(217 days)
The IO Needle Safety Sheath (IOSS) is intended to assist in the safe removal of intraosseous needles.
IOSS is Indicated for Use with 25mm EZ-IO Vascular Access Needles and BD Luer-Lok 10mL Syringes.
The IO Needle Safety Sheath (IOSS) is a single-use, non-sterile, antineedlestick accessory to assist in the removal of intraosseous (IO) needles. IOSS is placed around the syringe and IO needle prior to removal from the patient. It irreversibly captures the IO needle within the device upon removal from the patient; helping to prevent accidental needle sticks to the patient or user. There is tactile confirmation of capture, and the clear body of IOSS allows for visual confirmation that the IO needle is in Safe Mode.
This is a 510(k) premarket notification for the "IO Needle Safety Sheath (IOSS)", a device intended to assist in the safe removal of intraosseous needles. The information provided heavily focuses on proving substantial equivalence to a predicate device (EZ-IO Intraosseous Vascular Access System) and includes non-clinical performance data.
Here's an analysis of the acceptance criteria and the study data provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Pass for cytotoxicity, sensitization, irritation or intracutaneous reactivity, acute systemic toxicity, and material-mediated pyrogenicity per ISO 10993 series. | Pass. Final, finished devices tested for cytotoxicity, sensitization, irritation or intracutaneous reactivity, acute systemic toxicity, and material mediated pyrogenicity. All tests confirmed the suitability of IOSS. |
| Verification of ProductSpecification | IOSS must meet all product specifications after exposure to ambient, high temperature/humidity, and low temperature environmental conditions. | Pass. Confirmed that the IO Needle Safety Sheath (IOSS) met all product specifications high temperature/humidity, and low temperature environmental conditions. |
| Usability | The intended user population can use IOSS without encountering a needle stick, serious use errors, or problems for the intended use and expected use environment. | Pass. Human factors validation testing confirmed that the user population can safely and effectively use IOSS for the intended use in the expected use environment without encountering a needle stick, serious use errors, or other problems. |
| Distribution | IOSS must meet all product specifications and acceptance criteria after being exposed to shipping and transportation conditions (ISTA 3A 2018). | Pass. Distribution testing conforming to ISTA 3A 2018 (FDA Recognition Number 5-126) confirmed that IOSS met all product specifications and acceptance criteria after being exposed to shipping and transportation conditions. |
| Accelerated Shelf Life | IOSS must meet all product specifications and acceptance criteria after exposure to conditions simulating a shelf life of up to 5 years. | Pass. Confirmed that IOSS met all product specifications and acceptance criteria after exposure to conditions simulating a shelf life of one (1), three (3), and five (5) years. |
| Shelf Life (Real-Time) | IOSS must meet all product specifications following real-time ambient condition exposure for one (1), three (3), and five (5) years. | Test on-going. |
| Prevention of Needle Stick | Implicit within the usability acceptance criteria. The device should prevent accidental needle sticks. | Pass. "Usability Testing: Human factors validation testing confirmed that the user population can safely and effectively use IOSS for the intended use in the expected use environment without encountering a needle stick, serious use errors, or other problems." (This is inferential, as a specific quantitative criterion for needle stick prevention isn't explicitly stated but is the core function of a "safety sheath"). |
| Irreversible Capture | Implicit within the device description: "It irreversibly captures the IO needle within the device upon removal from the patient." | Confirmed during product specification testing and usability testing, as the device passed all specifications and was used safely and effectively. (Specific data on the mechanism of irreversible capture or its success rate is not explicitly detailed in the summary, but implied by the "Pass" for usability and product specifications). |
| Tactile and Visual Confirmation of Safe Mode | Implicit in device description: "There is tactile confirmation of capture, and the clear body of IOSS allows for visual confirmation that the IO needle is in Safe Mode." | Confirmed during product specification testing and usability testing. (No specific data points on tactile/visual confirmation success rates are provided, but its functionality is implied to be met). |
2. Sample Size Used for the Test Set and Data Provenance
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Usability Testing:
- Sample Size: 500 uses by thirty (30) users.
