(30 days)
No
The description focuses on mechanical and software control for stereotactic targeting based on calculated coordinates, with no mention of AI/ML terms or processes like training/testing data.
No.
The device is intended for guidance in interventional procedures like biopsy and localization, not for direct therapeutic treatment.
No
The device is described as an "optional accessory...designed to allow the accurate location of lesions in the breast in three dimensions...intended to provide guidance for interventional purposes (such as biopsy, pre-surgical localization or treatment devices)." This indicates its purpose is for interventional guidance rather than diagnosis.
No
The device description explicitly lists hardware components like the Biopsy Unit, SmartWindow control module, and a DSM computer workstation, indicating it is not solely software.
Based on the provided information, the Hologic Digital StereoLoc II is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is designed to "allow the accurate location of lesions in the breast in three dimensions" and "provide guidance for interventional purposes (such as biopsy, pre-surgical localization or treatment devices)." This describes a device used for image-guided procedures performed directly on the patient's body.
- Device Description: The description details a physical accessory attached to a mammography system, involving patient compression, needle guidance, and motion control. This is consistent with a device used for interventional procedures.
- Lack of In Vitro Activities: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) outside of the body. IVDs are specifically designed for testing these types of samples.
Therefore, the Hologic Digital StereoLoc II is a medical device used for image-guided interventions on the patient, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Hologic Digital StereoLoc II is an optional accessory for the Selenia full field digital mammography system. It is designed to allow the accurate location of lesions in the breast in three dimensions, using information extracted from stereo tactic pairs of twodimensional images. It is intended to provide guidance for interventional purposes (such as biopsy, pre-surgical localization or treatment devices).
Product codes
90 IZH
Device Description
The Digital StereoLoc II is an optional accessory to the Selenia Full Field Digital Mammography System. It is attached to the Selenia to perform stereotactic biopsies and is composed of the following elements:
- The Biopsy Unit or Stage used for patient compression and vertical mounting of the . biopsy needle.
- The SmartWindow control module for X and Y-axis motion control and Z-axis . positioning guidance.
- DSM computer workstation and software for stereotactic targeting.
The breast is compressed between the compression paddle and the carbon fiber breast platform of the biopsy unit. The biopsy unit has its own manual compression mechanism that is independent of the Selenia FFDM compression device. There are two compression knobs; one at each side of the biopsy unit. The Smart Window control module gets the Cartesian coordinates (X, Y, Z) of the target from the DSM workstation. - X and Y motion is motorized. Controlled by the operator via the SmartWindow. .
- . Z-axis motion is manual and controlled by the operator.
Safety Features include: - Automatic lockout of Biopsy Unit movement with C-Arm when patient is under . compression.
- . Automatic detection of biopsy unit and cables attached.
- . Audible alert when switched from Stereo to C-Arm mode.
- Audible alert when Selenia compression device may interfere with stereo imaging . movement.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Stereotactic pairs of two-dimensional images (X-ray mammography)
Anatomical Site
Breast
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The Digital StereoLoc II System was tested by UL to IEC 60601-1 Medical Electrical Equipment Standards. The DSM Workstation complies with ACR/NEMA Digital Imaging Communications in Medicine version 3.0.
Hologic performs design control verification and validation tests under 21 CFR Part 820.
Key Metrics
Not Found
Predicate Device(s)
K950220 Hologic Lorad StereoLoc II, K040884 Hologic Lorad DSM, K040125 Senographe Stereo General Electric Medical Systems
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
HOLOGIC
K07/542
Digital StereoLoc II
JUL - 5 2007
510(k) Summary of Safety Effectiveness
This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.87 (b)
Product Name: Digital StereoLoc II
Product Classification Name: Mammographic X-Ray System
Product Classification Code: 90 IZH CFR Section: 892.1710
Classification Panel: Radiology Class II
Manufacturer: Hologic, Inc. 36 Apple Ridge Road Danbury, CT 06810 USA
| Contact Person: | Gail Yaeker-Daunis |
|---|---|
| Telephone Number: (203) 731-8337 | |
| Fax Number: (203) 731-8440 |
Date Prepared: May 4, 2007
Predicate Devices: K952210 Hologic Lorad StereoLoc II K040884 Hologic Lorad DSM K040125 Senographe Stereo General Electric Medical Systems
Device Description:
The Digital StereoLoc II is an optional accessory to the Selenia Full Field Digital Mammography System. It is attached to the Selenia to perform stereotactic biopsies and is composed of the following elements:
- The Biopsy Unit or Stage used for patient compression and vertical mounting of the . biopsy needle.
- The SmartWindow control module for X and Y-axis motion control and Z-axis . positioning guidance.
- DSM computer workstation and software for stereotactic targeting. .
