(28 days)
K#991735, K#002209, K#974199, K#890323
Not Found
No
The document describes standard ECG analysis techniques and software options, but does not mention AI, ML, or related terms.
No
The device acquires, analyzes, displays, and records electrocardiographic information; it does not directly treat or cure any medical condition.
Yes
The device "acquire[s], analyze[s], display[s], and record[s] electrocardiographic information" and provides "12 lead interpretive analysis" in a clinical setting ("hospital or medical professional's facility"), under the supervision of a "licensed healthcare practitioner." This indicates its use in identifying or characterizing a disease or condition, which aligns with the definition of a diagnostic device.
No
The device description explicitly states that the device consists of two basic components: the processing unit and patient acquisition module, which are hardware components.
Based on the provided information, the MAC 5000 ECG Analysis System is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the body (in vitro). This typically includes blood, urine, tissue, etc.
- The MAC 5000 analyzes electrical signals from the body (in vivo). It acquires ECG signals directly from surface electrodes placed on the patient's skin.
The device's function is to acquire, analyze, display, and record electrical activity of the heart, which is a direct measurement from the living body, not an analysis of a sample taken from the body.
N/A
Intended Use / Indications for Use
The MAC 5000 ECG Analysis System is intended to acquire, analyze, display, and record electrocardiographic information from adult and pediatric populations. Basic systems electrocatulographic information from lead. and potitution playsis, vector loops, and can be upgraded to provide software analysis options such as high resolution signal averaging of upgraded to provide somnary of the electrocardiogram. Transmission and reception of ECG QRO and from a central ECG cardiovascular information system is optional.
The MAC 5000 is intended to be used under the direct supervision of a licensed healthcare practitioner, by trained operators in a hospital or medical professional's facility.
Product codes (comma separated list FDA assigned to the subject device)
74DQK, 74DXH, 74DPS, 74LOS, 74DSI
Device Description
The Mac 5000 ECG Analysis System is designed to acquire, analyze, display, and record ECG signals from surface ECG electrodes. The device consists of two basic components: the processing unit and patient acquisition module. Models provide rechargeable battery operation and/or optional trolley for transporting the equipment.
The MAC 5000 can deliver 3, 6, 12, or 15 lead ECG's, 12 lead interpretive analysis, vector loops, and can be upgraded to provide software analysis options such as high resolution signal averaging of QRS and P wave portions of the electrocardiogram. Transmission and reception of ECG data to and from a central ECG cardiovascular information system is optional.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult and pediatric populations
Intended User / Care Setting
used under the direct supervision of a licensed healthcare practitioner, by trained operators in a hospital or medical professional's facility.
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 MAC 5000 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 MAC 5000.
- Requirements specification reviews
- Code inspections
- Software and hardware testing
- Safety testing
- Environmental testing
- Final system validation
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.
Mac 5000 Rest ECG Analysis System K#991735, GE Marquette ECG Analysis Program K#002209, ACI TIPI Algorithm K#974199, MAX 1 System K#890323
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
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).
0
K014108
p.1/2
JAN 1 0 2002
Section 2 Summary & Certification
510(k) Summary of Safety and Effectiveness
-
December 13, 2001 Date:
GE Medical Systems - Information Technologies Submitter: 8200 W. Tower Ave. Milwaukee, WI 53223 USA -
Contact Person: David Wahlig GE Medical Systems - Information Technologies Phone: (262) 293-1705 Fax: (414) 371-3736
Karen Webb Contact Person: GE Medical Systems - Information Technologies Phone: (414) 362-3329 Fax: (414) 371-3736
MAC 5000 ECG Analysis System Trade/Proprietary Name:
Common/Usual Name: Electrocardiograph
Classification Names & Citations:
| 21 CFR 870.1425 Programmable diagnostic computer | 74DQK |
|---|---|
| 21 CFR 870.2920 Transmitters and Receivers, Electrocardiograph, Telephone | 74DXH |
| 21 CFR 870.2340 Electrocardiograph | 74DPS |
| 21 CFR 870.2340 System, ECG Analysis | 74LOS |
| 21 CFR 870.1025 Detector and Alarm, Arrhythmia | 74DSI |
Mac 5000 Rest ECG Analysis System K#991735 Predicate Devices: GE Marquette ECG Analysis Program K#002209 ACI TIPI Algorithm K#974199 MAX 1 System K#890323
Device Description: The Mac 5000 ECG Analysis System is designed to acquire, analyze, display, and record ECG signals from surface ECG electrodes. The device consists of two basic components: the processing unit and patient acquisition module. Models provide rechargeable battery operation and/or optional trolley for transporting the equipment.
The MAC 5000 can deliver 3, 6, 12, or 15 lead ECG's, 12 lead interpretive analysis, vector loops, and can be upgraded to provide software analysis options such as high resolution signal averaging of QRS and P wave portions of the electrocardiogram. Transmission and reception of ECG data to and from a central ECG cardiovascular information system is optional.
Intended Use: The MAC 5000 ECG Analysis System is intended to be used under the direct supervision of a licensed healthcare practitioner. The MAC 5000 is intended to be used by trained operators in a hospital or medical
1
professional's facility environment to record ECG signals from surface electrodes. The device is intended to acquire, analyze, display, and record electrocardiographic information from adult and pediatric populations.
- The technological characteristics of the MAC 5000 device have been Technology: updated to reflect use of current technology and to incorporate userrequested features. Data in this submission demonstrate that these technological characteristics do not raise new questions of safety or effectiveness.
The MAC 5000 complies with the voluntary standards as detailed in Test Summary: Section 9 of this submission.
The following quality assurance measures were applied to the development of the MAC 5000.
- Requirements specification reviews ●
- Code inspections .
- Software and hardware testing .
- Safety testing �
- Environmental testing .
- Final system validation �
Conclusion:
The MAC 5000 is a modification to GEMS-IT's existing MAC 5000 device incorporating features that have been previously cleared under different 510(k)'s. This premarket notification submission demonstrates that the MAC 5000 ECG Analysis System is substantially equivalent to the cleared MAC 5000 ECG Analysis System because this device has the same basic intended use and the differences in technological characteristics do not raise new questions of safety or effectiveness.
2
Image /page/2/Picture/1 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 a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 0 2002
Mr. David Wahlig Senior Regulatory Affairs Specialist GE Medical Systems Information Technologies 8200 West Tower Avenue Milwaukee, WI 53223
Re: K014108
Trade Name: MAC 5000 ECG Analysis Systems Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm Regulatory Class: Class III (three) Product Code: DSI Dated: December 13, 2001 Received: December 13, 2001
Dear Mr. Wahlig:
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.
3
Page 2 - Mr. David Wahlig
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. 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" (21CFR 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,
Walh Tlh
Dr. Brian D. Zuckerman, M.D.
m D. Zuckerman, M.L. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known):
Unknown;
510(k) filed on 13 December, 2001
MAC 5000 ECG Analysis System Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The MAC 5000 ECG Analysis System is intended to acquire, analyze, display, and record electrocardiographic information from adult and pediatric populations. Basic systems electrocatulographic information from lead. and potitution playsis, vector loops, and can be upgraded to provide software analysis options such as high resolution signal averaging of upgraded to provide somnary of the electrocardiogram. Transmission and reception of ECG QRO and from a central ECG cardiovascular information system is optional.
The MAC 5000 is intended to be used under the direct supervision of a licensed healthcare practitioner, by trained operators in a hospital or medical professional's facility.
(Please DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Cardiovascular & Respiratory Devices
510(k) Number K014108
Prescription Use V (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)