Who is the manufacturer of EZ-IO Intraosseous Vascular Access System?

Teleflex Medical filed the 510(k) submission for EZ-IO Intraosseous Vascular Access System (K231924).

What is the FDA product code for EZ-IO Intraosseous Vascular Access System?

FMI. It is classified under 21 CFR 880.5570 as a Class 2 device in the General Hospital panel.

What is the regulatory pathway for EZ-IO Intraosseous Vascular Access System?

510(k) clearance (submission type: Special).

Who can help prepare an FDA 510(k) submission like EZ-IO Intraosseous Vascular Access System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

EZ-IO Intraosseous Vascular Access System

Q: What are the predicate devices for EZ-IO Intraosseous Vascular Access System?

EZ-IO Intraosseous Vascular Access System (K202492).

K231924 · Teleflex Medical · FMI · Jul 25, 2023 · General Hospital

Device Facts

Record ID	K231924
Device Name	EZ-IO Intraosseous Vascular Access System
Applicant	Teleflex Medical
Product Code	FMI · General Hospital
Decision Date	Jul 25, 2023
Decision	SESE
Submission Type	Special
Regulation	21 CFR 880.5570
Device Class	Class 2
Attributes	Therapeutic, Pediatric

Intended 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.

Device Story

EZ-IO Intraosseous Vascular Access System facilitates vascular access via bone marrow infusion. System comprises reusable cordless battery-powered driver, single-use stainless steel needle sets (stylet/catheter), and accessories (EZ-Connect tubing, EZ-Stabilizer dressing). Clinician identifies anatomical landmarks, attaches needle to driver, and drills through bone cortex into medullary space. Tactile feedback (pop/give) indicates successful entry. Driver detached; stylet removed; catheter remains in bone for fluid/medication administration via Luer lock. Used in pre-hospital, in-hospital, and acute care settings. Provides rapid vascular access when IV access is difficult or unavailable, potentially life-saving in emergencies.

Clinical Evidence

Bench testing only. Testing included packaging integrity (ASTM F1886, ASTM F2096), sterilization validation (ISO 11135), biocompatibility (ISO 10993-1), and functional performance (RPM and insertion testing, useful life testing). All tests met pre-defined acceptance criteria.

Technological Characteristics

System includes cordless driver (Cycoloy housing, 304 stainless steel shaft, lithium CR2 batteries) and single-use 304 stainless steel needle sets (15mm, 25mm, 45mm). Biocompatible materials per ISO 10993-1. Sterilization: Ethylene Oxide (SAL 10^-6) for needle sets and new sterile driver version. MR Conditional. Connectivity: None (mechanical/manual operation).

Indications for Use

Indicated for intraosseous vascular access in emergent, urgent, or medically necessary cases where vascular access is difficult. Patient population: Adults (≥22 years) and Pediatrics (≤21 years). Contraindications: fracture in target bone; previous significant orthopedic procedure, prosthetic limb, or joint at site; IO access in target bone within past 48 hours; infection at insertion site; excessive tissue (severe obesity) or absence of adequate anatomical landmarks.

Regulatory Classification

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.

Predicate Devices

EZ-IO Intraosseous Vascular Access System (K202492)

Related Devices

K202492 — EZ-IO Intraosseous Vascular Access System · Teleflex Medical · Mar 22, 2021
K141117 — EZ-IO INTRAOSSEOUS INFUSION SYSTEM · Vidacare, LLC · Jul 8, 2014
K180395 — EZ-IO Intraosseous Vascular Access System · Arrow International, Inc. (Subsidiary of Teleflex, Inc.) · Nov 9, 2018
K052408 — EZ-IO · Vidacare Corporation · Nov 17, 2005
K062956 — EZ-MIO, EZ-IO DISTAL TIBIA · Vidacare Corporation · Dec 5, 2006

Submission Summary (Full Text)

{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: 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) ## 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 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.