(192 days)
The Electrosurgical Generator (OBS-350A) is a non-sterile, reusable multi-purpose electrosurgical generator that is designed to perform monopolar and bipolar functions in the surgical operation area.
The generator is enclosed in a metal and molded plastic enclosure and will have an angled front panel in the display and controls area. The front panel displays and controls will be sealed to facilitate cleaning and minimize the possibility of problems caused by accidental spills. The receptacles for the active electrosurgical accessories will be in a recessed area and will conform to IEC60601-1:2005/(R) 2012 And A1:2012.
Device components: Chassis and Cover, Front panel controls, Power supply board, Microprocessor board, Footswitch board, Interface circuits, Front panel receptacles.
Special features: Three CUT modes (Pure CUT, Blend 1, Blend 2), Three COAG modes (COAG1 (Spray), COAG2 (Forced), COAG3 (Soft)), Two Bipolar modes (Bipolar1 (Macro), Bipolar2 (Micro)), Memory (10 memory Presets), CQMS (contact quality monitoring system), Power ON self diagnostics, PPS (peak power system).
Here's a breakdown of the acceptance criteria and study information for the OBS Electrosurgical Generator (model: OBS-350A), based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria in this document are primarily based on achieving "substantial equivalence" to a predicate device (Valleylab Force FX). This means the OBS-350A is considered acceptable if its performance is comparable to the predicate across various parameters, particularly regarding safety and effectiveness.
| Acceptance Criteria Category | Specific Criteria/Tests | Reported Device Performance (OBS-350A vs. Predicate) | Outcome |
|---|---|---|---|
| Intended Use | Same as predicate | Electrosurgical Generator for monopolar and bipolar functions in surgical operations. | Achieved |
| Technological Characteristics & Principles of Operation | Similar to predicate | HF energy, Monopolar and Bipolar output waveforms. | Achieved |
| Electrical Waveforms | Comparable to predicate | "The electrical waveforms of the OBS-350A were comparable to the electrical waveforms of the predicate devices. This was confirmed for all output modes (waveforms) at rated load." | Achieved |
| Tissue Thermal Effects | Comparable to predicate | "The tissue thermal effects test was conducted by OBS-350A and predicate devices to demonstrate the tissue thermal effects equivalence in porcine muscle, kidney and liver tissue." "Tissue thermal effects tests by OBS-350A and predicate devices demonstrate the similarity of thermal effects in three tissues." | Achieved |
| Safety Standards | Compliance with ES60601-1:2005/(R)2012 And A1:2012 | Complies with ES60601-1:2005/(R)2012 And A1:2012 | Achieved |
| Performance Standards | Compliance with IEC60601-2-2:2009 | Complies with IEC60601-2-2:2009 | Achieved |
| EMC Standards | Compliance with IEC60601-1-2:2007 | Complies with IEC60601-1-2:2007 | Achieved |
| Output Powers | Comparable range to predicate | See detailed power output comparison in the document (Table on Page 8). Most values for power, voltage, and frequency are similar or within acceptable ranges. | Achieved (deemed "SE") |
| Open Circuit Vp-p (max) | Comparable range to predicate | See detailed open circuit voltage comparison in the document (Table on Page 8). Most values are similar or within acceptable ranges. | Achieved (deemed "SE") |
| Accessory Compatibility | Legally marketed and compatible. Maximum electrical capacity of accessories ≥4500 Vp | Accessories are legally marketed and have a max electrical capacity ≥4500 Vp. Specific OBS accessories are recommended. | Achieved |
| CQMS (Contact Quality Monitoring System) | Measures resistance between ESU pad and patient; alarms if >113 ohms; stops output. | Described as functioning as designed. | Achieved |
| Power ON self diagnostics | All working modes/functions simulated and monitored; displays error codes and alarms if failure occurs; disables operations. | Described as functioning as designed. | Achieved |
| PPS (Peak Power System) | Automatically senses resistance and adjusts output voltage to maintain consistent effect. | Described as functioning in Pure CUT, Blend CUT, and Bipolar modes. | Achieved |
| Duty Cycle | 10 seconds on, 30 seconds off for 1 hour at max power and rated load. | Described as suitable for this duty cycle. | Achieved |
2. Sample Size for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify a numerical sample size for the "test set" in terms of number of devices or number of tissue samples for the bench testing. It refers to "evaluations" and "tests."
- Data Provenance: The testing was "bench" testing, comparing the performance of the OBS-350A against its own design specifications and against the predicate device (Valleylab Force FX). The document implicitly indicates the testing was done by the manufacturer (Baisheng Medical Co., Ltd.) as part of their submission for market clearance. No country of origin for test data is explicitly stated beyond the manufacturer's location in China. The testing is considered prospective in the sense that it was conducted directly to support this 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- The document does not mention the use of experts to establish a "ground truth" for the test set. The evaluation is focused on direct comparison of physical and electrical characteristics and compliance with recognized standards. This is typical for electrosurgical generators, where performance is objectively measured rather than subjectively interpreted (like image analysis).
4. Adjudication Method for the Test Set
- No adjudication method is described, as the testing involves objective measurements rather than subjective assessments requiring reader adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical and animal studies were not deemed necessary to support substantial equivalence." This type of study would involve human readers (e.g., surgeons) evaluating the device's performance, which was not performed or required here.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable in the context of an electrosurgical generator. A standalone "algorithm" performance is relevant for AI/software devices that make diagnostic or treatment recommendations. The OBS-350A is a physical medical device that applies energy. Its performance is measured directly, not via an algorithm operating independently to produce an outcome. The document does mention software validation for the device's embedded software, which would be a form of "standalone" software assessment, but not in the AI/human-in-the-loop sense.
7. The Type of Ground Truth Used
- The "ground truth" in this context is established by:
- Design Specifications: The device's performance is compared against its own defined design specifications.
- Predicate Device Performance: Direct comparison of electrical waveforms and tissue thermal effects against a legally marketed predicate device (Valleylab Force FX).
- Recognized Standards: Compliance with international standards such as IEC 60601-1, IEC 60601-2-2, and IEC 60601-1-2.
8. The Sample Size for the Training Set
- This question is not applicable. The OBS-350A is an electrosurgical generator, not an AI/machine learning device that requires a "training set" of data.
9. How the Ground Truth for the Training Set was Established
- This question is not applicable, as there is no "training set" for this type of medical 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.