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 text is a 510(k) summary for the Rubicor EnCapsule™ Breast Biopsy Device. It primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain detailed information about acceptance criteria or a specific study proving the device meets those criteria in the way a modern AI/ML device submission would.

Therefore, much of the requested information cannot be found in the provided text.

Here's a breakdown of what can and cannot be extracted:

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

Acceptance Criteria: Not explicitly stated. For this type of device (a biopsy device), acceptance criteria would likely revolve around mechanical performance, accuracy of tissue acquisition, safety (e.g., integrity of the device, absence of harmful interactions with the body), and biological compatibility.
Reported Device Performance: 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, no specific performance metrics (e.g., amount of tissue collected, success rate of biopsy, complication rates) are provided.

Acceptance Criteria (Inferred/Generic for a Biopsy Device)	Reported Device Performance (from text)
Specific performance metrics (e.g., tissue yield, accuracy of sampling, mechanical integrity, sterility, biocompatibility) not detailed in the provided text.	"Results of in-vitro testing demonstrate that the Rubicor EnCapsule™ Breast Biopsy Device is safe and effective for its intended function."

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

Sample Size: Not mentioned.
Data Provenance: The study mentioned is "in-vitro testing," which typically means laboratory-based testing on non-human materials (e.g., tissue phantoms or excised tissue). No country of origin is specified. The nature of "in-vitro" suggests this would be a controlled environment rather than retrospective or prospective patient data.

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 this is an in-vitro performance test for a mechanical device, not a diagnostic AI/ML algorithm requiring expert interpretation of medical images. Ground truth for a biopsy device would be related to its mechanical function, tissue recovery, and safety.

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

Not applicable for an in-vitro performance test of a mechanical device.

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. This is a breast biopsy device, not an AI/ML diagnostic tool meant for human reader assistance.

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.

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

For "in-vitro testing" of a biopsy device, ground truth would likely refer to objective measurements of the device's function, such as:
- Confirmation of successful tissue acquisition (e.g., visual inspection, weighing tissue samples).
- Mechanical integrity of the device before, during, and after use.
- Absence of material degradation or unwanted interactions.
- Compliance with design specifications.
- No expert consensus, pathology, or outcomes data are mentioned for establishing ground truth of the device's performance in this context.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device that requires a training set.

In summary, the provided document is a 510(k) summary for a physical medical device (breast biopsy tool). It confirms that "in-vitro testing" was performed and deemed the device "safe and effective for its intended function," leading to a determination of substantial equivalence to predicate devices. However, it does not provide the detailed study results, acceptance criteria, or ground truth methodology that would be expected for an AI/ML device submission, due to the nature of the product.

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: August 18, 2003

510(k) number: Ko32584

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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is enclosed within a circle, and the text "U.S. HEALTH & HUMAN SERVICES" is written around the upper half of the circle.

SEP 1 7 2003

Food and Drug Administra 9200 Corporate Boulevard Rockville MD 20850

Rubicor Medical. Inc c/o Robert J. Chin. Ph.I). Regulatory Consultant 25 Hartford Avenue San Carlos, California 94070

Re: K032584

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: August 18, 2003 Received: August 22, 2003

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 scr forth in the quality systems (OS) 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 vour 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 (301) 594-4659. 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 yours,

Mark N. Milkeerson

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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Indication for Use Statement

Labels	Values
510(k) Number (if known):	K032584
Device Name:	Rubicor EnCapsule™ Breast Biopsy Device

Indications for Use:

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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign Off)

eral, Restorative

510(k) Number K032584

Prescription Use (Per 21 CFR 801.109)

Over-the Counter Use

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.