SiteSelect is a disposable, single use, diagnostic device used to obtain localized large core biopsies of breast tissue of a mammographic abnormality, identified by the placement of a needle/ localization wire, which is suspect to be malignant. The SiteSelect device is intended to provide tissue for histological examination with partial or complete removal of imaged lesions. The scope of a histological abnormality is not able to be determined from it's mammographic appearance. Therefore, it is essential that the tissue margins be examined for margin involvement and completeness of removal in cases where the tissue sample is not found to be benign.

SiteSelect is to be used in conjunction with stereotactic mammographic imaging systems capable of determining position of lesion within breast tissue.

This device is used in conjunction with the SiteSelect Instrument Accessories, which are mounted on a stereotactic table and used with a stereotactic mammographic imaging system.

Device Description

The SiteSelect device, a disposable breast biopsy device, is substantially equivalent to like devices in commercial distribution. These devices are marketed by Imagyn Surgical and United States Surgical Corporation (USSC).

SiteSelect, Imagyn Surgical, and USSC devices are all used to obtain biopsies within breast tissue. These devices are used in conjunction with instrument accessories which are used to mount the devices on a stereotactic table. These devices are used with stereotactic mammographic imaging systems.

The construction, materials, sterilization, and method of operation of the SiteSelect devices are identical to the Imagyn Surgical SiteSelect devices currently on the market.

The major difference between SiteSelect and USSC ABBI devices is that the ABBI device removes tissue in route to and including the target area. The SiteSelect device obturates up to the lesion, leaving intact the tissue in route to the target area.

AI/ML Overview

The provided text describes the SiteSelect breast biopsy device and its 510(k) submission for market clearance. It focuses on demonstrating substantial equivalence to existing devices and presents a clinical summary. However, it does not explicitly define acceptance criteria for device performance in the context of diagnostic accuracy, nor does it present a study specifically designed to prove the device meets such criteria with quantitative metrics like sensitivity or specificity.

The clinical summary describes the device's usage and outcomes in a patient cohort, but this is presented as an evaluation of the device for use in removing abnormalities for diagnostic evaluation, rather than a test against pre-defined performance thresholds.

Here's an analysis of the provided information, addressing your questions where possible:

1. Table of Acceptance Criteria and Reported Device Performance

No explicit acceptance criteria are provided in the document for diagnostic performance metrics (e.g., sensitivity, specificity, PPV, NPV). The document's purpose is to demonstrate substantial equivalence and usability, not to establish diagnostic performance against specific targets.

The "device performance" in the clinical summary relates to the ability to obtain tissue and the subsequent histological findings.

Acceptance Criteria (Not explicitly stated for diagnostic accuracy)	Reported Device Performance (Clinical Summary)
e.g., Sensitivity of X%, Specificity of Y%	87 patients underwent SiteSelect stereotactic breast biopsy.
e.g., Successful tissue acquisition rate of X%	12 patients (14%) were diagnosed with malignant lesions.
e.g., Margin status for malignancies	Of the 12 malignant lesions: 2 (16.7%) had negative margins, 7 (58.3%) had margin involvement, and 3 (25%) were undetermined.
	All patients with malignancies were treated with a surgical procedure after the SiteSelect procedure.

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

Sample Size for Test Set: 87 patients.
Data Provenance: The study was a "multi-center, non-randomized study" collected from "3 sites." The country of origin is not specified, but the FDA submission suggests it was likely
conducted in the United States. The study was prospective as it involved patients undergoing procedures to evaluate the device.

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

The document does not specify the number of experts used to establish the ground truth. It states that "malignant lesions" were "diagnosed," which implies pathological examination. The qualifications of these experts (e.g., pathologists) are not provided.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method for the test set. Diagnosis of malignancy would typically come from a pathology report, which serves as the ground truth.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study described focuses on the device's ability to obtain biopsies and the subsequent diagnostic findings, not on comparing reader performance with or without AI assistance. The SiteSelect device is a physical biopsy tool, not an AI-assisted diagnostic tool for image interpretation.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, this is not applicable. The SiteSelect is a physical medical device (a disposable breast biopsy device), not an algorithm or AI. Therefore, a standalone study of an algorithm's performance is not relevant in this context. The clinical summary describes its use in conjunction with human healthcare providers.

7. The Type of Ground Truth Used

The ground truth for the diagnosis of malignancy was pathology (histological examination), as indicated by the statement "diagnosed with malignant lesions" and the subsequent "surgical procedure after diagnostic SiteSelect procedure," implying confirmation of the diagnosis.

8. The Sample Size for the Training Set

Not applicable. The SiteSelect device is a physical, disposable breast biopsy device, not a machine learning model or algorithm that requires a training set. The clinical study described is for evaluating the device's use in tissue acquisition and diagnosis in patients.

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

Not applicable. As stated above, this is a physical device, not an AI model, and therefore does not have a "training set" in the context of machine learning.

Summary

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DEC 27 1999

K99 39 36

Appendix II

Summary of Safety and Effectiveness

The construction, materials, sterilization, and method of operation of the SiteSelect devices are identical to the Imagyn Surgical SiteSelect devices currently on the market.

Standards/guidelines used for the testing and manufacturing of the SiteSelect device are:

ANSI/AAMI/ISO 11135-1994 Medical Devices - Validation and routine control of ethylene oxide sterilization ANSI/AAMI/ISO 11135-1994 Medical Devices -Validation and routine control of ethylene oxide sterilization

ISO 10993-7: 1995 EtO Sterilization Residuals; for Limited Exposure Devices

FDA's Proposed Residue Limits; FDA, 43FR 279.82 (June 23, 1978)

ISO-10993 Biological evaluation of Medical Devices Part 1: Evaluation and Testing

EN 1441 Risk Analysis

ISO 11607 Packaging for Sterilized Devices

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Appendix II

Summary of Safety and Effectiveness (continued)

Clinical Summary:

Data from a multi-center, non-randomized study was collected. Eighty-seven patients, from 3 sites, underwent SiteSelect stereotactic breast biopsy procedures to evaluate device for the use in the removal of mammographically detected abnormalities for diagnostic evaluation.

Twelve patients (14%) were diagnosed with malignant lesions. Of the 12 patients with malignant lesions 2 (16.7%) had negative margins, 7 (58.3%) had margin involvement, and 3 (25%) were undetermined. Consistent with standard of care for excisional biopsies, all patients with malignancies were treated with a surgical procedure after diagnostic SiteSelect procedure.

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling a stylized bird or human profile, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 7 1999

Ms. Julie Powell Quality Assurance/Regulatory Affairs Director Imagyn Surgical 8850 M89, Box 351 Richland, Michigan 49083-0351

K993936 Re: Trade Name: SiteSelect Breast Biopsy Device Regulatory Class: II Product Code: KNW Dated: November 18, 1999 Received: November 19, 1999

Dear Ms. Powell:

We have reviewed your Section 510(k) 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Julie Powell

This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Rindtliya

Sor Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) Number (if known):

Device Name:

Indications for Use:

SiteSelect is to be used in conjunction with stereotactic mammographic imaging systems capable of determining position of lesion within breast tissue.

This device is used in conjunction with the SiteSelect Instrument Accessories, which are mounted on a stereotactic table and used with a stereotactic mammographic imaging system.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Signature

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number	K957556

Prescription Use	X	OR	Over-the-Counter Use
(Per 21 CFR 801.1091			(Optional Format 1-2-96)

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.