(25 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI or ML.
Yes.
The device facilitates the infusion of fluids and medications for vascular access, which is a therapeutic intervention.
No
The device is described as an intraosseous vascular access system designed to facilitate the infusion of fluids and medications, not to diagnose a condition.
No
The device description clearly outlines multiple hardware components including needle sets, a reusable cordless driver/drill, extension tubing, and an optional dressing. It is a physical medical device system, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for obtaining vascular access through the bone marrow for infusion of fluids and medications. This is a procedure performed directly on the patient's body.
- Device Description: The device is a system for inserting a needle into bone. It includes a driver, needle sets, and accessories for securing the needle and connecting to infusion lines. These are all tools for a medical procedure, not for analyzing samples outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze biological samples (like blood, urine, tissue, etc.) in vitro (outside the living body) to provide information about a physiological state, health, disease, or congenital abnormality.
Therefore, the EZ-IO Intraosseous Vascular Access System is a medical device used for a therapeutic procedure, not an in vitro diagnostic device.
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. 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 fibia, distal femur
Product codes (comma separated list FDA assigned to the subject device)
FMI
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ADULTS (≥22 years old): proximal humerus, proximal tibia, distal tibia
PEDIATRICS (≤21 years old): proximal humerus, proximal tibia, distal fibia, distal femur (Also listed as distal tibia and distal femur in other sections)
Indicated Patient Age Range
Patients ≥ 12 years old.
Adults (≥22 years old)
Pediatrics (≤21 years old)
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)
Non-Clinical Performance Testing including:
- 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
Key results: 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.
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.
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
§ 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).
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)
Device Name
EZ-IO Intraosseous Vascular Access System
Indications for Use (Describe)
INDICATIONS FOR USE:
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.
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)
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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
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
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 Equivalence Comparison to Predicate | |||
|---|---|---|---|
| Proposed Device | Predicate Device - K202492 | Comparison | |
| EZ-IO Intraosseous Vascular | |||
| Access System | |||
| (Sterile Driver) | EZ-IO Intraosseous Vascular | ||
| Access System | |||
| 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. | 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. | Combined the
verbiage above
and below the
insertion sites
into one
paragraph. No
change to
indication for
use statement. |
| Contraindications | • 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 |
| 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 Tibia | Same |
| | Proposed Device
EZ-IO Intraosseous Vascular
Access System
(Sterile Driver) | Predicate Device – K202492
EZ-IO Intraosseous Vascular
Access System | Comparison |
| | • Distal Tibia
• Distal Femur in pediatric
population | • Distal Tibia
• Distal Femur in pediatric
population | |
| EZ-IO Power Driver
Design | • Housing: Cycoloy, Sabic P/N
C6200-6T5D007, Maroon
• Drive Shaft: 304 Stainless Steel
• Driver Shaft Seal: Trosta, Black
Shore 58A Ethylene Propylene
Diene Monomer (EPDM) with
metal insert (1008 Steel)
• Gasket: HD Urethane Foam Tape,
Korel 8000, Shore A
• Magnet Bonding: Loctite 603
• Trigger Cover: Thermoplastic
Elastomer, Shore 25 A, Black
• Label: Facestock: Matte Radiant
White Polyester, Adhesive:
Permanent #300 Acrylic, Liner:
Densified Kraft, Ink: Black
• Trigger Guard: Cycoloy, Sabic P/N
C6200-BK1005, Black
• Lanyard: Buna-N, Hard, Dash
Number 42
• Batteries: Manganese Dioxide
Lithium Batteries, CR2 | • Housing: Cycoloy, Sabic P/N
C6200-6T5D007, Maroon
• Drive Shaft: 304 Stainless Steel
• Driver Shaft Seal: Trosta, Black
Shore 58A Ethylene Propylene
Diene Monomer (EPDM) with
metal insert (1008 Steel)
• Gasket: HD Urethane Foam Tape,
Korel 8000, Shore A
• Magnet Bonding: Loctite 603
• Trigger Cover: Thermoplastic
Elastomer, Shore 25 A, Black
• Label: Facestock: Matte Radiant
White Polyester, Adhesive:
Permanent #300 Acrylic, Liner:
Densified Kraft, Ink: Black
• Trigger Guard: Cycoloy, Sabic P/N
C6200-BK1005, Black
• Lanyard: Buna-N, Hard, Dash
Number 42
• Batteries: Manganese Dioxide
Lithium Batteries, CR2 | Same |
| Sterility of EZ-IO
Power Driver | • Sterile Driver: Ethylene Oxide
(SAL 10-6)
and
• Non-Sterile | • Non-Sterile | The proposed
device will be an
ethylene oxide
sterilized version
of the currently
marketed
product. The
current non-
sterile version
will still be
available |
| Needle/Cannula
Design | • Sterile, single use
• Hubs: polycarbonate and color
additive
• Stylet/catheter: Stainless Steel
• Faceted tip
• Standard Luer connection 15 mm; | • Sterile, single use
• Hubs: polycarbonate and color
additive
• Stylet/catheter: Stainless Steel
• Faceted tip
• Standard Luer connection 15 mm; | Same |
| | Proposed Device
EZ-IO Intraosseous Vascular
Access System
(Sterile Driver) | Predicate Device - K202492
EZ-IO Intraosseous Vascular
Access System | Comparison |
| | 15 gauge (0.071", 1.8 mm)
• Needle Cover: Polypropylene | 15 gauge (0.071", 1.8 mm)
• Needle Cover: Polypropylene | |
| 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 mm 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 |
| 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 |
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.