For intraosseous access anytime in which vascular access is difficult to obtain in emergent, urgent or medically necessary cases up to 24 hours. For patients ≥ 12 years old, the device may be extended for up to 48 hours when alternate intravenous access is not available or reliably established.

Device Description

The EZ-IO Intraosseous Vascular Access System previously cleared with K202492 is designed to allow the user to insert a needle set consisting of a stylet and catheter through the cortex of the bone to a desired depth within the bone marrow to facilitate intraosseous infusion of desired fluids and medications for vascular access. All system materials are biocompatible. Needle sets are single-use and composed of 304 stainless steel with polycarbonate hubs and available in 15 mm (for patients 3-39 kg); 25 mm (for patients 3 kg or over) and 45 mm (for patients 40 kg or over) lengths. Black lines on the needle set serve as depth markers. The reusable cordless driver/drill is powered by lithium batteries with a battery-power indicator light. An extension tubing set accessory, the EZ-Connect, is included with every needle set. The EZ-Connect contains a needleless connector system and Luer lock adapter. An optional dressing, the EZ-Stabilizer, is an accessory to the EZ-IO Vascular Access System. It is designed as a securement device with an adhesive backing that is placed over an EZ-IO Needle to keep the needle securely anchored to the patient; and is recommended in the Instructions for use (IFU).

AI/ML Overview

The provided document is an FDA 510(k) clearance letter for the EZ-IO Intraosseous Vascular Access System. It describes a Special 510(k) submission, which means the device being submitted is very similar to a previously cleared predicate device, with only minor changes. In this case, the only change is the sterilization of the EZ-IO Power Driver.

Therefore, the document does not describe a study involving AI performance, human reader improvement with AI assistance, or the establishment of ground truth by expert consensus for an AI-based device. It focuses on demonstrating the substantial equivalence of the modified (now sterile) power driver to the existing non-sterile one through non-clinical performance testing.

Consequently, much of the requested information (related to AI acceptance criteria, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone AI performance, and ground truth for AI) is not applicable to this document.

However, I can extract the information relevant to the provided text:

Acceptance Criteria and Device Performance (for the change in sterility of the driver)

The acceptance criteria for this 510(k submission are not directly stated as clinical performance metrics for the device's indications for use. Instead, they are related to demonstrating that the change (sterilization of the power driver) does not negatively impact the safety and effectiveness compared to the predicate device. The performance is demonstrated through non-clinical testing.

Table 1: Acceptance Criteria (Implied) and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Device remains substantially equivalent to the predicate device.	The proposed device is identical to the predicate device in design, materials, functional performance, principles of operation, manufacturing, packaging, sterilization (for other components), and shelf life, except for the sterility of the power driver.
Sterilization process effectiveness.	ISO 11135:2014 (Ethylene oxide sterilization standard) was met, ensuring a sterility assurance level (SAL) of 10^-6.
Packaging integrity and sterility maintenance.	Met ASTM F1886/F1886M-16, ASTM F2096-11 (2019), and ISO 11607-1:2019 standards.
Biocompatibility of materials.	Biocompatible materials were used per ISO 10993-1.
Functional performance of the Power Driver after sterilization.	EZ-IO Power Driver RPM and Insertion Testing and Useful Life Testing were performed, meeting previously established acceptance criteria for the predicate device.
Safety and effectiveness are maintained.	"The results of the bench tests demonstrate that the EZ-IO Power Driver is as safe and effective as the predicate device."

Detailed Information as per Request:

