K Number
K023601
Device Name
RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 30086
Date Cleared
2002-11-19

(22 days)

Product Code
Regulation Number
878.4400
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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 Description
Not Found
More Information

No
The summary describes a mechanical biopsy device and lacks any mention of AI, ML, image processing, or software analysis of data.

No.
The "Intended Use / Indications for Use" section explicitly states "The Rubicor EnCapsule™ Breast Biopsy Device is to be used for diagnostic purposes only and is not intended for therapeutic uses."

Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for diagnostic sampling of breast tissue during breast biopsy procedure" and "is to be used for diagnostic purposes only".

No

The device is described as a "Breast Biopsy Device" and the predicate device is also a "Breast Biopsy Device". The description of performance studies mentions "in-vitro testing" which is typically associated with hardware devices that interact with biological samples. There is no mention of software as the primary component or function.

Based on the provided information, the Rubicor EnCapsule™ Breast Biopsy Device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is for "diagnostic sampling of breast tissue during breast biopsy procedure." This describes a device used to obtain a sample from the body, not a device that tests a sample outside of the body.
  • Device Description (Not Found): While the description is missing, the intended use is the primary indicator.
  • Mentions image processing, AI, DNN, or ML (Not Found): These are often associated with IVDs that analyze images or data.
  • Input Imaging Modality (Not Found): IVDs often rely on specific imaging modalities for analysis.
  • Anatomical Site: The device interacts directly with the "breast tissue" within the body.
  • Summary of Performance Studies: The studies mention "in-vitro testing," but this likely refers to testing the device's mechanical or functional performance in a lab setting, not testing the diagnostic accuracy of analyzing a biological sample.
  • Predicate Device: The predicate device is also a "Breast Biopsy Device," which further supports the idea that this is a device for obtaining a sample, not for performing an in-vitro diagnostic test on a sample.

In summary, the Rubicor EnCapsule™ Breast Biopsy Device is a device used to collect a biological sample (breast tissue) from a patient. The diagnostic testing of that sample would then be performed separately, likely by an IVD.

N/A

Intended Use / 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.

Product codes

GEI

Device Description

Not Found

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

breast

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

Results of in-vitro testing demonstrate that Rubicor EnCapsule™ Breast Biopsy Device is safe and effective for its intended function.

Key Metrics

Not Found

Predicate Device(s)

K020047

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
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.(b)
Classification. Class II.

0

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:(650) 556-1070
Fax Number:(650) 556-1821

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.

1

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.

2

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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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

3

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) NumberK023601
Prescription Use (Per 21 CFR 801.109)
OR
Over-the Counter Use

Rubicor Medical, Inc.