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 catheterrelated 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 catheter is a radiopaque polyurethane peripherally inserted central venous catheter impregnated with antimicrobials and intended for short- or longterm use. The Spectrum Turbo-JeCT PICCs are 60 cm in length and available in 4 and 5 Fr single lumen and 5 Fr double lumen configurations.

The set components include an introducer needle, wire guide, locking Peel-Away introducer, 12cc syringe, drape, injection cap, catheter fixation device, tape measure, safety scalpel, and a hydrophilic-coated wire guide obturator for non-over-the-wire versions.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Spectrum® Turbo-JeCT™ PICC device:

The provided text is a 510(k) summary for a medical device (PICC catheter), which primarily focuses on demonstrating substantial equivalence to predicate devices and lists the types of tests performed. It does not contain the detailed information required to populate all the requested fields, especially concerning the acceptance criteria for each test, specific numerical results against those criteria, or complex study designs like MRMC studies or ground truth establishment for AI systems. This is typical for a 510(k) summary, which is a high-level overview.

However, I can extract what is present and indicate where information is missing.

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Implied/Explicit)	Reported Device Performance
PICC Catheter Performance (Explicit from Indications for Use)
Maximum Flow Rate:
4 Fr Single Lumen: Not to exceed 4 ml/sec (when using Omnipaque 300® at room temp and Medrad Stellant® CT injector)	Achieved (verified using Medrad Stellant® CT injector system)
5 Fr Single Lumen: Not to exceed 7 ml/sec (when using Omnipaque 300® at room temp and Medrad Stellant® CT injector)	Achieved (verified using Medrad Stellant® CT injector system)
5 Fr Double Lumen: Not to exceed 5 ml/sec (when using Omnipaque 300® at room temp and Medrad Stellant® CT injector)	Achieved (verified using Medrad Stellant® CT injector system)
Injection Pressure Limit Setting:
Maximum pressure limit setting for power injectors not to exceed 325 psi.	325 psi (This is the stated limit that the device is compatible with, implying it can withstand this or higher without failure, but no specific threshold for failure is given)
General Device Performance (Implied from listing of tests)
Flow rate tests: Not explicitly stated, but assumed to meet the flow rates specified above.	"The Spectrum 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 the summary.
Static burst failure pressure tests: Not explicitly stated, but implied to be sufficient for intended use (e.g., above 325 psi).	"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."
Cyclic fatigue test: Not explicitly stated, but implied to show durability over time for intended use.	"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."
Liquid leakage under pressure test: Not explicitly stated, but implied to demonstrate no leakage at intended pressures.	"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."
Air leakage during aspiration test: Not explicitly stated, but implied to demonstrate no air leakage during aspiration.	"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."
Tensile strength tests: Not explicitly stated, but implied to demonstrate sufficient strength to prevent breakage during use.	"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."
Bond strength tests: Not explicitly stated, but implied to demonstrate strong and reliable bonds between components.	"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."
Stiffness test: Not explicitly stated, but implied to meet requirements for insertion and flexibility.	"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."
Shelf life tests: Not explicitly stated, but implied to demonstrate stability and integrity over its intended shelf life.	"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."
Sterility tests: Not explicitly stated, but implied to meet sterility assurance level (SAL) requirements.	"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."
Biocompatibility tests: Not explicitly stated, but implied to meet ISO 10993 requirements for medical devices in contact with blood.	"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."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not specified in the provided summary for any of the tests.
Data Provenance: Not specified, but likely from in-house laboratory testing (prospective, non-clinical). The equipment used for flow rates (Medrad Stellant® CT injector system) is a commercial product. The "Omnipaque 300®" contrast is a commercial product (Amersham Health, New Jersey).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable. The device is a physical medical device (PICC catheter), not an AI/software device requiring expert interpretation of diagnostic images or data for ground truth establishment. The "ground truth" here is the physical performance of the catheter itself against engineering and physiological requirements.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This question is not applicable. Adjudication methods are typically used in clinical studies or studies involving human readers/interpreters to resolve discrepancies in diagnoses or assessments, not for physical performance testing of a catheter.