A table of acceptance criteria and the reported device performance: See Table above.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not specified in terms of clinical patient numbers. The testing appears to be primarily bench/laboratory testing on physical devices and packaging.
- Data Provenance: Not specified, but generally, such non-clinical testing for FDA submissions would be conducted in controlled laboratory environments, likely within the US or by certified labs adhering to international standards. The tests are prospective in nature as they evaluate the manufacturing process and design changes.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. Ground truth in the context of expert consensus for AI models is not relevant here. The ground truth for this submission is established through adherence to recognized international standards for sterilization, packaging, and functional performance testing, which are objectively measurable.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are typically for subjective assessments by multiple human readers, often in the context of AI performance evaluation. Here, the "truth" is determined by objective measurements against established engineering and sterilization standards.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. An MRMC study was not done as this clearance is not for an AI-enabled device or one that involves human interpretation of medical images.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This submission is not for an algorithm.
The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- The "ground truth" for this submission is based on engineering standards, validated sterilization processes, and functional performance specifications of the medical device components (specifically, the power driver). It is objective and measurable, rather than being derived from subjective expert consensus, pathology, or clinical outcomes data in the context of a diagnostic or treatment outcome.
The sample size for the training set:
- Not applicable. This submission does not involve an AI model or a training set.
How the ground truth for the training set was established:
- Not applicable. This submission does not involve an AI model or a training set.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows 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.

July 25, 2023

Teleflex Medical Rachel Rehl Regulatory Affairs Team Lead 3015 Carrington Mill Blvd Morrisville, North Carolina 27560

Re: K231924

Trade/Device Name: EZ-IO Intraosseous Vascular Access System Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: June 29, 2023 Received: June 30, 2023

Dear Rachel Rehl:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

{1}------------------------------------------------

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 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Alan Sthe

CAPT Alan M. 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

Submission Number (if known)

K231924

Device Name

EZ-IO Intraosseous Vascular Access System

Indications for Use (Describe)

INDICATIONS FOR USE:

INSERTION SITES:

ADULTS (≥22 years old): proximal humerus, proximal tibia, distal tibia PEDIATRICS (≤21 years old): proximal humerus, proximal tibia, distal fibia, distal femur

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Special 510(k) SUMMARY

EZ-10 Intraosseous Vascular Access System Sterile G3 Driver

1. Submitter Information

Name: Teleflex Medical
Address: 3015 Carrington Mill Blvd. Morrisville, NC 27560 USA
Contact Person: Rachel Rehl

Telephone Number:

Email: rachel.rehl@teleflex.com

Date Prepared: 29 June 2023

2. Device Name

Device Trade Name: EZ-IO Intraosseous Vascular Access System

Common Name: Intraosseous Infusion System

Classification Name: Needle, Hypodermic, Single Lumen (Class II, FMI, 21 CFR 880.557)

3. Predicate Device

EZ-IO Intraosseous Vascular Access System (K202492)

4. Device Description and Clinical Operation

Device Description

{4}------------------------------------------------

accessory to the EZ-IO Vascular Access System. It is designed as a securement device with an adhesive backing that is placed over an EZ-IO Needle to keep the needle securely anchored to the patient; and is recommended in the Instructions for use (IFU).

Clinical Operation

Clinicians locate anatomical landmarks and clean the insertion site. Using the cordless driver with needle set attached, the needle set is pressed through the soft tissue to the outer cortex of the bone. At least one depth marker on the cannula must be visible prior to powering the driver to ensure adequate needle length for proper placement within the medullary space. Clinicians then squeeze the driver trigger and apply moderate, steady pressure. The trigger is released when a sudden "give" or "pop" is felt, which indicates entry into the medullary space; the needle set will not always be inserted to the hub. After insertion of the needle set, the driver unit is detached from the needle set, leaving the stylet and cannula firmly seated in the bone. The stylet is then separated and removed from the cannula by turning the stylet hub counterclockwise leaving the catheter with a standard Luer lock hub securely seated in the bone. The cannula Luer lock permits attachment of the provided EZ-Connect, standard syringes or other IV tubing for administration of medications and fluids.

5. Indications for Use

For intraosseous access anytime in which vascular access is difficult to obtain in emergent, urgent or medically necessary cases for up to 24 hours. For patients ≥ 12 years old, the device may be extended for up to 48 hours when alternate intravenous access is not available or reliably established.

ADULTS (≥22 years old)

Proximal humerus
Proximal tibia
Distal tibia

PEDIATRICS (≤21 years old)

Proximal humerus
Proximal tibia
Distal tibia
Distal femur

6. Technological Characteristics and Substantial Equivalence

The proposed device is identical to the predicate device described in K202492 in design, materials of construction, functional performance, principles of operation, manufacturing, packaging, sterilization, and shelf life.