- Data Provenance: Not explicitly stated as retrospective or prospective, nor the country of origin. However, human factors validation testing typically involves prospective studies with enrolled participants.
-
Other tests (Biocompatibility, Product Specifications, Distribution, Accelerated Shelf Life): These involve device units, not human subjects, so "test set" and "data provenance" as typically applied to clinical studies are not directly applicable. These are conducted in a laboratory setting. The "final, finished devices" were tested.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
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Usability Testing: The document refers to "thirty (30) Users" to assess usability. It does not specify if these were "experts" in the sense of establishing ground truth for the device's functional performance, but rather participants for evaluating user experience and safety.
- Ground Truth: The "ground truth" for usability testing is whether these users encountered needle sticks, serious use errors, or problems. This is established by direct observation and feedback from the users themselves, evaluated against predefined safety and effectiveness criteria.
- Qualifications: The qualifications of these 30 users are not detailed beyond "intended user population." They likely represent healthcare professionals who would typically use such a device. There is no mention of "experts" specifically establishing a ground truth for the test set.
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Other tests: Ground truth for these bench tests is established by industry standards (e.g., ISO 10993, ISTA 3A) and internal product specifications, which are typically developed by engineers and quality assurance personnel. No external experts are mentioned for validating these specific test outcomes.
4. Adjudication Method for the Test Set
- No explicit adjudication method (like 2+1 or 3+1 consensus) is mentioned for any of the tests.
- For Usability Testing, the results would typically be analyzed by human factors engineers against predefined pass/fail criteria for safety and effectiveness (e.g., zero needle sticks, minimal serious use errors). This is more of a data analysis and evaluation process than an adjudication by multiple, independent experts as seen in, for example, image interpretation studies.
- For Bench Performance Testing, results are typically compared directly to quantitative specifications and pass/fail criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC comparative effectiveness study was not done.
- This device is a physical accessory (safety sheath) for an existing medical needle. The studies focus on its physical performance, safety features (preventing needle sticks), and usability, rather than diagnostic interpretation effectiveness that would necessitate an MRMC study.
- Therefore, there is no effect size of human readers improving with AI vs. without AI assistance, as AI is not a component of this device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) study was done
- No, a standalone algorithm-only study was not applicable or performed.
- This device is a mechanical accessory; it does not involve algorithms or AI. Its core function is to be used with a human operator and an existing IO needle.
7. The Type of Ground Truth Used
- Biocompatibility: Ground truth is established by adherence to recognized international standards (ISO 10993 series) and specific laboratory test parameters designed to detect cytotoxic, sensitization, irritation, acute systemic toxicity, and pyrogenicity responses.
- Verification of Product Specifications, Distribution, Accelerated Shelf Life, Shelf Life: Ground truth is established by the device meeting its predefined engineering and product specifications and demonstrating performance in accordance with recognized industry standards (e.g., ISTA 3A).
- Usability: Ground truth is established by direct observation of user interaction, user feedback, and analysis of adverse events (e.g., needle sticks) or serious use errors during simulated use scenarios, evaluated against predefined safety and effectiveness criteria.
8. The Sample Size for the Training Set
- Not applicable. This device is a mechanical safety accessory, not an AI/ML algorithm. There is no "training set" in the context of machine learning. The device itself is designed, manufactured, and tested, not "trained."
9. How the Ground Truth for the Training Set was Established
- Not applicable, as there is no training set for an AI/ML algorithm.
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October 31, 2022
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Actuated Medical, Inc Douglas Dillon Director, Quality Assurance & Regulatory Affairs 310 Rolling Ridge Drive Bellefonte, Pennsylvania 16823
Re: K220890
Trade/Device Name: IO Needle Safety Sheath Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: September 28, 2022 Received: September 29, 2022
Dear Douglas Dillon:
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
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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,
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
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Indications for Use
510(k) Number (if known) K220890
Device Name IO Needle Safety Sheath (IOSS)
Indications for Use (Describe)
The IO Needle Safety Sheath (IOSS) is intended to assist in the safe removal of intraosseous needles.
