Turbo-Flo® Peripherally Inserted Central Venous Catheters (PICC) are 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 maximum pressure setting/limit of power injectors used with the Turbo-Flo PICC may not exceed 300 psi for the 5 Fr single lumen and 200 psi for the 4 Fr single lumen and 5 Fr double lumen. The Turbo-Flo PICC is indicated for a single injection of contrast media through a power injection.

Device Description

Turbo-Flo® PICCs are polyurethane peripherally inserted central venous catheters 60 cm in length, available in 4 & 5 Fr single lumen and 5 Fr double lumen for short and long-term use. Catheters are inserted using an obturator version or an over-the-wire version.

AI/ML Overview

The provided document describes a Premarket Notification (510(k)) for the Cook Turbo-Flo® PICC, a peripherally inserted central venous catheter. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving de novo safety and effectiveness through clinical trials. Therefore, the information requested about acceptance criteria and a study proving those criteria are met, particularly in the context of AI/MRMC studies, ground truth establishment, and training sets, is not fully applicable or present in this document.

However, I can extract the relevant information regarding the device's performance claims and the testing conducted to support its substantial equivalence.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not present explicit, quantifiable acceptance criteria with corresponding performance metrics in a tabular format as would be seen in a de novo approval or a study with predefined endpoints. Instead, it states that the device "has undergone testing which provide reasonable assurance of safety and effectiveness for its intended use equivalent to predicate devices."

The types of testing conducted are listed:

Acceptance Criterion (Implicit)	Reported Device Performance (Implicit – "Equivalent to predicate devices")
Tensile Strength	Met requirements for safe and effective use.
Flow Rate	Met requirements for safe and effective use.
Leakage	Met requirements for safe and effective use.
Stability	Met requirements for safe and effective use.
Biocompatibility	Met requirements for safe and effective use.
Power Injector Limits:
5 Fr Single Lumen	Capable of withstanding 300 psi (maximum).
4 Fr Single Lumen	Capable of withstanding 200 psi (maximum).
5 Fr Double Lumen	Capable of withstanding 200 psi (maximum).

Note: The FDA letter explicitly adds a limitation based on these tests: "The safe and effective use of the 4 Fr Single Lumen and 5 Fr Double Lumen Turbo-Flo PICC catheters with power injector pump pressure settings above 200 psi has not been established." This indicates that while the device was tested, the performance at higher pressures for these specific configurations was not deemed sufficiently proven.

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

Sample Size: Not specified. The document states "Testing included tensile, flow rate, leakage, stability, and biocompatibility," but does not detail the number of units tested for each.
Data Provenance: Not specified. It can be assumed these were laboratory (bench) tests conducted by Cook Incorporated, likely in the US (Bloomington, IN). The data is retrospective in the sense that it was generated prior to the 510(k) submission.

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

Not applicable. This is a medical device 510(k) Pre-Market Notification, not a study evaluating expert performance or AI. The "ground truth" for the device's physical and mechanical properties would be established by standard engineering and materials science testing methodologies, not by expert consensus in diagnostic interpretation.

4. Adjudication Method for the Test Set:

Not applicable. This is not a study involving human interpretation of data where adjudication would be necessary.

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

No, an MRMC comparative effectiveness study was not done. This document is for a physical medical device (catheter), not an AI algorithm for diagnostic imaging, and therefore, human reader performance with or without AI assistance is not relevant to this submission.

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

Not applicable. This document is for a physical medical device, not an algorithm.

7. The Type of Ground Truth Used:

The "ground truth" for the tests mentioned (tensile, flow rate, leakage, stability, biocompatibility) would be based on:

Engineering Specifications/Standards: Established industry standards (e.g., ASTM, ISO), internal Cook specifications, or regulatory guidelines for medical device materials and performance.
Physical Measurements: Direct measurements of tensile strength, flow rates, leakage volumes, and material stability through laboratory instrumentation.
Biological Assays: For biocompatibility, established in vitro and/or in vivo biological testing methods according to standards like ISO 10993.

8. The Sample Size for the Training Set:

Not applicable. This is a medical device 510(k) for a physical product, not an AI algorithm that requires a training set.

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

Not applicable, as there is no training set for a physical medical device.

Summary

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K041849

JUL 2 1 2005

COOK

Cook Incorporated 1.0. Box 489 Bloomington, IN 47402-0489 Phone: 800 468-1379 www.cookgroup com

510(k) Summary

Submitted by:	COOK INCORPORATED750 Daniels Way, PO Box 489Bloomington, IN 47402-0489
Contact Person:	Earl E. Knight III, MPARegulatory AffairsPh: (812) 339-2235 Fax: (812) 332-0281
Date Prepared:	July 15, 2004
510(k) #:	K041849
Device:Trade Name:Common/Usual Name:Proposed Classification:	Turbo-Flo® PICCPeripherally Inserted Central Venous CatheterPercutaneous, Implanted, Long-Term Intravascular Catheter21 CFR Part 880.5970 (80 LIS) Class II

Device Description:

Intended Use:

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Substantial Equivalence:

Manufacturer	Device	510(k) #
Cook Incorporated	Urethane PICC Line (Turbo-Flo®)	K992198
Cook Incorporated	Double Lumen Urethane PICC (Turbo-Flo®)	K010034
CR Bard	PowerPICCT™ Catheters	K033389

In terms of section 510(k) substantial equivalence, the Turbo-Flo® PICC is similar in terms of material design, intended use and technological characteristics to predicate intravascular catheters for short or long-term use.

Test Data:

The Turbo-Flo® PICC has undergone testing which provide reasonable assurance of safety and effectiveness for its intended use equivalent to predicate devices. Testing included tensile, flow rate, leakage, stability, and biocompatibility.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name encircling a symbol. The symbol is a stylized representation of three human figures, possibly representing health and well-being.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Cook Incorporated Earl E. Knight III, MPA 750 Daniels Way P.O. Box 489 Bloomington, Indiana 47402

JUL 2 1 2005

Re: K041849 Trade/Device Name: Turbo-Flo PICC Regulation Number: 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: April 21, 2005 Received: April 22, 2005

Dear Mr. Knight:

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). You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. 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.

The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Warnings section of the devices' labeling:

The safe and effective use of the 4 Fr Single Lumen and 5 Fr Double Lumen Turbo-Flo PICC catheters with power injector pump pressure settings above 200 psi has not been established.

Please note that the above labeling limitation is required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before this limitation is modified in any way or removed from the device's labeling.

The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as

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Page 2 - Mr. Knight

described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling.

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.

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); 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 information about the application of other labeling requirements to your device (21 CFR Part 801), please contact the Office of Compliance at (240) 276-Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html,

Sincerely yours,

onna-Bea Tillman, Ph.D. Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications For Use Statement

510(k) Number (if known): K041849

Turbo-Flo® Peripherally Inserted Central Venous Catheter Device Name:

Indications for Use:

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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Suite Y. Hicham (m)

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

510(k) Number: K 041189

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.”