The only change is the change to the sterility of the EZ-IO Power Driver. Table 1 below provides a comparison of the proposed and predicate devices.

{5}------------------------------------------------

Table 1: Substantial Equivale parison to Predicate C

{6}------------------------------------------------

{7}------------------------------------------------

{8}------------------------------------------------

7. Non-Clinical Performance Testing

The following assessments and tests were performed to demonstrate substantial equivalence:

Packaging Verification Testing
EZ-IO Power Driver RPM and Insertion Testing
EZ-IO Power Driver Useful Life Testing
ASTM F1886/F1886M-16 - Package Integrity Visual Inspection
ASTM F2096-11 (2019) – Package Integrity Bubble Leak Testing
ISO 11607-1:2019 – Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
ISO 11135:2014 - Sterilization of health-care products - Ethylene oxide -Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO 10993-1: 2018 – Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

The EZ-IO Power Driver meets the acceptance criteria of the bench testing as well as met the acceptance criteria of the functional testing previously established for the predicate device. The results of the bench tests demonstrate that the EZ-IO Power Driver is as safe and effective as the predicate device.

8. Conclusions

The intended use of the EZ-IO Intraosseous Vascular Access System is the same as the predicate device. The addition of a sterile version of the EZ-IO Power Driver was shown to be substantially equivalent through non-clinical performance testing. There were no changes to the device itself, therefore we can conclude that the device is substantially equivalent to the predicate 510(k) K202492.

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).

