(90 days)
Not Found
No
The device description details a manually operated mechanical system for intraosseous access. There is no mention of AI, ML, image processing, or any data-driven components.
No.
The device provides a means for intraosseous access to administer drugs and fluids; it does not itself treat a disease or condition.
No
The device is described as an "Intraosseous Access System" used for administering drugs and fluids when intravenous access is difficult. Its function is to create a pathway into the bone marrow, not to diagnose a condition.
No
The device description clearly outlines physical components: a disposable needle assembly and a reusable manually powered drill. It describes mechanical actions like rotary cutting and force application, indicating a hardware-based system. There is no mention of software as a primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide intraosseous access for administering drugs and fluids. This is a therapeutic and access procedure, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a mechanical system for drilling into bone to create an access point. It does not involve the analysis of biological samples.
- Lack of Diagnostic Elements: There is no mention of analyzing blood, tissue, or any other biological sample for diagnostic purposes.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely for providing access for treatment.
N/A
Intended Use / Indications for Use
The ZIEN IO Intraosseous Access System provides intraosseous access in the proximal tibia, distal tibia and humeral head (proximal humerus) of adults and pediatric patients, and the distal femur in pediatric patients when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary cases for up to 24 hours.
Product codes
FMI
Device Description
The ZIEN IO Intraosseous Access System consists of a single use disposable intraosseous (IO) needle assembly (the ZIEN IO Needle Set) that connects to a reusable manually powered drill (the ZIEN IO Driver). Upon manual activation, the Driver penetrates through the cortex of the bone to a desired depth within the bone marrow by means of rotary cutting action along with force applied axially by the operator. The Driver can then be separated from the hub of the IO needle assembly, leaving the cannula securely seated in the bone. The stylet containing the driver connection is then removed.
The needle insertion can also be performed by hand, without the use of the Driver, as per the user's discretion.
A standard Luer lock (part of the needle assembly) permits attachment of standard syringes and IV lines for administration of drugs and fluids. Typical user profiles include Hospitals, Military, Medics, Nurses, EMTs (Emergency Medical Technicians).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
proximal tibia, distal tibia, humeral head (proximal humerus), distal femur
Indicated Patient Age Range
adults and pediatric patients
Intended User / Care Setting
Hospitals, Military, Medics, Nurses, EMTs (Emergency Medical Technicians) / emergent, urgent, or medically necessary cases
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)
Performance bench testing was conducted to ensure that the ZIEN IO Intraosseous Access System met the applicable design and performance requirements throughout its shelf life, verify conformity to applicable standards, and demonstrate substantial equivalence to the predicate system. The following performance testing was performed or fulfilled with the ZIEN IO Intraosseous Access System.
Simulated use: Simulated use results provided by ZIEN Medical Technologies, Inc. support the conclusion that the proposed device is clinically safe for prescription use. Furthermore, ZIEN Medical Technologies, Inc. conducted a risk analysis on the proposed system in accordance with ISO 14971. All identified risks have been addressed through device design, verification/validation or through documentation (labeling and Instructions for Use) provided to the user.
In summary, performance test (Bench and Simulated Use studies) results support a determination of substantial equivalence to the predicate system.
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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
July 2, 2024
ZIEN Medical Technologies, Inc. Tim Nieman CEO 2490 South 300 West Salt Lake City, Utah 84115
Re: K240915
Trade/Device Name: ZIEN IO Intraosseous Access System Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: March 28, 2024 Received: April 3, 2024
Dear Tim Nieman:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 801 and Part 809 ; medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Gang Peng -S for
Shruti Mistry Assistant Director Division of Drug Delivery and General Hospital Devices Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K240915
Device Name
ZIEN IO Intraosseous Access System
Indications for Use (Describe)
The ZIEN IO Intraosseous Access System provides intraosseous access in the proximal tibia, distal tibia and humeral head (proximal humerus) of adults and pediatric patients, and the distal femur in pediatric patients when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary cases for up to 24 hours.
| 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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Image /page/3/Picture/0 description: The image shows a logo with an orange circle and a white stylized letter 'Z' inside. Two horizontal lines extend from either side of the circle, creating a sense of movement or connection. The logo is simple, modern, and uses a bright color to attract attention. The overall design is clean and minimalist.
