(112 days)
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
| Acceptance Criteria (from predicate device) | Reported Device Performance (Ding Hwa AS-XXXX Suction Pump) |
|---|---|
| Substantially equivalent to and meets the same acceptance criteria as the predicate device (EMG Suction Unit SUA01-AXX 510(k)112421). | The Ding Hwa AS-XXXX Suction Pump is stated to be "substantially equivalent and meets the same acceptance criteria as the predicate device." |
| Compliance with IEC 60601-1, 3rd Ed. (General Requirements for Basic Safety and Essential Performance) | "All results of the testing met acceptance criteria." |
| Compliance with IEC 60601-1-2 (Collateral standard: Electromagnetic compatibility) | "All results of the testing met acceptance criteria." |
| Compliance with ISO 10079-1 (2009): Medical suction equipment -- Part 1: Electrically powered suction equipment -- Safety requirements. | "All results of the testing met acceptance criteria." |
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.
§ 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.