(170 days)
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.
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.
This document is a 510(k) Premarket Notification from the FDA regarding the SAM IO™ Intraosseous Access System, dated November 21, 2019. It primarily focuses on demonstrating substantial equivalence to a predicate device (EZ-IO® Intraosseous Infusion System, K141117) through non-clinical performance and comparative testing. It explicitly states that no clinical testing was performed.
Therefore, many of the requested details related to "clinical study" and "human readers" cannot be extracted as they are not present in this document.
Here's a breakdown of the requested information based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not present a formal table of "acceptance criteria" alongside specific "reported device performance" in a quantitative manner as typically seen in a clinical study. Instead, it lists various ISO and ASTM standards to which the device was tested and states whether it "Passed-Fulfilled" or "Fulfilled." The acceptance criteria for these tests are implicitly the requirements of the respective standards.
Here's a summary derived from the "NON-CLINICAL TESTING" section and Table 6-2:
| Acceptance Criteria (Implied by Standard) | Reported Device Performance |
|---|---|
| Needle/Cannula Performance: | |
| - Connectors for intravascular/hypodermic applications (ISO 80369-7) | Fulfilled (as per Argon's 510k K980196) |
| - Sharps injury protection features (ISO 23908) | Passed-Fulfilled |
| - Requirements/test methods for sterile hypodermic needles (ISO 7864) | Passed-Fulfilled |
| - Stainless steel needle tubing requirements (ISO 9626) | Passed-Fulfilled |
| - General requirements for intravascular catheters (ISO 10555-1) | Fulfilled (2X EO Exposure prior to testing) |
| - Seamless and Welded Austenitic Stainless Steel Tubing (ASTM A632-04) | Fulfilled (as per CoC's) |
| - Stainless Steel Spring Wire (ASTM A313-13) | Fulfilled (as per CoC's) |
| System Functionality/Safety: | |
| - Applicability of Risk Management (ISO 14971) | Fulfilled (All identified risks addressed through device design, verification, or documentation) |
| - Sterilization process validation (ISO 11135, ANSI/AAMI/ISO 11135) | Passed-Fulfilled (Sterility Assurance Level (SAL) of 10^-6 assured) |
| - Ethylene oxide sterilization residuals (ISO 10993-7, AAMI/ANSI/ISO 10993-7) | (Conclusion stated under ISO 11135: "Passed-Fulfilled") |
| - Packaging validation (ISO 11607-2) | Passed-Fulfilled (use of pouch previously validated) |
| - Seal integrity for flexible packaging (ASTM F1886-16) | Passed-Fulfilled |
| - Seal strength of flexible barrier materials (ASTM F88-15) | Passed-Fulfilled |
| - Detecting gross leaks in packaging (ASTM F2096-11) | Passed-Fulfilled |
| - Accelerated aging of sterile barrier systems (ASTM F1980-16) | Passed-Fulfilled |
| - Performance testing of shipping containers/systems (ASTM D4169-16) | Passed-Fulfilled |
| - Biological evaluation of medical devices (ISO 10993-1) | Fulfilled (patient-contacting components meet requirements for limited duration tissue/bone/blood contact) |
| - Penetration capabilities (comparative to predicate) | Ensured through non-clinical comparative testing. |
| - Time to establish IO access in in-vitro model | Less than 10 seconds (Same as predicate) |
| - Simulated use testing (addressing technological differences like manual vs. battery driver, interface shape, attachment mechanism, weight, dimensions) | Supports conclusion that device is clinically safe for prescription use; differences do not raise different questions of safety and effectiveness. |
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 primarily refers to "non-clinical testing" including "bench testing" and "simulated use testing." It does not specify sample sizes (e.g., number of devices tested on a given bench test) or data provenance (country of origin), nor does it categorize the tests as retrospective or prospective in the clinical sense. These would typically be detailed in the full test reports referenced by the 510(k) submission, not necessarily in the summary document provided.
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 as no clinical studies with expert-established ground truth were performed. The "ground truth" for non-clinical tests is based on adherence to engineering standards and specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical studies requiring expert adjudication were performed.
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
Not applicable. This device is an intraosseous access system, not an AI diagnostic tool involving human readers or interpretation of medical images. No MRMC study was mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a mechanical system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical testing, the "ground truth" is established by the specifications and requirements of the referenced ISO and ASTM engineering and biocompatibility standards. For simulated use, the "ground truth" is that the device functions as intended and safely meets its objectives in a simulated environment, without raising new questions of safety or effectiveness compared to the predicate.
8. The sample size for the training set
Not applicable. This document is for a mechanical medical device, not an AI or machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as no training set (for an AI/ML model) was used.
§ 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).