Table 1: Substantial Equivalence Comparison to Predicate
	Proposed Device	Predicate Device - K202492	Comparison
	EZ-IO Intraosseous VascularAccess System(Sterile Driver)	EZ-IO Intraosseous VascularAccess System
Indications forUse	For intraosseous access anytime inwhich vascular access is difficult toobtain in emergent, urgent ormedically necessary cases for up to 24hours. For patients ≥ 12 years old, thedevice may be extended for up to 48hours when alternate intravenousaccess is not available or reliablyestablished.	For intraosseous access anytime inwhich vascular access is difficult toobtain in emergent, urgent ormedically necessary cases for up to 24hours.Insertion sites:ADULTS (≥22 years old)• Proximal humerus• Proximal tibia• Distal tibiaPEDIATRICS (≤21 years old)• Proximal humerus• Proximal tibia• Distal tibia• Distal femurFor patients ≥12 years old, use of thedevice may be extended for up to 48hours when alternate intravenousaccess is not available or reliablyestablished.	Combined theverbiage aboveand below theinsertion sitesinto oneparagraph. Nochange toindication foruse statement.
Contraindications	• Fracture in target bone.• Previous, significant orthopedicprocedure at the site,prosthetic limb or joint.• IO access (or attempted IOaccess) in targeted bone withinpast 48 hours.• Infection at the area ofinsertion.• Excessive tissue (severeobesity) and/or absence ofadequate anatomicallandmarks.	• Fracture in target bone.• Previous, significant orthopedicprocedure at the site,prosthetic limb or joint.• IO access (or attempted IOaccess) in targeted bone withinpast 48 hours.• Infection at the area ofinsertion.• Excessive tissue (severeobesity) and/or absence ofadequate anatomicallandmarks.	Same
Target Population	Adult and pediatric patients whoare in need of vascular access.	Adult and pediatric patients whoare in need of vascular access.	Same
Where Used	Pre-hospital, In hospital, Acute care	Pre-hospital, In hospital, Acute care	Same
Anatomical SitesUsed	• Proximal Tibia	• Proximal Tibia	Same
	Proposed DeviceEZ-IO Intraosseous VascularAccess System(Sterile Driver)	Predicate Device – K202492EZ-IO Intraosseous VascularAccess System	Comparison
	• Distal Tibia• Distal Femur in pediatricpopulation	• Distal Tibia• Distal Femur in pediatricpopulation
EZ-IO Power DriverDesign	• Housing: Cycoloy, Sabic P/NC6200-6T5D007, Maroon• Drive Shaft: 304 Stainless Steel• Driver Shaft Seal: Trosta, BlackShore 58A Ethylene PropyleneDiene Monomer (EPDM) withmetal insert (1008 Steel)• Gasket: HD Urethane Foam Tape,Korel 8000, Shore A• Magnet Bonding: Loctite 603• Trigger Cover: ThermoplasticElastomer, Shore 25 A, Black• Label: Facestock: Matte RadiantWhite Polyester, Adhesive:Permanent #300 Acrylic, Liner:Densified Kraft, Ink: Black• Trigger Guard: Cycoloy, Sabic P/NC6200-BK1005, Black• Lanyard: Buna-N, Hard, DashNumber 42• Batteries: Manganese DioxideLithium Batteries, CR2	• Housing: Cycoloy, Sabic P/NC6200-6T5D007, Maroon• Drive Shaft: 304 Stainless Steel• Driver Shaft Seal: Trosta, BlackShore 58A Ethylene PropyleneDiene Monomer (EPDM) withmetal insert (1008 Steel)• Gasket: HD Urethane Foam Tape,Korel 8000, Shore A• Magnet Bonding: Loctite 603• Trigger Cover: ThermoplasticElastomer, Shore 25 A, Black• Label: Facestock: Matte RadiantWhite Polyester, Adhesive:Permanent #300 Acrylic, Liner:Densified Kraft, Ink: Black• Trigger Guard: Cycoloy, Sabic P/NC6200-BK1005, Black• Lanyard: Buna-N, Hard, DashNumber 42• Batteries: Manganese DioxideLithium Batteries, CR2	Same
Sterility of EZ-IOPower Driver	• Sterile Driver: Ethylene Oxide(SAL 10-6)and• Non-Sterile	• Non-Sterile	The proposeddevice will be anethylene oxidesterilized versionof the currentlymarketedproduct. Thecurrent non-sterile versionwill still beavailable
Needle/CannulaDesign	• Sterile, single use• Hubs: polycarbonate and coloradditive• Stylet/catheter: Stainless Steel• Faceted tip• Standard Luer connection 15 mm;	• Sterile, single use• Hubs: polycarbonate and coloradditive• Stylet/catheter: Stainless Steel• Faceted tip• Standard Luer connection 15 mm;	Same
	Proposed DeviceEZ-IO Intraosseous VascularAccess System(Sterile Driver)	Predicate Device - K202492EZ-IO Intraosseous VascularAccess System	Comparison
	15 gauge (0.071", 1.8 mm)• Needle Cover: Polypropylene	15 gauge (0.071", 1.8 mm)• Needle Cover: Polypropylene
Needle SetGuidelines	Available Needle Sets:• 15 mm: 3-39 kg• 25 mm: 3 kg or over• 45 mm: 40 kg or over	Available Needle Sets:• 15 mm: 3-39 kg• 25 mm: 3 kg or over• 45 mm: 40 kg or over	Same
Depth Control	Positioning marks at 5 mm and 10 mm apart to provide visual reference pointsTactile feedback for change of pressure	Positioning marks at 5 mm and 10 mm apart to provide visual reference pointsTactile feedback for change of pressure	Same
Sterile single usecomponents andaccessories	• EZ-IO Needle Sets• EZ-Connect Extension Set• EZ-IO Patient Wristband• NeedleVISE 1-port Sharps Block• EZ-Stabilizer Dressing	• EZ-IO Needle Sets• EZ-Connect Extension Set• EZ-IO Patient Wristband• NeedleVISE 1-port Sharps Block• EZ-Stabilizer Dressing	Same
Sterility of singleuse componentsand accessories	Ethylene Oxide	Ethylene Oxide	Same
Shelf life of singleuse componentsand accessories	4 Years	4 Years	Same
Biocompatibility	Biocompatible materials used (per ISO 10993-1 prolonged contact duration).	Biocompatible materials used (per ISO 10993-1 prolonged contact duration).	Same
MR Safety Status	MR Conditional	MR Conditional	Same