Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies section do not mention any AI or ML components. The device is a mechanical system for intraosseous access.

Therapeutic

Yes.
The device's stated intended use is to "provide intraosseous access" for "resuscitation and lifesaving fluid delivery," which includes delivering substances to the body for a medical purpose. Although it doesn't directly administer a therapeutic agent, it facilitates the delivery of fluids over 24 hours, including those for resuscitation, classifying it as a therapeutic device.

Diagnostic

No

This device is designed to provide access to the intraosseous space for fluid delivery and resuscitation, not to diagnose a medical condition.

SaMD (Software as a Medical Device)

No

The device description explicitly lists hardware components such as a hypodermic needle, powered or manual driver, extension set, and securement dressing.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to provide intraosseous access for fluid delivery in emergent situations when intravenous access is difficult. This is a procedure performed directly on the patient's body to administer substances, not to analyze samples taken from the body.
Device Description: The device components (needle, driver, extension set, dressing) are all designed for the physical act of inserting a needle into bone and connecting it for fluid administration. There is no mention of components for collecting, preparing, or analyzing biological samples.
Lack of IVD Characteristics: IVD devices are typically used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a patient's health status, diagnose conditions, or monitor treatment. This device does none of those things.

The BD Intraosseous Vascular Access System is a device used for therapeutic or procedural purposes directly on the patient, not for diagnostic testing of samples.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications 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.

Product codes (comma separated list FDA assigned to the subject device)

MHC

Device 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:
•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 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

proximal tibia, distal tibia and humeral head (proximal humerus) of adult and pediatric patients, and the distal femur in pediatric patients

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)

Applicable verification and validation tests have been performed in accordance with Design Controls as per 21 CFR §820.30.
The following guidance documents and standards in conjunction with in-house protocols were used to determine appropriate methods for evaluating the performance of the device:
ISO 14971: 2019 - Medical Devices - Risk Management for Medical Devices
ANSI AAMI ES 60601-1: 2012 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2: 2014 - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests
IEC 60601-1-6: 2013 - Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
IEC 60601-1-12: 2020 - Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment
IEC 60086-4: 2019 - Primary batteries - Part 4: Safety of lithium batteries.
UN3091: N/A - Lithium Battery Guidance Document
UN3090: N/A - Lithium Battery Guidance Document
UN38.3: N/A - UN Recommendations on the Transport of Dangerous Goods
AAMI TIR30: 2011 (R2016) - Cleaning Reusable Medical Device
FDA Guidance: N/A - FDA Guidance Document, Reprocessing Medical Devices in Health Care Setting
FDA Guidance: 2005 - Applying Human Factors and Usability Engineering
FDA Guidance: 2005 - Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
FDA Guidance: 2002 - General Principles of Software Validation, Guidance for Industry and FDA Staff
FDA Guidance: 2017 - Deciding When to Submit a 510(k) for a Software Change to an Existing Device
ISO 11607-1: 2019 - Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems
ISTA 1G: 2014 - Packaged-Products Weighing 150 lb (68 Kg) Or Less (Random Vibration)
ISO 15223-1, 2: 2016 - Symbols to be Used with medical device labels

The subject device met all predetermined acceptance criteria derived from the above listed reference standards and demonstrated substantially equivalent performance as compared to the cited predicated device.

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.

K203193

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

Regulation Number and Section

§ 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).

Summary

0

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

1

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 (DICE@tda.hhs.gov) or phone (1-800-638-2041 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

2

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)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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3

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
Salt Lake City, UT 84116
General
Provisions	Contact Person:	Nasreen A. Al-Quaid
Staff Regulatory Affairs Specialist
	Telephone Number:	484.569.2865
	Email:	Nasreenara.alquaid@bd.com
	Date of Preparation:	11/07/2022
		Trade Name:
Subject
Device	Common Name:	Intraosseous Infusion System
	Regulation Number:	21 CFR §880.5570
	Regulation Classification Name:	Hypodermic, Single Lumen Needle
	Regulatory Class:	II

