(214 days)
SonoMSK anesthesia conduction needles enhanced for ultrasound visibility are intended for the transient delivery of anesthetics to provide regional anesthesia and analgesia.
The subject device, the SonoMSK needle is a single-use anesthesia conducting needle intended for for the transient delivery of anesthetics to provide regional anesthesia and analgesia.
The SonoMSK needle is intended for use under ultrasound guidance. Visibility under ultrasound is enhanced by CornerStone reflectors as cleared by FDA in several Premarket Notification Submissions.
The SonoMSK needle is equipped with an injection tube. The distal connection of the tube is equipped with a LUER Connector according to ISO 80369-7.
The device in focus is a single use device and has an intended time of use up to 24 hours acc. EO-residuals acc. DIN EN ISO 10993-7. The standard time of use is less than 60 minutes.
The SonoMSK cannulas are not for intrathecal use.
The SonoMSK cannulas are produced at PAJUNK® GmbH Medizintechnologie in Geisingen, Germany.
Based on the provided FDA 510(k) Clearance Letter for SonoMSK, here's a detailed description of the acceptance criteria and the study proving the device meets them:
Disclaimer: This document is a 510(k) Summary, not the full submission. Therefore, it focuses on demonstrating "substantial equivalence" to a predicate device, rather than proving novel performance claims directly against established acceptance criteria for a new type of device. The acceptance criteria described below are primarily related to meeting established international standards for similar devices and ensuring equivalence to the predicate. The "study" largely consists of performance testing against these standards and validation of manufacturing processes (sterilization, packaging, shelf life).
Acceptance Criteria and Device Performance for SonoMSK
The SonoMSK device, as per this 510(k) submission, demonstrates substantial equivalence to its predicate device (SonoTAP) by meeting a series of performance and safety standards, particularly concerning its materials, manufacturing processes (sterilization, packaging), and device characteristics.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily defined by compliance with specific sections of recognized international standards for hypodermic needles and connectors. The reported device performance is a "Passed" status for each tested section, indicating compliance with the respective standard's requirements.
| Acceptance Criteria (Standard Section) | Device Performance | Notes |
|---|---|---|
| ISO 7864: Sterile hypodermic needles for single use - Requirements and test methods | ||
| 4.3 Cleanliness | Passed | Ensures the needle is free from debris and contaminants. |
| 4.4 Limits for acidity or alkalinity | Passed | Verifies the pH neutrality of the needle, crucial for patient safety. |
| 4.5 Limits for extractable metals | Passed | Guarantees that no harmful levels of metals leach from the device. |
| 4.10 Needle Tube | Passed | Assesses the integrity and specifications of the needle tubing itself. |
| 4.11 Needle point | Passed | Evaluates the sharpness and integrity of the needle tip. |
| 4.12 Bond between hub and needle tube | Passed | Confirms the strength and stability of the connection between the needle and its hub. |
| 4.13 Patency of lumen | Passed | Ensures the needle's internal passageway is clear and unobstructed for fluid delivery. |
| ISO 9626: Stainless steel needle tubing for manufacture of medical devices | ||
| 5.2 Surface finish and visual appearance | Passed | Verifies the acceptable finish and absence of visible defects. |
| 5.3 Cleanliness | Passed | Confirms the cleanliness of the tubing material prior to assembly. |
| 5.4 Limits for acidity and alkalinity | Passed | Ensures the tubing material is pH neutral. |
| 5.5 Size designation | Passed | Confirms accurate sizing (e.g., gauge) of the needle tubing. |
| 5.6 Dimensions | Passed | Verifies the tubing meets specified dimensional tolerances. |
| 5.7 Sample size | Passed | (Indicates proper sampling for testing, not a performance criterion itself.) |
| 5.8 Stiffness | Passed | Measures the needle's resistance to bending. |
| 5.9 Resistance to breakage | Passed | Assesses the needle's structural integrity against fracture. |
| 5.10 Resistance to corrosion | Passed | Checks the material's durability and resistance to degradation from bodily fluids or other environmental factors. |
| ISO 80369-7: Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications | ||
| 7.1 Fluid Leakage | Passed | Ensures the LUER connection prevents fluid escape. |
| 7.2 Air Leakage | Passed | Ensures the LUER connection prevents air ingress/egress. |
| 7.3 Stress Cracking | Passed | Evaluates the hub's resistance to cracking under stress. |
| 7.4 Separation Axial Load | Passed | Tests the force required to pull apart the connection. |
| 7.5 Unscrewing | Passed | Assesses the connection's resistance to accidental loosening. |
| 7.6 Overriding | Passed | Checks that connectors do not bypass intended engagement. |
| Biocompatibility | Complies with ISO 10993-series; meets FDA guidance. | Confirms biological safety; no specific pass/fail values listed, but overall compliance. |
| Sterility Assurance Level (SAL) | 10⁻⁶ | Validated according to ISO 11135-1 (Overkill Approach). |
| Ethylene Oxide (EO) and Ethylene Chlorhydrine (ECH) Residuals | ≤ 25 ppm (25µg/g/device) | Complies with ISO 10993-7. |
| Shelf Life | 60 months (5 years) | Validated based on sterility and performance testing; no decrease in performance or sterile barrier efficiency after 5 years. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the numerical sample sizes for each specific test (e.g., "n=X needles for cleanliness testing"). However, it indicates that testing was performed "on a regular basis as well as type tests performed after design transfer" and "using process most challenging worst case devices."
- Test Set Sample Size: Not explicitly stated for each test, but implied to be sufficient for compliance with the referenced ISO standards. For shelf-life testing, "process most challenging worst case devices" were used.
- Data Provenance: The device is manufactured in Geisingen, Germany by PAJUNK GmbH Medizintechnologie. Sterilization is performed at Sterigenics Germany GmbH (Wiesbaden, Germany) and HA2 Medizintechnik GmbH (Halberstadt, Germany). The testing itself would have been conducted by the manufacturer or accredited labs in support of the submission, likely within Germany. The data is retrospective, as it covers tests completed before the 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This submission does not involve clinical data or "ground truth" established by expert review in the sense of image interpretation or diagnostic accuracy. The "ground truth" here is adherence to engineering and safety standards (e.g., ISO, component specifications). Compliance is determined by objective measurements against these standards, not subjective expert consensus.
4. Adjudication Method for the Test Set
Not applicable. As noted above, the basis for "ground truth" is objective measurement against specified international standards, not subjective assessment requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. The device is an anesthesia conduction needle, not an AI-powered diagnostic imaging tool. The submission focuses on demonstrating substantial equivalence in physical characteristics, biocompatibility, sterilization, and basic performance parameters to a predicate device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
Not applicable. SonoMSK is a physical medical device (anesthesia needle), not a software algorithm.
7. The Type of Ground Truth Used
The "ground truth" used is defined by the objective requirements and test methods outlined in the cited international standards:
- ISO 7864 (Sterile hypodermic needles for single use)
- ISO 9626 (Stainless steel needle tubing)
- ISO 80369-7 (Small-bore connectors for intravascular or hypodermic applications)
- ISO 10993-series (Biological evaluation of medical devices)
- ISO 11135-1 (Sterilization of health care products - Ethylene oxide)
These standards specify measurable parameters (e.g., dimensions, force, pH limits, sterility levels, residual limits) that the device must meet.
8. The Sample Size for the Training Set
Not applicable. SonoMSK is a physical medical device, not an AI algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a physical device.
§ 868.5150 Anesthesia conduction needle.
(a)
Identification. An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.(b)
Classification. Class II (performance standards).