(27 days)
- The PK Needle is indicated for resection of soft tissue in laparoscopic and general surgical procedures.
- The PK Spatula is indicated for resection and coagulation of soft tissue and blood vessels in laparoscopic and general surgical procedures.
- The PK J-Hook is indicated for resection and coagulation of soft tissue and blood vessels in laparoscopic and general surgical procedures.
The Olympus PK Electrosurgical Instruments: PK Needle, PK Spatula, and PK J-Hook are bipolar electrosurgical instruments with the capability to resect, cut, and coagulate soft tissue and blood vessels in laparoscopic and general surgical procedures. They pass through a 5mm cannula or operating laparoscope working channel of 5mm or larger diameter. The devices are activated via buttons on the handle or by a foot pedal and plug into compatible Olympus generators (ESG-400 and ESG-410). The generator and device make up a medical electrical system.
This FDA 510(k) summary (K213831) describes the Olympus PK Electrosurgical Instruments (PK Needle, PK Spatula, PK J-Hook). The submission is a modification to the device labeling to add compatibility with an Olympus generator, ESG-410 cleared under K203277. The document states that the devices themselves are unchanged from their original clearances in terms of intended use, design, performance, and technological characteristics.
Therefore, the study information requested is based on the original clearances of these devices (K142154 for PK Needle, K142289 for PK Spatula, and K142350 for PK J-Hook) and the specific testing performed for the current submission to confirm compatibility with the new generator.
Here's the breakdown of the acceptance criteria and study information provided in the document:
1. A table of acceptance criteria and the reported device performance
The document does not provide a specific table of quantitative acceptance criteria with reported numerical device performance as typically expected for software or diagnostic device studies. Instead, it refers to compliance with recognized consensus safety standards and successful completion of non-clinical testing.
| Acceptance Criteria Category | Specific Standard/Test Ref. | Reported Device Performance |
|---|---|---|
| Safety and Essential Performance | AAMI/ANSI ES 60601-1:2005/(R)2012 and C1:2009/(R)2012 and, A2:2010/(R)2012 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance) | The design of the subject device complies with this standard. |
| High Frequency Surgical Equipment Safety | IEC 60601-2-2 Ed. 6.0:2017-03 (Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories) | The design of the subject device complies with this standard. |
| Risk Management | ANSI AAMI ISO 14971 2019 (Medical devices – Application of risk management to medical devices) | A risk analysis was completed to identify any new risks associated with the update. The design of the subject device complies with this standard. |
| Sterilization (Ethylene Oxide) | ISO 11135: 2014 (Sterilization of health care products - Ethylene oxide - Requirements for development, validation and routine control of a sterilization process for medical devices) | The product and packaging materials as well as the sterilization mode has not changed since the original clearance, therefore no additional testing was needed. The design complies with this standard. |
| Labeling Symbols | ISO 15223-1:2016 (Medical devices - Symbols to be used with medical device labels, labeling, and information to be supplied – Part 1 General requirements) | The design of the subject device complies with this standard. |
| Sterile Barrier Packaging | ISO 11607-1 Second Edition 2019-2 (Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems) | The design of the subject device complies with this standard. |
| Biocompatibility (General) | ISO 10993-1:2018 (Biological Evaluation of Medical Devices, Part 1: Evaluation and testing within a risk management process) | Full biocompatibility information was provided in original clearance. The design complies with this standard. |
| Biocompatibility (Cytotoxicity) | ISO 10993-5:2009 (Biological Evaluation of Medical Devices, Part 5: Tests for In Vitro Cytotoxicity) | Full biocompatibility information was provided in original clearance. The design complies with this standard. |
| Biocompatibility (Irritation/Sensitization) | ISO 10993-10:2010 (Biological Evaluation of Medical Devices, Part 10: Tests for Irritation and Skin Sensitization) | Full biocompatibility information was provided in original clearance. The design complies with this standard. |
| Biocompatibility (Ethylene Oxide Residuals) | ISO 10993-7 Second Edition 2008-10-15 (Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals) | Full biocompatibility information was provided in original clearance. The design complies with this standard. |
| Non-clinical Performance | Electrical, mechanical, functional, and cutting equivalency to predicate in original clearances. | Testing was conducted and the performance criteria were met when used with the additional compatible generator. |
| Generator Compatibility | Specific tests for compatibility with the Olympus ESG-410 generator. | Testing was conducted and the performance criteria were met when used with the additional compatible generator. The generator recognizes and automatically presets the default output settings. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document relates to electrosurgical instruments and their compatibility with a new generator. The testing described is primarily non-clinical (electrical, mechanical, functional). Therefore, the concept of a "test set sample size" as applied to patient data or images (common in AI/ML devices) is not directly applicable here. The document mentions "testing was conducted" on the subject device. Details on the specific number of devices tested for each non-clinical performance category are not provided within this summary.
Data provenance: Not applicable as this submission primarily concerns non-clinical hardware compatibility performance rather than patient data analysis.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. Ground truth, in the context of expert review for medical imaging or diagnostic devices, is not relevant for this type of electrosurgical instrument compatibility submission. The "ground truth" for electrosurgical instruments is their ability to perform cutting and coagulation safely and effectively, and this is assessed through engineering testing against established standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically used for expert consensus on clinical findings in diagnostic studies. This is a non-clinical performance and compatibility 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
Not applicable. This is not an AI/ML device or a diagnostic device. It is an electrosurgical instrument.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML algorithm. The performance of the device is described as "algorithm only" in the sense that its electrosurgical function is inherent to its design and energy delivery, rather than requiring human interpretation of an output. However, it is an instrument used by a human surgeon.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable in the typical sense. The "ground truth" for this device's performance is established by engineering specifications, recognized international safety and performance standards (e.g., IEC 60601 series, ISO 14971), and the original performance characteristics of the predicate devices. Performance is measured against these technical benchmarks.
8. The sample size for the training set
Not applicable. This is not a machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not a machine learning device that requires a training set.
§ 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.