(22 days)
Not Found
Not Found
No
The summary does not mention AI, ML, or any related terms, nor does it describe features or performance metrics typically associated with AI/ML-powered image analysis or decision support.
No
The device is described as a "Mammography System" that performs "upright biopsy," indicating it is used for diagnostic procedures in the detection and characterization of breast abnormalities, not for treatment.
Yes
Explanation: The device description states "Mamex (Mammography System)", and the intended use mentions "capabilities of performing upright biopsy". Mammography systems, particularly those used for biopsies, are diagnostic tools used to detect and characterize abnormalities (e.g., breast cancer).
No
The device description explicitly states "Mamex (Mammography System)", which is a hardware system. The summary does not mention any software-only component or function.
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 such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- Device Description: The device is described as a "Mammography System" (Mamex) with the capability of performing "upright biopsy."
- Modality: The input imaging modality is "Mammography."
Mammography is an imaging technique that uses X-rays to examine the breast. While a biopsy involves taking a tissue sample, the Mamex system itself is an imaging device used to guide the biopsy procedure, not to perform a diagnostic test on a sample in vitro. The diagnostic testing of the biopsy sample would be performed separately in a laboratory, which would involve IVD procedures.
Therefore, the Mamex system as described is a medical imaging device used for diagnosis and intervention (biopsy guidance), not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Provide the capabilities of performing upright biopsy.
Product codes
90 IZH
Device Description
Not Found
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an abstract symbol that resembles an eagle or bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 26 1998
Jeffrey N. Moeller, R.T. (R)(ARRT) Director, Quality and Regulatory Affairs Medical Systems Group 11550 West King Street Franklin Park, IL 60131
Re:
K993740 Mamex (Mammography System) Dated: October 29, 1999 Received: November 4, 1999 Regulatory class: II 21 CFR 892.1710/Procode: 90 IZH
Dear Mr. Moeller:
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 vour device is classified (see above) into either 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 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 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 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
1
510(k) Number (if known):
Device Name: Mamex
Indications For Use:
Provide the capabilities of performing upright biopsy.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Simil li. Segm
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Dev 510(k) Number
Prescription Use
(Per 21 CFR 801.109) /
OR
Over-The-Counter Use
(Optional Format 1-2-96)