The breast is compressed between the compression paddle and the carbon fiber breast platform of the biopsy unit. The biopsy unit has its own manual compression mechanism
1
Image /page/1/Picture/0 description: The image shows the logo for Hologic. The logo consists of the word "HOLOGIC" in large, bold, black letters. Below the word "HOLOGIC" is the phrase "CLARITY OF VISION" in smaller, black letters.
that is independent of the Selenia FFDM compression device. There are two compression knobs; one at each side of the biopsy unit. The Smart Window control module gets the Cartesian coordinates (X, Y, Z) of the target from the DSM workstation.
- X and Y motion is motorized. Controlled by the operator via the SmartWindow. .
- . Z-axis motion is manual and controlled by the operator.
Safety Features include:
- Automatic lockout of Biopsy Unit movement with C-Arm when patient is under . compression.
- . Automatic detection of biopsy unit and cables attached.
- . Audible alert when switched from Stereo to C-Arm mode.
- Audible alert when Selenia compression device may interfere with stereo imaging . movement.
How the Device Works:
Digital StereoLoc II for Selenia uses the Selenia detector for stereo image acquisition similar to the CCD camera used on the DSM system for the M-IV version of StereoLoc II (SLI). Stereotactic images are acquired at +/-15°. These stereo images are then automatically forwarded to the DSM Workstation for automatic calculation of the stereo coordinates and targeting of the lesion by the user (same as DSM operation with M-IV). The Compression Paddle and biopsy needle stage are the same as the StereoLoc II used with the Hologic Lorad M-IV, as are the X and Y-axis motion controllers. Both Compression and Z-axis movements are manually applied as with the M-IV. The stereo coordinates are then sent from the DSM Workstation to the Smart Window Control Module on the Digital StereoLoc LCD display (same as with StereoLoc II operation on M-IV). As with previous DSM Workstation versions, stereo images may be sent to PACS for archiving via DICOM protocol.
Indications for Use:
The Hologic Digital StereoLoc II is an optional accessory for the Selenia full field digital mammography system. It is designed to allow the accurate location of lesions in the breast in three dimensions, using information extracted from stereo tactic pairs of twodimensional images. It is intended to provide guidance for interventional purposes (such as biopsy, pre-surgical localization or treatment devices).
Comparison With Predicate Devices:
The Hologic Digital StereoLoc II is substantially equivalent to the following devices:
K950220 Hologic Lorad StereoLoc II K040884 Hologic Lorad DSM K040125 Senographe Stereo General Electric Medical Systems
These devices are Mammographic X-Ray Systems which aid in the performance of breast biopsies and pre-surgical localization.
2
Image /page/2/Picture/0 description: The image shows the logo for Hologic. The logo is in black and the words "Clarity of Vision" are written below the logo. There is a registered trademark symbol to the right of the "C" in Hologic.
Summary of Testing
The Digital StereoLoc II System was tested by UL to IEC 60601-1 Medical Electrical Equipment Standards. The DSM Workstation complies with ACR/NEMA Digital Imaging Communications in Medicine version 3.0.
Hologic performs design control verification and validation tests under 21 CFR Part 820.
Conclusion
The Digital StereoLoc II principles of operation, clinical effectiveness, design, construction and materials are similar to existing marketed devices. This system poses no additional risk.
3
Image /page/3/Picture/0 description: The image shows a circular seal with text around the perimeter and a symbol in the center. The text reads "U.S. Department of Health & Human Services - USA" in a circular arrangement. The symbol in the center consists of three stylized, curved lines that resemble a bird or a flowing design. The image is in black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
2007
Ms. Gail Yaeker-Daunis Senior Regulatory Specialist Hologic, Inc. 36 Apple Ridge Road DANBURY CT 06810
Re: K071542
Trade/Device Name: Digital StereoLoc II Regulation Number: 21 CFR 892.1710 Regulation Name: Mammographic x-ray system Regulatory Class: II Product Code: IZH Dated: June. 1, 2007 Received: June 5, 2007
Dear Ms. Yeaker-Daunis:
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 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/10 description: The image is a black and white circular logo. The logo has the text "1906-2006" at the top, "PA" in the center, and "Centennial" below that. The letters "USA" are at the bottom of the logo.
roloting and Promoting Publio Hoalth
4
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 forth 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 (800) 638-2041 or (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/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
5
510(k) No. _
Indications For Use
Device Name: Digital StereoLoc II
The Hologic Digital StereoLoc II is an optional accessory for the Selenia full field digital mammography system. It is designed to allow the accurate location of lesions in the breast in three dimensions, using information extracted from stereotactic pairs of twodimensional images. It is intended to provide guidance for interventional purposes (such as biopsy, pre-surgical localization or treatment devices).
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| -------------------------------------------------------- |
| Prescription Use
| 21 CFR 801.109 | OR | Over-the-Counter Use __________ |
|---|---|---|
| ------------------------------------ | ---- | --------------------------------- |
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal and | |
| Radiological Devices | |
| 510(k) Number | K071542 |
Section A
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