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The en-bloc Biopsy System is indicated to provide tissue samples for diagnostic sampling of breast abnormalities.

The en-bloc Biopsy System is intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality.

The en-bloc Biopsy System is intended to provide breast tissue for histologic examination with partial removal of a palpable abnormality.

The extent of a histologic abnormality cannot always be readily determined from palpation or imaged appearance. Therefore, the extent of removal of the palpable or imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality, e.g., malignancy. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.

In instances when a patient presents with a palpable abnormality that has been classified as benign by clinical and/or radiological criteria (e.g., fibroadenoma, fibrocystic lesion), the en-bloc Biopsy System may also be used to partially remove such palpable lesions. Whenever breast tissue is removed, histologic evaluation of the tissue is the standard of care. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.

The en-bloc is a percutaneous high frequency, automated, vacuum-assisted electrosurgical device used 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, with an integral cable to connect 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 shaft of the Probe™ is encased in a stainless steel cannula. An outer plastic sleeve surrounds this stainless steel cannula and an annular gap between the sleeve and the cannula provides a conduit for vacuum-assisted 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 vacuum also helps maintain the required cutting arc during automated tissue capture.

The provided text is a 510(k) summary for the Neothermia Corporation's en-bloc Biopsy System™. It discusses the device's intended use and technological characteristics, as well as its substantial equivalence to predicate devices. However, the document does NOT contain information about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, or specific performance metrics that would be typically found in a clinical study report.

Therefore, I cannot provide the requested table and study details. The document is primarily a regulatory submission establishing substantial equivalence to existing devices, not a detailed technical report of a new study to prove device performance against specific acceptance criteria.

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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 used 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, with an integral cable to connect 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 shaft of the Probe is encased in a stainless steel cannula. An outer plastic sleeve surrounds this stainless steel cannula and an annular gap between the sleeve and the cannula provides a conduit for vacuum-assisted 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 vacuum also helps maintain the required cutting arc during automated tissue capture.

The provided text is a 510(k) summary for the Neothermia Corporation's en-bloc Biopsy System™. It focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than presenting a study with specific acceptance criteria and performance metrics for a new device's efficacy or accuracy.

Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, efficacy studies (MRMC, standalone), and ground truth establishment cannot be extracted from this document. This document primarily describes the device, its intended use, and argues for its substantial equivalence based on technological characteristics and principles of operation.

Here's what can be extracted and a clear statement of what cannot:

1. A table of acceptance criteria and the reported device performance

• Cannot be provided. This document does not specify performance acceptance criteria or report performance data to meet such criteria. It focuses on demonstrating equivalence in design and intended use to existing devices.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Cannot be provided. The document does not describe any specific test set or clinical study to evaluate the device's performance. It primarily discusses the manufacturing modification of the probe and its similarity to predicate devices.

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)

• Cannot be provided. No test set or ground truth establishment is described in this document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Cannot be provided. No test set or adjudication process is described.

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

• Cannot be provided. This device is an electrosurgical biopsy system, not an AI-powered diagnostic tool for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and not mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Cannot be provided. This device does not have an "algorithm only" component. It is a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Cannot be provided. No ground truth is mentioned as no performance study is detailed.

8. The sample size for the training set

• Cannot be provided. This document is for a physical device, not a machine learning algorithm that requires a training set.

9. How the ground truth for the training set was established

• Cannot be provided. (Same reason as above).

Summary of available information from the document:

This 510(k) summary is for a modification to an existing device, specifically the Neothermia Corporation's en-bloc Biopsy System™. The submission argues for substantial equivalence to previously cleared versions of the device, rather than presenting new performance data for a novel device.

• Device Name: en-bloc Biopsy System™
• Intended Use: Diagnostic sampling of breast tissue during a breast biopsy procedure.
• Technological Characteristics: Percutaneous high frequency, automated, vacuum-assisted electrosurgical device used to remove tissue by automated electrosurgical cutting and simultaneous capture of incised tissue volume.
• Predicate Devices: Neothermia's cleared 10mm, 12mm, 15mm, and 20mm en-bloc probes.
• Basis for Substantial Equivalence: The probe with the manufacturing modification has the "same intended use, principles of operation, and technological characteristics" as the previously cleared predicate devices. Both the modified probe and predicate devices are electrosurgical devices used to biopsy breast tissue.

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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.

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