IOSS is Indicated for Use with 25mm EZ-IO Vascular Access Needles and BD Luer-Lok 10mL Syringes.
| 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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310 Rolling Ridge Drive Bellefonte, PA 16823 + p (814) 355-0003 + f (814) 355–1532
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K 220890 510(k) SUMMARY
Applicant Information
Date Prepared: October 28, 2022
Name and Address: Actuated Medical, Inc. 320 Rolling Ridge Drive Bellefonte, PA 16823 Ph: (814) 355-0003 Fx: (814) 355-1523
Contact Person: Douglas R. Dillon Director, Quality Assurance and Regulatory Affairs Ph: (814) 355-0003 x107 Fx: (814) 355-1523 Email: Douglas.Dillon@actuatedmedical.com
Device Information
| Trade Name | IO Needle Safety Sheath (IOSS) |
|---|---|
| Common Name: | IO Needle Safety Sheath (IOSS) |
| Classification: | 21 C.F.R. §880.5570 |
| Classification Name: | Needle, Hypodermic, Single Lumen |
| Product Code: | FMI |
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Predicate Device
The legally marketed device to which substantial equivalence is being claimed:
| 510(k)Number | Trade Name | Submitter |
|---|---|---|
| K180395 | EZ-IO IntraosseousVascular Access System(EZ-IO) | Arrow International, Inc.(Subsidiary of Teleflex) |
Device Description
The IO Needle Safety Sheath (IOSS) is a single-use, non-sterile, antineedlestick accessory to assist in the removal of intraosseous (IO) needles. IOSS is placed around the syringe and IO needle prior to removal from the patient. It irreversibly captures the IO needle within the device upon removal from the patient; helping to prevent accidental needle sticks to the patient or user. There is tactile confirmation of capture, and the clear body of IOSS allows for visual confirmation that the IO needle is in Safe Mode.
Intended Use
IOSS is intended to assist in the safe removal of intraosseous needles.
Indications for Use
The IO Needle Safety Sheath (IOSS) is intended to assist in the safe removal of intraosseous needles. IOSS is indicated for use with 25mm and 45mm EZ-10® Vascular Access Needles and BD Luer-Lok™ 10 mL Syringe.
Technological Characteristics
Because IOSS is only used to remove the parent predicate device (EZ-IO) from the patient, substantial equivalence considerations are primarily focused on the removal of EZ-IO as compared to the removal of EZ-IO with IOSS. The contraindications, target population, and anatomical sites used are identical to the predicate device. Key differences between the predicate and IOSS include needle removal technique, required accessories, sterility, patient contact, and materials of construction.
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| Category | Predicate EZ-IO | Proposed IOSS Used asIndicated with PredicateDevice | Comparison |
|---|---|---|---|
| Indications forUse | For intraosseous accessanytime in which vascularaccess is difficult to obtainin emergent, urgent, ormedically necessary casesfor up to 24 hours. Insertionsites: ADULTS (≥22 yearsold): proximal humerus,proximal tibia, distal tibia.PEDIATRICS (≤21 yearsold): proximal humerus,proximal tibia, distal tibia,distal femur.Use of the device may beextended for up to 48 hourswhen alternate intravenousaccess is not available orreliably established.Insertion sites:ADULTS (≥22 years):proximal humerus, proximaltibia, distal tibia.PEDIATRICS (≥12 yearsthrough 21 years old):proximal humerus, proximaltibia, distal tibia, distalfemur. | The IO Needle SafetySheath (IOSS) is intendedto assist in the safe removalof intraosseous needles.IOSS is Indicated for Usewith 25 mm and 45 mm EZ-IO® Vascular AccessNeedles and BD Luer-Lok™ 10 mL Syringes. | Different -Indications forthe sameintended useand a subset ofthe availableneedle setsdoes not raisenew questionsof safety orefficacy. |
| Category | Predicate EZ-IO | Proposed IOSS Used asIndicated with PredicateDevice | Comparison |
