The Spectrum Turbo-JeCT PICC is indicated for short- or long-term use for yenous 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 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 Spectrum Turbo-JeCT PICC may not exceed 325 psi and the flow rate may not exceed the maximum flow rate indicated.

Device Description

The Spectrum Turbo-JeCT PICC catheters are radiopaque polyurethane peripherally inserted central venous catheters impregnated with the antimicrobials minocycline and rifampin for short- or long-term use. The devices are currently available in the following configurations: 4 Fr single lumen, 5 Fr single lumen, 5 Fr double lumen. The proposed devices add two additional configurations, more specifically, a 3 Fr single lumen catheter and a 6 Fr triple lumen catheter.

AI/ML Overview

The provided 510(k) summary describes a medical device modification (Spectrum® Turbo-JeCT™ PICC Set) and the testing performed to demonstrate its substantial equivalence to a predicate device. However, it does not detail a study involving AI or machine learning. Therefore, many of the requested categories related to AI performance, ground truth, and expert involvement are not applicable to this document.

Here's the information that can be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present acceptance criteria in a quantitative table for all tests. It lists the maximum flow rates for different catheter sizes and the maximum pressure limit setting, which can be interpreted as performance targets. The study, in essence, aimed to verify these stated flow rates and pressure limits.

Acceptance Criteria (Target)	Reported Device Performance (Achieved)
For all catheter sizes:
Injection Pressure Limit Setting:	325 psi (Stated as a maximum limit setting, implying the device can withstand this pressure without failure, and the flow rates are achieved at or below this pressure. The tests would confirm performance within this limit.)
Specific to Catheter Sizes (for Omnipaque 300® at 20°C with Medrad Stellant® CT injector):
3 Fr Single Lumen Maximum Flow Rate:	2 mL/sec (Flow rates were achieved for this configuration, implying it met or exceeded this target under the specified conditions. Implied acceptance: The device should achieve at least 2 mL/sec.)
4 Fr Single Lumen Maximum Flow Rate:	4 mL/sec (Flow rates were achieved for this configuration. Implied acceptance: The device should achieve at least 4 mL/sec.)
5 Fr Single Lumen Maximum Flow Rate:	7 mL/sec (Flow rates were achieved for this configuration. Implied acceptance: The device should achieve at least 7 mL/sec.)
5 Fr Double Lumen Maximum Flow Rate:	5 mL/sec (Flow rates were achieved for this configuration. Implied acceptance: The device should achieve at least 5 mL/sec.)
6 Fr Triple Lumen Maximum Flow Rate (Lumen #1 only):	7 mL/sec (Flow rates were achieved for this configuration. Implied acceptance: The device should achieve at least 7 mL/sec.)
Other Performance Requirements (Implicit Acceptance)	The device meets applicable design and performance requirements for:- Tensile Testing - Cyclic Bending - Zone of Inhibition - Elution Profile - Air and Liquid Leakage - Burst Pressure - Cyclic Pinch Clamping - HPLC Analysis - Stability Testing

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

The document lists "Test Data" but does not specify the sample sizes used for each test (Tensile Testing, Flow Rate, Cyclic Bending, etc.). It does mention "Flow rates achieved using room temperature Omnipaque 300® contrast and verified using a Medrad Stellant® CT injector system," indicating a laboratory-based, prospective testing methodology. There is no information regarding the country of origin of the data beyond the implied US-based manufacturing and testing by Cook Incorporated.

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

Not applicable. This is a medical device performance and safety study involving physical and chemical tests, not a diagnostic or AI-based study requiring expert ground truth for interpretation of complex data like images or patient records. The "ground truth" for these tests would be established by objective measurements against predefined specifications.

4. Adjudication Method for the Test Set

Not applicable. As noted above, this is not a study requiring human adjudication of results in the traditional sense. Test results would be generated by instruments and procedures, and then compared against engineering specifications or regulatory requirements.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC study was not done. This type of study is specifically for evaluating the performance of diagnostic systems or AI in clinical settings with human readers, which is not relevant to the physical and chemical performance tests described for this PICC line.

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

Not applicable. There is no algorithm or AI component discussed in this 510(k) summary. The "device" being tested is a physical medical catheter.

7. The Type of Ground Truth Used

The "ground truth" for this device modification study is based on engineering specifications, material science principles, and predefined performance targets for physical and chemical properties. For example, flow rates must meet specific mL/sec values, burst pressure must exceed a certain psi, and antimicrobial activity must be demonstrated (zone of inhibition). These are objective, measurable criteria, not subjective expert interpretations.

