(27 days)
The en-bloc Biopsy System is intended for diagnostic sampling of breast tissue during a breast biopsy procedure.
The en-bloc is a percutaneous high frequency, automated, vacuum-assisted electrosurgical device intended to remove tissue by automated electrosurgical cutting and simultaneous capture of an incised tissue volume. The Neothermia en-bloc ™ consists of a hand-held biopsy handle, upon which the single-use en-bloc Biopsy Probe is attached, and a cable connecting the handle to the control unit. The Probe™ contains two sets of active electrodes at its distal end - a precursor electrode and cutting/capture electrodes. The basket of active electrodes of the Probe™ is encased in a stainless steel cannula. An outer plastic sleeve surrounds the stainless steel cannula and an annular gap between the sleeve and the cannula provides a conduit for vacuum-assisted removal of the gaseous products and any liquids (e.g., blood) that may accumulate at the distal electrode during the biopsy procedure. The vacuum also helps maintain the required cutting arc during automated tissue capture.
The provided text is a 510(k) summary for the "en-bloc Biopsy System™" from Neothermia Corporation, submitted in 2004. This document focuses on establishing substantial equivalence to predicate devices and does NOT contain information about specific acceptance criteria, study details, or performance metrics in the way a modern AI/device study would.
Instead, the document asserts substantial equivalence based on intended use, principles of operation, and technological characteristics, and notes that any differences do not raise new questions of safety or effectiveness.
Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not present in this 510(k) submission.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Not available in the provided text. The 510(k) focuses on equivalence to predicate devices rather than setting and meeting specific quantitative performance criteria.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not available in the provided text. The document describes the device and its intended use but does not mention any clinical study or test set data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not available in the provided text. No information about ground truth establishment is present as no clinical or testing data is discussed.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not available in the provided text. No information about adjudication is present.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not available in the provided text. This device is a biopsy system, not an AI or imaging diagnostic tool. Therefore, an MRMC study with human readers and AI assistance is not relevant to this type of device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not available in the provided text. This device is a physical biopsy system, not an algorithm, so this concept does not apply.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not available in the provided text. No ground truth data is discussed.
8. The sample size for the training set
- Not available in the provided text. No training data is applicable or discussed for this physical medical device.
9. How the ground truth for the training set was established
- Not available in the provided text. Not applicable.
Summary based on the provided document:
The 510(k) summary for the Neothermia Corporation's en-bloc Biopsy System™ (K042170) primarily establishes substantial equivalence to legally marketed predicate devices. It states that the 12mm en-bloc probe has the same intended use, principles of operation, and technological characteristics as previously cleared predicate devices. The document explicitly notes that "The 12mm en-bloc probe and its predicate devices have no gross difference in the technological characteristics... this difference does not raise new questions of safety or efficacy."
The predicate devices mentioned are Neothermia's 10mm, 15mm, and 20mm en-bloc probes. The device is a "percutaneous high frequency, automated, vacuum-assisted electrosurgical device" intended for "diagnostic sampling of breast tissue during a breast biopsy procedure."
This type of 510(k) submission prior to 2004 typically relies on bench testing, engineering verification, and comparison to existing products, rather than extensive clinical studies with specific performance metrics and acceptance criteria as might be expected for novel diagnostic algorithms or AI-driven systems today. The FDA's letter confirms that a substantial equivalence determination was made.
§ 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.