(162 days)
Bipolar tissue coagulation in gynecologic and laparoscopic surgical procedures.
The POWERGRIP coagulation forceps are designed for grasping, cutting and bipolar coagulation in minimally invasive surgery. The POWERGRIP handle actuates the jaws of the electrode inserts by means of a double-hinge and serves as the point of attachment for accessories (shafts, inserts, cables).
The provided text is a 510(k) summary for the Guenter Bissinger Medizintechnik GmbH POWERGRIP Bipolar Coagulation Forceps. It's a regulatory document for a medical device and describes modifications to an existing device, rather than a study proving performance against acceptance criteria in the typical sense of a clinical trial or performance study.
Based on the document, here's what can be extracted and what information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not contain a table of acceptance criteria or reported device performance in the way a clinical study report would. Instead, it makes claims of substantial equivalence to a predicate device and states that modifications improve handling and do not affect safety or effectiveness.
| Acceptance Criteria (Implied) | Reported Device Performance (Claimed) |
|---|---|
| Safety and Effectiveness not adversely affected by modification | "THIS CHANGE DOES NOT AFFECT THE SAFETY OR EFFECTIVENESS OF THE DEVICE." |
| Improved handling control for direction and accuracy | "To improve handling control with respect to direction and accuracy of forceps during surgical procedures" |
| Easier, faster, more effective disassembly and re-assembly for exchange and reprocessing | "To make disassembly and re-assembly easier, faster and more effective for exchange of electrode jaws during procedure and for reprocessing." |
| Surgeon's control of electrode jaws improved | "the internal mechanical connection to the jaws improves the surgeon's control of the electrode jaws" |
| Well-adjustable opening and closing of jaws | "assures well adjustable opening and closing of the jaws with very high pressure during grasping and cutting and high precision in tissue coagulation." |
| No new risk for patient or surgeon | "The device modification introduces no new risk for patient or surgeon and enhances device safety and effectiveness when compared to the predicate." |
| Compliance with industry standards | "BISSINGER certifies compliance with all appropriate industry standards and the validation of methods and processes covered by these standards." |
| UL Compliant (implied acceptance criteria from predicate) | UL-544 |
| ISO Compliant (implied acceptance criteria from predicate) | ISO 9001 |
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a test set or a study involving a particular sample size of cases/patients. The submission is for a modification to an existing device and relies on showing substantial equivalence to a predicate device and that the change does not adversely affect safety or effectiveness. There's no mention of country of origin or whether hypothetical data would be retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This document does not describe a study involving experts to establish ground truth. The claims made are based on design rationale and comparison to a predicate device.
4. Adjudication Method for the Test Set
Not applicable, as no test set or study with expert ground truth establishment is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done or described in this document. The submission is a regulatory filing for a device modification, focusing on substantial equivalence and design changes, not a comparative clinical effectiveness study.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This is a physical medical device (coagulation forceps), not an algorithm or AI.
7. Type of Ground Truth Used
Not applicable. No ground truth in the context of a performance study is mentioned. The "ground truth" for this regulatory submission is the substantial equivalence to the predicate device and the engineering/design justification that the modifications do not compromise safety or effectiveness.
8. Sample Size for the Training Set
Not applicable. This is a physical medical device, not a machine learning model, so there is no training set mentioned or relevant.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set is mentioned.
§ 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.