(112 days)
Not Found
No
The device description and performance studies focus on mechanical and electrical components for needle insertion and fluid delivery, with no mention of AI or ML capabilities.
Yes
The device is used to gain intraosseous access for resuscitation and fluid delivery in emergent or urgent situations, which directly addresses a medical condition to restore health or improve a medical condition.
No
The device is an intraosseous infusion system designed to provide access for fluid delivery, not to diagnose a medical condition.
No
The device description explicitly lists multiple hardware components, including a hypodermic needle, powered or manual driver, extension set, and securement dressing. The performance studies also detail testing of these physical components.
Based on the provided information, the Piper GO-IO® Intraosseous Infusion System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to provide intraosseous access for fluid delivery in emergent, urgent, or medically necessary cases when intravenous access is difficult or impossible. This is a therapeutic and access procedure, not a diagnostic test performed on samples outside the body.
- Device Description: The device components (needle, driver, extension set, securement dressing) are designed for physically accessing the intraosseous space and delivering substances, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
Therefore, the Piper GO-IO® Intraosseous Infusion System is a medical device used for providing access and delivering fluids, not an IVD.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
FMI
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, 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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
proximal tibia, distal tibia, humeral head (proximal humerus), distal femur
Indicated Patient Age Range
adult and pediatric patients
Intended User / Care Setting
clinicians and emergency personnel
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 Kit Performance Tests:
- 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 Prevention Features & 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 11607-1:2006, ASTM F88/F88M: 2015, ASTM F1886/F1886M: 2016, ASTM F1929: 2015
- Sharps Injury Prevention Feature (in Simulated Clinical Use) - FDA Guidance for Sharps Injury Prevention Features & ISO 23908: 2011
Powered Drill Performance Tests:
- 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 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
- Firmware Verification and Validation - Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
Sterilization, Packaging, and Shelf-Life:
- Sterilization Validation/Adoption - ISO 11135:2014
- Packaging/Shelf-Life Validations - ISO 11607-1 AMD 1: 2014, ASTM F88/F88M: 2015, ASTM F1886/F1886M: 2016, ASTM F1929: 2015
- Residuals - ISO 10993-7: 2008
- Bacterial Endotoxin - USP , USP
Biocompatibility Evaluation (per ISO 10993-1:2009):
- Cytotoxicity - ISO 10993-05: 2009
- Sensitization - ISO 10993-10: 2010
- Irritation/Intracutaneous Reactivity - Not Found (listed as blank in table)
- Acute Systemic Toxicity - ISO 10993-11: 2006
- Material Mediated Pyrogenicity - Not Found (listed as blank in table)
- Hemocompatibility - ISO 10993-4: 2017
Key results: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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.
1
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
2
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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3
K191976
510(k) Summary 21 CFR 807.92(a)
Applicant
| Name: | Piper Access, LLC |
|---|---|
| Address: | 3981 South 700 East Suite #15 |
| Salt 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.
4
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.
5
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® Intraosseous | |
| Infusion System | ||
| (Subject Device) | EZ-IO® Intraosseous | |
| Infusion System | ||
| (Predicate) | ||
| 510(k) | Subject of this Premarket | |
| Notification | K141117 | |
| Product Code | Same as predicate | FMI |
| Intended Use | Same as predicate | Intended to provide clinicians and |
| emergency personnel with access to | ||
| the intraosseous space. | ||
| Indications for Use | Same as predicate with the | |
| exception of the subject device | ||
| brand name | The EZ-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. | ||
| Target Patient | ||
| Population | Same as predicate | Adults and Pediatrics |
| Anatomical | ||
| Insertion Site | Same as predicate | Adults: Proximal tibia, distal tibia, |
| proximal humerus | ||
| Pediatrics: Proximal tibia, distal | ||
| tibia, proximal humerus, distal | ||
| femur | ||
| Primary IO System | ||
| Components | Same as predicate with the | |
| exception of the subject stylet, | ||
| which includes a passive safety | ||
| sharps 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® Intraosseous | |
| Infusion System | ||
| (Subject Device) | EZ-IO® Intraosseous | |
| Infusion System | ||
| (Predicate) | ||
| Needle: Outer | ||
| Diameter | Same as predicate | 15 gauge |
| Needle: Materials | Same as predicate | 304 Stainless Steel |
| Needle: Tip Design | Touhy/Huber Style Needle Tip | Faceted Tip |
| Needle: Depth | ||
| Markers | Same as predicate | Depth markers every 1 cm |
| Needle: Hub | ||
