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510(k) Data Aggregation
(15 days)
The AIRO Suction Unit, Model AIRO-01, is a portable, battery-powered medical suction device intended for use in emergency airway management procedures by professional medical providers. It is intended for intermittent operation to remove secretions, such as blood or vomit, during airway management procedures and other procedures for which an intermittent suction medical device may be applicable. The device is indicated for the suctioning of adult patients.
The AIRO Suction Unit, Model AIRO-01, is a compact, handheld, portable battery-powered medical suction device intended for use in emergency airway management procedures by professional medical providers such as emergency medical technicians, paramedics, and hospital personnel. The device is not intended for contact with patient tissue during procedures. It is intended for intermittent operation to remove secretions, such as blood or vomit, during airway management procedures and other procedures for which an intermittent suction medical device may be applicable. The device is indicated for the suctioning of adult patients.
The provided FDA 510(k) clearance letter for the AIRO Suction Unit (AIRO-01) is for a powered suction pump. Such devices are typically evaluated based on their physical and functional performance rather than AI/ML algorithm performance.
Therefore, many of the requested categories related to AI/ML specific studies (like MRMC studies, sample sizes for AI training sets, ground truth establishment for AI, number of experts for ground truth, adjudication methods) are not applicable to this type of medical device submission.
Here's a breakdown of the available information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document states the device was tested to ISO 10079-1 and ISO 10079-4, and all applicable clauses were successfully executed, meeting the established criteria. However, the specific quantitative acceptance criteria and detailed performance results are not explicitly provided in the excerpt. We can infer the performance from the device description and the ISO standards it complies with.
| Acceptance Criterion (Inferred from ISO 10079-1:2015 and device description) | AIRO Suction Unit (AIRO-01) Reported Performance |
|---|---|
| Vacuum Pressure Range: | 20-550 mmHg |
| Low Vacuum Level (≤ 150 mmHg / ≤ 20 kPa) compliance: | Compliant (device achieves a continuous range of vacuum pressures from 20 mmHg) |
| Medium Vacuum Level (150 - 450 mmHg / 20 - 60 kPa) compliance: | Compliant (device achieves a continuous range of vacuum pressures between 150-450 mmHg) |
| High Vacuum Level (≥ 450 mmHg / ≥ 60 kPa) compliance: | Compliant (device achieves a continuous range of vacuum pressures up to 550 mmHg) |
| Low Flowrate Device (Free air flowrate < 20 LPM) compliance: | Achieves all vacuum levels while maintaining a low flowrate of less than 20 LPM (nominal airflow rate given as 0.75 LPM in comparison table, which is < 20 LPM) |
| Electrical Safety/Electromagnetic Compatibility (ES/EMC): | Tested to applicable standards (not specified which ones, but implied by ES/EMC testing mentioned) |
| Biocompatibility: | Tested to applicable standards (not specified which ones, but implied by biocompatibility testing mentioned) |
| Use-Life: | Tested to applicable standards (implied by Use-Life testing mentioned) |
| Reprocessing: | Tested to applicable standards (implied by reprocessing testing mentioned) |
| Software Verification & Validation (V&V): | Tested to applicable standards (implied by software V&V testing mentioned) |
| Packaging Integrity (ISTA standards): | Packaging is sufficient to maintain device functionality according to ISTA standards |
| Usability (Performance for target user group): | Results indicate the device performs adequately for the target user group (professional medical providers in emergency airway management) |
| Water Protection (IP rating): | IP33 (Identical to reference device TACVAC K153459, similar to predicate S-SCORT Jr Quickdraw Model 2400 K041154 which has IPX4) |
| Canister Capacity: | 500 mL (Same as reference device TACVAC K153459, different from predicate S-SCORT Jr Quickdraw Model 2400 K041154 which has 300 mL) |
| Compatibility with standard third-party disposable tubing/catheters: | Compatible with Standard Disposable Suction Tubing (9/32" ID x 36" L) and Standard Disposable Suction Catheters (e.g., Yankauer, DuCanto, others) – This is a functional requirement for usability and integration with existing medical practice. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified in the provided text for any of the non-clinical tests (e.g., ES/EMC, biocompatibility, use-life, reprocessing, software V&V, distribution, usability). For physical device testing, sample sizes are often determined by relevant standards (e.g., ISO, ASTM) and internal quality protocols.
- Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. These are typically internal corporate studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable for this type of device (powered suction pump). Ground truth is not established by expert consensus in the way it is for diagnostic AI devices. Performance is measured against engineering specifications and international standards (like ISO 10079-1).
For the usability study, it "employed users expected to operate the device." This implies medical professionals, but their number and specific qualifications are not detailed.
4. Adjudication Method for the Test Set
Not applicable for this type of device. Adjudication methods (like 2+1, 3+1) are relevant for subjective interpretations, often in diagnostic studies with human readers. Device performance is measured objectively against defined engineering and safety standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. MRMC studies are used to assess the impact of AI on human reader performance, typically in diagnostic imaging. This device is a physical medical instrument, not a diagnostic AI tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This device is a physical medical instrument, not an AI algorithm. While it has "software V&V" mentioned, this likely refers to embedded firmware controlling the physical function of the pump, not a diagnostic or decision-support algorithm.
7. Type of Ground Truth Used
Engineering Specifications and International Standards: The "ground truth" for this device's performance is compliance with established engineering specifications (e.g., vacuum pressure range, airflow rate, battery life) and recognized international standards such as ISO 10079-1 (for medical suction equipment), ISO 10079-4 (likely for specific aspects like safety or cleaning), and ISTA (for packaging validation).
8. Sample Size for the Training Set
Not applicable. This device is not an AI/ML system that requires a "training set" in the conventional sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no "training set" for an AI/ML algorithm in this context, the method for establishing its ground truth is irrelevant.
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