Turbo-Ject 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 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 rated indicated, as shown on the following table.

Catheter Size	Maximum Flow Rate*	Injection PressureLimit Setting
4 Fr Single Lumen	4 ml/sec	325 psi
4 Fr Double Lumen	3 ml/sec	325 psi
5 Fr Single Lumen	7 ml/sec	325 psi
5 Fr Double Lumen	5 ml/sec	325 psi

*Flow rates achieved using room temperature Omnipaque 3000 contrast and veriffed using a Medrad Stellant® 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. Omnipaque 300® is a registered trademark of Amersham Health, New Jersey.

Device Description

The Turbo-Ject PICC catheters are radiopaque polyurethane peripherally inserted central venous catheters for short or long-term use. The Turbo-Ject PICC catheters are 60 cm in length and available in 4 and 5 Fr single lumen and 4 and 5 Fr double lumen.

The set components include an introducer needle, wire guide, locking Peel-Away sheath introducer, 12cc syringe and hydrophilic-coated wire guide obturator for non-over-thewire versions. The tray components include all set items in addition to 22 and 25 gauge needles, lidocaine, antiseptic sponges, drape, gauze, 3 cc syringe, suture with needle and needle holder. The set components will be the same for the single and double lumen Turbo-Ject PICC catheter.

AI/ML Overview

The provided text describes acceptance criteria and testing for the Turbo-Ject Peripherally Inserted Central Venous Catheter (PICC). However, it does not contain information about a study proving the device meets the acceptance criteria in the context of an AI/ML device, as requested in the prompt. The device described is a physical medical device, not an AI/ML algorithm. Therefore, many of the requested fields related to AI/ML studies cannot be addressed from the given document.

Here's a breakdown of what can be extracted and what cannot, based on the provided text:

Acceptance Criteria and Device Performance (as much as can be derived for a physical device):

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Maximum Flow Rate (Contrast Injection)	Maximum pressure limit setting for power injectors not to exceed 325 psi. Flow rates not to exceed indicated maximums (e.g., 4 Fr Single Lumen: 4 ml/sec, 5 Fr Single Lumen: 7 ml/sec, etc.).	The device was tested and achieved the specified flow rates using room temperature Omnipaque 300® contrast and verified with a Medrad Stellant® CT injector system.
Mechanical Performance	Reliable design and performance under specified testing parameters for: 1. Flow rate tests, 2. Static burst failure pressure tests, 3. Cyclic fatigue test, 4. Liquid leakage under pressure test, 5. Air leakage during aspiration test, 6. Tensile strength tests, 7. Bond strength test, 8. Shelf life testing.	"The Turbo-Ject PICC Catheter was subjected to the following tests to assure reliable design and performance under the specified testing parameters. The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a PICC catheter." Specific numerical results for each test are not detailed in this summary.
Biocompatibility	Biocompatibility requirements met.	Biocompatibility tests were performed. ("Biocompatibility tests"). Specific results are not detailed.
Sterilization	Sterilization similar to currently marketed and distributed devices.	"This device will undergo sterilization similar to the devices currently marketed and distributed."
Packaging	Packaging similar to currently marketed and distributed devices.	"This device will undergo packaging similar to the devices currently marketed and distributed by Cook Incorporated."

Since the device described is a physical medical device and not an AI/ML algorithm, the following sections cannot be answered from the provided document as they pertain to AI/ML device studies:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for a physical medical device. The document mentions tests but not a "test set" in the context of data for an algorithm.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. Ground truth for an AI/ML algorithm is not relevant for the physical performance tests of a catheter.
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. This relates to AI/ML performance compared to human performance, which is not relevant for a catheter's physical properties.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for a physical device's performance is adherence to engineering specifications and safety standards, validated through physical testing.
The sample size for the training set: Not applicable. No training set for an AI model.
How the ground truth for the training set was established: Not applicable.

In summary, the provided document details the safety and performance testing for a physical medical device (Turbo-Ject PICC Catheter) to demonstrate its substantial equivalence to predicate devices, rather than an AI/ML diagnostic or therapeutic device.

Summary

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K072625

1 of 2

510(k) Summary

Submitted By:

Karen Bradburn, RAC Senior Regulatory Affairs Specialist Cook Incorporated 750 Daniels Way, PO Box 489 Bloomington, IN 47402 812-339-2235

Device:

Trade Name: Turbo-Ject Peripherally Inserted Central Venous Catheter (PICC) Proposed Classification: Percutaneous, Implanted, Long-Term Intravascular Catheter (LJS)

Indications for Use:

Catheter Size	Maximum Flow Rate*	Injection PressureLimit Setting
4 Fr Single Lumen	4 ml/sec	325 psi
4 Fr Double Lumen	3 ml/sec	325 psi
5 Fr Single Lumen	7 ml/sec	325 psi
5 Fr Double Lumen	5 ml/sec	325 psi

Predicate Devices:

The Turbo-Ject PICC Catheter is similar in terms of intended use, materials of construction and technological characteristics to predicate devices,

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Device Description:

Substantial Equivalence:

This device will be manufactured according to specified process controls and a Quality Assurance Program. This device will undergo packaging similar to the devices currently marketed and distributed by Cook Incorporated. This device will undergo sterilization similar to the devices currently marketed and distributed. Being similar with respect to indications for use, materials and physical construction to predicate devices, this device meets the requirements for section 510(k) substantial equivalence.

Test Data:

The Turbo-Ject PICC Catheter was subjected to the following tests to assure reliable design and performance under the specified testing parameters. These tests were comprised of:

Flow rate tests ﺴﻬ
1. Static burst failure pressure tests
1. Cyclic fatigue test
1. Liquid leakage under pressure test
1. Air leakage during aspiration test
Tensile strength tests 6.
Bond strength test 7.
1. Shelf life testing
1. Biocompatibility tests

The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a PICC catheter.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three human profiles facing to the right, with flowing lines connecting them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 3 2007

Ms. Karen Bradburn Senior Regulatory Affairs Specialist Cook Incorporated 750 Daniels Way P.O. Box 489 Bloomington, Indiana 47402

Re: K072625

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: September 14, 2007 Received: September 18, 2007

Dear Ms. Bradburn:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. Bradburn

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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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,

Chiu Lin, Ph.D.

Chiu Lin, Ph.D. 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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510(k) Number (if known):

Device Name: Turbo-Ject Peripherally Inserted Central Venous Catheter (PICC)

Kora675

Indications for Use:

Catheter Size	Maximum Flow Rate*	Injection PressureLimit Setting
4 Fr Single Lumen	4 ml/sec	325 psi
4 Fr Double Lumen	3 ml/sec	325 psi
5 Fr Single Lumen	7 ml/sec	325 psi
5 Fr Double Lumen	5 ml/sec	325 psi

*Flow rates achieved using room temperature Omnipague 300® contrast and vertified using a Medrad Stellant® CT injector system. Omnipage 300 has a viscosity of 11.8 centipoise at room temperature (20 degrees C). A change in temperature or viscosìty of the contrast medium used will result in a change in achievable flow rates. Omnipaque 300€ is a registered trademark of Amersham Health, New Jersey.

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)

Cuma Vm

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

510(k) Number: _ 麻雀门26고S

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.”