(59 days)
No
The summary describes a physical medical device (a central venous catheter) with antimicrobial properties and power injection capabilities. There is no mention of software, algorithms, data analysis, or any other components that would suggest the use of AI or ML. The performance studies focus on physical and microbiological properties, not algorithmic performance.
No
The device is a central venous catheter used for various medical procedures such as drug infusion, blood sampling, and monitoring, but it is not intended for the treatment of existing infections or other therapeutic interventions. Its antimicrobial properties are to reduce microbial colonization of the catheter, not to treat the patient.
No
Explanation: The device is a central venous catheter used for various therapeutic purposes such as drug infusion, blood sampling, and monitoring, but not for diagnosing medical conditions. It helps reduce microbial colonization rather than identifying or diagnosing an infection.
No
The device description clearly describes a physical catheter made of polyurethane with antimicrobial agents, intended for percutaneous insertion. There is no mention of software as the primary or sole component of the device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Function: The Cook® Spectrum® 2 MRC Central Venous Catheter is a device that is inserted into the body (specifically, the central venous system) for various therapeutic and monitoring purposes (infusion, monitoring, blood sampling, etc.). It is not used to analyze specimens outside the body.
- Antimicrobial Activity: While the device has antimicrobial agents, their purpose is to reduce microbial colonization on the catheter itself, not to diagnose or test for infections in a patient's sample. The text explicitly states "The activity of the antimicrobial agents... is not intended for treatment of existing infections." and "The effectiveness was evaluated using in vitro methods; no correlation between in vitro and clinical outcome has currently been ascertained." This further reinforces that the in vitro testing mentioned is related to the device's performance, not diagnostic testing of a patient sample.
Therefore, the Cook® Spectrum® 2 MRC Central Venous Catheter is a therapeutic and monitoring medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Cook® Spectrum® 2 MRC Central Venous Catheter is indicated to provide short-term ( 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
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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
1
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
2
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 ( Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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K223648 - 510K Summary
-
- Date of Preparation: February 3, 2023
- Cook Advanced Technologies 2. Submitter Name: 1400 Cumberland Avenue West Lafayette, IN 47906
-
- Contact Person: Matthew S. Waninger Vice President Product Approval Processes Email: mwaninger@medinstitute.com Phone Number: (765) 269-4190 Fax Number: (765) 463-0570
-
- 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
4
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
Cook® Spectrum®/Spectrum® Glide | Subject Device
Cook® Spectrum® 2 MRC Central |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Central Venous Catheter
K081113 | Venous Catheter
K223648 |
| Indication for Use | The Cook® Spectrum®/ Spectrum®
Glide Central Venous Catheter is
used for:
• Continuous or intermittent drug
infusions
• Central venous blood pressure
monitoring (CVP)
• Acute hyperalimentation
• Blood sampling | The Cook® Spectrum® 2 MRC
Central Venous Catheter is
indicated to provide short-term ( 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
11
- 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.