| Needleremovaltechnique | Remove any extension setsand dressings.Attach a luer-lock syringe tothe hub of the catheter.While maintainingalignment of the needle andthe syringe, the syringe isrotated clockwise whilepulling straight up. Rockingor bending the catheterupon removal should beavoided. | Remove any extension setsand dressings.Attach a BD Luer-Lok 10mL Syringe to the hub ofthe catheter.Latch IOSS around thesyringe. Hold IOSS in placewith one hand.While maintainingalignment of the needle andthe syringe, the syringe isrotated clockwise whilepulling straight up until theEZ-IO hub locks in SafeMode. Rocking or bendingthe catheter upon removalshould be avoided. | Different -Adding the useof IOSS intothe removalprocess is adifference. Itdoes not raisenew questionsof safety orefficacy. |
| Disposal | Dispose of the catheter withthe syringe attached in anapproved sharps container. | Dispose of catheter with thesyringe attached andcovered by IOSSimmediately after use in anapproved sharps container. | Same |
| Requiredaccessories | Luer-lock syringe (notincluded) to use as handlefor removal of needle. | IOSS indicated only for onespecific syringe: BD Luer-Lok™ 10 mL Syringe (notincluded) to use as handlefor removal of needle. | Same |
| Contra-indications | · Fracture in target bone.· Previous, significantorthopedic procedure at thesite, prosthetic limb or joint.· IO access (or attemptedIO access) in targeted bonewithin past 48 hours.• Infection at the area ofinsertion.· Excessive tissue (severeobesity) and/or absence ofadequate anatomicallandmarks. | Unchanged | Same |
| Category | Predicate EZ-IO | Proposed IOSS Used asIndicated with PredicateDevice | Comparison |
| Targetpopulation | Adult and pediatric patientswho are in need of vascularaccess. | Unchanged | Same |
| Where used | Pre-hospitalIn hospitalAcute care | Unchanged | Same |
| Anatomicalsites used | Proximal HumerusProximal TibiaDistal TibiaDistal Femur (pediatricsonly) | Unchanged | Same |
| Needle/Cannuladesign | Sterile, single useHubs: coloredpolycarbonateStylet/catheter: StainlessSteelFaceted tipStandard luer connectionThree lengths:15 mm; 25 mm; 45 mmSize: 15 gauge (0.071", 1.8mm)Needle Cover:Polypropylene | Device has noneedle/cannula. | Different -IOSS assists inthe saferemovalintraosseousneedles. |
| Needle setquidelines | Available Needle Sets:15 mm: 3-39 kg25 mm: 3 kg or over45 mm: 40 kg or over | Indicated for Needle Sets:IOSS only indicated for the25 mm and 45 mm NeedleSets | Different -IOSS onlyindicated forthe 25 mm and45 mm NeedleSets due to 15mm Needledesign. |
| Depth control | Positioning marks at 5 cmand 10 cm apart to providevisual reference pointsTactile feedback for changeof pressure | Unchanged. | Same |
| Single usecomponents/accessories | EZ-IO Needle SetsEZ-Connect Extension SetEZ-IO Patient WristbandEZ-Stabilizer Dressing | BD Luer-Lok™ 10 mLSyringe | Different -IOSS onlyrequires asyringe for use. |
| Sterility | Sterile: Ethylene Oxide | IOSS is non-sterile. | Different -Patient contactfor IOSS doesnot requiresterilization. |
| Category | Predicate EZ-IO | Proposed IOSS Used asIndicated with PredicateDevice | Comparison |
| Shelf life | 4 Years | 5 years | Different -Additional yearof shelf lifedoes not raisenew questionsof safety orefficacy. |
| Bio-compatibility | Biocompatible materialsused (per ISO 10993-1prolonged contactduration). | Biocompatibility of IOSSestablished per ISO 10993-1 for limited durationsurface contact:Cytotoxicity, Sensitization,Irritation, Pyrogenicity, andSystemic Toxicity | Different -IOSS andPredicate bothmeetbiocompatibilityendpointsappropriate fortheir patientcontact. |
| Materials ofconstruction | Stainless steel catheter,polycarbonate and coloradditive hubs, andpolypropylene needlecover. | Clear, colorless, INEOS K-Resin KR01 styrenebutadiene block copolymer | Different -differentmaterials meetallrequirementsforbiocompatibilityand physicalproperties:raising no newquestions ofsafety orefficacy. |
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Non-Clinical Performance Data
The methods and performance data for evaluating the technological differences, the questions of safety and effectiveness, as well as IOSS integrity and compatibility with the predicate device (EZ-IO) include bench performance testing, usability testing, and biocompatibility testing.
