(127 days)
The BD Intraosseous Infusion System provides intraosseous access in the proximal tibia, distal tibia and humeral head (proximal humerus) of adult and pediatric patients, and the distal femur in pediatric patients when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary cases for up to 24 hours.
The BD Intraosseous Infusion System provides clinicians and emergency personnel with access to the intraosseous space for resuscitation and lifesaving fluid delivery for up to 24 hours. The BD Intraosseous Infusion System consists of the following: a single use hypodermic needle (with needle safety cap), a powered or manual driver to assist with needle insertion, an extension set, and; an adhesive-backed securement dressing. For insertions using the powered driver, the hypodermic needle includes a needle hub that mates with a stylet connected to a drive adapter hub. The drive adapter hub includes a magnetic insert that attaches to the powered driver prior to needle insertion. The BD Intraosseous Infusion System is an easy-grip, hand-held, battery-powered device with a rechargeable lithium battery used to assist in the insertion of the subject device needle through the bone cortex. The assembly of the hypodermic needle and stylet with connected drive adapter hub is referred to as the needle set. For insertions using the manual driver, the needle and the needle hub mate with a stylet in the same way as the needle set that is used with the powered driver, except the stylet is integrated into the handle of the manual driver instead of a drive adaptor hub (i.e. the manual driver needle assembly does not include a drive adapter hub). The stylet was designed to include a passive safety feature to protect the placer from sharps injury. After the needle is inserted, the stylet is separated from the needle and needle hub. Upon separation of the stylet from the needle hub, the passive safety feature is released onto the stylet tip and can be safely discarded into a sharps container. Following needle insertion, the securement dressing can be applied to secure the needle hub to the skin. An extension set is available for access to the needle hub to support fluid exchange. The subject device BD Intraosseous Infusion System will be offered in needle set (for use with the powered driver) and manual driver needle kit configurations. Each kit configuration will include a securement dressing and an extension set.
The provided text describes the BD Intraosseous Infusion System and its substantial equivalence to a predicate device, the Piper GO-IO® Intraosseous Infusion System. It outlines various performance, sterilization, packaging, and biocompatibility tests conducted to demonstrate the device meets acceptance criteria.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document lists numerous performance tests and standards followed for both the Needle Set Kit and Manual Driver Kit configurations of the BD Intraosseous Infusion System. While specific numerical acceptance criteria and detailed performance results are not explicitly stated in a quantified manner for each test, the general reporting indicates that the device met all predetermined acceptance criteria.
| Acceptance Criteria (Test Category) | Standard Followed / Test Conducted | Reported Device Performance |
|---|---|---|
| Needle Set Kit and Manual Driver Kit Performance Tests | ||
| Needle Outer Diameter (OD) | ISO 9626: 2016 and Internal Protocol/Standard | Met predetermined acceptance criteria |
| Needle Length | Internal Protocol/Standard | Met predetermined acceptance criteria |
| Needle Lubricity | ISO 7864: 2016 | Met predetermined acceptance criteria |
| Needle Quality, Surface Finish, and Cleanliness | ISO 9626: 2016 | Met predetermined acceptance criteria |
| Needle to Hub Assembly Tensile | Internal Protocol/Standard | Met predetermined acceptance criteria |
| Stylet to Drive Adapter Hub Tensile | Internal Protocol/Standard | Met predetermined acceptance criteria |
| Needle and Stylet Disassembly Force | Internal Protocol/Standard | Met predetermined acceptance criteria |
| Safety Activation | FDA Guidance for Sharps Injury Prevention Features & ISO 23908: 2011 | Met predetermined acceptance criteria |
| Stylet Safety Override (force to failure) | ISO 23908: 2011 | Met predetermined acceptance criteria |
| Manual Driver Hub to Stylet Tensile | Internal Protocol/Standard | Met predetermined acceptance criteria |
| Needle Resistance to Corrosion | ISO 9626: 2016 | Met predetermined acceptance criteria |
| Needle Hub Luer | ISO 594-1: 1986 and ISO 594-2: 1998 | Met predetermined acceptance criteria |
| Needle Hub Cleanliness | ISO 7864: 2016 | Met predetermined acceptance criteria |
| Needle Point | ISO 7864: 2016 | Met predetermined acceptance criteria |
| Needle Resistance to Breakage | ISO 9626: 2016 | Met predetermined acceptance criteria |
| Needle Stiffness | ISO 9626: 2016 and Internal Protocol/Standard | Met predetermined acceptance criteria |
| Gravity Flow Rate | Internal Protocol/Standard | Met predetermined acceptance criteria |
