MODIFICATION TO EN-BLOC BIOPSY SYSTEM

K041347 · Neothermia Corp. · GEI · Jun 4, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K041347
• Device Name: MODIFICATION TO EN-BLOC BIOPSY SYSTEM
• Applicant: Neothermia Corp.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jun 4, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4400
• Device Class: Class 2

Intended Use

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

Device Story

The en-bloc Biopsy System is a percutaneous, automated, vacuum-assisted electrosurgical device used for breast tissue biopsy. It consists of a hand-held biopsy handle, a single-use biopsy probe, and a control unit. The probe features two sets of active electrodes (precursor and cutting/capture) at its distal end, encased in a stainless steel cannula with an outer plastic sleeve. An annular gap between the sleeve and cannula provides a vacuum conduit to remove gaseous electrosurgical byproducts and fluids, while also maintaining the cutting arc during automated tissue capture. The device is operated by a clinician to perform tissue sampling. The system enables the removal of an incised tissue volume for diagnostic purposes.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Percutaneous, vacuum-assisted electrosurgical device. Components: hand-held handle, single-use probe, control unit. Probe construction: stainless steel cannula, outer plastic sleeve, dual active electrodes (precursor and cutting/capture). Energy source: high-frequency electrosurgical generator. Vacuum system: integrated for fluid/gas removal and arc maintenance. Connectivity: integral cable to control unit.

Indications for Use

Indicated for diagnostic sampling of breast tissue during a breast biopsy procedure.

Regulatory Classification

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.

Predicate Devices

• Neothermia's 10mm, 15mm and 20mm en-bloc probes (K041347)

Submission Summary (Full Text)

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### 510(k) SUMMARY

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# 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: [phone] Facsimile: [phone]

May 11, 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 &<br>Accessories (21 C.F.R. § 878.4400)<br>Biopsy Instrument (21 C.F.R. § 876.1075) |

Neothermia Corporation One Apple Hill, Suite 316 Natick, Massachusetts 01760 Phone: [phone] Facsimile: [phone]

#### 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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041347 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 probe with the material change has the same intended use, principles of operation. and technological characteristics as the previously cleared predicate devices. The en-bloc probe with the material change and its predicate devices are both electrosurgical devices used to biopsy breast tissue. The en-bloc probwith the material change is substantially equivalent to Neothermia's cleared 10mm, 15mm and 20mm en-bloc probes.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a circular seal or logo. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the seal is a stylized emblem that resembles three abstract shapes, possibly representing birds in flight or flowing lines. The emblem is black, and the text is also black, set against a white background.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 4 2004

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

Re: K041347

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: May 20, 2004 Received: May 20, 2004

Dear Ms. Coval-Goldsmith:

We have reviewed your Section 510(k) premarket notification of intent to market the device wf nave ro rowe 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 for use barea in 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). and Cosmette Free (110) was the device, subject to the general controls provisions of the Act. The r ou mayy aters or visions 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 may or backed to easil 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 or any I 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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours,

Sincerely yours,

Mark N. Millman

elia 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):

Device Name: en-bloc Biopsy System™

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

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

O Mark N. Milkerson

Division of General, Restorative, and Neurological Devices

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510(k) Number K041347