Search Results

The Penumbra Pump MAX™ is intended for general suction use in hospitals or clinics.

The Penumbra Pump MAX™ is designed to provide general suction for use in hospitals or clinics. The Aspiration Pump operates using AC power and is designed to be portable if needed. The Aspiration Pump provides vacuum of up to 29 inHg. The pump is available in both 110Vac and 230Vac versions.

The front face of the Aspiration Pump has a display panel with a vacuum gauge, suction regulating valve, and power switch. The pump is used with the available 1000 ml canister / tubing set.

The Aspiration Pump connects to the canister reservoir with a tubing assembly (Penumbra Pump/Canister Tubing), which is provided as an accessory. The Penumbra Pump/Canister Tubing consists of a short tubing segment with an inline filter with connectors on each end to facilitate attachment to the Pump's vacuum port. The tubing is supplied pre-attached to the canister reservoir lid. The Penumbra Pump/Canister Tubing is provided non-sterile and is used outside the sterile field.

This document (K122756) describes the 510(k) summary for the Penumbra Pump MAX™, a general suction apparatus for hospitals or clinics. The submission focuses on demonstrating substantial equivalence to a predicate device, the Penumbra Aspiration Pump (K051758), through non-clinical performance testing.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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 describes "Pump Design Verification Testing Summary" through non-clinical data. It does not specify a "test set" in the context of clinical studies with human subjects. The testing described appears to be engineering verification and validation, likely conducted in a laboratory setting by the manufacturer (Penumbra, Inc. in Alameda, CA, USA). There is no information provided on sample sizes for these engineering tests in terms of the number of devices or components tested, nor does it specify if the data is retrospective or prospective in a clinical sense. The provenance of the data is implicitly from Penumbra, Inc.

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 to the type of non-clinical testing described. The "ground truth" for compliance with standards (IEC 60601-1, IEC 60601-1-2, ISO 10079-1) or performance attributes (e.g., uniform vacuum level, durability, quiet operation) would be established by relevant engineering standards, internal specifications, and measurement protocols, not by expert medical consensus.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not applicable as the document describes non-clinical engineering and performance testing, not a clinical study involving human interpretation or adjudication.

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

This information is not applicable. The device is a medical suction pump, not an AI-powered diagnostic or assistive technology. No MRMC study was conducted or is relevant for this type of device.

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

This information is not applicable. The Penumbra Pump MAX™ is a mechanical medical device, 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 based on:

• Compliance with international standards (IEC 60601-1, IEC 60601-1-2, ISO 10079-1).
• Adherence to design specifications and functional requirements (e.g., uniform vacuum level, durability, quiet operation, identifiable controls, usability, canister features).
  These are objective, measurable criteria established through engineering principles and regulatory requirements.

8. The sample size for the training set

This information is not applicable. There is no "training set" as this is not a machine learning or AI device. The development of the pump would involve engineering design, prototyping, and iterative testing.

9. How the ground truth for the training set was established

This information is not applicable as there is no training set mentioned or relevant for this type of device.

Ask a specific question about this device