8. The Sample Size for the Training Set

Not applicable. There is no mention of a training set as this is not an AI or machine learning study.

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

Not applicable. As there is no training set, there is no ground truth for it to be established.

Summary

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Special 510(k): Device Modification Spectrum® TurboJeCT™ PICC Set COOK INCORPORATED 07 April 2010

KIO0974

510(k) SUMMARY

Submitted By:

Susanne Galin, RAC Regulatory Affairs Specialist Cook Incorporated 750 Daniels Way, P.O. Box 489 Bloomington, IN 47402 (812) 339-2235 x 2296 April 2, 2010

Device:

Trade Name:	Spectrum® Turbo-JeCT™ PICC Set
Proposed Classification Name:	Percutaneous, Implanted, Short- and Long-TermIntravascular Catheter21 CFR §880.5200, Product Code FOZ, LJS

Indications for Use:

Catheter Size	Maximum Flow Rate*	Injection PressureLimit Setting
3 Fr Single Lumen	2 mL/sec	325 psi
4 Fr Single Lumen	4 mL/sec	325 psi
5 Fr Single Lumen	7 mL/sec	325 psi
5 Fr Double Lumen	5 mL/sec	325 psi
6 Fr Triple Lumen **	7 mL/sec	325 psi

*Flow rates achieved using room temperature Omnipaque 300® contrast and verified 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. **Lumen #1 only.

Omnipaque 300® is a registered trademark of Amersham Health, New Jersey.

MAY - 6 2010

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Special 510(k): Device Modification Spectrum® TurboJeCTTM PICC Set COOK INCORPORATED 07 April 2010

Predicate Devices:

Spectrum® Turbo-JeCT™ PICC Set, 510(k) number K081690

Device Description:

Substantial Equivalence:

The Spectrum Turbo-JeCT PICC Sets in 3 Fr and 6 Fr sizes are identical to the predicate Spectrum Turbo-JeCT PICC Sets in 4 Fr and 5 Fr sizes (cleared under premarket notification 510(k) number K081680) in terms of intended use, technological characteristics, drugs used for impregnation, impregnation process, and material which support a determination of substantial equivalence.

Test Data:

The following tests were presented to demonstrate that the Spectrum Turbo-JeCT PICC Set meets applicable design and performance requirements.

Tensile Testing .
Flow Rate .
Cyclic Bending .
Zone of Inhibition .
Elution Profile �
Air and Liquid Leakage .
Burst Pressure .
Cyclic Pinch Clamping .
. HPLC Analysis
Stability Testing ●

The results of these tests provide reasonable assurance that the device is safe and effective for its intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle with three stripes representing the three levels of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.

Public Health Service

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

Ms. Susanne Galin, RAC Regulatory Affairs Specialist Cook, Incorporated 750 Daniels Way, P.O. Box 489 Bloomington, Indiana 47402

MAY - 6 2010

Re: K100974

Trade/Device Name: Spectrum® Turbo-JeCT™ Peripherally Inserted Central Venous Catheter (PICC) Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ, LJS Dated: April 7, 2010 Received: April 8, 2010

Dear Ms. Galin:

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. Galin

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 (OS) 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Susan Rurres

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 Spectrum® TurboJeCTTM PICC Set COOK INCORPORATED 07 April 2010

Indications for Use

510(k) Number (if known):

K100974

Device Name:

Spectrum® Turbo-JeCT™ Peripherally Inserted Central Venous Catheter (PICC)

Indications for Use:

The Spectrum 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 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 Spectrum Turbo-JeCT PICC may not exceed 325 psi and the flow rate may not exceed the maximum flow rate indicated.

Catheter Size	Maximum Flow Rate*	Injection PressureLimit Setting
3 Fr Single Lumen	2 mL/sec	325 psi
4 Fr Single Lumen	4 mL/sec	325 psi
5 Fr Single Lumen	7 mL/sec	325 psi
5 Fr Double Lumen	5 mL/sec	325 psi
6 Fr Triple Lumen**	7 mL/sec	325 psi

*Flow rates achieved using room temperature Omnipaque 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 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 Amersham Health, New Jersey.

Prescription Use XX (Per 21 CFR 801.109)

Over-the-Counter Use

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER

	PAGE IF NEEDED)
I

Sumalatha

Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number:	K1004
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Regulation Number and Section

§ 880.5200 Intravascular catheter.

(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).