(170 days)
Not Found
No
The device description and performance studies focus on mechanical function and manual operation, with no mention of AI or ML technologies.
Yes
The device is used for intraosseous access to administer drugs and fluids, which falls under therapeutic intervention to treat a patient's condition.
No
The device is used for obtaining intraosseous access for administration of drugs and fluids, not for diagnosing medical conditions.
No
The device description clearly outlines physical components including a disposable needle assembly and a reusable manually powered drill. It is a hardware device with mechanical action.
Based on the provided information, the SAM IO™ Intraosseous Access System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to provide access to the bone marrow for administering drugs and fluids when intravenous access is difficult or impossible. This is a procedure performed directly on a patient's body.
- Device Description: The device is a mechanical system for inserting a needle into bone. It does not involve the examination of specimens (like blood, urine, or tissue) outside of the body.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples or providing diagnostic information based on those samples.
IVD devices are specifically designed to perform tests on specimens taken from the human body to provide information for diagnosis, monitoring, or screening. The SAM IO™ system is a therapeutic access device, not a diagnostic one.
N/A
Intended Use / Indications for Use
The SAM IO™ Intraosseous Access System provides Intraosseous access in the proximal tibia, distal tibia and humeral head (proximal humerus) of adults and pediatic 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 (comma separated list FDA assigned to the subject device)
FMI
Device Description
The SAM IO™ Intraosseous Access System consists of a single use disposable intraosseous (IO) needle assembly (the SAM IO™ Needle Set) that connects to a reusable manually powered drill (the SAM™ 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
proximal tibia, distal tibia and humeral head (proximal humerus) of adults and pediatric patients, and the distal femur in pediatric patients
Indicated Patient Age Range
Adult and pediatric patients
Intended User / Care Setting
Hospitals, Clinics, Physicians, Military, Nurses, EMTs (Emergency Medical Technicians).
Emergency settings: Pre-hospital, In hospital, Acute care, Military
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: Performance bench testing was conducted to ensure that the SAM 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.
Non-clinical comparative testing was provided to ensure penetration capabilities were the same and testing per ISO standards ensures it meets the same standards as the predicate.
Simulated use: Simulated use results provided by SAM® Medical Products, Inc. support the conclusion that the proposed device is clinically safe for prescription use. Furthermore, SAM® Medical Products, Inc. conducted a risk analysis on the proposed system in accordance with ISO 14971:2007. All identified risks have been addressed through device design, verification 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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains 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.
November 21, 2019
SAM® Medical Products, Inc. % Michelle Lott Senior RA & QA Consultant Lean RAQA, LLC 12602 North Summerwind Drive Marana, Arizona 85658
Re: K191488
Trade/Device Name: SAM IO Intraosseous Access System Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: October 24, 2019 Received: October 28, 2019
Dear Michelle Lott:
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
1
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); 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 medical devices and radiation-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,
For Alan 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
510(k) Number (if known) K191488
Device Name SAM IOTM Intraosseous Access System
Indications for Use (Describe)
The SAM IO™ Intraosseous Access System provides Intraosseous access in the proximal tibia, distal tibia and humeral head (proximal humerus) of adults and pediatic 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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3
510(K) Summary: K191488
GENERAL INFORMATION
Submitted by:
| Owner's Name: | SAM® Medical Products, Inc. |
|---|---|
| Address: | 27350 SW 95th Ave, Suite 3038 |
| Wilsonville, OR 97070 USA | |
| Contact Person: | Jeff Lipps |
| Title: | Director of Quality Assurance and Regulatory Affairs |
| Tel: | +1 (503) 639-5474 |
| Fax: | +1 (503) 639-5425 |
| Email: | jeff.lipps@sammedical.com |
| Contact Person: | |
| Name: | Michelle Lott |
| Title: | Senior RA & QA Consultant at Lean RAQA, LLC |
| Tel: | +1 (520) 275-9838 |
| Email: | michelle@leanraqa.com |
| Date Prepared: | November 20, 2019 |
| Trade Name: | SAM 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: | EZ-IO® Intraosseous Infusion System, Vidacare Corporation (now owned by Teleflex, Inc. (K141117)). |
DEVICE DESCRIPTION:
The SAM IO™ Intraosseous Access System consists of a single use disposable intraosseous (IO) needle assembly (the SAM IO™ Needle Set) that connects to a reusable manually powered drill (the SAM™ 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
4
of drugs and fluids. Typical user profiles include Hospitals, Clinics, Physicians, Military, Nurses, EMTs (Emergency Medical Technicians).
INTENDED USE:
The SAM 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.
