(192 days)
Tissue grasping and control of bleeding of small vessels by bipolar coagulation.
The Bipolar Forceps device is a single use hand held insulated medical device approximately 295mm in overall length featuring a 190mm distance from the user's grasp to the tip. The bayonet offset is 1.5cm. The tips are Titanium Nitride coated and have polished contact surfaces 1.5mm wide by 1cm long. The device is offered in straight and 20 degree angled tips. The Bipolar Forceps are sold as a single use sterile packaged device used in general surgical procedures. The Bipolar Forceps are limited to maximum 70 watts and shall be used only by personnel with training in electrosurgical procedures and with compatible generators compliant with IEC 60601 requirements. The Bipolar Forceps are rated at 1000V peak and can be used with a compatible reusable pin plug cable (1.8mm pin, 5.8mm spacing). The Bipolar Forceps are single use disposable devices packaged in double blisters with Tyvek lid.
The provided text describes the 510(k) submission for the Boston Endo Surgical Technologies (division of Lacey Manufacturing) Bipolar Forceps. However, it does not contain a study explicitly designed to prove device performance against specific acceptance criteria in the manner typically seen for complex diagnostic or AI-driven medical devices.
Instead, this submission focuses on demonstrating substantial equivalence to a predicate device (K032327 Modern Medical Bipolar Forceps) through a comparison of technological characteristics and performance testing to ensure safety and basic functionality.
Here's an breakdown of the information that is present, and what is absent from the provided text, in relation to your request:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, there are no explicitly stated numerical "acceptance criteria" for clinical performance (e.g., sensitivity, specificity, accuracy) or device performance beyond general functional and safety standards. The performance section focuses on safety and biocompatibility.
| Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Cytotoxicity | Non-cytotoxic | Non-cytotoxic |
| Irritation | Non-irritating | Non-irritating |
| Sensitization | Non-sensitizing | Non-sensitizing |
| Electrosurgical Function | Proper cutting and coagulation | The device properly cut and coagulated the tissue. (Animal tissue testing) |
| Electrical Safety | Met standards | No issues found |
| Packaging Validation | Met standards | No issues found |
| Shipping & Transportation | Met standards | No issues found |
| Aging Shelf Life | Met standards | No issues found |
| Hi-Pot | Met standards | No issues found |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: The text mentions "animal tissue of various diameters" for the electrosurgical function testing. No specific sample size (number of animals, number of tissue samples) or details about the tissue types or conditions (e.g., healthy vs. diseased) are provided.
- Data Provenance: Not specified. It's internal company testing, likely conducted in a lab setting rather than clinical data from a specific country.
- Retrospective/Prospective: Not applicable in the context of this device's performance testing. The biocompatibility and safety tests are laboratory-based, and the functional testing on animal tissue is a controlled experimental setup.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable. The "ground truth" for these types of tests (biocompatibility, electrical safety, functional cutting/coagulation) is typically determined objectively by laboratory measurements and observation against established standards, not by expert consensus on clinical findings.
- Qualifications of Experts: Not applicable beyond the implicit assumption that the testers were qualified laboratory personnel.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. This concept (e.g., 2+1, 3+1 for clinical image interpretation) is not relevant for the type of testing described for this device.
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
- MRMC Study: No. This is a basic surgical instrument, not an AI-assisted diagnostic device. Therefore, no MRMC study or AI-related effectiveness analysis was performed or is relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Ground Truth: For biocompatibility tests, the ground truth is defined by the results of the specific ISO 10993 tests (e.g., presence/absence of cytotoxic effects, irritation, sensitization). For electrical safety, it's compliance with electrical standards. For functional testing, "properly cut and coagulated" acts as the objective ground truth against the expected performance of an electrosurgical device on tissue.
8. The sample size for the training set
- Training Set Sample Size: Not applicable. This device does not use machine learning or AI, so there is no training set in the typical sense.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable.
Summary of the Study Demonstrated in the K131058 Submission:
The submission for the Bipolar Forceps primarily relies on design and material equivalence to a predicate device (K032327 Modern Medical Bipolar Forceps), coupled with benchtop and laboratory testing to ensure safety, biocompatibility, and basic functional performance.
The "study" that proves the device meets (implied) acceptance criteria consists of:
- Biocompatibility Testing: Performed according to ISO 10993 guidelines, FDA General Program Memorandum No. G95-1, and ODE Bluebook Memorandum G95-1. These tests (Cytotoxicity, Irritation, Sensitization) concluded the device was non-cytotoxic, non-irritating, and non-sensitizing.
- Performance Testing: Conducted after sterilization, using "animal tissue of various diameters" to simulate vessels at different power settings. The conclusion was that "The device properly cut and coagulated the tissue."
- Safety and Efficacy Testing: This included Electrical safety, Biocompatibility (reiterated), Packaging validation, Shipping & transportation, Aging Shelf Life, and Hi-Pot tests. All testing "found no issues of safety or effectiveness."
The core argument for substantial equivalence is that the new device is almost identical to the predicate, with the only significant difference being that the subject device is sterile and single-use, while the predicate is reusable. This difference does not alter the fundamental mechanism of action or intended use.
§ 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.