(356 days)
Not Found
No
The description mentions "parallel-computing algorithms" for segmentation and regionalization, which are image processing techniques, but does not explicitly mention or imply the use of AI or ML. The "Mentions AI, DNN, or ML" field is also marked as "Not Found".
No
The device is a software system for radiological image processing, storage, display, and communication. It assists in image viewing and report generation but explicitly states that processed images should not be used for primary image diagnosis, and a clinician interprets the images, allowing for human intervention in clinical decisions. It is not directly treating or diagnosing patients.
No
The 'Intended Use' section explicitly states, "These processed images should not be used for primary image diagnosis." While the device processes and displays medical images for various uses, it is not intended for diagnostic purposes.
Yes
The device description explicitly states "MED-SEG™ software is a Picture Archiving and Communications System (PACS) for radiological image processing, storage, display and communication." and the intended use describes it as a "software device". There is no mention of accompanying hardware components that are part of the regulated device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- MED-SEG's function: MED-SEG is a software device that processes and displays medical images obtained from imaging modalities like CT, MR, etc. It works with images of the body, not with specimens taken from the body.
- Intended Use: The intended use describes the processing and display of medical images for various purposes, including PACS use, image segmentation, and facilitating reporting. It explicitly states that the processed images should not be used for primary image diagnosis and that a clinician interprets the images. This further reinforces that it's not performing a diagnostic test on a specimen.
Therefore, MED-SEG falls under the category of medical imaging software, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
MED-SEG is a software device that receives medical images and data from various imaging sources (including but not limited to CT, MR, US, RF units), computed and direct radiographic devices, and secondary capture devices, (scanners, imaging gateways or imaging sources). Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
In addition to general PACS use, this system can be used by trained professionals (e.g. physicians, radiologists, nurses, medical technicians, and assistants) to separate 2D images into "digitally related" sections or regions that, after colorization, can be individually labeled by the user. These images can be used to find appropriate window/level settings, to facilitate report generation and communication, or for other uses. These processed images should not be used for primary image diagnosis.
Only DICOM "for presentation" uncompressed or non-lossy compressed images can be used on an FDA cleared or approved monitor for primary image diagnosis in mammography.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
MED-SEG™ software is a Picture Archiving and Communications System (PACS) for radiological image processing, storage, display and communication. The system can receive digital images via a secure internet communication link. The system incorporates parallel-computing algorithms that perform high-speed segmentation and regionalization. The system does not contact the patient nor does it control any life sustaining devices. A clinician interprets the images and information displayed by the system. providing ample opportunity for human intervention in the clinical decision process.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MR, US, RF units, computed and direct radiographic devices, and secondary capture devices, (scanners, imaging gateways or imaging sources).
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained professionals (e.g. physicians, radiologists, nurses, medical technicians, and assistants)
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)
Laboratory testing documented that MED-SEG™ complies with the recognized consensus standards for radiological image processing systems.
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
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
MEDICAL IMAGING INC RTH A THOUSAND WORDS
510 (k) SUMMARY
Bartron Medical Imaging MED-SEG™ System
JUL 26 2010
KO92328 P. 1082
Submitter's Name, Address, Telephone Number, Contact Person and Date Prenared:
| Prepared: | |
|---|---|
| Manufacturer: | Bartron Medical Imaging, Inc. |
| 1100 Mercantile Lane, Ste 115A | |
| Largo, MD 20774 | |
| Telephone: (301) 583-4642 /x243 | |
| Facsimile: (301) 772-8540 | |
| Contact Person: | Zvi Ladin, PhD. |
| Principal | |
| Boston MedTech Advisors, Inc. | |
| 990 Washington Street | |
| Suite #204 | |
| Dedham, MA 02026 | |
| Telephone: (781) 407 0900 x104 | |
| Facsimile: (781) 407 0901 | |
| Email: zladin@bmtadvisors.com | |
| Date Prepared: | July 12, 2010 |
| Name of Device and Name/Address of Sponsor | |
| Trade/Proprietary Name: | MED-SEG™ |
| Common Name: | Picture Archiving and Communication System |
| Classification Name: | System, Image Processing, Radiological |
| Regulatory Class: | II |
| Product Code: | LLZ |
| Federal Regulation: | 21 CFR §892.2050 |
| Manufacturing Facility: | Bartron Medical Imaging, Inc. |
| 91 Shelton Street | |
| New Haven, CT 06511 | |
| Telephone: (203) 498-2184 | |
| Facsimile: (203) 498-2189 | |
| Establishment Registration Number: | N/A |
| Owner/operator number: | N/A |
1
AEDICAL IMAGING INC H A THOUSAND WORDS
Predicate Device
DEMASQ Imaging Software, manufactured by DEMASQ Ltd of Wales, United Kingdom and cleared under 510(k) #K090481 on March 19, 2009.
