(90 days)
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 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.
The ZIEN IO Intraosseous Access System is a medical device designed to provide intraosseous access when intravenous access is difficult or impossible. The provided document, a 510(k) premarket notification, indicates that no clinical testing was performed for this submission. The substantial equivalence to a predicate device (SAM IO™ Intraosseous Access System, K191488) was established through non-clinical bench and simulated use testing.
Therefore, information regarding acceptance criteria and performance derived from a study involving human subjects or AI effectiveness studies is not available in the provided text. The following sections will address the available information based on the non-clinical testing detailed in the document.
1. A table of acceptance criteria and the reported device performance
The document primarily refers to "applicable design and performance requirements" and "conformity to applicable standards" as the acceptance criteria for non-clinical testing. The device's performance is reported as "Fulfilled" or "Passed-Fulfilled" against these standards.
| Acceptance Criteria (Standard ID # and Title) | Reported Device Performance |
|---|---|
| ISO 80369-7: 2021 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications | Fulfilled |
| 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 |
| 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 |
| 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. | 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 | Fulfilled |
| 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 |
| 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 |
| Demonstrated ability for the ZIEN IO Intraosseous Access System to establish IO access in in-vitro model. | Less than 10 seconds |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample sizes used for the non-clinical bench testing or simulated use testing. It also does not provide details on the data provenance such as the country of origin or whether the data was retrospective or prospective, as these terms are typically relevant for clinical studies, which were not performed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable and therefore not provided in the document. The testing was non-clinical (bench and simulated use) and did not involve expert establishment of ground truth in a clinical context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the testing was non-clinical and did not involve human-based assessment requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
A multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is an intraosseous access system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable. The ZIEN IO Intraosseous Access System is a physical medical device, not an algorithm, and therefore does not have "standalone" algorithm performance in the sense of AI. Its performance was tested as a standalone physical system in bench and simulated use.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical testing, the "ground truth" was established by conformity to established international and industry standards (e.g., ISO, ASTM) and the successful completion of specified performance tests. For instance, mechanical properties were tested against standard specifications, and sterility against validated sterilization processes. The "simulated use" testing implies a simulated environment, rather than a clinical ground truth.
8. The sample size for the training set
This information is not applicable as the device is a physical medical device and does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
This information is not applicable as the device is a physical medical device and does not involve a "training set" for AI.
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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).
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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
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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 WestSalt 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.
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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 providesintraosseous access in the proximal tibia, distal tibiaand humeral head (proximal humerus) of adults andpediatric patients, and the distal femur in pediatricpatients when intravenous access is difficult orimpossible to obtain in emergent, urgent, or medicallynecessary cases for up to 24 hours. | The SAM IO® Intraosseous Infusion Systemprovides intraosseous access in the proximal tibia,distal tibia and humeral head (proximal humerus) ofadults and pediatric patients, and the distal femurin pediatric patients when intravenous access isdifficult or impossible to obtain in emergent, urgent,or medically necessary cases for up to 24 hours. | |
| IntendedUse | Intended Use: | For intraosseous access anytime in which vascularaccess is difficult to obtain in emergent, urgent, ormedically necessary cases. | For intraosseous access anytime in which vascularaccess is difficult to obtain in emergent, urgent, ormedically necessary cases. |
