Cook® Spectrum® 2 MRC Central Venous Catheter

K223648 · Cook Advanced Technologies · FOZ · Feb 3, 2023 · General Hospital

Device Facts

• Record ID: K223648
• Device Name: Cook® Spectrum® 2 MRC Central Venous Catheter
• Applicant: Cook Advanced Technologies
• Product Code: FOZ · General Hospital
• Decision Date: Feb 3, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5200
• Device Class: Class 2

Intended Use

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). 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 Story

Single-use, antibiotic-impregnated, antimicrobial-coated, power-injectable central venous catheter (CVC). Percutaneously inserted via Seldinger technique; tip positioned at SVC-RA junction. Input: none (mechanical device). Operation: provides venous access for infusion, monitoring, and sampling. Output: venous access. Used in clinical settings by healthcare professionals. Antimicrobial agents (minocycline, rifampin, chlorhexidine) reduce microbial colonization on catheter surfaces. Power injection capability supports contrast media delivery up to 300 psi. Benefits include reduced microbial colonization risk during short-term indwelling use.

Clinical Evidence

Bench testing only. Microbiological performance evaluated using an In Vitro Microbial Colonization Model simulating elution over 4 weeks; demonstrated log reductions in colonizing microbes. Biocompatibility testing per ISO 10993-1 (cytotoxicity, sensitization, irritation, hemolysis, complement activation, hemocompatibility, pyrogenicity, 4-week implantation, chronic toxicity, carcinogenicity, genotoxicity). No clinical data provided.

Technological Characteristics

Aliphatic polyether-based polyurethane shaft; radiopaque; bonded soft distal tip. Antimicrobials: minocycline, rifampin, chlorhexidine. 7 Fr triple lumen. Power injectable (max 300 psi). Standards: BS EN ISO 10555-1/3, BS EN 13868, ASTM F2503-13, ASTM F640, BS EN ISO 80369-7. Sterilization: E-beam (catheter) and secondary EO (packaging).

Indications for Use

Indicated for short-term (<30 days) central venous access in patients requiring drug infusion, CVP monitoring, hyperalimentation, blood sampling, blood product delivery, or power injection of contrast media. Contraindicated in patients with known allergy to tetracyclines (including minocycline) or rifampin. Not for treatment of existing infections. Safety not established in pregnant women, pediatric, or neonatal patients.

Regulatory Classification

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.

Predicate Devices

• Cook® Spectrum®/Spectrum® Glide Central Venous Catheter (K081113)

Reference Devices

• ARROWg+ard Blue PLUS® Central Venous Catheter (K071538)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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).

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.

| Type of Use (Select one or both, as applicable) |
|----------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-size:10pt"> <span style="font-family:Wingdings"> </span> Prescription Use (Part 21 CFR 801 Subpart D)</span> |
| <span style="font-size:10pt"> <span style="font-family:Wingdings"> </span> Over-The-Counter Use (21 CFR 801 Subpart C)</span> |

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## K223648 - 510K Summary

- 1. Date of Preparation: February 3, 2023
- Cook Advanced Technologies 2. Submitter Name: 1400 Cumberland Avenue West Lafayette, IN 47906
- 3. Contact Person: Matthew S. Waninger Vice President Product Approval Processes Email: [e-mail] Phone Number: [phone] Fax Number: [phone]
- 4. 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:

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.

| | Predicate Device<br>Cook® Spectrum®/Spectrum® Glide | Subject Device<br>Cook® Spectrum® 2 MRC Central |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Central Venous Catheter<br>K081113 | Venous Catheter<br>K223648 |
| Indication for Use | The Cook® Spectrum®/ Spectrum®<br>Glide Central Venous Catheter is<br>used for:<br>• Continuous or intermittent drug<br>infusions<br>• Central venous blood pressure<br>monitoring (CVP)<br>• Acute hyperalimentation<br>• Blood sampling | The Cook® Spectrum® 2 MRC<br>Central Venous Catheter is<br>indicated to provide short-term (<30<br>days) central venous access<br>intended for:<br>• Continuous or intermittent drug<br>infusion<br>• Central venous blood pressure<br>monitoring (CVP)<br>• Acute hyperalimentation |

