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The BD SmartSite™ Needle-Free Connector (NFC) is a sterile, single patient use connector for needle free access to the IV line and/or IV catheter during IV therapy. The BD SmartSite™ NFC can be used for direction, intermittent infusion and/or the continuous infusion of fluids, drugs, IV nutrition, lipids, and/or blood/blood products or the aspiration of blood. The BD SmartSite™ NFC may be used with power injector procedures to a maximum pressure of 325 psi up to a flow rate of 10 mL per second.

Device Description

The BD SmartSite™ NFC allows the user to add medication into the primary line without the use of a needle. It consists of a female luer on one side and a male luer connection on the other side. Both connections have locking threads. The connector has a silicone valve inside which is in an expanded position in the free state. When the male luer end of a compatible vascular access device is attached securely to the female luer of the SmartSite connector, the valve/piston is compressed which opens the fluid pathway. This open pathway allows administration of fluids as well as aspiration through the connector without the use of a needle.

AI/ML Overview

This FDA 510(k) summary describes the BD SmartSite™ Needle-Free Connector (NFC) and its equivalence to a predicate device. The information provided is for a medical device (intravascular administration set) and does not involve AI or algorithms, human readers, or image analysis. Therefore, many of the requested categories in your prompt are not applicable to this document.

However, I can extract and present the relevant information that is available:

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

The document doesn't explicitly list "acceptance criteria" alongside "reported device performance" in a direct table format for each performance claim. Instead, it describes "equivalence discussion" which implies the subject device met the criteria established by the predicate device or a new test. The performance attributes and the testing conducted to support them are discussed.

Performance Attribute	Predicate Device Performance (K061285)	Subject Device Claim (BD SmartSite™ NFC)	Equivalence Discussion / Supporting Study
Duration of Use	72 hours; 24 hours for infusions of blood, blood products or lipids emulsions	7 days (168 hours) or 200 activations, whichever occurs first	Different. Verification testing was conducted to extend the device duration (to 7 days) and include all intended fluids per indications. See Section 18 for Harsh Infusate testing.
Sterilization Claim	Fluid Path Sterile	Content Sterile	Different. Package integrity testing was conducted to verify the sterile barrier claim.
Number of Valve Activations	100	200	Different. Verification conducted to extend the number of valve activations.
Disinfection Swab Time	Swab top of port for 1-2 seconds with 70% IPA, allow 30 seconds to dry	Swab top of access surface for 2-5 seconds with 70% IPA, allow to dry	Different. The longer swab time does not raise new or different questions of safety or effectiveness.
Priming Volume	0.11 mL	0.1 mL	Equivalent. The priming volume is within the specification of the predicate and has no impact on functional or performance characteristics.
Indication for Use (Blood Aspiration)	Includes fluids, medication, blood and blood products	Includes aspiration of blood (in addition to fluids, drugs, IV nutrition, lipids, and/or blood/blood products)	Different. Mechanical hemolysis and blood compatibility testing was conducted to verify the blood aspiration claim.
Particulate Testing	(Not explicitly stated for predicate)	Meets USP requirements	Tested to demonstrate the product meets particulate requirements of United States Pharmacopeia, National Formulary (USP), General Chapter , Particulate Matter in Injections.
Biocompatibility	Biocompatible per ISO 10993-1	Biocompatible for the intended use per ISO 10993-1	Evaluated for biocompatibility appropriate to the contact characterization (externally communicating, blood path (indirect) for prolonged duration). Testing performed according to ISO 10993-1, ISO 10993-4, ISO 10993-5, ISO 10993-10, ISO 10993-11, ISO 10993-23, ISO 8536-4, USP .
Sterilization	Radiation (SAL 10-6)	Radiation (SAL 10-6)	Same. Sterilization and shelf-life testing completed in accordance with ISO 11137-1, ISO 11137-2, USP , USP , ANSI/AAMI ST72.
Shelf-Life	3 years	3 years	Same. Data supports a shelf-life claim of 3 years. Shelf-life testing includes packaging tests (ASTM F1886, ASTM F88/F88M-21, ASTM F2096, ASTM F1929, internal tests for Seal Transfer Width, Ink Legibility, Label Adhesion) and ISO 11607-1, ISO 11607-2.
General Performance	(Implied by predicate clearance)	Complies with ISO 8536-4, ISO 594-1, ISO 594-2	Performance testing was conducted to verify compliance with relevant sections of ISO 8536-4, ISO 594-1, ISO 594-2.
Microbial Ingress	(Implied by predicate clearance)	Meets FDA guidance	Microbial ingress testing performed based on FDA guidance document "Intravascular Administration Sets Premarket Notification Submissions [510(k)], July 11, 2008".
Harsh Infusates	(Not explicitly stated for predicate)	Device tests for multiple days with worst case infusates	Additional performance testing was conducted to simulate use with fluids, specifically Harsh Infusates testing. This supports the extended duration of use claim.

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

The document is a 510(k) summary for a medical device. It does not provide specific sample sizes for test sets (e.g., number of devices tested for each performance criterion) or data provenance details like country of origin or retrospective/prospective nature. This level of detail is typically found in the full submission, not the summary.

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)

This is not applicable as the document describes a physical medical device, not an AI/algorithm-based diagnostic tool requiring expert ground truth establishment for a test set.

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

This is not applicable for the same reasons as point 3.

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

This is not applicable as the document describes a physical medical device and does not involve AI or human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable as the document describes a physical medical device and does not involve an algorithm.

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

Given this is a physical medical device, "ground truth" as typically defined for AI/diagnostic studies is not directly applicable. The "truth" for device performance is established through adherence to recognized standards (e.g., ISO, USP, ASTM) and successful completion of specific verification and validation tests as outlined. For instance:

Biocompatibility: Demonstrated by passing tests defined in ISO 10993 series.
Sterilization: Demonstrated by meeting requirements of ISO 11137 series and USP chapters.
Performance: Demonstrated by compliance with ISO 8536-4, ISO 594-1, ISO 594-2, and internal test protocols for specific claims (e.g., Harsh Infusates, Microbial Ingress, Valve Activations).
Particulate Matter: Demonstrated by meeting USP .
Package Integrity/Shelf Life: Demonstrated by passing tests defined in ISO 11607 series and ASTM standards.

8. The sample size for the training set

This is not applicable as the document describes a physical medical device and does not involve a "training set" in the context of machine learning.

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

This is not applicable.

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