510(K)Summary
GENERAL INFORMATION
Submitted by:
| Owner's Name: | ZIEN Medical Technologies, Inc. |
|---|---|
| Address: | 2490 South 300 West |
| Salt Lake City, UT 84115 USA | |
| Contact Person: | Tim Nieman |
| Title: | CEO |
| Tel: | +1 (385) 444-2666 |
| Email: | Tim.nieman@zienmedical.com |
| Date Prepared: | July 2, 2024 |
|---|---|
| Trade Name: | ZIEN IO Intraosseous Access System |
| Common Name: | Intraosseous Infusion System |
| Classification name: | Needle, Hypodermic, Single Lumen |
| Regulation name: | Hypodermic single lumen needle |
| Classification: | Class II |
| Product Code: | FMI |
| Regulation Number: | 880.5570 |
| Predicate Device: | SAM IO™ Intraosseous Access System, SAM® Medical Products, Inc. (K191488) |
DEVICE DESCRIPTION:
The ZIEN IO Intraosseous Access System consists of a single use disposable intraosseous (IO) needle assembly (the ZIEN IO Needle Set) that connects to a reusable manually powered drill (the ZIEN IO Driver). Upon manual activation, the Driver penetrates through the cortex of the bone to a desired depth within the bone marrow by means of rotary cutting action along with force applied axially by the operator. The Driver can then be separated from the hub of the IO needle assembly, leaving the cannula securely seated in the bone. The stylet containing the driver connection is then removed.
The needle insertion can also be performed by hand, without the use of the Driver, as per the user's discretion.
4
Image /page/4/Picture/0 description: The image contains the logo for ZIEN Medical Technologies. The logo consists of an orange circle with a stylized white "Z" inside, along with the text "ZIEN Medical Technologies" in a sans-serif font. The text is positioned to the right of the circular logo.
A standard Luer lock (part of the needle assembly) permits attachment of standard syringes and IV lines for administration of drugs and fluids. Typical user profiles include Hospitals, Military, Medics, Nurses, EMTs (Emergency Medical Technicians).
INDICATION FOR USE:
The ZIEN IO Intraosseous Access System provides intraosseous access in the proximal tibia, distal tibia and humeral head (proximal humerus) of adults and pediatric patients, and the distal femur in pediatric patients when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary cases for up to 24 hours.
The proposed system is indicated for Rx (prescription) use.
INTENDED USE:
For intraosseous access anytime in which vascular access is difficult to obtain in emergent, urgent, or medically necessary cases.
LABELING AND TECHNOLOGICAL CHARACTERISTICS COMPARISON:
As shown in Table 6-1 (see next page), the proposed ZIEN IO Intraosseous Access System has identical intended use and different technology characteristics to the currently marketed SAM IO™ Intraosseous Access System (K191488).
| Table 6-1: Comparison table | |||
|---|---|---|---|
| Proposed system | Predicate system | ||
| Device Proprietary Name | ZIEN IO Intraosseous Access System | SAM IO™ Intraosseous Access System | |
| Manufacturer | ZIEN Medical Technologies, Inc. | SAM® Medical Products, Inc. | |
| 510(k) | K191488 | ||
| 1. LABELING | |||
| Regulation | 21 CFR 880.5570 | Same | |
| Class. | Product Code | FMI | Same |
| Class. Name | Needle, Hypodermic, Single Lumen | Same | |
| Indication for Use: | The ZIEN IO Intraosseous Access System provides | ||
| intraosseous access in the proximal tibia, distal tibia | |||
| and humeral head (proximal humerus) of adults and | |||
| pediatric patients, and the distal femur in pediatric | |||
| patients when intravenous access is difficult or | |||
| impossible to obtain in emergent, urgent, or medically | |||
| necessary cases for up to 24 hours. | The SAM IO® Intraosseous Infusion System | ||
| provides intraosseous access in the proximal tibia, | |||
| distal tibia and humeral head (proximal humerus) of | |||
| adults and pediatric patients, and the distal femur | |||
| in pediatric patients when intravenous access is | |||
| difficult or impossible to obtain in emergent, urgent, | |||
| or medically necessary cases for up to 24 hours. | |||
| Intended | |||
| Use | Intended Use: | For intraosseous access anytime in which vascular | |
| access is difficult to obtain in emergent, urgent, or | |||
| medically necessary cases. | For intraosseous access anytime in which vascular | ||
| access is difficult to obtain in emergent, urgent, or | |||
| medically necessary cases. | |||
| Rx or OTC | Rx | Rx | |
| Target | |||
| population | Adult and pediatric patients who are | ||
| in need of vascular access. | Same | ||
| Contraindications | Fracture in targeted bone | ||
| Previous, significant orthopedic procedure at site | |||
| selected for insertion | |||
| Intraosseous catheter placement in targeted bone | |||
| within past 48 hours. | |||
| Infection at site selected for insertion | |||
| Excessive tissue or absence of anatomic landmarks | Same |
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Image /page/5/Picture/0 description: The image shows a logo with an orange circle and a white stylized "Z" shape inside. Two horizontal lines extend from either side of the circle, intersecting with the "Z" shape. The logo is simple and modern, with a focus on geometric shapes and a bright color.
