(74 days)
The Bipolar Laparoscopic Loop is a 5mm bipolar electrosurgical device. The device is intended to be used for the amputation of the mobilised uterus during Laparoscopic Supracervical (Subtotal) Hysterectomy and the resection of devascularized subserosal pedunculated myomas. It is used in conjunction with the Olympus Electrosurgical Generator ESG-400.
The Bipolar Laparoscopic Loop is a single use disposable high frequency RF bipolar accessory to be used in conjunction with the Olympus Electrosurgical Generator ESG-400. It is available in an 88mm x 227mm loop size. The device is sterilized by ethylene.
This document describes the premarket notification (510(k)) for the PK Lap Loop, a bipolar electrosurgical device. The submission focuses on demonstrating substantial equivalence to a predicate device (PKS BiLL) rather than presenting a standalone study with defined acceptance criteria and performance metrics in the typical sense of AI/algorithmic device evaluation.
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1. A table of acceptance criteria and the reported device performance
The concept of specific "acceptance criteria" for performance metrics like sensitivity, specificity, or F1-score, as seen in AI/ML device submissions, is not directly applicable here. This document is for a traditional medical device (electrosurgical loop) and focuses on demonstrating substantial equivalence to an already cleared predicate device. The "performance" is implicitly tied to demonstrating that the new device functions equivalently and safely to the predicate.
The closest to acceptance criteria are the characteristics compared between the PK Lap Loop and the predicate PKS BiLL. The reported device performance is that these characteristics are identical or similar to the predicate, implying they meet the predicate's established performance and safety profile.
| Characteristic | Acceptance Criteria (Implicit: Substantial Equivalence to Predicate) | Reported Device Performance (PK Lap Loop vs. PKS BiLL) |
|---|---|---|
| Electrosurgical Generator | Compatibility with a cleared generator | Different (Olympus ESG 400 vs. Gyrus G400) |
| Energy used and delivered | Identical output waveforms and power levels | Identical |
| Compatibility with other devices | Same as predicate | Identical |
| Design | Fundamentally same, minor changes no impact on safety/usability | Similar (minor corporate branding changes) |
| Performance (tissue effect, speeds, forces) | Same as predicate | Identical |
| Device Min and Max output powers | Average power of one cycle period is 200W | Identical |
| Cutting time |
§ 884.4150 Bipolar endoscopic coagulator-cutter and accessories.
(a)
Identification. A bipolar endoscopic coagulator-cutter is a device used to perform female sterilization and other operative procedures under endoscopic observation. It destroys tissue with high temperatures by directing a high frequency electrical current through tissue between two electrical contacts of a probe. This generic type of device may include the following accessories: an electrical generator, probes, and electrical cables.(b)
Classification. Class II. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(ii) “510(k) Sterility Review Guidance 2/12/90 (K-90),” and
(iii) “Guidance (‘Guidelines’) for Evaluation of Laproscopic Bipolar and Thermal Coagulators (and Accessories),”
(2) International Electrotechnical Commission's IEC 60601-1-AM2 (1995-03), Amendment 2, “Medical Electrical Equipment—Part 1: General Requirements for Safety,”
(3) American National Standards Institute/American Association for Medical Instrumentation's HF-18, 1993, “Electrosurgical Devices,”
(4) Labeling:
(i) Indication: For female tubal sterilization, and
(ii) Instructions for use:
(A) Destroy at least 2 centimeters of the fallopian tubes,
(B) Use a cut or undampened sinusoidal waveform,
(C) Use a minimum power of 25 watts, and
(D) For devices with ammeters: continue electrode activation for 5 seconds after the visual endpoint (tissue blanching) is reached or current flow ceases indicating adequate tissue destruction.