FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The CONMED Aer Defense™ Smoke Evacuator is designed to remove smoke, aerosols and mitigate odors produced by surgical smoke during electrosurgical procedures.

Device Description

The CONMED Aer Defense™ Smoke Evacuator has been designed with a high suction, high flow rate, two-stage thru flow vacuum motor. Its motor is used to draw the surgical smoke from the surgical site, through the vacuum tubing and into the CONMED Aer Defense™ Smoke Evacuator's filter where the surgical smoke is processed by a series of filtration stages. A single disposable filter is used to simplify the installation and removal during filter changes.

AI/ML Overview

The CONMED® Aer Defense™ Smoke Evacuator's acceptance criteria are based on its substantial equivalence to predicate devices (Porta Plumesafe™ 601 Smoke Evacuation System, K924732 and the Smoke Evacuation section of the ConMed Integrated Service Manager SM40SE, K053464) in terms of design, composition, function, performance, and safety.

Here's an analysis of the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Technological Characteristics
Filter Efficiency	Filter efficiency of 99.9995% for particle sizes of 0.12um or greater for ULPA grade filter (identical to predicate filters).	Met: "The FilterOne™ is an Ultra Low Penetration Air (ULPA) grade with carbon filter that has a filter efficiency of 99.9995% for particle sizes of 0.12um or greater. These characteristics are identical to the predicate filters."
Filter Life	Substantially equivalent filter life to predicate devices (predicate: 8 hrs maximum).	Met: "Bench testing has shown that the filter life for the Aer Defense™ Smoke Evacuator is substantially equivalent to the predicate filters based on bench testing." (Aer Defense: 35 hrs in Lap Mode, 10 hrs at maximum flow in Normal Mode).
Suction Flow Rate	Substantially equivalent to predicate flow range (predicate: 20 LPM in Normal Mode and 34 CFM in Boost Mode).	Met: "The maximum suction flow rate for the Aer Defense™ Smoke Evacuator ranges from a maximum 20 LPM in Laparoscopic Mode to 25 CFM in Normal Mode and is substantially equivalent to the flow range of 20 LPM in Normal Mode and 34 CFM in Boost Mode for the predicate devices."
Performance Characteristics
Electrical Verification	Meets operational mode and electrical design requirements; substantially equivalent to predicate devices.	Met: "Electrical Verification testing showed that the Aer Defense™ Smoke Evacuator met its operational mode and electrical design requirements as specified in the test protocol. Test results indicate that the Aer Defense™ Smoke Evacuator is substantially equivalent to the predicate devices."
Mechanical Verification	Meets mechanical design requirements; substantially equivalent to predicate devices.	Met: "Mechanical Verification testing has shown that the Aer Defense™ Smoke Evacuator has met its mechanical design requirements as specified in the protocol. Test results indicate that the Aer Defense™ Smoke Evacuator is substantially equivalent to the predicate devices."
Software Verification	Meets operational mode and software design requirements; substantially equivalent to predicate devices.	Met: "Software Verification testing has shown that the Aer Defense™ Smoke Evacuator has met the operational mode and software design requirements as specified in the protocol. Test results indicate that the Aer Defense™ Smoke Evacuator is substantially equivalent to the predicate devices."
Validation Testing	Meets operational mode and validation requirements; substantially equivalent to predicate devices.	Met: "Validation testing has shown that the Aer Defense™ Smoke Evacuator has met its operational mode and validation requirements. Test results indicate that the Aer Defense™ Smoke Evacuator is substantially equivalent to the predicate devices."
Electrical Safety	Meets standards of IEC 60601-1-1, IEC 60601-1-2, and UL 60601-1; substantially equivalent to predicate devices.	Met: "Electrical Safety testing that was conducted for the Aer Defense™ Smoke Evacuator was done according to IEC 60601-1-1, IEC 60601-1-2, and UL 60601-1. This testing indicates that the electrical safety for the Aer Defense™ Smoke Evacuator is substantially equivalent to the predicate devices."
Modes of Operation
Normal Mode	Substantially equivalent to predicate devices.	Met: "The Normal Mode is substantially equivalent to the Normal Mode and Boost Mode in predicate devices, K924732 and K053464."
Laparoscopic Mode	Substantially equivalent to predicate devices.	Met: "The Laparoscopic Mode is substantially equivalent to the Laparoscopic Mode and the Normal Mode in predicate devices K053464 and K924732 respectively."
Footswitch Mode	Functions the same as predicate devices.	Met: "This mode functions the same as the Footswitch Mode for the predicate devices, K924732 and K053464."
Continuous Activation Mode	As safe and effective as normal operation; substantially equivalent to predicate devices (despite not being present in predicate).	Met: "Electrical and Software Verification bench testing has shown this mode to be as safe and effective as the normal operation of the device and is substantially equivalent to the predicate devices."
ConMed ESU Automatic Mode	As safe and effective as normal operation; substantially equivalent to predicate devices (despite not being present in predicate).	Met: "Electrical and Software Verification bench testing has shown this mode to be as safe and effective as the normal operation of the device and is substantially equivalent to the predicate devices."
Integrated Operating Room Interface Mode	As safe and effective as normal operation; substantially equivalent to predicate devices (despite not being present in predicate).	Met: "Electrical and Software Verification bench testing has shown this mode to be as safe and effective as the normal operation of the device and is substantially equivalent to the predicate devices."
Biocompatibility	Does not contact the patient; substantially equivalent to predicate devices.	Met: "The CONMED® Aer Defense™ Smoke Evacuator and the predicate devices do not contact the patient and are substantially equivalent regarding biocompatibility."
Indication for Use	Designed to remove smoke, aerosols, and mitigate odors produced by surgical smoke during electrosurgical procedures; substantially equivalent to predicate devices.	Met: "The CONMED® Aer Defense™ Smoke Evacuator is designed to remove smoke, aerosols and mitigate odors produced by surgical smoke during electrosurgical procedures. This indication is substantially equivalent to the indications of the predicate devices."