## 6. Indications for Use:

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| | Predicate Device<br>Cook® Spectrum®/Spectrum® Glide<br>Central Venous Catheter<br>K081113 | Subject Device<br>Cook® Spectrum® 2 MRC Central<br>Venous Catheter<br>K223648 |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | • Delivery of whole blood or blood<br>products<br>• Power injection of contrast media | • Blood sampling<br>• Delivery of whole blood or blood<br>products<br>• Simultaneous, separate infusion<br>of drugs and<br>• Power injection of contrast<br>media (max 300 psi). |
| Indication for Use<br>(continued) | The activity of the antimicrobial<br>agents, minocycline and rifampin, is<br>localized at the internal and external<br>catheter surface, and helps to<br>provide protection against catheter-<br>related bloodstream infections<br>(CRBSI). It is not intended for<br>treatment of existing infection. The<br>device is a short-term use catheter. | The activity of the antimicrobial<br>agents minocycline, rifampin and<br>chlorhexidine is located at the<br>internal and external catheter<br>surfaces, and is not intended for<br>treatment of existing infections.<br>This combination of antimicrobials<br>has been shown to reduce<br>microbial colonization of the<br>catheter. The effectiveness was<br>evaluated using in vitro methods;<br>no correlation between in vitro and<br>clinical outcome has currently been<br>ascertained. Controlled studies of<br>this product have not been<br>conducted in pregnant women,<br>pediatric or neonatal patients. The<br>benefits of the use of this catheter<br>should be weighed against any<br>possible risk. Consider CDC<br>Guidelines and institutional<br>protocols for catheter exchange. |
| Prescription Only or<br>Over 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®<br>Spectrum®/Spectrum®<br>Glide Central Venous<br>Catheters<br>(K081113) | Cook® Spectrum® 2 MRC<br>Central Venous Catheter<br>(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®<br>Spectrum®/Spectrum®<br>Glide Central Venous<br>Catheters<br>(K081113) | Cook® Spectrum® 2 MRC<br>Central Venous Catheter<br>(K223648) | |
| Indications for<br>Use<br>(General Use) | The Cook® Spectrum®/<br>Spectrum® Glide Central<br>Venous Catheter is used for:<br>• Continuous or intermittent<br>drug infusions<br>• Central venous blood<br>pressure monitoring (CVP)<br>• Acute hyperalimentation<br>• Blood sampling<br>• Delivery of whole blood or<br>blood products<br>• Power injection of contrast<br>media | The Cook® Spectrum® 2 MRC<br>Central Venous Catheter is indicated<br>to provide short-term (<30 days)<br>central venous access intended for:<br>• Continuous or intermittent drug<br>infusion<br>• Central venous blood pressure<br>monitoring (CVP)<br>• Acute hyperalimentation<br>• Blood sampling<br>• Delivery of whole blood or blood<br>products<br>• Simultaneous, separate infusion of<br>drugs and<br>• Power injection of contrast media<br>(max 300 psi). | Different /See<br>comment 1 |
| Indications for Use<br>(Antimicrobial<br>Activity) | The activity of the antimicrobial<br>agents, minocycline and<br>rifampin, is localized at the<br>internal and external catheter<br>surface and helps to provide<br>protection against catheter-<br>related bloodstream infections<br>(CRBSI). It is not intended for<br>treatment of existing infection.<br>The device is a short-term use<br>catheter. | The activity of the antimicrobial<br>agents, minocycline, rifampin and<br>chlorhexidine is located at the<br>internal and external catheter<br>surfaces and is not intended for<br>treatment of existing infections. This<br>combination of antimicrobials has<br>been shown to reduce microbial<br>colonization of the catheter. The<br>effectiveness was evaluated using in<br>vitro methods; no correlation<br>between in vitro and clinical outcome<br>has currently been ascertained. | Different /See<br>comment 1 |
