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 submission (K021577) is a 510(k) premarket notification for the Neothermia Corporation's en-bloc Biopsy System™. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than presenting a performance study with detailed acceptance criteria in the manner one might find for a novel AI/software component within a medical device.

Therefore, the provided text does not contain the information requested regarding acceptance criteria related to a performance study, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or detailed ground truth establishment.

The document discusses:

The intended use of the device ("diagnostic sampling of breast tissue during a breast biopsy procedure").
Its technological characteristics (percutaneous high frequency, automated, vacuum-assisted electrosurgical device for tissue removal).
The components of the system (hand-held biopsy handle, single-use probe with electrodes, cannula, plastic sleeve, vacuum).
The basis of substantial equivalence: The 15mm en-bloc probe has the same intended use, principles of operation, and technological characteristics as the previously cleared predicate devices (Neothermia's 10mm and 20mm en-bloc probes).
A minor difference in technological characteristics (size of basket) is noted, but the submission claims this "does not raise new questions of safety or efficacy."

Conclusion:

Based on the provided text, it is not possible to extract the detailed information requested about acceptance criteria and a performance study. The submission relies on establishing substantial equivalence to existing devices, implying that the safety and effectiveness are supported by the predicate devices, not a new clinical performance study within this document.

Summary

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021577 1/2

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 (508) 655-7820 Phone: Facsimile: (508) 655-7822

April 23, 2002 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) 655-6239

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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K021577 2/2

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 15mm en-bloc probe has the same intended use, principles of operation, and technological characteristics as the previously cleared predicate devices. The 15mm enbloc probe and its predicate devices are both electrosurgical devices used to biopsy breast tissue. Although there is one minor difference in the technological characteristics of the 15 mm probe and its predicate devices (e.g., size of basket) this difference does not raise new questions of safety or efficacy. The 15mm en-bloc probe is substantially equivalent to Neothermia's 10mm and 20mm en-bloc probes.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three curved lines representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 9 2002

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

Re: K021577

Trade/Device Name: en-bloc Biopsy System™ Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI and KNW Dated: May 13, 2002 Received: May 14, 2002

Dear Ms. Coval-Goldsmith:

We have reviewed your Section 510(k) premarket notification of intent to market the devices in we nave reviewed your becaon 310(x) premail.co.is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the clerosure) to regars actiment date of the Medical Device Amendments, or to commerce prior to May 20, 1976, the exactions of the Federal Food. Drug.
devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. devices mail have been recuire approval of a premarket approval application (PMA). and Cosment Act (Act) that do not require appro the general controls provisions of the Act. The I ou may, ucterore, market the act include requirements for annual registration, listing of general controls provisions of ractice, 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 If your device is blussified (600 above) as . Existing major regulations affecting your device can thay be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Our acements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I least of advised that I Dris issualite or our device complies with other requirements of the Act that I Dri has made a acterimentations administered by other Federal agencies. You must or any I coolar surated and regisments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFR Part 6077, idocinig (21 CFR Rart 820); and if applicable, the electronic forth in the quality by became (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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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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K021577 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) Concurrence of

CDRH, Office of Device Evaluation (ODE)

Prescription Use K

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

(Optional Format 1-2-96)

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Miriam C. Provost

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

510(k) Number K021577

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.