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Intraosseous Infusion Needles are sterile, disposable devices used primarily during pediatric emergencies as an alternative to unsuccessful intravenous access to allow for effective infusion of resuscitative drugs or fluids.

The Intraosseous Infusion Needles are intended for use as an alternative to intravenous access during pediatric emergencies, permitting infusion of drugs and fluids. Intraosseous Infusion Needles consist of two basic components - the needle (composed of a knob, a stylet luer-lock, and a beveled stylet) and the cannula (comprised of a hub, a base plate, and a cannula shaft). The cannula attaches to the needle by the stylet luer-lock and is supplied attached and ready to use. The Intraosseous Infusion Needles are available in the following configurations:

Intraosseous Infusion Needle (with Dieckmann Modification – Standard Hub Design)

Cannula Gauge: 14, 16, 18
Cannula/Stylet Length (cm): 14 Gauge: 3.0; 16 Gauge: 2.5, 3.0, 4.0; 18 Gauge: 2.5, 3.0
Stylet Length (cm): 14 Gauge: 4.6; 16 Gauge: 4.2 (for 2.5cm cannula), 4.65 (for 3.0cm cannula), 5.65 (for 4.0cm cannula); 18 Gauge: 4.2 (for 2.5cm cannula), 4.65 (for 3.0cm cannula)
Stylet Bevel Style: Trocar
Hub Material: Clear Polycarbonate (for 14 and 16 Gauge), Pink Polycarbonate (for 18 Gauge)

The provided FDA 510(k) clearance letter and summary for the Intraosseous Infusion Needles does not contain the detailed information necessary to answer most of the questions you've posed regarding acceptance criteria and study particulars.

This document focuses on justifying "substantial equivalence" to a predicate device, primarily by demonstrating that changes to the sterilization process do not negatively impact safety or effectiveness. It explicitly states that "No additional performance testing was conducted because the design of the subject device is identical to the predicate, K160887."

Therefore, I can only provide limited information based on the text.

Here's what can be inferred and what cannot:

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

The document does not explicitly state acceptance criteria or performance metrics for the device's primary function (intraosseous infusion). The "performance testing" described is related only to the sterilization process.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Test Set Sample Size: Not specified for any performance testing related to the device's functional use or even for the sterilization validation beyond general statements of "performance testing was conducted."
• Data Provenance: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. The document does not describe studies requiring expert ground truth for device performance related to patient outcomes or imaging. The testing focuses on sterilization process validation.

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

Not applicable. The document does not describe studies requiring adjudication.

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

Not applicable. This device is a physical medical needle, 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 device is a physical medical needle, not an algorithm.

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

For the sterilization validation, the "ground truth" would be objective laboratory measurements and adherence to international standards (e.g., ANSI/AAMI/ISO 11135 and ISO 10993-7) for sterility and residuals. It's not related to clinical "ground truth" like pathology or outcomes.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI model requiring a training set.

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

Not applicable.

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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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