(76 days)
The IDS-310 High Frequency Electrosurgical Generator is used to deliver RF energy via an assortment of surgical devices to cut and coagulate different kinds of tissue.
The IDS-310 Electrosurgical Generator is an electrosurgical device that utilizes High Frequency electrical current, via an assortment of surgical devices to cut and coagulate different kinds of tissue.
The IDS-310 Generator is a high frequency isolated generator featuring cutting up to 300 watts, 4 blend modes, 3 coagulation modes and 4 bipolar modes with an Auto Bipolar option. There is a characteristic electrical wave form associated with each mode. The electrical properties of the waveform (frequency and duration) produce the clinical effect (i.e. cut, coagulation). The shape and duration of waveforms are comparable between the generator and predicate devices. The generator offers 2 monopolar handpiece outputs, monopolar foot controlled output, bipolar handpiece output, and bipolar foot controlled output. The generator has a return electrode contact and quality monitoring system (NEM) to reduce the risk of patient burns at the return electrode site. The pad-sensing feature allows the user to use either a split or solid return electrode.
The generator is designed to comply with applicable Medical Electrical Equipment safety standards, including electromagnetic compatibility and other safety standards. It is also designed to meet the requirements of the European RoHS directive.
The device consists of a generator, power cord, and a User's Guide. The main device components are a front panel containing the power button, wattage selection buttons, LED numeric displays, alarm and return electrode indicator lights, and connector ports for accessories, a back panel consisting of footswitch ports, volume controls, a power cord outlet, and internal components (printed circuit boards, speakers, cabling).
The provided document describes a 510(k) summary for the Bovie® IDS-310 High Frequency Electrosurgical Generator, focusing on establishing substantial equivalence to predicate devices rather than detailing a study with specific acceptance criteria for performance measures like sensitivity, specificity, or reader improvement.
Therefore, many of the requested sections about acceptance criteria and study design elements (like sample size for test sets, expert qualifications, MRMC studies, or training sets) are not applicable or not present in this type of regulatory submission.
This submission primarily relies on bench testing and comparison to predicates to demonstrate that the device meets design specifications and is substantially equivalent to existing legally marketed devices.
Here's a breakdown based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Demonstrated via compliance with standards & similarity to predicates) | Reported Device Performance |
|---|---|
| Safety Standards Compliance: | Compliant: |
| - IEC 60601-1 (General requirements for basic safety and essential performance) | The generator is designed to comply with applicable Medical Electrical Equipment safety standards. Device testing and evaluation demonstrated compliance with IEC 60601-1: 2005. |
| - IEC 60601-1-2 (Electromagnetic Compatibility - Requirements and Tests) | Device testing and evaluation demonstrated compliance with IEC 60601-1-2: 2007. |
| - IEC 60601-2-2 (Particular requirements for high frequency surgical equipment) | Device testing and evaluation demonstrated compliance with IEC 60601-2-2: 2007. |
| - RoHS Directive Compliance (Restriction of Hazardous Substances) | The IDS-310 was designed compliant with the Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment (RoHS) Directive. |
| Intended Use: | Same Intended Use as Predicate Devices: |
| - To deliver RF energy via surgical devices to cut and coagulate tissue | The IDS-310 "is used to deliver RF energy via an assortment of surgical devices to cut and coagulate different kinds of tissue," which is identical to the primary predicate (Bovie IDS-300) and very similar to the secondary predicate (ERBE VIO300D). The Bovie IDS-310 has the same intended use as the predicate devices. |
| Technology / Principle of Operation: | Same Technology and Principles of Operation: |
| - High Frequency (RF) energy | Uses High Frequency (RF) electrical current. The Bovie IDS-310 utilizes the same technology and principles of operation as the predicate devices. |
| - Monopolar and Bipolar output | Offers Monopolar and Bipolar output. |
| - Waveform characteristics (frequency, duration, shape) producing clinical effect | Characteristic electrical waveforms associated with each mode. The electrical properties of the waveform (frequency and duration) produce the clinical effect (i.e. cut, coagulation). The shape and duration of waveforms are comparable between the generator and predicate devices. The Cut I/II, Blend, Pinpoint Coagulation, and Spray Coagulation modes of the IDS-310 and primary predicate IDS-300 have the same waveform and maximum output power. The Bovie Bipolar mode of the IDS-310 has a similar waveform and the same output power as the VIO 300D BiClamp mode. Other IDS-310 Bipolar modes are similar to VIO 300D Bipolar modes but have lower output power. |
| Safety Features: | Equivalent Safety Features: |
| - Return electrode contact and quality monitoring system (NEM) | Has a return electrode contact and quality monitoring system (NEM) to reduce the risk of patient burns. The pad-sensing feature allows the use of split or solid return electrodes. |
| No New Safety/Efficacy Issues: | No New Issues Identified: |
| - Device does not raise additional issues of safety or efficacy | The Bovie IDS-310 does not raise additional issues of safety or efficacy compared to the predicate devices. |
2. Sample size used for the test set and the data provenance:
- Not Applicable. This submission is for an electrosurgical generator, not an AI or diagnostic device that uses "test sets" in the typical sense of medical image analysis or similar diagnostic applications. The "testing" involved bench testing to verify compliance with engineering and safety standards.
- Data Provenance: Not relevant for this type of device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. Ground truth in the context of expert consensus is not applicable here as the device is not a diagnostic tool or an AI algorithm requiring human interpretation for validation. The device's performance is assessed against engineering specifications and safety standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods are not relevant for this type of device submission.
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. This is not an AI-assisted device subject to an MRMC study.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an algorithm. The device, an electrosurgical generator, operates as intended based on its design and validated performance against standards.
7. The type of ground truth used:
- For this device, the "ground truth" is primarily based on established engineering and safety standards (e.g., IEC 60601 series) and functional specifications derived from the predicate devices. Bench testing demonstrated that the generator met its design specifications and complied with these standards. The clinical effectiveness is inferred from its similarity in operating principles, waveforms, and intended use to already-marketed and accepted predicate devices.
8. The sample size for the training set:
- Not Applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established:
- Not Applicable. As there is no training set mentioned, this question is not applicable.
§ 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.