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510(k) Data Aggregation
(165 days)
The EndoShield Burn Protection System is an accessory for use with electrosurgical generators and is designed to safely deliver electrosurgical energy and to prevent injury caused by insulation failure and capacitive coupling. EndoShield performs acive electrode monitoring intended to control stray monopolar energy, caused by insulation failure and capacitive coupling in surgical instruments, along the instrument.
EndoShield is a self-contained battery-powered electronic module (about the size of a cell phone) with integral instrument and HF power cords:
• Module plugs directly into return-electrode receptacle of ESU
- Integral cords connect module to
- AEM laparoscopic instrument
- Foot-control power output receptacle of ESU
The EndoShield Burn Protection System is an accessory for use with electrosurgical generators, designed to safely deliver electrosurgical energy and prevent injury caused by insulation failure and capacitive coupling by performing active electrode monitoring.
Here's an analysis of the acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily focuses on demonstrating substantial equivalence to a predicate device (EM3 AEM Monitor) rather than detailing specific numerical acceptance criteria. However, we can infer the performance standard from the claim of equivalence and the description of the device's functions.
| Acceptance Criteria (Inferred from Predicate Equivalence) | Reported Device Performance (EndoShield Burn Protection System) |
|---|---|
| Functional Equivalence: | |
| * Enables AEM Monitoring and protection during monopolar laparoscopy. | Yes, enables AEM Monitoring and protection during monopolar laparoscopy. |
| * Transfers HF energy from ESU to AEM laparoscopic instruments while monitoring HF current returning from the instrument's shield. | Yes, transfers high-frequency (HF) energy from monopolar electrosurgical unit (ESU) to AEM laparoscopic instruments while providing AEM Monitoring of HF current returning from the instrument's shield. |
| * Disables HF energy delivery and presents a visual alert whenever a setup or operational fault is detected (due to stray HF energy). | Yes, disables HF energy delivery and presents a visual alert whenever a set up or operational fault is detected (when energy in shield approaches excessive levels). Indicates fault by extinguishing green "✓" and lighting red "X". |
| * Assures proper connections before enabling and indicating "ready." | Yes, assures all connections are proper before enabling energy delivery and presenting a visual "ready" indication by lighting a green "✓" on the face of the electronic module. |
| * Shunts stray energy from instrument shaft back to ESU. | Yes, monitor connections shunt stray energy, attempting to pass through the insulated shaft of an AEM instrument by insulation breakdown or capacitive coupling, back to the ESU. |
| Safety and Compliance: | |
| * Compliance with IEC 60601-1 (3rd Ed.), IEC 60601-1-2, IEC 60601-2-2. | Identical standards and internal design control assurances, including recognized international standards: IEC 60601-1 (3rd Ed.) compliant, IEC 60601-1-2 compliance, IEC 60601-2-2 compliance. |
| * Compliance with IEC 60601-1-6, IEC 62366 (Human Factors/Usability). | Identical standards and internal design control assurances, including recognized international standards: IEC 60601-1-6 compliance, IEC 62366 compliance. |
| * Sterility Assurance Level of 10⁻⁶ or better. | Yes, Sterility Assurance Level: 10⁻⁶ or better, achieved via ethylene oxide gas sterilization (ANSI-AAMI-ISO 11135-1:2007) by a qualified contract sterilizer. |
| * One-year shelf life for sterility and function. | Yes, validated for sterility and function to one year shelf life through accelerated aging. |
| Electromagnetic Compatibility (EMC) and Electrical Safety: | Equivalent performance to monopolar function of EM3 AEM Monitor predicate system demonstrated through third-party testing and design-file review. |
| Biocompatibility: | None required due to no direct or indirect contact with patient. |
The study supporting these claims is described as Bench Testing.
2. Sample Size Used for the Test Set and the Data Provenance:
- Sample Size for Test Set: "Essential performance tested in 10 units" of the EndoShield Burn Protection System.
- Data Provenance: The document does not specify the country of origin for the data, but it falls under the jurisdiction of the FDA (United States). The testing appears to be prospective as it involves new units of the EndoShield device undergoing performance evaluation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not provided in the document. The testing described is technical bench testing against design control requirements and predicate device performance, not clinical evaluation requiring expert interpretation of results for ground truth.
4. Adjudication Method for the Test Set:
This information is not provided. Given the nature of the bench testing, an adjudication method as typically understood in clinical studies (e.g., 2+1, 3+1 for discordant reads) is not applicable. The documentation suggests direct measurement and comparison against established performance metrics of the predicate device and relevant standards.
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 comparative effectiveness study was done or reported. This device is a hardware accessory designed to prevent injury by monitoring stray energy and shutting down the ESU if necessary, not an AI-assisted diagnostic or interpretive tool that would 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 electronic module that actively monitors and controls electrosurgical energy based on its internal logic and DSP (Digital Signal Processor) measurements. The "Bench Testing" section implicitly covers its standalone performance against design control requirements and the predicate device's monopolar function. There is no specific mention of an "algorithm only" standalone study in the context of an AI/ML algorithm. The "logic" described is battery-powered digital and analog electronic circuitry with DSP for HF current measurement.
7. The Type of Ground Truth Used:
The ground truth for the bench testing was the performance parameters and established functional behavior of the predicate device (monopolar function of the EM3 AEM Monitor) and compliance with recognized international standards (IEC 60601 series). It also includes internal design control requirements per 21 CFR 820.30.
8. The Sample Size for the Training Set:
This information is not applicable/not provided. The device is a hardware accessory with electronic logic, not an AI/ML system that utilizes a "training set" in the conventional sense. The development likely involved traditional engineering design, simulation, and hardware testing.
9. How the Ground Truth for the Training Set was Established:
This information is not applicable/not provided for the reasons stated above (not an AI/ML system). The device's operational principles and intended effects are based on known physics of electrosurgery and established safety standards, not learned from a data training set.
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