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 its 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 a stereotactic mammographic imaging system 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

SiteSelect Breast Biopsy System consists of the SiteSelect device and the Site Select table mount accessories. We have previously received clearance under 510(k) # K972328 for the 10mm and 15mm SiteSelect device. We have since received clearance under 510(k) #K993963 to expand the intended use. The Instrument Accessories have received clearance under 510(k) # K972328 and are currently on the market.

The SiteSelect device is provided sterile for single use only. It contains a Localization Needle, Localization Wire, a Stylet, and Cutting Cannula. The device is equipped with a Garrote Wire and Disc Blades to transect the specimen. The device is packaged in individual thermoformed blisters with peel off Tyvek® lid.

AI/ML Overview

Here's a summary of the acceptance criteria and the study backing the SiteSelect Breast Biopsy Device, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

The provided 510(k) summary (K011575) for the 22mm SiteSelect Breast Biopsy Device does not explicitly state pre-defined acceptance criteria in terms of specific numerical thresholds for performance metrics. Instead, the study's primary goal was to demonstrate comparability to a legally marketed predicate device (the 15mm SiteSelect device).

The "acceptance criteria" can be inferred from the stated conclusions: that the 22mm device is safe for its intended use, has accurate targeting of selected tissue, captures adequate tissue specimens for histological analysis, and is comparable to the 15mm SiteSelect device with no significant variances in key clinical categories.

Table of Acceptance Criteria and Reported Device Performance (Inferred):

Acceptance Criteria (Inferred)	Reported Device Performance
Safety: Device is safe for its intended use.	The 22mm SiteSelect device was shown to be safe for its intended use. Data from the 22mm and 15mm devices were comparable across patient population, procedure variables (time, incision length, blood loss, electrocautery use), and patient discomfort levels during the procedure. Breast tissue appearance at follow-up was also comparable.
Targeting Accuracy: Accurate targeting of selected tissue.	In all clinical cases, the device had accurate targeting of selected tissue.
Specimen Adequacy: Capture of adequate tissue specimen for histological analysis.	In all clinical cases, the device captured adequate tissue specimen for histological analysis. Specimens were suitable for pathological analysis.
Comparability to Predicate (15mm SiteSelect): No significant variances in key clinical areas.	The clinical study showed the 22mm SiteSelect device was comparable to the 15mm SiteSelect device with no significant variances between the two across patient population, procedure variables, discomfort level, breast tissue appearance at follow-up, and suitability of specimens for pathological analysis.

Study Details:

This submission describes a clinical study comparing the new 22mm SiteSelect device to the existing 15mm SiteSelect device.

Sample Size used for the test set and the data provenance:
- Test Set Size: A total of 50 procedures were completed, with 25 procedures using the 22mm device and 25 procedures using the 15mm device.
- Data Provenance: The document does not explicitly state the country of origin. It is a prospective clinical study, as procedures were "completed" for the purpose of the comparison.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not provide details on the number of experts or their qualifications for establishing the "ground truth." However, it states that "Specimens were suitable for pathological analysis," implying that pathologists (experts) would have performed this analysis.
Adjudication method for the test set:
- The document does not describe any specific adjudication method (e.g., 2+1, 3+1). The "comparable" assessment likely refers to a direct comparison of the collected data points without explicit expert adjudication of conflicting results.
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 was a clinical study comparing two medical devices for biopsy, not an AI-based imaging study involving human readers. Therefore, an MRMC study and AI-related effect sizes are not applicable here.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This device is a manual biopsy instrument and does not involve an algorithm. Its performance is directly tied to human use in a medical procedure.
The type of ground truth used:
- The ground truth primarily relates to histological analysis of the tissue specimens obtained. The study also evaluated clinical parameters like targeting accuracy, pain, and follow-up appearance, which rely on direct observation and patient reporting during the procedure and follow-up visits.
The sample size for the training set:
- This was a clinical study comparing a new device size to an existing one. It is not an algorithm development study, so the concept of a "training set" in the context of machine learning does not apply.
How the ground truth for the training set was established:
- As this is not an algorithm development study, the concept of establishing ground truth for a training set is not applicable. The "ground truth" for the clinical study was based on the pathological analysis of the biopsy specimens and clinical observations during the procedures and follow-up.

