The activity of the antimicrobial agents, minocycline, rifampin and chlorhexidine is located at the internal and external catheter surfaces and is not intended for treatment of existing infections. This combination of antimicrobials has been shown to reduce microbial colonization of the catheter. The effectiveness was evaluated using in vitro methods; no correlation between in vitro and clinical outcome has currently been ascertained. Controlled studies of this product have not been conducted in pregnant women, pediatic or neomatal patients. The use of this catheter should be weighed against any possible risk. Consider CDC Guidelines and institutional protocols for catheter exchange.

Device Description

The Cook® Spectrum® 2 MRC Central Venous Catheter is a single-use, antibiotic impregnated, antimicrobial coated, power injectable catheter that is percutaneously inserted into the vasculature using the Seldinger technique, and advanced over a wire guide until its tip is positioned above the superior vena cava-right atrium (SVC-RA) junction within the lower third of the SVC. The Cook® Spectrum® 2 MRC Central Venous Catheter, 7 Fr triple lumen CVC, is made from an aliphatic polyether-based polyurethane catheter shaft with a radiopaque constituent and a bonded soft distal tip. The catheter shaft is impregnated with Spectrum® (minocycline, rifampin) antimicrobial agents and coated with chlorhexidine antiseptic. The Cook® Spectrum® 2 MRC Central Venous Catheter is not intended for treatment of existing infections in patients; the presence of the three antimicrobial agents has been shown to reduce microbial colonization of the catheter. The antimicrobial activity of these agents is localized to the internal and external catheter surfaces. The working length (15, 20, or 25 cm) of the catheter is measured from distal tip to the double bar line approximately 1.5 cm distal to the manifold. The catheter shaft features centimeter length markings. The proximal portion of the Cook® Spectrum® 2 MRC Central Venous Catheter, like the predicate catheter, has three extension tubes with injection-molded Luer hubs connected to a manifold. The injectionmolded manifold with suture wings serves as the transition point for lumens of the extension tubes into each lumen of the catheter shaft. All three lumens are power injectable; the maximum flow rate is labeled on the hub of each extension tube.

AI/ML Overview

The provided text is a 510(k) summary for the Cook® Spectrum® 2 MRC Central Venous Catheter. It outlines the device's characteristics, indications for use, and a comparison to a predicate device to establish substantial equivalence. However, this document does not describe a study that proves the device meets specific acceptance criteria in the context of an AI/ML medical device, nor does it contain the requested detailed information regarding test set size, data provenance, expert adjudication, MRMC studies, standalone performance, or ground truth establishment.

The document primarily focuses on demonstrating the substantial equivalence of a medical device (a central venous catheter) to a previously cleared predicate device. This is typically done through non-clinical performance testing (e.g., tensile strength, flow rate, biocompatibility) and a comparison of technological characteristics, rather than clinical studies with human readers or AI algorithms.

Therefore, I cannot extract the information required to answer your specific questions related to acceptance criteria and a study proving device performance as if it were an AI/ML device. The document does not contain this type of data or study design.

Here's what I can infer from the document regarding the acceptance criteria and performance, keeping in mind it's for a traditional medical device, not an AI/ML one:

Implied Acceptance Criteria and Reported Device Performance (Based on Substantial Equivalence and Performance Testing):

The "acceptance criteria" here are implicitly tied to demonstrating the Cook® Spectrum® 2 MRC Central Venous Catheter is as safe and effective as the predicate device. This is achieved by showing that the new device meets relevant industry standards and performs similarly to the predicate in key technical areas.

Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility: Meet ISO 10993-1 requirements for externally communicating devices with circulating blood contact for up to a 30-day duration.	Addressed: Cytotoxicity, Sensitization, Irritation, Hemolysis, Complement Activation, Hemocompatibility, Materials Mediated Pyrogenicity, Implantation (4-week), Chronic Toxicity, Carcinogenicity, Genotoxicity were evaluated and adequately addressed. Particulate matter testing met USP<788> acceptance criteria.
Microbiological Performance: Demonstrate reduction of microbial colonization equivalent to predicate.	Demonstrated: Studied in an In Vitro Microbial Colonization Model (simulated elution up to 4 weeks). Results showed lack of development of antimicrobial resistance and comparable log reductions in colonizing microbe concentrations to predicate and reference devices. The effectiveness was evaluated using in vitro methods; no correlation between in vitro and clinical outcome has currently been ascertained.
Physical/Mechanical Performance: Adherence to FDA-recognized standards for intravascular catheters (e.g., tensile strength, flow rate, power injection, static burst, liquid/air leakage, kink, radiopacity, luer hub compatibility, bending fatigue, insertability, chemical injectate compatibility, extension tube clamp functionality, dimensional testing, MRI safety).	Demonstrated: The device was tested and conformed with BS EN ISO 10555-1, BS EN ISO 10555-3, BS EN 13868, ASTM F2503-13, ASTM F640, BS EN ISO 80369-7:2017. Specific tests performed include tensile strength, flow rate, power injection, static burst, liquid leakage, air leakage, kink (flow), MRI safety, radiopacity, luer hub compatibility, bending fatigue, insertability, chemical injectate compatibility, extension tube clamp functionality, dimensional testing, and sterilization. (Specific numerical performance values are not provided in this summary).
Sterilization & Packaging: Meet sterility assurance levels (10-6), demonstrate package integrity and shelf life.	Demonstrated: Terminal sterilization by E-beam and secondary EO sterilization (ANSI/AAMI/ISO 11135-1) for specific packaging configurations. EO residuals conform to ISO 10993-7. Package integrity testing (ISTA 3A, ASTM F88/F88-15, ASTM F1929-15) and 6-month shelf life validation (ASTM F1980-16) were performed.
Substantial Equivalence: Differences from predicate do not raise new or different questions of safety or effectiveness.	Concluded: "The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness." The device is "substantially equivalent to the Cook® Spectrum®/Spectrum® Glide Central Venous Catheter with respect to the indications for use, target populations, treatment method, and technological characteristics."

Since the requested information pertains to AI/ML device studies, and this document is for a traditional catheter, the following points cannot be addressed from the provided text:

Sample size used for the test set and the data provenance: Not applicable in this context. The "test set" refers to physical, chemical, and biological tests on the device itself.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML device involves expert annotations of data (e.g., images), which is not relevant here.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 is not an AI/ML device, and no human reader studies are described.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no ground truth for image interpretation or diagnosis is being established.
The sample size for the training set: Not applicable. There is no AI/ML algorithm being trained.
How the ground truth for the training set was established: Not applicable.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

February 3, 2023

Cook Advanced Technologies Matthew Waninger VP, Product Approval Processes 1400 Cumberland Avenue West Lafayette, Indiana 47906

Re: K223648

Trade/Device Name: Cook® Spectrum® 2 MRC Central Venous Catheter Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: Class II Product Code: FOZ Dated: December 6, 2022 Received: December 7, 2022

Dear Matthew Waninger:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

David Walloschek

David Wolloscheck, PhD Acting Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices. and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K223648

Device Name

Cook® Spectrum® 2 MRC Central Venous Catheter

Indications for Use (Describe)

The Cook® Spectrum® 2 MRC Central Venous Catheter is indicated to provide short-term ( <30 days) central venous access intended for:

Continuous or intermittent drug infusion
· Central venous blood pressure monitoring (CVP)
· Acute hyperalimentation
· Blood sampling
Delivery of whole blood or blood products
· Simultaneous, separate infusion of drugs and
· Power injection of contrast media (max 300 psi).

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)

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Image /page/3/Picture/0 description: The image is a logo for Cook Advanced Technologies. The logo is set against a red background. The word "COOK" is written in white, bold, sans-serif font at the top. Below that, the words "ADVANCED TECHNOLOGIES" are written in white, bold, sans-serif font.

K223648 - 510K Summary

1. Date of Preparation: February 3, 2023
Cook Advanced Technologies 2. Submitter Name: 1400 Cumberland Avenue West Lafayette, IN 47906
1. Contact Person: Matthew S. Waninger Vice President Product Approval Processes Email: mwaninger@medinstitute.com Phone Number: (765) 269-4190 Fax Number: (765) 463-0570
1. Trade Name: Cook® Spectrum® 2 MRC Central Venous Catheter Regulation Name: Intravascular catheter Common Name: Short-Term less than 30 days Therapeutic, Intravascular Catheter Regulation Number: 21 CFR 880.5200 Product Code: FOZ Device Class: ll
- K081113, Cook® Spectrum®/Spectrum® Glide Predicate Device: Central Venous Catheter
- K071538, ARROWg+ard Blue PLUS® Central Venous Reference Device: Catheter

