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The DV-300 is intended for general suction use in hospitals or clinics.

The DV-300 is a portable AC suction pump capable of delivering 24.4 inHg of negative pressure (vacuum) to draw fluids and small particles through tubing and into a disposable collection canister, where the suctioned fluids and particles are trapped for proper disposal. The device is comprised of a maintenance-free pump unit, a power cord, an on/off switch, a pressure relief valve and pressure adjustment knob, an analog pressure gauge, a microbial filter, intermediate tubing, and a disposable collection canister (≥ 800 ml) with overflow protection.

The DV-300 requires an AC input voltage of 110-120V 60Hz. Housed in ABS plastic, the DV-300 has an IP22 ingress protection rating; and, as a Class II (double-insulated) electrical appliance, the unit affords Type BF applied part protection against electric shock.

The DV-300 must only be used on the order of a physician.

This document describes the Cliq Aspirator DV-300, a powered suction pump, seeking 510(k) clearance. The focus of the document is on the device's substantial equivalence to a predicate device and its performance and safety testing.

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

The document explicitly states that "Full test reports can be found in Section 16 of this submission." However, Section 16 is not provided in the given text. Therefore, the sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective) cannot be determined from the provided excerpt.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the given document. The acceptance criteria largely relate to technical specifications and physical performance of the device and its components, rather than diagnostic accuracy that would typically require expert ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not provided in the given document. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, which are not detailed here for the performance tests.

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 is not applicable as the device (Cliq Aspirator DV-300) is a powered suction pump, not an AI or imaging device that would involve human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This is not applicable as the device is mechanical, not an algorithm. The reported performance is standalone with respect to the device's physical attributes and functionality.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for the performance tests appears to be based on engineering and physical measurements, compliance with international standards (IEC, ISO), and functional assessments against predefined technical criteria. For usability-related criteria, it would likely be based on internal testing and possibly user feedback, but the specific methodologies are not detailed.

8. The sample size for the training set:

This is not applicable as the device is a physical medical device (suction pump), not a machine learning model that requires a "training set."

9. How the ground truth for the training set was established:

This is not applicable for the same reason as above.

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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

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.

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Intended Use: AS-XXXX Suction Pump is intended to be used to remove bodily fluids from a patient's airvay or respiratory system.

The AS-XXXX (FAMILY SERIES) suction pump is a portable AC-powered suction pump. The AS-XXXX (FAMILY SERIES) suction pump creates a negative pressure (vacuum) that draws fluids through a disposable suction catheter that is connected by suction tubing to a collection container. The suctioned fluids are then trapped in the collection container for proper disposal. The device must only be used on the order of a physician. If practiced outside of the hospital setting, the care giver must be trained by a certified healthcare professional and the training must be recorded and documented. The AS-XXXX (FAMILY SERIES) suction pump consists of an on/off switch, a pump unit, a power cord, a collection container, relief valve, pressure adjustment knob, pressure gauge, microbial filter, long intermediate tubing, short intermediate tubing, and suction tubing. Disposable suction catheters are not packaged with this device and must be purchased separately.

The provided text describes the acceptance criteria and the study for the Ding Hwa AS-XXXX (Family Series) Suction Pump.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

The text explicitly states: "Ding Hwa AS-XXXX Suction Pump is substantially equivalent and meets the same acceptance criteria as the predicate device, EMG Suction Unit SUA01-AXX 510(k)112421. Non-clinical performance testing includes IEC 60601-1, 3rd Ed. MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE, IEC 60601-1-2: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility and ISO 10079-1 (2009): Medical suction equipment -- Part 1: Electrically powered suction equipment -- Safety requirements. All results of the testing met acceptance criteria." |

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document refers to "non-clinical performance testing" and the results meeting "acceptance criteria," but does not detail the methodology, sample sizes, or data provenance for these tests beyond citing the standards. This device is a hardware product (suction pump), not an AI device, so typical AI study parameters like "test set" and "data provenance" often don't apply in the same way.

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 for this type of medical device (a suction pump) and is not provided in the document. The "ground truth" for a suction pump would be its adherence to established performance and safety standards, not expert consensus on diagnostic images or other data typically associated with AI.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable for this type of medical device and is not provided in the document.

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 information is not applicable for this type of medical device (suction pump). MRMC studies are typically for medical imaging diagnostics or similar AI-assisted interpretation, which is not relevant here.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable for this type of medical device. The device is a physical pump, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance is established through compliance with recognized international and national standards for medical electrical equipment and suction equipment, specifically:

• IEC 60601-1, 3rd Ed. (General Requirements for Basic Safety and Essential Performance)
• IEC 60601-1-2 (Electromagnetic compatibility)
• ISO 10079-1 (2009): Medical suction equipment -- Part 1: Electrically powered suction equipment -- Safety requirements.

The device also based its "ground truth" on substantial equivalence to a predicate device (EMG Suction Unit, Model SUA01-AXX Series 510(k)112421), implying its performance matches that of an already cleared device.

8. The sample size for the training set

This information is not applicable for this type of medical device. "Training set" is a concept related to machine learning and AI, not mechanical medical devices like a suction pump.

9. How the ground truth for the training set was established

This information is not applicable for this type of medical device.

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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.

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.

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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

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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