(189 days)
TWBM Pump is intended for general suction use in hospitals or clinics.
The TWBM Pump is intended for general suction use in hospitals or clinics where secretions, blood and other body fluids must be removed through the application of continuous negative pressure. The TWBM Canister is an accessory to the TWBM Pump and the removed body fluids are collected in it. The TWBM Pump is an AC powered oil-less positive displacement pump capable of delivering up to 29 inHg (737 mmHg) of vacuum to draw fluid and small particles. The TWBM Pump has a plastic casing fitted with a power (ON/OFF) button, one vacuum regulator, an analog pressure gauge and one sliding canister holder. The TWBM Canister is a preassembled 1000 mL canister including canister tubing fitted with a microbial filter at the distal end. The canister is fitted with a removable lid for fluid containment and an overflow protection device. The TWBM Canister should be placed in the in-built sliding canister holder, and connect the TWBM Canister with the TWBM Pump via the connectors of the canister tubing prior to use. Both, the TWBM Pump and the TWBM Canister, are provided non-sterile and are packaged separately.
The provided document describes the predicate comparison for the TWBM Pump and its substantial equivalence determination to the Penumbra Pump MAX™. It outlines acceptance criteria and test results for non-clinical performance and regulatory compliance.
Here's an analysis based on your request:
Acceptance Criteria and Reported Device Performance
| Attributes | Acceptance Criteria | Reported Device Performance (Result) | Study that Proves Acceptance Criteria Met |
|---|---|---|---|
| TWBM Pump | |||
| Compliance with ANSI/AAMI ES60601-1 and CAN/CSA C22.2 NO. 60601-1 | 100% Pass | YES (Passed) | Performance bench testing |
| Compliance with IEC 60601-1-2 | 100% Pass | YES (Passed) | Electromagnetic Compatibility testing |
| Compliance with ISO 10079-1 | 100% Pass | YES (Passed) | Performance bench testing |
| Compliance with IEC 60529 for IP Code | The requirement for the IP 21 marking should be met. | YES (Met) | Performance bench testing |
| TWBM Canister (Compliance with ISO 10079-1) | |||
| Design and Operational Requirements for TWBM Canister and its Components | 100% Pass | YES (Passed) | Performance bench testing |
Key takeaway: The document states that "All the test results from the performance testing passed the acceptance criteria set forth by the respective standards."
Further Information (Based on the provided document)
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Sample size used for the test set and the data provenance: The document does not specify the number of units (sample size) for the TWBM Pump and TWBM Canister that were subjected to the performance and EMC testing. The provenance of the data is from laboratory testing conducted by Taiwan Biomaterial Co., Ltd. (TWBM) and implied third-party testing for compliance standards. The document doesn't mention country of origin for data in terms of patient data, as this is a non-clinical submission. It is a non-clinical (bench) study rather than a study involving patient data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is a non-clinical (bench) study for device performance and regulatory compliance, not an AI/imaging device. Therefore, the concept of "ground truth" as established by medical experts (e.g., radiologists) for diagnostic accuracy is not applicable here. The "ground truth" in this context is defined by the technical specifications and performance requirements of the relevant industry standards (e.g., ISO 10079-1, IEC 60601-1-2). Testers/engineers conducted the tests against these pre-defined standards.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This refers to consensus among medical experts for image interpretation or diagnosis. For bench testing, results are objective (pass/fail against a standard).
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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 study focuses on the safety and performance of a physical medical device (suction pump) and its substantial equivalence to a predicate device through non-clinical testing, not an AI or imaging diagnostic device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an algorithm or AI device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this non-clinical study is the technical specifications and performance requirements outlined in the cited international and national standards (e.g., ISO 10079-1, ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 60529). The device's performance was measured against these engineering and safety benchmarks.
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The sample size for the training set: Not applicable. This is a non-clinical submission for a physical device, not an AI model that requires a training set.
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How the ground truth for the training set was established: Not applicable, as no training set was used.
§ 878.4780 Powered suction pump.
(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.