POLYGRAM NET ELECTROGASTROGRAPHY APPLICATION SOFTWARE, MODEL 9043S0151; POLYGRAF ID, MODEL 9043G0102
K014269 · Medtronic Functional Diagnostics A/S · MYE · Nov 21, 2002 · Gastroenterology, Urology
Device Facts
Record ID
K014269
Device Name
POLYGRAM NET ELECTROGASTROGRAPHY APPLICATION SOFTWARE, MODEL 9043S0151; POLYGRAF ID, MODEL 9043G0102
Applicant
Medtronic Functional Diagnostics A/S
Product Code
MYE · Gastroenterology, Urology
Decision Date
Nov 21, 2002
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 876.1735
Device Class
Class 2
Indications for Use
The PolygrafID with POLYGRAM NET™ ElectroGastroGraphy Application is intended to record, store, process and view gastric myoelectrical activity as an aid in the diagnosis of gastrointestinal motility disorders.
Device Story
Stationary electrogastrography (EGG) system; measures myoelectrical activity of gastrum via skin-surface sensors. System captures, stores, and displays data on computer screen; allows review, analysis, and reporting. Operated by trained technician, nurse, or physician in clinical setting. Replaces external strip chart recorder and external amplifier of predicate; uses software-based protocol settings for measurement setup. Software high-pass filter eliminates need for 5-minute settling period. Provides 1 to 4 channels for analysis. Output used by healthcare provider to assist in diagnosing gastrointestinal motility disorders.
Clinical Evidence
No clinical data. Bench testing only; verification results demonstrate performance equivalent to predicate system.
Technological Characteristics
PC-based stationary system; 1-4 channels; disposable electrodes. Software-based high-pass filtering for DC offset removal. Connectivity: external data acquisition device. Standards: EN 60601-1, EN 60601-1-1, EN 60601-1-2, CAN/CSA 22.2 No. 601.1-M90. Digital resolution: 1.12 µV (Gain 1), 0.112 µV (Gain 10), 0.0112 µV (Gain 100).
Indications for Use
Indicated for adults with symptoms consistent with gastrointestinal motility disorders to record, store, process, and view gastric myoelectrical activity as an aid in diagnosis.
Regulatory Classification
Identification
An electrogastrography system (EGG) is a device used to measure gastric myoelectrical activity as an aid in the diagnosis of gastric motility disorders. The device system includes the external recorder, amplifier, skin electrodes, strip chart, cables, analytical software, and other accessories.
Special Controls
*Classification.* Class II (Special Controls). The special controls are as follows:(1) The sale, distribution and use of this device are restricted to prescription use in accordance with § 801.109 of this chapter.
(2) The labeling must include specific instructions:
(i) To describe proper patient set-up prior to the start of the test, including the proper placement of electrodes;
(ii) To describe how background data should be gathered and used to eliminate artifact in the data signal;
(iii) To describe the test protocol (including the measurement of baseline data) that may be followed to obtain the EGG signal; and
(iv) To explain how data results may be interpreted.
(3) The device design should ensure that the EGG signal is distinguishable from background noise that may interfere with the true gastric myoelectric signal.
(4) Data should be collected to demonstrate that the device has adequate precision and the EGG signal is reproducible and is interpretable.
In addition to the general controls of the act, the 3CPM EGG Machine is subject to the following special controls: (1) The sale, distribution and use of this device are restricted to prescription use in accordance with 21 CFR 801.109. (2) The labeling must include specific instructions (a) to describe proper patient set-up prior to the start of the test, including the proper placement of electrodes; (b) to describe how background data should be gathered and used to eliminate artifact in the data signal; (c) to describe the test protocol (including the measurement of baseline data) which may be followed to obtain the EGG signal; and (d) to explain how data results may be interpreted. (3) The device design should ensure that the EGG signal is distinguishable from background noise that may interfere with the true gastric myoelectric signal. (4) Data should be collected to demonstrate that the device has adequate precision and the EGG signal is reproducible and is interpretable.
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# KO14269 OF 4
## 510(k) Notification Electrogastrography (EGG) System
NOV 2 1 2002
## 510(k) SUMMARY
as required per 807.92(c)
#### 1. Submitters Name, Address:
Medtronic A/S Tonsbakken 16-18 DK-2740 SKOVLUNDE Tel: + 45 44 57 90 00 Fax: + 45 44 57 90 10 Contact person for this submission: Liselotte Sander Date submission was prepared: August 20, 2002.
#### 2. Trade Name, Common Name and Classification Name:
A. Trade Name: Electrogastrography (EGG) System
B. Common Name, Classification Name, Class and Requlation Number:
| Common Name | Classificati<br>on Number | Class | Regulation<br>Number |
|--------------|---------------------------|-------|----------------------|
| Polygraf ID | MYE | II | 21 CFR 876.1735 |
| Polygram NET | MYE | II | 21 CFR 876.1735 |
#### 3. Predicate Device Identification:
The scientific technology and the functionality and intended use of the Polygram NET and the Polygraf ID are equivalent to 3CPM Company's 3CPM EGG Machine (K 984637)
#### 4. Device Description:
The system is a stationary electrogastrography system for use in the evaluation of gastrointestinal motility disorders. The system measures the myoelectrical activity of the gastrum using sensors situated on the skin. The parameters measured are presented on a computer screen during the capture and are also stored for later display, review, analysis and reporting.
In the daily use, a trained technician, nurse and/or a physician are the main users of the system.
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## 510(k) Notification Electrogastrography (EGG) System
The main tasks when performing an electrogastrography procedure with a stationary EGG system are:
- Prepare equipment including verification of correct levels for skin/electrode . impedance levels.
