The device is indicated for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone.

The device is also 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 Sanarus Centrica™ Core Tissue Biopsy System consists of a sticking probe, tissue cutter, control unit and specimen container. The sticking probe is operated by the control unit and utilizes cold temperatures at its tip to engage the tissue to be sampled. The tissue cutter is coaxially mounted around the sticking probe and is used to core the tissue specimen. The tissue cutter will be available in several gauge sizes and lengths.

AI/ML Overview

The provided text describes the Sanarus Centrica™ Core Tissue Biopsy System and its substantial equivalence to a predicate device. However, it does not contain information about specific acceptance criteria or a study that definitively "proves" the device meets these criteria in the way described by the prompt's request for performance metrics, ground truth establishment, or sample sizes for testing.

Instead, the document states that the new device has "the same indications for use and technological characteristics as the predicate device" and that "Testing confirms that the quality of samples obtained with the Sanarus Centrica™ Core Tissue Biopsy System is equivalent to the predicate device and that the use of a cooled probe to engage the tissue does not affect the histological evaluation." This indicates a substantial equivalence (SE) pathway, which primarily relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than requiring a detailed clinical study demonstrating specific performance metrics against pre-defined acceptance criteria.

Therefore, many of the requested fields cannot be directly extracted from the provided text.

Here's a breakdown of what can and cannot be answered based on the provided input:

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

Acceptance Criteria	Reported Device Performance
Implicit: Quality of samples is equivalent to predicate device.	"Testing confirms that the quality of samples obtained with the Sanarus Centrica™ Core Tissue Biopsy System is equivalent to the predicate device."
Implicit: Use of cooled probe does not affect histological evaluation.	"Testing confirms... that the use of a cooled probe to engage the tissue does not affect the histological evaluation."
Implicit: Same indications for use as predicate.	"The Sanarus Centrica™ Core Tissue Biopsy System has the same indications for use... as the predicate device."
Implicit: Same technological characteristics as predicate.	"The Sanarus Centrica™ Core Tissue Biopsy System has the same... technological characteristics as the predicate device."

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.
Data provenance: Not specified.

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 specified. The document globally refers to "histological evaluation" without detailing the process or personnel involved in ground truth establishment for a specific test set.

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

Not specified.

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 MRMC comparative effectiveness study is described. The device is a biopsy system, not an AI-assisted diagnostic tool.

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

Not applicable, as this is a physical biopsy device, not an algorithm.

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

The document mentions "histological evaluation," implying pathology as the ground truth for tissue sample quality.

8. The sample size for the training set

Not applicable/not specified. The device is not an AI algorithm that requires a training set in the typical sense. The "testing" mentioned is likely engineering or preclinical testing to demonstrate equivalence.

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

Not applicable/not specified.

Summary

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JUN 2 6 2002

KOZ 1137

Section II - Summary of Safety and Effectiveness

Contact Information (1)

Vincent Cutarelli Vice President, Regulatory Affairs Telephone: (949) 768-1184 ext. 105 FAX: (925) 460-6084

(2) Company Information

Sanarus Medical, Inc. 5880 W. Las Positas Blvd., Suite 52 Pleasanton, CA 94588 Telephone: (925) 460-6080 FAX: (925) 460-6084 વિધુ વ

(3) Device Name

Sanarus Core Tissue Biopsy System

(4) Device Description

(5) Indications for Use

The device is indicated for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone.

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(6) Name of Predicate or Legally Marketed Device

Sanarus Core Tissue Biopsy System

Substantial Equivalence (7)

The Sanarus Centrica™ Core Tissue Biopsy System is substantially equivalent to the Sanarus Core Tissue Biopsy System that was determined to be substantially equivalent on May 3, 2001 (reference K013528).

The Sanarus Centrica™ Core Tissue Biopsy System has the same indications for use and technological characteristics as the predicate device. The patient contact components and component materials for obtaining core biopsy samples in both the new and predicate device are the same. The packaging materials, packaging configurations, sterilization methods and sterility assurance level are also equivalent.

Based on the indications for use, technological characteristics and testing results, the Sanarus Centrica™ Core Tissue Biopsy System does not raise significant new questions of safety and effectiveness.

Performance Data Summary (8)

Testing confirms that the quality of samples obtained with the Sanarus Centrica™ Core Tissue Biopsy System is equivalent to the predicate device and that the use of a cooled probe to engage the tissue does not affect the histological evaluation.

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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 is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a symbol consisting of three stylized human profiles facing to the right, with flowing lines connecting them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 6 2002

Vincent Cutarelli Vice President, Regulatory Affairs Sanarus Medical, Inc. 5880 W. Las Positas Boulevard, Suite 52 Pleasanton, California 94588

Re: K021137

Trade Name: Sanarus Centrica Core Tissue Biopsy System Regulation Number: 876.1075 Regulation Name: Gastroenterology/Urology Biopsy Device Regulatory Class: II Product Code: KNW Dated: April 5, 2002 Received: April 9, 2002

Dear Mr. Cutarelli:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 reguirements 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 - Mr. Vincent Cutarelli

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" (21CFR 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.

Stipta Rurda

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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Indications For Use

510(k) Number: _ | |<02 1137

Device Name: Sanarus Centrica™ Core Tissue Biopsy System

Indications for Use: The device is indicated for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone.

Concurrence of CDRH, Office of Device Evaluation (ODE):

Styt Rhodes

Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________

Prescription Use: _ X (Per 21 CFR 801.109)

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.