(30 days)
The MAC 5500 ECG Analysis System is intended to acquire, analyze, display, and record electrocardiographic information adult and pediatric populations. Basic systems deliver 3, 6, 12, or 15 lead ECG's, 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.
The MAC 5500 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.
The MAC 5500 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 the patient acquisition module. Models provide rechargeable battery operation and/or optional trolley for transporting the equipment. The MAC 5500 can deliver 3, 6, 12, or 15 lead ECG's, 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. The MAC 5500 system acquires ECG data using the CAM14 patient data acquisition module. By placing the data acquisition device closer to the patient, signal fidelity is improved and noise is reduced. MAC 5500 delivers 12 or 15 lead ECG's on full-size reports. The MAC 5500 incorporates a alphanumeric keyboard for patient demographics and other data entry, a full size VGA graphics and waveform display, an integrated thermal writer and removable data storage. Additionally, the MAC 5500 utilizes battery power for customer convenience and can transmit and receive ECGs to and from a central ECG cardiovascular information system via optional communication links. The system is intended as a mobile device but the main unit can be separated from the trolley and used as a desktop unit.
The provided text does not contain detailed information about specific acceptance criteria, a study proving device performance against those criteria, sample sizes for test or training sets, data provenance, expert qualifications, or adjudication methods for ground truth. It largely focuses on regulatory classification and the device's intended use. No information is available regarding MRMC studies or standalone algorithm performance.
However, based on the Conclusion statement on page 2 of 7:
Conclusion: The results of these measurements demonstrated that the MAC 5500 ECG Analysis System is as safe, as effective, and performs as well as the predicate devices.
This implies that the acceptance criteria are implicitly met if the device performs "as well as the predicate devices" in terms of safety and effectiveness.
Here's an attempt to structure the answer based on the limited information, with many fields marked as 'Not provided in the text'.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| As safe as predicate devices | Demonstrated to be as safe as predicate devices (Implied) |
| As effective as predicate devices | Demonstrated to be as effective as predicate devices (Implied) |
| Performs as well as predicate devices (functional equivalency) | Performs as well as predicate devices (Implied) |
2. Sample size used for the test set and the data provenance
- Test set sample size: Not provided in the text.
- Data provenance: Not provided in the text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of experts: Not provided in the text.
- Qualifications of experts: Not provided in the text.
4. Adjudication method for the test set
- Adjudication method: Not provided in the text.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC study: Not provided in the text. The device is described as an ECG analysis system, but no details of a human-in-the-loop study are present.
- Effect size: Not applicable, as no MRMC study details are provided.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone study: The conclusion states "The results of these measurements demonstrated that the MAC 5500 ECG Analysis System is as safe, as effective, and performs as well as the predicate devices." This suggests that some form of performance evaluation was conducted for the device's algorithms, likely in a standalone capacity, to establish its equivalency to predicate devices. However, no specific details of such a study are provided.
7. The type of ground truth used
- Type of ground truth: Not explicitly stated. Given it's an ECG analysis system, the ground truth would likely involve expert-interpreted ECGs or potentially correlated clinical outcomes, but this is speculative.
8. The sample size for the training set
- Training set sample size: Not provided in the text.
9. How the ground truth for the training set was established
- Ground truth establishment for training set: Not provided in the text.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for GE Healthcare. The logo consists of the GE monogram on the left and the words "GE Healthcare" on the right. The GE monogram is a circular design with the letters "GE" intertwined.
