(83 days)
The device is intended to be used for aspiration during flexible endoscopy.
The Cliq Aspirator model DV-300 is an AC-powered high-vacuum / low-flow suction unit used for endoscopic aspiration. The DV-300 creates a negative pressure (vacuum) that draws fluids through disposable tubing, and into a collection container. The fluids are trapped within the collection container for proper disposal. The device is comprised of a maintenance-free pump unit; power cord, on/off switch, pressure relief valve, pressure adjustment knob, pressure gauge, microbial filter, and intermediate tubing.
The Cliq Aspirator: model DV-300 requires 110-120 V and 60 Hz. It has Class II with Type BF applied part protection against electric shock. The DV-300 suction pump operates via a piston pump type, and has a maximum vacuum pressure of 620 mm Hg. The pump produces a flow rate of up to 18 Liters per minute.
The Cliq Aspirator Model DV-300 underwent performance testing to establish substantial equivalence to the predicate device, Olympus Suction Pump Model KV-5. The evaluation focused on electrical safety, electromagnetic compatibility, and overall performance, comparing key specifications between the two devices.
1. Acceptance Criteria and Reported Device Performance
| Criterion | Acceptance Criteria (Predicate Device: Olympus Suction Pump Model KV-5) | Reported Device Performance (Cliq Aspirator Model DV-300) | Meets Acceptance Criteria |
|---|---|---|---|
| Electrical Requirements | 100-120 V, 50/60 Hz | 110-120 V, 60 Hz | Yes |
| Protection against electric shock | Class I with Type BF applied part | Class II with Type BF Applied part | No (Different Class) |
| Maximum Vacuum Pressure | 638 mm Hg | 620 mm Hg | Yes (Comparable) |
| Vacuum Pump Type | Piston | Piston | Yes |
| Flow | Up to 20 L/min | Up to 18 L/min | Yes (Comparable) |
| Sound Level | Not known (for predicate) | 53 dBA | NA (No direct comparison) |
| Weight | 12.7 kg | 3.5 kg | No (Significant Difference) |
| Dimensions | 31 x 25.5 x 22 cm | 30 x 16.5 x 19 cm | Yes (Comparable) |
| Operating Environment (Temperature) | 10 - 40 °C | 0 - 40 °C | Yes (Wider Range) |
| Operating Environment (Humidity) | 0 - 95 % | 0 - 90 % | Yes (Comparable) |
| Operating Environment (Atm. Pressure) | 70 - 106 kPa | 70 - 106 kPa | Yes |
| Storage Environment (Temperature) | -40 - 70 °C | -20 - 50 °C | No (Narrows Range) |
| Storage Environment (Humidity) | 0 - 95 % | 0 - 95 % | Yes |
| Storage Environment (Atm. Pressure) | 23.5 - 106 kPa | 50 - 106 kPa | Yes (Comparable) |
| Filter | Microbial, hydrophobic | Microbial, hydrophobic | Yes |
| Suction Tube length | 2 m | 1.8 m | Yes (Comparable) |
| Filter Tube length | 900 mm | 250 mm | No (Significant Difference) |
| Power Cable | Yes | Yes | Yes |
| Suction Jar Volume | 2 liter (one liter optional) | 1.5 L or 2.4 L | Yes (Comparable) |
| Performance Standards adherence | EN IEC 60601-1, EN IEC 60601-1-2, EN ISO10079-1, UL 2601-1, CAN/CSA Std. No. C22.2 No.601.1-M90 | EN IEC 60601-1, EN IEC 60601-1-2, EN ISO10079-1 | Yes (subset met) |
Note on "Meets Acceptance Criteria": The statement "Yes (Comparable)" or "Yes (Wider Range)" indicates that the Cliq Aspirator's performance is either directly equivalent or within an acceptable range compared to the predicate device, supporting substantial equivalence. Differences in Class protection, weight, and filter tube length while noted, were evidently not deemed critical enough by the FDA to prevent substantial equivalence, given the overall conclusion. The "Not known" for predicate sound level means no direct comparison could be made for that specific metric.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state a specific "test set" sample size for a particular number of devices or clinical cases. The testing reported is related to general device performance, electrical safety, and electromagnetic compatibility standards. These types of tests typically involve a sample of manufactured devices (e.g., a few units from a production run) rather than patient data.
- Data Provenance: The testing was conducted in the context of regulatory submission for a device manufactured by Ding Hwa Co., Ltd in Taiwan. The tests are likely laboratory-based and performed by the manufacturer or a contracted testing facility to meet international standards. No information is provided regarding country of origin of data in terms of patient population or clinical studies, as this is not a clinical performance study.
- Retrospective or Prospective: Not applicable, as this is not a clinical study involving retrospective or prospective data collection from patients.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. The "ground truth" for this type of device (an aspirator) is its adherence to predefined engineering specifications and safety standards. This is objectively measured and verified according to scientific and engineering principles, not through expert consensus on clinical findings. Therefore, no experts in a clinical sense were used to establish ground truth for a test set.
4. Adjudication Method for the Test Set:
Not applicable. As noted above, the "tests" refer to measurements against engineering and safety standards, not clinical assessments requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
No. This document describes the regulatory submission for a medical device (an aspirator pump), not an AI/CAD system. Therefore, an MRMC comparative effectiveness study, which is relevant for evaluating human reader performance with and without AI assistance in interpretation tasks, was not performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
No. This is a physical, electromechanical device, not an algorithm or AI. Standalone performance as typically understood for AI was not applicable or performed.
7. The Type of Ground Truth Used:
The ground truth used was adherence to established international and national engineering standards for medical devices, specifically:
- EN ISO 10079-1:2009: Electrically powered suction equipment safety requirements.
- IEC/EN 60601-1-2:2007 (3rd Ed.): Electromagnetic Compatibility.
- IEC 60601-1: General basic safety and essential performance of medical electrical equipment.
- Performance Verification Testing: Testing against predefined functional specifications (e.g., maximum vacuum pressure, flow rate).
The comparison against the predicate device (Olympus Suction Pump Model KV-5) also served as a basis for evaluating substantial equivalence in performance characteristics.
8. The Sample Size for the Training Set:
Not applicable. This is not an AI/machine learning device that utilizes a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As this device does not use a training set, the establishment of ground truth for such a set is irrelevant.
§ 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.