Summary

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K011575

AUG 1 7 2001

510(k) Summary of Safety and Effectiveness May 18, 2001

1. Submitter

Julie Powell, Quality Assurance/Regulatory Affairs Vice President Imagyn Surgical, A Division of Imagyn Medical Technologies, Inc. 8850 M-89, P.O. Box 351 Richland, MI 49083 ph: (616) 629-5811 fax: (616) 629-9654 e-mail: julie.powell(@imagyn.com

2. Name of device

Common name: Biopsy Instrument Trade name: SiteSelect Breast Biopsy Device Classification name: Instrument, Biopsy

3. Devices to which substantial equivalence is claimed

510(k)#	Device	Manufacturer
K993936	SiteSelect Breast Biopsy Device	Imagyn Surgical
K972328	SiteSelect Breast Biopsy Device	Imagyn Surgical
K983296	ABBI	USSC
K954628	ABBI	USSC

4. Description of Device

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5. Intended Use

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 its 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 a stereotactic mammographic imaging system 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.

6. Device compared to predicate device

The 22mm SiteSelect is substantially equivalent to like devices in commercial distribution and currently marketed by Imagyn Surgical and United States Surgical Corporation (USSC).

Imagyn Site Select and USSC devices are all used to obtain biopsies of the breast. These devices are used in conjunction with instrument accessories, which are used to mount the devices on a stereotactic table. The devices are used with stereotactic mammographic imaging systems, such as Fischer or Lorad prone stereotactic tables.

The 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.

The difference between the 22mm SiteSelect and currently marketed SiteSelect devices is the 22mm device has disc blades along with a garrote wire to transect tissue. The other difference is the method of trigger deployment. The triggers are pulled away from patient instead of being pushed forward

The construction, materials, and sterilization of the 22mm SiteSelect device is similar to the Imagyn Surgical SiteSelect devices currently on the market.

K011575

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K011575

7. Clinical Performance Data

The 22mm SiteSelect clinical data was compared to data gathered on the current 15mm SiteSelect device. A total of 50 procedures (25-22mm and 25-15mm) were completed. The data in the following categories from both devices were comparable with no significant variances between the two:

Patient population .
Procedure variables-procedure time, incision length, blood loss, . use of electrocautery
Discomfort level during the procedure ●
Breast tissue appearance at follow up visit ●
Specimens were suitable for pathological analysis .

8. Conclusions drawn from clinical study

The 22mm SiteSelect device was shown to be safe for its intended use. In all clinical cases the device had accurate targeting of selected tissue and capture of adequate tissue specimen for histological analysis.

The clinical study showed the 22mm SiteSelect device was comparable to the 15mm SiteSelect device with no significant variances between the two.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three swooping lines representing its wings.

AUG 1 7 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Julie Powell Vice President, Quality Assurance/Regulatory Affairs Imagyn Surgical A Division Of Imagyn Medical Technologies, Inc. 8850 M-89 P.O. Box 351 Richland, Michigan 49083

Re: K011575

Trade/Device Name: SiteSelect Breast Biopsy Device Regulation Number: 876.1075 Regulatory Class: II Product Code: KNW Dated: May 18, 2001 Received: May 22, 2001

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 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). 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 requirements, 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) 594-4659. 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 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.

Mark McMillan

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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Ver/3-4/24/96

Applicant: Imagyn Surgical

5109(k) Number (if known):

Device Name: SiteSelect Breast Biopsy Device

Indications for Use:

SiteSelect is to be used in conjunction with a stereotactic mammographic imaging system 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) (Per 21 CFR 801.1091)

Murk N. Milbersen

vision of General, Restorative and Neurological Devices 1011575

510(k) Number_

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.