(85 days)
Not Found
No
The description focuses on data management, normalization, measurement, interpretation, comparison, and workflow automation, without mentioning AI or ML techniques. The "interpretation" mentioned is likely rule-based or algorithmic, not learned via ML.
No.
The device manages and displays ECG data for diagnosis, but it does not directly treat or provide therapy to a patient.
Yes
The device automates the processing, storage, and display of ECGs, which are then "measured, interpreted, compared to previous ECGs ('serial comparison'), optionally printed and stored with a preliminary diagnosis," and physicians can "review these computer-generated reports, modify them or add comments... electronically apply his or her signature and trigger the automatic distribution of final, confirmed diagnostic reports." This direct involvement in interpretation and the generation of confirmed diagnostic reports indicates it is a diagnostic device.
No
The device description explicitly states that it accepts ECGs from "a variety of manufacturers' cardiographs and patient monitors," which are hardware devices. While the HeartStation™ itself is a software system for managing these ECGs, it relies on external hardware for data acquisition.
Based on the provided information, the Heartlab HeartStation™ ECG Management System is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The HeartStation™ system processes electrocardiograms (ECGs), which are electrical signals measured on the surface of the body, not samples taken from the body (like blood, urine, or tissue).
- The intended use and device description focus on managing and interpreting electrical signals. The system's function is to process, store, display, measure, interpret, and compare ECG data. This is distinct from analyzing biological or chemical components of a sample.
- The input modality is ECGs. This is a physiological measurement, not a biological sample.
Therefore, the Heartlab HeartStation™ ECG Management System falls under the category of a medical device that processes physiological signals, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Heartlab HeartStation™ ECG Management System is a comprehensive data management solution which automates the processing, storage and display of electrocardiograms (ECGs) throughout a healthcare enterprise. HeartStation™ accepts standard 12-lead ECGs, which originate from any one of a variety of manufacturers' cardiographs and patient monitors, and normalizes them to a common format. ECGs are then measured, interpreted, compared to previous ECGs ("serial comparison"), optionally printed and stored with a preliminary diagnosis. A graphical user interface allows a physician to review these computer-generated reports, modify them or add comments as appropriate, electronically apply his or her signature and trigger the automatic distribution of final, confirmed diagnostic reports to other care providers.
Product codes (comma separated list FDA assigned to the subject device)
LOS, DQK, DPS
Device Description
The Ascentia HeartStation™ ECG Management System ("HeartStation™") is a comprehensive data management solution, which automates the processing, storage and display of electrocardiograms (ECGs) throughout a healthcare enterprise. HeartStation™ accepts standard 12-lead ECGs, which originate from any one of a variety of manufacturers' cardiographs and patient monitors, and normalizes them to a common format. ECGs are then measured, interpreted, compared to previous ECGs ("serial comparison"), optionally printed and stored with a preliminary diagnosis. A graphical user interface allows a physician to review these computer-generated reports, modify them or add comments as appropriate, electronically apply his or her signature and trigger the automatic distribution of final, confirmed diagnostic reports to other care providers.
HeartStation™ allows access to ECG records from web-enabled PCs throughout a network. Authorized clinical users may also access HeartStation™ from remote locations, including a home office. The type of access that is permitted depends on the clinical user within the healthcare enterprise, and can include the ability to produce confirmed, signed diagnostic reports
Comprehensive workflow management software enables HeartStation™ to be tailored to the needs of the enterprise, resulting in the highest possible level of automation for routine tasks. The processing of an ECG can be adjusted depending on a patient's stage within the care process, from an emergency event to a routine follow-up test. Final ECG reports are distributed by printing, faxing, e-mailing and automatic exporting to other systems, including an electronic medical record.
A patient's confirmed ECGs become a part of his or her cardiology information and image record within the Heartlab Ascentia™ database. Authorized clinicians may review patients' integrated ECG, X-ray Angiography, Echocardiography and other cardiology tests through a web-enabled Ascentia PortalTM.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Heart
Indicated Patient Age Range
adult and pediatric
Intended User / Care Setting
qualified clinicians responsible for the diagnosis and treatment of patients with heart disease; healthcare enterprise
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): 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.
K031970, K946281, K032103, K032038
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
§ 870.2340 Electrocardiograph.
(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for Heartlab Cardiac Solutions. The word "Heartlab" is in a large, bold, sans-serif font, with the letters in white against a black background. Below "Heartlab" is the phrase "CARDIAC SOLUTIONS" in a smaller, sans-serif font, also in white against a black background. The logo is simple and modern, with a focus on clarity and readability.