4

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
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
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:
•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 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
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
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:
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
BD Intraosseous Vascular Access
System EMS Powered Driver	Predicate device
BD Intraosseous Infusion System
(K203193)	Discussion of Substantial
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
System is intended to provide clinicians	The BD Intraosseous Vascular Access
System is intended to provide clinicians	Identical
Indications for
use	and emergency personnel with access
to the intraosseous space
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.	and emergency personnel with access to
the intraosseous space
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.	Identical
Powered
Driver Use	Reusable	Reusable	Identical
Intended
Patient
Population	Adults and Pediatrics who require short-
term (less than 30 days intraosseous
infusion therapy	Adults and Pediatrics who require short-
term (less than 30 days intraosseous
infusion therapy	Identical
General Device
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:
•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 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.	The BD Intraosseous Vascular Access
System provides clinicians and
emergency personnel with access to the
intraosseous space for resuscitation and

                                                                                                                                                                                                                                                                                           | Identical                                                                                                                                                                                                    |           |

| | | | | |
| Insertion Site | Adults: proximal tibia, distal tibia, and
proximal humerus
Pediatrics: proximal tibia, distal tibia
proximal humerus, and the distal femur | Adults: proximal tibia, distal tibia, and
proximal humerus
Pediatrics: proximal tibia, distal tibia
proximal humerus, and the distal femur | Identical | |
| Needle Set
Configurations | 15mm (0-10 mm tissue depth)
25mm (0-20 mm tissue depth)
35mm (10-30 mm tissue depth)
45mm (20-40 mm tissue depth)
55mm (30-50 mm tissue depth) | 15mm (0-10 mm tissue depth)
25mm (0-20 mm tissue depth)
35mm (10-30 mm tissue depth)
45mm (20-40 mm tissue depth)
55mm (30-50 mm tissue depth) | Identical | |
| Powered
Driver
Attachment to
Needle | Ferromagnetic material that is attracted
by the magnet in the powered driver at
the distal end of device | Ferromagnetic material that is attracted
by the magnet in the powered driver at
the distal end of device | Identical | |
| Powered
Driver
Technique to
Insert | Powered: Manually press needle set
through soft tissue to bone. Check
black depth marks. Drill needle set
through bone until change in pressure
is felt or to desired depth. Remove
driver.
Remove stylet. Connect IV extension
set. Check placement. Monitor site. | Powered: Manually press needle set
through soft tissue to bone. Check
black depth marks. Drill needle set
through bone until change in pressure
is felt or to desired depth. Remove
driver.
Remove stylet. Connect IV extension
set. Check placement. Monitor site. | Identical | |
| Powered
Driver Design -
Shape | In-Line Driver Shape | Traditional Drill Shape | Modification in Shape
(Housing and Addition of
Rear Threaded Cap).
Changes to the housing
shape do not raise new or
different questions of safety
or effectiveness. | |
| Powered
Driver LED
Battery Display | Placement modification of LED Battery
Indicator light, indicating the status of
the battery | LED Battery Indicator light, indicating the
status of the battery | Modification in Placement
due to Shape | |
| Powered
Driver Design -
Materials | Co-polyester and 30% Glass-fiber
reinforced polypropylene | Copolyester | Modification in Material
(Housing and Rear Threaded
Cap). Changes to the driver
material are not patent
contacting and do not raise
new or different questions of
safety or effectiveness. | |
| Power Driver
Design -Switch | Power Switch - Button | Power Switch - Trigger | Modification in Ergonomics
of the Power Switch.
Changes to the trigger
location do not raise new or
different questions of safety
or effectiveness. | |
| Powered
Driver Design -
Internal
Hardware | Redesigned Motor and Circuit board
Assembly | Motor and Circuit board Assembly | Redesigned to support
battery type and shape
change. Changes to the
hardware do not raise new or
different questions of safety
or effectiveness. | |
| Powered
Driver Battery
Type | Lithium-ion Batteries
Primary, (Replaceable), Removable | Lithium-ion Battery
Secondary (Rechargeable),
Non-Removeable | Modification in Battery Type.
Changes to the battery type
do not raise new or different
questions of safety or
effectiveness. | |
| Powered
Driver
Software | Updated Firmware developed for 32-bit
Microcontroller ARM processor | Firmware developed for 32-bit
Microcontroller ARM processor | Firmware was developed
using the same architecture
to support hardware
changes. Changes to the
firmware do not raise new or
different questions of safety
or effectiveness. | |
| | Powered
Driver
Cleaning
Method | Intermediate level disinfection | Intermediate level disinfection | Identical |
| | Powered
Driver Service
Life | 1500 insertions at 10 seconds per insertion | 1500 insertions at 10 seconds per insertion | Identical |
| A risk analysis was conducted in accordance with ISO 14971, Medical Devices - Risk Management for Medical Devices to
determine the impact of design & technology, software and labeling modifications to the device, the BD IO EMS Powered
Driver. Attributes identified that presented different risks as per the risk analysis were mitigated using well-established
methods and the following consensus standards for general use, listed below. Therefore, these differences in technological
characteristics in the subject devices do not raise any significant changes in safety and effectiveness as compared to the
predicate design. | | | | |
| Performance
Tests | Applicable verification and validation tests have been performed in accordance with Design Controls as per 21 CFR §820.30.
The following guidance documents and standards in conjunction with in-house protocols were used to determine appropriate
methods for evaluating the performance of the device: | | | |
| | Document
Number | Revision | Title | |
| | ISO 14971 | 2019 | Medical Devices - Risk Management for Medical Devices | |
| | ANSI AAMI ES
60601-1 | 2012 | Medical electrical equipment - Part 1: General requirements for basic safety
and essential performance | |

