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.q., 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 II Rotational Core Biopsy System consists of a sticking needle, cutting cannula, fully integrated control unit and specimen container. The sticking needle is operated by the control unit and uses cold temperatures at its tip to engage the tissue to be sampled. The cutting cannula is coaxially mounted around the sticking needle and is used to core the tissue specimen. The cutting cannula will be available in several qauge sizes and lengths.

AI/ML Overview

The provided text describes the Sanarus Centrica™ II Rotational Core Biopsy System and its substantial equivalence to a predicate device. However, it does not contain information on specific acceptance criteria and a study proving the device meets those criteria in the context of diagnostic accuracy, sensitivity, specificity, or other performance metrics typically associated with AI/software devices.

The document focuses on demonstrating substantial equivalence for a physical medical device (a biopsy system) based on similar indications for use, technological characteristics, and performance testing confirming equivalent sample quality. It does not involve AI or software performance evaluation as would be typical for the detailed questions asked.

Therefore, many of your requested points about acceptance criteria, sample sizes for test and training sets, expert consensus, MRMC studies, or standalone algorithm performance cannot be answered from the provided text.

Here's what can be extracted based on the information given:

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

Acceptance Criteria	Reported Device Performance
Implicit Criteria: Equivalence in sample quality for histological examination.	"Performance testing confirms that the quality of samples obtained with the Sanarus Centrica II Rotational Core Biopsy System is equivalent to the predicate device." (Section 8)
Implicit Criteria: Substantial equivalence to predicate device in indications for use, technological characteristics, patient contact components, component materials, packaging, sterilization methods, and sterility assurance level.	The device "has the same indications for use and technological characteristics as the predicate device. The patient contact components and component materials... are the same. The packaging materials, packaging configurations, sterilization methods and sterility assurance level are also equivalent." (Section 7)

Note: The document implies acceptance criteria by stating how the new device is equivalent to the predicate. Specific numerical targets (e.g., sensitivity, specificity, or specific tissue quality scores) are not provided.

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

This information is not provided in the document. The text only vaguely refers to "Performance testing."

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)

This information is not provided in the document. The evaluation focuses on sample quality for histological examination, presumably by pathologists, but no details are given.

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

This information is not provided in the document.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported for this device, as it is a physical biopsy system, not an AI/software diagnostic tool.

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

No, this device is not an algorithm, so a standalone performance study in that context is not applicable.

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

The "ground truth" implicitly referred to is the histological examination of tissue samples, which would involve pathologists. The document states the device provides "breast tissue for histologic examination."

8. The sample size for the training set

This information is not provided in the document. As this is not an AI/ML device, a "training set" in the conventional sense is not applicable.

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

This information is not provided in the document, and a "training set" is not relevant for this type of device submission.

Summary

{0}------------------------------------------------

Section 2 - Summary of Safety and Effectiveness

Contact Information (1)

Trena Depel Clinical & Requlatory Affairs Manager Telephone: (925) 460-6080, x-6715 FAX: (925) 460-6084 e-mail: tdepel@sanarus.com

Company Information (2)

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

(3) Device Name

Sanarus Centrica™ II Rotational Core Biopsy System

Device Description (4)

(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.

{1}------------------------------------------------

K032506 2/2

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 surqical procedures.

(6) Name of Predicate or Legally Marketed Device

Sanarus Centrica™ Rotational Core Biopsy System

(7) Substantial Equivalence

The Sanarus Centrica II Rotational Core Biopsy System is substantially equivalent to the Centrica Rotational Core Biopsy System that was determined to be substantially equivalent on Sep 23, 2002 (reference K022879).

The Sanarus Centrica II Rotational Core Biopsv 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 performance testing results, the Sanarus Centrica II Rotational Core Biopsy System does not raise significant new questions of safety and effectiveness.

(8) Performance Testing Summary

Performance testing confirms that the quality of samples obtained with the Sanarus Centrica II Rotational Core Biopsy System is equivalent to the predicate device.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

OCT - 9 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Trena Depel Clinical & Regulatory Affairs Manager Sanarus Medical, Inc. 5880 W. Las Positas Boulevard, Suite 52 Pleasanton, California 94588

Re: K032506

Trade/Device Name: Sanarus Centrica™ II Rotational Core Biopsy System Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: II Product Code: KNW Dated: August 13, 2003 Received: August 14, 2003

Dear Ms. Depel:

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.

{3}------------------------------------------------

Page 2 - Ms. Trena Depel

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 (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,

Miriam 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

{4}------------------------------------------------

Indications For Use

510(k) Number:

Device Name: Sanarus Centrica™ II Rotational Core 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):

Miriam C. Provost

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

510(k) Number K032506

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.