(112 days)
The Piper GO-IO® 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 Piper GO-IO® 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 Piper GO-IO® 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 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 Piper GO-IO® Powered Driver is a hand-held, batterypowered 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 Piper GO-IO® 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.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document details various performance tests conducted on the Piper GO-IO® Intraosseous Infusion System. For most entries, the "acceptance criteria" are implied by the standard followed (e.g., ISO 9626:2016 for Needle Outer Diameter) and the "reported device performance" is stated as "met all predetermined acceptance criteria" within the "Summary of Substantial Equivalence" section. Specific quantitative acceptance criteria or detailed performance results are not provided in this document for individual tests.
Therefore, a table cannot be constructed with explicit quantitative acceptance criteria and reported device performance for each test. However, a summary table indicating the tests performed and the general outcome can be presented:
| Performance Test Category | Standard Followed | Reported Device Performance |
|---|---|---|
| Needle Set Kit and Manual Driver Kit Tests | Various ISO standards and Internal Protocols | Met all predetermined acceptance criteria |
| Needle Outer Diameter (OD) | ISO 9626: 2016 | Met all predetermined acceptance criteria |
| Effective Needle Length | ISO 7864: 2016 | Met all predetermined acceptance criteria |
| Needle Lubricity | ISO 7864: 2016 | Met all predetermined acceptance criteria |
| Needle Cleanliness | ISO 9626: 2016 | Met all predetermined acceptance criteria |
| Needle to Hub Assembly Tensile | Internal Protocol/Standard | Met all predetermined acceptance criteria |
| Stylet to Drive Adapter Hub Tensile | Internal Protocol/Standard | Met all predetermined acceptance criteria |
| Needle and Stylet Disassembly Force | ISO 23908: 2011 | Met all predetermined acceptance criteria |
| Safety Activation | FDA Guidance for Sharps Injury Prevention Features & ISO 23908: 2011 | Met all predetermined acceptance criteria |
| Stylet Safety Override (force to failure) | ISO 23908: 2011 | Met all predetermined acceptance criteria |
| Securement Dressing - Pinch Force | Internal Protocol/Standard | Met all predetermined acceptance criteria |
| Securement Dressing – Peel Strength | Internal Protocol/Standard | Met all predetermined acceptance criteria |
| Securement Dressing – Liner Removal | Internal Protocol/Standard | Met all predetermined acceptance criteria |
| Manual Driver Hub to Stylet Tensile | Internal Protocol/Standard | Met all predetermined acceptance criteria |
| Cannula Needle Resistance to Corrosion | ISO 9626: 2016 | Met all predetermined acceptance criteria |
| Cannula Needle Surface Finish | ISO 7864: 2016 | Met all predetermined acceptance criteria |
| Needle Surface Finish and Visual Appearance | ISO 9626: 2016 | Met all predetermined acceptance criteria |
| Needle Hub Luer | ISO 594-1: 1986 and ISO 594-2: 1998 | Met all predetermined acceptance criteria |
| Needle Hub Cleanliness | ISO 7864: 2016 | Met all predetermined acceptance criteria |
| Needle Point | ISO 7864: 2016 | Met all predetermined acceptance criteria |
| Needle Resistance to Breakage | ISO 9626: 2016 | Met all predetermined acceptance criteria |
| Needle Stiffness | ISO 9626: 2016 | Met all predetermined acceptance criteria |
| Gravity Flow Rate | Internal Protocol/Standard | Met all predetermined acceptance criteria |
| Liquid Leak Needle Hub | Internal Protocol/Standard | Met all predetermined acceptance criteria |
| Limits for Acidity or Alkalinity (Needle) | ISO 7864: 2016 | Met all predetermined acceptance criteria |
| Limits for Extractable Metals (Needle) | ISO 7864: 2016 | Met all predetermined acceptance criteria |
| Depth Markings | Internal Protocol/Standard | Met all predetermined acceptance criteria |
| Chemical Resistance | Internal Protocol/Standard | Met all predetermined acceptance criteria |
| Needle Durability | Internal Protocol/Standard | Met all predetermined acceptance criteria |
| Manual Drilling | Internal Protocol/Standard | Met all predetermined acceptance criteria |
| Packaging Integrity and Seal Strength | ISO 11607-1:2006, ASTM F88/F88M: 2015, ASTM F1886/F1886M: 2016, ASTM F1929: 2015 | Met all predetermined acceptance criteria |
| Sharps Injury Prevention Feature (in Simulated Clinical Use) | FDA Guidance for Sharps Injury Prevention Features & ISO 23908: 2011 | Met all predetermined acceptance criteria |
| Powered Drill Performance Tests | Various IEC/ANSI/Internal Standards | Met all predetermined acceptance criteria |
| Needle Set Coupling | Internal Protocol/Standard | Met all predetermined acceptance criteria |
