(169 days)
The LiNA Bipolar Loop is a 5mm bipolar electrosurgical device intended for amputating the mobilized uterus during laparoscopic supracervical (subtotal) hysterectomy and resection of devasculated subserosal pedunculated myomas. To be used with an electrosurgical generator that provides a bipolar outlet.
The LiNA Bipolar Loop is a 5 mm single use laparoscopic instrument. It is available with three different loop dimensions; 160mm x 80mm, 200mm x 100mm x 120mm x 120mm. The outer 15mm on each side of the loop is not insulated i.e. the bipolar cutting area length totals 30mm. The device is single use ethylene oxide sterilized and is compatible with most standard electrosurgical generators that provide a bipolar outlet.
This describes the acceptance criteria and study for the LiNA Bipolar Loop, an electrosurgical device.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Efficacy and Functionality Test | ||
| - Cutting Quality (Simulated Tissue) | Qualitatively scored as 5 on a scale of 1-9 | Both the LiNA Loop (predicate) and LiNA Bipolar Loop (new device) were qualitatively scored as a 5 in simulated tissue studies using pork and beef muscle. |
| - Cutting Time (Simulated Tissue) | Within acceptable limits (±4 seconds) average deviation time between cuts compared to predicate device | Average deviation time between cuts was 0.85 seconds, assessed at respective high and low power settings using three different generators. This was found to be within acceptable limits (±4 seconds) compared to the LiNA Loop. |
| Overall Design | Meets all requirements | The LiNA Bipolar Loop meets all requirements. |
| Sterilization | Meets all requirements (SAL 10-6) | The LiNA Bipolar Loop meets all requirements and is sterile packed using Ethylene Oxide Gas (SAL 10-6). |
| Biocompatibility | Meets all requirements (Complies with ISO 10993-1) | The LiNA Bipolar Loop meets all requirements and complies with ISO 10993-1. |
| Electrical Safety | Meets all requirements (IEC 60601) | The LiNA Bipolar Loop meets all requirements and passed Electrical Safety Testing (IEC 60601). |
| Other Applicable Voluntary Standards | Passed all testing in accordance with national and international standards | The LiNA Bipolar Loop passed all testing in accordance with national and international standards. This confirms the output meets design inputs and specifications and that the device passed all testing stated. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document specifies that "200mm sized loops were selected as this represented the mid-size loop for both the Bipolar Loop and Loop." It also mentions "pork and beef muscle" for simulated tissue studies and "three different generators" for cutting time assessment. However, the exact number of loops tested, the quantity of tissue samples, or the number of cuts made is not explicitly stated.
- Data Provenance: The data is non-clinical performance data from tests conducted by LiNA Medical ApS. The country of origin of the data is not explicitly stated beyond the sponsor being LiNA Medical ApS in Glostrup, Denmark. The study is prospective in the sense that the tests were conducted specifically to support this 510(k) submission for the LiNA Bipolar Loop.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Not Applicable. For non-clinical performance data like this, "experts" in the sense of clinical reviewers establishing ground truth for a diagnostic output are not mentioned. The assessment of "cutting quality" was "qualitatively scored as a 5," implying an internal assessment based on predefined criteria, likely by engineering or technical personnel. The document does not specify who performed this scoring or their qualifications.
4. Adjudication Method for the Test Set
- Not Applicable. There is no mention of an adjudication method as this involves non-clinical performance testing rather than human interpretation of diagnostic data.
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 submission is for an electrosurgical device, not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant and was not conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is an electrosurgical instrument and does not involve AI algorithms. Therefore, standalone algorithm performance is not relevant.
7. The Type of Ground Truth Used
- The "ground truth" used for this non-clinical testing was based on predefined performance specifications and industry standards.
- For cutting quality, the ground truth was a qualitative score of '5' on a scale of 1-9.
- For cutting time, the ground truth was an acceptable deviation of ±4 seconds from the predicate device.
- For other aspects like sterilization, biocompatibility, and electrical safety, the ground truth was compliance with relevant national and international standards (e.g., ISO 10993-1, IEC 60601) and meeting internal design requirements.
8. The Sample Size for the Training Set
- Not Applicable. There is no mention of a "training set" as this is not an AI/machine learning device. The testing described focuses on validating the physical and functional performance of the device against established criteria and a predicate device.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set mentioned, the establishment of ground truth for such a set is not relevant.
§ 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.