(82 days)
The en-bloc Biopsy System is intended for diagnostic sampling of breast tissue during a breast biopsy procedure.
The en-bloc is a high frequency, vacuum-assisted electrosurgical device used to remove and simultaneous capture of an incised tissue volume. The Neothermia en-bloc TM consists of a hand-held biopsy handle, upon which the single use disposable Probe is attached, with an integral cable to connect the handle to the en-bloc Electrosurgical Generator. The Probe contains two sets of active electrodes at its distal end - a precursor electrode and cutting/capture electrodes. The shaft of the Probe™ is encased in a stainless steel cannula. A plastic sleeve surrounds this stainless steel cannula and an annular gap between the sleeve and the cannula provides a conduit for vacuumassisted removal of the gaseous products of electrosurgical cutting and any liquids (e.g., blood) that may accumulate at the distal end of the Probe during the biopsy procedure.
The provided text is a 510(k) summary for the Neothermia Corporation's en-bloc Biopsy System™. It discusses the device's intended use, technological characteristics, and a performance study. However, it does not provide specific acceptance criteria in a quantifiable manner, nor does it detail a study that explicitly "proves the device meets acceptance criteria" with the level of detail requested in your prompt (e.g., sample sizes, expert qualifications, ground truth methodology as typically seen in AI/diagnostic device studies).
This submission focuses on demonstrating substantial equivalence to predicate devices, particularly the ability to obtain viable tissue samples for pathology, rather than statistical performance against predefined clinical metrics.
Here's an attempt to extract the information you requested based on the limited data, acknowledging where information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Ability to cut and capture a predictable volume of tissue. | "It was determined that the 20mm probe is capable of obtaining intact, unfragmented biopsy specimens having a predictable diameter and length." |
| Suitability of excised tissue for post-biopsy histopathologic examination. | "...and suitable for post-biopsy histopathologic examination." |
| (Implicit) Maintain safety and efficacy comparable to predicate devices. | "Although there are minor differences... those differences do not raise new questions of safety or efficacy." |
| (Implicit by intended use) Diagnostic sampling of breast tissue. | The device's performance aligns with its intended use for diagnostic sampling, by providing specimens suitable for examination. |
Note: The acceptance criteria are inferred from the stated purpose of the performance testing and the general concept of substantial equivalence for a biopsy device. No quantitative thresholds (e.g., "capture rate > 95%", "fragmentation rate
§ 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.