The intended uses of the Biopsy Digit are mammographic procedures requiring stereotactic guidance, such as fine needle aspiration, needle biopsy and guide wire placement. The intended uses are identical to those of the predicate device.

Device Description

The Biopsy-Digit device uses two stereo images taken by a digital solid state camera to determine the location of a lesion in three dimensions. Once the coordinates of the lesion are determined by the Biopsy-Digit they are used to position a needle holder such that when the physician inserts the needle or guide-wire, the tip will be precisely positioned at the pre-determined coordinates.

AI/ML Overview

The provided text does not contain specific acceptance criteria or a detailed study proving the device meets them. It describes the device's function, intended use, and substantial equivalence to a predicate device, but lacks the quantitative performance data needed to populate the requested table and answer several questions about a performance study.

Therefore, many of the requested fields will state "Not available in the provided text."

Here's a breakdown based on the available information:

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

Acceptance Criteria	Reported Device Performance
Not available	Not available

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 (Test Set): Not available in the provided text.
Data Provenance: Not available in the provided text.

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)

Number of Experts: Not available in the provided text.
Qualifications of Experts: Not available in the provided text.

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

Adjudication Method: Not available in the provided text. The document focuses on the mechanical and functional equivalence of the device, not on diagnostic performance where adjudication would be relevant.

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

MRMC Study: Not available in the provided text. The device is a stereotactic guidance system, not an AI-powered image analysis tool that would typically be evaluated in an MRMC study for reader improvement.
Effect Size: Not applicable, as no MRMC study is mentioned.

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

Standalone Performance Study: Not available in the provided text. The device is described as a system that facilitates a physician's procedure, implying human-in-the-loop operation, rather than a standalone AI algorithm.

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

Type of Ground Truth: Not available in the provided text. The submission focuses on the mechanical accuracy of the device in determining lesion location and guiding a needle, rather than a diagnostic outcome where "ground truth" (e.g., pathology) would typically be established for diagnostic accuracy.

8. The sample size for the training set

Sample Size (Training Set): Not applicable. The device described appears to be a mechanical device based on "human binocular vision" principles, rather than a machine learning model that requires a training set.

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

Ground Truth Establishment (Training Set): Not applicable, as the device does not appear to be a machine learning model requiring a training set.

Summary

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3/12/99

KC 990192

Submitter Information: 1.

1.1. Submitter: SITCO Incorporated 3456 N. Ridge Ave. #100 Arlington Heights, IL 60004 Phone: (847) 463-2001 FAX: (847) 463-2011
1.2. Manufacturing Facility: Internazionale Medico Scientifica S.r.I. Via Pila, 1/8 - 40044 Pontecchio Marconi Bologna, Italy
1.3. Contact: Robert H. McCarthy
Date: December 31, 1998 1.4.

2. Device Name

2.1.	Classification Name:Classification Number:	System Mammographic901ZH
2.2.	Trade/Proprietary Name:	Biopsy Digit
2.3.	Predicate Device:	Fischer MammoVision (DCK923061)

Device Description 3.

3.1. Function

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3.2. Scientific Concepts:

The Biopsy-Digit works on the same principle as human binocular vision. Two images of the same object are taken with the x-ray source in two different positions. Objects between the source and film plane appear at a different location as the source is moved from position A to B as shown in the figure below. Since the geometry of the system is fixed, given the apparent position of the object in the two views, shown as C and D in the figure, the true position of the object can be calculated.

Image /page/1/Figure/3 description: The image shows a diagram of a source emitting rays to points A and B. Above the source, there is a film plane labeled with points C and D. A point is located between the source and the film plane, with dashed lines connecting it to the source and the film plane. The diagram illustrates the relationship between the source, the points A and B, and the film plane.

Physical And Performance Characteristics: 3.3.

Mammography has been demonstrated to be the best imaging choice for screening of women for breast cancer by many studies and is currently recommended as a routine procedure for women over 50 vears of age. Mammography, however, has been shown to have a high rate of false positive examinations. Stereotactic needle localization has been shown to be a minimally invasive procedure for obtaining the tissue samples needed determining the lesion type for a positive mammography examination. The procedure removes much less tissue than and produces much less scar tissue than conventional surgical biopsy.

4. Device Intended Use:

4.1. The intended uses of the Biopsy Digit are mammographic procedures requiring stereotactic guidance, such as fine needle aspiration, needle biopsy and quide wire placement. The intended uses are identical to those of the predicate device.

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Device Technological Characteristics: 5.

The characteristics of the Biopsy-Digit system compare 5.1. substantially with the Fischer Mammovision predicate device, in both materials used, technology applied, and functional methodology. Differences of note do not affect safety and effectiveness of the device, intended use, or application methods. The device operates in a manner substantially equivalent to other cleared devices in this category, and performs as well as the predicate Mammovision.

5.2. Biocompatibility

The components of the Biopsy-Digit that come in direct contact with the patient (paddles, supports, holders, Digital camera) are of the same materials as the the Biopsy-M (Premarket notification K982049)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 2 1999

Robert H. McCarthy Vice President SITCO, Inc. 3456 N. Ridge Avenue #100 Arlington Heights, IL 60004 Re:

K990192 Biopsy-Digit Dated: December 31, 1998 Received: January 21, 1999 Regulatory class: II 21 CFR 892.1710/Procode: 90 IZH

Dear Mr. McCarthy:

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 redassified 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 conceming 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.

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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K940192 510(k) Number (if known):

Device Name:_Biopsy-Digit ・

Indications For Use:

The intended uses of the Biopsy Digit are mammographic procedures requiring
ed in the same of the collection needle aspiration, needle bionsy and guide wi The intended uses of the blopsy Digit are manunographis posses.
stereotactic guidance, such as fine needle aspiration, needle biopsy and guide wire placement.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

	(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number	K990192

Prescription Use_V (Per 21 CFR 801.109)

હત્વ

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Regulation Number and Section

§ 892.1710 Mammographic x-ray system.

(a)
Identification. A mammographic x-ray system is a device intended to be used to produce radiographs of the breast. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.