(83 days)
The adeor® Meridian™ Cranial Perforator is a sterile, single-use cutting accessory intended for cranial burr-hole trephination in neurological surgery.
The Meridian™ Perforator is a single-use surgical device for cranium perforation. The device automatically releases and stops perforating at cranial bone thickness of at least 3 mm. The Meridian™ pediatric perforator version automatically releases and stops perforating at cranial bone thickness of at least 1.5 mm.
The perforators are available in three sizes: for burr-hole diameters of 6 mm, 7 mm and 11 mm.
The Meridian™ Cranial Perforator is a sterile packed, single-use cutting device intended to perform cranial burr-hole trephination in neurosurgery, driven by powered sources having a standardized and commonly used Hudson fitting clutch. The device automatically releases and stops perforating at cranial bone thickness of at least 3 mm. The Meridian™ pediatric perforators automatically release and stop perforating at cranial bone thickness of at least 1.5 mm. Both versions are available for burr-hole diameters of Ø6. Ø7 and Ø11 mm.
The Meridian™ Cranial Perforator per CFR. Part 882.4305, is a bone cutting and drilling instrument driven by a pneumatic or electric surgical motor in order to drill burr-holes through the skull of a patient. An integrated clutch mechanism prevents plunging of the perforator tip into the underlying dura and parenchyma tissue. The device is a Class II (USA) device and classified IIa in Europe (EEC).
The Meridian™ Cranial Perforator is a device similar in design and construction to other cranial perforators currently on the market; (e.g.: Acra-Cut models DGR-II and Codman Disposable Perforators etc ... )
The Meridian™ Cranial Perforator requires a motor and an attached or integrated speed reducer in order to run the perforators at a speed range of 800 ... 1200 RPM.
The Adeor Meridian™ Cranial Perforator is a sterile, single-use cutting device intended to perform cranial burr-hole trephination in neurosurgery. Its primary function is to automatically release and stop perforating once a specific cranial bone thickness is reached, preventing plunging into underlying tissue.
Here's an analysis of its acceptance criteria and the study proving it meets these criteria:
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Meridian™ Cranial Perforator are primarily centered around its ability to automatically release and stop perforation at specified bone thicknesses, and its general mechanical functionality.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Automatic release at ≥ 3 mm cranial bone thickness (standard adult perforator) | The device automatically released and stopped cutting as soon as the thin remaining pad of material became elastic in wood and animal bone tests. On animal cadavers, the release mechanism worked reliably, and a clear bone pad was formed. |
| Automatic release at ≥ 1.5 mm cranial bone thickness (pediatric perforator) | The device automatically released and stopped cutting as soon as the thin remaining pad of material became elastic in wood and animal bone tests. On animal cadavers, the release mechanism worked reliably, and a clear bone pad was formed. (The document states both versions are available with this feature, and the general performance section covers "the release mechanism," implying it functioned for both. Specific separate testing for the 1.5mm criteria is implied but not separately detailed here beyond the general statement.) |
| Reliable mechanical functionality (e.g., cutting performance, no friction, no skidding, firm rotation, plain surface finish) | Samples of each model were used to drill holes in wood and animal bone to verify mechanical functionality. All tests were performed satisfactorily with positive remarks: |
- No friction observed between rotating cutting parts.
- No skidding of the device on animal cadaver bone.
- A firm axial rotation and no wobbling observed.
- A plain and even surface of the perforated bone and on the bone flap was observed. |
| Sterility Assurance Level (SAL) of
§ 882.4305 Powered compound cranial drills, burrs, trephines, and their accessories.
(a)
Identification. Powered compound cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments employ a clutch mechanism to disengage the tip of the instrument after penetrating the skull to prevent plunging of the tip into the brain.(b)
Classification. Class II (performance standards).