Study that Proves the Device Meets Acceptance Criteria

The study described is a Design Verification & Validation bench testing program. The primary methodology employed is demonstrating substantial equivalence to existing predicate devices.

All sections below will contain "Not applicable" unless explicitly stated otherwise in the provided text.

2. Sample size used for the test set and the data provenance

Sample Size: The document does not specify a distinct "test set" sample size in terms of number of units or data points. The testing is described as "bench testing" and "Verification & Validation testing" on the device itself.
Data Provenance: The tests were "bench testing," meaning they were conducted in a laboratory or controlled environment. There is no mention of country of origin for specific data or whether it was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This study does not involve human interpretation or the establishment of ground truth by medical experts in the context of diagnostic accuracy. The "ground truth" for this device's performance is objective measurement against specified engineering and safety standards, and comparison to predicate device characteristics.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

None. This type of adjudication is typically used in clinical studies involving interpretation of medical images or data by multiple readers. For engineering performance and safety testing, the results are typically objectively measured and compared to specifications or predicate device performance.

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

No MRMC study was done. This device is a smoke evacuator, not an AI-assisted diagnostic tool or an imaging device that would typically involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device itself is a standalone electrosurgical smoke evacuator. Performance tests (electrical, mechanical, software, validation, safety) were conducted on the device operating independently to demonstrate its functionality and safety characteristics, confirming it meets its design requirements. Therefore, in a sense, a "standalone" performance assessment of the hardware and software functionality was conducted. There is no AI algorithm involved in the traditional sense.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device's performance is based on:

Objective Engineering Specifications: Electrical design requirements, mechanical design requirements, software design requirements, operational mode requirements, and validation requirements.
Established Safety Standards: IEC 60601-1-1, IEC 60601-1-2, and UL 60601-1 for electrical safety.
Predicate Device Characteristics: Performance parameters (filter efficiency, filter life, suction flow rate, modes of operation) were directly compared to those of the legally marketed predicate devices.

8. The sample size for the training set

Not applicable. This study does not involve machine learning or AI models that require a training set.

9. How the ground truth for the training set was established

Not applicable. As no training set was used, no ground truth needed to be established for it.

Summary

Regulation Number and Section

§ 878.5070 Air-handling apparatus for a surgical operating room.

(a)
Identification. Air-handling apparatus for a surgical operating room is a device intended to produce a directed, nonturbulent flow of air that has been filtered to remove particulate matter and microorganisms to provide an area free of contaminants to reduce the possibility of infection in the patient.(b)
Classification. Class II (special controls). The device, when it is an air handling bench apparatus, an air handling room apparatus, or an air handling enclosure apparatus, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.