(430 days)
Bipolar tissue coagulation in: Gynecology and and Laparascopic surgical procedures
The bissinger® detachable bipolar coagulation-forceps 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. The device consists of a Forceps Body (grip), Exterior tube (available in three working lengths), Interior tube (sliding tube, available in three working lengths), 1mm Electrode (fluted bit, available in three working lengths), 3mm Electrode (tong-type bit, available in three working lengths), Hirsch-electrode (rippled bar, available in three working lengths), and various types of plugs (Erbe-type, Martin/Berchtold-type, Codman-type, Valleylab-type) to connect to different current generators, and a Cable.
The provided text describes a 510(k) premarket notification for the bissinger® detachable bipolar coagulation-forceps. It addresses the device description, classification, and a comparison to a predicate device. However, it does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.
The document specifically states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent...". This indicates that the approval was based on a demonstration of substantial equivalence to a legally marketed predicate device (WISAP bipolar coagulators), rather than a separate device performance study with acceptance criteria.
Therefore, I cannot fulfill your request for a table of acceptance criteria, reported device performance, sample sizes, ground truth details, or expert information as this data is not present in the provided text.
The text focuses on administrative details of the 510(k) submission, including:
- Device Name: bissinger® detachable bipolar coagulation-forceps
- Common Name: Coagulation forceps
- Classification Name: Bipolar, Coagulator-Cutter, Endoscopic, Bipolar and Accessories
- Device Class: Class III (but noted that "No effective date has been established of the requirement for premarket approval. See § 884.3.")
- Classification Panel: OB/GYN
- Product Code: 85HIN (later updated in the FDA response letter to 85HET and 78KNS)
- Predicate Device: WISAP bipolar coagulators from WISAP USA
- Intended Use: Bipolar tissue coagulation in Gynecology and Laparoscopic surgical procedures.
The "Feature Comparison Table" (section 7) primarily details physical and material similarities between the device and the predicate, which is typical for demonstrating substantial equivalence for 510(k) submissions. It lists features like intended use, materials, length, forcep style, insulation material, and compliance with UL and ISO standards. All features are marked as "Yes" for "SE?" (Substantial Equivalence). This table does not represent performance acceptance criteria.
§ 884.1720 Gynecologic laparoscope and accessories.
(a)
Identification. A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for gynecologic laparoscope accessories that are not part of a specialized instrument or device delivery system, do not have adapters, connector channels, or do not have portals for electrosurgical, lasers, or other power sources. Such gynecologic laparosope accessory instruments include: the lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument, suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable), scissors, and suction/irrigation probe. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.