- Enter patient/study demographic information ●
- Perform procedure and obtain relevant data ●
- Review, analysis and post procedure activities ●
- Create and print a report ●
The Polygram NET application software runs on the Microsoft Windows® 2000 operating system.
#### 5. Intended Use:
The Polygaf ID with Electrogastrography (EGG) System is intended to record, store view and process gastric myoelectrical activity as an aid in the diagnosis of gastrointestinal motility disorders.
| | 6. Table of Device Similarities and differences to predicate device | | | |
|--|---------------------------------------------------------------------|--|--|--|
| | | | | |
| Manufacturer | 3CPM CO., Inc. | Medtronic Functional Diagnostics |
|---------------|----------------------|------------------------------------------------------------|
| 510(k) nummer | Predicate device | New device |
| | • 3CPM EGG Machine – | K011468 |
| | K984637 | Polygram NET Electrogastro-graphy |
| | | (EGG) Application: |
| | | • Polygraf ID |
| | | • Polygram NET Electrogastrography<br>Application Software |
| General: | Predicate device<br>3CPM | Modified device<br>Polygram NET<br>Electrogastrography<br>(EGG) Application | Explanation of the<br>differences compared to<br>the predicate device |
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|
| PC. Based | Yes | Yes | same |
| External data acquisition<br>device | Yes | Yes | same |
| External amplifier | Yes | No | Better |
| Use of a external Strip<br>Chart Recorder | Yes | No1 | Better<br>Makes the system simpler. |
| Measurement setup | On HW devices | By use of protocol | Better |
| | | settings in SW. | Ensures initially same setting<br>every time |
| Visualize signals in time<br>domain. | Yes | Yes | same |
| Running Spectrum<br>Analysis | Yes | Yes | same |
| Gain | 100 | 1, 10, 1002 | same |
| High-Freq. | 0.25 Hz | 0.25Hz | same |
| Low Freq. | 0.016 Hz | DC,<br>0.0083Hz;<br>0.016Hz;<br>0.030Hz | Better |
| Offset | 0 | High Pass filter3 | Same result |
| SW high pass filter | NO | Yes | Better.<br>No need for 5 minutes period<br>to "settle down". The recor-<br>ding can begin immediately |
| Number of channels | 1 | 1 to 4 | Better.<br>Gives the ability to analyze<br>the channel with the most<br>significant data |
| Motion sensor | Yes | Yes | Same |
| Indications for use | To be used to record<br>electrogastro-grams,<br>as a component of a<br>comprehensive clini-<br>cal evaluation in pa-<br>tients with symptoms<br>consistent with ga-<br>strointestinal motility<br>disorders | Record, store view and<br>analyze gastric myoe-<br>lectrical activity as an<br>aid in the diagnosis of<br>gastrointestinal motility<br>disorders | Same |
| Intended populations | Infants, pediatrics to<br>adults | Adults | Less |
| Sterilization | Accessories are not<br>supplied sterile,<br>manufacturer labels<br>the accessories with<br>cleaning instructions | Electrodes are dispo-<br>sable. Cables are not<br>supplied sterile, manu-<br>facturer labels the ac-<br>cessories with cleaning<br>instructions | Same |
| Biocompatibility | The sensors are the<br>only part that comes<br>into contact with the<br>patients | Same | Same |
I The raw data is presented on the screen formatted as a strip chart. The hole recording or part's of it can be printed or included in the report.
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## 510(k) Notification Electrogastrography (EGG) System
י
#### 7. Assessment of non-clinical performance data for equivalence:
Verifications results show that the enhanced system performs as its predicate system.
² The Digital resolution is as following: Gain 1 -> 1.12 µV ; Gain 10 -> 0.112 µV; Gain 100 -> 0.0112µV
<sup>3</sup> The Polygraf ID handles signals in the range of f +- 2.5 V. The DC offset is removed by use of a software high pass filter.
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KC14269
PAGE 4 OF 4
## 510(k) Notification Electrogastrography (EGG) System
#### 8. Assessment of clinical performance data for equivalence: Clinical trials are not performed. This new system does not raise any new safety or performance issues.
#### 9. Biocompatability:
Not applicable
#### 10. Sterilization:
Not applicable
#### 11. Standards and Guidances:
The Polygraf ID conforms to the following voluntary and mandatory standards:
- EN 60601-1, Medical equipment .
- EN 60601-1-1, Electrical Safety ●
- EN 60601-1-2, Electro magnetic Compatibility ●
- CAN/CSA 22.2 No. 601.1 - M90
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20:350
NOV 21 2002
Re: K014269
Mr. Toni Kennet Jørgensen Regulatory Affairs Specialist Medtronic Functional Diagnostics A/S Tonsbakken 16-18 DK-2740 Skovlunde DENMARK
Trade/Device Name: Polygraf ID with POLYGRAM NET™ ElectroGastroGraphy (ECG) Application Software Regulation Number: 21 CFR 8876.1735 Regulation Name: Electrogastrography system Regulatory Class: II Product Code: 78 MYE Dated: August 20, 2002 Received: August 23, 2002
Dear Mr. Jørgensen:
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 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.
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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
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510(k) Number (if known): K014269
Device Name: ElectroGastroGraphy (EGG) Application Software
Indications For Use:
The PolygrafID with POLYGRAM NET™ ElectroGastroGraphy Application is intended to record, store, process and view gastric myoelectrical activity as an aid in the diagnosis of gastrointestinal motility disorders.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGIE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David C. Ingram
(Optional Format 3-10-98)
Prescription Use
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.
