The Biopsy Digit S and SL are intended to be used for mammographic procedures requiring stereotactic guidance, such as fine needle aspiration, needle biopsy and guide wire placement.

Device Description

The Biopsy Digit S and Biopsy Digit SL are modifications to the Biopsy Digit AM needle guidance system. previously cleared as #K062039. and supplied as an accessory to the Giotto Image 3D/DL mammography system. The CMOS digital camera used on the Biopsy Digit AM is not used on the Biopsy Digit S/SL. Rather a 65mm (high) X 80mm (wide) portion of the full field amorphous selenium detector of the Giotto Image 3D/DL is used to acquire the mammographic, targeting, image data. The mechanics, cleanable surfaces, on-board electronics, and user interface software are all the same as on the biopsy Digit AM. The Biopsy Digit S/SL receives power from the Giotto Image 3D/DL. The Biopsy Digit S/SL in conjunction with the Giotto Image 3D/DL, take two exposures at separate angles ± 22.6° from the perpendicular of the digital detector centerline. The x-ray tube is driven first to one side of center and then to the other by an electro-mechanical mechanism, which is an integral part of the Giotto Image 3D/3DL, so that a stereo pair of images can be acquired. The two views provide two separate 2dimensional projections of the subject anatomy. The two views are stored in the computer system, and can be retrieved and viewed on the computer monitor. The operator, using a mouse, identifies the region of interest on the monitor. The computer then calculates of the region of interest in three dimensions, using trigonometry, and then transfers the coordinates to the needle-positioning unit. The software algorithm used for the calculation is identical to that used by the Biopsy Digit AM (#K062039). The needle-positioning unit then drives the needle holder to the required location so that the operator can insert the needle or locating wire into the exact coordinates necessary.

AI/ML Overview

The provided 510(k) summary for the Giotto Biopsy Digit S/SL does not contain explicit acceptance criteria or a detailed study description with specific performance metrics and statistical analyses typically associated with proving a device meets acceptance criteria.

The document describes the device as a modification of a previously cleared device (Biopsy Digit AM) and focuses on demonstrating substantial equivalence through non-clinical testing. It highlights changes in the detector technology (from CMOS to an amorphous selenium detector) and confirms that the mechanics and software algorithms remain the same.

However, based on the information provided, here's what can be inferred and what is explicitly missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred from testing description)	Reported Device Performance (Inferred/Stated)
Equivalent image parameters between new aSe detector and old CMOS detector	Comparative image parameter testing performed. (No specific quantitative results provided)
Stereotactic accuracy in compliance with IEC Standard 60601-2-45	Stereotactic accuracy testing performed for both biopsy systems. (No specific quantitative results provided)
User validation of the Biopsy Digit S/SL system	End user validation testing performed. (No specific quantitative results or success criteria provided)
Compliance with International Standards: IEC 60601-1-2, 60601-1-3, 62304	Testing performed to demonstrate compliance. (No detailed report of compliance provided, only a statement)

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

This information is not provided in the document. There is no mention of the number of images, cases, or subjects used in any of the described tests. The provenance of any data (e.g., country of origin, retrospective/prospective) is also not stated.

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

This information is not provided. The document mentions "end user validation testing," but does not specify how many users participated, their qualifications, or how any "ground truth" for this validation was established. For stereotactic accuracy testing, the "ground truth" would likely be derived from physical measurements against a known standard, not expert consensus.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of the testing described (comparative image parameters, stereotactic accuracy, end-user validation), an adjudication method (like 2+1 or 3+1 expert consensus) is unlikely to be directly applicable in the way it would be for diagnostic AI performance. For end-user validation, feedback mechanisms would be used, but the specific method is not detailed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed or described in this 510(k) submission. The device is a needle guidance system, not a diagnostic AI intended to assist human readers in interpretation. Therefore, assessing how human readers improve with or without AI assistance is not relevant to this device's function as described.

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

Standalone performance, especially for the "software algorithm used for the calculation" of the region of interest in three dimensions, was implicitly tested. The document states:

"Stereotactic accuracy testing for both biopsy systems in compliance with IEC Standard 60601-2-45"
This testing would assess the accuracy of the system (including the algorithm) in guiding the needle, independent of a specific human operator's interpretation. However, specific results of this standalone accuracy are not provided. The document emphasizes that "The software algorithm used for the calculation is identical to that used by the Biopsy Digit AM (#K062039)," relying on the previous clearance for the algorithm's validation.