5. 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

This question is not applicable. This device is a physical catheter, not an AI or software device intended for diagnostic interpretation or to assist human readers. Therefore, an MRMC study comparing human readers with and without AI assistance was not performed.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This question is not applicable. This device is a physical catheter, not an algorithm or software. "Standalone performance" in this context would refer to the catheter's physical performance, as evaluated by the listed tests, independent of human operators (though human operators would be involved in setting up the tests). The tests performed are effectively "standalone" in this physical sense.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the physical performance tests would be defined by engineering specifications, regulatory standards, and established physiological requirements for central venous catheters. For example:
- Flow rate ground truth: The measured flow rate through the catheter compared against the specified maximum flow rate for safe and effective contrast delivery.
- Pressure ground truth: The pressure the catheter can withstand compared against the maximum allowed pressure for power injectors.
- Material integrity ground truth: Absence of leakage, breakage, or degradation under specified conditions.
- Biocompatibility ground truth: Absence of cytotoxic effects, sensitization, irritation, etc., as per ISO 10993 standards.

8. The sample size for the training set

This question is not applicable. This device is a physical catheter, not an AI/machine learning model that requires a "training set" of data.

9. How the ground truth for the training set was established

This question is not applicable for the same reason as #8.

Summary

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K081690-Response to Request for Additional Information Spectrum® Turbo-JeCTTM PICC Cook Incorporated

510(k) Summary

Submitted By:

$\Upsilon0\gamma/6,90$

JUL 1 4 2008

Nathan Simon, M.S. Regulatory Affairs Specialist Cook Incorporated 750 Daniels Way, PO Box 489 Bloomington, IN 47402 812-339-2235

Device:

Trade Name:	Spectrum® Turbo-JeCT™ Peripherally InsertedCentral Venous Catheter (PICC)
Proposed Classification:	Percutaneous, Implanted, Short- and Long-TermIntravascular Catheter(FOZ and LJS)

Indications for Use:

Catheter Size	Maximum Flow Rate*	Injection PressureLimit Setting
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

*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 (). A change in temperature on viscosity of the contrast medium used will result in a change in achievable flow rates. Omnipague 300® is a registered trademark of Amersham Health, New Jersey.

Predicate Devices:

The Spectrum Turbo-JeCT PICC Catheter is similar in terms of intended use, materials of construction and technological characteristics to predicate devices Cook Spectrum Silicone Catheter and Cook Turbo-JeCT PICC catheters that were found substantially equivalent under Premarket Notification #K021557, May 30, 2003 and #K072625, December 13, 2007, respectively.

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Device Description:

Substantial Equivalence:

Cook currently markets the PICC Catheter which is considered substantially equivalent to the Spectrum Turbo-JeCT PICC Catheter. The identical indications for use, principles of operation, similar materials of construction, and technological characteristics of the Spectrum Turbo-JcCT PICC Catheter as compared to the predicate devices support a determination of substantial equivalency.

Test Data:

The Spectrum 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:

1. Flow rate tests
1. Static burst failure pressure tests
1. Cyclic fatigue test
1. Liquid leakage under pressure test
Air leakage during aspiration test റ
1. Tensile strength tests
1. Bond strength tests
1. Stiffness test
1. Shelf life tests
1. Sterility tests
Biocompatibility tests 11.

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 seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle-like symbol on the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Nathan Simon Regulatory Affairs Specialist Cook, Incorporated P.O. Box 489 Bloomington, Indiana 47402 IJUL 1 4 2008

Re: K081690

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: June 16, 2008 Received: June 17, 2008

Dear Mr. Simon:

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 - Mr. Simon

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-[See Below For Phone Numbers]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Anthony D. norton
Shiela J. Perez

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

Indications for Use:

Catheter Size	Maximum Flow Rate*	Injection PressureLimit Setting
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

*Flow rates achieved using room temperature Omnipaque 3000 contrast and verified using a Medrad Stellant® CT iniector system. Omnipaque 300 has a viscosity of 11.8 centipoise at room temperature (20 degrees C). A change in temperature on 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.

Cintin Vm

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

510(k) Number: K481640

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)

Company Confidential

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).