JUN 2 9 2005
Abbreviated 510(K) Summary
This is a summary of 510(k) safety and effectiveness information, submitted in accordance with the SMDA 1990 and 21 CFR 807.92.
March 31, 2005 DATE:
SUBMITTER:
Heartlab Inc. One Crosswind Road Westerly, RI 02891 Phone: (401) 596-0592 Fax: (401) 596-8562
OFFICIAL CONTACT PERSON:
Richard Petrocelli, President Tel No: (401) 596-0592
510(k) SUBMITTAL CONTACT PERSON:
Lori Kahler, Director of Quality & Regulatory Affairs Tel No: (401) 596-0592
IDENTIFICATION OF THE PRODUCT
| TRADE NAME: | Ascentia HeartStation™ ECG Management System |
|---|---|
| COMMON NAME: | Ascentia HeartStation™ |
| CLASSIFICATION NAME: | System, ECG Analysis |
| Product Code LOS, 21 CFR 870.2340 |
Computer, Diagnostic, Programmable Product Code DQK, 21 CFR 870.1425
—
.....
1
Image /page/1/Picture/1 description: The image shows the logo for Heartlab Cardiac Solutions. The word "Heartlab" is in large, bold, white letters on a black background. Below that, "CARDIAC SOLUTIONS" is in smaller, white letters on a black background.
DEVICE DESCRIPTION / INTENDED USE:
The Ascentia HeartStation™ ECG Management System ("HeartStation™") is a comprehensive data management solution, which automates the processing, storage and display of electrocardiograms (ECGs) throughout a healthcare enterprise. HeartStation™ accepts standard 12-lead ECGs, which originate from any one of a variety of manufacturers' cardiographs and patient monitors, and normalizes them to a common format. ECGs are then measured, interpreted, compared to previous ECGs ("serial comparison"), optionally printed and stored with a preliminary diagnosis. A graphical user interface allows a physician to review these computer-generated reports, modify them or add comments as appropriate, electronically apply his or her signature and trigger the automatic distribution of final, confirmed diagnostic reports to other care providers.
HeartStation™ allows access to ECG records from web-enabled PCs throughout a network. Authorized clinical users may also access HeartStation™ from remote locations, including a home office. The type of access that is permitted depends on the clinical user within the healthcare enterprise, and can include the ability to produce confirmed, signed diagnostic reports
Comprehensive workflow management software enables HeartStation™ to be tailored to the needs of the enterprise, resulting in the highest possible level of automation for routine tasks. The processing of an ECG can be adjusted depending on a patient's stage within the care process, from an emergency event to a routine follow-up test. Final ECG reports are distributed by printing, faxing, e-mailing and automatic exporting to other systems, including an electronic medical record.
A patient's confirmed ECGs become a part of his or her cardiology information and image record within the Heartlab Ascentia™ database. Authorized clinicians may review patients' integrated ECG, X-ray Angiography, Echocardiography and other cardiology tests through a web-enabled Ascentia PortalTM.
2
૦રીત
Image /page/2/Picture/1 description: The image shows the logo for Heartlab Cardiac Solutions. The word "Heartlab" is in large, white, bold letters against a black background. Below "Heartlab" are the words "CARDIAC SOLUTIONS" in smaller, white, bold letters against a black background.
SUBSTANTIAL EQUIVALENCE INFORMATION:
Ascentia HeartStation™ is considered comparable and substantially equivalent to the following predicate devices currently in commercial distribution:
| Model | Manufacturer |
|---|---|
| Infinity MegaCare (K031970) | Dräger-Siemens |
| Eclipse ECG (K946281) | Burdick |
| Tracemaster ECG Management System (K032103) | Philips |
| Pyramis ECG Management System (K032038) | Quinton |
Predicate device specifications comparison:
| | Principal
Device –
Heartlab
Ascentia
HeartStationTM | Predicate
Device –
Dräger-
Siemens
Infinity
MegaCare | Predicate
Device –
Burdick
Eclipse ECG | Predicate
Device –
Philips
Tracemaster
ECG Mgmt.
System | Predicate
Device –
Quinton
Pyramis ECG
Mgmt.
