(12 days)
The SmartSuction HARMONY device is an AC-powered suction device intended to be used as a suction source to replace wall suction in the hospital operating room to remove fluids and debris from the surgical field during surgical procedures.
The SmartSuction HARMONY device is not intended for endotracheal suction. The SmartSuction HARMONY device automatically adjusts suction up to 150 mmHg negative pressure when the suction tip is occluded. Do not use SmartSuction HARMONY device as a suction source in any procedure where 150 mmHg of suction could damage underlying tissue.
The SmartSuction HARMONY" device is an AC-powered, stand-alone device, designed to be used as a suction source to replace wall suction in the hospital operating room to remove fluids and debris from the surgical field during surgical procedures. The SmartSuction HARMONY device is designed to be used intra-operatively by trained operating room personnel under the direction of a physician. Therefore, it is to be used as a prescription medical device, which is indicated in the labeling as "Rx only".
The provided text describes a 510(k) summary for the Haemonetics SmartSuction HARMONY device. It outlines the device's intended use and performance testing. However, it does not contain detailed information regarding specific acceptance criteria, the methodology of a study proving those criteria, sample sizes for test or training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC comparative effectiveness studies. The primary focus of the document is on establishing substantial equivalence to a predicate device based on similar technological characteristics and intended use, supported by "bench" performance testing.
Here's a summary of the requested information based only on the provided text, acknowledging what is missing:
Acceptance Criteria and Device Performance
The document states that "Haemonetics has conducted testing to verify the electrical safety and performance characteristics as described in the Operation Manual." However, the specific acceptance criteria and the reported performance values are not detailed in the provided text.
| Acceptance Criteria (Not Detailed in Provided Text) | Reported Device Performance (Not Detailed in Provided Text) |
|---|---|
| Electrical Safety | Verified (details not provided) |
| Performance Characteristics (as described in Operation Manual) | Verified (details not provided) |
| Automatic Suction Adjustment Feature | Automatically adjusts suction up to 150 mmHg negative pressure when the suction tip is occluded. |
Note: The document asserts that "Verification and validation testing has been completed on the SmartSuction HARMONY and provide valid scientific evidence to demonstrate the devices are functionally equivalent" to the predicate device. This implies the device met its internal performance and safety criteria, but these criteria themselves are not listed.
Study Details
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Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided text.
- Data Provenance: The testing is referred to as "Performance Testing - Bench." This suggests laboratory or bench-top testing, not clinical data from patients. No country of origin is specified for data. The testing is implicitly prospective, as it's for a new product verification, but this is not explicitly stated.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable/Not specified. The testing described is "bench" performance testing, implying measurements against technical specifications rather than interpretations requiring expert consensus.
- Qualifications of Experts: Not applicable/Not specified.
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Adjudication method for the test set:
- Adjudication Method: Not applicable/Not specified. The nature of "bench" testing typically involves objective measurements rather than subjective assessments requiring adjudication.
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If a multi reader multi case (MRMC) comparative effectiveness study was done:
- MRMC Study: No, an MRMC comparative effectiveness study was not done. The document focuses on demonstrating substantial equivalence through "bench" performance testing and comparison of technological characteristics with a predicate device, not on assessing human reader performance with or without AI assistance.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable. The SmartSuction HARMONY is an AC-powered suction device, not an AI algorithm. Its performance is inherent to its electromechanical function.
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The type of ground truth used:
- Ground Truth: Not explicitly stated as "ground truth." For "bench" performance testing, the ground truth would typically be the established engineering specifications, safety standards, and functional requirements for the device. The device's ability to "automatically adjust suction up to 150 mmHg negative pressure when the suction tip is occluded" is a performance characteristic verified against a defined standard.
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The sample size for the training set:
- Sample Size: Not applicable. This is a hardware device, not an AI/machine learning algorithm that requires a training set.
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How the ground truth for the training set was established:
- Ground Truth Establishment: Not applicable, as there is no training set for this type of device.
§ 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.