(27 days)
No
The summary describes image processing and measurement tools but does not mention AI, ML, or related terms, nor does it describe training or test sets typically associated with AI/ML development.
No
The device is a software package for reviewing, analyzing, and reporting on magnetic resonance (MR) images, specifically for quantifying cardiac function. It is used to present information to a physician to support the determination of a diagnosis, rather than directly treating or diagnosing a condition.
Yes
The device provides tools for displaying regional motion properties of the heart and outputs measurements that are interpreted by a physician to support the determination of a diagnosis. It is specifically intended for the quantification of regional and global cardiac function from MR images, which are diagnostic activities.
Yes
The device is explicitly described as a "stand-alone software package" and its function is to process and analyze existing medical images. There is no mention of accompanying hardware or hardware components being part of the device itself.
Based on the provided information, the Diagnosoft, Inc. HARP 2.06 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.
- HARP 2.06 Function: The HARP 2.06 software analyzes medical images (MR images) of the heart. It does not perform tests on biological samples.
- Intended Use: The intended use is to "review, analyze, and report on magnetic resonance (MR) images" and for "quantification of regional and global cardiac function from magnetic resonance images." This is image analysis, not in vitro testing.
- Device Description: The description focuses on analyzing tagged MR images and producing measurements from those images.
- Input: The input is "magnetic resonance (MR) images," not biological samples.
Therefore, the HARP 2.06 falls under the category of medical image analysis software, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Diagnosoft, Inc. HARP 2.06 is a stand-alone software package which provides the capability to review, analyze, and report on magnetic resonance (MR) images. HARP can import images from an MR system and display them in a viewing area on the computer screen. Images can be organized and displayed by study and series and organized into three-dimensional and temporal (multi-phase) collections. Temporal sequences can be displayed in a cine mode to facilitate visualization.
Tagged MR images can be imported, displayed and analyzed. Available measurements include displacement, twist, and radial, circumferential, and principle strains. Tools are provided for display of regional motion properties of the heart.
A report interface is provided. Measurement tools provide information that can be output in standardized or specialized report formats. This interface makes it possible to quickly and reliably fill out a complete clinical report of an imaging exam. The results of the measurement tools are interpreted by the physician and can be communicated to referring physicians in supporting the determination of a diagnosis.
Product codes
LNH
Device Description
The Diagnosoft, Inc. HARP 2.06 is intended for the quantification of regional and global cardiac function from magnetic resonance images. It includes a user friendly implementation of the HARP methods for fast and reproducible measuring of myocardial motion and strain in the heart. With a friendly graphic user interface, users are able to analyze tagged MR images in minutes and produce many measurements including strain, torsion, and regional wall thickening.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
magnetic resonance (MR) images
Anatomical Site
cardiac / heart
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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)
Testing of the modified Diangosoft, Inc. HARP 2.06 has demonstrated that the device fulfills prospective defined performance criteria and that the modified device meets the user needs.
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
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
Diagnosoft, Inc. HARP 2.06 510(k) Summary (per 21 CFR 807.92(c))
MAR 1 1 2010
1. SPONSOR/MANUFACTURER
Diagnosoft, Inc. 6501 Weston Parkway Suite 125 Cary, NC 27513 Primary Contact:
Linda Horne
Date Prepared: February 11, 2010
2. DEVICE NAME
Proprietary Name: Diagnosoft HARP 2.06 Common/Usual Name: HARP Classification Name: System, Image Processing, MRI Accessory
3. PREDICATE DEVICE
Predicate Device: Diagnosoft, Inc. HARP 1.1.0, K061368
4. DEVICE DESCRIPTION
The Diagnosoft, Inc. HARP 2.06 is intended for the quantification of regional and global cardiac function from magnetic resonance images. It includes a user friendly implementation of the HARP methods for fast and reproducible measuring of myocardial motion and strain in the heart. With a friendly graphic user interface, users are able to analyze tagged MR images in minutes and produce many measurements including strain, torsion, and regional wall thickening.
5. INDICATION FOR USE
The Diagnosoft, Inc. HARP 2.06 is a stand-alone software package which provides the capability to review, analyze, and report on magnetic resonance (MR) images. HARP can import images from an MR system and display them in a viewing area on the computer screen. Images can be organized and displayed by study and series and organized into
Diagnosoft, Special 510(k): Device Modification HARP 2.06
1
three-dimensional and temporal (multi-phase) collections. Temporal sequences can be displayed in a cine mode to facilitate visualization.
Tagged MR images can be imported, displayed, and analyzed. Available measurements include displacement, twist, and radial, circumferential, and principle strains. Tools are provided for display of regional motion properties of the heart.
A report interface is provided. Measurement tools provide information that can be output in standardized or specialized report formats. This interface makes it possible to quickly and reliably fill out a complete clinical report of an imaging exam. The results of the measurement tools are interpreted by the physician and can be communicated to referring physicians in supporting the determination of a diagnosis.
6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
The modified Diagnosoft, Inc. HARP 2.06 is an upgrade of the predicate Diagnosoft, Inc. HARP 1.1.0. The modified Diagnosoft, Inc. HARP 2.06 is substantially equivalent to the predicate Diagnosoft, Inc. HARP 1.1.0 based on intended use, indications for use, operational characteristics, and fundamental technology characteristics. The performance specifications for the software characteristics performed by the HARP 2.06 are substantially equivalent to those of the HARP 1.1.0.
7. PERFORMANCE TESTING
Testing of the modified Diangosoft, Inc. HARP 2.06 has demonstrated that the device fulfills prospective defined performance criteria and that the modified device meets the user needs.
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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.
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
Diagnosoft, Inc. % Mr.. Jeffrey Roberts Regulatory Consultant Medical Device Consultants, Inc. 49 Plain Street NORTH ATTLEBORO MA 02760
MAR 1 1 2010
Re: K100352
Trade/Device Name: Diagnosoft, Inc. HARP 2.06 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: February 11, 2010 Received: February 12, 2010
Dear Mr. Roberts:
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 includions 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, Drig 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, inting 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 frither 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 manufact 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,
Amih Jt. R
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
510(k) Number (if known);
Device Name:
Diagnosoft, Inc. HARP 2.06
Indications for Use:
The Diagnosoft, Inc. HARP 2.06 is a stand-alone software package which provides the capability to review, analyze, and report on magnetic resonance (MR) images. HARP can import images from an MR system and display them in a viewing area on the computer screen. Images can be organized and displayed by study and series and organized into three-dimensional and temporal (multi-phase) collections. Temporal sequences can be displayed in a cine mode to facilitate visualization.
Tagged MR images can be imported, displayed and analyzed. Available measurements include displacement, twist, and radial, circumferential, and principle strains. Tools are provided for display of regional motion properties of the heart.
A report interface is provided. Measurement tools provide information that can be output in standardized or specialized report formats. This interface makes it possible to quickly and reliably fill out a complete clinical report of an imaging exam. The results of the measurement tools are interpreted by the physician and can be communicated to referring physicians in supporting the determination of a diagnosis.
Prescription Use x (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
D.V.R.
(Division Sign Off)
Page 1 of 1
Division Sign-Off Division of Radiological De Office of In Vitro Diagnostic Device Evalua
510K. K100352