(78 days)
Vital Images Vitrea, AccuImage Image Display Software, Siemens BOLD MRI, Voxar Plug n' View 3D
Not Found
Yes
The device description explicitly mentions "multivariate pattern recognition methods" which is a common technique used in machine learning for classification and segmentation tasks.
No
The device is a computerized tissue segmentation device used for screening and diagnosis, not for treating any condition. Its output is information for a physician to interpret, and it is explicitly stated that patient management decisions should not be made based solely on its results.
No
Explanation: The device is intended for tissue segmentation and classification which provides information for screening and diagnosis, but the document explicitly states that "Patient management decisions should not be made based solely on the results of ACCENT analysis," implying it's a tool to assist in diagnosis rather than a standalone diagnostic device.
No
The device description explicitly states that the ACCENT system consists of proprietary software installed on an off-the-shelf personal computer and a monitor, indicating it includes hardware components beyond just the software itself.
Based on the provided information, the ACCENT™ device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze biological samples: IVDs are designed to examine specimens taken from the human body, such as blood, urine, tissue, etc., to provide information about a person's health.
- ACCENT analyzes imaging data: The ACCENT device processes magnetic resonance (MRI) imaging data, which is a form of medical imaging, not a biological sample.
- The description focuses on image processing and segmentation: The device description clearly states that it analyzes pixel signal intensities from MR sequences to perform tissue segmentation and classification. This is a function of medical image analysis, not in vitro testing.
Therefore, ACCENT falls under the category of medical imaging software or a medical image processing device, not an IVD.
No
The provided text does not contain any explicit statement that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
Intended Use / Indications for Use
ACCENT™ is a computerized tissue segmentation device intended for use in conjunction with magnetic resonance (MRI) imaging data to identify similar tissue types. When interpreted by a skilled physician, this device provides information that may be useful in screening and diagnosis. ACCENT can also be used to provide accurate and reproducible measurements of the longest diameter and volume of identified tissue. Patient management decisions should not be made based solely on the results of ACCENT analysis.
Product codes
90 LLZ
Device Description
The ACCENT device relies on the assumption that pixels having similar MR signal intensities represent similar tissues. The ACCENT software simultaneously analyzes the pixel signal intensities from multiple MR sequences and applies multivariate pattern recognition methods to perform tissue segmentation and classification.
The ACCENT system consists of proprietary software developed by Confirma installed on an off-the-shelf personal computer and a monitor configured as an ACCENT display station.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
magnetic resonance (MRI) imaging data
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
skilled physician
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)
Vital Images Vitrea, AccuImage Image Display Software, Siemens BOLD MRI, Voxar Plug n' View 3D
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Administrative Information
'JAN 1 5 2002
a. Summary of Safety and Effectiveness
1. Company Identification
Confirma, Inc. 821 Kirkland Avenue Kirkland, WA 98033-6318 Phone: (425) 576-1226 FAX: (425) 576-9295 www.confirma.com
2. Official Correspondent
Cheryl L. Shea VP - RA/QA/CA Phone: (425) 576-3247 cshea@confirma.com
3. Date of Submission: October 26, 2001
4. Device Trade Name: ACCENT™
5. Device Description
The ACCENT device relies on the assumption that pixels having similar MR signal intensities represent similar tissues. The ACCENT software simultaneously analyzes the pixel signal intensities from multiple MR sequences and applies multivariate pattern recognition methods to perform tissue segmentation and classification.
The ACCENT system consists of proprietary software developed by Confirma installed on an off-the-shelf personal computer and a monitor configured as an ACCENT display station.
6. Intended Use
ACCENT™ is a computerized tissue segmentation device intended for use in conjunction with magnetic resonance (MRI) imaging data to identify similar tissue types. When interpreted by a skilled physician, this device provides information that may be useful in screening and diagnosis. ACCENT can also be used to provide accurate and reproducible measurements of the longest diameter and volume of identified tissue. Patient management decisions should not be made based solely on the results of ACCENT analysis.
1
7. Software
The ACCENT device developed and manufactured by Confirma, Inc. has been designed, developed, tested and validated according to has been aesigned, acvelopment identify functions within the while procuurersponsible for developing and approving product organizations, coding and testing, verification and validation testing, and technical support.
8. Hazard Analysis
Hazard analysis on this product has been performed throughout the Hazard unalysis ent process in accordance with internal procedures and IEC 601-1-4. This process emphasizes:
- Identification of potential hazards, their causes, and their effects; 해
- Development of methodologies to control the occurrence of . hazards and to mitigate their effects; and,
- Determination of any effect on patient safety and system ● effectiveness.
It is our conclusion that there is no hardware or software component integral to this device, operating in a properly configured integral to this dove failure or latent design defect would be expected to result in death or serious injury to a patient. The "Level of Concern" is categorized as "Minor."
9. Substantial Equivalence
The intended use, design, function and performance characteristics for ACCENT are substantially equivalent to the following predicate devices:
- Vital Images Vitrea ■
- Acculmage Image Display Software .
- Siemens BOLD MRI I
- Voxar Plug n' View 3D 체
It is the opinion of Confirma, Inc. that ACCENT raises no new issues of safety and effectiveness as compared to the predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three overlapping birds in flight, representing the department's mission to protect the health of all Americans and provide essential human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 5 2002
Ms. Cheryl Shea Vice President, RA/QA/CA Confirma 821 Kirkland Avenue KIRKLAND WA 98033
Re: K013574 Trade/Device Name: Accent MRI Image Processing Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving and Communications system Regulatory Class: II Product Code: 90 LLZ Dated: October 26, 2001 Received: October 29, 2001
Dear Ms. Shea:
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 (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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
3
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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,
Nancy C. Brogdon
Nancy C. Brogdo Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
b. Indication for Use Form
510(k) Number (if known): _K (ك / 35 74
Device Name: ACCENT™
Indication for Use:
ACCENT™ is a computerized tissue segmentation device intended for use in conjunction with magnetic resonance (MRI) imaging data to identify similar tissue types. When interpreted by a skilled physician, this device provides information that may be useful in screening and diagnosis. ACCENT can also be used to provide accurate and reproducible measurements of the longest diameter and volume of identified tissue. Patient management decisions should not be made based solely on the results of ACCENT analysis.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Hodgson
(Division Sign-ON)
Division of Reproductive, Abdominal
and Radiological Devices
510(k) Number
K01
Prescription Use