| Material | Same as predicate | Medical grade polycarbonate |
| Needle: Hub | ||
| Connection | Same as predicate | Standard Luer Lock |
| Stylet: Materials | Same as predicate | Stainless Steel |
| Stylet: Sharps | ||
| Injury Prevention | ||
| Feature | Includes a stylet tip safety feature | Does not include a sharps |
| prevention feature on the stylet | ||
| Drive Adapter Hub: | ||
| Materials | Same as predicate | Polycarbonate and stainless steel |
| Inclusion of a | ||
| Needle Protective | ||
| Cover | Yes, includes a cover made of | |
| polypropylene | Yes, includes a cover made of | |
| unknown material | ||
| Needle Set | ||
| Sterilization Method | ||
| & SAL | Same as predicate | EO, 10-6 |
| Manual Driver | ||
| Attachment | Manual driver handle with | |
| integrated stylet mates with internal | ||
| lumen of needle and needle hub | ||
| attaches to manual driver | Manual handle attaches to | |
| needle set (i.e. assembly of needle | ||
| and stylet) with magnet | ||
| Manual Driver | ||
| Component | ||
| Materials | Handle: ABS | |
| Stylet: Stainless Steel (304) | Handle: Polycarbonate | |
| Stylet: The manual handle does not | ||
| include an integrated stylet | ||
| Manual Driver | ||
| Sterilization Method | Same as predicate | EO |
| Manual Driver SAL | Same as predicate | 10-6 |
| Powered Driver | ||
| Features | Same as predicate | Cordless, Battery-powered |
| Powered Driver Use | Same as predicate | Reusable |
| Powered Driver | ||
| Materials | Copolyester | Polycarbonate |
| Powered Driver | ||
| Energy Source | Rechargeable Lithium Batteries | Lithium Batteries |
| Subject and Predicate Device Comparison Table | ||
| Attribute | Piper GO-IO® Intraosseous | |
| Infusion System | ||
| (Subject Device) | EZ-IO® Intraosseous | |
| Infusion System | ||
| (Predicate) | ||
| Powered Driver | ||
| Battery Light | ||
| Indicator | 4 battery light indicators to | |
| represent battery charge level | One battery light indicator | |
| Powered Driver | ||
| Needle Attachment | Same as predicate | Magnetic |
| Powered Driver | ||
| Cleaning Method | Same as predicate | High level disinfectant |
| Powered Driver: | ||
| Type of protection | ||
| against electric | ||
| shock | Internally Powered and Class II | Internally Powered |
| Powered Driver: | ||
| Degree of protection | ||
| against electric | ||
| shock | Same as predicate | Type BF applied part |
| Powered Driver: | ||
| Degree of protection | ||
| against ingress of | ||
| water | IP33, Spraying water and solid | |
| foreign body protection (objects |
2.5mm diameter) | IPX0 Ordinary Protection |
| Means to Insert
Needle | Same as predicate | Manual or Powered Driver |
| General Method of
Insertion | Same as predicate | Push needle through soft tissue until
it contacts bone. Confirm depth
markings. Insert needle set through
bone until change in pressure is felt
or to desired depth. Remove stylet.
Connect IV extension set. |
| Degree of safety
or application in
the presence of a
flammable
anesthetic
mixture: | Not intended for use in an oxygen
rich environment | Equipment not suitable for use in
the presence of a flammable
anesthetic mixture with air or with
oxygen or nitrous oxide |
6
7
8
| Subject and Predicate Device Comparison Table | ||||
|---|---|---|---|---|
| Attribute | Piper GO-IO® Intraosseous | |||
| Infusion System | ||||
| (Subject Device) | EZ-IO® Intraosseous | |||
| Infusion System | ||||
| (Predicate) | ||||
| Expected Service | ||||
| Life (Powered | ||||
| Driver) | Expected service life is | |||
| approximately 400 insertions. | ||||
| Service life expectancy is | ||||
| dependent on actual usage (bone | ||||
| density and average insertion time), | ||||
| storage, and frequency of testing. | The predicate device is warranted to | |||
| a service life of 500 insertions. | ||||
| Service Life expectancy is | ||||
| dependent on actual usage (bone | ||||
| density and average insertion | ||||
| time), storage, and frequency of | ||||
| testing. | ||||
| Electromagnetic | ||||
| Immunity and | ||||
| Emissions (IEC | ||||
| 60601-1-2) | Same as predicate | Complies with standard | ||
| Maximum RPM | Same as predicate | 1587 or less |
9
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 Kit
| Performance 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 Prevention |
| Features & 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 11607-1:2006 |
| ASTM F88/F88M: 2015 | |
| ASTM F1886/F1886M: 2016 | |
| ASTM F1929: 2015 | |
| Sharps Injury Prevention Feature (in Simulated | |
| Clinical Use) | FDA Guidance for Sharps Injury Prevention |
| Features & ISO 23908: 2011 |
10
| 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 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 | |
| Firmware Verification and Validation | Guidance for the Content of |
| Premarket Submissions for Software Contained | |
| in Medical Devices |
| Sterilization, Packaging, and Shelf-Life | Standard Followed |
|---|---|
| Sterilization Validation/Adoption | ISO 11135:2014 |
| Packaging/Shelf-Life Validations | ISO 11607-1 AMD 1: 2014 |
| ASTM F88/F88M: 2015 | |
| ASTM F1886/F1886M: 2016 | |
| ASTM F1929: 2015 | |
| Residuals | ISO 10993-7: 2008 |
| Bacterial Endotoxin | USP |
| USP |
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 |
11
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.