(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 <85>USP <161> | 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.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
November 13, 2019
Piper Access, LLC % Mark Job Official Correspondent Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114
Re: K191976
Trade/Device Name: Piper GO-IO Intraosseous Infusion System Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic single lumen needle Regulatory Class: Class II Product Code: FMI Dated: September 5, 2019 Received: September 17, 2019
Dear Mark Job:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Alan Stevens Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name Piper GO-IO® Intraosseous Infusion System
Indications for Use (Describe)
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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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K191976
510(k) Summary 21 CFR 807.92(a)
Applicant
| Name: | Piper Access, LLC |
|---|---|
| Address: | 3981 South 700 East Suite #15Salt Lake City, UT 84107 |
| Ph: | 801-210-2886 |
| Manufacturer Contact: | Jay Muse, President and CEO |
| Email: | Jay.muse@piperaccess.com |
| Application Correspondent: | Jacob Lee |
| Email: | Jacob.Lee@bd.com |
| Date prepared: | November 08, 2019 |
Subject Device
| Trade Name: | Piper GO-IO® Intraosseous Infusion System |
|---|---|
| Common Name: | Intraosseous Infusion System |
| Classification Name: | Hypodermic single lumen needle |
| Class: | II |
| Regulation: | 21 CFR 880.5570 |
| Product Code: | FMI |
| Panel: | General Hospital |
Predicate Device
| 510(k): | K141117 (Clearance Date July 8, 2014) |
|---|---|
| Trade Name: | EZ-IO® Intraosseous Infusion System |
| Manufacturer: | Arrow/Teleflex Medical |
| Common Name: | Intraosseous Infusion System |
| Classification Name: | Hypodermic single lumen needle |
| Class: | II |
| Regulation: | 21CFR 880.5570 |
| Product Code: | FMI |
| Panel: | General Hospital |
Reason for Submission
This is a new device.
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Subject Device Description
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.
Intended Use
The Piper GO-IO® is intended to provide clinicians and emergency personnel with access to the intraosseous space.
Indications for Use
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.
Technological Characteristics
The technological characteristics of the subject Piper GO-IO® Intraosseous Infusion System are substantially equivalent with respect to the basic design and function as compared to the predicate EZ-IO® Intraosseous Infusion System. The differences between the subject and predicate devices are not critical to the intended use of the device and do not raise different questions of safety and effectiveness.
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The following table provides a comparison of the technological characteristics between the subject and predicate device in sufficient detail to provide an understanding of the basis for a determination of substantial equivalence.
| Subject and Predicate Device Comparison Table | ||
|---|---|---|
| Attribute | Piper GO-IO® IntraosseousInfusion System(Subject Device) | EZ-IO® IntraosseousInfusion System(Predicate) |
| 510(k) | Subject of this PremarketNotification | K141117 |
| Product Code | Same as predicate | FMI |
| Intended Use | Same as predicate | Intended to provide clinicians andemergency personnel with access tothe intraosseous space. |
| Indications for Use | Same as predicate with theexception of the subject devicebrand name | The EZ-IO® Intraosseous InfusionSystem provides intraosseous accessin the proximal tibia, distal tibia andhumeral head (proximal humerus) ofadult and pediatric patients, and thedistal femur in pediatric patientswhen intravenous access is difficultor impossible to obtain in emergent,urgent, or medically necessary casesfor up to 24 hours. |
| Target PatientPopulation | Same as predicate | Adults and Pediatrics |
| AnatomicalInsertion Site | Same as predicate | Adults: Proximal tibia, distal tibia,proximal humerusPediatrics: Proximal tibia, distaltibia, proximal humerus, distalfemur |
| Primary IO SystemComponents | Same as predicate with theexception of the subject stylet,which includes a passive safetysharps prevention feature | • Hypodermic Needle w/Stylet· Needle Safety Cap· Securement Dressing· Extension Set• Powered Driver· Manual Driver |
| Needle: Dwell Time | Same as predicate | 24 hours or less |
