(23 days)
The Easycess Aspiration Pump is intended for general suction use in hospitals or clinics.
The Easycess Aspiration Pump is mainly composed of negative pressure suction pump host and Easycess Canister(Model: DC1000). The Easycess Aspiration Pump 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 110V and 220Vac versions. The pump is used with the available 1000ml canister / tubing set. The Easycess Aspiration Pump is provided in non-sterile; it is reusable and should be managed as a prescription device. The Easycess Canister is for single use only.
The Easycess Aspiration Pump is a medical device intended for general suction use in hospitals or clinics. The study provided in the document focuses on bench testing to demonstrate its substantial equivalence to a predicate device, the Penumbra Pump MAX (K122756).
Here's an analysis of the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Specification) | Reported Device Performance (Conclusion) |
|---|---|---|
| Appearance | The surface of the product is clear, the shell component has no burr sharp edge, the assembly splicing fixed firmly, no obvious gap, loose. | The appearance is suitable for intended clinical use. The subject device is equivalent to the predicate device. |
| Vacuum levels | 10s vacuum levels ≥60.0Kpa(18 inHg) | The vacuum level is suitable for intended clinical use and met requirements of ISO 10079-1 and 10079-4. The subject device is equivalent to the predicate device. |
| Free air flows | Free air flows ≥20L/min | The free air flow is suitable for intended clinical use and met requirements of ISO 10079-1 and 10079-4. The subject device is equivalent to the predicate device. |
| Final vacuum | -98.2Kpa±7 Kpa(-29 inHg±2inHg) | The final vacuum is suitable for intended clinical use. The subject device is equivalent to the predicate device. |
| Vacuum adjustment range | -98.2Kpa(-29 inHg) | The vacuum adjustment range is suitable for intended clinical use. The subject device is equivalent to the predicate device. |
| Liquid level | Clearly show the level of contents. | The liquid level is suitable for intended clinical use and met requirements of ISO 10079-1 and 10079-4. The subject device is equivalent to the predicate device. |
| Volume | Volume ≥1L | The volume is suitable for intended clinical use and met requirements of ISO 10079-1 and 10079-4. The subject device is equivalent to the predicate device. |
| Strength | Collection containers shall not implode, crack or permanently deform after 5 minutes of continuous pumping at atmospheric pressure of -95 Kpa. | The strength is suitable for intended clinical use and met requirements of ISO 10079-1 and 10079-4. The subject device is equivalent to the predicate device. |
| Vacuum level indicators | The full scale of analogue vacuum level indicators shall be ≤ 60 inHg. Analog displays shall have graduations ≥ 2mm apart with each graduation representing ≤ 5% of the full-scale value. | The vacuum level indicators are suitable for intended clinical use and met requirements of ISO 10079-1 and 10079-4. The subject device is equivalent to the predicate device. |
| Vacuum level indicators accuracy | Digital displays shall indicate the vacuum level at intervals ≤ 5% of the full-scale value. | The vacuum level indicators accuracy is suitable for intended clinical use and met requirements of ISO 10079-1 and 10079-4. The subject device is equivalent to the predicate device. |
| Operating position | When placed at any position on an incline at an Angle of (10±1) °with the horizontal plane, the equipment meets the requirements for use. | The operating position is suitable for intended clinical use and met requirements of ISO 10079-1 and 10079-4. The subject device is equivalent to the predicate device. |
| Overfill protection devices | Overfill protection devices shall not activate until at least 90% of the indicated maximum capacity of the collection container has been reached. When an overfill protection devices is activated, suction shall cease and prevent > 5ml of fluid from passing downstream of the overfill protection device within 2min. | The overfill protection devices are suitable for intended clinical use and met requirements of ISO 10079-1 and 10079-4. The subject device is equivalent to the predicate device. |
| Noise | The maximum A-weighted sound pressure level (steady or peak value) ≤70 dB(A). | The noise is suitable for intended clinical use and met requirements of ISO 10079-1 and 10079-4. The subject device is equivalent to the predicate device. |
| Pharyngeal suction equipment | Suction equipment intended for pharyngeal suction shall evacuate ≥200ml of simulated vomitus in not more than 10s. | The pharyngeal suction equipment is suitable for intended clinical use and met requirements of ISO 10079-1 and 10079-4. |
| Negative pressure values and flow performance requirements - Power interruption | The interruption and restoration of the power supply of the suction device should not cause any danger, and the change of the negative pressure value and flow rate should not exceed ±10% of the set value. The same performance requirement applies if the original power supply is replaced by another power supply. | The negative pressure values and flow performance requirements - Power interruption is suitable for intended clinical use and met requirements of ISO 10079-1. The subject device is equivalent to the predicate device. |
| Simulated use | The pump could provide stable vacuum in accompany with compatible devices. | Device performs as intended under simulated use conditions. The subject device is equivalent to the predicate device. |
| Connections | With the company's production of disposable suction pipe, and suitable for the vast majority of the market suction extension tube. | The connections are suitable for intended clinical use and met requirements of ISO 10079-1 and 10079-4. The subject device is equivalent to the predicate device. |
| Work cycle | Non-continuous duty [ 45min( 97.8%) ON/ 1 min (2.2%) OFF ] | The work cycle is suitable for intended clinical use. The subject device is equivalent to the predicate device. |
| Vacuum feedback lamp | When the device runs to vacuum less than -85 Kpa, the vacuum feedback light will turn on. | The negative pressure feedback lamp is suitable for intended clinical use. |
| Electrical Safety | Comply with IEC 60601-1:2020 | Comply with IEC 60601-1. |
| Electromagnetic Compatibility (EMC) | Comply with IEC 60601-1-2:2014+A1:2020 | Comply with IEC60601-1-2. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document describes bench testing, which typically does not involve patient data. The tests were performed on the Easycess Aspiration Pump itself to verify its physical and mechanical performance. Therefore, there is no specific "sample size" of patient data for a test set in the traditional sense, nor data provenance related to country of origin or retrospective/prospective collection as one would find in clinical studies.
The testing was conducted according to the FDA special control guidance document: Guidance Document for Powered Suction Pump 510(k)s, and the ISO 10079-1:2022 Medical suction equipment - Part 1: Electrically powered suction equipment.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
There is no mention of experts or their qualifications being used to establish a ground truth. Since this was bench testing of a hardware device's performance characteristics, the "ground truth" was the objective measurement of the device against established engineering and safety standards (e.g., ISO, IEC, FDA guidance).
4. Adjudication Method for the Test Set
As there were no human readers or interpretations involved in establishing a ground truth for a test set (it was objective bench testing), there was no adjudication method applied.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The study presented here is focused on the device's adherence to technical standards and its substantial equivalence based on bench testing.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The Easycess Aspiration Pump is a hardware medical device; it is not an algorithm-based device or an AI system. Therefore, the concept of a "standalone" algorithm performance study is not applicable.
7. The Type of Ground Truth Used
For this device, the "ground truth" for the bench testing was established by objective engineering specifications, regulatory standards (ISO 10079-1:2022, IEC 60601-1, IEC 60601-1-2), and FDA guidance documents for powered suction pumps. These are physical and mechanical performance metrics rather than clinical outcomes or expert interpretations.
8. The Sample Size for the Training Set
As this is a hardware medical device and not an AI/ML algorithm, there is no concept of a "training set" for an algorithm.
9. How the Ground Truth for the Training Set Was Established
Again, since there is no training set, this question is not applicable.
§ 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.