(45 days)
Not Found
No
The summary describes a PET imaging system and mentions an improved reconstruction algorithm, but there is no mention of AI, ML, or related concepts in the provided text.
No
MAMMI is an imaging system used to detect abnormal metabolic activities for diagnostic purposes, not to treat or cure a disease.
Yes
The device obtains PET images of the breast to detect abnormal metabolic activities, which is a diagnostic function.
No
The device description clearly states that MAMMI is a "ring PET scanner, equipped with lutetium-containing gamma-ray detectors (LYSO)," which are hardware components. The summary also mentions "no hardware changes were made from the predicate device," further indicating it is a hardware system.
Based on the provided information, the MAMMI device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the body. IVDs typically involve testing blood, urine, tissue, or other biological samples outside of the body to diagnose or monitor conditions.
- MAMMI is an in vivo imaging device. The description clearly states that MAMMI collects gamma rays emitted by injected radiopharmaceuticals within the patient's body to generate images. This is a form of in vivo (within the living body) imaging, not in vitro (in glass, or outside the body) testing.
- The intended use is for obtaining images of the breast. The purpose is to visualize metabolic activity within the breast, not to analyze a sample taken from the breast or elsewhere.
Therefore, while MAMMI is a medical device used for diagnostic purposes (detecting abnormal metabolic activities), it falls under the category of in vivo imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
MAMMI (Models FP-0202 and FP-0203) is intended to obtain Positron Emission Tomography (PET) images of breast to detect abnormal metabolic activities, when the patient was injected with FDA approved PET agent. MAMMI should not be used for breast cancer screening.
Product codes (comma separated list FDA assigned to the subject device)
KPS
Device Description
MAMMI is a high spatial resolution, small field-of-view breast PET dedicated (PEM) imaging system, specifically developed for close-range, spot, i.e. limited field, imaging. MAMMI is a ring PET scanner, equipped with lutetium-containing gamma-ray detectors (LYSO), which collects gamma rays emitted by injected positron-emitting radiopharmaceuticals, and generates images corresponding to concentration of these radiopharmaceuticals in the body. MAMMI is designed to collect gamma rays from a patient's body part with high efficiency and resolution. In order to achieve this high efficiency, the detectors are positioned around and must cover the body part under examination.
Mentions image processing
- An improvement in the reconstruction algorithm with PSF correction: it ● improves the image quality for reconstructed images used for the quality control validation;
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Positron Emission Tomography (PET)
Anatomical Site
breast
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
No new testing was performed as no hardware changes were made from the predicate device.
Software verification and validation testing has been conducted and documentation provided is consistent with a "moderate" level of concern.
Test results indicated that MAMMI complies with its predetermined specification.
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.
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
§ 892.1200 Emission computed tomography system.
(a)
Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, 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 consists of the department's name encircling a stylized image of three human profiles facing right. The profiles are stacked on top of each other, creating a sense of depth and unity. The overall design is simple and conveys a sense of health and well-being.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
General Equipment for Medical Imaging (Oncovision-Gem Imaging S.A.) July 28, 2016 % Mr. Jose Montes Ouality and Regulatory Affairs Manager Eduardo Primo Yúfera, nº 3 Valencia, 46012 SPAIN
Re: K161631
Trade/Device Name: MAMMI Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: KPS Dated: July 20, 2016 Received: July 25, 2016
Dear Mr. Montes:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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 Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D'Hara
For
Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K161631
Device Name MAMMI
Indications for Use (Describe)
MAMMI (Models FP-0202 and FP-0203) is intended to obtain Positron Emission Tomography (PET) images of breast to detect abnormal metabolic activities, when the patient was injected with FDA approved PET agent. MAMMI should not be used for breast cancer screening.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Special 510 (K) GENERAL EQUIPMENT FOR MEDICAL IMAGING S.A. MAMMI 510(k) Summary
Image /page/3/Picture/1 description: The image shows the OncoVision logo. The logo consists of a blue sphere on the left and the word "ONCO" in blue and "VISION" in green on the right. The sphere has a gradient effect, with lighter shades of blue on the top and darker shades on the bottom.
510(k) number: K161631
Owner's name: General Equipment for Medical Imaging, S. A. Address: Eduardo Primo Yúfera, 3, 46012, Valencia (Spain) Phone: + 34 96 372 24 72 Fax number: +34 96 355 65 32 Name of contact person: Jose Montes, Quality and Regulatory Affairs Manager Date: 04/25/2016
Name of the device: MAMMI System trade name: MAMMI Common name: MAMMI Breast PET Regulatory Class: II Product Code: KPS Classification name: Emission computed tomography system
A. LEGALLY MARKETED PREDICATED DEVICES
Product: MAMMI Manufacturer: General Equipment for Medical Imaging, S. A. (Oncovision-GEM Imaging S.A.) 510(k) number: K140996 Substantial Equivalence Date: 11/06/2014
B. DEVICE DESCRIPTION
MAMMI is a high spatial resolution, small field-of-view breast PET dedicated (PEM) imaging system, specifically developed for close-range, spot, i.e. limited field, imaging. MAMMI is a ring PET scanner, equipped with lutetium-containing gamma-ray detectors (LYSO), which collects gamma rays emitted by injected positron-emitting radiopharmaceuticals, and generates images corresponding to concentration of these radiopharmaceuticals in the body. MAMMI is designed to collect gamma rays from a patient's body part with high efficiency and resolution. In order to achieve this high efficiency, the detectors are positioned around and must cover the body part under examination.
