EN-BLOC BIOPSY SYSTEM, MODELS 777-110, 777-120, 770-001, 777002, 777-006, 777-301, 777-302

K020031 · Neothermia Corp. · GEI · Mar 27, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K020031
• Device Name: EN-BLOC BIOPSY SYSTEM, MODELS 777-110, 777-120, 770-001, 777002, 777-006, 777-301, 777-302
• Applicant: Neothermia Corp.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Mar 27, 2002
• Decision: SESE
• Submission Type: Traditional
• 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

High-frequency, vacuum-assisted electrosurgical device for breast tissue biopsy. System comprises hand-held biopsy handle, disposable probe, and electrosurgical generator. Probe features distal precursor and cutting/capture electrodes; stainless steel cannula; plastic sleeve. Annular gap between sleeve and cannula provides vacuum-assisted removal of gaseous electrosurgical byproducts and fluids. Device removes incised tissue volume for histopathologic examination. Used in clinical settings by healthcare providers. Benefits include acquisition of intact, unfragmented biopsy specimens of predictable diameter and length.

Clinical Evidence

Bench testing only. Porcine tissue study conducted to evaluate 20mm probe performance in cutting and capturing predictable tissue volumes. Results confirmed ability to obtain intact, unfragmented biopsy specimens suitable for histopathologic examination.

Technological Characteristics

High-frequency, vacuum-assisted electrosurgical device. Components: hand-held handle, disposable probe (stainless steel cannula, plastic sleeve), electrosurgical generator. Sensing/actuation: active electrodes at distal end for electrosurgical cutting and tissue capture. Vacuum-assisted removal of gaseous/liquid byproducts. Dimensions: 20mm probe diameter.

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 Corp.'s en-bloc Biopsy System (K003190)
• 20mm Auto Suture ABBI Breast Biopsy System (K983296)

Reference Devices

• 20mm Auto Suture (ABBI) Breast Biopsy System (K9963825)

Submission Summary (Full Text)

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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 [phone] Phone: [phone] 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 &<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™ (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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or at [phone] 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

OR

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