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5. Device Description:

	Predicate DeviceCook® Spectrum®/Spectrum® Glide	Subject DeviceCook® Spectrum® 2 MRC Central
	Central Venous CatheterK081113	Venous CatheterK223648
Indication for Use	The Cook® Spectrum®/ Spectrum®Glide Central Venous Catheter isused for:• Continuous or intermittent druginfusions• Central venous blood pressuremonitoring (CVP)• Acute hyperalimentation• Blood sampling	The Cook® Spectrum® 2 MRCCentral Venous Catheter isindicated to provide short-term (<30days) central venous accessintended for:• Continuous or intermittent druginfusion• Central venous blood pressuremonitoring (CVP)• Acute hyperalimentation

6. Indications for Use:

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	Predicate DeviceCook® Spectrum®/Spectrum® GlideCentral Venous CatheterK081113	Subject DeviceCook® Spectrum® 2 MRC CentralVenous CatheterK223648
	• Delivery of whole blood or bloodproducts• Power injection of contrast media	• Blood sampling• Delivery of whole blood or bloodproducts• Simultaneous, separate infusionof drugs and• Power injection of contrastmedia (max 300 psi).
Indication for Use(continued)	The activity of the antimicrobialagents, minocycline and rifampin, islocalized at the internal and externalcatheter surface, and helps toprovide protection against catheter-related bloodstream infections(CRBSI). It is not intended fortreatment of existing infection. Thedevice is a short-term use catheter.	The activity of the antimicrobialagents minocycline, rifampin andchlorhexidine is located at theinternal and external cathetersurfaces, and is not intended fortreatment of existing infections.This combination of antimicrobialshas been shown to reducemicrobial colonization of thecatheter. The effectiveness wasevaluated using in vitro methods;no correlation between in vitro andclinical outcome has currently beenascertained. Controlled studies ofthis product have not beenconducted in pregnant women,pediatric or neonatal patients. Thebenefits of the use of this cathetershould be weighed against anypossible risk. Consider CDCGuidelines and institutionalprotocols for catheter exchange.
Prescription Only orOver the Counter	Prescription Only	Prescription Only

7. Comparison to Predicate Device and Substantial Equivalence:

The table below includes a comparison of the technological characteristics between the predicate device and subject device.

