(372 days)
Faulhaber Single Use Non-Stick Bipolar Forceps sterile and Single Use Non-Stick Bipolar Irrigating Forceps sterile/ non-sterile are intended for use by a physician familar with electrosurgery for bipolar coagulation and irrigation of tissue for general surgery. The bipolar forceps are used with the bipolar output for standard electrosurgical generators. The products are intended for single use and are provided sterile as well as non-sterile.
Products supplied non-sterile must be cleaned, disinfected and sterilized prior to their use by the validated cleaning, disinfection and sterilization process.
The bipolar forceps have not been shown to be effective for tubal coagulation for sterilization procedures and should not be used for these procedures.
The types of surgery intended are
- General surgery
- Laryngeal coagulation
- Orthopedic coagulation
- Thoracic coagulation
- Neurosurgical coagulation
- Gynecological coagulation (except for use in female sterilization)
- Urological coagulation
- Ear-, Nose-, Throat coagulation
The product family "Single Use Bipolar Forceps", including Faulhaber Single Use Non-Stick Bipolar Forceps and Single Use Non-Stick Bipolar Irrigating Forceps, are intended to be used for bipolar coagulation and irrigation of tissue by physicians familiar with bipolar coagulation in medical practices and clinics.
The Single Use Bipolar Forceps are single use products and must not be reused. They are provided sterile as well as non-sterile. Products delivered non sterile must be cleaned, disinfected and sterilized before use.
For the application the Single Use Bipolar Forceps have to be connected by appropriate bipolar cable to the bipolar output of an HF generator. Bipolar cables and ESU are not part of the subject device.
The Single Use Bipolar Forceps are provided in bayonet design with non-stick tips and are identical in design, construction, materials and manufacturing to the reusable device EGON FAULHABER Bipolar Non-Stick Forceps (K101080). The principles of operation and mechanism of action are identical as well.
In addition to the cleared and leqally marketed EGON FAULHABER devices, the products are with irrigation function available. The irrigation function works via a drain running along the forceps tines from tip to handle height, the drain is connected by Luer-Lock via an irrigation tubing with an irrigation pump.
This FDA 510(k) summary describes the "Single Use Non-Stick Bipolar Forceps sterile/non-sterile" and "Single Use Non-Stick Bipolar Irrigating forceps sterile/non-sterile" and their substantial equivalence to predicate devices. However, the document does not provide acceptance criteria in a tabular format with reported device performance for specific clinical metrics. Instead, it focuses on demonstrating safety and efficacy through non-clinical performance tests and comparison to a predicate device.
Here's an analysis based on the provided text, addressing your points where information is available:
1. A table of acceptance criteria and the reported device performance
The document does not present acceptance criteria and reported device performance in a formal table with specific numerical metrics commonly associated with AI/ML device evaluations (e.g., sensitivity, specificity, AUC). Instead, it focuses on demonstrating compliance with recognized standards and successful completion of engineering tests.
The general "acceptance criterion" implicit throughout the document is that the subject device performs as safely and effectively as the predicate devices and meets relevant electrical safety and mechanical strength standards.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Mechanical Strength (Drop Test) | Passed without damage; outer packaging remained in transportable condition. Demonstrated suitability of the packaging system. |
| Electrical Safety (DIN EN IEC 60601-2-2) | Completed entire test cycles without changes or impairments to insulation, mechanics, or function. Complies with the standard. |
| Performance (Mechanical Strength, Electrical Performance, Thermal Effects on Tissue) | All test results met pre-defined acceptance criteria. Products with irrigation function achieved same results, and in some cases better results (with maximum power setting) than products without irrigation function. Provided safe and appropriate results for intended use. |
| Biocompatibility (ISO 10993-1) | Manufactured from identical material using identical processes and procedures as the primary predicate device (K101080). Safety for use of materials proven in past and monitored by Post Market Surveillance. |
2. Sample size used for the test set and the data provenance
The document describes non-clinical performance testing.
- Sample Size: The document does not specify general "sample sizes" in terms of number of devices tested for each performance test. For the thermal effects on tissue, it states "three different types of tissue (liver, kidney and muscle) were coagulated." This refers to the tissue types, not the number of devices or test repetitions.
- Data Provenance: The tests are described as in vitro or bench tests conducted "in accordance with the Guidance for industry and food and drug administration staff 'Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery' from August 15, 2016." The location of these tests or the "country of origin of the data" is not explicitly stated, but the manufacturer is based in Germany, and European standards (DIN EN IEC) are cited. These are non-clinical, controlled tests, not derived from clinical patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to this submission. The device is a medical instrument (electrosurgical forceps), not an AI/ML device that generates diagnoses or interpretations requiring human expert "ground truth." The performance is evaluated based on objective physical, electrical, and thermal properties as per engineering standards and guidance.
4. Adjudication method for the test set
This information is not applicable. As stated above, this is not an AI/ML device evaluating clinical cases requiring expert adjudication.
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
A multi-reader multi-case (MRMC) comparative effectiveness study is not applicable as this is not an AI/ML device that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as this is not an AI/ML device.
7. The type of ground truth used
For this electrosurgical device, "ground truth" is established by:
- Compliance with recognized international standards for electrical safety (DIN EN IEC 60601-2-2) and biocompatibility (ISO 10993-1).
- Demonstration of mechanical integrity through drop testing.
- Demonstration of appropriate thermal effects on tissue, tested on "three different types of tissue (liver, kidney and muscle)" in comparison to a predicate device and meeting "pre-defined acceptance criteria." This could be considered a form of "bench test ground truth" where expected thermal effects are the standard.
8. The sample size for the training set
This is not applicable as this is not an AI/ML device and therefore does not have a "training set."
9. How the ground truth for the training set was established
This is not applicable as this is not an AI/ML device and does not have a "training set."
In summary, the provided document describes a device submission for an electrosurgical instrument, not an AI/ML-driven device. Therefore, many of the requested details regarding AI/ML device evaluation (like expert ground truth, MRMC studies, training sets) are not relevant to this specific K182773 submission.
§ 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.