C. INDICATIONS FOR USE
MAMMI (Models FP-0202 and FP-0203) is intended to obtain Positron Emission Tomography (PET) images of breast to detect abnormal metabolic activities, when the patient was injected with FDA approved PET agent. MAMMI should not be used for breast cancer screening.
D. TECHNOLOGY COMPARISON
The technology has not changed. This consists of lutetium-containing gamma-ray detectors (LYSO) that collect gamma rays emitted by injected positron-emitting
10/1
INNOVATIVE MEDICAL IMAGING
General Equipment for Medical Inaging S.A | C/ Eduardo Primo Yifera, 3 46012 Valencia, Spain | t : +3 963 722 472 | e.info@oncovision.com | www.oncovision
4
Special 510 (K) GENERAL EQUIPMENT FOR MEDICAL IMAGING S.A. MAMMI 510(k) Summary
Image /page/4/Picture/1 description: The image contains the logo for OncoVision. The logo consists of a blue sphere on the left and the word "ONCO" in blue and "VISION" in green on the right. The sphere has a gradient of blue shades, giving it a three-dimensional appearance. The text is in a sans-serif font, with "ONCO" stacked above "VISION".
radiopharmaceuticals, and generates images corresponding to concentration of these radiopharmaceuticals in the body.
Change of the software version from 2.0 to 2.2
- An improvement in the reconstruction algorithm with PSF correction: it ● improves the image quality for reconstructed images used for the quality control validation;
- Multilanguage support: all texts have been translated to several languages
- DICOM support: two new software modules to work with the DICOM world: WorkList Tool, used to retrieve worklists from a DICOM Modality Worklist server in order to avoid the manual introduction of patient data and PACSTool, which is used to submit reconstructed images to a DICOM PACS server;
- Automatic deletion of personal health information feature, which is ● responsible to remove personal data from the system when it is no longer required or when it must be removed due to HIPAA rules.
There have been no hardware changes.
E. BIOCOMPATIBILITY
No new testing was performed as no hardware changes were made from the predicate device
F. ELECTRICAL SAFETY TESTING
No new testing was performed as no hardware changes were made from the predicate device
G. ELECTROMAGNETIC COMPATIBILITY TESTING
No new testing was performed as no hardware changes were made from the predicate device
H. PERFORMANCE TESTING
No new testing was performed as no hardware changes were made from the predicate device
SOFTWARE TESTING .
Change of the software version from 2.0 to 2.2
Software for MAMMI was designed and developed according to a robust software development process, and was rigorously verified and validated, according to IEC 62304 Medical Device Software - Software Life Cycle Processes and the Guidance For The Content Of Premarket Submissions For Software Contained In Medical Devices - Guidance For Industry And FDA Staff, as was done with the previous version.
INNOVATIVE MEDICAL IMAGING
General Equipment for Medical Imaging S.A | Cl Eduardo Primo Yufera, 3 40012 Valencia, Spain | t. +3 963 722 472 | e.info@oncovison.com | www.oncovison.
5
Image /page/5/Picture/0 description: The image contains text related to a medical device submission. It starts with "Special 510 (K)", indicating a type of submission to the FDA for medical devices. The text "GENERAL EQUIPMENT FOR MEDICAL IMAGING S.A." suggests the name of a company involved in medical imaging equipment. The word "MAMMI" is present, possibly referring to a specific product or project name, and the phrase "510(k) Summary" indicates that the document is a summary of a 510(k) submission.
Image /page/5/Picture/1 description: The image contains the logo for OncoVision. The logo consists of a blue sphere on the left and the word "ONCO" in blue above the word "VISION" in green on the right. The sphere has a gradient of light and dark blue, giving it a three-dimensional appearance.
Test results indicated that MAMMI complies with its predetermined specification.
Software verification and validation testing has been conducted and documentation provided is consistent with a "moderate" level of concern.
J. CLINICAL IMAGES
No new clinical images have been included. The clinical images included in "Mammi e-book" (Annex 1 of Section 20 of the Submission K140996) are still up to date.
K. CONCLUSION
Based upon a comparison of devices and performance testing results, MAMMI is substantially equivalent to the predicate device.
INNOVATIVE MEDICAL IMAGING