(29 days)
The Boehringer Laboratories Suction Pump System is intended for the application of low flow suction for the removal of fluids, including irrigation fluids, body fluids and infectious materials.
The Boehringer Laboratories Suction Pump System consists of a powered suction pump for the application of low flow suction. A rigid disposable canister for the collection of fluids is included as an accessory.
This document is a 510(k) Summary for a medical device called the "Boehringer Laboratories Suction Pump System". It aims to demonstrate substantial equivalence to predicate devices, rather than establishing acceptance criteria and proving performance against them in a detailed study.
Therefore, many of the requested categories (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details, and training set information) are not applicable or not provided in this type of submission.
Here's what can be extracted from the provided text:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as quantifiable metrics. The device is deemed substantially equivalent based on similarity to predicate devices.
- Reported Device Performance: Not quantified. The submission states "Areas of similarity include performance parameters, control mechanisms, power source, canister for use with pumps and dimensions" when comparing to predicates.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable/Not provided. This type of 510(k) submission for this device does not typically involve a clinical "test set" in the way a diagnostic imaging or AI device would. It relies on demonstrating similarity to already approved predicate devices.
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)
- Not applicable/Not provided. No "ground truth" establishment in the context of a clinical study is described for this device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided.
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
- Not applicable/Not provided. This is a suction pump, not an AI or diagnostic imaging device that would typically undergo MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable/Not provided. This is a hardware device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable/Not provided.
8. The sample size for the training set
- Not applicable/Not provided. This is a hardware device, not a machine learning model.
9. How the ground truth for the training set was established
- Not applicable/Not provided.
§ 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.