EN-BLOC BIOPSY SYSTEM MODEL#777-110,777-001,777-002,777-006,777-301,777-302,777-115,777-120

K042170 · Neothermia Corporation · GEI · Sep 7, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K042170
• Device Name: EN-BLOC BIOPSY SYSTEM MODEL#777-110,777-001,777-002,777-006,777-301,777-302,777-115,777-120
• Applicant: Neothermia Corporation
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Sep 7, 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 control unit, and a single-use biopsy probe. The probe features a precursor electrode and cutting/capture electrodes at its distal end, encased in a stainless steel cannula. An outer plastic sleeve surrounds the cannula, creating an annular gap for vacuum-assisted removal of gaseous products and fluids (e.g., blood) generated during the procedure. The vacuum also maintains the cutting arc during automated tissue capture. The device is operated by a clinician to perform electrosurgical cutting and simultaneous capture of an incised tissue volume.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and design similarities to previously cleared predicate devices.

Technological Characteristics

Percutaneous, vacuum-assisted electrosurgical system. Components: hand-held handle, control unit, single-use probe. Probe construction: stainless steel cannula, precursor electrode, cutting/capture electrodes, outer plastic sleeve. Energy source: electrosurgical generator. Connectivity: probe connects to control unit. Vacuum system: removes gaseous products and fluids, maintains cutting arc.

Indications for Use

Indicated for diagnostic sampling of breast tissue during breast biopsy procedures.

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 10mm en-bloc probe
• Neothermia 15mm en-bloc probe
• Neothermia 20mm en-bloc probe

Submission Summary (Full Text)

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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 [phone] Phone: [phone] 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 &<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 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 [phone] 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