(73 days)
Not Found
No
The document describes image analysis and measurement tools, but there is no mention of AI or ML algorithms being used for these functions. The focus is on standard image processing and measurement techniques.
No
The device is a software package for reviewing, analyzing, and reporting on magnetic resonance images, intended to support clinicians in the diagnosis of heart disease, not to treat it.
Yes
The device is described as supporting clinicians in the diagnosis of heart disease and provides tools to review, analyze, and report on medical images, with results interpreted by a physician to support diagnosis.
Yes
The device is explicitly described as a "stand-alone software package" and its function is to process and analyze existing MR images, not to acquire them or interact with hardware beyond importing data.
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 taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- DIAGNOSOFT HARP's function: The description clearly states that DIAGNOSOFT HARP is a software package that analyzes magnetic resonance (MR) images. These images are generated by an external medical imaging device (an MR scanner) and are not samples taken from the body for testing.
- Intended Use: The intended use is to "review, analyze, and report on magnetic resonance (MR) images" and "support clinicians in the diagnosis of heart disease" based on these images. This is image analysis and interpretation, not in vitro testing of biological samples.
Therefore, DIAGNOSOFT HARP falls under the category of medical image analysis software, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
DIAGNOSOFT HARP is a stand-alone software package which provides the capability to review, 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
DIAGNOSOFT HARP is a stand-alone software package, designed for the Microsoft Windows operating system, providing the capability to import, display, and analyze magnetic resonance images of the heart. HARP imports DICOM images containing anatomical MRI, tagged MRI, perfusion MRI, or delayed enhancement MRI and is independent of the MR scanner manufacturer. HARP is intended to support clinicians in the diagnosis of heart disease.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance (MR)
Anatomical Site
Heart
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Clinicians, 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)
A large body of literature exists describing the performance of HARP methods. Additional verification and validation tests were performed by Diagnosoft, Inc. to demonstrate that Diagnosoft HARP fulfills performance specifications.
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
Kol 1368
JUL 2 8 2006
510(k) Summary for the Diagnosoft HARP (per 21 CFR 807.92)
1. SPONSOR
Diagnosoft, Inc. 3461 Kenneth Dr Palo Alto, CA 94303 Telephone: 650-320-9397 Facsimile: 253-663-0205
Primary Contact: Amr A. Awadallah Secondary Contact: Jerry L. Prince
-
- DATE PREPARED: February 1, 2006
3. DEVICE NAME
Proprietary Name: DIAGNOSOFT HARP Common/Usual Name: HARP Classification Name: System, Image Processing
4. PREDICATE DEVICES
"Cardiac Tagging Techniques/Magnetom Vision and Impact (MR accessory)," 510(k) Number K973799, Siemens Medical Solutions, USA, Inc. Decision (Substantially Equivalent) Date 01/02/1998.
ನೆ DEVICE DESCRIPTION
DIAGNOSOFT HARP is a stand-alone software package, designed for the Microsoft Windows operating system, providing the capability to import, display, and analyze magnetic resonance images of the heart. HARP imports DICOM images containing anatomical MRI, tagged MRI, perfusion MRI, or delayed enhancement MRI and is independent of the MR scanner manufacturer. HARP is intended to support clinicians in the diagnosis of heart disease.
1
6. INTENDED USE
DIAGNOSOFT HARP is a stand-alone software package which provides the capability to review, 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.
7. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
Diagnosoft claims substantial equivalence to the visual analysis of myocardial tagging based on similarities in intended use, indications for use, principles of operation, technology, and performance. A side-by-side comparison of Siemens myocardial tagging and Diagnosoft HARP is provided in Table 1 below.
2
| Vendor | Siemens | Diagnosoft |
|---|---|---|
| Product Name | Cardiac Tagging | |
| Techniques | ||
| K973799 | HARP | |
| Intended Use | Support diagnosis | Support diagnosis |
| Indications for Use | Measures heart | |
| motion | Measures heart | |
| motion | ||
| Reveals myocardial motion | Yes | Yes |
| Assists in characterization of kinetic, | ||
| hypokinetic, akinetic, and diskinetic | ||
| myocardial regions | Yes | Yes |
| Permits regional functional analysis | Yes | Yes |
| Quantitative parameters viewed | ||
| graphically | No | Yes |
| Reports containing visualization of images | ||
| and quantitative parameters. | No | Yes |
Table 2 Side-by-Side Comparison of Siemens Cardiac Tagging Visual Analysis and Diagnosoft HARP.
8. PERFORMANCE TESTING
A large body of literature exists describing the performance of HARP methods. Additional verification and validation tests were performed by Diagnosoft, Inc. to demonstrate that Diagnosoft HARP fulfills performance specifications.
3
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
JUL 2 8 2006
Mr. Amr A. Awadallah President Diagnosoft. Inc. 3461 Kenneth Dr. PALO ALTO CA 94303
Re: K061368
Trade/Device Name: Diagnosoft Harp Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: April 15, 2006 Received: May 16, 2006
Dear Mr. Awadallah:
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 (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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Image /page/3/Picture/9 description: The image is a circular logo with the text "1906-2006" at the top and "Centennial" at the bottom. In the center of the logo are the letters "FDA" in a stylized font. Below the letters are three stars arranged in a horizontal line. The logo appears to be a commemorative emblem for the centennial of the Food and Drug Administration.
Protecting and Promoting Public Health
4
Page 2 -
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 (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.
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 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:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150
or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Bogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Number (if known): ___ Not Yet Assigned Ko 6 1368
Device Name: DIAGNOSOFT HARP
Indications For Use:
DIAGNOSOFT HARP 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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices
| 510(k) Number | K0 61368 |
|---|---|
| --------------- | ---------- |
| Prescription Use | X | OR | Over-the-Counter Use |
|---|---|---|---|
| ------------------ | --- | ---- | ---------------------- |
(Per 21 CFR 801.109)Diagnosoft Inc., Traditional 510(k) DIAGNOSOFT HARP