(58 days)
The TACVAC™ portable battery powered suction device is intended to provide a battery powered medical suction source to clear bodily fluids and particulate matter from a patient. The primary intended use is to clear the airway by removing bodily fluids (including blood, saliva, mucous, vomitus or other aspirant) and particulate matter (less than 0.100"/2.50mm in diameter). The typical use environment is a pre-hospital in the field setting, transport, hospital and other healthcare applications by trained health care providers (EMTs, nurses, doctors, first responders, etc.). The patient population includes adults.
The TACVAC™ portable battery powered suction device is designed for the same application and intended use as the SSCOR, Inc. Jr® Quickdraw, Model 2400 listed predicate device. The TACVAC™ portable battery powered suction device is capable of the same functions as have been provided by the predicate device referenced above. The TACVAC™ consist of both re-useable and disposable (one-time use components). The device is very light weight (8 ounces) and can be compactly stowed (7.25" x 7.38" x 3.0") by inserting the suction unit inside the bottle to reduce space required to carry the device to the point of injury. To assemble from the stowed condition the valve unit is simply removed (unscrewed from the bottle) and the suction unit is removed. Then the valve unit is replaced back on the bottle and the suction unit is inserted into the valve unit and locked in place by twisting to engage the bayonet fittings. The assembled size is 7.25" x 11.88" x 3.0". A third party suction tip is installed on the suction tubing and then the unit can be turned on/off with the power switch. Once the unit is switched on suction will build in the bottle. Suction is applied at the suction tip by depressing the suction button. The device must be kept upright during use to prevent the overfill float check valve from engaging and shutting off suction to the tip. Once the user has finished using the device on a particular patient the valve unit, bottle and suction tip are discarded. The Suction unit is to be cleaned and disinfected. New batteries are installed as required to ensure full suction and use time. A new valve unit, bottle and suction tip are needed for the next use of the device.
The provided text describes the 510(k) premarket notification for the "TACVAC™ Portable Battery Powered Suction Device." The submission establishes substantial equivalence to a predicate device rather than presenting a study to prove acceptance criteria for a novel device. Therefore, the information requested regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, which are typical for studies validating new algorithms or diagnostic tools, is not directly applicable in the context of this 510(k) submission.
However, based on the provided text, I can infer the "acceptance criteria" and "reported device performance" in the context of demonstrating substantial equivalence to the predicate device. These are primarily related to performance characteristics and safety standards.
Here's a breakdown of the information that can be extracted, framed to address your questions where possible:
Acceptance Criteria and Device Performance (in the context of Substantial Equivalence for a 510(k))
| Acceptance Criteria (Expected/Predicate Performance) | Reported Device Performance (TACVAC™) |
|---|---|
| Vacuum and Flow Rating | Employs substantially equivalent performance as the predicate device. |
| Operational Times | Similar operational times to the predicate device. |
| Environmental Ratings | Similar environmental ratings to the predicate device. |
| IPX4 Rating (Fluid Ingress Protection) | Maintains the same IPX4 rating as the predicate device. |
| Compliance with IEC 60601-1 | Verified compliance with IEC 60601-1 (General requirements for basic safety and essential performance). |
| Compliance with IEC 60601-1-2 | Verified compliance with IEC 60601-1-2 (Electromagnetic compatibility requirements and tests). |
| Compliance with ISO 10079-1 (Tests) | Performed mechanical strength (drop height), vibration and noise, means to prevent inadvertent contamination of the pump, fluid ingress protection, environmental (temperature and humidity), medium vacuum, pharyngeal suction (simulated vomitus), and minimum battery life tests. |
| Medium Vacuum Setting | Has a fixed vacuum setting (medium), while the predicate has two settings (high and low). |
| Pharyngeal Suction (Simulated Vomitus) | Has a reported longer 200mL simulated vomitus suction time compared to the predicate. |
| Size and Weight | Is smaller and lighter than the predicate. |
| Battery Type/Voltage | Uses a lower voltage Lithium-based battery compared to the predicate's higher voltage sealed lead-acid or alkaline battery. |
| Electrical Circuit Protection | Includes protection against fluid overflow and electrical circuit protection (with an additional reverse voltage protection circuit). |
Study Information (as inferable from a 510(k) submission focused on substantial equivalence)
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable in the traditional sense for this type of submission. Performance was evaluated based on device specifications and compliance with standards, not on a clinical test set of patients or data points. The "tests" mentioned are engineering and performance validation tests on the device itself.
- Data Provenance: Not applicable. The "data" comes from engineering tests conducted on the TACVAC™ device. No patient data (clinical or retrospective/prospective) is referenced.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. "Ground truth" in the clinical sense (e.g., expert consensus on medical images or pathology reports) is not relevant for this engineering-focused substantial equivalence submission. The "ground truth" here is compliance with established engineering standards and performance specifications, likely verified by engineers and quality control personnel.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This is typically for clinical data review, not device performance testing against engineering standards.
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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:
- No. This is a medical device (powered suction pump), not an AI/diagnostic software. MRMC studies are not relevant here.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a physical medical device; the concept of an "algorithm only" or "human-in-the-loop" performance is not applicable.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this submission are recognized national and international standards for safety and performance for medical devices (e.g., IEC 60601-1, IEC 60601-1-2, ISO 10079-1) and the performance specifications of the legally marketed predicate device.
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The sample size for the training set:
- Not applicable. This device does not involve machine learning or a "training set."
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How the ground truth for the training set was established:
- Not applicable.
In summary: The provided document is a 510(k) premarket notification for a medical device (a powered suction pump). Its purpose is to demonstrate that the new device, TACVAC™, is "substantially equivalent" to an already legally marketed predicate device. This is achieved primarily through engineering and performance testing to show compliance with relevant standards and comparable performance characteristics, rather than through clinical studies involving patient data, expert interpretations, or AI algorithm validation. The questions asked are more pertinent to diagnostic AI/software submissions.
§ 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.