(71 days)
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Not Found
Unknown
The description mentions "semi-automatic segmentation" and "automatic calculation of anatomical and functional parameters," which could be implemented using AI/ML, but the summary does not explicitly state this or provide details about the underlying technology.
No
The device assists in diagnosis and provides information for therapeutic decisions, but it does not directly provide therapy or treatment.
Yes
The "Intended Use / Indications for Use" states that the information provided by the system "may be helpful in diagnosis."
Unknown
The provided text describes the intended use and functionality of the device, which is software-based image analysis. However, it lacks a "Device Description" section, which would explicitly state whether the device is solely software or includes hardware components. Without this information, it's impossible to definitively determine if it's a software-only medical device.
Based on the provided information, the Chase Cardiac Analysis System 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.
- Chase Cardiac Analysis System Function: The description clearly states that the system derives information from digital images acquired from imaging modalities (magnetic resonance, computed tomography). It analyzes these images to provide anatomical and functional information about the heart.
- No Mention of Biological Samples: There is no mention of the system analyzing any biological samples from the patient.
Therefore, the Chase Cardiac Analysis System is a medical device that processes and analyzes medical images, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Chase Cardiac Analysis System is indicated for use by trained physicians to derive anatomical and functional information from digital images acquired from a variety of imaging modalities including: magnetic resonance, computed tomography. This information is presented as both an interactive 3D model and as text reports. The System is designed to assist the analysis of coronary vessels, provide semi-automatic segmentation of cardiac structure and automatic calculation of anatomical and functional parameters. This information, when interpreted by a trained physician, may be helpful in diagnosis and therapeutic decisions.
Product codes
LLZ
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
magnetic resonance, computed tomography
Anatomical Site
cardiac
Indicated Patient Age Range
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Intended User / Care Setting
trained physicians
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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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).
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
SEP 2 7 2006
Mr. David M. Hernon Vice President, Regulatory Affairs Chase Medical 1876 Firman Drive RICE ARDS OF AND 2508 1-
Re: K062031
Trade/Device Name: Chase Cardiac Analysis System Regulation Number: 21 CFR §892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: July 14, 2006 Received: August 7, 2006
Dear Mr. Hernon:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Section 9 to(x) premainer is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce use stated in the encrosury manated pevice Amendments, or to device Amendments, or to devices that prov to May 20, 1770, and chaolions and the provisions of the Federal Food, Drug, and Cosmetic Ilave been reclassified in accordance with are por oval application (PMA). You may, Act (Act) that do not roquire approval or a preneral controls provisions of the Act. The general therefore, mailier the device, subjoct to the general for annual registration, listing of devices, good controls provisions or also ing, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into cither class II (Special Controls) or class III (Premarker If your device is classified (300 additional controls. Existing major regulations affecting your Approval), it thay be subject to such aderal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Image /page/0/Picture/10 description: The image shows a logo with the letters "FDA" in a stylized font. Above the letters are the numbers "1906-2006". Below the letters is the word "Centennial" and three stars. The logo is surrounded by a circular border with text. The words "omoting Public" are visible below the logo.
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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 your over the your desires and excilled in your Section 510(k) rms retet notification. The FDA finding of substantial equivalence of your device to a legally promated 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) | 240-276-011: |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-011: |
| 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 Hodgon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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510(k) Number (if known): Ko 42 o 7 (
Device Name: Chase Cardiac Analysis System
Indications for Use:
The Chase Cardiac Analysis System is indicated for use by trained physicians to derive anatomical and functional information from digital images acquired from a variety of imaging modalities including: magnetic resonance, computed tomography. This information is presented as both an interactive 3D model and as text reports. The System is designed to assist the analysis of coronary vessels, provide semi-automatic segmentation of cardiac structure and automatic calculation of anatomical and functional parameters. This information, when internreted by a trained physician, may be helpful in diagnosis and therapeutic decisions.
Prescription Use ✓
Nancy C Broadon
(Division Sign-Off)
Division of Reproductive, Abdominal and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________