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

This document is a 510(k) Pre-market Notification for the Neothermia Corporation's en-bloc Biopsy System™. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for a new device or algorithm.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not directly applicable or available in this type of submission.

Here's an analysis based on the provided text, highlighting what is and isn't present:

Key Takeaway: This 510(k) submission is for a modified version of an already cleared device ("modified cradle") and aims to show it has the "same intended use, principles of operation, and technological characteristics as the previously cleared predicate devices." It explicitly states, "The change does not raise new questions of safety or efficacy." This type of submission does not typically include new performance studies with specific acceptance criteria in the way a novel device or AI algorithm would.

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

Not Applicable. This submission is based on substantial equivalence to predicate devices, not on proving new performance against defined acceptance criteria with reported metrics. The document asserts that the modified device has the "same intended use, principles of operation, and technological characteristics" as existing cleared predicate devices.

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

Not Applicable. No specific test set data is described for performance evaluation in this 510(k) summary. Given it's a "modified cradle" and not a fundamentally new device, performance testing (if any) would likely be limited to verification and validation of the modification's impact, not a full-scale clinical or diagnostic accuracy study.

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 Applicable. No test set requiring expert-established ground truth is described.

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

Not Applicable. No test set 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

Not Applicable. This is an electrosurgical biopsy system, not an AI-based diagnostic tool. Therefore, an MRMC study related to AI assistance would not be relevant.

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

Not Applicable. This is a hardware device (electrosurgical biopsy system). There is no "algorithm only" component to test for standalone performance in the context of diagnostic accuracy.

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

Not Applicable. No specific ground truth establishment for a performance study is mentioned in this submission. The device itself is intended for diagnostic sampling of breast tissue, implying that the tissue samples it yields would then be subject to pathology for definitive diagnosis.

8. The sample size for the training set

Not Applicable. This is an electrosurgical device, not a machine learning algorithm. Therefore, there is no "training set."

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

Not Applicable. No training set is involved.

Summary regarding acceptance criteria and studies:

The provided text from the 510(k) summary emphasizes substantial equivalence to predicate devices. The core argument is that the "modified cradle" of the en-bloc Biopsy System™ retains the "same intended use, principles of operation, and technological characteristics" as previously cleared devices, and that the modification "does not raise new questions of safety or efficacy."

Therefore, this document does not contain information about:

Specific quantitative acceptance criteria for device performance (e.g., sensitivity, specificity, accuracy).
Clinical studies or diagnostic accuracy studies with sample sizes, data provenance, ground truth establishment, or reader performance metrics.
Any AI-related performance metrics or studies.

The "study" implicitly referenced is the comparison to predicate devices, demonstrating that the modified device is similar enough not to warrant new, extensive performance studies typically required for novel devices.

Summary

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Ko 33 427

NOV 1 0 2003

510(k) SUMMARY

Neothermia Corporation's en-bloc Biopsy System™

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

Sherrie Coval-Goldsmith VP. RA/QA Neothermia Corporation One Apple Hill, Suite 316 Natick, Massachusetts 01760 Phone: (508) 655-7820 Facsimile: (508) 655-7822

Date Prepared: October 21, 2003

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) 655-6239

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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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 modified cradle has the same intended use, principles of operation, and technological characteristics as the previously cleared predicate devices. The modified device and its predicate devices are both electrosurgical devices used to biopsy breast tissue. The change does not raise new questions of safety or efficacy. The modified cradle is substantially equivalent to Neothermia's cleared en-bloc cradles.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 0 2003

Ms. Sherrie Coval-Goldsmith Vice President, Regulatory Affairs Neothermia Corporation One Apple Hill, Suite 316 Natick, Massachusetts 01760

Re: K033427

Trade/Device Name: en-bloc Biopsy System™ Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology urology biopsy instrument Regulatory Class: II Product Code: KNW Dated: October 27, 2003 Received: October 31, 2003

Dear Ms. Coval-Goldsmith:

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 - Ms. Sherrie Coval-Goldsmith

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Office of Compliance at (301) 594-4659. 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 Manufacturers, 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/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): ___________________________________________________________________________________________________________________________________________________

Device Name: en-bloc Biopsy System™

Indications for Use:

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

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

CDRH, Office of Device Evaluation (ODE)

. ____________________________________________________________________________________________________________________________________________________________________________

Prescription Use _____________________________________________________________________________________________________________________________________________________________

Over-The-Counter Use_ (Per 21 C.F.R. 801.109)

(Optional Format 1-2-96)

Miriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K033427

Regulation Number and Section

§ 876.1075 Gastroenterology-urology biopsy instrument.

(a)
Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification. (1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.