(135 days)
The PK Spatula is indicated for resection and coagulation of soft tissue and blood vessels in laparoscopic and general surgical procedures when used with the Olympus ESG-400 Generator.
The PK Spatula is a bipolar electrosurgical instrument with the capability to cut and coagulate soft tissue and blood vessels in laparoscopic and general surgery. The instrument will pass through a 5mm cannula or through an operating laparoscope working channel of 5mm or larger diameter. The instrument is to be used only with the ESG-400 electrosurgical generator. The generator and device make up a medical electrical system. The instrument is to be used only with the Gyrus ESG-400 Generator and associated 5 way connector cable. The device is intended for use in a non-irrigated (dry) environment.
This document describes the PK Spatula, an electrosurgical device, and its substantial equivalence to a predicate device. Detailed acceptance criteria and extensive study information (like sample sizes for test and training sets, expert qualifications, and specific ground truth methods) as typically found in an AI/software device submission are not provided in this type of 510(k) submission for a physical medical device. This submission focuses on comparing the new device to an existing one to demonstrate similar safety and effectiveness.
Here's a breakdown of the requested information based on the provided text, recognizing the limitations:
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device, "acceptance criteria" and "device performance" are typically defined by engineering specifications and functional testing, rather than metrics like sensitivity, specificity, or AUC as seen in AI/software. The document states the new device is "substantially equivalent" to the predicate.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Equivalence in cutting and coagulation performance to predicate. | "Cutting and Coagulation equivalency to predicate" met. |
| Dimensional compliance. | "Dimensional Measurements" met. |
| Withstand expected forces. | "Expected forces on devices" met. |
| Proper design feature functionality (rotation, button activation). | "Design feature testing (rotation and button activation)" met. |
| Sterility and specified shelf life. | "Sterilization" and "Shelf Life" testing results are satisfactory. |
| Biocompatibility. | "Biocompatibility testing has been carried out with passing results." |
| Compliance with relevant voluntary standards. | Device "complies with the following standards" (listed). |
2. Sample Size Used for the Test Set and Data Provenance
This information is not explicitly provided in the document. The "performance tests" mentioned (dimensional, cutting/coagulation equivalency, forces, design features, shelf life, sterilization, biocompatibility) are laboratory-based engineering and bench tests, not clinical studies with "test sets" in the context of data analysis.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable and not provided. "Ground truth" in the context of expert consensus is typically for diagnostic/interpretive devices (e.g., radiologists reviewing images). For an electrosurgical tool, "ground truth" refers to established engineering principles and objective measurements of its physical and functional properties.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in expert interpretations, which is not relevant to the physical and functional testing of an electrosurgical device.
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
This information is not applicable and not provided. An MRMC study is relevant for AI-assisted diagnostic or interpretive devices. The PK Spatula is a surgical tool, not an AI-based diagnostic system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable and not provided. Standalone algorithm performance is a concept for AI/software devices; the PK Spatula is a physical electrosurgical instrument.
7. The Type of Ground Truth Used
For this device, the "ground truth" for the performance testing is based on:
- Engineering specifications and objective measurements: For dimensional measurements, expected forces, and design feature testing.
- Established laboratory-based testing protocols: For cutting and coagulation equivalency (likely measured on tissue surrogates or ex vivo tissue), sterilization effectiveness, shelf life stability, and biocompatibility.
- Compliance with recognized standards: Such as ISO and IEC standards for medical devices.
8. The Sample Size for the Training Set
This information is not applicable and not provided. "Training set" is a term used for machine learning. This device's development involves engineering design and validation, not model training.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided for the same reasons as #8.
Summary of the K142289 Submission:
The provided document is a 510(k) premarket notification for a traditional medical device (PK Spatula, an electrosurgical instrument). The core of this submission is to demonstrate substantial equivalence to an already legally marketed predicate device (Gyrus PlasmaCision Laparoscopic Spatula K041633).
The "study" that proves the device meets (implied) acceptance criteria consists of:
- Bench Testing: A series of laboratory tests confirm the device's physical dimensions, mechanical strength, functionality (rotation, button activation), and performance characteristics (cutting and coagulation equivalency to the predicate).
- Biocompatibility Testing: To ensure patient safety with the materials used.
- Sterilization and Shelf Life Validation: To confirm the device remains sterile and functional over its stated shelf life.
- Compliance with Voluntary Standards: Adherence to recognized medical device standards (ISO, IEC).
The document asserts that these tests, along with a detailed comparison of intended use, design, and technological characteristics, ensure the PK Spatula is "substantially equivalent" to the predicate and "raises no new concerns or safety or effectiveness."
§ 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.