Spectrum 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 catheter is impregnated with the antimicrobials minocycline and rifampin to help provide protection against catheter-related bloodstream infections (CRBSIs). The Spectrum 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 Spectrum 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 and 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 describes a 510(k) summary for the Cook Medical Spectrum Turbo-Ject® Peripherally Inserted Central Venous Catheter Set. It outlines the device's intended use, comparison to predicate devices, and the testing conducted to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance
Tensile Testing	Peak load value > 10 N	Peak load value was greater than 10 N
Dynamic Pressure Testing	Catheters do not fail during simulated use	Catheters did not fail during simulated use
Static Failure Pressure Testing	Static failure pressure at or above the acceptance criterion	Static failure pressure was at or above the acceptance criterion
Liquid Leakage Testing	Catheters do not leak liquid	Catheters did not leak liquid
Air Leakage Testing	Catheters do not exhibit air leakage	Catheters did not exhibit air leakage
Antimicrobial Testing	Minimum zone of inhibition of 15 mm	Catheters met the predetermined acceptance criteria

Note: For "Static Failure Pressure Testing" and "Antimicrobial Testing", the specific numerical acceptance criteria (other than >15mm for antimicrobial, which is also stated as "predetermined") are not explicitly defined in the document, but the document states the device met them.

2. Sample Size and Data Provenance

The document does not explicitly state the sample sizes used for each specific test (e.g., number of catheters tested for tensile strength or leakage).
The data provenance is retrospective, as the submission is for modifications to previously cleared devices (K081690, K072625, K132334, K132885). The testing was conducted to demonstrate substantial equivalence to these predicate devices. The country of origin of the data is not specified, but the applicant address is in Bloomington, IN, USA.

3. Number of Experts and Qualifications

The document does not mention the involvement of experts to establish ground truth for a test set. The tests describe physical and performance characteristics of the device, which are typically evaluated through laboratory testing against predefined engineering specifications.

4. Adjudication Method

Not applicable. This type of submission (510k for a medical device) typically relies on laboratory testing and engineering specifications rather than expert adjudication of a test set, which is more common in diagnostic device or AI algorithm evaluations.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was mentioned. The device is a "Peripherally Inserted Central Venous Catheter Set," a physical medical device, not a diagnostic imaging or AI-assisted system that would typically involve human readers.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This is a physical medical device, not an algorithm or AI system.

7. Type of Ground Truth Used

The "ground truth" for this device's performance is based on engineering specifications and established criteria for medical device safety and effectiveness. For example:

Tensile strength: Measured against a force (10 N).
Leakage: Absence of liquid/air leakage.
Pressure: Ability to withstand specified pressure (325 psi).
Antimicrobial activity: Measured zone of inhibition (15 mm).
These are objective, quantitative measurements against predefined standards.

8. Sample Size for the Training Set

Not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI. The design and manufacturing process would involve internal validation and verification activities, but these are not referred to as training sets.

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

Not applicable, as there is no training set for this type of device. The specifications and acceptable performance limits are derived from industry standards (e.g., ISO 10555-1:1995), regulatory requirements, and the performance characteristics of predicate devices.

Summary

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Image /page/0/Picture/0 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.

DEC 2 3 2013

510(k) SUMMARY - K133634 Spectrum Turbo-Ject® Peripherally Inserted Central Venous Catheter Set 21 CFR $807.92 Date Prepared: December 09, 2013

Submitted By:

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

Device Information:

Contact Fax Number:

Contact Phone Number:

Trade name:	Spectrum Turbo-Ject® Peripherally Inserted Central Venous Catheter Set
Common name:	PICC Set
Classification Name:	Percutaneous, Implanted, Long-Term Intravascular Catheter
Regulation:	21 CFR §880.5970
Product Code:	LJS

Intended Use:

Predicate Devices:

The Spectrum Turbo-Ject® PICC Sets, subject of this submission, are modifications to the following Cook Incorporated PICCs:

K081690, Spectrum Turbo-Ject® Peripherally Inserted Central Venous Catheter �
- O K072625, Turbo-Ject® Peripherally Inserted Central Venous Catheter
  - o K132334 & K132885, modifications to add minimal taper design

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

COOK INCORPORATED 750 DANIELS WAY. P.O. BOX 489 BLOOMINGTON, IN 47402-0489 U.S.A. 1. 012.339.2235 rou firer 800.457.4500 WWW.COOKMEDICAL.COM

Comparison to Predicate Devices:

The scope of this submission is to first add a minimal taper design modification to the 4.0 Fr single and 5.0 Fr single and double lumen antimicrobial (Spectrum) PICCs cleared in the primary predicate, K081690. Second, this submission will add a Spectrum 4.0 Fr double lumen configuration not found in the primary predicate. Complete performance testing, including power injection, was reviewed for a 4.0 Fr double lumen PICC without Spectrum under K072625. Subsequently, the design was modified under K132334 to a minimal taper. Due to market demand, the Spectrum technology from K081690 is being added to the 4.0 Fr double lumen device design cleared under K132334. Lastly, this submission is also meant to standardize the labeling (IFU) format with the non-Spectrum minimally tapered PICCs as amended during K132334 (4.0 Fr) and K132885 (5.0 Fr).

