(115 days)
The MicroMed PD-8K system is a non-destructive, non-patient contact, high voltage insulation tester designed to test the insulation integrity of electrosurgical instruments.
The MicroMed PD-8K system (MMPD-8K) is comprised of a reusable hand-held instrument probe, a detector or control/base unit, a ground wire and a high voltage wire in which the appropriate electrode (instrument probe) is control with and a fight vone in a mich in appropriate electrode housed at the end of the detector (control/base) unit The battery adaptor (recharger) is provided with the system for recharging the battery. The MicroMed PD-8K electrodes are reusable.
MicroMed PD-8K System includes:
- Detector (base unit)
- Battery with Charging adaptor
- Probe handle with 2m (6ft) lead-Red HV Wire
- 2m (6ft) lead ground wire with clamp-Green Wire
- Brush electrode 8mm (0.31inch) wide brass wires
- Ring Electrode with brass wires
- Carrying case
- Standard Operating Instruction manuals. CD With additional information.
Here's an analysis of the provided text regarding the acceptance criteria and study for the MicroMed PD-8K device:
Based on the provided 510(k) summary, the device is an insulation tester, and the documentation focuses on its substantial equivalence to predicate devices rather than reporting a detailed clinical study with specific acceptance criteria in the traditional sense of diagnostic or therapeutic devices.
The "acceptance criteria" here are met through demonstrating that the device has the same indications for use, similar design, and comparable performance to legally marketed predicate devices. The study proving this is primarily a comparison to predicate devices and an internal assessment of the device's technical specifications.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by 510(k) Equivalence) | Reported Device Performance of MicroMed PD-8K |
|---|---|
| Indications for Use: Insulation / Continuity testing for electrosurgical instruments. | Indications for Use: Insulation / Continuity testing for electrosurgical instruments. Matches predicate devices. |
| Design: Tester and accessories, battery-operated, rechargeable. | Design: Tester and accessories (Detector, Battery, Probe handle, Wires, Electrodes, Carrying case), battery operated and rechargeable. Similar to predicate devices. |
| Materials: Housing materials acceptable for intended use. | Materials: Plastic housing (different from predicate's aluminum casing, but implicitly acceptable). |
| Performance (Voltage Insulation Tester): Capable of high voltage insulation testing comparable to predicate devices. | Performance (Voltage Insulation Tester): Voltage: 0 to 8kV adjustable; Current Output: |
§ 884.4160 Unipolar endoscopic coagulator-cutter and accessories.
(a)
Identification. A unipolar endoscopic coagulator-cutter is a device designed to destroy tissue with high temperatures by directing a high frequency electrical current through the tissue between an energized probe and a grounding plate. It is used in female sterilization and in other operative procedures under endoscopic observation. This generic type of device may include the following accessories: an electrical generator, probes and electrical cables, and a patient grounding plate. This generic type of device does not include devices used to perform female sterilization under hysteroscopic observation.(b)
Classification. Class II (performance standards).