7. The Type of Ground Truth Used

For Image Parameter Testing: Likely objective measures derived from test phantoms or calibrated imaging standards.
For Stereotactic Accuracy Testing: Established through physical measurements against known targets or a gold standard measurement device, as per IEC Standard 60601-2-45.
For End User Validation: Likely user feedback and possibly a demonstration of successful task completion based on the device's intended use.
For Compliance with Standards: Objective verification against the requirements of the specified IEC standards.

The document does not explicitly state the exact nature of the ground truth for each test, but it can be inferred from the type of testing.

8. The Sample Size for the Training Set

This information is not applicable / not provided. The device is an accessory for stereotactic guidance, not a machine learning or AI algorithm that requires a training set in the conventional sense. The "software algorithm" for coordinate calculation is stated to be "identical" to the predicate device, implying it was developed and validated previously, not "trained" in this submission.

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

This information is not applicable / not provided for the same reasons as #8. If the "software algorithm" for coordinate calculation was developed using any form of historical data or training, those details are not within this 510(k) submission. The submission relies on the previous clearance (K062039) for the validation of this specific algorithm.

Summary

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K113607

Section 5: 510(k) Summary

AUG 1 0 2012

Submitter:	Giotto USA, LLC7324 Greenbriar CircleWichita, KS 67226
Official Correspondent:	Jillian M. ReedRegulatory and Clinical Affairs ConsultantReed Technical Associates, LLC23 Griswold LaneWinsted, CT 06098
	O: 860-238-7734
	F: 203-538-3960
	jillianreed@charter.net
Date Prepared:	August 8, 2012
Classification Name:	System, X-Ray, Mammographic
Common Name:	Mammographic X-Ray System
Product Code:	IZH
Proprietary Name:	Giotto Biopsy Digit S/SL
Predicate Devices:	#K062039 Giotto Biopsy Digit AM

Device Description:

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that used by the Biopsy Digit AM (#K062039). The needle-positioning unit then drives the needle holder to the required location so that the operator can insert the needle or locating wire into the exact coordinates necessary.

Intended Use:

The Biopsy Digit S and SL are intended to be used for mammographic procedures requiring stereotactic guidance, such as fine needle aspiration, needle biopsy and guide wire placement.

Substantial Equivalence:

Non-Clinical testing has demonstrated that the Biopsy Digit S/SL is substantially equivalent to the predicate device, the Biopsy Digit AM. The use of new technology does not introduce new issues of safety or effectiveness.

Discussion of Non-Clinical Testing Performed:

Thorough non-clinical testing was performed to demonstrate that the Biopsy Digit S/SL is substantially equivalent to the predicate device, the Biopsy Digit AM, for the safe and effective use of the device for its intended use. This testing included comparative image parameter testing performed between the new aSe detector and the older CMOS detector, stereotactic accuracy testing for both biopsy systems in compliance with IEC Standard 60601-2-45, and end user validation testing of the Biopsy Digit S/SL system. In addition, testing was performed to demonstrate that the Biopsy Digit S/SL, in conjunction with the Giotto Image 3D/DL complies with the following International Standards: #60601-1-2, #60601-1-3, and #62304.

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Conclusions:

The information provided in this premarket notification submission has shown that the eRAD PACS/eRAD RIS/PACS/ eRAD EPVLite Viewer Software Product is substantially equivalent to the predicate devices and are safe and effective for its intended use.

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Image /page/3/Picture/0 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" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a bird-like figure with three curved lines representing wings or streams.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

AUG 1 0 2012

Giotto USA, LLC % Ms. Jillian M. Reed Regulatory and Clinical Affairs Consultant Reed Technical Associates, LLC 23 Griswold Lane WINSTED CT 06098

Re: K113607

Trade/Device Name: Biopsy Digit S and Biopsy Digit SL Regulation Number: 21 CFR 892.1710 Regulation Name: Mammographic x-ray system Regulatory Class: II Product Code: IZH Dated: July 25, 2012 Received: July 26, 2012

Dear Ms. Reed:

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice modical device-related ad retse ovelity systems (QS) regulation (21 CFR Part 820). 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 predication. 1110 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket o 150. Theo, prodot 100.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the

Tou may of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for use

510(k) number (if known:

Device names:

Biopsy Digit S and Biopsy Digit SL

Indications for use:

The Biopsy Digit S and SL are intended to be used for mammographic procedures requiring stereotactic guidance, such as fine needle aspiration, needle biopsy and guide wire placement.

Prescription use Over-The-Counter use And/or (Part 21 CFR 801 Subpart D) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation

(Division Sign-Off)
Division of Radiological Devices
K/12/2007

510k

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.