BIOPSY DIGIT-AM

K062039 · Giotto USA, LLC · IZH · Sep 11, 2006 · Radiology

Device Facts

• Record ID: K062039
• Device Name: BIOPSY DIGIT-AM
• Applicant: Giotto USA, LLC
• Product Code: IZH · Radiology
• Decision Date: Sep 11, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1710
• Device Class: Class 2

Intended Use

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

Device Story

Device uses digital solid-state camera to capture two stereo X-ray images of breast tissue from different angles; binocular vision principle calculates 3D coordinates of lesions. Physician uses calculated coordinates to position needle holder for precise needle or guide-wire insertion. Used in clinical settings for minimally invasive tissue sampling; reduces tissue removal and scarring compared to surgical biopsy. Benefits patient by providing accurate, less invasive diagnostic localization for suspicious lesions identified via mammography.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and functional comparison to the predicate device.

Technological Characteristics

Mammographic X-ray system utilizing digital solid-state camera for stereotactic imaging. Patient-contact components (paddles, supports, holders) utilize same materials as predicate. Operates via fixed-geometry binocular vision principle to calculate 3D lesion coordinates.

Indications for Use

Indicated for patients undergoing mammographic procedures requiring stereotactic guidance, including fine needle aspiration, needle biopsy, and guide-wire placement.

Regulatory Classification

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.

Predicate Devices

• BIOPSY DIGIT (K990192)

Submission Summary (Full Text)

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(062039

#### Submitter Information 1.

- 1.1. Submitter: GIOTTO USA, LLC 1822 East 1st Street Wichita, KS 67214 Phone: [phone] Fax. [phone]
- 1.2. Manufacturing Facility: Internazionale Medico Scientifica S.r.l. Via Sagittario, 5 - 40044 Pontecchio Marconi Bologna, Italy
- 1.3. Contact: Robert Rusk
- 1.4. Date: 17-Jul-06

# 2. Device Name

| 2.1. | Classification Name:<br>Classification Number: | System Mammographic<br>90IZH |
|------|------------------------------------------------|------------------------------|
| 2.2. | Trade/Proprietary Name: | BIOPSY DIGIT-AM |
| 2.3. | Predicate Device: | BIOPSY DIGIT (DC K990192) |

## 3. Device Description

## 3.1. Function

The BIOPSY DIGIT-AM 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-AM 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.

# 3.2. Scientific Concepts:

The BIOPSY DIGIT-AM 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

SEP 1 1 2006

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# 510(k) Summary

K62039

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 and knew, 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 an X-ray imaging system. The diagram includes an X-ray source labeled "X-ray Source" with points A and B indicating the source's extent. An object is positioned between the source and the image detector plane, and the image detector plane is labeled "Image detector plane" with points C and D indicating the plane's extent.

# 3.3. Physical and Performance Characteristics:

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 years 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 sample needed determining the lesion type for a positive mammography examination. The procedure removes much less tissue and produces much less scar tissue than conventional surgical biopsy.

## Device Intended Use 4.

- 4.1. The intended uses of the BIOPSY DIGIT-AM are identical to the intended uses of the BIOPSY DIGIT predicate device (Premarket notification K990192),
## Device Technological Characteristics 5.

- 5.1. The characteristics of the BIOPSY DIGIT-AM system compare substantially with the BIOPSY DIGIT, 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 BIOPSY DIGIT.

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K062039

- The components of the BIOPSY DIGIT-AM that come in direct contact with 5.2. the patient (paddles, supports, holders, digital camera) are of the same materials as the BIOPSY DIGIT predicate device (Premarket notification K990192).

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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Giotto USA c/o Ms. Allison Scott Consultant The Anson Group, LLC 11460 N. Meridian St., Suite 150 CARMEL IN 46032

Re: K062039

> Trade/Device Name: Biopsy Digit-AM Regulation Number: 21 CFR §892.1710 Regulation Name: Mammographic x-ray system Regulatory Class: II Product Code: IZH Dated: July 18, 2006 Received: July 19, 2006

Dear Ms. Scott:

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.

SEP 1 1 2006

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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Image /page/3/Picture/8 description: The image is a circular logo with the text "1906-2006" at the top. The letters "FDA" are in the center of the logo in a bold, stylized font. Below the letters, the word "Centennial" is written in a cursive font. Three stars are arranged in a horizontal line at the bottom of the logo. The logo appears to be a commemorative emblem for the centennial of the Food and Drug Administration.

*Protecting and Promoting Public Health*

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Page 2 -

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 orth 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.

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 one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

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 [phone] or [phone]

or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known):

K04 2039

Biopsy Digit-AM Device Name:

Indications For Use:

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

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel R. Simpson

(Division Sign-Of Division of Reprodu and Radiological D 510(k) Number