	PREDICATE DEVICE	SUBJECT DEVICE	COMMENT
	Cook®Spectrum®/Spectrum®Glide Central VenousCatheters(K081113)	Cook® Spectrum® 2 MRCCentral Venous Catheter(K223648)
Regulation	21 CFR 880.5200	21 CFR 880.5200	Same
Product Code	FOZ	FOZ	Same
Classification	II	II	Same
	PREDICATE DEVICE	SUBJECT DEVICE	COMMENT
	Cook®Spectrum®/Spectrum®Glide Central VenousCatheters(K081113)	Cook® Spectrum® 2 MRCCentral Venous Catheter(K223648)
Indications forUse(General Use)	The Cook® Spectrum®/Spectrum® Glide CentralVenous Catheter is used for:• Continuous or intermittentdrug infusions• Central venous bloodpressure monitoring (CVP)• Acute hyperalimentation• Blood sampling• Delivery of whole blood orblood products• Power injection of contrastmedia	The Cook® Spectrum® 2 MRCCentral Venous Catheter is indicatedto provide short-term (<30 days)central venous access intended for:• Continuous or intermittent druginfusion• Central venous blood pressuremonitoring (CVP)• Acute hyperalimentation• Blood sampling• Delivery of whole blood or bloodproducts• Simultaneous, separate infusion ofdrugs and• Power injection of contrast media(max 300 psi).	Different /Seecomment 1
Indications for Use(AntimicrobialActivity)	The activity of the antimicrobialagents, minocycline andrifampin, is localized at theinternal and external cathetersurface and helps to provideprotection against catheter-related bloodstream infections(CRBSI). It is not intended fortreatment of existing infection.The device is a short-term usecatheter.	The activity of the antimicrobialagents, minocycline, rifampin andchlorhexidine is located at theinternal and external cathetersurfaces and is not intended fortreatment of existing infections. Thiscombination of antimicrobials hasbeen shown to reduce microbialcolonization of the catheter. Theeffectiveness was evaluated using invitro methods; no correlationbetween in vitro and clinical outcomehas currently been ascertained.	Different /Seecomment 1
Special PatientPopulations	Patient age / weightrecommendation is notspecifiedThe device is a short-term usecatheter.	IFU indicates controlled studies ofthis product have not beenconducted in pregnant women,pediatric or neonatal patients andthat the benefits of the use of thiscatheter should be weighed againstany possible risk. Consider CDCGuidelines and institutional protocolsfor catheter exchange.	Different /Seecomment 1
Contraindications	IFU contraindicates use inpatients with known allergy orhistory of allergy totetracyclines (includingminocycline) or rifampin.	Identical to predicate	Same
ChlorhexidineHypersensitivityPotential	N/A	IFU includes a warning for thepotential development of ahypersensitivity reaction.	Different /Seecomment 1
	PREDICATE DEVICE	SUBJECT DEVICE	COMMENT
	Cook®Spectrum®/Spectrum®Glide Central VenousCatheters(K081113)	Cook® Spectrum® 2 MRCCentral Venous Catheter(K223648)
Flow Rate	The flow rate of the CookCentral Venous Catheters maynot exceed 10 mL/sec.	The flow rate may not exceed 10mL/sec for the main lumen and 5mL/sec for the two smaller lumens.	Different /Seecomment 2
MaximumPressure Limit forPower Injection	325 psi	300 psi	Different /Seecomment 2
Concentration ofAntimicrobials onCatheter Shaft(µg/cm)	7 Fr:Minocycline: 520Rifampin: 470	Minocycline: 450Rifampin: 450Chlorhexidine: 350	Different /Seecomment 2
Device for One-time Use	Yes	Identical to predicate	Same
CatheterPlacementMethod	Percutaneous via Seldingertechnique	Identical to predicate	Same
Catheter TipTarget Anatomy	SVC-RA junction	Identical to predicate	Same
Catheter TipLocationConfirmationMethod	ECG/Ultrasound/Fluoroscopy	Identical to predicate	Same
HydrophilicCoating	With or without hydrophiliccoating	No hydrophilic coating	Different /Seecomment 2
Catheter LumenDesign	Round, Crescent	Round	Different /Seecomment 2
Catheter ShaftMarkings	Yes	Identical to predicate	Same
Catheter Tip	Molded tip	Bonded tip	Different /Seecomment 2
Catheter ShaftMaterial	Polyurethane(aromatic polyester)	Polyurethane(aliphatic polyether)	Different /Seecomment 2
Number ofCatheter Lumens	Two, three, or five	Three	Same as 7 Frpredicate
Catheter ShaftOuter Diameter	7 to 10 Fr	7 Fr	Same as 7 Frpredicate
Catheter ShaftLength	15 to 25 cm	Identical to predicate	Same
Extension TubeLength	Distal: 5.5 +/- 1 cmMedial: 10.0 +/- 1 cmProximal: 6.5 +/- 1 cm	Distal: 7.8 +/- 0.2 cmMedial: 12.9 +/- 0.8 cmProximal: 10.3 +/- 0.8 cm	Different /Seecomment 2
Extension TubeDiameter	ID (inches): 0.80-0.120OD (inches): 0.083-0.123	ID (inches): 0.058-0.088OD (inches): 0.061-0.091	Different /Seecomment 2
Main AccessoryComponents	Wire Guide, dilator, introducerneedle, syringe, and injectioncaps	Identical to predicate	Same
	PREDICATE DEVICE	SUBJECT DEVICE	COMMENT
	Cook®Spectrum®/Spectrum®Glide Central VenousCatheters(K081113)	Cook® Spectrum® 2 MRCCentral Venous Catheter(K223648)
Wire Guide	Included	Included as part of the standard set orin a kit tray. None for stand-alonecatheter.	Same for kit tray
Packaging	Kit tray with Tyvek® lid stock	Two configurations available:1) Kit tray with Tyvek® lid stock2) CVC catheter (in a foil pouch)packaged inside a Tyvek outerpouch	Different /Seecomment 2
SterilizationMethod	EO	For packaging configurationsdescribed above:1) E-beam of foil pouch, thenEO of entire tray2) E-beam of foil pouch, thenEO of foil pouch in Tyvek pouch	Different /Seecomment 2
SterilityAssurance Level	10-6	Identical to predicate	Same

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Discussions of differences in technological characteristics

Comment 1

Added specificity to labeling regarding general use, the reduction of microbial colonization established through in vitro methods, special patient populations, indwell times/catheter exchanges, and chlorhexidine hypersensitivity potential. Reduction of microbial colonization of the catheter was demonstrated through microbiological testing using an In Vitro Microbial Colonization Model and clinically virulent microorganisms.