LABELING AND TECHNOLOGICAL CHARACTERISTICS COMPARISON:
As shown in Table 6-1 (see next page), the proposed SAM IO™ Intraosseous Access System has identical intended use and similar technology characteristics to the currently marketed EZ-10® Intraosseous Infusion System (K141117).
| Table 6-1: Comparison table | |||
|---|---|---|---|
| Proposed system | Predicate system | ||
| Device Proprietary | |||
| Name | SAM IO™ Intraosseous Access System | EZ-IO® Intraosseous Infusion System | |
| Manufacturer | SAM® Medical Products, Inc. | Vidacare Corporation | |
| (now owned by Teleflex, Inc.) | |||
| 510(k) | K191488 | K141117 | |
| 1. LABELING | |||
| Class. | Regulation | 21 CFR 880.5570 | Same |
| Product | |||
| Code | FMI | Same | |
| Class. Name | Needle, Hypodermic, Single lumen | Same | |
| Intended use | The SAM 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 EZ-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. | |||
| Indication | |||
| for use | Rx or OTC | Rx | Same |
| 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 | |||
| Not for sternal use | Same | ||
| Labels | Different labels for each needle size. Include | ||
| relevant symbols and warnings. Identify specification | |||
| for patient's weight. | Equivalent, predicate labeling contains appropriate | ||
| symbols and warnings. | |||
| Instructions for Use | |||
| (IFU) | Step-by-step procedure to establish IO access. One | ||
| (1) IFU document for the Needle Set & Accessories | |||
| and one (1) IFU document for the Driver. | Equivalent, IFU includes the same critical tasks and | ||
| only differs by information specific to the predicate | |||
| system. | |||
| 2. TECHNOLOGY | |||
| Use Environment | |||
| (Where used) | Emergency settings: | ||
| Pre-hospital, In hospital, Acute care, Military | Same | ||
| Anatomical sites used | Four (4) insertion sites | ||
| • Proximal tibia | |||
| • Distal tibia | |||
| • Humeral head (proximal humerus) | |||
| • Distal femur (pediatric patients only) | Same | ||
| Proposed system | Predicate system | ||
| 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 | System includes: | ||
| • Needle sets | |||
| • Extension Tubing Set | |||
| • 1-port Sharps Block | Same | ||
| 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 | Equivalent - Faceted, a patented cutting tip with a | |
| match ground cannula tip | |||
| Stylet use | Yes | Same | |
| IV lines connection | Standard Luer connection | Same | |
| Needle set guidelines | |||
| and corresponding | |||
| hubs colors | 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) | Same | ||
| Depth indicator | |||
| markings on cannula | • 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 | ||
| Shelf life | 12 months (1 year) | 4 years | |
| Sterility | |||
| Biocompatibility | Ethylene Oxide (EO), SAL 10-6 | ||
| Meets ISO 10993-1 for a device contacting | |||
| Tissue/Bone/Blood (Intraosseous) for a limited | |||
| duration (≤ 24h) | Same | ||
| Same | |||
| 2.b) Driver | |||
| Weight | ~75g | ~300g | |
| Dimensions | • Back handle to trigger: 80mm | ||
| • Top to bottom: 105mm | • Back handle to trigger: 70mm | ||
| • Top to bottom: 105mm | |||
| Design | The SAM IO™ Driver is a reusable manually | ||
| operated drill connected to a disposable IO needle | |||
| assembly. | |||
| Hand-held, cordless drilling device | The EZ-IO® Power Driver (which looks similar to a | ||
| cordless drill) consists of a reusable battery powered | |||
| rotational driver connected to a disposable IO needle | |||
| assembly. | |||
| Same | |||
| Mode of action | Upon manual activation, the drill penetrates through | ||
| the cortex of the bone to a preset depth within the | |||
| bone marrow. | Same | ||
| Proposed system | Predicate system | ||
| The driver then separates from the hub of the IO needle assembly, leaving the cannula securely seated in the bone. | Same | ||
| The trocar stylet that acts as the drill bit is then removed. | Same | ||
| Source of power | Manual | Sealed lithium battery not intended to be opened. | |
| Battery is not replaceable. | |||
| 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, medical grade silicone lubricant. | Injection molded rigid polymer (unknown material likely polycarbonate or ABS), thermoplastic elastomer, electromagnetic drive mechanism |
5
6
Discussion of Differences
Technological differences are mainly due to the fact that the proposed system includes a manually operated driver whereas the predicate includes a battery-powered driver and that the interface between the needle and the drilling device has a different shape (pentagonal) and a different type of attachment mechanism (magnetic vs. snap-in). In addition, there are differences in weight and dimensions of the drilling device. These differences were addressed through simulated use testing and non-clinical comparative testing.
