BD Intraosseous Infusion System

K203193 · Bard Access Systems, Inc(Bas)[Wholly-Owned Subsidiary of Bd] · MHC · Mar 4, 2021 · General Hospital

Device Facts

• Record ID: K203193
• Device Name: BD Intraosseous Infusion System
• Applicant: Bard Access Systems, Inc(Bas)[Wholly-Owned Subsidiary of Bd]
• Product Code: MHC · General Hospital
• Decision Date: Mar 4, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The BD Intraosseous Infusion System is intended to provide clinicians and emergency personnel with access to the intraosseous space.

Device Story

System provides intraosseous (IO) access for fluid delivery; used in emergent/urgent cases when IV access is difficult/impossible. Components: hypodermic needle (with safety cap), powered or manual driver, extension set, adhesive securement dressing. Powered driver uses rechargeable lithium battery and magnetic drive adapter hub to insert needle through bone cortex. Manual driver features integrated stylet. Passive safety feature on stylet protects against sharps injury upon separation from needle hub. Used by clinicians/emergency personnel in clinical settings. Output: established IO access point for resuscitation/lifesaving fluids. Benefits: rapid vascular access in critical patients.

Clinical Evidence

Bench testing only. Performance testing included needle OD (ISO 9626), lubricity (ISO 7864), tensile strength, disassembly force, safety activation (ISO 23908), corrosion resistance, flow rate, and packaging integrity (ASTM F88, F1886, F1929). Biocompatibility evaluated per ISO 10993-1 (cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, hemocompatibility). Device usability/simulated clinical use testing performed.

Technological Characteristics

Needles: 304 stainless steel, 15 gauge, faceted tip, 15-55mm lengths. Hubs: medical grade polycarbonate. Manual driver: ABS handle, stainless steel stylet. Powered driver: rechargeable lithium battery, magnetic drive adapter. Sterilization: Ethylene Oxide (SAL 10^-6). Connectivity: None. Standards: ISO 9626, ISO 7864, ISO 594-1/2, ISO 23908, ISO 11135, ISO 10993.

Indications for Use

Indicated for 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.

Regulatory Classification

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.

Predicate Devices

• Piper GO-IO® Intraosseous Infusion System (K191976)

Submission Summary (Full Text)

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March 4, 2021

Bard Access Systems, Inc. (BAS) [Wholly-owned subsidiary of BD] Connor Dahl Regulatory Affairs Specialist 605 North 5600 West Salt Lake City, Utah 84116

Re: K203193

Trade/Device Name: BD Intraosseous Infusion System Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: MHC Dated: January 29, 2021 Received: February 1, 2021

Dear Connor Dahl:

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.

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

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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 (OS) 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 mediation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For Rumi Young 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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## DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known) K203193

Device Name BD Intraosseous Infusion System

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.

Type of Use (Select one or both, as applicable)

| <span style="font-weight:bold;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-weight:bold;">□</span> Over-The-Counter Use (21 CFR 801 Subpart C) |
|---------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
|---------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|

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## 510(k) Summary for BD Intraosseous Infusion System

21 CFR 807.92(a)

As required by the Safe Medical Devices Act of 1990, coded under Section 513, Part(l)(3)(A) of the Food, Drug and Cosmetic Act, a 510(k) summary upon which substantial equivalence determination is presented in the following table:

| General Provisions | Submitter Name: | Bard Access Systems, Inc. (BAS) [Wholly-owned subsidiary of BD] |
|--------------------|---------------------------|-----------------------------------------------------------------|
| | Submitter Address: | 605 North 5600 West<br>Salt Lake City, UT 84116 |
| | Contact Person: | Connor Dahl<br>Regulatory Affairs Specialist |
| | Telephone Number: | 801.522.5834 |
| | Fax Number: | 801.522.5425 |
| | Date of Preparation: | 1/26/2021 |
| | | |
| | | |
| Subject Device | Trade Name(s): | BD Intraosseous Infusion System |
| | Common Name: | Interosseous Infusion System |
| | Classification Name: | Hypodermic single lumen needle |
| | Class: | 2 |
| | Regulation Number: | 21 CFR 880.5570 |
| | Product Code: | MHC |
| | Classification Panel | General Hospital |
| Predicate Device | Predicate Trade Name: | Piper GO-IO® Intraosseous Infusion System |
| | Classification Name: | Intraosseous Infusion System |
| | Class: | 2 |
| | Product Code: | FMI |
| | Regulation Number: | 21 CFR 880.5570 |
| | Premarket Notification #: | K191976 |
| | Manufacturer: | Piper Access, LLC |
| | Classification Panel: | General Hospital |

