RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 30086

K023601 · Rubicor Medical, Inc. · GEI · Nov 19, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K023601
• Device Name: RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 30086
• Applicant: Rubicor Medical, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Nov 19, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4400
• Device Class: Class 2

Intended Use

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

Device Story

The Rubicor EnCapsule™ Breast Biopsy Device is a diagnostic instrument used to obtain breast tissue samples. It functions as an electrosurgical device for tissue cutting and coagulation. The device is intended for use by clinicians in a clinical setting for diagnostic purposes only; it is not indicated for therapeutic use. The device operates by extracting tissue samples for subsequent pathological examination, aiding in the diagnosis of breast abnormalities. It is substantially equivalent to the previously cleared Rubicor Breast Biopsy Device.

Clinical Evidence

Bench testing only. In-vitro testing demonstrated safety and effectiveness for the intended function. Biocompatibility of materials was confirmed.

Technological Characteristics

Electrosurgical device for cutting and coagulation. Classified under 21 CFR 878.4400 (Product Code GEI). Materials are confirmed biocompatible.

Indications for Use

Indicated for diagnostic sampling of breast tissue during biopsy procedures. Patient population not specified.

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

• Rubicor Breast Biopsy Device (K020047)

Submission Summary (Full Text)

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# 510 (k) Summary

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: October 24, 2002

510(k) number:

NOV 1 9 2002

## Applicant Information:

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

| Contact Person: | Ary Chernomorsky |
|-----------------|------------------|
| Phone Number: | [phone] |
| Fax Number: | [phone] |

### Device Information:

| Classification: | Class II |
|----------------------|----------------------------------------------------------|
| Trade Name: | Rubicor EnCapsuleTM Breast Biopsy Device |
| Classification Name: | 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 Rubicor Breast Biopsy Device (K020047)

### Intended Use:

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

The Rubicor EnCapsule™ 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 Rubicor EnCapsule™ Breast Biopsy Device is safe and effective for its intended function.

### Biocompatibility

The materials used in the Rubicor EnCapsule™ Breast Biopsy Device have been shown to be biocompatible.

### 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 and unmodified predicate device.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name arranged in a circular pattern around a central emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three wavy lines representing the serpent entwined around a staff.

Public Health Service

NOV 1 9 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Rubicor Medical. Inc. Robert J. Chin, Ph.D. Regulatory Consultant 849 Veterans Boulevard Redwood City, California 94063

Re: K023601

Trade/Device Name: Rubicor Encapsule Breast Biopsy Device, Model 30086 Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: October 24, 2002 Received: October 28, 2002

Dear Dr. Chin:

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 - Dr. Robert J. Chin

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 and additionally 21 CFR 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]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 yours,

Muriam 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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Rubicor Breast Biopsy Device

#### Indication for Use Statement

510(k) Number (if known):

Device Name:

Rubicor EnCapsule™ Breast Biopsy Device

Indications for Use:

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

The Rubicor EnCapsule™ 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)

| | Miriam C. Provost | |
|---------------------------------------|------------------------------------------------------------|---|
| | (Division Sign-Off) | |
| | Division of General, Restorative and Neurological Devices | |
| 510(k) Number | K023601 | |
| Prescription Use (Per 21 CFR 801.109) | <div> <table border="1"><tr><td>✓</td></tr></table> </div> | ✓ |
| ✓ | | |
| | OR | |
| | Over-the Counter Use | |

Rubicor Medical, Inc.