The COOK Spectrum® Silicone Catheter is used for the intravenous administration of nutrient fluids, chemotherapeutic agents and other drugs for therapy, blood sampling, blood delivery, and venous pressure monitoring. The catheter is impregnated with the antimicrobials minocycline and rifampin to help provide protection against catheter-related bloodstream infections (CRBSI). It is not intended to be used as a treatment for existing infections. Catheters are available in single and double lumen PICC: and single, double and triple lumen CVC. The device is supplied sterile and intended for one-time use.

Device Description

The COOK Spectrum® Silicone Catheters are single, double or triple lumen central venous catheters; and single and double lumen peripherally inserted central catheters available in sizes ranging from 4Fr single lumen to 12Fr double lumen. including an 8Fr triple lumen device. Catheter lengths range from 8 to 60 cm. The catheter is impregnated with an antimicrobial combination of minocycline and rifampin. The device is supplied sterile and intended for one-time use.

AI/ML Overview

The document describes a 510(k) premarket notification for the COOK Spectrum® Silicone Catheter, but it does not provide explicit acceptance criteria with numerical thresholds or a detailed study report that proves the device meets specific acceptance criteria for outcomes related to AI or algorithmic performance.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices and describes various non-clinical and clinical tests conducted to assure safety and effectiveness.

Here's an analysis based on the provided text, addressing your points where possible, and noting what information is not available in the document:

Description of Acceptance Criteria and Device Performance (Based on provided text)

The document describes several aspects tested to ensure safety and effectiveness, but it doesn't present these as explicit "acceptance criteria" with numerical targets and reported performance in a table format as you requested. Moreover, the focus is on a medical device (catheter) with antimicrobial properties, not an AI or algorithmic device.

Table 1: Acceptance Criteria and Reported Device Performance (Reconstructed from available information)

Acceptance Criteria (Implied)	Reported Device Performance (Summary from text)
Biocompatibility: Device material is safe for human contact.	Biocompatibility testing was performed. (No specific results or acceptance levels reported in this summary).
Mechanical Integrity (Tensile, Vacuum, Pressure): Catheter can withstand expected forces and pressures.	Tensile Testing, Vacuum and Pressure Testing were performed. (No specific results or acceptance levels reported).
Antimicrobial Effectiveness (Minocycline and Rifampin): Catheter impregnation effectively inhibits microbial growth.	HPLC and Zone of Inhibition Testing were performed.
Flow Performance: Catheter maintains adequate flow rates for intended use.	Flow Testing was performed. (No specific results or acceptance levels reported).
Shelf-Life Stability: Device maintains its properties over its shelf life.	Shelf-Life Testing was performed. (No specific results or acceptance levels reported).
Reduction of Catheter-Related Bloodstream Infection (CRBSI): Significantly reduces the rate of CRBSI.	In a prospective, randomized clinical trial, results indicate the COOK Spectrum® Silicone Catheter can significantly reduce the rate of catheter-related bloodstream infection (CRBSI).
Clinical Safety (Other Complications): Does not increase other complications compared to control.	Clinical safety was evaluated by comparing rates of each complication (other than CRBSI) for treatment vs. control cohort. (Implied that no significant increase was found, but no specific data provided).
Prevention of Catheter Colonization: Reduces microbial colonization on the catheter.	Catheters were evaluated after removal by zone of inhibition testing against MRSA (CI4371) and culture techniques (roll plate and sonication). (Relates to mechanism of CRBSI reduction, specific results not detailed).
Catheter Performance (Mechanical): Low incidence of leaks, bleeding, thrombosis, or need for repositioning.	Performance was evaluated by comparing incidence of catheter removal due to leak, bleeding, thrombosis, and incidence of repositioning between study groups. (Implied no adverse performance, specific data not detailed).

Detailed Study Information (Where Available or Not Applicable)

Sample size used for the test set and the data provenance:
- Test Set Sample Size: The document mentions a "prospective, randomized clinical trial" with "well matched treatment and control cohorts" but does not specify the sample size for either cohort.
- Data Provenance: The study was a "prospective, randomized clinical trial," implying real-world data collection, likely from clinical sites where the study was conducted. The country of origin is not specified, but Cook Incorporated is a US-based company.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This document describes a clinical trial for a physical medical device (catheter) and does not involve experts establishing "ground truth" for a test set in the context of an AI/algorithmic device. Clinical outcomes (CRBSI, complications) served as the primary endpoints, assessed by standard clinical methods.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable in the context of an AI/algorithmic medical device. Clinical trial outcomes are typically adjudicated by an independent clinical events committee or defined clinical criteria, but this is not detailed in the provided summary.
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 study is for a physical medical device, not an AI or image-reading algorithm.
If a standalone (i.e., algorithm only without human-in-the loop performance) was done:
- Not applicable. This study is for a physical medical device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the clinical trial, the "ground truth" for effectiveness was outcomes data, specifically the occurrence of "definite CRBSI" as the primary outcome measure. Clinical safety was also based on the incidence of various complications. Catheter colonization was determined by laboratory culture techniques (roll plate and sonication) and zone of inhibition testing against MRSA for removed catheters.
The sample size for the training set:
- Not applicable. This document describes a traditional medical device, not an AI/ML model that requires a training set. The clinical trial described is for validating the device's performance directly.
How the ground truth for the training set was established:
- Not applicable. As above, there is no AI/ML training set involved.

