For patients ≥12 years old, use of 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 K180395 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 text describes a 510(k) submission for the EZ-IO Intraosseous Vascular Access System. This submission is for a device that already has a predicate (K180395) and the only change is to its MR Safety Status labeling, from "MR Unsafe" to "MR Conditional."

The document does not describe a study involving "AI assistance" or "human readers" or "ground truth established by experts" in the context of diagnostic performance, as the device is a medical access system, not an imaging or diagnostic AI. Therefore, many of the requested points regarding AI/MRMC study details are not applicable to this submission.

However, I can extract information related to the non-clinical testing performed to justify the change in MR safety status.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in a quantitative table for this specific update, as the change is primarily about MR compatibility, not a functional performance metric beyond its existing predicate. The "performance" being evaluated is its behavior in an MRI environment.

Acceptance Criteria (Implied)	Reported Device Performance (Summary of Test Results)
MR Conditional Status	The evaluation concluded that the EZ-IO Needle Set should be labeled as MR Conditional.
Compliance with Standards	Evaluation conducted using methodologies prescribed in ASTM F2052, ASTM F2213, ASTM F2182, and ASTM F2119 as a guide. (This implies that the device met the safety thresholds defined by these standards for MRI compatibility, particularly RF-induced heating).

2. Sample size used for the test set and the data provenance

Test Article Sample Size: The tests were conducted on the "45 mm needle" as the test article. It's common in such engineering studies to test a representative sample rather than a large clinical cohort. The exact number of 45mm needles tested is not specified, but it's implied to be a sufficient and representative sample for engineering testing.
Data Provenance: The testing was conducted by "Exponent, 2020," which is a consulting firm specializing in engineering and scientific consulting. The location is not specified, but this is a laboratory/engineering study rather than a clinical data set. It is a prospective test specifically for this regulatory submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is a physical device MR compatibility test, not a diagnostic study requiring human expert interpretation or ground truth establishment in the typical clinical sense. The "ground truth" here is determined by the physical measurements and compliance with engineering standards.

4. Adjudication method for the test set

Not applicable. This is a physical device test, not a study requiring adjudication of expert opinions.

5. 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. This is not an AI-assisted diagnostic device study. It is a physical medical device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No. This is not an algorithm.

7. The type of ground truth used

Engineering/Physical Measurements against established safety standards. The "ground truth" for MR compatibility is determined by the quantitative measurements of parameters like RF-induced heating (as per ASTM F2052, ASTM F2213, ASTM F2182, and ASTM F2119 standards) and ensuring these measurements fall within safe limits for MRI environments.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. As above, no training set was involved.

Summary

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March 22, 2021

Teleflex Medical Rachel Rehl Regulatory Affairs Specialist 3015 Carrington Mill Blyd. Morrisville, North Carolina 27560

Re: K202492

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: February 19, 2021 Received: February 23, 2021

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

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

Sincerely,

For Rumi Young Acting 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) K202492

Device Name

EZ-IO Intraosseous Vascular Access System

Indications for Use (Describe)

For intraosseous access anytime in which vascular access is difficult to obtain in emergent, urgent or medically necessary cases for up to 24 hours.

Insertion sites:

ADULTS (≥22 years old)

· Proximal humerus
Proximal tibia
· Distal tibia

PEDIATRICS (<21 years old)

Proximal humerus
Proximal tibia
· Distal tibia
· Distal femur

For patients ≥12 years old, use of the device may be extended for up to 48 hours when alternate intravenous access is not available or reliably established.

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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K202492 510(k) SUMMARY

EZ-IO Intraosseous Vascular Access System MR Conditional Safety Status Labeling

1. Submitter Information

Name:	Teleflex Medical
Address:	3015 Carrington Mill Blvd.Morrisville, NC 27560 USA
Contact Person:	Rachel Rehl
Telephone Number:	(919)433-2588
Email:	rachel.rehl@teleflex.com

Date Prepared: August 28, 2020

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 880.5570)

3. Predicate Device

EZ-IO Intraosseous Vascular Access System (K180395)

4. Device Description and Clinical Operation

Device Description

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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.

Insertion sites:

ADULTS (≥22 years old)

Proximal humerus
Proximal tibia
· Distal tibia

PEDIATRICS (≤21 years old)

Proximal humerus
Proximal tibia
· Distal tibia
· Distal femur

For patients 2 years old, use of the device may be extended for up to 48 hours when alternate intravenous access is not available or reliably established.

