RUBICOR BREAST BIOPSY DEVICE

K020047 · Rubicor Medical, Inc. · GEI · Apr 5, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K020047
• Device Name: RUBICOR BREAST BIOPSY DEVICE
• Applicant: Rubicor Medical, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Apr 5, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2

Intended Use

The Rubicor Breast Biopsy Device is intended for diagnostic sampling of breast tissue during breast biopsy procedure. The Rubicor Breast Biopsy Device is to be used for diagnostic purposes only and is not intended for therapeutic uses.

Device Story

Rubicor Breast Biopsy Device is an electrosurgical instrument for diagnostic breast tissue sampling. Device functions by excising tissue samples for pathology; operation involves electrosurgical cutting and coagulation. Used in clinical settings by physicians to obtain tissue for diagnostic evaluation. Benefits include minimally invasive tissue acquisition for breast cancer diagnosis. Device is manual/electrosurgical; no automated analysis or software components described.

Clinical Evidence

Bench testing only. In-vitro testing demonstrated safety and effectiveness. Biocompatibility testing performed per ISO 10993-1.

Technological Characteristics

Electrosurgical cutting and coagulation device. Materials meet ISO 10993-1 biocompatibility requirements. Product code GEI; regulation 21 CFR 878.4400.

Indications for Use

Indicated for diagnostic sampling of breast tissue during biopsy procedures. For diagnostic use only; not for therapeutic use.

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 En Bloc Biopsy System (K003190)
• Ethicon Mammotome Hand-Held System (K991980)
• USSC Autosuture Endo Catch (K922123)

Submission Summary (Full Text)

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This summary of 510(k)-safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. Date Prepared: December 21, 2001

510(k) number: K020047

APR = 5 2002

Applicant Information:

Rubicor Medical, Inc. 849 Veterans Blvd. Redwood City, CA 94063

Contact Person: Arv Chernomorsky [phone] Phone Number: Fax Number: [phone]

# Device Information:

Classification: Trade Name: Classification Name: Class II Rubicor Breast Biopsy Device Electrosurgical Device and accessories (21 CFR 870.4400)

# Equivalent Device:

The subject device is substantially equivalent in intended use and/or method of operation to the Neothermia En Bloc Biopsy System (K003190), the Ethicon Mammotome Hand-Held System (K991980) and the USSC Autosuture Endo Catch (K922123).

# Intended Use:

The Rubicor Breast Biopsy Device is intended for diagnostic sampling of breast tissue during breast biopsy procedure.

The Rubicor Breast Biopsy Device is to be used for diagnostic purposes only and is not intended for therapeutic uses.

# Test Results:

#### Performance

Results of in-vitro testing demonstrate that the Breast Biopsy Device is safe and effective for its intended use.

#### Biocompatibility

The materials used in the Rubicor Breast Biopsy Device meets the requirements of ISO 10993-1.

Summary: Based on the intended use, product, performance and biocompatability information provided in this notification, the subject device has been shown to be substantially equivalent to the currently marketed predicate devices.

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Image /page/1/Picture/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like figure with three curved lines representing its body and wings. The bird is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circumference of the circle. The text is in all caps and is evenly spaced around the circle.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Ary Chernomorsky Vice President, Research and Development Rubicor Medical, Inc. 849 Veterans Boulevard Redwood City, CA 94063

APR - 5 2002

Re: K020047

Trade/Device Name: Rubicor Breast Biopsy Device Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: January 4, 2002 Received: January 7, 2002

Dear Mr. Chernomorsky:

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 - Mr. Ary Chernomorsky

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 premation of interior. The 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 -11 - 11 - 11 - 1659. Additionally, for questions on the promotion and advertising of Compliance w (201) of the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Oiner general 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 yours,

Muriam C. Provost

For 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):

Kozoo47

Device Name:

Rubicor Breast Biopsy Device

Indications for Use:

The Rubicor Breast Biopsy Device is intended for diagnostic sampling of breast tissue during breast biopsy procedure.

The Rubicor Breast Biopsy Device is to be used for diagnostic purposes only and is not intended for therapeutic uses.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Muriam C. Provost

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

OR

510(k) Number_

**Prescription Use**
(Per 21 CFR 801.109) ✓

Over-the Coun

020047

Over-the Counter Use

(Optional Format 1-2-96)