(23 days)
Not Found
No
The summary describes a PC-based software system for quantitative analysis of cardiac images using established functional scientific technology, similar to its predicate devices. There is no mention of AI, ML, or related concepts like training or test sets for model development.
No
The device is intended for quantitative analysis and documentation of cardiac function and coronary artery stenosis, not for direct treatment or therapy.
Yes
Explanation: The device is intended to provide and document an objective quantification of coronary artery stenosis and measurement and quantification of left ventricular function, which are diagnostic purposes for patient cardiac status.
No
The device is described as a "PC based software system" that is "designed to be permanently installed in a hospital". While the core functionality is software, the description of it being a "complete turn-key system" or being "ported into other GE cardiac image devices" suggests it is either sold with dedicated hardware (a PC) or integrated into existing hardware systems, rather than being purely software running on general-purpose user-provided hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the analysis of images from cardiac catheterization procedures to quantify coronary artery stenosis and left ventricular function. This is analysis of in vivo (within the living body) images, not in vitro (outside the living body) samples like blood, urine, or tissue.
- Device Description: The device is a PC-based software system that processes images from cardiac catheterization procedures. It's installed in or near the cardiac catheterization laboratory, which is where these in vivo procedures are performed.
- Input Imaging Modality: The input is "Images from cardiac catheterization procedures," which are images of the inside of the body.
- Anatomical Site: The anatomical sites mentioned (Left Ventricular, coronary artery, patient's vessels) are all within the living body.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic purposes. This device analyzes images of the body itself, not samples taken from the body.
N/A
Intended Use / Indications for Use
AccuSketch Cardiac Quantitative Analysis System w/ Advanced Analysis Components is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. AccuSketch is intended to provide and document an objective quantification of coronary artery stenosis and measurement and quantification of left ventricular function. Also provided is the ability to digitize and store video images and the ability to interactively annotate and report current and post procedural patient cardiac status.
Product codes (comma separated list FDA assigned to the subject device)
90 LLZ
Device Description
The AccuSketch Cardiac Quantitative Analysis System w/ Advanced Analysis Components is a PC based software system comprised of 4 individual programs used to view, capture/print, analyze and annotate images from cardiac catheterization procedures. AccuSketch is offered as a complete turn-key system or can be ported into other GE cardiac image devices for image analysis. The AccuSketch is a Personal Computer (PC) based software system designed to be permanently installed in a hospital in or near the cardiac catheterization laboratory. AccuSketch is comprised of four individual programs responsible for a specific function. Their purpose is to view, capture/print, analyze and annotate images from cardiac catheterization procedures.
Mentions image processing
System, Image Processing Radiological
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Left Ventricular, coronary artery, patient cardiac status
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Cardiologist or trained technician, licensed healthcare practitioner or by personnel trained in its proper use, hospital in or near the cardiac catheterization laboratory.
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)
The AccuSketch Cardiac Quantitative Analysis System w/ Advanced Test Summary: Analysis Components complies with the voluntary standards as detailed in Section 9 of this submission. The following quality assurance measures were applied to the development of the AccuSketch Cardiac Quantitative Analysis System w/ Advanced Analysis Components:
- Risk Analysis
- Requirements Reviews
- Design Reviews
- Testing on unit level (Module verification)
- Integration testing (System verification)
- Final acceptance testing (Validation)
- Performance testing
- Safety testing
- Environmental testing
The results of these measurements demonstrated that the AccuSketch Conclusion: Cardiac Quantitative Analysis System w/ Advanced Analysis Components is as safe, as effective, and performs as well as the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
KO23100
OCT 1 1 2002
Section 2 Summary and Certification
o samo per co
... ... .. .. .. ... ... ... ... ... ... ... .......