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| Device Description | The BD Intraosseous Infusion System provides clinicians and emergency personnel with access to the intraosseous<br>space for resuscitation and lifesaving fluid delivery for up to 24 hours. The BD Intraosseous Infusion System consists<br>of the following:<br>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.<br>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).<br>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.<br>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. |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The BD Intraosseous Infusion System is intended to provide clinicians and emergency personnel with access to the intraosseous space. |
| Indications for Use | 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. |
| Technological<br>Characteristics | The technological characteristics of the subject BD Intraosseous Infusion System are substantially equivalent with respect to the basic design and function as compared to the predicate Piper GO-IO® Intraosseous Infusion System. The technological characteristics between the subject and predicate devices are the same, with the exception of the addition of the 35 mm and 55 mm needle lengths under review in this submission. The technological differences listed below were evaluated using industry consensus standards, validation, and as defined in the risk assessment.<br>Therefore, the differences in technological characteristics between the subject and predicate devices do not raise new or different questions of safety or effectiveness. |

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| The following table provides a comparison between the subject and predicate devices. | | |
|--------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Attribute | Subject Device - BD Intraosseous<br>Infusion System | Predicate Device - Piper GO-IO®<br>Intraosseous Infusion System |
| Owner | Bard Access Systems, Inc. | Piper Access, LLC |
| Classification | Same as predicate | FMI - 21 CFR 880.5570 |
| 510(k) Status | Subject of this Premarket Notification | K191976 - Concurrence date November<br>13, 2019 |
| Intended Use | Same as predicate | Intended to provide clinicians and<br>emergency personnel with access to the<br>intraosseous space. |
| Indications for<br>Use | The BD Intraosseous Infusion System<br>provides intraosseous access in the proximal<br>tibia, distal tibia and humeral head (proximal<br>humerus) of adult and pediatric patients, and<br>the distal femur in pediatric patients when<br>intravenous access is difficult or impossible<br>to obtain in emergent, urgent, or medically<br>necessary cases for up to 24 hours. | The Piper GO-IO® Intraosseous Infusion<br>System provides intraosseous access in the<br>proximal tibia, distal tibia and humeral head<br>(proximal humerus) of adult and pediatric<br>patients, and the distal femur in pediatric<br>patients when intravenous access is difficult<br>or impossible to obtain in emergent, urgent,<br>or medically necessary cases for up to 24<br>hours. |
| Commercial<br>Name | BD Intraosseous Infusion System | Piper GO-IO® Intraosseous Infusion<br>System |
| Target Patient<br>Population | Same as predicate | Adults and Pediatrics |
| Anatomical<br>Insertion Site | Same as predicate | Adults: Proximal tibia, distal tibia, proximal<br>humerus<br>Pediatrics: Proximal tibia, distal tibia,<br>proximal humerus, distal femur |
| Primary IO<br>System<br>Components | Same as predicate<br>The previously cleared Securement<br>Dressing and Power Driver are not<br>under review in this submission | ● Hypodermic Needle w/Stylet<br>● Needle Safety Cap<br>● Securement Dressing<br>● Powered Driver |

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| | | | Manual Driver |
|--|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| | Needle: Dwell Time | Same as predicate | 24 hours or less |
| | Needle: Use | Same as predicate | Single Use |
| | Needle Lengths | Needle lengths with corresponding tissue depth recommendations:<br>• 15mm (0-10 mm tissue depth)<br>• 25mm (0-20 mm tissue depth)<br>• 35mm (10-30 mm tissue depth)<br>• 45mm (20-40 mm tissue depth)<br>• 55mm (30-50 mm tissue depth) | Needle lengths with corresponding patient weight recommendations:<br>• 15mm (3-39kg)<br>• 25mm (>3kg)<br>• 45mm (>40kg) |
| | Needle: Outer Diameter | Same as predicate | 15 gauge |
| | Needle: Materials | Same as predicate | 304 Stainless Steel |
| | Needle: Tip Design | Same as predicate | 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 | Same as predicate | Includes a stylet tip safety feature |
| | Drive Adapter Hub: Materials | Same as predicate | Polycarbonate and stainless steel |

