(154 days)
Enivo™ is indicated for use to remove surgical and bodily fluids from a closed wound for hematoma and seroma prophylaxis following plastic surgery or other general surgeries where large flaps are formed.
Enivo™ is a surgical drainage system intended for the removal of surgical and bodily fluids from a closed wound. The system can be used in both home and healthcare environments. The system includes two primary components: - A vacuum device unit that includes a single-use, portable, and battery-powered vacuum device that provides continuous operation for up to 30 days and a disposable exudate reservoir. - a removable silicone drainage catheter
The provided document is a 510(k) summary for the Enivo™ device, which is a powered suction pump. It outlines the device's intended use and compares it to a predicate device (SOMAVAC Device, K222856) to establish substantial equivalence.
Here's an analysis of the acceptance criteria and supporting studies based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table with explicit acceptance criteria (e.g., minimum vacuum pressure, maximum flow rate) and corresponding measured device performance values. Instead, it lists various types of non-clinical tests that were conducted to demonstrate that "the device performs as intended" and "no new types of risk to the patent have been introduced by these differences." Without specific criteria, it's impossible to create such a table.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document lists only non-clinical (bench) testing. Therefore, there is no "test set" in the context of patient data (e.g., diagnostic images, clinical samples), nor is there data provenance related to patient demographics or study design (retrospective/prospective). The tests listed are primarily engineering and performance evaluations.
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 question is not applicable. The studies conducted are non-clinical engineering and performance tests, not studies requiring expert interpretation of patient data to establish ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable. There is no "test set" in the context of patient data that would require an adjudication method.
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 question is not applicable. The Enivo™ device is a powered suction pump, not an AI-assisted diagnostic or therapeutic device. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The Enivo™ device is a hardware device; it does not involve algorithms or AI for standalone performance evaluation in this context.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests conducted, the "ground truth" would be established by:
- Voluntary Standards: Compliance with recognized standards like IEC 60601-1, ISO 10993-1, ISO 20697, ASTM F1929, etc.
- Engineering Specifications: Internal design specifications for vacuum pressure, flow rate, battery life, mechanical strength, alarm thresholds, etc.
- Test Method Requirements: The specifications and procedures defined in the various ASTM and ISO standards for package integrity, sterilization, biocompatibility, etc.
8. The sample size for the training set
This question is not applicable. The Enivo™ device is not an AI/machine learning device, so there is no concept of a "training set" in this submission.
9. How the ground truth for the training set was established
This question is not applicable as there is no training set mentioned or implied for this device.
Summary of Acceptance Criteria and Supporting Studies (Based on available information):
Due to the nature of the device (a powered suction pump) and the 510(k) submission type, the acceptance criteria are based on compliance with recognized consensus standards and internal engineering performance specifications rather than clinical performance metrics typically seen for diagnostic or AI-powered devices.
The document lists a comprehensive set of non-clinical tests to demonstrate substantial equivalence by showing that the device meets safety and performance requirements and does not introduce new risks compared to the predicate device. However, specific numerical acceptance criteria and reported values for each test are not detailed in this summary.
In essence, the "acceptance criteria" can be inferred as "compliance with the listed standards and satisfactory performance per internal specifications," and the "study that proves the device meets the acceptance criteria" is the entirety of the non-clinical testing performed.
§ 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.