Summary

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K021557

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

MAY 3 0 2003

510(k) Summary

Page 1 of 2

Submitted by:	Cook Incorporated
Contact Person:	Jennifer Bosley, MBAPh: (812) 339-2235 x2093Fax: (812) 332-0281
Date Prepared:	March 26, 2003
510(k) #:	K021557
Device:	COOK Spectrum® Silicone Catheter
Trade Name:	Intravascular Catheter, Central Venous Catheter
Common/Usual Name:	Intravascular Catheter, Therapeutic, Long-term and Short-term
Proposed Classification:	21 CFR Part 880.5970 (80 LJS), Class II21 CFR Part 880.5200 (80 FOZ), Class II

Device Description:

Intended Use:

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Predicate Devices:

The COOK Spectrum® Silicone Catheter is comparable in terms of intended use and technological characteristics to predicate intravascular catheters used to sample blood, administer fluids intravenously, and to monitor venous pressure.

Manufacturer	Device	510(k) Number
COOK Incorporated	Silicone Catheter	A137605
COOK Incorporated	Single Lumen Urethane PICC	K992198
COOK Incorporated	Double Lumen Urethane PICC	K010034
COOK Incorporated	Spectrum® Catheter	K950118
COOK Incorporated	Spectrum® Ventricular Catheter	K011812
COOK Urological/OB/GYN	Spectrum® Silicone Foley Catheter	K000251
Arrow International, Inc.	ARROWgard Blue PlusTM Multi-Lumen CVC	K993691

Substantial Equivalence:

The device will be manufactured according to specified process controls, adhering to Good Manufacturing Practices and Quality System Regulations, undergoing processing, sterilization and packaging procedures similar to devices currently manufactured and marketed by Cook Incorporated. This device is similar with respect to indications for use and design to predicate devices in terms of section 510(k) substantial equivalence.

Test Data:

The COOK Spectrum® Silicone Catheter has undergone biocompatibility, performance, and clinical testing which provide reasonable assurance of safety and effectiveness for its intended use. Testing includes:

Biocompatibility
. Tensile Testing
Vacuum and Pressure Testing
HPLC and Zone of Inhibition Testing ●
Flow Testing .
Shelf-Life Testing .

Clinical Evaluation:

In this prospective, randomized clinical trial with well matched treatment and control cohorts, results indicate that the COOK Spectrum® Silicone Catheter can significantly reduce the rate of catheter-related bloodstream infection (CRBSI). Clinical safety was evaluated by comparing rates of each complication (other than CRBSI) for the treatment cohort versus the control cohort. To determine effectiveness, the occurrence of definite CRBSI was evaluated as the primary outcome measure. When available, catheters were evaluated after removal from patients by zone of inhibition testing against MRSA (CI4371). Determination of catheter colonization was based on results of any culture from the subcutaneous and tip segment of the catheter using roll plate and sonication culture techniques. Performance was evaluated by comparing the incidence of catheter removal due to catheter leak, bleeding around the catheter thrombosis between the two study groups and by comparing the incidence of catheter repositioning.

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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 with three wing-like shapes, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the perimeter of the circle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 3 0 2003

Ms. Jennifer Bosley, MBA Regulatory Affairs Coordinator Cook. Incorporated 925 South Curry Pike P.O. Box 489 Bloomington, Indiana 47402-0489

Re: K021557

Trade/Device Name: COOK Spectrum® Silicone Catheter Regulation Number: 880.5200, 880.5970 Regulation Name: Intravascular Catheter, Percutaneous, Implanted, Long-term Intravascular Catheter Regulatory Class: II Product Code: FOZ, LJS Dated: March 26, 2003 Received: March 27, 2003

Dear Ms. Bosley:

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 vour 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. Bosley

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 vour 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 (301) 594-4618. 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/dsma/dsmamain.html

Sincerely yours

Susan Runse

Susan Runner, DDS, MA Interim 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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Indications for Use Statement

510(k) Number (if known):

K021557

Device Name:

COOK Spectrum® Silicone Catheter

Indications for Use:

The COOK Spectrum® Silicone Catheter is used for the intravenous administration of nutrient fluids, chemotherapeutic agents and other drugs for therapy, blood sampling, blood delivery, and venous pressure monitoring. The catheter is impregnated with the antimicrobials minocycline and rifampin to help provide protection against catheterrelated bloodstream infections (CRBSI). It is not intended to be used as a treatment for existing infections. Catheters are available in single and double lumen PICC: and single, double and triple lumen CVC. The device is supplied sterile and intended for one-time use.

PLEASE DO NOT WRITE BELOW THIS LINE—CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Salvatore Cucenti

Division Sian-Off) Division of Anesthesiology, General Hospital. Infection Control, Dental Devices

510(k) Number: K021557

V Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use (Optional Format 1-2-96)

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).