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510(k) Data Aggregation
(113 days)
SPARMAX ASPIRATOR, MODELS TC-2000V ND VC-701
The device is to be used to remove fluids from the treated tracheotomy patient airway.
SPARMAX Aspirator VC-701 and TC-2000V are the portable AC powered suction pumps. Each one consists of an on/off switch, a pump unit, a non detachable flexible power cord, collection jar, relief valve, pressure gauge, pressure adjustment knob, bacteria filter, suction tubing.
The provided text describes a 510(k) summary for the SPARMAX Aspirator VC-701 and TC-2000V. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a clinical study with detailed acceptance criteria and performance metrics typically seen for AI/ML-based devices.
Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable or not available in this type of submission.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Description of Criteria (as implied by the document) | Reported Device Performance |
|---|---|---|
| Intended Use | Device is used to remove fluids from the treated tracheotomy patient airway. | The device's intended use is identical to the predicate device. |
| Technological Characteristics | Similar in construction, function, safety, operating environmental conditions, and effectiveness to the predicate device. | "substantially equivalent to the predicate device" in these aspects. |
| Safety Features | Thermal switch for overheat/voltage lack protection. | SPARMAX includes a thermal switch that automatically shuts off the compressor when it becomes overheated or lacks voltage. |
| Electrical Safety & EMC | Compliance with relevant medical device electrical safety and electromagnetic compatibility standards. | Complies with UL 60601, EN 60601-1-2, UL 1450, and CAN/CSA-C22.2 No.68-92. |
2. Sample Size Used for the Test Set and Data Provenance
- Not applicable. This submission focuses on demonstrating substantial equivalence through comparison of technical characteristics and performance standards compliance, not on a clinical study involving a test set of patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. No ground truth for a test set was established in the context of this 510(k) submission.
4. Adjudication Method for the Test Set
- Not applicable. No test set requiring adjudication was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No. An MRMC study was not conducted as this is a traditional medical device (aspirator), not an AI/ML diagnostic tool requiring human reader performance evaluation.
6. If a Standalone Performance Study (algorithm only without human-in-the-loop performance) was Done
- Not applicable. This device is a powered suction pump, not an algorithm. Its performance is evaluated through engineering and safety standards, not standalone algorithmic performance.
7. The Type of Ground Truth Used
- Not applicable. For this type of device, "ground truth" typically refers to engineering specifications, performance standards, and comparison to the predicate device's established performance and safety profiles. There is no "expert consensus," "pathology," or "outcomes data" in the typical sense for proving the performance of an aspirator in a 510(k) application.
8. The Sample Size for the Training Set
- Not applicable. This device is a hardware product, not an AI/ML model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. No training set was used.
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