| Proposed system | Predicate system | ||||
|---|---|---|---|---|---|
| Labels | Not for sternal use | ||||
| Different labels for each needle size. Include relevant | |||||
| symbols and warnings. Identify specification for | |||||
| patient's weight. | Same | ||||
| Instructions for Use (IFU) | Step-by-step procedure to establish IO access, | ||||
| including the same critical tasks. One (1) IFU | |||||
| document for the Needle Set & Accessories and one | |||||
| (1) IFU document for the Driver. | Same | ||||
| 2. TECHNOLOGY | |||||
| Use Environment | |||||
| (Where used) | Emergency settings: | ||||
| Pre-hospital, In hospital, Acute care, Military, and | |||||
| other | Same | ||||
| Anatomical sites used | Four (4) insertion sites | ||||
| ● Proximal tibia | |||||
| ● Distal tibia | |||||
| ● Humeral head (proximal humerus) | |||||
| ● Distal femur (pediatric patients only) | Same | ||||
| IO insertion depth | |||||
| assessment | ● Tactile feedback for change of pressure | ||||
| ● Depth indicator markings on cannula to provide | |||||
| visual reference points | Same | ||||
| Clinical decisions to | |||||
| make by clinicians | ● Decision to use IO access instead of IV access | ||||
| ● Insertion site selection, anatomical landmarks | |||||
| identification and site preparation | |||||
| ● Needle size selection | |||||
| ● Determination of depth of tissue overlying the | |||||
| bone and the distance needed to adequately | |||||
| pass into medullary bone | |||||
| ● Decision to insert with or without using the driver | Same | ||||
| Time to establish IO | |||||
| access in in-vitro model | Less than 10 seconds | Same | |||
| Mode of action | The user inserts the needle set assembly through the | ||||
| cortex of the bone to a preset depth within the bone | |||||
| marrow (with or without using the driver). Once the | |||||
| cannula is securely seated in the bone, the stylet is | |||||
| removed and a standard Luer lock (part of the needle | |||||
| assembly) then permits attachment of standard | |||||
| syringes and IV lines for administration of drugs and | |||||
| fluids. | Same | ||||
| Possibility to use manual | |||||
| insertion (i.e. without | |||||
| using the driver) | Yes | Same | |||
| 2.a) Needle Set & Accessories | |||||
| Sterile single use | |||||
| components/accessories | ● ZIEN IO Needle Sets | ||||
| ● ZIEN IO Extension Tubing Set | |||||
| ● NeedleVISE® 1-port Sharps Block | ● SAM IO™ Needle Sets | ||||
| ● SAM IO™ Extension Tubing Set | |||||
| ● NeedleVISE® 1-port Sharps Block | |||||
| Needles length offered | 15, 25, 45mm | Same | |||
| Needles OD | 15 gauge (G) for all lengths | Same | |||
| Needle tip shape | Double diamond stylet tip, 5-point crown cannula tip | Same | |||
| Stylet use | Yes | Same | |||
| IV lines connection | Standard Luer connection | Same | |||
| Needle set quidelines | |||||
| and corresponding hubs | |||||
| colors | Depth indicator markings | ||||
| on cannula | Available needle sets: | ||||
| ● 15 mm: 3-39 kg (pink hub) | |||||
| ● 25 mm: 3 kg or over (blue hub) | |||||
| ● 45 mm: 40 kg or over, excessive tissue, | |||||
| humerus (yellow hub) | |||||
| ● 15 mm: 1 marking | 25 mm: 2 markings 45 mm: 4 markings Black indicator lines are located at 5 mm increments | ||||
| from the hub for assessing insertion depth. | Same | Same |
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Image /page/6/Picture/0 description: The image shows a logo with an orange circle and a white stylized letter 'Z' inside. Two horizontal lines extend from either side of the circle, creating a sense of movement or connection. The logo is simple, modern, and uses a bright color to attract attention. The overall design is clean and minimalist.
