The en-bloc is a high frequency, vacuum-assisted electrosurgical device used to remove and simultaneous capture of an incised tissue volume. The Neothermia en-bloc TM consists of a hand-held biopsy handle, upon which the single use disposable Probe is attached, with an integral cable to connect the handle to the en-bloc Electrosurgical Generator. 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. A plastic sleeve surrounds this stainless steel cannula and an annular gap between the sleeve and the cannula provides a conduit for vacuumassisted 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.

AI/ML Overview

The provided text is a 510(k) summary for the Neothermia Corporation's en-bloc Biopsy System™. It discusses the device's intended use, technological characteristics, and a performance study. However, it does not provide specific acceptance criteria in a quantifiable manner, nor does it detail a study that explicitly "proves the device meets acceptance criteria" with the level of detail requested in your prompt (e.g., sample sizes, expert qualifications, ground truth methodology as typically seen in AI/diagnostic device studies).

This submission focuses on demonstrating substantial equivalence to predicate devices, particularly the ability to obtain viable tissue samples for pathology, rather than statistical performance against predefined clinical metrics.

Here's an attempt to extract the information you requested based on the limited data, acknowledging where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred)	Reported Device Performance
Ability to cut and capture a predictable volume of tissue.	"It was determined that the 20mm probe is capable of obtaining intact, unfragmented biopsy specimens having a predictable diameter and length."
Suitability of excised tissue for post-biopsy histopathologic examination.	"...and suitable for post-biopsy histopathologic examination."
(Implicit) Maintain safety and efficacy comparable to predicate devices.	"Although there are minor differences... those differences do not raise new questions of safety or efficacy."
(Implicit by intended use) Diagnostic sampling of breast tissue.	The device's performance aligns with its intended use for diagnostic sampling, by providing specimens suitable for examination.

Note: The acceptance criteria are inferred from the stated purpose of the performance testing and the general concept of substantial equivalence for a biopsy device. No quantitative thresholds (e.g., "capture rate > 95%", "fragmentation rate < 2%") are provided in this summary.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not explicitly stated, but the testing was conducted "on porcine tissue."
Data Provenance: Porcine tissue (animal model). The data is likely prospective as it was collected for the purpose of this evaluation. The country of origin of the porcine tissue is not mentioned.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Number of Experts: Not specified.
Qualifications of Experts: Not specified. However, the evaluation mentions "pathology evaluation" and "histopathologic examination," implying that pathologists or histotechnicians would have been involved in assessing the suitability of the specimens.

4. Adjudication Method for the Test Set

Adjudication Method: Not specified. Given the nature of the "pathology evaluation," it likely involved one or more experts assessing the tissue samples.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

MRMC Study: No, an MRMC comparative effectiveness study was not done. This document describes a device for tissue extraction, not an interpretation aid for diagnostic imaging, which is where MRMC studies are typically employed for AI products.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Standalone Performance: Not applicable. This is a physical biopsy device, not a diagnostic algorithm or AI system.

7. The Type of Ground Truth Used

Type of Ground Truth: The ground truth was based on the histopathologic examination of the excised porcine tissue. This assessed whether the specimens were "intact, unfragmented," had a "predictable diameter and length," and were generally "suitable for post-biopsy histopathologic examination."

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This device is not an AI/algorithm that requires a training set. The performance testing was for the physical device's cutting and capture capabilities.

9. How the Ground Truth for the Training Set Was Established

Ground Truth for Training Set Establishment: Not applicable, as there is no training set for this type of device.

Summary

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020031 1/2

MAR 2 7 2002

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: (508) 655-6239 Facsimile:

Date Prepared:January 3, 2002

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™ (K003190) and the 20mm Auto Suture ABBI Breast Biopsy System (K983296).

Intended Use

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

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020031 2/2

Technological Characteristics

The en-bloc is a high frequency, vacuum-assisted electrosurgical device used to remove The on bloc is a might no quating and simultaneous capture of an incised tissue volume. The Neothermia en-bloc TM consists of a hand-held biopsy handle, upon which the singler the roomering on orobe is attached, with an integral cable to connect the handle to the use chool Droppy 11000 is antains two sets of active electrodes at its distal end - a precursor electrode and cutting/capture electrodes. The shaft of the Probe™ is encased in provinsity clostrode and canning the plastic sleeve surrounds this stainless steel cannula and an annular gap between the sleeve and the cannula provides a conduit for vacuumassisted removal of the gaseous products of electrosurgical cutting and any liquids (e.g., abood) that may accumulate at the distal end of the Probe during the biopsy procedure.

Performance Data

Testing of the device was conducted on porcine tissue to evaluate the ability of the 20mm probe to cut and capture a predictable volume of tissue and to assess its suitability for proble to our pathology evaluation. It was determined that the 20mm probe is capable of obtaining intact, unfragmented biopsy specimens having a predictable diameter and length and suitable for post-biopsy histopathologic examination.

Substantial Equivalence

The Company's en-bloc Biopsy System™ with a 20mm probe covered by this submission is substantially equivalent to its en-bloc Biopsy System™ with a 10mm probe ( K003190). Additionally, it is substantially equivalent to United States Surgical Corp.'s 20mm Auto Suture (ABBI) Breast Biopsy System (K9963825).

The modified en-bloc Biopsy System™ with a 20mm probe is identical to the cleared enbloc Biopsy System™ with a 10mm probe except that the former is available with a 20mm disposable probe, as well as the cleared 10mm disposable probe.

With respect to the predicate device (en-bloc Biopsy System™ with a 10mm probe), the en-bloc Biopsy System™ with a 20mm probe has the same intended use, principles of operation, and technological characteristics.

With respect to the predicate device (20mm ABBI Breast Biopsy System), the en-bloc Biopsy System™ with a 20mm probe has similar intended use, both devices remove breast tissue for diagnostic biopsies. Both devices have similar principles of operation, and similar technological characteristics. Both devices remove a 20mm specimen.

Although there are minor differences in the characteristics of the 20mm en-bloc Biopsy System™ and its predicate devices, those differences do not raise new questions of safety or efficacy.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized graphic of three human profiles facing to the right, stacked on top of each other. The profiles are simple and abstract, with only the outlines of the faces visible.

7 2002 JUN

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Sherrie Coval-Goldsmith Vice President, Regulatory Affairs and Quality Assurance Neothermia Corporation One Apple Hill, Suite216 Natick, MA 01760

Re: K020031

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: January 3, 2002 Received: January 4, 2002

Dear Ms. Coval-Goldsmith:

This letter corrects our substantially equivalent letter of March 27, 2002 regarding the product code.

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). 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 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

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Page 2 - Ms. Sherrie Coval-Goldsmith

This letter will allow you to continue 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 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. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours.

Miriam C. Provost

(W 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

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510(k) Number (if known): _ КО 2 ОО 3/

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)

Concurrence of

Prescription Use

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

(Optional Format 1-2-96)

Miriam C. Provost

ion Sion-Off Division of General, Restorative and Neurological Devices

510(k) Number K020031

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.