(203 days)
No
The device description and performance studies focus on the mechanical and material properties of the intraosseous access system, with no mention of AI or ML components.
No.
The device facilitates vascular access for fluid and medication delivery but does not directly treat a disease or condition; it's an access tool rather than a therapeutic agent itself.
No
Explanation: The device is described as an "Intraosseous Vascular Access System" designed to facilitate "intraosseous infusion of desired fluids and medications for vascular access." Its purpose is to provide a way to deliver substances into the bone marrow, not to diagnose a condition.
No
The device description clearly outlines physical components such as needle sets, a cordless driver/drill, extension tubing, and an optional dressing, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for intraosseous access to facilitate the infusion of fluids and medications. This is a procedure performed directly on the patient's body to gain access to the vascular system through the bone marrow.
- Device Description: The device is a system for inserting a needle into the bone. It includes a needle set, a driver/drill, and accessories for securement and connection. These are all tools used for a medical procedure on a living patient.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide diagnostic information. This device is designed for therapeutic access to the vascular system.
N/A
Intended Use / 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 ≥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.
Product codes
FMI
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Proximal humerus, Proximal tibia, Distal tibia, Distal Femur (in pediatric population)
Indicated Patient Age Range
ADULTS (≥22 years old)
PEDIATRICS (≤21 years old)
For patients ≥12 years old (for extended use)
Intended User / Care Setting
Not Found
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)
Study Type: MRI Testing
Summary: 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.
Key Results: The evaluation concluded that the EZ-IO Needle Set should be labeled as MR Conditional and included labeling guidelines in the report.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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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
1
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
2
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 ( 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
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
4
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.
-
- 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.
- Technological Characteristics and SubstantialEquivalence
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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.
| | Proposed Device
EZ-IO Intraosseous Vascular
Access System
(MR Conditional Safety
Status Labeling) | Predicate Device K180395
EZ-IO Intraosseous Vascular
Access System | Comparison |
|--------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| 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 ≥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. | 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
Use of the device may be extended for
up to 48 hours when alternate
intravenous access is not available or
reliably established. Insertion sites:
ADULTS (≥22 years): proximal
humerus, proximal tibia, distal tibia
PEDIATRICS (≥12 years through 21
years old): proximal humerus,
proximal tibia, distal tibia, distal femur | Wording
updated for
clarity but the
indications for
use are the
same. |
| Contraindicati
ons | • Fracture in target bone.
• Previous, significant orthopedic
procedure at the site,
prosthetic limb or joint.
• IO access (or attempted IO
access) in targeted bone within
past 48 hours.
• Infection at the area of
insertion.
• Excessive tissue (severe
obesity) and/or absence of
adequate anatomical
landmarks. | • Fracture in target bone.
• Previous, significant orthopedic
procedure at the site,
prosthetic limb or joint.
• IO access (or attempted IO
access) in targeted bone within
past 48 hours.
• Infection at the area of
insertion.
• Excessive tissue (severe
obesity) and/or absence of
adequate anatomical
landmarks. | Same |
| | Proposed Device
EZ-IO Intraosseous Vascular
Access System
(MR Conditional Safety
Status Labeling) | Predicate Device K180395
EZ-IO Intraosseous Vascular
Access System | Comparison |
| Target
Population | Adult and pediatric patients who
are in need of vascular access. | Adult and pediatric patients who
are in need of vascular access. | Same |
| Where Used | Pre-hospital, In hospital, Acute care | Pre-hospital, In hospital, Acute care | Same |
| Anatomical
Sites Used | Proximal Tibia Proximal Humerus Distal Tibia Distal Femur in pediatric
population | Proximal Tibia Proximal Humerus Distal Tibia Distal Femur in pediatric
population | Same |
| Needle/Cannula
Design | Sterile, single use Hubs: polycarbonate and color
additive 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 color
additive 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 Set
Guidelines | 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
cm apart to provide visual reference
points
Tactile feedback for change of
pressure | Positioning marks at 5 mm and 10
mm apart to provide visual reference
points
Tactile feedback for change of
pressure | Same |
| Sterile single
use components
and 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 of
single use
components
and accessories | Ethylene Oxide | Ethylene Oxide | Same |
| Shelf life of
single use
components
and accessories | 4 Years | 4 Years | Same |
| | Proposed Device
EZ-IO Intraosseous Vascular
Access System
(MR Conditional Safety
Status Labeling) | Predicate Device K180395
EZ-IO Intraosseous Vascular
Access System | Comparison |
| 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 Unsafe | Update to MR
Safety Status
as described in
submission. |
Table 5-1: Substantial Equivalence Comparison to Predicate
6
7
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. |
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.