K042177 · Ge Medical Systems Information Technologies · DPS · Aug 27, 2004 · Cardiovascular
Device Facts
Record ID
K042177
Device Name
MODIFICATION TO MAC 5000 ECG ANALYSIS SYSTEM
Applicant
Ge Medical Systems Information Technologies
Product Code
DPS · Cardiovascular
Decision Date
Aug 27, 2004
Decision
SESE
Submission Type
Special
Regulation
21 CFR 870.2340
Device Class
Class 2
Attributes
Pediatric
Indications for Use
The MAC 5000 ECG Analysis System is intended to acquire, analyze, display, and record electrocardiographic information for adult and pediatric populations. Basic systems 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. The MAC 5000 is intended to be used under the direct supervision of a licensed medical professional in a hospital or medical professional's facility.
Device Story
MAC 5000 is a mobile electrocardiograph system used in hospitals/clinics under physician supervision. It acquires ECG signals via surface electrodes using the CAM14 modular acquisition device; signal fidelity is improved by placing the module near the patient. The system processes signals to provide 3, 6, 12, or 15 lead ECGs, 12-lead interpretive analysis, vector loops, and optional high-resolution signal averaging of QRS/P wave segments. Output is presented on a full-size VGA display and integrated thermal writer; data can be stored or transmitted to a central cardiovascular information system. The device operates on battery or AC power and can be used as a mobile unit on a trolley or as a desktop unit. It assists clinicians in diagnosing cardiac conditions by providing automated analysis and visual waveform data.
Clinical Evidence
Bench testing only. Evidence includes risk analysis, technical and design reviews, code inspections, module verification, system integration testing, final acceptance validation, performance testing, and safety testing. No clinical data provided.
Technological Characteristics
System consists of a processing unit and CAM14 patient acquisition module. Features include rechargeable battery, thermal writer, VGA display, and alphanumeric keyboard. Connectivity includes optional transmission/reception to central cardiovascular information systems. Software provides interpretive analysis and signal averaging. Complies with voluntary standards for safety and performance.
Indications for Use
Indicated for adult and pediatric populations requiring acquisition, analysis, display, and recording of electrocardiographic information (3, 6, 12, or 15 lead ECGs).
Regulatory Classification
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.
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## AUG 27 2004
510(k) Summary of Safety and Effectiveness
August 6, 2004 Date:
GE Medical Systems Information Technologies Submitter: 8200 West Tower Avenue Milwaukee, WI 53223 USA
Lisa M. Baumhardt Contact Person: Regulatory Affairs Specialist GE Medical Systems Information Technologies Phone: 262-293-1699 Fax: 262-293-1460
MAC 5000 ECG Analysis System Trade Name: Device:
Electrocardiograph Common/Usual Name:
Classification Names:
| 21 CFR 870.1025 Monitor, Physiological Patient (with Arrhythmia Detection or Alarms) | 74MHX |
|--------------------------------------------------------------------------------------|-------|
| 21 CFR 870.1025 Detector and Alarm, Arrhythmia | 74DSI |
| 21 CFR 870.1425 Programmable Diagnostic Computer | 74DQK |
| 21 CFR 870.2340 Electrocardiograph | 74FYW |
| 21 CFR 870.2920 Transmitters and Receivers, Electrocardiograph, Telephone | 74DXH |
K033492 MAC 5000 ECG Analysis System Predicate Device:
The MAC 5000 ECG Analysis System is designed to acquire, analyze, Device Description: display, and record ECG signals from surface ECG electrodes. The display, and 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 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.
> The MAC 5000 system acquires ECG data using a modular patient data acquisition device called the CAM14 (K991735). By placing the data acquisition device closer to the patient, signal fidelity is improved and noise is reduced. MAC 5000 delivers 12 or 15 lead ECG's on fullsize reports with alphanumeric keyboard for patient demographics and other data entry, a full size VGA graphics and waveform display, integrated thermal writer and removable data storage.
> Additionally, the MAC 5000 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.
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K04277
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- The MAC 5000 ECG Analysis System is intended to acquire, analyze, Intended Use: The MAC 3000 EOO Analysis information adult and pediation ulsplay, and record clock. Sie and all gr 3, 6, 12, or 15 lead ECG's, 12 lead populations. Dasio systems don'ts of can be upgraded to provide merpretive analysis, vootor loops, and resolution signal averaging of Sollware analysis options of the electrocardiogram. Transmission and QRS and I wave portions of and from a central ECG cardiovascular information system is optional.
The MAC 5000 is intended to be used under the direct supervision of a The MAC 5000 is michaou to be be as a loss and a hospital or medical professional's facility.
- The MAC 5000 ECG Analysis System employs the same functional Technology: technology as the predicate devices.
- The MAC 5000 ECG Analysis System complies with the voluntary Test Summary: standards as detailed in Section 9 of this submission. The following Standards as detailed in Soction of the development of the system:
- Risk Analysis .
- Technical Reviews .
- Design Reviews .
- Code Inspections .
- Unit level Testing (module verification) .
- Integration Testing (system verification) .
- Final Acceptance Testing (validation) .
- Performance Testing .
- Safety Testing .
- The results of these measurements demonstrated that the MAC 5000 Conclusion: The Tosalto of thosem is as safe, as effective, and performs as well as the predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
JAN 2 2 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: K042177
Trade/Device Name: MAC 5500 Resting ECG Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: II (two) Product Code: DPS Dated: August 6, 2004 Received: August 11, 2004
Dear Ms. Mucha:
This letter corrects our substantially equivalent letter of August 27, 2004.
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 (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 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.
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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 (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 continue 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) 276-0120. 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 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/dsma/dsmamain.html
Sincerely yours, .
Blommerfor fr
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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长042177
Page 1 of 1
510(k) Number (if known):
MAC 5000 ECG Analysis System
Device Name:
Indications For Use:
The MAC 5000 ECG Analysis System is intended to acquire, analyze, display, and record
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Prescription Use_X (Per 21 CFR 801.109 Subpart D) OR
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510(k) Number K042177
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
