(60 days)
Sterile, single-patient-use electrosurgical accessory intended to conduct electrosurgical current for cutting and coagulation of tissue and/or to provide suction and irrigation functions to the surgical site. These accessories have applications in general endoscopy and laparoscopy procedures.
AEM instruments incorporate the use of AEM technology and are intended for use with the AEM monitoring system and electrosurgical generators compatible with the AEM system.
AEM Single-Use Suction Irrigation Instruments are
• Electrosurgical accessories, which combine
– Classic active electrode functions of cutting and coagulating tissue with monopolar high-frequency electrical energy
– Shape, size and reach to work laparoscopically or endoscopically
– Elimination of stray-energy emission outside surgeon view provided by AEM shielding and monitoring
– Convenience/peace-of-mind provided by product provided clean and sterile from manufacturer to operating room
– Convenience of providing suction or irrigation to the surgical site without having to swap instruments in and out of the cannula
• Used to ablate, remove, resect, and coagulate soft tissue where associated hemostasis and visualization is required
• For use in open, endoscopic, and laparoscopic surgical procedures
The instruments of this submission are configured to support foot-controlled laparoscopic electrosurgery
• Direct connection from instrument tip to electrosurgical unit foot-switched power outlet via AEM Cord and Monitor
• Suction irrigation channel adapted directly to commercially available suction-irrigation valves
• Working length: 32 cm
• Fits within 5.5 mm diameter cannula
The document describes the AEM Single-Use Suction Irrigation Instrument, a device intended to combine electrosurgical functions (cutting and coagulation) with suction and irrigation capabilities during endoscopic and laparoscopic procedures. The submission is a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to previously cleared predicate devices, rather than an independent clinical study proving novel performance.
Here's an analysis of the provided information regarding acceptance criteria and the "study" (bench testing in this case) that supports it:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Electrosurgical Performance: Functions of cutting and coagulating tissue with monopolar high-frequency electrical energy, and elimination of stray-energy emission outside surgeon view (AEM technology). | "Electrosurgical application or performance" demonstrated no significant differences from predicate devices. AEM shielding and monitoring are key features. Bench testing characterized essential specifications not covered by equivalent designs and successfully demonstrated no significant effect on primary specifications due to aging and shipping. |
| Suction/Irrigation Performance: Ability to provide suction or irrigation to the surgical site without having to swap instruments. | "Suction/irrigation performance" demonstrated no significant differences from predicate devices. Bench testing characterized essential specifications not covered by equivalent designs and successfully demonstrated no significant effect on primary specifications due to aging and shipping. |
| Biocompatibility: Materials in direct or indirect contact with the patient must be safe. | Biocompatibility of all materials was verified "through analogy with identical materials, processes, and uses from the predicate devices." |
| Sterility: Product must be sterile when delivered and maintain sterility over its shelf life. | Sterilized in shipping boxes on pallets via electron-beam irradiation, in accordance with ANSI-AAMI-ISO 11137-1:2006 guidelines. Shelf life validated for sterility and function for at least one year by accelerated aging, verified by real-time aging. Packaging: individually packaged in Tyvek pouch, then six pouches in a cardboard shipping container. |
| Packaging Integrity/Shelf Life: Packaging must protect the device and maintain sterility for its specified shelf life, and withstand aging and shipping stresses. | Shelf life validated for product and packaging for at least one year by accelerated aging, verified by real-time aging. Extended as data from aging tests demonstrate greater longevity. "use by" date on all boxes and pouches. Bench testing successfully demonstrated no significant effect on primary specifications due to aging (both with accelerated and real-time testing) and shipping drop/shock/vibration. Substantially equivalent to predicate hub sterility (slightly less packaged density for more effective sterilization). |
| Dimensions/Fit: Instrument must fit within a 5.5 mm diameter cannula and have a working length of 32 cm. Connection to electrosurgical unit foot-switched power outlet via AEM Cord and Monitor. Suction irrigation channel adapted to commercially available valves. | Specific description confirms: Working length: 32 cm; Fits within 5.5 mm diameter cannula. Direct connection from instrument tip to electrosurgical unit foot-switched power outlet via AEM Cord and Monitor. Suction irrigation channel adapted directly to commercially available suction-irrigation valves. Bench testing characterized all essential specifications not covered by equivalent designs on production-equivalent units. Electrode shaft and tip, and hub and adapter are identical or substantially equivalent in design, construction, materials, packaging, and sterility to predicate devices. |
| Safety and Effectiveness: Demonstrate acceptable safety and performance outcomes and successful attainment of all essential specifications; no new issues of safety and effectiveness. | "Product testing of subject instruments and direct analogy with predicate device design and materials demonstrates acceptable safety and performance outcomes and successful attainment of all essential specifications for the devices." "There are no significant differences between the subject instruments and their predicate devices which would raise new issues of safety and effectiveness, performance, function or intended use..." Bench testing characterized all essential specifications and demonstrated no significant effect due to aging and shipping. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated as a number of devices or cases in the provided text. The document refers to "production-equivalent units" and "subject instruments" for bench testing. Given this is a 510(k) for substantial equivalence based on bench testing and analogy, a traditional "test set" with a specific number of patient samples is not applicable here.
- Data Provenance: The data comes from bench testing performed internally by Encision, Inc. It is retrospective in the sense that it relies on established data and performance of predicate devices for comparison and analogy. It is not clinical data derived from patients.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- This information is not applicable to this 510(k) submission. The "ground truth" for demonstrating substantial equivalence is established through engineering and performance specifications validated via bench testing and direct comparison/analogy to predicate devices, not through expert review of patient data.
4. Adjudication Method for the Test Set
- Not applicable. There is no adjudication method described as this is not a study involving human interpretation of results requiring consensus. The verification and validation were performed "in accordance with Design Control requirements per 21 CFR 820.30 and company quality system procedures."
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, an MRMC comparative effectiveness study was not done. This device is a surgical instrument and accessory, not an AI-powered diagnostic tool. Therefore, the concept of "human readers improve with AI" does not apply.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical electrosurgical instrument, not an algorithm or AI system.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc)
- The "ground truth" for the performance claims in this 510(k) is based on engineering and performance specifications derived from the predicate devices and industry standards. For biocompatibility, it's analogy to predicate materials. For sterility and shelf life, it's adherence to relevant standards (ANSI-AAMI-ISO 11137-1:2006) and accelerated/real-time aging studies. No clinical ground truth (e.g., pathology, outcomes data, expert consensus on patient images) was used.
8. The Sample Size for the Training Set
- Not applicable. As this is a physical medical device and not an AI/ML algorithm, there is no "training set."
9. How the Ground Truth for the Training Set was Established
- Not applicable. There is no training set for this device.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.