| Needle: Use | Same as predicate | Single Use |
| Needle Lengths | 15mm (3-39kg)25mm (>3kg)45mm (>40kg) | 15 mm (3-39kg)25 mm (3kg and over)45 mm (40kg and over) |
| Subject and Predicate Device Comparison Table | ||
| Attribute | Piper GO-IO® IntraosseousInfusion System(Subject Device) | EZ-IO® IntraosseousInfusion System(Predicate) |
| Needle: OuterDiameter | Same as predicate | 15 gauge |
| Needle: Materials | Same as predicate | 304 Stainless Steel |
| Needle: Tip Design | Touhy/Huber Style Needle Tip | Faceted Tip |
| Needle: DepthMarkers | Same as predicate | Depth markers every 1 cm |
| Needle: HubMaterial | Same as predicate | Medical grade polycarbonate |
| Needle: HubConnection | Same as predicate | Standard Luer Lock |
| Stylet: Materials | Same as predicate | Stainless Steel |
| Stylet: SharpsInjury PreventionFeature | Includes a stylet tip safety feature | Does not include a sharpsprevention feature on the stylet |
| Drive Adapter Hub:Materials | Same as predicate | Polycarbonate and stainless steel |
| Inclusion of aNeedle ProtectiveCover | Yes, includes a cover made ofpolypropylene | Yes, includes a cover made ofunknown material |
| Needle SetSterilization Method& SAL | Same as predicate | EO, 10-6 |
| Manual DriverAttachment | Manual driver handle withintegrated stylet mates with internallumen of needle and needle hubattaches to manual driver | Manual handle attaches toneedle set (i.e. assembly of needleand stylet) with magnet |
| Manual DriverComponentMaterials | Handle: ABSStylet: Stainless Steel (304) | Handle: PolycarbonateStylet: The manual handle does notinclude an integrated stylet |
| Manual DriverSterilization Method | Same as predicate | EO |
| Manual Driver SAL | Same as predicate | 10-6 |
| Powered DriverFeatures | Same as predicate | Cordless, Battery-powered |
| Powered Driver Use | Same as predicate | Reusable |
| Powered DriverMaterials | Copolyester | Polycarbonate |
| Powered DriverEnergy Source | Rechargeable Lithium Batteries | Lithium Batteries |
| Subject and Predicate Device Comparison Table | ||
| Attribute | Piper GO-IO® IntraosseousInfusion System(Subject Device) | EZ-IO® IntraosseousInfusion System(Predicate) |
| Powered DriverBattery LightIndicator | 4 battery light indicators torepresent battery charge level | One battery light indicator |
| Powered DriverNeedle Attachment | Same as predicate | Magnetic |
| Powered DriverCleaning Method | Same as predicate | High level disinfectant |
| Powered Driver:Type of protectionagainst electricshock | Internally Powered and Class II | Internally Powered |
| Powered Driver:Degree of protectionagainst electricshock | Same as predicate | Type BF applied part |
| Powered Driver:Degree of protectionagainst ingress ofwater | IP33, Spraying water and solidforeign body protection (objects>2.5mm diameter) | IPX0 Ordinary Protection |
| Means to InsertNeedle | Same as predicate | Manual or Powered Driver |
| General Method ofInsertion | Same as predicate | Push needle through soft tissue untilit contacts bone. Confirm depthmarkings. Insert needle set throughbone until change in pressure is feltor to desired depth. Remove stylet.Connect IV extension set. |
| Degree of safetyor application inthe presence of aflammableanestheticmixture: | Not intended for use in an oxygenrich environment | Equipment not suitable for use inthe presence of a flammableanesthetic mixture with air or withoxygen or nitrous oxide |
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| Subject and Predicate Device Comparison Table | ||||
|---|---|---|---|---|
| Attribute | Piper GO-IO® IntraosseousInfusion System(Subject Device) | EZ-IO® IntraosseousInfusion System(Predicate) | ||
| Expected ServiceLife (PoweredDriver) | Expected service life isapproximately 400 insertions.Service life expectancy isdependent on actual usage (bonedensity and average insertion time),storage, and frequency of testing. | The predicate device is warranted toa service life of 500 insertions.Service Life expectancy isdependent on actual usage (bonedensity and average insertiontime), storage, and frequency oftesting. | ||
| ElectromagneticImmunity andEmissions (IEC60601-1-2) | Same as predicate | Complies with standard | ||
| Maximum RPM | Same as predicate | 1587 or less |
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Performance Testing
The following tables identify the performance tests completed on the subject device system, including the standard followed for each test.