	Cook Spectrum Turbo-Ject PICCK081690!	Cook Spectrum Turbo-Ject PICC SetSUBJECT OF THIS SUBMISSION
Regulation Number/Product Code	21 CFR 880.5970, LJS	Identical
Classification Name	Intravascular Catheter	Identical
Class	II	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 catheter is impregnated withthe antimicrobials minocycline and rifampin tohelp provide protection against catheter-relatedbloodstream infections (CRBSIs). The Spectrum 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 Spectrum Turbo- Ject PICC may not exceed 325 psi and the flow rate may not exceed the maximum flow rated indicated.	Identical
Catheter Shaft Material.	Polyurethane	Identical
French Size /Length (cm)	4.0 and 5.0 / 60	Identical
Taper	2 Fr sizes	1 Fr size
Number of Lumens.	4.0 Fr - Single lumen4.0 Fr - Double lumen (K132334)5.0 Fr - Single lumen5.0 Fr - Double lumen	4.0 Fr - Single lumen4.0 Fr - Double lumen5.0 Fr - Single lumen5.0 Fr - Double lumen
Flow Rate.	4.0 Fr Single lumen - 4 mL/sec4.0 Fr Double lumen - 3 mL/sec (K132334)5.0 Fr Single lumen - 7mL/sec5.0 Fr Double lumen - 5mL/sec	4.0 Fr Single lumen - 5 mL/sec4.0 Fr Double lumen - 3 mL/sec5.0 Fr Single lumen - 7mL/sec5.0 Fr Double lumen - 5mL/sec
Maximum PressureRating	325 psi	Identical

Table 1: Comparison Table

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	Cook Spectrum Turbo-Ject PICC K081690'	Cook Spectrum Turbo-Ject PICC SetSUBJECT OF THIS SUBMISSION
Antimicrobial Agents	Minocycline• Synonym: Minocin• Chemical family : Tetracycline• Formula : C23 H27 N3 O7 · HClRifampin• Synonym: Rifampicin• Chemical family : Macrolide antibiotic• Formula : C43H58N4O12	Identical
Antimicrobial ActivitySpecification	Minimum zone of inhibition of 15 mm
Method ofantimicrobialapplication	Impregnation	Identical
Inside Diameter (inch)	4.0 Fr Single lumen - 0.0304.0 Fr Double lumen - 0.022/0.038* (K132334)5.0 Fr Single lumen - 0.0375.0 Fr Double lumen - 0.022/0.044*	4.0 Fr Single lumen - 0.0374.0 Fr Double lumen - 0.022/0.0385.0 Fr Single lumen - 0.0485.0 Fr Double lumen - 0.024/0.048
Outside Diameter (inch)	4.0 Fr Single lumen - 0.0534.0 Fr Double lumen - 0.055 (K132334)5.0 Fr Single lumen - 0.0665.0 Fr Double lumen - 0.066	4.0 Fr Single lumen - 0.0554.0 Fr Double lumen - 0.0555.0 Fr Single lumen - 0.0665.0 Fr Double lumen - 0.066
Primary set components	Obturator, Peel-Away introducer, entry needles,wire guide, injection caps, syringe, scalpel, andsecurement device	Identical

1K 132334 is referenced where appropriate for the 4.0 Fr double lumen device *height/width

Device Description:

Test Data:

The following tests were performed to demonstrate that the proposed Spectrum 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.

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Image /page/3/Picture/0 description: The image shows the logo for Cook Medical. The logo is in black and white, with the word "COOK" in large, bold letters on the top line. Below the word "COOK" is the word "MEDICAL" in smaller letters. The logo is simple and professional.

COOK INCORPORATED 750 DANIELS WAY, P.O. BOX 489

Dynamic Pressure Testing Testing demonstrated that the catheters did not fail during . simulated use.
Static Failure Pressure Testing demonstrated that static failure pressure was at or above the . acceptance criterion.
트 Liquid Leakage Testing - Testing demonstrated that the catheters did not leak liquid.
l Air Leakage Testing – Testing demonstrated that the catheters did not exhibit air leakage.
. Antimicrobial Testing - Testing demonstrated that the catheters met the predetermined acceptance criteria.

Conclusions Drawn from the Tests:

The results of these tests provide reasonable assurance that the Spectrum 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 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 23, 2013

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

Re: K133634

Trade/Device Name: Spectrum Turbo-Jet Peripherally Inserted Central Venous Catheter Set Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: November 25, 2013 Received: November 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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· 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/Resourcesfor YowIndustry/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 yours.

Kwame O Ulmer
-s FDA

for

Erin I. Keith, M.S. Acting 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

*** : : ... . ...

Indications for Use

510(k) Number (if known) K133634

Device Name

Spectrum (antimicrobial) Turbo-Ject PICCs

Indications for Use (Describe)

Spectrum Turbo-Ject Peripherally Inserted Central Venous Catherer (PICC) Sets and Trays are intended for short-or long-term use for venous pressure monitoring, blood sampling, administration of drugs and for use with power injectors for delivery of contrast in CT studies. The catheter is impregnated with the antimicrobials minocycline and rifampin to help protection against catherer-related bloodstream infections (CRBSIs). The Spectrum Turbo-Ject PICC is indicated for multiple injections of contrast media through a power injector. The maximum pressure liniectors used with the Spectrum Turbo-Ject PICC may not exceed 325 psi and the flow rate may not exceed the maximum flow rate indicated.

Type of Use (Select one or both, as applicable)

[ Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

Form Approved: OMB No. 0910-0120

Expiration Date: December 31, 2013

See PRA Statement on last page.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

CONTRACTORIE FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR Concurrence of Center for Devices and Radiological Health (CDRH) (Signalure)

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Digitally signed by Richard C. Chapman Date: 2013.12.23 14:21:50 -05'00'

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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.”