BD Intraosseous Vascular Access System EMS Powered Driver (D001003)

K223198 · Bard Access Systems · MHC · Nov 10, 2022 · General Hospital

Device Facts

• Record ID: K223198
• Device Name: BD Intraosseous Vascular Access System EMS Powered Driver (D001003)
• Applicant: Bard Access Systems
• Product Code: MHC · General Hospital
• Decision Date: Nov 10, 2022
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

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

Device Story

The BD Intraosseous Vascular Access System is a hand-held, battery-powered driver used by clinicians and emergency personnel to assist in the insertion of a single-use hypodermic needle through the bone cortex for intraosseous fluid delivery. The system includes a needle set (hypodermic needle, stylet, and drive adapter hub with a ferromagnetic insert), an extension set, and an adhesive-backed securement dressing. The powered driver uses a magnet to attach to the drive adapter hub. The operator manually presses the needle set through soft tissue to the bone, then activates the driver via a button to drill through the bone cortex until a change in pressure is felt. The device provides access for up to 24 hours. The output is the establishment of vascular access, which facilitates resuscitation and lifesaving fluid delivery. The device is designed for use in emergent, urgent, or medically necessary clinical contexts.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including verification and validation activities performed in accordance with 21 CFR 820.30 and relevant consensus standards (e.g., ANSI AAMI ES 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-12).

Technological Characteristics

Reusable battery-powered driver; housing made of co-polyester and 30% glass-fiber reinforced polypropylene. Uses a 32-bit ARM microcontroller. Powered by replaceable lithium-ion batteries. Features LED battery status display and button-operated switch. Needle set uses ferromagnetic attachment. Intermediate level disinfection required. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-12, and ISO 14971.

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

• BD Intraosseous Infusion System (K203193)

Submission Summary (Full Text)

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November 10, 2022

Bard Access Systems Nasreen Al-Quaid Staff Regulatory Affairs Specialist 605 North 5600 West Salt Lake City, UT

Re: K223198

Trade/Device Name: BD Intraosseous Vascular Access System EMS Powered Driver (D001003) Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: MHC Dated: October 11, 2022 Received: October 13, 2022

Dear Nasreen Al-Quaid:

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.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

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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-safetyreporting-combination-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-devices/medical-device-safety/medicaldevice-reporting-mdr-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/medical-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-devices/device-advicecomprehensive-regulatory-assistance/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,

Joyce M. Whang -S

CAPT 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) K223198

#### Device Name

BD Intraosseous Vascular Access System EMS Powered Driver (D001003)

Indications for Use (Describe)

The BD Intraosseous Vascular Access 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) | |
|----------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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Bard Access Systems, Inc. (Bard has joined BD) Special 510(k) Premarket Notification BD Intraosseous Vascular Access System EMS Powered Driver 510(k) Summary

# 510(k) Summary

## 21 CFR 807.92(a)

As required by the Safe Medical Devices Act of 1990, coded under Section 513, Part (1)(3)(A) of the Food, Drug and Cosmetic Act, a 510(k) summary upon which substantial equivalence determination is based is as follows:

| | Submitter Name: | Bard Access Systems, Inc. (Bard has joined BD) |
|-----------------------|---------------------------------|------------------------------------------------------------|
| | Submitter Address: | 605 North 5600 West<br>Salt Lake City, UT 84116 |
| General<br>Provisions | Contact Person: | Nasreen A. Al-Quaid<br>Staff Regulatory Affairs Specialist |
| | Telephone Number: | 484.569.2865 |
| | Email: | [e-mail] |
| | Date of Preparation: | 11/07/2022 |
| | | Trade Name: |
| Subject<br>Device | Common Name: | Intraosseous Infusion System |
| | Regulation Number: | 21 CFR §880.5570 |
| | Regulation Classification Name: | Hypodermic, Single Lumen Needle |
| | Regulatory Class: | II |

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| Product Code: | MHC | |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|
| Classification Panel: | General Hospital | |
| Trade Name: | BD Intraosseous Infusion System | |
| Common Name: | Intraosseous Infusion System | |
| Regulation Number: | 21 CFR §880.5570 | |
| Predicate<br>Device | Regulation Classification Name: | Hypodermic, Single Lumen Needle |
| Regulatory Class: | II | |
| Product Code: | MHC | |
| Classification Panel: | General Hospital | |
| 510(k) Status: | K203193 (Concurrence date: March 4, 2021) | |
| Device<br>Description | The BD Intraosseous Vascular Access System provides clinicians and emergency personnel with access to the intraosseous space for resuscitation and lifesaving fluid delivery for up to 24 hours. The BD Intraosseous Vascular Access System consists of the following:<br>•a single use hypodermic needle (with needle safety cap),<br>•a powered or manual driver to assist with needle insertion,<br>•an extension set, and<br>•an adhesive-backed securement dressing.<br><br>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 ferromagnetic material that is attracted by the magnet in the powered driver and attaches to the powered driver prior to needle insertion. The BD Intraosseous Vascular Access System is an easy-grip, hand-held, battery-powered device 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. | |