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| IEC 60601-1-2 | 2014 | Medical electrical equipment - Part 1-2: General requirements for basic
safety and essential performance - Collateral Standard: Electromagnetic
disturbances -Requirements and tests |
|----------------|-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 60601-1-6 | 2013 | Medical electrical equipment - Part 1-6: General requirements for basic
safety and essential performance - Collateral standard: Usability |
| IEC 60601-1-12 | 2020 | Medical electrical equipment - Part 1-12: General requirements for basic
safety and essential performance - Collateral Standard: Requirements for
medical electrical equipment and medical electrical systems intended for
use in the emergency medical services environment |
| IEC 60086-4 | 2019 | Primary batteries - Part 4: Safety of lithium batteries. |
| UN3091 | N/A | Lithium Battery Guidance Document |
| UN3090 | N/A | Lithium Battery Guidance Document |
| UN38.3 | N/A | UN Recommendations on the Transport of Dangerous Goods |
| AAMI TIR30 | 2011
(R2016) | Cleaning Reusable Medical Device |
| FDA Guidance | N/A | FDA Guidance Document, Reprocessing Medical Devices in Health Care
Setting |
| FDA Guidance | 2005 | Applying Human Factors and Usability Engineering |

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K223198 Page 11 of 11

| | FDA Guidance | 2005 | Guidance for the Content of Premarket Submissions for Software Contained
in Medical Devices |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|--------------------------------------------------------------------------------------------------------------------------------------------|
| | FDA Guidance | 2002 | General Principles of Software Validation, Guidance for Industry and FDA
Staff |
| | FDA Guidance | 2017 | Deciding When to Submit a 510(k) for a Software Change to an Existing
Device |
| | ISO 11607-1 | 2019 | Packaging for terminally sterilized medical devices – Part 1: Requirements
for materials, sterile barrier systems and packaging systems |
| | ISTA 1G | 2014 | Packaged-Products Weighing 150 lb (68 Kg) Or Less (Random Vibration) |
| | ISO 15223-1, 2 | 2016 | Symbols to be Used with medical device labels |
| | The subject device met all predetermined acceptance criteria derived from the above listed reference standards and
demonstrated substantially equivalent performance as compared to the cited predicated device. | | |
| Summary of
Substantial
Equivalence | Based on the risk management activities, intended use, technological characteristics, and performance testing, the subject, BD
IO EMS Powered Driver demonstrated to be substantial equivalent for its intended use and fundamental scientific technology
as the cited predicate device. | | |