| Special Patient<br>Populations | Patient age / weight<br>recommendation is not<br>specified<br>The device is a short-term use<br>catheter. | IFU indicates controlled studies of<br>this product have not been<br>conducted in pregnant women,<br>pediatric or neonatal patients and<br>that the benefits of the use of this<br>catheter should be weighed against<br>any possible risk. Consider CDC<br>Guidelines and institutional protocols<br>for catheter exchange. | Different /See<br>comment 1 |
| Contraindications | IFU contraindicates use in<br>patients with known allergy or<br>history of allergy to<br>tetracyclines (including<br>minocycline) or rifampin. | Identical to predicate | Same |
| Chlorhexidine<br>Hypersensitivity<br>Potential | N/A | IFU includes a warning for the<br>potential development of a<br>hypersensitivity reaction. | Different /See<br>comment 1 |
| | PREDICATE DEVICE | SUBJECT DEVICE | COMMENT |
| | Cook®<br>Spectrum®/Spectrum®<br>Glide Central Venous<br>Catheters<br>(K081113) | Cook® Spectrum® 2 MRC<br>Central Venous Catheter<br>(K223648) | |
| Flow Rate | The flow rate of the Cook<br>Central Venous Catheters may<br>not exceed 10 mL/sec. | The flow rate may not exceed 10<br>mL/sec for the main lumen and 5<br>mL/sec for the two smaller lumens. | Different /See<br>comment 2 |
| Maximum<br>Pressure Limit for<br>Power Injection | 325 psi | 300 psi | Different /See<br>comment 2 |
| Concentration of<br>Antimicrobials on<br>Catheter Shaft<br>(µg/cm) | 7 Fr:<br>Minocycline: 520<br>Rifampin: 470 | Minocycline: 450<br>Rifampin: 450<br>Chlorhexidine: 350 | Different /See<br>comment 2 |
| Device for One-<br>time Use | Yes | Identical to predicate | Same |
| Catheter<br>Placement<br>Method | Percutaneous via Seldinger<br>technique | Identical to predicate | Same |
| Catheter Tip<br>Target Anatomy | SVC-RA junction | Identical to predicate | Same |
| Catheter Tip<br>Location<br>Confirmation<br>Method | ECG/Ultrasound/<br>Fluoroscopy | Identical to predicate | Same |
| Hydrophilic<br>Coating | With or without hydrophilic<br>coating | No hydrophilic coating | Different /See<br>comment 2 |
| Catheter Lumen<br>Design | Round, Crescent | Round | Different /See<br>comment 2 |
| Catheter Shaft<br>Markings | Yes | Identical to predicate | Same |
| Catheter Tip | Molded tip | Bonded tip | Different /See<br>comment 2 |
| Catheter Shaft<br>Material | Polyurethane<br>(aromatic polyester) | Polyurethane<br>(aliphatic polyether) | Different /See<br>comment 2 |
| Number of<br>Catheter Lumens | Two, three, or five | Three | Same as 7 Fr<br>predicate |
| Catheter Shaft<br>Outer Diameter | 7 to 10 Fr | 7 Fr | Same as 7 Fr<br>predicate |
| Catheter Shaft<br>Length | 15 to 25 cm | Identical to predicate | Same |
| Extension Tube<br>Length | Distal: 5.5 +/- 1 cm<br>Medial: 10.0 +/- 1 cm<br>Proximal: 6.5 +/- 1 cm | Distal: 7.8 +/- 0.2 cm<br>Medial: 12.9 +/- 0.8 cm<br>Proximal: 10.3 +/- 0.8 cm | Different /See<br>comment 2 |
| Extension Tube<br>Diameter | ID (inches): 0.80-0.120<br>OD (inches): 0.083-0.123 | ID (inches): 0.058-0.088<br>OD (inches): 0.061-0.091 | Different /See<br>comment 2 |
| Main Accessory<br>Components | Wire Guide, dilator, introducer<br>needle, syringe, and injection<br>caps | Identical to predicate | Same |
| | PREDICATE DEVICE | SUBJECT DEVICE | COMMENT |
| | Cook®<br>Spectrum®/Spectrum®<br>Glide Central Venous<br>Catheters<br>(K081113) | Cook® Spectrum® 2 MRC<br>Central Venous Catheter<br>(K223648) | |
| Wire Guide | Included | Included as part of the standard set or<br>in a kit tray. None for stand-alone<br>catheter. | Same for kit tray |
| Packaging | Kit tray with Tyvek® lid stock | Two configurations available:<br>1) Kit tray with Tyvek® lid stock<br>2) CVC catheter (in a foil pouch)<br>packaged inside a Tyvek outer<br>pouch | Different /See<br>comment 2 |
| Sterilization<br>Method | EO | For packaging configurations<br>described above:<br>1) E-beam of foil pouch, then<br>EO of entire tray<br>2) E-beam of foil pouch, then<br>EO of foil pouch in Tyvek pouch | Different /See<br>comment 2 |
| Sterility<br>Assurance 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.