| Rx or OTC | Rx | Rx | |
| Targetpopulation | Adult and pediatric patients who arein need of vascular access. | Same | |
| Contraindications | Fracture in targeted bonePrevious, significant orthopedic procedure at siteselected for insertionIntraosseous catheter placement in targeted bonewithin past 48 hours.Infection at site selected for insertionExcessive 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 useDifferent labels for each needle size. Include relevantsymbols and warnings. Identify specification forpatient's weight. | Same | |||
| Instructions for Use (IFU) | Step-by-step procedure to establish IO access,including the same critical tasks. One (1) IFUdocument 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, andother | Same | |||
| Anatomical sites used | Four (4) insertion sites● Proximal tibia● Distal tibia● Humeral head (proximal humerus)● Distal femur (pediatric patients only) | Same | |||
| IO insertion depthassessment | ● Tactile feedback for change of pressure● Depth indicator markings on cannula to providevisual reference points | Same | |||
| Clinical decisions tomake by clinicians | ● Decision to use IO access instead of IV access● Insertion site selection, anatomical landmarksidentification and site preparation● Needle size selection● Determination of depth of tissue overlying thebone and the distance needed to adequatelypass into medullary bone● Decision to insert with or without using the driver | Same | |||
| Time to establish IOaccess in in-vitro model | Less than 10 seconds | Same | |||
| Mode of action | The user inserts the needle set assembly through thecortex of the bone to a preset depth within the bonemarrow (with or without using the driver). Once thecannula is securely seated in the bone, the stylet isremoved and a standard Luer lock (part of the needleassembly) then permits attachment of standardsyringes and IV lines for administration of drugs andfluids. | Same | |||
| Possibility to use manualinsertion (i.e. withoutusing the driver) | Yes | Same | |||
| 2.a) Needle Set & Accessories | |||||
| Sterile single usecomponents/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 quidelinesand corresponding hubscolors | Depth indicator markingson 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 incrementsfrom 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 devicedoes not introduce any different questions of safety oreffectiveness, the shelf life has been evaluated perASTM F1980-21 |
| Sterility | Ethylene Oxide (EO), SAL 10-6 | Same |
| Biocompatibility | Meets ISO 10993-1 for a device contactingTissue/Bone/Blood (Intraosseous) for a limitedduration (≤ 24h) | Same |
| 2.b) Driver | ||
| Weight | ~75g | Same |
| Dimensions | Back handle to trigger: 80mmTop to bottom: 105mm | Same |
| Design | The ZIEN IO Driver is a reusable manually operateddrill connected to a disposable IO needle assembly.Hand-held, cordless drilling device | Same |
| Mode of action | Upon manual activation, the drill penetrates throughthe cortex of the bone to a preset depth within thebone marrow.The driver then separates from the hub of the IOneedle assembly, leaving the cannula securely seatedin the bone.The trocar stylet that acts as the drill bit is thenremoved. | 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 samebetween the proposed and predicate systems, andthe performance of the system has not been altered,the difference in materials does not raise differentquestions of safety and effectiveness | DifferentPlease see comment # 1Polycarbonate, stainless steel, santoprene,silicone. Adhesive is used in the predicate NeedleSet 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 | FulfilledChanges made to mold toconform to the updatedstandard |
| ISO 23908(1st edition 2011-06-11) | Sharps injury protection - Requirements and test methods - Sharpsprotection features for single-use hypodermic needles, introducers forcatheters 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 totesting) |
| ASTM A632-19(2029) | Standard specification for Seamless and Welded Austenitic Stainless SteelTubing (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 forThe Development, Validation and Routine Control of a Sterilization Processfor Medical Devices | Passed-Fulfilled |
| ISO 10993-7:2008/Amd2019 | Biological Evaluation of Medical Devices - Part 7: Ethylene OxideSterilization Residuals | |
| ISO 11607-2: 2019 | Packaging for Terminally Sterilized Medical Devices - Part 2: ValidationRequirements for Forming, Sealing and Assembly Processes | Passed-Fulfilled |
| ASTM F1886-16 | Standard Test Method for Determining Integrity of Seals for FlexiblePackaging 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 InternalPressurization (Bubble Test) | Passed-Fulfilled |
| ASTM F1980-21 | Standard Guide for Accelerated Aging of Sterile Barrier Systems forMedical Devices | Passed-Fulfilled |
| ASTM D4169-16 | Standard Practice for Performance Testing of Shipping Containers andSystems | Passed-Fulfilled |
| ISO 10993-1:2018 | Biological evaluation of medical devices-Part 1: Evaluation and testingwithin 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).
§ 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).