| Proposed system | Predicate system | |
|---|---|---|
| Shelf life | 6 months | Different (12 months) |
| The 6 months expiry claimed for the subject device | ||
| does not introduce any different questions of safety or | ||
| effectiveness, the shelf life has been evaluated per | ||
| ASTM F1980-21 | ||
| Sterility | Ethylene Oxide (EO), SAL 10-6 | Same |
| Biocompatibility | Meets ISO 10993-1 for a device contacting | |
| Tissue/Bone/Blood (Intraosseous) for a limited | ||
| duration (≤ 24h) | Same | |
| 2.b) Driver | ||
| Weight | ~75g | Same |
| Dimensions | Back handle to trigger: 80mm | |
| Top to bottom: 105mm | Same | |
| Design | The ZIEN IO Driver is a reusable manually operated | |
| drill connected to a disposable IO needle assembly. | ||
| Hand-held, cordless drilling device | Same | |
| Mode of action | Upon manual activation, the drill penetrates through | |
| the cortex of the bone to a preset depth within the | ||
| bone marrow. | ||
| The driver then separates from the hub of the IO | ||
| needle assembly, leaving the cannula securely seated | ||
| in the bone. | ||
| The trocar stylet that acts as the drill bit is then | ||
| removed. | Same | |
| Source of power | Manual | Same |
| Sterility | Sold non-sterile | Same |
| Biocompatibility | Contact intact skin only. To be used with gloves. | Same |
| Reuse instructions | Reusable as per IFU instructions | Same |
| Prior to use | Inspection required to verify normal operation | Same |
| Materials | Polycarbonate, stainless steel, santoprene, silicone. |
Since the needle set design and function is the same
between the proposed and predicate systems, and
the performance of the system has not been altered,
the difference in materials does not raise different
questions of safety and effectiveness | Different
Please see comment # 1
Polycarbonate, stainless steel, santoprene,
silicone. Adhesive is used in the predicate Needle
Set Assembly. |
Discussions of differences in technological characteristics.
Comment # 1
The proposed ZIEN IO Needle Set Assembly uses a press-fit for the Argon needle and assembly whereas the predicate SAM IO™ Needle Set Assembly used adhesive for this junction. This difference is minimal and does not raise different questions of safety or effectiveness. Performance verification data confirms that the press fit design of the proposed system meets the same acceptance criteria as the predicate system. Otherwise, the proposed system and predicate system are identical besides the legal manufacturer and trade name.
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Image /page/7/Picture/0 description: The image features the logo for ZIEN Medical Technologies. The logo consists of an orange circle with a white stylized "Z" inside, with horizontal lines extending from either side of the circle. To the right of the logo, the text "ZIEN Medical Technologies" is written in a simple, sans-serif font.
NON-CLINICAL TESTING
Performance (Bench) Testing: Performance bench testing was conducted to ensure that the ZIEN IO Intraosseous Access System met the applicable design and performance requirements throughout its shelf life, verify conformity to applicable standards, and demonstrate substantial equivalence to the predicate system. The following performance testing was performed or fulfilled with the ZIEN IO Intraosseous Access System.
| Standard ID # | Title | Conclusion |
|---|---|---|
| ISO 80369-7: 2021 | Small-bore connectors for liquids and gases in healthcare applications - | |
| Part 7: Connectors for intravascular or hypodermic applications | Fulfilled | |
| Changes made to mold to | ||
| conform to the updated | ||
| standard | ||
| ISO 23908 | ||
| (1st edition 2011-06-11) | Sharps injury protection - Requirements and test methods - Sharps | |
| protection features for single-use hypodermic needles, introducers for | ||
| catheters and needles used for blood sampling | Passed-Fulfilled | |
| ISO 7864 | ||
| (4th edition 2016-08-01) | Sterile hypodermic needles for single use - Requirements and test methods | Passed-Fulfilled |
| ISO 9626 | ||
| (2nd edition 2016-08-01) | Stainless steel needle tubing for the manufacture of medical devices - | |
| Requirements and test methods | Passed-Fulfilled | |
| ISO 10555-1 | ||
| (2nd Edition 2013-06-15) | Intravascular catheters - Sterile and single-use intravascular catheters - | |
| Part 1: General requirements | Fulfilled | |
| (2X EO Exposure prior to | ||
| testing) | ||
| ASTM A632-19 | ||
| (2029) | Standard specification for Seamless and Welded Austenitic Stainless Steel | |
| Tubing (small-diameter) for general service | Fulfilled | |
| ASTM A313-13 | ||
| (2013) | Standard Specification for Stainless Steel Spring Wire | Fulfilled |
| (as per CoC's) |
Simulated use: Simulated use results provided by ZIEN Medical Technologies, Inc. support the conclusion that the proposed device is clinically safe for prescription use. Furthermore, ZIEN Medical Technologies, Inc. conducted a risk analysis on the proposed system in accordance with ISO 14971. All identified risks have been addressed through device design, verification/validation or through documentation (labeling and Instructions for Use) provided to the user.
