(86 days)
The DeVilbiss Suction Unit is used to remove fluids from the airway or respiratory support system and infectious materials from wounds. Configurations of the device will be intended for the home, institutional, and field/transport environments. The device is for use only on the order of a physcian or other lincensed practitioner (e.g. EMT-field use).
The DeVilbiss Suction Unit is a portable AC/DC powered suction pump. It consists of (depending on configuration) a pump unit, collection bottle, relief valve, vacuum gage, bacteria filter, suction tubing, internal battery, and an AC to DC adapter. The device is designed and manufactured to comply with UL 2601-1 and/or CAN/CSA-C22.2 No. 601.1 M90 safety standards.
The manufacturer, Sunrise Medical HHG Inc., states that the DeVilbiss Suction Unit will meet the performance standards per ISO 10079-1:1991, "Medical Suction Equipment", which covers aspects such as vacuum level, flow, construction, life test, and sound level. This standard itself outlines the acceptance criteria for these parameters.
1. Table of Acceptance Criteria and Reported Device Performance:
Since the provided text states the device will meet the performance standards per ISO 10079-1:1991 without providing specific numeric values for the device's performance, the table will reflect the general nature of these criteria as described in the standard.
| Acceptance Criteria (per ISO 10079-1:1991) | Reported Device Performance (per 510(k) Summary) |
|---|---|
| Vacuum Level Requirements | Device "will meet performance standards per ISO 10079-1:1991" |
| Flow Rate Requirements | Device "will meet performance standards per ISO 10079-1:1991" |
| Construction Requirements | Device "will meet performance standards per ISO 10079-1:1991" |
| Life Test Requirements | Device "will meet performance standards per ISO 10079-1:1991" |
| Sound Level Requirements | Device "will meet performance standards per ISO 10079-1:1991" |
2. Sample Size Used for the Test Set and Data Provenance:
The provided 510(k) summary does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It simply states that "Performance Testing" was conducted to confirm compliance with ISO 10079-1:1991.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not provided in the 510(k) summary. The performance testing described relates to engineering standards rather than clinical evaluation requiring expert ground truth establishment.
4. Adjudication Method for the Test Set:
This information is not applicable and not provided. The testing relates to objective engineering measurements against a standard, not subjective clinical assessments requiring adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. The 510(k) pertains to a non-diagnostic medical device (suction pump) and its performance against engineering standards, not a diagnostic algorithm or image analysis system. Therefore, the concept of human readers improving with AI assistance is not relevant.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
Yes, in a sense. The "Performance Testing" described is analogous to a standalone study for the device's physical and functional characteristics. The device (algorithm only, if considering its operational mechanics as an "algorithm") was tested independently against the engineering standard ISO 10079-1:1991. Human-in-the-loop performance is not a relevant concept for a suction pump's primary performance criteria.
7. The Type of Ground Truth Used:
The ground truth used for the performance testing of the DeVilbiss Suction Unit is the objective performance specifications and requirements outlined in the international standard ISO 10079-1:1991, "Medical Suction Equipment." This standard defines measurable targets for vacuum level, flow rate, construction integrity, operational life, and sound levels.
8. The Sample Size for the Training Set:
This information is not applicable and not provided. Suction pumps are not typically developed using "training sets" in the context of machine learning or AI. Their design and manufacturing are based on engineering principles and iterative development/testing, not data-driven machine learning.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable. As stated above, a "training set" with established ground truth, as understood in AI/ML, is not relevant for the development and testing of a medical suction pump, which relies on established engineering and safety standards.
§ 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.