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K223198 Page 3 of 11

| Intended Use | The BD Intraosseous Vascular Access System is intended to provide clinicians and emergency personnel with access to the intraosseous space. |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications<br>for Use | The BD Intraosseous Vascular Access 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 | At a high level, the subject device, BD Intraosseous Vascular Access System EMS Powered Driver and the cited predicate device are based on the following same technological and use elements:<br>Intended Use, Indications for Use, Target Patient Population Reusable Powered Intraosseous Driver- used to provide intraosseous access Power Driver Attachment to Needle - at distal end of device and same insertion technique |

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# K223198

# Page 4 of 11

| • | Use of the same Needle Set Configurations – choice of use based on tissue depth | | | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| • | Use of LED Battery Display - indication the status of the battery | | | |
| • | Use of an Operating Switch to run the device | | | |
| • | Use of a Motor and Circuit Board Assembly and Microcontroller ARM Processor | | | |
| • | Use of Lithium-ion Batteries to run the device | | | |
| The modifications made to the predicate device include modifications to the design and technology, software and labeling. The following technological differences exist between the subject and predicate devices: | | | | |
| 1. | Design and Technology; | | | |
| • | Change in driver shape, placement of LED battery indicator lights &operating switch. | | | |
| • | Housing and Rear Cap material difference due to shape modification | | | |
| • | Hardware and battery changes to facilitate replaceable battery | | | |
| 2. | Software: Modification to structure of software (firmware). | | | |
| 3. | Labeling: Separate IFU to support charging differences of the device | | | |
| The following tables provides a summary comparison between the subject and predicate device. | | | | |
| Attribute | Subject Device<br>BD Intraosseous Vascular Access<br>System EMS Powered Driver | Predicate device<br>BD Intraosseous Infusion System<br>(K203193) | Discussion of Substantial<br>Equivalence | |
| Owner | Bard Access Systems, Inc. | Bard Access Systems, Inc. | Identical | |
| 510(k) status | Subject of this 510(k) | K203193 | Identical | |
| Intended Use | The BD Intraosseous Vascular Access<br>System is intended to provide clinicians | The BD Intraosseous Vascular Access<br>System is intended to provide clinicians | Identical | |
| Indications for<br>use | and emergency personnel with access<br>to the intraosseous space<br>The BD Intraosseous Vascular Access<br>System provides intraosseous access in<br>the proximal tibia, distal tibia and<br>humeral head (proximal humerus) of<br>adult and pediatric patients, and the<br>distal femur in pediatric patients when<br>intravenous access is difficult or<br>impossible to obtain in emergent, urgent,<br>or medically necessary cases for up to<br>24 hours. | and emergency personnel with access to<br>the intraosseous space<br>The BD Intraosseous Vascular Access<br>System provides intraosseous access in<br>the proximal tibia, distal tibia and<br>humeral head (proximal humerus) of<br>adult and pediatric patients, and the<br>distal femur in pediatric patients when<br>intravenous access is difficult or<br>impossible to obtain in emergent, urgent,<br>or medically necessary cases for up to<br>24 hours. | Identical | |
| Powered<br>Driver Use | Reusable | Reusable | Identical | |
| Intended<br>Patient<br>Population | Adults and Pediatrics who require short-<br>term (less than 30 days intraosseous<br>infusion therapy | Adults and Pediatrics who require short-<br>term (less than 30 days intraosseous<br>infusion therapy | Identical | |
| General Device<br>Description | The BD Intraosseous Vascular Access<br>System provides clinicians and<br>emergency personnel with access to the<br>intraosseous space for resuscitation and<br>lifesaving fluid delivery for up to 24<br>hours. The BD Intraosseous Vascular<br>Access System consists of the following:<br>•a single use hypodermic needle (with<br>needle safety cap),<br>•a powered or manual driver to assist<br>with needle insertion,<br>•an extension set, and<br>•an adhesive-backed securement<br>dressing.<br>For insertions using the powered driver,<br>the hypodermic needle includes a<br>needle hub that mates with a stylet<br>connected to a drive adapter hub. The<br>drive adapter hub includes a magnetic<br>insert that attaches to the powered<br>driver prior to needle insertion. The BD<br>Intraosseous Vascular Access System is<br>an easy-grip, hand-held, battery-<br>powered device used to assist in the<br>insertion of the subject device needle<br>through the bone cortex. The assembly<br>of the hypodermic needle and stylet with<br>connected drive adapter hub is referred<br>to as the needle set. | The BD Intraosseous Vascular Access<br>System provides clinicians and<br>emergency personnel with access to the<br>intraosseous space for resuscitation and<br> | Identical | |
| | | | | |
| Insertion Site…