Intended Use / Indications for Use
MED-SEG is a software device that receives medical images and data from various imaging sources (including but not limited to CT, MR, US, RF units), computed and direct radiographic devices, and secondary capture devices, (scanners, imaging gateways or imaging sources). Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
In addition to general PACS use, this system can be used by trained professionals (e.g. physicians, radiologists, nurses, medical technicians, and assistants) to separate 2D images into "digitally related" sections or regions that, after colorization, can be individually labeled by the user. These images can be used to find appropriate window/level settings, to facilitate report generation and communication, or for other uses. These processed images should not be used for primary image diagnosis.
Only DICOM "for presentation" uncompressed or non-lossy compressed images can be used on an FDA cleared or approved monitor for primary image diagnosis in mammography.
Technological Characteristics
MED-SEG™ software is a Picture Archiving and Communications System (PACS) for radiological image processing, storage, display and communication. The system can receive digital images via a secure internet communication link. The system incorporates parallel-computing algorithms that perform high-speed segmentation and regionalization. The system does not contact the patient nor does it control any life sustaining devices. A clinician interprets the images and information displayed by the system. providing ample opportunity for human intervention in the clinical decision process.
Performance Data
Laboratory testing documented that MED-SEG™ complies with the recognized consensus standards for radiological image processing systems.
Substantial Equivalence
MED-SEG™ is a PAC system that uses the same software technology, and complies with the same recognized consensus standards as its predicate device. It has the same intended use and indications for use as the predicate system and therefore is substantially equivalent.
2
Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains an eagle-like symbol in the center. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged around the perimeter of the circle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Bartron Medical Imaging, Inc. % Zvi Ladin, Ph.D. Principal Boston Medtech Advisors, Inc. 990 Washington Street, Suite 204 DEDHAM MA 02026
JUL 2 6 2010
Re: K092328
Trade/Device Name: MED-SEGTM Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: February 5, 2010 Received: February 16, 2010
Dear Dr. Ladin:
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. Isting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
3
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Donald J. Trump
Donald J. St.Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indications for Use
JUL 2 6 2010
510(k) Number (if known): K092328
| Device Name: | MED-SEG™ |
|---|---|
| -------------- | ---------- |
Indications For Use:
MED-SEG is a software device that receives medical images and data from various imaging sources (including but not limited to CT, MR, US, RF units), computed and direct radiographic devices, and secondary capture devices, (scanners, imaging gateways or imaging sources). Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
In addition to general PACS use, this system can be used by trained professionals (e.g. physicians, radiologists, nurses, medical technicians, and assistants) to separate 2D images into "digitally related" sections or regions that, after colorization, can be individually labeled by the user. These images can be used to find appropriate window/level settings, to facilitate report generation and communication, or for other uses. These processed images should not be used for primary image diagnosis.
Only DICOM "for presentation" uncompressed or non-lossy compressed images can be used on an FDA cleared or approved monitor for primary image diagnosis in mammography.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, @ffice of Beview Evaluation (ODE) OTV(
signature
(Division Sign-Of Division of Raulological Devices Office of In Vitro Diagnostic Devices Exaluation and Safety
510K K692328
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