| Liquid Leak Needle Hub | Internal Protocol/Standard | Met predetermined acceptance criteria |
| Limits for Acidity or Alkalinity (Needle) | ISO 9626: 2016 / ISO 7864: 2016 | Met predetermined acceptance criteria |
| Limits for Extractable Metals (Needle) | ISO 7864: 2016 | Met predetermined acceptance criteria |
| Depth Markings | Internal Protocol/Standard | Met predetermined acceptance criteria |
| Insertion Force | Internal Protocol/Standard | Met predetermined acceptance criteria |
| Needle Bone Retention - Needle Point OD | Internal Protocol/Standard | Met predetermined acceptance criteria |
| Packaging Integrity and Seal Strength | ISO 11607-1:2006, ASTM F88/F88M: 2015, ASTM F1886/F1886M: 2016, ASTM F1929: 2015 | Met predetermined acceptance criteria |
| Device Usability/Simulated Use | Internal Protocol/Standard | Met predetermined acceptance criteria |
| Sharps Injury Prevention Feature (Simulated Clinical Use) | FDA Guidance for Sharps Injury Prevention Features & ISO 23908: 2011 | Met predetermined acceptance criteria |
| Sterilization, Packaging, and Shelf-Life | ||
| Sterilization Validation/Adoption | ISO 11135:2014 | Met predetermined acceptance criteria |
| Packaging/Shelf-Life Validations | ISO 11607-1 AMD 1: 2014, ASTM F88/F88M: 2015, ASTM F1886/F1886M: 2016, ASTM F1929: 2015 | Met predetermined acceptance criteria |
| Sterilant Residuals | ISO 10993-7: 2008 | Met predetermined acceptance criteria |
| Bacterial Endotoxin | USP , USP | Met predetermined acceptance criteria |
| Biocompatibility Evaluation | ||
| Cytotoxicity | ISO 10993-05: 2009 | Met predetermined acceptance criteria |
| Sensitization | ISO 10993-10: 2010 | Met predetermined acceptance criteria |
| Irritation/Intracutaneous Reactivity | ISO 10993-10: 2010 (Assumed, as it's listed under this section without a separate standard) | Met predetermined acceptance criteria |
| Acute Systemic Toxicity | ISO 10993-11: 2006 | Met predetermined acceptance criteria |
| Material Mediated Pyrogenicity | ISO 10993-11: 2006 (Assumed, as it's listed under this section without a separate standard) | Met predetermined acceptance criteria |
| Hemocompatibility | ISO 10993-4: 2017 | Met predetermined acceptance criteria |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes used for each individual performance or biological test. It generally refers to "performance (verification and validation testing)" and "biological tests."
The data provenance is internal to the manufacturer ("Internal Protocol/Standard") or based on established industry standards (e.g., ISO, ASTM, FDA Guidance). The document does not specify country of origin for data or if it was retrospective or prospective, as this is a device submission focused on technical performance and safety rather than clinical trial data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The tests performed are primarily engineering and laboratory-based, adhering to established standards, rather than requiring expert consensus for a "ground truth" in a clinical sense. For "Device Usability/Simulated Use" and "Sharps Injury Prevention Feature (Simulated Clinical Use)" tests, it's implied that users were involved, but their qualifications and numbers are not detailed.
4. Adjudication method for the test set
This information is not provided in the document. Given the nature of the tests (physical, chemical, mechanical, and biological properties according to standards), adjudication methods typically used for subjective clinical assessments are not relevant here.
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 information is not applicable and therefore not provided. The BD Intraosseous Infusion System is a physical medical device (needle, driver, etc.) for infusion access, not an AI-powered diagnostic or assistive technology that would involve human "readers" or an AI component.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable and therefore not provided. The device is not an algorithm or software-only system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the technical and biological tests, the "ground truth" is defined by the established criteria within the referenced ISO, ASTM standards, FDA guidance, and internal protocols. These standards define acceptable ranges, material properties, and performance limits. For "Device Usability/Simulated Use" and "Sharps Injury Prevention Feature (Simulated Clinical Use)", the ground truth would be successful completion of tasks and demonstration of safety features as per pre-defined objectives. There is no mention of expert consensus, pathology, or outcomes data to establish ground truth in this submission.
8. The sample size for the training set
This information is not applicable and therefore not provided. This device does not use machine learning or AI, so there is no "training set."
9. How the ground truth for the training set was established
This information is not applicable and therefore not provided for the same reason as above.
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).