-Ject® PICC in 3.0 Fr and 6.0 Fr are within the range of previously cleared Turbo-Jecte PICC devices (cleared under premarket notification 510(k) number K072625) in regards to the intended use, technological characteristics, and material. The Turbo-Ject® PICC in 3.0 Fr and 6.0 Fr are also within the range of previously cleared Spectrum® Turbo-Ject® PICC devices (cleared under premarket notification 510(k) number K100974) in regards to intended use, technological characteristics, and configurations.

The differences between the proposed Turbo-Ject® PICC and the predicate Turbo-Ject® PICC, D.C. # K072625, include French size, length (proposed 3.0 Fr device is shorter), number of lumens (proposed 6.0 Fr device has three lumens), and flow rate. The difference between the proposed Turbo-Ject® PICC and the predicate Spectrum® Turbo-Ject® PICC, D.C. # K100974, is the antimicrobial agent on the predicate device. The proposed devices add two additional nonimpregnated configurations, a 3.0 Fr single lumen catheter and a 6.0 Fr triple lumen catheter. The similar technological characteristics of the devices support a determination of substantial equivalence.

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Special 510(k): Device Modification Turbo-Ject® Peripherally Inserted Central Venous Catheter (PICC) COOK INCORPORATED 6 June 2011

Test Data:

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

Static Failure Pressure Testing shows the pressures reached during proper clinical use . (maximum pressure at maximum flow rate) are less than the static burst pressure of the catheter, and should not fracture or rupture the catheter. Predetermined acceptance criteria met.
Flow Rate Testing shows the pressure exerted at the maximum flow rate during proper . clinical use should not fracture or rupture the catheter. Predetermined acceptance criteria met.
Tensile Strength Testing shows the tensile strength during proper clinical use should . not fracture or rupture the catheter. In conformance with the applicable sections of BS EN ISO 10555-1:2009, predetermined acceptance criteria were met.
Biocompatibility Testing shows the device is biocompatible. In conformance with the . applicable sections of BS EN ISO 10993-1:2009, predetermined acceptance criteria were met.

In conclusion, the results of these tests provide reasonable assurance that the device is safe and effective for its intended use and supports a determination of substantial equivalence.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with its wings spread, and below the eagle are three wavy lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

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

JUN 1 4 2011

Ms. Mironda Carpenter Regulatory Affairs Specialist Cook, Incorporated 750 Daniels Way P.O. Box 489 Bloomington, Indiana 47402

Re: K111244

Trade/Device Name: Turbo-Ject® Peripherally Inserted Central Venous Catheter (PICC) Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: June 6, 2011 Received: June 7, 2011

Dear Ms. Carpenter:

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. Carpenter

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 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Anthony D. Avaturn

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 Turbo-Ject® Peripherally Inserted Central Venous Catheter (PICC) COOK INCORPORATED 2 May 2011

Indications for Use

510(k) Number (if known):
---------------------------	--

Device Name:

... ► n

Turbo-Ject® Peripherally Inserted Central Venous Catheter (PICC)

Indications for Use: -

Catheter Size	Maximum Flow Rate*	Injection PressureLimit Setting
3.0 Fr Single Lumen	2 mL/sec	325 psi
4.0 Fr Single Lumen	4 mL/sec	325 psi
4.0 Fr Double Lumen	3 mL/sec	325 psi
5.0 Fr Single Lumen	7 mL/sec	325 psi
5.0 Fr Double Lumen	5 mL/sec	325 psi
6.0 Fr TripleLumen**	7 mL/sec	325 psi

*Flow rates achieved using room temperature Omnipague 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 viscosiv of the contrast medium used will result in a change in achievable flow rates. **Lumen #1 only.

Omnipaque 300® is a registered trademark of GE Healthcare.

Prescription Use XX

OR Over-the-Counter Use -----------

(Per 21 CFR 801.109)

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

Concurrence of CDRH Office of Device Evaluation (ODE)

Division Sign-Off)
RICHARD CHAPMAN

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K111244

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.”