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The SV Spectrum MRC Central Venous Catheter is indicated to provide short-term (

The SV Spectrum MRC Central Venous Catheter (CVC) 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 SV Spectrum 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 SV Spectrum 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 SV Spectrum MRC CVC has demonstrated efficacy against the following organisms:

• Staphylococcus aureus
• Staphylococcus epidermidis
• Enterococcus faecalis
• Escherichia coli
• Klebsiella pneumoniae
• Acinetobacter baumanni
• Candida albicans
• Candida glabrata

The effectiveness was evaluated using in vitro methods. 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 SV Spectrum MRC Central Venous Catheter, like the predicate catheter, has three extension tubes with injection-molded Luer hubs connected to a manifold. The injection-molded 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.

The SV Spectrum MR Central Venous Catheter is identical to the SV Spectrum MRC Central Venous Catheter except that it is not coated with chlorohexidine antiseptic.

The SV Central Venous Catheter is identical to the SV Spectrum MRC Central Venous Catheter and SV Spectrum MR Central Venous Catheter except it is not impregnated with minocycline or rifampin, nor is it coated with chlorhexidine antiseptic.

This FDA 510(k) clearance letter pertains to a central venous catheter and, as such, does not contain information about the acceptance criteria and study that proves the device meets acceptance criteria for an AI/ML-driven medical device.

The document states:

• "Software: Not applicable. The device contains no software." (Page 18)
• The performance testing for this device focuses on mechanical and shelf-life properties, biocompatibility, and antimicrobial efficacy (for certain versions), all of which are standard for physical medical devices and unrelated to AI/ML performance.

Therefore, I cannot provide the requested information based on the provided text. The prompt asks for details specifically relevant to AI/ML device performance and testing (e.g., sample size for training/test sets, expert adjudication methods, MRMC studies, standalone algorithm performance, ground truth establishment) which are not present in this document as it's for a non-software, non-AI medical device.

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The NMI Intravascular Catheter (IC) is indicated for short or long-term vascular access (including peripheral) to the central venous system for intravenous therapy, including but not limited to the administration of fluids, medications and nutrients, the sampling of blood, for central venous pressure monitoring, and for power injection of contrast media.

The NMI IC has an open ended lumen with proximally located luer lock adapters(s), extension tube(s) with clamp(s) and suture wing for catheter securement; available in single and multi-lumen with burnif(s) and the reverse tapered shaft to aid in staunching bleeding at the insertion site. The comingulations, when a revelod with depth indicators along its length. The lumens are differentiated by proximally located colored clamps and luer adapter(s) marked with lumen size. Maximum power injection flow rates are indicated on the clamp(s). The proposed NMI IC will be offered in kits with other legally marketed products.

The provided document is a 510(k) premarket notification for a medical device (NMI Intravascular Catheter). It focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and providing detailed study results for a new device's performance.

Therefore, the document does not contain the information requested to describe acceptance criteria and the study that proves the device meets those criteria, specifically:

• A table of acceptance criteria and reported device performance.
• Sample sizes, data provenance, number of experts, adjudication methods for a test set.
• Information on MRMC comparative effectiveness studies.
• Standalone algorithm performance.
• Details on ground truth for test and training sets, or training set sample size.

The performance data section (H) only lists the FDA guidance documents and international standards that the NMI IC was assessed in accordance with, such as:

• EN ISO 10555-1:1996, AMD 1: 1999, AMD 2: 2004, Sterile, Single use intravascular catheters - Part 1: General Requirements
• EN ISO 10555-3:1997 COR 2002, Sterile, Single-Use Intravascular Catheters Part 3: Central Venous Catheters
• FDA's "Guidance on Premarket Notification [510(K)] Submissions for Short-Term and Long-Term Intravascular Catheters dated March 16, 1995"
• IEC 60601-2-34:2000-10 - Medical Electrical Equipment Part 2-34: Particular Requirements for Invasive Blood Pressure Monitoring Equipment
• AAMI TIR 9: 1992 - Evaluation of Clinical Systems for Invasive Blood Pressure Monitoring
• AAMI/ANSI/ISO 10993-1: 2003, Biological evaluation of medical devices Part 1: Evaluation and testing

These standards outline general requirements and testing methodologies for intravascular catheters and medical devices, but the document does not provide the specific acceptance criteria derived from these standards or the detailed results of the studies conducted to meet them. The conclusion states that the device is "substantially equivalent to the predicate devices" based on responses to FDA's 510(k) Decision Making Tree, implying that its performance is considered acceptable if it is comparable to already approved devices.

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