In summary, performance test (Bench and Simulated Use studies) results support a determination of substantial equivalence to the predicate system. The following Table 6-3 presents the other applicable standards as they pertain to biocompatibility, sterilization and packaging:
Table 6-3: Summary of other applicable standards
| Other applicable standards | ||
|---|---|---|
| Standard ID # | Title | Conclusion |
| ISO 14971:2019 | Medical Devices - Application of Risk Management to Medical Devices | Fulfilled |
| 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 | Passed-Fulfilled | |
| ISO 10993-7:2008/Amd | ||
| 2019 | Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide | |
| Sterilization Residuals | ||
| ISO 11607-2: 2019 | Packaging for Terminally Sterilized Medical Devices - Part 2: Validation | |
| Requirements for Forming, Sealing and Assembly Processes | Passed-Fulfilled | |
| ASTM F1886-16 | Standard Test Method for Determining Integrity of Seals for Flexible | |
| Packaging by Visual Inspection | Passed-Fulfilled |
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Image /page/8/Picture/0 description: The image shows a logo with an orange circle in the center. A white, stylized "Z" shape is inside the circle. Two horizontal orange lines extend from either side of the circle, creating a sense of connection or movement. The logo appears simple and modern.
| ASTM F88/F88-23 | Standard Test Method for Seal Strength of Flexible Barrier Materials | Passed-Fulfilled |
|---|---|---|
| ASTM F2096-11:2019 | Standard Test Method for Detecting Gross Leaks in Packaging by Internal | |
| Pressurization (Bubble Test) | Passed-Fulfilled | |
| ASTM F1980-21 | Standard Guide for Accelerated Aging of Sterile Barrier Systems for | |
| Medical Devices | Passed-Fulfilled | |
| ASTM D4169-16 | Standard Practice for Performance Testing of Shipping Containers and | |
| Systems | Passed-Fulfilled | |
| ISO 10993-1:2018 | Biological evaluation of medical devices-Part 1: Evaluation and testing | |
| within a risk management process | Fulfilled |
Biocompatibility: The patient-contacting (direct/indirect fluid path) components of the ZIEN IO Intraosseous Access System, namely the ZIEN IO Needle Set Assembly and the ZIEN IO Extension Tubing Assembly, fulfil the requirements as set forth in:
-
. ISO 10993-1:2018, Biological evaluation of medical devices - Part 1: Guidance on selection of tests.
Sterilization: The sterile component of the system (the ZIEN IO Needle Set & Accessories) is sterilized via ethylene oxide (EO) sterilization. The sterility Assurance Level (SAL) of 10-0 is assured using an EO sterilization method validated in accordance with: -
ANSI/AAMI/ISO 11135:2014, Sterilization of healthcare products Ethylene oxide -. Requirements for Development. Validation, and Routine Control of a Sterilization Process for Medical Devices
-
AAMI/ANSI/ISO 10993-7:2008 / Amd.1:2019. Biological Evaluation of Medical Devices ● Part 7: Ethylene Oxide Sterilization Residuals – Amd.1, applicability of allowable limits for neonates and infants
Packaging: The sterilization validation, stability (accelerated aging followed by seal integrity and seal strength testing) testing and package (sealing process) validation results demonstrate that the proposed terminally sterilized packaging system allows sterilization, provides physical protection, maintains sterility up to the point of use and allows aseptic presentation of the ZIEN IO Needle Set & Accessories.
CLINICAL TESTING
Clinical testing was not included as part of this submission.
CONCLUSION OF COMPARISON
Based on the performance testing conducted and provided in this submission, it was concluded that the ZIEN IO Intraosseous Access System is substantially equivalent to the SAM IO™ Intraosseous Access System (K191488).