In addition, the needle tip geometry is different. However, non-clinical comparative testing was provided to ensure penetration capabilities were the same and testing per ISO standards (See Table 6-2) ensures it meets the same standards as the predicate.
The differences identified do not raise different question of safety and effectiveness.
NON-CLINICAL TESTING
Performance (Bench) Testing: Performance bench testing was conducted to ensure that the SAM 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 SAM IO™ Intraosseous Access System.
7
| Performance Standards | ||
|---|---|---|
| Standard ID # | Title | Conclusion |
| ISO 80369-7 | ||
| (1st edition 2016-10-15) | Small-bore connectors for liquids and gases in healthcare applications - | |
| Part 7: Connectors for intravascular or hypodermic applications | Fulfilled | |
| (as per Argon's 510k K980196) | ||
| 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 A632-04 | ||
| (2004) | ||
| ASTM A313-13 | ||
| (2013) | Standard specification for Seamless and Welded Austenitic Stainless Steel Tubing (small-diameter) for general service | |
| Standard Specification for Stainless Steel Spring Wire | Fulfilled | |
| (as per CoC's) |
| Table 6-2: Summary of performance standards |
|---|
| Performance Standards |
Comparative testing: The functions of the subject system that are equivalent to the predicate system have been subjected to comparative testing to ensure that the subject system performs these functions without raising different questions of safety and effectiveness.
Simulated use: Simulated use results provided by SAM® Medical Products, Inc. support the conclusion that the proposed device is clinically safe for prescription use. Furthermore, SAM® Medical Products, Inc. conducted a risk analysis on the proposed system in accordance with ISO 14971:2007. All identified risks have been addressed through device design, verification 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:
| Other applicable standards | ||
|---|---|---|
| Standard ID # | Title | Conclusion |
| ISO 14971 | ||
| (2nd Edition 2007-03-01) | Medical Devices - Application of Risk Management to Medical Devices | Fulfilled |
| ISO 11135 | ||
| (2nd Edition 2014-07-15) | Sterilization of Health-Care Products - Ethylene Oxide - Requirements for | |
| The Development, Validation and Routine Control of a Sterilization Process | ||
| for Medical Devices | Passed-Fulfilled | |
| (as per Section 015, | ||
| Sterilization and Shelf Life) | ||
| ISO 10993-7 | ||
| (2nd Edition 2008-10-15) | Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide | |
| Sterilization Residuals | ||
| ISO 11607-2 | ||
| (1st Edition 2006-04-15) | Packaging for Terminally Sterilized Medical Devices - Part 2: Validation | |
| Requirements for Forming, Sealing and Assembly Processes | Passed-Fulfilled | |
| (use of pouch previously | ||
| validated) | ||
| ASTM F1886-16 | ||
| (2016) | Standard Test Method for Determining Integrity of Seals for Flexible | |
| Packaging by Visual Inspection | Passed-Fulfilled | |
| ASTM F88-15 | ||
| (2015) | Standard Test Method for Seal Strength of Flexible Barrier Materials | Passed-Fulfilled |
| ASTM F2096-11 | ||
| (2011) | Standard Test Method for Detecting Gross Leaks in Packaging by Internal | |
| Pressurization (Bubble Test) | Passed-Fulfilled | |
| ASTM F1980-16 | ||
| (2016) | Standard Guide for Accelerated Aging of Sterile Barrier Systems for | |
| Medical Devices | Passed-Fulfilled | |
| ASTM D4169-16 | ||
| (2016) | Standard Practice for Performance Testing of Shipping Containers and | |
| Systems | Passed-Fulfilled | |
| ISO 10993-1 | ||
| (5th Edition 2018-08) | Biological evaluation of medical devices-Part 1: Evaluation and testing | |
| within a risk management process | Fulfilled | |
| (as per Section 016, | ||
| Biocompatibility) |
Table 6-3: Summary of other applicable standards
8
Biocompatibility: The patient-contacting (direct/indirect fluid path) components of the SAM IO™ Intraosseous Access System, namely the SAM IO™ Needle Set Assembly and the SAM IO™ Extension Tubing Assembly, fulfil the requirements as set forth in:
-
ISO 10993: Biological evaluation of medical devices Part 1: Guidance on selection of tests. ●
Sterilization: The sterile component of the system (the SAM IO™ Needle Set & Accessories) is sterilized via ethylene oxide (EO) sterility to a Sterility to a Sterility Assurance Level (SAL) of 10 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(R)2012, Biological Evaluation of Medical Devices Part 7: . Ethylene Oxide Sterilization Residuals
Packaging: The sterilization, 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 SAM 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 SAM IO™ Intraosseous Access System is substantially equivalent to the EZ-10® Intraosseous Infusion System (K141117).