CHASE CARDIAC ANALYSIS SYSTEM

• K Number: K032531
• Device Name: CHASE CARDIAC ANALYSIS SYSTEM
• Manufacturer: CHASE MEDICAL, INC.
• Date Cleared: 2004-02-02 ( 171 days)
• Product Code: LLZ
• Regulation Number: 892.2050

Intended Use

The Chase Cardiac Analysis System is indicated for use by trained physicians to derive anatomical and functional information from cardiac magnetic resonance image (MRI) studies. This information is presented as both an interactive 3D model and as text reports. The System is designed to automate the segmentation of cardiac structure and calculate anatomical and functional parameters and this information, when interpreted by a trained physician, may be helpful in diagnosis and therapeutic decisions.

Device Description

Not Found

Predicate Devices

Not Found

Reference Devices

None

AI/ML (Artificial Intelligence / Machine Learning)

Unknown
The summary mentions "automate the segmentation of cardiac structure," which is a task often performed by AI/ML algorithms in medical imaging. However, it does not explicitly state that AI or ML is used, nor does it provide details about training or testing data, which are typical indicators of AI/ML development.

Therapeutic

No
The device aids in diagnosis and therapeutic decisions by providing information to physicians, but it does not directly treat or prevent a disease or condition.

Diagnostic

Yes
The device provides information (anatomical and functional parameters) that, when interpreted by a trained physician, "may be helpful in diagnosis and therapeutic decisions." This indicates its role in aiding the diagnostic process.

SaMD (Software as a Medical Device)

Unknown

The summary does not explicitly state whether the device is software-only or includes hardware components. While it processes MRI images, it doesn't clarify if it's solely a software application or part of a larger system.

IVD (In Vitro Diagnostic)

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.
• Device Function: The Chase Cardiac Analysis System processes medical images (MRI studies) to derive anatomical and functional information. It does not analyze biological samples.
• Intended Use: The intended use clearly states it analyzes cardiac magnetic resonance image (MRI) studies.

Therefore, the device falls under the category of medical image analysis software, not in vitro diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Chase Cardiac Analysis System is indicated for use by trained physicians to derive anatomical and functional information from cardiac magnetic resonance image (MRI) studies. This information is presented as both an interactive 3D model and as text reports. The System is designed to automate the segmentation of cardiac structure and calculate anatomical and functional parameters and this information, when interpreted by a trained physician, may be helpful in diagnosis and therapeutic decisions.

Product codes

90 LLZ

Device Description

Not Found

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

cardiac magnetic resonance image (MRI)

Anatomical Site

cardiac structure

Indicated Patient Age Range

Not Found

Intended User / Care Setting

trained physicians

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)

Not Found

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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).

Summary

0

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 2 2004

Mr. David M. Hernon Vice President Regulatory Affairs Chase Medical 1876 Firman Drive RICHARDSON TX USA 75081

Re: K032531

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: 90 LLZ Dated: November 5, 2003 Received: November 6, 2003

Dear Mr. Hernon:

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 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.

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.

1

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 the letter:

8xx.1xxx	[phone]
876.2xxx, 3xxx, 4xxx, 5xxx	[phone]
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	[phone]
892.2xxx, 3xxx, 4xxx, 5xxx	[phone]
Other	[phone]

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brydon

Nancv C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

2

510(k) Number (if known): _ K o 3 2 S 3 1

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 cardiac magnetic resonance image (MRI) studies. This information is presented as both an interactive 3D model and as text reports. The System is designed to automate the segmentation of cardiac structure and calculate anatomical and functional parameters and this information, when interpreted by a trained physician, may be helpful in diagnosis and therapeutic decisions.

Prescription Use (Per 21 CFR 801.109)

David A. Lynn

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device 510(k) Number