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The ZOLL® Model 330 Multifunction Aspirator is a self-contained suction device designed for removing debris from a patient's airway or respiratory system, secretions, blood, vomitus, tissue (including bone), bodily fluids and infectious materials during surgery. Programmable intermittent gastrointestinal and abdominal wound drainage can also be performed with the device. It is suitable for use in pre-hospital, mass casualty and transport environments, including aeromedical. The Model 330 is only for use by or on the order of a physician.

The ZOLL Model 330 Multifunction Aspirator is a product based on the currently marketed Model 326/326M Aspirator (acquired by ZOLL Medical Corporation through an asset acquisition of Impact Instrumentation, Inc., reviewed and cleared under K951423). Similar to the currently marketed 326 Aspirator, the ZOLL 330 Aspirator is a small, durable, full-featured portable aspirator designed to operate in the hospital, prehospital, field hospital, mass casualty and during ground or air transport settings.

Like the predicate 326 Aspirator, the proposed 330 Aspirator is an electrically powered suction pump intended to remove debris from a patient's airway or respiratory system, secretions, blood, yomitus, surgical fluids, tissue (including bone), bodily fluids and infectious materials during surgery. Both the devices can also be used to perform programmable intermittent gastrointestinal and abdominal wound drainage.

Both Aspirators can be operated from an AC or DC external power source, or from an internal rechargeable battery system, and supports both aspiration modes: Continuous and Intermittent. The Continuous mode in the proposed 330 Aspirator is sub-divided into four procedure types: Surgical, Pharyngeal, Tracheal, and CASS (Continuous Aspiration of Subglottic Secretions). Each procedure has a pre-set pressure range under which the device can be operated. Additionally with the proposed device we have introduced the following functionality:

• . Start Menu Functionality: Start Menu functionality is developed that allows the user to select from a series of preconfigured options that are appropriate for different patient groups: adult, pediatric, the last device settings and a custom start configuration established by the user or their organization.
• SMART FLOW Functionality: The feature detects a drop in the measured vacuum level when the ● therapy is not being applied and in response allows the aspirator to reduce the applied vacuum thereby allowing quieter operation of the device in the continuous mode.
• . ALARMS: The 330 Aspirator offers a suite of visual alarm indicators by illuminating red, yellow and green LED lights, and audible alarm indicators, to alert the user about issues relating to external power or battery, environmental conditions that could affect device performance, and device selfcheck failures.

The provided document describes a 510(k) premarket notification for the ZOLL Model 330 Multifunction Aspirator. This device is a powered suction pump and the submission focuses on demonstrating its substantial equivalence to a predicate device (Model 326/326M Aspirator).

Here's an analysis of the acceptance criteria and supporting studies based on the provided text:

Key Takeaway: This submission primarily relies on non-clinical performance testing to demonstrate substantial equivalence, rather than clinical studies or extensive statistical evaluations of diagnostic performance. The device is a physical medical device, not an AI or imaging diagnostic tool, so the typical AI/ML-specific criteria requested in the prompt (like multi-reader studies, ground truth for training data, etc.) are not applicable to this document.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantified, pass/fail manner for the device's overall performance. Instead, it demonstrates compliance with recognized standards and verifies specific performance parameters through testing. The "reported device performance" is largely described by meeting these standards and verifying functional requirements.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: Not explicitly stated in terms of a "test set" for performance evaluation, as this is not a diagnostic device involving patient data samples. The testing described (software V&V, safety, EMC, usability) refers to engineering and functional tests on the device hardware and software. There is no information about a "test set" in the context of patient data.
• Data Provenance: Not applicable. The "data" here refers to test results from engineering and functional evaluations of the device, not patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

• Number of Experts & Qualifications: Not applicable. Ground truth, in the context of diagnostic AI/ML, refers to a definitive diagnosis or outcome. For a physical medical device like an aspirator, "ground truth" is established by engineering specifications, safety standards, and functional requirements. Expert review likely occurred in the design, testing, and regulatory submission process by engineers and regulatory specialists, but not in the sense of physicians establishing ground truth for a diagnostic test.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. No "test set" of cases requiring adjudication for diagnostic accuracy is present.

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

• MRMC Study: No. This is not an AI/ML diagnostic device, so a MRMC study is not relevant.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Standalone Performance: Not applicable. This is a physical aspirator device, not an algorithm. Its performance is inherent to its mechanical and electrical function.

7. The Type of Ground Truth Used

• Type of Ground Truth: For a physical medical device like the Model 330 Multifunction Aspirator, the "ground truth" for demonstrating performance and safety is derived from:
  • Engineering Specifications: The device must perform according to its design specifications (e.g., free flow rate, suction pressure range).
  • International Consensus Standards: Compliance with established safety (e.g., IEC 60601-1) and performance (e.g., ISO 10079-1 for suction equipment) standards serves as the ground truth for safety and baseline functionality.
  • Predicate Device Performance: The device's ability to operate with similar, or improved, functional characteristics compared to its legally marketed predicate device (Model 326/326M Aspirator) is a key "ground truth" for substantial equivalence.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This device does not employ machine learning or AI that requires a "training set" of data.

9. How the Ground Truth for the Training Set was Established

• Ground Truth for Training Set: Not applicable, as there is no training set for an AI/ML algorithm.

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