| Battery Capacity/Indicator | Internal Protocol/Standard | Met all predetermined acceptance criteria |
| Battery Usable Life | Internal Protocol/Standard | Met all predetermined acceptance criteria |
| Battery Indicator / State of Charge | Internal Protocol/Standard | Met all predetermined acceptance criteria |
| Drill High Temperature Shut Down | Internal Protocol/Standard | Met all predetermined acceptance criteria |
| Use Life | Internal Protocol/Standard | Met all predetermined acceptance criteria |
| Duty Cycle | Internal Protocol/Standard | Met all predetermined acceptance criteria |
| Motor Stall/Stuck Shutoff | Internal Protocol/Standard | Met all predetermined acceptance criteria |
| Usability | IEC 60601-1-6: 2013 | Met all predetermined acceptance criteria |
| Electrical Safety and Electromagnetic Compatibility | ANSI AAMI ES60601-1:2005/(R)2012, A1:2012, C1:2009/(R)2012, A2:2010/(R)2012; IEC 60601-1-2: 2014; IEC 60601-1-12: 2014; IEC 62133: 2012 | Met all predetermined acceptance criteria |
| Firmware Verification and Validation | Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices | Met all predetermined acceptance criteria |
| Sterilization, Packaging, and Shelf-Life Tests | Various ISO standards and ASTM | Met all predetermined acceptance criteria |
| Sterilization Validation/Adoption | ISO 11135:2014 | Met all 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 all predetermined acceptance criteria |
| Residuals | ISO 10993-7: 2008 | Met all predetermined acceptance criteria |
| Bacterial Endotoxin | USP | |
| USP | Met all predetermined acceptance criteria | |
| Biocompatibility Tests | ISO 10993 series | Met all predetermined acceptance criteria |
| Cytotoxicity | ISO 10993-05: 2009 | Met all predetermined acceptance criteria |
| Sensitization | ISO 10993-10: 2010 | Met all predetermined acceptance criteria |
| Irritation/Intracutaneous Reactivity | ISO 10993-10: 2010 | Met all predetermined acceptance criteria |
| Acute Systemic Toxicity | ISO 10993-11: 2006 | Met all predetermined acceptance criteria |
| Material Mediated Pyrogenicity | ISO 10993-11: 2006 | Met all predetermined acceptance criteria |
| Hemocompatibility | ISO 10993-4: 2017 | Met all predetermined acceptance criteria |
2. Sample Size for Test Set and Data Provenance
The document does not provide specific sample sizes for the test sets (e.g., number of needles, drivers, or tests performed on each). The provenance of the data is not specified; it refers to "performance tests completed on the subject device system" and implies the data was generated internally as part of the regulatory submission. There is no information regarding country of origin or whether the studies were retrospective or prospective beyond the stated date of preparation of the summary (November 8, 2019).
3. Number of Experts and Qualifications for Ground Truth
This information is not applicable. The device is a medical instrument (intraosseous infusion system), and the performance testing described is engineering and biological in nature, evaluating physical and material properties, and adherence to established standards. It does not involve diagnostic interpretation or human reader performance that would require experts to establish ground truth in the context of image analysis or similar AI/algorithm-driven tasks.
4. Adjudication Method for Test Set
This information is not applicable, as the performance tests are objective engineering and biological assessments against established standards, not subjective interpretations requiring adjudication.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. The document describes premarket notification for a medical device, which typically involves demonstrating substantial equivalence to a predicate device through engineering, biocompatibility, and performance testing, rather than comparative effectiveness studies with human readers and AI.
6. Standalone (Algorithm Only) Performance Study
No standalone (algorithm only) performance study was done. The device is a physical medical instrument, not an AI or software algorithm.
7. Type of Ground Truth Used
The "ground truth" for the performance tests outlined in the document is established by adherence to recognized international and national standards (e.g., ISO, ASTM, FDA guidance, USP) and internal protocols. These standards define the methods, parameters, and acceptable ranges for various tests related to material properties, mechanical performance, electrical safety, biocompatibility, and sterilization.
8. Sample Size for Training Set
This information is not applicable. The device is a hardware medical device, not an AI or machine learning model that requires a training set.
9. How Ground Truth for Training Set Was Established
This information is not applicable, as there is no training set for a hardware medical device.
§ 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).