(158 days)
The device is to be used to remove fluids from the treated tracheotomy patient airway.
The predicate devices and the subject device have the same technological characteristics. Those devices are intended to be used to remove fluids from the treated tracheotomy patient airway. It creates a negative pressure (vacuum) that draws the fluids through disposable tubing that is connected to a collection jar. The fluids are trapped in the collection jar for the proper disposal. The devices are for use on the order of a physician only. If practiced out of the hospital, the care giver has to be trained and recorded.
The predicate devices and the subject device 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 major differences between the predicate devices and the subject device are the capacities and dimensions.
Based on the provided text, here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance:
The document describes the device, the Cliq Aspirator, DV-300, and compares its performance characteristics to two predicate devices (SPARMAX Aspirator TC-2000V and VC-701), both manufactured by Ding Hwa Co., Ltd. The acceptance criteria are implicitly defined by these performance characteristics, and the "reported device performance" refers to the values listed for the subject device.
| Performance Characteristic | Predicate Device 1 (TC-2000V) | Predicate Device 2 (VC-701) | Acceptance Criteria (Implicit) | Reported Device Performance (Cliq Aspirator DV-300) |
|---|---|---|---|---|
| Sound level | 32 LPM | > 16 LPM | Air Flow Rate > 16 LPM (as per predicate 2) | > 18 LPM |
| Electrical requirements | 110-120 VAC, 60Hz, 1.2A(max) | 110-120 VAC, 60Hz, 0.9A(max) | N/A (Comparison only) | 110-120 VAC, 60Hz, 0.5A(max) |
| Size (LWH) (mm) | 380165240 | 340155210 | N/A (Comparison only) | 300165190 |
| Weight | 5.2kg | 4.25kg | N/A (Comparison only) | 3.5 kg |
| Collection jar | 1800c.c. | 800c.c. | N/A (Comparison only) | 800c.c. |
| Other shared characteristics (Implicit acceptance criteria: "Same" as predicate, meaning meets predicate's criteria) | ||||
| Intended Use | Same | Same | To remove fluids from treated tracheotomy patient airway. | Same |
| Collection tubing Length / material | 180cm / PVC | 180cm/ PVC | "Same" (180cm / PVC) | Same |
| Connection tubing length / material | 400mm / Silicon | 400mm / Silicon | "Same" (400mm / Silicon) | Same |
| Internal battery | None | None | "Same" (None) | Same |
| Adaptor | None | None | "Same" (None) | Same |
| Bacteria filter | Appointed | Appointed | "Same" (Appointed) | Same |
| Thermal switch | Appointed | Appointed | "Same" (Appointed) | Same |
| Operating temp. | 0 ~ 40°C | 0 ~ 40°C | "Same" (0 ~ 40°C) | Same |
| Operating relative humidity | 0 ~ 95% | 0 ~ 95% | "Same" (0 ~ 95%) | Same |
| Storage & transport temp | -40°C ~ 70°C | -40°C ~ 70°C | "Same" (-40°C ~ 70°C) | Same |
| Storage & transport humidity | 0 ~ 95% | 0 ~ 95% | "Same" (0 ~ 95%) | Same |
| Where used | Hospital | Hospital | "Same" (Hospital) | Same |
| Standards complied | IEC 60601-1-2, UL 60601, CAN/CSA-C22.2 No.68~92, UL 1450 | IEC 60601-1-2, UL 60601, CAN/CSA-C22.2 No.68~92, UL 1450 | Compliance with relevant medical electrical equipment and suction standards. | IEC 60601-1-2:2007, IEC 60601-1:2005 +C1:2006+C2:2007, ISO 10079-1:2009, IEC 60601-1-11:2010 |
The study proving the device meets these criteria is a substantial equivalence comparison to legally marketed predicate devices. The document explicitly states: "The major difference between the subject device and the predicate devices is the electrical power. The subject device has a less electrical power than the predicate devices. This leads to the differences of the sound levels, maximum vacuum levels, air flow rates, sizes, weights, and the collection jars. The differences are not related to the safety and effectiveness."
This statement, combined with the detailed comparison table, implies that the manufacturer performed tests on the Cliq Aspirator DV-300 to determine its specifications (sound level, vacuum, air flow rate, etc.) and compared these specifications to those of the predicate devices. The conclusion of the 510(k) summary is that the new device "does not raise any safety and effectiveness compared to the predicate devices, thus the subject device is substantially equivalent to the predicate devices."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a sample size for a "test set" in the context of clinical or performance data from human/patient cases. This 510(k) summary describes a comparison of device specifications and compliance with recognized standards, not a clinical trial with a patient test set. The data provenance is based on engineering specifications and compliance testing, likely conducted by the manufacturer (Ding Hwa Co., Ltd. in Taiwan). It's a technical comparison, not a clinical data comparison.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable and not provided in the document. The "ground truth" here is the engineering specifications and safety/performance standards. These are established through recognized industry standards (e.g., IEC, ISO, UL, CSA) and the technical expertise of the device manufacturer's engineers, rather than through expert clinical review of a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as there is no "test set" in the sense of patient data requiring adjudication in this 510(k) summary. The comparison is based on technical specifications and standard compliance, which are typically verified through engineering tests and documentation.
5. 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
This document describes a medical device (an aspirator), not an AI-powered diagnostic tool or image analysis system. Therefore, an MRMC comparative effectiveness study involving human readers or AI assistance is not applicable and was not done.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical, powered medical suction pump, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context is based on engineering specifications and compliance with recognized national and international safety and performance standards. The manufacturer compared the subject device's technical characteristics (sound level, vacuum, airflow, etc.) and its adherence to standards like IEC 60601-1-2, IEC 60601-1, ISO 10079-1, and IEC 60601-1-11, to established values and predicate devices.
8. The sample size for the training set
This is not applicable. This document describes a physical medical device submission, not a machine learning or AI model that requires a training set.
9. How the ground truth for the training set was established
This is not applicable as there is no training set for this 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.