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.

AI/ML Overview

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.

Summary

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MAR 3 ] 2005

P 1 of 2

510(k) SUMMARY

K050737

Neothermia Corporation's en-bloc Biopsy System™

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

David Jacobs VP. Engineering and Operations Neothermia Corporation One Apple Hill, Suite 316 Natick, Massachusetts 01760 (508) 655-7820 Phone: (508) 655-7822 Facsimile:

March 10, 2005 Date Prepared:

Name of Device and Name/Address of Sponsor

Common or Usual Name:	Electrosurgical Generator
Trade or Proprietary Name:	en-bloc Biopsy System™
Classification Name:	Electrosurgical Cutting & Coagulation Device &Accessories (21 C.F.R. § 878.4400)Biopsy Instrument (21 C.F.R. § 876.1075)

Neothermia Corporation One Apple Hill, Suite 316 Natick, Massachusetts 01760 Phone: (508) 655-7820 Facsimile: (508) 655-7822

Predicate Devices

Neothermia Corp.'s en-bloc Biopsy System™

Intended Use

The en-bloc Biopsy System is intended for diagnostic sampling of breast tissue during a breast biopsy procedure.

Technological Characteristics

The en-bloc is a percutaneous high frequency, automated, vacuum-assisted electrosurgical device used to remove tissue by automated electrosurgical cutting and

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KOSO737

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.

Substantial Equivalence

The probe with this manufacturing modification has the same intended use, principles of operation, and technological characteristics as the previously cleared predicate devices. The en-bloc probe with the manufacturing modification and its predicate devices are both electrosurgical devices used to biopsy breast tissue. The en-bloc probe with the manufacturing modification is substantially equivalent to Neothermia's cleared 10mm, 12mm, 15mm and 20mm en-bloc probes.

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Image /page/2/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with text around the perimeter. In the center of the seal is a stylized symbol that resembles a caduceus, a symbol often associated with medicine and healthcare.

MAR 3 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. David Jacobs V.P. Engineering Neothermia Corporation One Apple Hill, Suite 316 Natick, Massachusetts 01760

Re: K050737

Trade/Device Name: en-bloc Biopsy System™ Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: March 18, 2005 Received: March 21, 2005

Dear Mr. Jacobs:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 -- Mr. David Jacobs

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and in your be only finding of substantial equivalence of your device to a legally premative notification ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you desire specific acrive 101 7 216-0120 . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other generers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

A
Miriam C. Provost, Ph.D.

n C. Provost, Ph.D. Mi Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

K050737

510(k) Number (if known):

Device Name: en-bloc Biopsy SystemTm

・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・

Indications For Use: The en-bloc Biopsy System is intented for diagnostic sampling of breast tissue during a breast biopsy procedure.

Prescription Use

AND/OR

Over-The-Counter Use

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ・・・

்படுகின்றன.
இந்து இருக்கு இருக்கு இருக்கு இருக்கும் இருக்கும் இருக்கும் இருக்கும் இருக்கும் இருக்கும் இருக்கும் இருக்கும் இருக்கும் இருக்கும் இருக்கும் இருக்கும் இருக்கும் இ

(Part 21 CFR 801 Subcart D)

(21 CFR 807 Subpart C)

(Please Do Not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Stypt Rhodes
(Division Sign-Off)

Division of General, Restorative and Neurological Devices

510(1) ATarshage K050737

Regulation Number and Section

§ 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.