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

The EnCapsule Breast Biopsy Device is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It is designed to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.

The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore, the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality (e.g., malignancy). When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.

Device Description

Not Found

AI/ML Overview

The provided document describes a Rubicor EnCapsule™ Breast Biopsy Device and its 510(k) submission to the FDA. Unfortunately, the document does not contain the detailed information requested regarding acceptance criteria and a study proving the device meets those criteria.

Here's an analysis based on the available text:

1. Table of Acceptance Criteria and Reported Device Performance

Not available in the provided text. The document states: "Results of in-vitro testing demonstrate that the Rubicor EnCapsule Breast Biopsy Device is safe and effective for its intended function." However, it does not provide specific acceptance criteria or quantitative performance metrics.

2. Sample Size Used for the Test Set and Data Provenance

Not available in the provided text. The document only mentions "in-vitro testing" without detailing the sample size or the nature of the test set (e.g., human tissue samples, phantom, animal models). There is no information on data provenance (country of origin, retrospective/prospective).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable/available. Since the document only refers to "in-vitro testing" and does not describe a human-read or human-interpreted test set, there is no mention of experts establishing ground truth for such a set.

4. Adjudication Method for the Test Set

Not applicable/available. As there's no mention of a human-interpreted test set, an adjudication method is not described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size of Human Reader Improvement with AI vs. Without AI Assistance

Not applicable. The device described is a physical breast biopsy device, not an AI or software-as-a-medical-device (SaMD) that assists human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to this device type.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device, not an algorithm, so a standalone algorithm performance study is not relevant.

7. The Type of Ground Truth Used

Not explicitly stated due to limited information on the "in-vitro testing." For a physical biopsy device, the ground truth for performance would typically relate to the quality and adequacy of tissue samples obtained (e.g., tissue quantity, integrity, diagnostic yield). The document vaguely refers to "safe and effective for its intended function," implying that the in-vitro tests confirmed the device's ability to collect tissue for histologic examination.

8. The Sample Size for the Training Set

Not applicable/available. This is a physical device, not an algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable. As above, this is a physical device, not an algorithm.

In summary, the provided 510(k) summary is very high-level and only states that in-vitro testing was performed to demonstrate safety and effectiveness. It lacks specific details about the study design, acceptance criteria, sample sizes, ground truth establishment, or any human-reader involvement that would be needed to answer your questions comprehensively. The document focuses on establishing substantial equivalence to a predicate device (K023601 & K030049) based on intended use and method of operation, rather than providing detailed performance metrics of a novel study.

Summary

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510 (k) Summarv

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: September 8, 2005

510(k) number:

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 EnCapsule™ Breast Biopsy Device
Classification Name:	Electrosurgical Device and accessories (21 CFR 870.4400)

Equivalent Device:

The subject device and accessory are substantially equivalent in intended use and/or method of operation to the Rubicor EnCapsule™ Breast Biopsy Device (K023601 & K030049)

Intended Use:

Test Results:

Performance

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

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Summary:

Based on the intended use, product, and performance 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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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The logo is black and white and appears to be a scanned image.

OCT 6 - 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Robert J. Chin, Ph.D. Regulatory Consultant Rubicor Medical, Inc. 25 Hartford Avenue San Carlos, California 94070

Re: K052506

Trade/Device Name: Rubicor EnCapsule™ Breast Biopsy Device Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: September 8, 2005 Received: September 13, 2005

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- Robert J. Chin, Ph.D.

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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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 vours.

Barbara Buelup

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indication for Use Statement

510(k) Number (if known):

KOS2506

Device Name:

Rubicor EnCapsule™ Breast Biopsy Device

Indications for Use:

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Oarbare Buehrd Armem
Division Sign-Off

Division of General, Restorative, Page of of and Neurological D

Number K052506

Regulation Number and Section

§ 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.