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| Safety &<br>Performance Tests | Inclusion of a<br>Needle Protective<br>Cover | Same as predicate | Yes, includes a needle cover made of<br>polypropylene |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Needle Set<br>Sterilization<br>Method & SAL | Same as predicate | Ethylene Oxide, 10-6 |
| | Manual Driver<br>Attachment | Same as predicate | Manual driver handle with integrated stylet<br>mates with internal lumen of needle and<br>needle hub attaches to manual driver |
| | Manual Driver<br>Component<br>Materials | Same as predicate | Handle: ABS<br>Stylet: Stainless Steel |
| | Manual Driver<br>Sterilization<br>Method and SAL | Same as predicate | Ethylene Oxide, 10-6 |
| | Means to Insert<br>Needle | Same as predicate | Manual or Powered Driver |
| | General Method<br>of Insertion | Same as predicate | Push needle through soft tissue until it<br>contacts bone. Confirm depth markings.<br>Insert needle set through bone until change<br>in pressure is felt or to desired depth.<br>Remove stylet. Connect IV extension set. |
| | The following performance tests were conducted in determining substantial equivalence of the BD Intraosseous<br>Infusion System to the predicate Piper GO-IO® Intraosseous Infusion System: | | |
| | Needle Set Kit and Manual Driver Kit<br>Performance Tests | | Standard Followed |
| | Needle Outer Diameter (OD) | | ISO 9626: 2016 and Internal Protocol/Standard |
| | Needle Length | | Internal Protocol/Standard |
| | Needle Lubricity | | ISO 7864: 2016 |
| | Needle Quality, Surface Finish, and Cleanliness | | ISO 9626: 2016 |

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| Needle to Hub Assembly Tensile | Internal Protocol/Standard |
|-------------------------------------------|----------------------------------------------------------------------------------------|
| Stylet to Drive Adapter Hub Tensile | Internal Protocol/Standard |
| Needle and Stylet Disassembly Force | Internal Protocol/Standard |
| Safety Activation | FDA Guidance for Sharps Injury Prevention<br>Features & ISO 23908: 2011 |
| Stylet Safety Override (force to failure) | ISO 23908: 2011 |
| Manual Driver Hub to Stylet Tensile | Internal Protocol/Standard |
| Needle Resistance to Corrosion | 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 and Internal Protocol/Standard |
| Gravity Flow Rate | Internal Protocol/Standard |
| Liquid Leak Needle Hub | Internal Protocol/Standard |
| Limits for Acidity or Alkalinity (Needle) | ISO 9626: 2016 / ISO 7864: 2016 |
| Limits for Extractable Metals (Needle) | ISO 7864: 2016 |
| Depth Markings | Internal Protocol/Standard |
| Insertion Force | Internal Protocol/Standard |
| Needle Bone Retention - Needle Point OD | Internal Protocol/Standard |
| Packaging Integrity and Seal Strength | ISO 11607-1:2006<br>ASTM F88/F88M: 2015<br>ASTM F1886/F1886M: 2016<br>ASTM F1929: 2015 |
| Device Usability/Simulated Use | Internal Protocol/Standard |

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| Sharps Injury Prevention Feature (Simulated<br>Clinical Use) | FDA Guidance for Sharps Injury Prevention<br>Features & ISO 23908: 2011 |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| Sterilization, Packaging, and Shelf-Life | Standard Followed |
| Sterilization Validation/Adoption | ISO 11135:2014 |
| Packaging/Shelf-Life Validations | ISO 11607-1 AMD 1: 2014<br>ASTM F88/F88M: 2015<br>ASTM F1886/F1886M: 2016<br>ASTM F1929: 2015 |
| Sterilant Residuals | ISO 10993-7: 2008 |
| Bacterial Endotoxin | USP <85><br>USP <161> |
| A biocompatibility evaluation was conducted on the subject device per ISO 10993-1:2009,<br>Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk<br>Management Process. According to the evaluation, the biological tests in the table below were<br>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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| Technological<br>Comparison to<br>Predicate Device | The subject device, BD Intraosseous Infusion System, has the same intended use and the same fundamental scientific technology as the predicate device, Piper GO-IO® Intraosseous Infusion System. The main difference between the subject device is the addition of the 35 mm and 55 mm needle lengths as compared to the predicate device needle lengths. This technological difference was assessed by the performance of verification testing to applicable test standards and the performance of additional user validation to address the acceptability and risks associated with the new subject device needle lengths. |
|----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The results of the user validation, performance (verification and validation testing) and biological tests conducted on the BD 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 BD Intraosseous Infusion System can be considered substantially equivalent to the cited predicate device. |
| Summary of<br>Substantial<br>Equivalence | Based on the risk management activities and testing, the subject BD Intraosseous Infusion System has been demonstrated to be substantially equivalent to the cited predicate device. |