The Spectrum® Central Venous 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. The device is a short-term use catheter, supplied sterile and intended for one-time use.

Device Description

The nominal 7-French Triple Lumen Spectrum® Central Venous Catheter with Hydrophilic Coating is a polyurethane catheter with three non-communicating vascular access lumens. The coating is impregnated with the antimicrobials minocycline and rifampin (avg. concentration 520 ug/cm and 470 ug/cm respectively) and has a hydrophilic coating consisting of polyacrylamide and polyvinylpyridone to enhance insertion.

AI/ML Overview

This document is a 510(k) summary for the Cook Spectrum® Central Venous Catheter, which primarily focuses on regulatory approval based on substantial equivalence to a predicate device. It briefly mentions test data but does not contain a detailed study report that describes the acceptance criteria and a study proving the device meets those criteria.

Therefore, most of the requested information cannot be extracted from the provided text.

Here's what can be gathered and what cannot:

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

Acceptance Criteria: Not explicitly stated in the document.
Reported Device Performance: Not explicitly stated in the format of direct performance against acceptance criteria.

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 mentioned.
Data Provenance: Not mentioned.
Retrospective or Prospective: Not mentioned.

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

This information is not provided as the document does not detail a clinical study with expert-established ground truth.

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

Not applicable/Not mentioned, as a clinical study with adjudication is not described.

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

No MRMC comparative effectiveness study is mentioned. This device is a Central Venous Catheter, not an AI-assisted diagnostic tool.

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

Not applicable. This is not an algorithm or AI device.

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

Not applicable/Not mentioned. The "Test Data" section refers to bench testing and in-vitro testing ("HPLC and zone of inhibition") rather than clinical ground truth for diagnostic performance.

8. The sample size for the training set

Not applicable/Not mentioned, as this is not an AI/machine learning device.

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

Not applicable/Not mentioned.

Summary of available information related to testing:

The document states:

"The device has undergone testing that provides reasonable assurance of safety and effectiveness for its intended use."
"Testing includes: biocompatibility, tensile, vacuum and pressure, flow rate, HPLC and zone of inhibition."

This indicates that various types of bench and in-vitro testing were performed to evaluate physical properties, material compatibility, and antimicrobial properties. However, it does not detail the specific acceptance criteria for these tests or the results in a comparative table as requested for an AI model's performance. The review process was primarily focused on substantial equivalence to an existing predicate device (Cook ABRM Central Venous Catheter, K950118), with the main difference being the addition of a hydrophilic coating.

Summary

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AUG 1 2 2004

COOK®

K033843

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

510(k) Summary

Submitted by:	Cook Incorporated750 Daniels Way, P.O. Box 489Bloomington, IN 47402
Contact Person:	Jennifer J. Bosley, MBA, RACPh: (812) 339-2235Fax: (812) 332-0281
Date Prepared:	August 5, 2004
510(k) #:	K033843
Device:
Trade Name:	Spectrum® Central Venous Catheter with or without Hydrophilic Coating
Common/Usual Name:	Central Venous Catheter
Proposed Classification:	Intravascular Catheter, 21 CFR Part 880.5200 (80 FOZ) Class II

Device Description:

The nominal 7-French Triple Lumen Spectrum® Central Venous Catheter with Hydrophilic Coating is a polyurethane catheter with three non-communicating vascular access lumens. The cothing is impregnated with the antimicrobials minocycline and rifamping (avg. concentration 520 ug/clin and 470 ug/cm respectively) and has a hydrophilic coating consisting of polyacrylamide and polyvinylpyridone to enhance insertion.

Intended Use;

The Spectrum® Central Venous 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 animorobials minocycline and relieves to help provide protection against catheter-related bloodstream infections (CRBSI). II is not intended to be used as a treatment for existing infections. The device is a short-term use catherer, supplied to and intended for one-time use.

Substantial Equivalence:

Manufacturer	Device
the consideration of the program and the first of the first of the first of the first	And Property of Concession,
Cook Incorporated	ABRM Central Venous Catheter

510(k) Number K950118

In terms of section 510(k) substantial equivalence, the device is identical in terms of design, intended use and technological characteristics to the predicate Cook ABRM Catheter except for the addition of the hydrophilic coating.

Test Data:

The device has undergone testing that provides reasonable assurance of safety and effectiveness for its intended use. Testing includes: biocompatibility, tensile, vacuum and pressure, flow rate, HPLC and zone of inhibition.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 2 2004

Ms. Jennifer Bosley, MBA, RAC Regulatory Affairs Coordinator Cook, Incorporated 750 Daniels Way P.O. Box 489 Bloomington, Indiana 47402-0489

Re: K033843

Trade/Device Name: Spectrum® Central Venous Catheter with or without Hydrophilic Coating Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: June 22, 2004 Received: June 23, 2004

Dear Ms. Bosley:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your ed your extermined the device is substantially equivalent (for the itsienced above and nave acteringlosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Interstate conmisered pror to that have been reclassified in accordance with the provisions of Allendinents, or to devroos that in tic Act (Act) that do not require approval of a premarket the rodelar F ood, Drag, and Comments , therefore, market the device, subject to the general approval application (1 Million ) . The general controls provisions of the Act include condors provisions of an 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 If your device is classified (see associety) in a controls. Existing major regulations affecting g (FMA), it may of Subject to Bach ademic and Regulations, Title 21, Parts 800 to 898. In your device can be found in the Seas nouncements 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 Frease be advisod that I Dri o issualites on that your device complies with other requirements mean that I DA nas made a decemmand regulations administered by other Federal agencies. of the Act of ary I outhal bates requirements, including, but not limited to: registration You must comply with an me Hee s roq 21 CFR Part 801); good manufacturing practice allo listing (21 CF RT att 007), laoulity systems (QS) regulation (21 CFR Part 820); and if requirements as set form in are qt 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) ITILS felt will anow you to objall finding of substantial equivalence of your device to a premarket notified.com - The PDF 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), If you desire specific at no for your as (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 may obtain 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,

Clus

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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Indications for Use Statement

K033843 510(k) Number:

Spectrum® Central Venous Catheter with or without Hydrophilic Coating Device Name:

Indications for Use:

The Spectrum Central Venous Catheter is used for the intravenous administration of nutrient The Spectrum® Central Venous Catheter is used for therapy, blood sampling, blood delivery, and
fluids, chemothers in the sether is impremated with the animicrobials minorobia fluids, chemotherapeutic and other drigs intressmed with the antipics of the open to the courses of the opening the minocyclines (CRBS).
Venous pressure monities and stimes venous pressure monitoring. The extention against catherer-related bloodstream forctions (CRBS).
and rifampin to help provide protection against catheter-related bloodstream and rifampin to help provide protection against cated blooders. The device is a short-term use
It is not intended to be used as treatment for existing use It is not intended to be used as a creading.
catheter, supplied sterile and intended for one-time use.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The Counter Use (Part 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)

Arata V. nxt

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

510(k) Number: Ky3384)

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).