(136 days)
The PKS™ (Plasmakinetic System) BiLL™ (Bipolar Laparoscopic Loop) instrument is a 5mm bipolar electrosurgical device. The device is intended to be used for the amputation/sectioning of the mobilised uterus during Laparoscopic Supracervical (Subtotal) Hysterectomy and the resection of devascularized subserosal pedunculated myomas. It is used in conjunction with the Gyrus ACMI G400 Workstation Generator.
The Bipolar Laparoscopic Loop (PKSTM BiLL™) is-a single use disposable high frequency RF bipolar accessory to be used in conjunction with the Gyrus ACMI G400 Workstation Generator. The PKSTM BiLL™ is a laparoscopic instrument. It is available in an 88mm x 215mm loop. The device is sterile for single use sterilized by gamma irradiation to an SAL of 10°0
Here's an analysis of the provided text regarding the PKS™ BiLL™ device, focusing on the requested acceptance criteria and study information:
PKS™ BiLL™ Device Study Analysis
The provided 510(k) summary for the PKS™ BiLL™ device does not contain detailed acceptance criteria and a specific study proving the device meets those criteria in the typical sense of a clinical trial. Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and pre-clinical testing.
1. Table of Acceptance Criteria and Reported Device Performance
No explicit acceptance criteria with numerical targets are provided in the document. The performance assessment is primarily qualitative, stating that:
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Electrical Safety (IEC 60601) | Compliant to electrical standards, specifically applicable sections of IEC 60601 incorporating electrical, thermal safety, and Electromagnetic Interference. |
| Biocompatibility (ISO 10993) | Full biocompatibility testing on all patient contacting parts has been performed in compliance with the relevant requirements of ISO-10993. |
| Packaging and Sterilization (ISO 11607, ISO 11137) | Packaged and sterilized as a sterile single-use device and tested to comply with ISO 11607 and ISO11137. |
| Mechanical Design / Usability / Software Selection for Cut & User Performance | Preclinical testing has been undertaken to validate the mechanical design, usability considerations, and software selection to provide the desired cut and user performance requirements. Performance was compared against the predicate LiNA Loop. Bench and preclinical testing demonstrated that the performance requirements were met, and that the PKSTM BiLLTM exhibited comparable performance characteristics to the LiNA Loop. |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "Preclinical testing" and "Bench and preclinical testing". It states that this testing was done to validate mechanical design, usability, and software selection, and the performance was compared against the predicate LiNA Loop.
- Sample Size for Test Set: Not specified. The document does not provide a number of devices or subjects used in this testing.
- Data Provenance: The nature of the "preclinical testing" suggests in-house laboratory or animal testing. The country of origin of this data is not explicitly stated, but being a US-based manufacturer, it's reasonable to infer the testing was conducted in the US or by its contracted facilities. The testing is prospective in nature, as it's being conducted to validate the new device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. The "preclinical testing" described for this device focuses on engineering performance characteristics (electrical, mechanical, sterilization, biocompatibility, and functional "cut and user performance requirements") rather than diagnostic accuracy or clinical outcomes that would typically involve expert ground truth establishment for a test set. There's no mention of experts establishing a ground truth for this type of performance testing.
4. Adjudication Method
Not applicable. As the "preclinical testing" primarily involves engineering and functional performance, clinical adjudication methods like 2+1 or 3+1 for ground truth are not relevant to the described studies.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document does not describe a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The evaluation focuses on substantial equivalence based on technological features and in-vitro/pre-clinical performance compared to predicates, not on the improvement of human readers with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable/Not relevant. This device is an electrosurgical instrument, not an AI algorithm. Its performance is inherent to its design and how it interacts with the G400 Workstation Generator, meaning "standalone" performance without human interaction (as in, no one is operating the laparoscopic loop) is not a practical concept for this device type. The "cut and user performance requirements" inherently involve human interaction for usability.
7. Type of Ground Truth Used
For the described preclinical testing, the "ground truth" implicitly refers to:
- Engineering specifications and regulatory standards: (e.g., IEC 60601, ISO 10993, ISO 11607, ISO 11137).
- Performance characteristics of the predicate device (LiNA Loop): The new device's performance was "compared against the performance characteristics of the predicate LiNA Loop" and found to "exhibit comparable performance characteristics."
8. Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm that requires a "training set." Its function is based on established electrosurgical principles and mechanical design.
9. How the Ground Truth for the Training Set Was Established
Not applicable. See point 8.
§ 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.