Bench Performance Testing: Verification of Product Specification testing confirmed that the IO Needle Safety Sheath (IOSS) met all product specifications high temperature/humidity, and low temperature environmental conditions. Distribution testing conforming to ISTA 3A 2018 (FDA Recognition Number
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5-126) confirmed that IOSS met all product specifications and acceptance criteria after being exposed to shipping and transportation conditions. Accelerated Shelf Life testing confirmed that IOSS met all product specifications and acceptance criteria after exposure to conditions simulating a shelf life of up to 5 years.
| Test Performed | Test Description | StandardsOrganization andDesignation | Results |
|---|---|---|---|
| Biocompatibility | Final, finished devices tested forcytotoxicity, sensitization, irritation orintracutaneous reactivity, acutesystemic toxicity, and materialmediated pyrogenicity. | ISO 10993-12, 2021ISO 10993-5, 2009ISO 10993-10, 2010ISO 10993-23, 2021ISO 10993-11, 2017 | Pass |
| Verification ofProductSpecification | Verification of Product Specificationsafter exposure to ambient, hightemp/humidity, and low temperatureenvironmental conditions. | NA | Pass |
| Usability | A total of 500 uses by thirty (30)Users to assess whether theintended user population can useIOSS without encountering a needlestick, serious use errors, or problemsfor the intended use and expecteduse environment. | NA | Pass |
| Distribution | Confirmation of ProductSpecifications following exposure tosimulated distribution stress andconditions. | ISTA 3A 2018 | Pass |
| AcceleratedShelf Life | Confirmation of ProductSpecifications following exposureaccelerated conditions simulating ashelf life of one (1), three (3), and five(5) years. | NA | Pass |
| Shelf Life | Confirmation of ProductSpecifications following real-timeambient condition exposure for one(1), three (3), and five (5) years. | NA | Test on-going. |
Usability Testing: Human factors validation testing confirmed that the user population can safely and effectively use IOSS for the intended use in the expected use environment without encountering a needle stick, serious use errors, or other problems.
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Image /page/10/Picture/1 description: The image is an abstract design featuring a combination of geometric shapes and wavy lines. The color palette is dominated by shades of orange, with a lighter orange used for the wavy lines and some of the geometric shapes, creating a contrast against the darker orange background. The geometric shapes appear to be arranged in a grid-like pattern, adding a structured element to the design. The wavy lines overlay the geometric shapes, introducing a sense of movement and fluidity to the overall composition.
Biocompatibility Testing: IOSS is categorized as a limited duration surface device expected to normally contact intact skin, but which may incidentally contact breached or compromised skin. Cytotoxicity, sensitization, irritation, acute systemic toxicity, and material mediated pyrogenicity testing was conducted on IOSS in its final finished form. All tests confirmed the suitability of IOSS.
Conclusions
After evaluating IOSS for its intended use with EZ-IO (the predicate device), then identifying, evaluating, and mitigating the risks associated with both use and foreseeable misuse where practicable, and confirming the safety and effectiveness of the device was through worst-case testing, it is concluded that IOSS is as safe and effective as EZ-IO when used as indicated to remove EZ-IO 25 mm and 45 mm intraosseous needles.
§ 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).