| Needle Set Kit and Manual Driver KitPerformance Tests | Standard Followed |
|---|---|
| Needle Outer Diameter (OD) | ISO 9626: 2016 |
| Effective Needle Length | ISO 7864: 2016 |
| Needle Lubricity | ISO 7864: 2016 |
| Needle Cleanliness | ISO 9626: 2016 |
| Needle to Hub Assembly Tensile | Internal Protocol/Standard |
| Stylet to Drive Adapter Hub Tensile | Internal Protocol/Standard |
| Needle and Stylet Disassembly Force | ISO 23908: 2011 |
| Safety Activation | FDA Guidance for Sharps Injury PreventionFeatures & ISO 23908: 2011 |
| Stylet Safety Override (force to failure) | ISO 23908: 2011 |
| Securement Dressing - Pinch Force | Internal Protocol/Standard |
| Securement Dressing – Peel Strength | Internal Protocol/Standard |
| Securement Dressing – Liner Removal | Internal Protocol/Standard |
| Manual Driver Hub to Stylet Tensile | Internal Protocol/Standard |
| Cannula Needle Resistance to Corrosion | ISO 9626: 2016 |
| Cannula Needle Surface Finish | ISO 7864: 2016 |
| Needle Surface Finish and Visual Appearance | ISO 9626: 2016 |
| Needle Hub Luer | ISO 594-1: 1986 and ISO 594-2: 1998 |
| Needle Hub Cleanliness | ISO 7864: 2016 |
| Needle Point | ISO 7864: 2016 |
| Needle Resistance to Breakage | ISO 9626: 2016 |
| Needle Stiffness | ISO 9626: 2016 |
| Gravity Flow Rate | Internal Protocol/Standard |
| Liquid Leak Needle Hub | Internal Protocol/Standard |
| Limits for Acidity or Alkalinity (Needle) | ISO 7864: 2016 |
| Limits for Extractable Metals (Needle) | ISO 7864: 2016 |
| Depth Markings | Internal Protocol/Standard |
| Chemical Resistance | Internal Protocol/Standard |
| Needle Durability | Internal Protocol/Standard |
| Manual Drilling | Internal Protocol/Standard |
| Packaging Integrity and Seal Strength | ISO 11607-1:2006ASTM F88/F88M: 2015ASTM F1886/F1886M: 2016ASTM F1929: 2015 |
| Sharps Injury Prevention Feature (in SimulatedClinical Use) | FDA Guidance for Sharps Injury PreventionFeatures & ISO 23908: 2011 |
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| Powered Drill Performance Tests | Standards Followed |
|---|---|
| Needle Set Coupling | Internal Protocol/Standard |
| Battery Capacity/Indicator | Internal Protocol/Standard |
| Battery Usable Life | Internal Protocol/Standard |
| Battery Indicator / State of Charge | Internal Protocol/Standard |
| Drill High Temperature Shut Down | Internal Protocol/Standard |
| Use Life | Internal Protocol/Standard |
| Duty Cycle | Internal Protocol/Standard |
| Motor Stall/Stuck Shutoff | Internal Protocol/Standard |
| Usability | IEC 60601-1-6: 2013 |
| Electrical Safety and ElectromagneticCompatibility | • 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 |
| Firmware Verification and Validation | Guidance for the Content ofPremarket Submissions for Software Containedin Medical Devices |
| Sterilization, Packaging, and Shelf-Life | Standard Followed |
|---|---|
| Sterilization Validation/Adoption | ISO 11135:2014 |
| Packaging/Shelf-Life Validations | ISO 11607-1 AMD 1: 2014ASTM F88/F88M: 2015ASTM F1886/F1886M: 2016ASTM F1929: 2015 |
| Residuals | ISO 10993-7: 2008 |
| Bacterial Endotoxin | USP <85>USP <161> |
A biocompatibility evaluation was conducted on the subject device per ISO 10993-1:2009, Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process. According to the evaluation, the biological tests in the table below were conducted.
| Biological Endpoint | Standard Followed |
|---|---|
| Cytotoxicity | ISO 10993-05: 2009 |
| Sensitization | ISO 10993-10: 2010 |
| Irritation/Intracutaneous Reactivity | |
| Acute Systemic Toxicity | ISO 10993-11: 2006 |
| Material Mediated Pyrogenicity | |
| Hemocompatibility | ISO 10993-4: 2017 |
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Summary of Substantial Equivalence
The subject device, Piper GO-IO® Intraosseous Infusion System, has the same intended use and the same fundamental scientific technology as the predicate device, EZ-IO Intraosseous Infusion System. The results of performance and biological tests conducted on the Piper GO-IO® Intraosseous Infusion System met all predetermined acceptance criteria and demonstrated that the different technological characteristics of the subject device do not raise different questions of safety and effectiveness. Based on the intended use, technological characteristics, performance and biological test results, the Piper GO-IO® Intraosseous Infusion System can be considered substantially equivalent to the cited predicate 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).