(75 days)
Thopaz+ is intended to be used for aspiration and removal of surgical fluids, tissue, gases, bodily fluids or infectious materials. Thopaz+ is indicated for all situations where chest drains are applied - especially for thoracic drainage in the pleural and mediastinal cavity in situations such as pneumothorax, after cardiac or thoracic surgery (post-operative), thorax injury, pleural effusion, pleural empyema or other related conditions. Thopaz+ is intended for use on patients in appropriate care settings.
The Medela® THOPAZ* suction 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® THOPAZ* are: User friendliness, patient mobility, simple cleaning and integrated safety features. A comprehensive range of accessories makes the Medela® THOPAZ* suction pump 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 for air and fluid being drained 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 pleural and mediastinal drainage are available.
This document describes a Special 510(k) submission for the Medela® THOPAZ+ Suction Pump, which is a modified version of the legally marketed Medela® THOPAZ (K130210). The submission focuses on demonstrating substantial equivalence to the predicate device and the safety and effectiveness of the modifications.
Based on the provided information, it's important to note that this is NOT a study demonstrating the performance of an AI/ML-based medical device against specific acceptance criteria for diagnostic or prognostic tasks. Instead, it's a 510(k) summary for a hardware medical device (a suction pump) that has undergone modifications. The acceptance criteria and performance data discussed relate to the functional and safety aspects of the device, rather than diagnostic accuracy.
Here's an analysis based on the provided text, addressing your points where applicable:
Acceptance Criteria and Device Performance
The document does not present a formal table of acceptance criteria and reported device performance in the way one would for a diagnostic algorithm (e.g., sensitivity, specificity, AUC). Instead, the "acceptance criteria" are implied by the verification and validation activities conducted for the device modifications, ensuring that the device's fundamental performance characteristics (suction capacity, vacuum, and safety) remain equivalent to the predicate device and that the new features function as intended without compromising safety or effectiveness.
The core performance claims are:
- Suction capacity: 5 liters per minute
- Maximum vacuum: up to -10 kPa (-75 mmHg)
- Classification: "low flow – low vacuum"
These are described as having the "same performance characteristics as the unmodified legally marketed device Medela® THOPAZ."
The document highlights several modifications and their justifications, which implicitly serve as "performance improvements" or "safety enhancements" that were verified.
| Acceptance Criteria (Implied) | Reported Device Performance (Summary of Modifications/Verification) |
|---|---|
| Proper fixation on hospital beds (Bed Holder Fixation) | The new bed holder is optimized to allow fixation of the pump on a wider variety of hospital bed types, ensuring continuous proper fixation. |
| Resistance to disinfection agents/fluids (Housing Sealing) | The device is now sealed to prevent disinfection agents from entering the housing, enhancing resistance against fluids. The IP classification remains the same, indicating no degradation in ingress protection. |
| Reliable fluid level detection (New PCB & Fluid Level Measurement) | A new level PCB, included in the housing, is used for capacitive fluid level detection through the device wall. This provides reliable fluid measurement independent of fluid consistency (e.g., blood, water, fatty liquids). This required minor changes to the assembly (power supply, digital communication, resistors/capacitors for communication speed) and firmware adaptations to display fluid amount parameters. The normal therapy function and negative pressure generation are not impacted. |
| Improved seal retention and visibility (Seal/O-ring) | The color of the seal (connecting canister to device) was changed to orange and its shape slightly adapted to prevent undesired removal and improve detection of a missing seal, ensuring a better fit and better visibility that helps detecting if the seal is missing. |
| Compatibility with a wider range of catheter sizes (New Tubing) | New tubing sizes are introduced, extending the range available for the legally marketed device to improve connection to large catheter sizes. |
| Ergonomics and usability (Carrying Strap, Display, Keypad) | The carrying strap was slightly adapted in diameter and wideness to complement an optimized handle. A new, slightly bigger color display (73.4x49mm active area) was included to accommodate fluid measurement parameters. The keypad was adapted due to display size but maintains the same number of buttons for smooth transition. An environment sensor was added to the keypad to adapt display brightness to environmental conditions. |
| Overall Safety and Effectiveness | The modifications do not alter the Indications for Use, fundamental scientific technology, or introduce new scientific technology. All changes were evaluated as part of risk management. Subsequent verification and validation activities for the applied changes were referenced and evidence is contained within the submission, demonstrating that the product is safe for the patient, user, and bystander and raises no new safety/effectiveness questions. The device retains its core performance of 5 L/min suction capacity and -10 kPa max vacuum ("low flow – low vacuum"). The device firmware controls, checks and regulates all main device functions. The user interface (except for fluid measurement) and regulation of negative pressure functions remain unchanged from the predicate. |
Here's an assessment of the other requested points, noting that many are not applicable or cannot be determined from this specific type of document (a 510(k) summary for a hardware device, not an AI study).
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Applicable in the AI/ML context: This document is about a hardware medical device (a suction pump). There is no "test set" in the context of evaluating an algorithm's diagnostic or predictive performance.
- For the device itself: The document refers to "Subsequent verification and validation activities for the applied changes" and "risk management" with "documented evidence" in the submission. These would involve testing of the physical device and its software (firmware) functions, likely under controlled laboratory conditions, to ensure functionality, safety, and performance (e.g., flow rates, vacuum stability, alarm functions, fluid level detection accuracy, user interface operation). The specific sample sizes for these engineering tests are not detailed in this summary. Data provenance is not mentioned.
-
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: There is no "ground truth" establishment by medical experts in the sense of labeling diagnostic images or clinical outcomes for an AI algorithm in this document. The "truth" for this device relates to its engineering specifications, safety standards, and functional performance. Experts involved would be engineers, human factors specialists, and potentially clinical users for usability studies, but their numbers and qualifications are not specified here.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable: No adjudication method for a "test set" in the AI/ML context is mentioned or relevant here.
-
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: This is a hardware device (a suction pump), not an AI-assisted diagnostic tool. No MRMC study was performed.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable: This is a hardware device. While it contains firmware (software running on the device), it's part of an electro-mechanical system. Its performance is always "human-in-the-loop" as it requires a clinician to operate it. There isn't an "algorithm only" performance in the sense of an AI model making independent decisions. The firmware controls pump functions and displays data to the user.
-
The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Not Applicable in the AI/ML diagnostic sense: The "ground truth" for this device's performance relates to engineering specifications, safety standards (e.g., ISO, IEC), and functional requirements met through verification and validation testing. For example, the "ground truth" for suction capacity would be a measured flow rate, for vacuum it would be a measured pressure, and for fluid level detection it would be the actual fluid volume present vs. what the sensor reports. This is based on objective physical measurements, not medical expert consensus for a diagnostic task.
-
The sample size for the training set:
- Not Applicable: As this is a hardware device with firmware, there isn't a "training set" in the machine learning sense for an AI model. The firmware is developed through traditional software engineering methods, including coding, debugging, and testing, not by training on a dataset.
-
How the ground truth for the training set was established:
- Not Applicable: No training set in the AI/ML sense exists for this 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.