1. Technological Characteristics and SubstantialEquivalence
  The proposed device is identical to the predicate device described in K180395 in design, materials of construction, functional performance, principles of operation, manufacturing, packaging, sterilization, and shelf life.

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The only change is the labeled MR Conditional Safety Status. Table 5-1 below provides a comparison of the proposed and predicate devices.

Table 5-1: Substantial Equivalence Comparison to Predicate

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7. Non-clinical Testing

Non-clinical testing was conducted as the basis of the MR Conditional safety status claims that are proposed in this 510(k). The testing is listed in Table 5-2 below. Summaries of the testing are provided as well. The test article was the 45 mm needle.

Testing	Summary
MRI Testing,Exponent, 2020	This study evaluated the MRI compatibility of the EZ-IO Needle Set in regard to radiofrequency (RF)-induced heating in 1.5 T and 3 T clinical scanners. The evaluation was conducted using methodologies prescribed in ASTM F2052, ASTM F2213, ASTM F2182, and ASTM F2119 as a guide.The evaluation concluded that the EZ-IO Needle Set should be labeled as MR Conditional and included labeling guidelines in the report.

Testing

Summary

MRI Testing,Exponent, 2020

This study evaluated the MRI compatibility of the EZ-IO Needle Set in regard to radiofrequency (RF)-induced heating in 1.5 T and 3 T clinical scanners. The evaluation was conducted using methodologies prescribed in ASTM F2052, ASTM F2213, ASTM F2182, and ASTM F2119 as a guide.The evaluation concluded that the EZ-IO Needle Set should be labeled as MR Conditional and included labeling guidelines in the report.

Table 5-2: Non-Clinical Testing

8. Conclusions

The conclusions drawn from the non-clinical tests inform the MRI labeling that is proposed in this 510(k). As there is no change to the device itself, we can conclude that the device is substantially equivalent to the predicate 510(k) K180395.

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).

	Proposed DeviceEZ-IO Intraosseous VascularAccess System(MR Conditional SafetyStatus Labeling)	Predicate Device K180395EZ-IO Intraosseous VascularAccess System	Comparison
Indicationsfor Use	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.	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): proximalhumerus, proximal tibia, distal tibiaPEDIATRICS (≤21 years old): proximalhumerus, proximal tibia, distal tibia,distal femurUse of the device may be extended forup to 48 hours when alternateintravenous access is not available orreliably established. Insertion sites:ADULTS (≥22 years): proximalhumerus, proximal tibia, distal tibiaPEDIATRICS (≥12 years through 21years old): proximal humerus,proximal tibia, distal tibia, distal femur	Wordingupdated forclarity but theindications foruse are thesame.
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
	Proposed DeviceEZ-IO Intraosseous VascularAccess System(MR Conditional SafetyStatus Labeling)	Predicate Device K180395EZ-IO Intraosseous VascularAccess System	Comparison
TargetPopulation	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
AnatomicalSites Used	Proximal Tibia Proximal Humerus Distal Tibia Distal Femur in pediatricpopulation	Proximal Tibia Proximal Humerus Distal Tibia Distal Femur in pediatricpopulation	Same
Needle/CannulaDesign	Sterile, single use Hubs: polycarbonate and coloradditive Stylet/catheter: Stainless Steel Faceted tip Standard Luer connection 15 mm;25 mm; 45 mm 15 gauge (0.071", 1.8 mm) Needle Cover: Polypropylene	Sterile, single use Hubs: polycarbonate and coloradditive Stylet/catheter: Stainless Steel Faceted tip Standard Luer connection 15 mm;25 mm; 45 mm 15 gauge (0.071", 1.8 mm) Needle Cover: Polypropylene	Same
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 10cm apart to provide visual referencepointsTactile feedback for change ofpressure	Positioning marks at 5 mm and 10mm apart to provide visual referencepointsTactile feedback for change ofpressure	Same
Sterile singleuse componentsand accessories	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 ofsingle usecomponentsand accessories	Ethylene Oxide	Ethylene Oxide	Same
Shelf life ofsingle usecomponentsand accessories	4 Years	4 Years	Same
	Proposed DeviceEZ-IO Intraosseous VascularAccess System(MR Conditional SafetyStatus Labeling)	Predicate Device K180395EZ-IO Intraosseous VascularAccess System	Comparison
Biocompatibility	Biocompatible materials used (perISO 10993-1 prolonged contactduration).	Biocompatible materials used (perISO 10993-1 prolonged contactduration).	Same
MR SafetyStatus	MR Conditional	MR Unsafe	Update to MRSafety Statusas described insubmission.