System |
|----------------------------|-----------------------------------------------------------------------------|------------------------------------------------------------------------|-------------------------------------------------|------------------------------------------------------------------------|------------------------------------------------------------------------|
| Product
description | ECG
information
management | ECG
information
management | ECG cart with
software | ECG
information
management | ECG
information
management |
| User Interface | Off-the-shelf
Personal
Computer | Off-the-shelf
Personal
Computer | NA | Compaq
Proliant ML
370 G3 server | Off-the-shelf
Personal
Computer |
| Operating
System | Windows
2000/XP | Windows 2000 | NA | Windows
Server 2003 | Windows 2000 |
| Record export
interface | TIFF, XML,
PDF or HL-7 | HL-7 | NA | TIFF, XML,
HL-7 | HL-7 |
| Display | 17" (19"
recommended)
SVGA display,
1280 x 1024
min. resolution | Minimum
resolution
1280 x 1024 | NA | 17" SVGA | Not specified |
| Web software | Microsoft
Internet
Explorer 6.0 | Microsoft
Internet
Explorer 6.0 | NA | Microsoft
Internet
Explorer 6.0 | NA |
| Measurement
model | Glasgow
Interpretive
ECG Program | Glasgow
Interpretive
ECG Program | Glasgow
Interpretive
ECG Program | Philips 12-lead
algorithm | NA |
| Format
translator | Datamed
Format
Translator
(Engineering
Solutions,
Inc.) | Datamed
Format
Translator
(Engineering
Solutions,
Inc.) | NA | Datamed
Format
Translator
(Engineering
Solutions,
Inc.) | Datamed
Format
Translator
(Engineering
Solutions,
Inc.) |
3
Image /page/3/Picture/1 description: The image shows the logo for Heartlab Cardiac Solutions. The word "Heartlab" is in large, white, bold letters on a black background. Below that, "CARDIAC SOLUTIONS" is in smaller, white letters on a black background.
The similar predicate systems above provide information for qualified clinicians responsible for the diagnosis and treatment of patients (adult and pediatric) with heart disease.
The differences in the hardware platforms and off the shelf software used to operate the proposed device are considered to be improvements in the "state of the art" as compared to the predicate devices, and offer no affect to the safety or efficacy of the product.
STANDARDS:
Ascentia HeartStation™ is designed in accordance with product safety and performance requirements set forth in the following standards:
-
- 21 CFR 1020.10 Video Monitor Performance Requirements
-
- 21 CFR 1040.10 Fiberoptic Communications Performance
-
- Society of Motion Picture and Television Engineers (SMPTE)
-
- ACR/NEMA Data Compression Standard
-
- Underwriters Laboratories (U.L.) Standard No. 544 for Medical and Dental Equipment
-
- Underwriters Laboratories (U.L.) Standard No. 1950 Safety Standards
SUMMARY OF DESIGN CONTROL ACTIVITIES:
The software utilized was designed, developed, tested according to written Design Control procedures. These procedures specify individuals within the organization responsible for developing and approving product specifications, coding, testing, validating and maintenance. Potential hazards have been studied and controlled by a Risk Management Plan.
The following quality assurance design control measures were applied to the development of the Ascentia HeartStation™ product:
-
- Risk Analysis
-
- Requirement Reviews
-
- Design Reviews
-
- Testing on unit level (Module verification)
-
- Integration testing (System verification)
-
- Final acceptance testing (Validation)
-
- Performance testing
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is positioned to the right of the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA", which is arranged in a circular pattern.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 9 2005
Heartlab Inc. c/o Ms. Lori Kahler Director of Quality & Regulatory Affairs One Crosswind Road Westerly, RI 02891
Re: K050858
Trade Name: Ascentia HeartStation™ ECG Management System Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II (two) Product Code: DPS Dated: June 13, 2005 Received: June 14, 2005
Dear Ms. Kahler:
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.
5
Page 2 - Ms. Lori Kahler
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 (240) 276-0295 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Bzimtuma for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known): K050858
Device Name: Heartlab Ascentia HeartStation™ ECG Management System
Indications For Use:
The Heartlab HeartStation™ ECG Management System is a comprehensive data management solution which automates the processing, storage and display of electrocardiograms (ECGs) throughout a healthcare enterprise. HeartStation™ accepts standard 12-lead ECGs, which originate from any one of a variety of manufacturers' cardiographs and patient monitors, and normalizes them to a common format. ECGs are then measured, interpreted, compared to previous ECGs ("serial comparison"), optionally printed and stored with a preliminary diagnosis. A graphical user interface allows a physician to review these computer-generated reports, modify them or add comments as appropriate, electronically apply his or her signature and trigger the automatic distribution of final, confirmed diagnostic reports to other care providers.
| Prescription Use | |
|---|---|
| (Part 21 CFR 801 Subpart D) |
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF |
|---|
| NEEDED) |
| Richard Petrocelli, President | Date: 6/22/05 |
|---|---|
| All State Address of the States |
Concurrence of CDRH, Office of Device Evaluation (ODE)
B. Mamma
Divison Sign-Off) Division of Cardlovascular Devices , 10(k) Number
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