| 510(k) Summary of Safety and Effectiveness | ||
|---|---|---|
| Date: | September 17, 2002 | |
| Submitter: | GE Medical Systems Information Technologies | |
| 8200 West Tower Avenue | ||
| Milwaukee, WI 53223 | ||
| USA | ||
| Contact Person: | Lisa Lee Michels | |
| Regulatory Affairs Specialist | ||
| GE Medical Systems Information Technologies | ||
| Phone: (262) 293-1609 | ||
| Fax: (414) 918-8203 | ||
| Trade Name: | ||
| Device: | AccuSketch Cardiac Quantitative Analysis System w/ Advanced | |
| Analysis Components | ||
| Common/Usual Name: | Cardiac Image Analysis Station | |
| Classification Names: | System, Image Processing Radiological | |
| Predicate Devices: | CardioTrace K912829; *MUSE Cardiovascular Information System with | |
| Accusketch K992937 | ||
| *NOTE: AccuSketch Cardiac Quantitative Analysis System w/ Advanced Analysis | ||
| Components is being compared to AccuSketch, classification code LLZ, integrated into | ||
| MUSE in K#992637. MUSE classification codes of DQK Programmable Diagnostic | ||
| Computer (Class II) and DSI Detector & Alarm, Arrhythmia (Class III) are not applicable to | ||
| AccuSketch component of MUSE. | ||
| Device Description: | The AccuSketch Cardiac Quantitative Analysis System w/ Advanced | |
| Analysis Components is a PC based software system comprised of 4 | ||
| individual programs used to view, capture/print, analyze and annotate | ||
| images from cardiac catheterization procedures. AccuSketch is offered | ||
| as a complete turn-key system or can be ported into other GE cardiac | ||
| image devices for image analysis. The AccuSketch is a Personal | ||
| Computer (PC) based software system designed to be permanently | ||
| installed in a hospital in or near the cardiac catheterization laboratory. | ||
| AccuSketch is comprised of four individual programs responsible for a | ||
| specific function. Their purpose is to view, capture/print, analyze and | ||
| annotate images from cardiac catheterization procedures. | ||
| Intended Use: | The AccuSketch LV HL is intended to aid the Cardiologist or trained | |
| technician in providing and documenting an objective quantification of a | ||
| patient's Left Ventricular function. The AccuSketch STN HL is intended | ||
| to aid the Cardiologist or trained technician in providing and | ||
| documenting an objective quantification of coronary artery stenosis (the | ||
| amount of vessel closure due to coronary artery disease). The Image | ||
| Capture system provides image capture and printing. |
1
The CardioTree is an editable coronary tree tool used to electronically annotate and document the anatomy of the patient's vessels.
- The AccuSketch Cardiac Quantitative Analysis System w/ Advanced Technology: Analysis Components employs the same functional scientific technology as its predicate devices.
- The AccuSketch Cardiac Quantitative Analysis System w/ Advanced Test Summary: Analysis Components complies with the voluntary standards as detailed in Section 9 of this submission. The following quality assurance measures were applied to the development of the AccuSketch Cardiac Quantitative Analysis System w/ Advanced Analysis Components:
- Risk Analysis
.
- Requirements Reviews .
- Design Reviews .
- Testing on unit level (Module verification) .
- Integration testing (System verification) ●
- . Final acceptance testing (Validation)
- Performance testing .
- Safety testing .
- . Environmental testing
- The results of these measurements demonstrated that the AccuSketch Conclusion: Cardiac Quantitative Analysis System w/ Advanced Analysis Components is as safe, as effective, and performs as well as the predicate devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows a circular logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the top half of the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Lisa Lee Michels Regulatory Affairs Specialist GE Medical Systems Information Technologies 8200 West Tower Avenue MILWAUKEE WI 53223
Re: K023100
Trade/Device Name: AccuSketch Cardiac Quantitative Analysis System "/Advanced Analysis Components Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system
Regulatory Class: II Product Code: 90 LLZ Dated: September 17, 2002 Received: September 18, 2002
Dear Ms. Michels:
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 adultcration.
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 (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.
3
Page 2
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. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 1 of 1
K D.23/00
510(k) Number (if known):
Haknown, 510(k) filed on September 17, 2002
AccuSketch Cardiac Quantitative Analysis System w/Advanced Analysis Device Name: Components.
Indications for Use:
AccuSketch Cardiac Quantitative Analysis System w/ Advanced Analysis Components is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. AccuSketch is intended to provide and document an objective quantification of coronary artery stenosis and measurement and quantification of left ventricular function. Also provided is the ability to digitize and store video images and the ability to interactively annotate and report current and post procedural patient cardiac status.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
David A. Lyman
(Division Sign-Off) Division of Reproductive, Abdomin and Radiological Devices 510(k) Number