The Rubicor Magic ™ 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 Rubicor Magic ™ 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

The Rubicor Magic Breast Biopsy Device is a sterile, single-use percutaneous biopsy device. The working end of the device includes an 8 cm long, 10 gauge, stainless steel coring cannula and a sharp stylet that runs through the center of the cannula and extends from its distal end. The handle of the device contains an actuation button, two indicator lights, a removable sample collection chamber, a drive mechanism for advancing and rotating the coring cannula and transporting the core specimen to the collection chamber, a DC motor, and a 9 V battery.

AI/ML Overview

The provided 510(k) summary for the Rubicor Magic™ Breast Biopsy Device does not contain detailed acceptance criteria, specific study results, or information regarding a comparative effectiveness study (MRMC). The document states that "Results of in-vitro testing demonstrate that the Rubicor Magic Breast Biopsy Device is safe and effective for its intended function," and that the materials used meet ISO 10993-1 for biocompatibility. However, it does not provide quantitative performance metrics, sample sizes for test or training sets, details about ground truth establishment, or expert qualifications.

Based on the provided text, here is what can be extracted and what information is missing:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Safety	Demonstrated as safe via in-vitro testing.
Effectiveness	Demonstrated as effective for its intended function via in-vitro testing.
Biocompatibility	Materials meet ISO 10993-1 requirements.
Intended Use	Provides breast tissue samples for diagnostic sampling of breast abnormalities for histologic examination.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not specified. The document only mentions "in-vitro testing."
Data Provenance: Not specified. The testing is described as "in-vitro," which typically refers to laboratory-based testing rather than clinical data from human subjects.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. As the testing was "in-vitro," it would not involve human experts establishing ground truth in the context of clinical images or pathological samples in the same way an AI diagnostic device would.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This device is a biopsy instrument, not an AI diagnostic system requiring adjudication of interpretations.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. An MRMC study was not done. The device is a physical biopsy instrument, not an AI diagnostic system intended to assist human readers.

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

Not applicable. This device is a physical biopsy instrument, not a standalone AI algorithm. The performance mentioned refers to the physical operation of the device (e.g., ability to core tissue, mechanism function).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For "in-vitro testing," ground truth would likely refer to engineering specifications, mechanical performance targets, and material properties. The document does not specify the exact type of "ground truth" or reference standard used to evaluate the device's efficacy in obtaining diagnostic samples in the in-vitro setting. It does mention that the device is "designed to provide breast tissue for histologic examination," implying the ultimate goal is tissue suitable for pathology, but the "in-vitro" nature of the test means this wasn't tested with actual pathology outcomes from human biopsies.

8. The sample size for the training set

Not applicable. This document describes a physical medical device, not an AI system that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This document describes a physical medical device, not an AI system.

Summary

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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 18, 2005

510(k) number: 1 1 65315 15) | _______________________________________________________________________________________________________________________________________________

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 Rubicor Magic TM Breast Biopsy Device Trade Name: Biopsy Instrument (21 CFR 876.1075) Classification Name:

Equivalent Device:

The subject device is substantially equivalent in intended use and/or method of operation to the Ethicon Mammotome® Hand-Held System (K991980), the Sanarus Cassie™ Rotational Core Biopsy System (K042136), and the BIP VacuFlash® Biopsy System (K024089).

Device Description:

Intended Use:

The Rubicor Magic 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 Rubicor Magic TM 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.

: :

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Test Results:

Performance

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

Biocompatibility

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

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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Indication for Use Statement

510(k) Number (if known):	K053151
---------------------------	---------

Device Name:

Rubicor Magic TM Breast Biopsy Device

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use V (Per 21 CFR 801.109)

Over-the Counter Use

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three human profiles facing to the right, with flowing lines above them.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 8 2005

Rubicor Medical, Inc. c/o Morten Simon Christensen Underwriters Laboratories, Inc. 1655 Scott Boulevard Santa Clara, California 95050

Re: K053151

Trade/Device Name: Rubicor Magic "" Breast Biopsy Device Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: II Product Code: KNW Dated: November 8, 2005 Received: November 10, 2005

Dear Mr. Christensen:

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- Morten Simon Christensen

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/industry/support/index.html.

Sincerely yours,

Mark McMillan

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):

KOSSISI

Device Name:

Rubicor Magic ™ Breast Biopsy Device

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation(ODE)
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(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices

510(k) Number	K053151
---------------	---------

ription Use	OR	Over-the Counter Use
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Prescr (Per 21 CFR 801.109)

Rubicor Medical, Inc.

Regulation Number and Section

§ 876.1075 Gastroenterology-urology biopsy instrument.

(a)
Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification. (1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.