(176 days)
The Medela THOPAZ Suction Pump is indicated for aspiration and removal of surgical fluids, tissue, gases, bodily fluids or infectious materials from a patient's respiratory support system (after surgery).
Generally the Medela THOPAZ is intended to be used in all situations where chest drains are applied - especially for thoracic drainage and in situations such as pneumothorax, after surgery (post operative), thorax injury, pleura effusion, pleuryempyem or other related conditions.
The Medela® THOPAZ pump is an innovative secretion aspirator intended to be used for thoracic drainage. Its well-proven membrane system guarantees maximum suction performance and quiet, dependable operation. Additional advantages of the Medela® THO-PAZ are: user friendliness, patient mobility, simple cleaning and integrated safety features. A comprehensive range of accessories makes the Medela® THOPAZ ideally suited for thoracic drainage while mobilizing the patient.
The Medela® THOPAZ suction pump is an AC/DC powered, maintenance-free aspirator which incorporates a DC-motor with membrane aggregate power actuation in its housing. A user friendly MMI (man machine interface) guides the user through first installation, change of settings, use, data transfer and alarm handling.
The Medela® THOPAZ suction pump has an electronic measuring and monitoring system with optical and acoustic status display. The device is a dry system, which means that no fluids are necessary for operation. Important information about the course of therapy is displayed digitally and as graphics in the display. These data can be transferred to a PC upon completion of the therapy.
The Medela® THOPAZ suction pump has a suction capacity of 5 liters per minute and a maximum vacuum up to -10 kPa (-75 mmHg). The pump is marked "low flow - low vacuum".
A variety of reusable and disposable accessories for thoracic drainage are available.
The provided text, K080212 for the Medela® THOPAZ Suction Pump, is a 510(k) summary for a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a performance study with detailed acceptance criteria and supporting research in the way a clinical trial for a novel drug or a complex AI diagnostic system might.
Therefore, many of the requested sections about explicit acceptance criteria, detailed study designs, sample sizes, ground truth establishment, and multi-reader comparative studies are not directly applicable or inferable from this type of regulatory document.
Here's an attempt to address your request based on the available information:
Acceptance Criteria and Device Performance Study for Medela® THOPAZ Suction Pump (K080212)
1. Table of Acceptance Criteria and Reported Device Performance
Based on the 510(k) summary, the primary "acceptance criteria" for this device are its performance characteristics and intended use being substantially equivalent to its predicate devices. The reported device performance is presented in terms of its specifications and how they align with the predicate.
| Acceptance Criteria (Implied for Substantial Equivalence to Predicate) | Reported Medela® THOPAZ Device Performance |
|---|---|
| Intended Use: For aspiration and removal of surgical fluids, tissue, gases, bodily fluids or infectious materials from a patient's respiratory support system (after surgery), especially for thoracic drainage in conditions like pneumothorax, post-operative, thorax injury, pleura effusion, pleuryempyem. | Identical Intended Use: The Medela® THOPAZ Suction Pump is indicated for aspiration and removal of surgical fluids, tissue, gases, bodily fluids or infectious materials from a patient's respiratory support system (after surgery). Generally intended for all situations where chest drains are applied – especially for thoracic drainage and in situations such as pneumothorax, after surgery (post operative), thorax injury, pleura effusion, pleuryempyem or other related conditions. |
| Technological Characteristics: Similar pump mechanism (e.g., membrane system), user interface, monitoring capabilities to predicate devices. | Similar Technological Characteristics: Incorporates a DC-motor with membrane aggregate power actuation. Features a user-friendly MMI (man machine interface) and an electronic measuring and monitoring system with optical and acoustic status display. The device is a "dry system." Digital and graphical display of therapy course data, transferable to PC. Stated to have "identical technology like other marketed devices" and that differences are "marginal and state of the art today." |
| Performance Data: Suction capacity, maximum vacuum, and flow rate comparable to predicate devices. | Specifics provided: Suction capacity of 5 liters per minute. Maximum vacuum up to -10 kPa (-75 mmHg). Described as "low flow – low vacuum." The document explicitly states, "The Medela® THOPAZ has the same performance characteristics as the predicate devices." |
| Safety and Effectiveness: Demonstrate that new device is as safe and effective as predicate devices. | Conclusion: "There are no differences in performance or technology which significantly affect the safety and effectiveness of the device or the application (thoracic drainage)." "proven that the proposed Medela® THOPAZ powered suction pump is substantially equivalent, safe and effective for the intended use." |
2. Sample Size Used for the Test Set and Data Provenance
This is a 510(k) premarket notification, which primarily relies on comparison to predicate devices, not typically extensive clinical trials with "test sets" in the conventional sense of an AI or diagnostic study.
- Sample Size for Test Set: Not applicable or not described in this document. The submission focuses on demonstrating equivalence through comparison of design, specifications, and performance to predicate devices (Medela® Vario 8/18/ci Suction Pumps, K061205, and Medela® Dominant 35 c/i Suction Pump, K043544).
- Data Provenance: Not applicable in the context of a "test set" for a performance study. Any data supporting the device's technical specifications would typically come from internal engineering testing and validation based on design inputs, rather than external clinical data used for a diagnostic assessment.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. This type of submission does not involve a "ground truth" established by experts for a test set in the way a diagnostic study would. The safety and effectiveness are established by demonstrating substantial equivalence to already cleared devices.
4. Adjudication Method for the Test Set
Not applicable. No "test set" requiring adjudication by multiple experts is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size.
Not applicable. MRMC studies are typically performed for diagnostic imaging devices or AI systems where human reader performance is being evaluated with and without AI assistance. This document is for a powered suction pump.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done.
Not applicable. This device is a physical medical pump, not an algorithm.
7. The Type of Ground Truth Used
Not applicable in the context of a diagnostic "ground truth." The "ground truth" in this submission is the established safety and effectiveness of the predicate devices, against which the new device is compared. Its performance characteristics (suction capacity, vacuum) are objective measurements.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI device, so there is no "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable for the same reason as above.
§ 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.