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.

AI/ML Overview

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.

Summary

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042170 1/2

SEP - 7 2004

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) 655-7822 Facsimile:

August 5, 2004 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 The on broe is a perculance as remove tissue by automated electrosurgical cutting and

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K042170 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, a nand note bropey manase, mandle to the control unit. The Probe™ contains two with an micegrar castors at its distal end - a precursor electrode and cutting/capture sees of active crocalers of the Probe™ is encased in a stainless steel cannula. An outer electrodes. The bhair of any stainless steel cannula and an annular gap between the sleeve plastic slove surrounds and suduit for vacuum-assisted removal of the gaseous products and the cannula provides and any liquids (e.g., blood) that may accumulate at the distal or crectroomgrounding the biopsy procedure. The vacuum also helps maintain the required cutting arc during automated tissue capture.

Substantial Equivalence

The 12mm en-bloc probe has the same intended use, principles of operation, and The Izimir on oroo probo has the earleviously cleared predicate devices. The 12mm entechnological Character.itles as the pressurgical devices used to biopsy breast bloc proble and to progreate as rioss aifference in the technological characteristics of the 12 mm probe and its predicate devices (e.g., size of basket) this difference does not raise 12 min probo and to promotion acy. The 12mm en-bloc probe is substantially equivalent to Neothermia's 10mm, 15mm and 20mm en-bloc probes.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the eagle in a circular fashion. The logo is presented in black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 7 2004

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

Re: K042170

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: August 9, 2004 Received: August 11, 2004

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)
This and the supportunity of all confeence of your device of your device to a le This letter will allow you to begin marketing your actives of your device to a legally
premarket notification. The FDA finding of substantial equivalence of your devi premarket notification. The FDA finding of substantal equivaliso or your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
rs the regulation and 1901 - 1601 - Algo, please note the regulation entitl If you desire specific advice for your device on our nacemits (a mease not the regulation entitled, and the regulation entitled, and the regulation contact the Office of Compliance at (301) 594-407. The Pat 807.97). You may obtain
"Misbranding by reference to premarket notification" (21CFR Patt 807.97). You may obtain "Misbranding by reference to premarks nouthcapon" (17 er er t er trom the Division of Small
other general information on your responsibilities under the Act from the Division other general information on your responsibilities uner are a more (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its toll-fire mumbin.html Manufacturers, International and Consumer Assistance and Carlineral Constitutional dismamain.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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Indications for Use

510(k) Number (if known):

K047170

Device Name: en-bloc Biopsy System™

Indications For Use: The en-bloc Biopsy System is intented for diagnostic
Children For Use: The en-blocationsy procedure Indications For Ose. The en bloodstopsy of any of any of any procedure.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

(21 CFR 807 Subpart C)

Over-The-Counter Use

(Part 21 CFR 801 Subcart D)

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

AND/OR

iriam C. Provost

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

510(k) Number_K 04 3/70

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.