(50 days)
No
The description focuses on mechanical and electrical modifications to the compression system for smoother control and paddle positioning. There is no mention of data processing, algorithms, or learning capabilities.
No
The device is a modification kit for an x-ray mammography system, designed to improve compression control and paddle positioning, not to diagnose, treat, prevent, or cure disease.
No
Explanation: The device is a modification kit for an x-ray mammography system, designed to improve compression control and paddle positioning. It does not generate or interpret medical data for diagnostic purposes; rather, it modifies equipment used for imaging, which is a diagnostic procedure.
No
The device description explicitly states it is comprised of two parts: a "Compression Control Module" (an electrical circuit) and "Paddle Leveling Spacers" (aluminum pieces), indicating it includes hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Digitec Two Stage Compression Kit is a modification for an X-ray mammography system. Its purpose is to improve the mechanical operation of the compression system during a mammogram. It directly interacts with the imaging equipment and the patient's breast, not with a biological sample.
- Intended Use: The intended use clearly states it modifies the compression system of an X-ray machine to improve control and paddle positioning. It does not mention any analysis of biological samples or diagnostic testing performed outside of the body.
Therefore, the device falls under the category of a medical device used for imaging, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The kit is intended to improve the performance of the compression system of the GE Senographe 600T series x-ray mammography systems. It is designed to position the compression paddles flat and parallel with the bucky surface and to give the technologist a smoother method for applying "fine adjustment" compression force.
It is not intended to change the basic operation of the compression system, the operator controls, or the amount of compression force applied to the breast. The kit does not change the compression release features in any way.
The Digitec Two Stage Compression Kit is a modification for the GE Senographe 600T series x-ray mammography systems. It modifies two aspects of the compression system.
First, the kit is intended to improve the "fine adjustment" control of the compression sequence. The original design of the compression system uses the same control method for applying initial compression force and for "fine adjustment" force. The kit does not change the method to apply initial compression force. It modifies the control sequence to achieve smoother fine adjustment control. "Fine adjustment" control is required to slowly and incrementally add the last little bit of compression just prior to making the exposure.
The modification kit also repositions the compression paddle to be flat and parallel with the breast support plate. The original design elevates the chestwall edge of the compression paddle off of the breast support plate. The kit removes the 1.2-degree tilt of the original design.
The kit is not intended to change the basic operation of the compression system, the operator controls, or the amount of compression force applied to the breast. Finally, the kit does not change the safety or compression release features in any way.
Product codes
90 IZH
Device Description
The Digitec Two Stage Compression Kit is an accessory item designed for use in the GE Senographe 600T series X-Ray Mammography Systems. It is comprised of two parts:
-
- Compression Control Module
The compression control module is a small electrical circuit added to the original compression control system. It modifies the system to give the technologist a smoother method for applying "fine adjustment" compression force.
- Compression Control Module
-
- Paddle Leveling Spacers
The leveling spacers are used to change the position of the compression paddles relative to the bucky surface. The spacers are small aluminum pieces designed to fit on the compression paddle mounting arms. The spacers remove the 1.2 degree tilt of the original design and reposition the paddles flat and parallel with the surface of the bucky.
- Paddle Leveling Spacers
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
DEC 21 1996
510 (K) SUMMARY
| Name: | Digitec Medical Service Corporation |
|---|---|
| Address: | 465 Maltbie Street, Suite 407, |
| Lawrenceville, GA. 30045 | |
| Phone: | 770-995-0050 |
| Fax: | 770-995-8553 |
| Contact person: | James McGinty |
| Date of preparation: | October 29, 1999 |
| Name of Device: | Digitec Two Stage Compression Kit |
| Trade: | Digitec Two Stage Compression Kit |
| Common: | Accessory to Mammography Compression Device |
| Classification name: | Accessory to Mammographic X-Ray System |
| Per 21 CFR SEC 892.1710 |
Legally marketed device to which we are claiming equivalence:
The device to which substantial equivalence is being claimed is the GE Senographe 600T and 600Ts. X-ray mammography systems. The 510(k)document control number for this comparison device is K881882.
Description of Device
The Digitec Two Stage Compression Kit is an accessory item designed for use in the GE Senographe 600T series X-Ray Mammography Systems. It is comprised of two parts:
-
- Compression Control Module
The compression control module is a small electrical circuit added to the original compression control system. It modifies the system to give the technologist a smoother method for applying "fine adjustment" compression force.
- Compression Control Module
1
-
- Paddle Leveling Spacers
The leveling spacers are used to change the position of the compression paddles relative to the bucky surface. The spacers are small aluminum pieces designed to fit on the compression paddle mounting arms. The spacers remove the 1.2 degree tilt of the original design and reposition the paddles flat and parallel with the surface of the bucky.
- Paddle Leveling Spacers
Intended Use of The Digitec Two Stage Compression Kit
The kit is intended to improve the performance of the compression system of the GE Senographe 600T series x-ray mammography systems. It is designed to position the compression paddles flat and parallel with the bucky surface and to give the technologist a smoother method for applying "fine adjustment" compression force.
It is not intended to change the basic operation of the compression system, the operator controls, or the amount of compression force applied to the breast. The kit does not change the compression release features in any way.
2
Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 21 1999
James J. McGinty Digitec Medical Service Corporation 465 Maltbie Street, Suite 407 Lawrenceville, GA 30045
Re:
K993681 Digitec Two Stage Compression Kit Dated: October 29, 1999 Received: November 1, 1999 Regulatory class: II\ 21 CFR 892.1710/Procode: 90 IZH
Dear Mr. McGinty:
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). Vou 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 III (Special Controls) or dass 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 requlation (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.
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 vour 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) 594-4613. 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,
APT 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
3
STATEMENT OF INDICATIONS OF USE
The Digitec Two Stage Compression Kit is a modification for the GE Senographe 600T series x-ray mammography systems. It modifies two aspects of the compression system.
First, the kit is intended to improve the "fine adjustment" control of the compression sequence. The original design of the compression system uses the same control method for applying initial compression force and for "fine adjustment" force. The kit does not change the method to apply initial compression force. It modifies the control sequence to achieve smoother fine adjustment control. "Fine adjustment" control is required to slowly and incrementally add the last little bit of compression just prior to making the exposure.
The modification kit also repositions the compression paddle to be flat and parallel with the breast support plate. The original design elevates the chestwall edge of the compression paddle off of the breast support plate. The kit removes the 1.2-degree tilt of the original design.
The kit is not intended to change the basic operation of the compression system, the operator controls, or the amount of compression force applied to the breast. Finally, the kit does not change the safety or compression release features in any way.
David A. Sezman
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Dey 510(k) Number
Prescription Use
(Per 21 CFR 801.109)