(273 days)
The Karl Storz Bipolar Electrode is intended for use in tissue cutting, removal and desiccation as required or encountered in gynecologic hysteroscopic electrosurgical procedures for the treatment of intrauterine myomas, polyps, adhesions and septa, and benign conditions requiring endometrial ablation. Procedures include:
Excision of intrauterine myomas
Excision of intrauterine polyps
Lysis of intrauterine adhesions
Incision of uterine septa
Endometrial ablation
The Karl Storz Bipolar Electrode is a single-use.cutting loop electrode that is designed to be used in combination with a 4 mm resectoscope with a 24 or 26 Fr sheath that is connected to a generator via a high frequency cable.
The provided document is a 510(k) summary for the Karl Storz Bipolar Electrode. It aims to demonstrate substantial equivalence to predicate devices, not to perform a standalone study with acceptance criteria related to clinical performance or AI performance. Therefore, many of the requested data points (such as sample sizes for test sets, number of experts for ground truth, adjudication methods, MRMC studies, and AI-related details) are not applicable to this type of submission.
The document focuses on demonstrating the safety and performance equivalence of the subject device to predicate devices through technical characteristics, bench studies, and adherence to established standards.
Here's an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a substantial equivalence submission for a physical medical device, the "acceptance criteria" are not framed in terms of diagnostic performance metrics (e.g., sensitivity, specificity) but rather in terms of meeting established safety and performance standards for electrosurgical devices and demonstrating equivalence to predicate devices.
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Technological Equivalence | The subject KSEA Electrode should have the same features, dimensions, body contact, and insulation materials as the predicate Bipolar Electrotome (K061541), with the primary difference being an indication for gynecological vs. urological procedures. | "The subject KSEA Electrode is substantially equivalent to Bipolar Electrotome (K061541) with the same features, dimensions, body contact and insulation materials, and intended use. The only difference between the subject electrodes and the predicate electrodes is that the subject electrodes are indicated for gynecological procedures whereas the predicate device is indicated for urological procedures." |
For GYNECARE VERSAPOINT II (K111751): "There is no significant technological difference between the predicate and subject device. Both devices are bipolar and have the same intended use. Both uses a generator for the source of energy." |
| Safety Standard Conformance | Compliance with IEC 60601-1 (General requirements for basic safety and essential performance of medical electrical equipment). | "The Safety and performance equivalence are demonstrated by the testing of IEC 60601-1..." "Both the predicate and subject device have undergone and passed IEC 60601-2-2 to demonstrate the equivalence to the essential performance of the HF equipment and accessories. For additional safety requirements equivalence, both subject and predicate devices have also undergone and pass IEC 60601-1 and IEC 60601-2-18." |
| | Compliance with IEC 60601-2-2 (Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories). | "The Safety and performance equivalence are demonstrated by the testing of... IEC 60601-2-2..." "Both the predicate and subject device have undergone and passed IEC 60601-2-2 to demonstrate the equivalence to the essential performance of the HF equipment and accessories." |
| | Compliance with IEC 60601-2-18 (Particular requirements for the basic safety and essential performance of endoscopic equipment). | "The Safety and performance equivalence are demonstrated by the testing of... IEC 60601-2-18." "For additional safety requirements equivalence, both subject and predicate devices have also undergone and pass IEC 60601-1 and IEC 60601-2-18." |
| Biocompatibility | The device must meet biocompatibility requirements. | "In addition, both predicate and subject devices have undergone sterilization, biocompatibility testing and non-clinical conformance standard testing..." |
| Sterilization | The device must meet sterilization requirements. | "In addition, both predicate and subject devices have undergone sterilization, biocompatibility testing and non-clinical conformance standard testing..." |
| Performance Equivalence (Bench Studies) | Demonstrated equivalence in gas product comparison and visual depth of thermal penetration compared to predicate devices. | "Two bench studies, Comparison of Gas Product and Visual Depth of Thermal Penetration, are used to demonstrate the performance substantial equivalence of the subject and predicate devices." "The test results presented in the testing report of abovementioned testing have demonstrated the substantial equivalence in both safety and performance of the predicate and subject device." |
Since this is not an AI/software device, the following points are not applicable:
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not Applicable (N/A) - This is a physical electrosurgical device, not a diagnostic AI/software. Performance was assessed through bench testing and conformance to standards, not through clinical test sets of patient data.
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)
N/A - Ground truth for this type of device typically refers to engineering specifications, validated test methods for physical properties, and adherence to recognized standards. It does not involve expert consensus on medical images or clinical outcomes in the same way an AI diagnostic device would.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
N/A - Adjudication methods are relevant for clinical trials or studies where there's a need to resolve discrepancies in expert interpretations, which is not the case for this device's testing.
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
N/A - This device does not involve human readers interpreting images, nor does it involve AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A - This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's evaluation is primarily based on:
- International Electrotechnical Commission (IEC) Standards: IEC 60601-1, IEC 60601-2-2, and IEC 60601-2-18 define the acceptance criteria for safety and essential performance of electrosurgical equipment.
- Bench Testing Results: Comparative data from controlled laboratory bench studies (Gas Product comparison and Visual Depth of Thermal Penetration) serve as objective measures of performance to establish equivalence.
- Material Specifications and Design: Adherence to predicate device features, dimensions, body contact, and insulation materials forms part of the "ground truth" for technological equivalence.
- Biocompatibility and Sterilization Standards: Established industry and regulatory standards for these aspects.
8. The sample size for the training set
N/A - There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
N/A - No training set, no ground truth needed to be established for it.
§ 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.