December 21, 2007
JAN 25 2008
| 2. | 510(k) Summary | |||
|---|---|---|---|---|
| Date: | 12/17/2007 | |||
| Submitter: | GE Medical Systems Information Technologies 9900 Innovation DriveWauwatosa, WI 53226 USA | |||
| Primary Contact: | Margaret MuchaRegulatory Affairs LeaderGE Medical Systems Information TechnologiesPhone: 414-416-2716Fax: 414-721-3863 | |||
| Secondary Contact: | Matthias BuergerGlobal Director QA/RA,Diagnostic CardiologyGE Medical Systems Information TechnologiesPhone: 414-416-2317Fax: 414-721-3863 | |||
| Device: | Trade Name: MAC 5500 ECG Analysis System | |||
| Common/Usual Name: | Electrocardiograph | |||
| Classification Names1: | 21 CFR 870.2340 | Electrocardiograph | DPS | |
| 21 CFR 870.1425 | Programmable Diagnostic Computer | DQK | ||
| 21 CFR 870.2920 | Transmitters and Receivers,Electrocardiograph, Telephone | DHX | ||
| Predicate Device: | K042177 MAC 5500 ECG Analysis System | |||
| Device Description: | The MAC 5500 ECG Analysis System is designed to acquire, analyze,display, and record ECG signals from surface ECG electrodes. Thedevice consists of two basic components: the processing unit and thepatient acquisition module. Models provide rechargeable batteryoperation and/or optional trolley for transporting the equipment. |
The Classification Names/Numbers and Code assigned during the clearance of the MAC 5500 ECC Analysis System for K042777 was MHX - Detector Arrhythmia Detector and Alarm (including ST-segment measurement and alarm) (870.1025). GE Medical Systems Information Technologies formally requested on 12/14/07 that the MAC 5500 ECG be reclassified as DPS – Electrocardiograph (870.2340) as this code more accurately reflects the intended use of this device as this device is not intended to detect an arrhythmia and alarm or produce an audible signal when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation ocurs, which is the Identification statement contained in Code MHX (Section 870.1025). The intended use more closely matches the Identification statement for Section 870.2340 Electrocardiograph, which states that an Electrocarding 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. This submission is reflective of this requested code change to DPS for the MAC 5500.
{1}------------------------------------------------
Page 20 of 727
Image /page/1/Picture/1 description: The image shows the GE Healthcare logo. The logo consists of the GE monogram in a circle on the left, followed by the words "GE Healthcare" in a simple, sans-serif font. The text is aligned horizontally with the monogram.
December 21, 2007
Device Description: (continued) The MAC 5500 can deliver 3, 6, 12, or 15 lead ECG's, 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.
The MAC 5500 system acquires ECG data using the CAM14 patient data acquisition module. By placing the data acquisition device closer to the patient, signal fidelity is improved and noise is reduced. MAC 5500 delivers 12 or 15 lead ECG's on full-size reports. The MAC 5500 incorporates a alphanumeric keyboard for patient demographics and other data entry, a full size VGA graphics and waveform display, an integrated thermal writer and removable data storage.
Additionally, the MAC 5500 utilizes battery power for customer convenience and can transmit and receive ECGs to and from a central ECG cardiovascular information system via optional communication links. The system is intended as a mobile device but the main unit can be separated from the trolley and used as a desktop unit.
Indications for Use
The MAC 5500 ECG Analysis System is intended to acquire, analyze, display, and record electrocardiographic information adult and pediatric populations. Basic systems deliver 3, 6, 12, or 15 lead ECG's, 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.
The MAC 5500 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.
Technology The MAC 5500 ECG Analysis System employs the same functional technology as the predicate devices.
Conclusion: The results of these measurements demonstrated that the MAC 5500 ECG Analysis System is as safe, as effective, and performs as well as the predicate devices.
{2}------------------------------------------------
Public Health Service
Image /page/2/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services, USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, which is a common symbol of the United States.
JAN 25 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
GE Medical Systems Information Technologies c/o Ms. Margaret Mucha Regulatory Affairs Leader 9900 Innovation Drive Wauwatosa, WI 53226
Re: K073625
Trade/Device Name: MAC 5500 Resting ECG Analysis System Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II (two) Product Code: DPS, DQK, DHX Dated: December 21, 2007 Received: December 26, 2007
Dear Ms. Mucha:
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 – Ms. Margaret Mucha
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 (OS) 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 vours.
Bfsimima fr
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Image /page/4/Picture/1 description: The image shows the GE Healthcare logo. The logo consists of the GE monogram in a circle on the left, followed by the words "GE Healthcare" in a simple, sans-serif font. The text is aligned horizontally with the monogram.
December 21, 2007
- Intended Use
510(k) Number (if known):
Page 1 of 1
Device Name:
MAC 5500 ECG Analysis System
Intended Use:
The MAC 5500 ECG Analysis System is intended to acquire, analyze, display, and record electrocardiographic information adult and pediatric populations. Basic systems deliver 3, 6, 12, or 15 lead ECG's, 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.
The MAC 5500 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.
Prescription Use X (Per 21 CFR 801.109 Subpart D) OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Brammer
Division of Cardiovascular Devices
510(k) Number K073625
§ 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).