DEN990005 · 3pm Co., Inc. · MYE · Aug 20, 1999 · Gastroenterology, Urology
Device Facts
Record ID
DEN990005
Device Name
THE 3PM EGG MACHINE
Applicant
3pm Co., Inc.
Product Code
MYE · Gastroenterology, Urology
Decision Date
Aug 20, 1999
Decision
DENG
Submission Type
Post-NSE
Regulation
21 CFR 876.1735
Device Class
Class 2
Indications for Use
The 3CPM EGG Machine is intended for use as a diagnostic device that receives, records, and produces a visual display of the electrical signal produced by the stomach. This device is to be used to record electrogastrograms, as a component of a comprehensive clinical evaluation in patients with symptoms consistent with gastrointestinal motility disorders.
Device Story
3CPM EGG Machine records gastric myoelectrical activity; inputs electrical signals from stomach via skin electrodes; system includes external recorder, amplifier, cables, and analytical software. Device processes signals to produce visual electrogastrogram (EGG) display. Used in clinical settings by healthcare professionals; output aids diagnosis of gastric motility disorders. Clinicians interpret EGG results alongside other clinical data to inform patient management. Benefits include non-invasive assessment of gastric electrical activity.
Clinical Evidence
No clinical data provided. Special controls require data demonstrating adequate precision, signal reproducibility, and interpretability.
Technological Characteristics
System includes external recorder, amplifier, skin electrodes, strip chart, cables, and analytical software. Sensing principle: surface electrogastrography (measurement of gastric myoelectrical activity). Design must ensure EGG signal is distinguishable from background noise.
Indications for Use
Indicated for patients with symptoms consistent with gastrointestinal motility disorders to record electrogastrograms as part of a comprehensive clinical evaluation.
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.
Submission Summary (Full Text)
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850
AUG 20 1999
3CPM Company, Inc.
c/o Daniel J. Manelli
Regulatory Consultant
2000 M. Street N.W., 7th Floor
Washington, D.C. 20036
Re: K984637
Evaluation of Automatic Class III Designation
The 3CPM EGG Machine
Dear Mr. Manelli:
The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has completed its review of your petition for classification of the 3CPM EGG Machine that is intended for use as a diagnostic device that receives, records, and produces a visual display of the electrical signal produced by the stomach. This device is to be used to record electrogastrograms, as a component of a comprehensive clinical evaluation in patients with symptoms consistent with gastrointestinal motility disorders. FDA concludes that this device, and substantially equivalent devices of this generic type, should be classified into class II. This order, therefore, classifies the 3CPM EGG Machine, and substantially equivalent devices of this generic type into class II under the generic name, Electrogastrography (EGG) System. This order also identifies the special controls applicable to this type of device.
FDA identifies this generic type of device as a gastroenterology-urology device under 21 CFR 876.1735, as an electrogastrography system, which 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.
In accordance with section 513(f)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360c(f)(1)) (the act), devices that were not in commercial distribution prior to May 28, 1976 (the date of enactment of the Medical Devices Amendments of 1976 (the amendments)), generally referred to as postamendments devices, are classified automatically by statute into class III without any FDA rulemaking process. These devices remain in class III and require premarket approval, unless and until the device is classified or reclassified into class I or II or FDA issues an order finding the device to be substantially equivalent, in accordance with section 513(i) of the act (21 U.S.C. 360c(i)), to a predicate device that does not require premarket approval. The agency determines whether new devices are substantially equivalent to previously marketed devices by
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means of premarket notification procedures in section 510(k) of the act (21 U.S.C. 360(k)) and Part 807 of the FDA regulations (21 CFR 807).
Section 513(f)(2) of the act provides that any person who submits a premarket notification under section 510(k) for a device may, within 30 days after receiving an order classifying the device in class III under section 513(f)(1), request FDA to classify the device under the criteria set forth in section 513(a)(1). FDA shall, within 60 days of receiving such a request, classify the device. This classification shall be the initial classification of the device. Within 30 days after the issuance of an order classifying the device, FDA must publish a notice in the Federal Register classifying the device.
On July 12, 1999, FDA filed your petition requesting classification of the 3CPM EGG Machine into class II. The petition was submitted under 513(f)(2) of the act. In accordance with section 513(f)(1) of the act, FDA issued an order on July 2, 1999, automatically classifying the 3CPM EGG Machine in class III, because it was not within a type of device which was introduced or delivered for introduction into interstate commerce for commercial distribution before May 28, 1976, which was subsequently reclassified into class I or class II. In order to classify the 3CPM EGG Machine into class I or II, it is necessary that the proposed class have sufficient regulatory controls to provide reasonable assurance of the safety and effectiveness of the device for its intended use.
After review of the information submitted in the petition, FDA has determined that the 3CPM EGG Machine can be classified in class II with the establishment of special controls. You may now market the device. The 3CPM EGG Machine is intended for use as a diagnostic device that receives, records, and produces a visual display of the electrical signal produced by the stomach. This device is to be used to record electrogastrograms, as a component of a comprehensive clinical evaluation in patients with symptoms consistent with gastrointestinal motility disorders. FDA believes that class II special controls provide reasonable assurance of the safety and effectiveness of the device.
FDA has identified the following risks to health associated specifically with this type of device: (a) misdiagnosis due to erroneous data output and (b) misuse of the device and misinterpretation of the system results by an untrained individual.
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
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demonstrate that the device has adequate precision and the EGG signal is reproducible and is interpretable.
Section 510(m) of the act provides that FDA may exempt a class II device from the premarket notification requirements under section 510(k) of the act, if FDA determines that premarket notification is not necessary to provide reasonable assurance of the safety and effectiveness of the device. FDA has determined premarket notification is necessary to provide reasonable assurance of the safety and effectiveness of this type of device, and, therefore, the type of device is not exempt from premarket notification requirements. Thus, persons who intend to market this type of device must submit to FDA a premarket notification, prior to marketing the device, which contains information about the electrogastrography system they intend to market.
A notice announcing this classification order will be published in the Federal Register. A copy of this order and supporting documentation are on file in the Dockets Management Branch (HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857 and are available for inspection between 9 a.m. and 4 p.m., Monday through Friday.
As a result of this order, you may immediately market the device, subject to the general controls provisions of the Act and the special controls identified in this order.
If you have any questions concerning this classification order, please contact Carolyn Y. Neuland, Ph.D. at (301) 594-1220.
Sincerely,
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.