Comment 2

Technological design modifications are intended to increase flexibility and improve usability. The following tests were performed to demonstrate substantial equivalence: tensile strength, flow rate, power injection, static burst, liquid leakage, air leakage, kink (flow), MRI safety. radiopacity, luer hub compatibility, bending fatigue, insertability, chemical injectate compatibility, extension tube clamp functionality, dimensional testing, and sterilization. The difference between the proposed device and the predicate does not raise different questions of safety and effectiveness and that the device is as safe and effective as a legally marketed device.

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8. Technological Characteristics and Performance Testing:

The single use, sterile Cook® Spectrum® 2 MRC Central Venous Catheter described in this summary was tested and demonstrated to be in conformance with the following FDA-recognized standards:

. BS EN ISO 10555-1: 2013: Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements
BS EN ISO 10555-3: Intravascular catheters Sterile and single-use . catheters - Part 3: Central venous catheters
BS EN 13868: Catheters Test Methods for Kinking of Single Lumen . Catheters and Medical Tubing
. ASTM F2503-13: Standard Practice For Marking Medical Devices And Other Items For Safety In The Magnetic Resonance Environment
ASTM F640: Standard Test Methods for Determining Radiopacity for . Medical Use
BS EN ISO 80369-7:2017: Small-bore connectors for liquids and gases in . healthcare applications Part 7: Connectors for intravascular or hypodermic applications

Biocompatibility

According to the requirements identified in ISO 10993-1 for externally communicating devices with circulating blood contact for up to a 30-day duration, the following biocompatibility endpoints were evaluated and adequately addressed:

Cytotoxicity, .
Sensitization, ●
Irritation, ●
Hemolysis, ●
Complement Activation, .
Hemocompatibility, ●
Materials Mediated Pyrogenicity, ●
Implantation (4-week), ●
Chronic Toxicity ●
Carcinogenicity, ●
Genotoxicity

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Particulate matter testing was conducted in accordance with USP<788> Particulate Matter in Injection and met the USP acceptance criteria.

Microbiological evaluations

The Cook® Spectrum® 2 MRC Central Venous Catheter has been studied in an In Vitro Microbial Colonization Model that simulated elution of antimicrobial agents over intravascular dwell times up to 4 weeks. Results from the microbiological performance testing including lack of development of antimicrobial resistance, and comparison of log reductions in colonizing microbe concentrations, demonstrated that the microbiological performance of the Cook® Spectrum® 2 MRC Central Venous Catheter is substantially equivalent to the predicate and reference devices.

Sterility, Shipping and Shelf life

Terminal sterilization is accomplished by electron-beam processing of the . subject catheter within a sealed (inner) foil pouch. Secondary EO sterilization is used to sterilize the outside of the foil pouch and the airspace within the tray or (outer) Tyvek® pouch. Applicable standards include:
- o Terminal sterilization: Method 1 BS EN ISO 11137-1:2015+A2:2019
- Secondary EO sterilization: Half-cycle method ANSI/AAMI/ISO 11135-1
- EO residuals: ISO 10993-7:2008/(R)2012
. Package integrity testing, after environmental conditioning and simulated transportation in accordance with ISTA 3A, was conducted on the final, packaged, and sterile devices.
Sterile Barrier Packaging Testing was performed on the proposed device . according to these standards:
- Seal strength ASTM F88/F88-15
- Dye penetration ASTM F1929-15

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Shelf life of 6 months was validated using the FDA-recognized standard . ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices

9. Conclusions:

The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. The Cook® Spectrum® 2 MRC Central Venous Catheter is substantially equivalent to the Cook® Spectrum®/Spectrum® Glide Central Venous Catheter with respect to the indications for use, target populations, treatment method, and technological characteristics.

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).