K052338 · Medical Measurement Systems B.V. · FFX · Dec 15, 2005 · Gastroenterology, Urology
Device Facts
Record ID
K052338
Device Name
SOLAR GI
Applicant
Medical Measurement Systems B.V.
Product Code
FFX · Gastroenterology, Urology
Decision Date
Dec 15, 2005
Decision
SESE
Submission Type
Special
Regulation
21 CFR 876.1725
Device Class
Class 2
Indications for Use
The Solar GI system is intended to record, store, view and analyse pressure, EMG, swallow and respiration and various auxiliary input device data on-line anywhere in the gastrointestinal tract (pharynx, esophagus, stomach, duodenum, sphincter of oddi, small bowel, colon and anorectal area including rectum and pelvic floor) to assist in the diagnosis and evaluation of gastrointestinal and swallowing disorders.
Device Story
Solar GI system records, stores, views, and analyzes physiological data including pressure, EMG, swallow, and respiration; utilizes specialized catheters and CIM-AUX module for data acquisition; intended for clinical use by healthcare professionals to assist in diagnosing gastrointestinal and swallowing disorders; system provides on-line monitoring and analysis of GI tract function; output allows clinicians to evaluate motility and functional integrity of various GI segments; benefits patients by facilitating accurate diagnosis of complex GI and swallowing pathologies.
Clinical Evidence
No clinical data provided; substantial equivalence based on technological characteristics and intended use.
Technological Characteristics
Gastrointestinal motility monitoring system; includes CIM-AUX module; utilizes specialized catheters for pressure, EMG, swallow, and respiration sensing; software-based data acquisition and analysis; Class II device.
Indications for Use
Indicated for patients requiring diagnostic evaluation of gastrointestinal and swallowing disorders via pressure, EMG, swallow, and respiration monitoring across the GI tract (pharynx, esophagus, stomach, duodenum, sphincter of oddi, small bowel, colon, rectum, and pelvic floor).
Regulatory Classification
Identification
A gastrointestinal motility monitoring system is a device used to measure peristalic activity or pressure in the stomach or esophagus by means of a probe with transducers that is introduced through the mouth into the gastrointestinal tract. The device may include signal conditioning, amplifying, and recording equipment. This generic type of device includes the esophageal motility monitor and tube, the gastrointestinal motility (electrical) system, and certain accessories, such as a pressure transducer, amplifier, and external recorder.
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Image /page/0/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HUMAN & CULTURAL..." arranged around the top half of the circle. Inside the circle is a stylized image of a bird in flight, with its wings spread and its body angled upwards. The bird's design is somewhat abstract, using thick, curved lines to suggest its form. The overall impression is that of an official emblem or logo.
DEC 1 5 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Karin Ogink-Somhorst Ms. Karin Ognar e and Regulatory Affairs Manager Medical Measurement Systems, B.V. Colosseum 25 Enschede NETHERLANDS 7521 PV
Re: K052338
K032336
Trade/Device Name: Solar GI including CIM-AUX Module Regulation Number: 21 CFR §876.1725 Regulation Name: Gastrointestinal motility monitoring system Regulatory Class: II Product Code: FFX Dated: November 7, 2005 Received: November 15, 2005
Dear Ms. Ogink-Somhorst:
Dour and 100 -We have revewed your Section 510(x) promation institutions for use stated in
above and have determined the device is substantially equivalent (for the stated in above and have delemined the devices marketed in interstate commerce prior to devices that her the enclosure) to regally marketed predical Device Amendments, or to devices that have been a May 28, 1976, the enactified in the Frederal Food, Dugg, and Cosmetic Act (Act) that reclassified in accordance with the provisions of and instal. You may, therefore, market the A do not require approval of a prematics approvisions of the Act. The general controls provisions of the Act
device, subject to the general controls provisions of the Act. device, subject to the gelleral controls of the real and of the solor of the practice, labeling, morado roquires against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Prematket If your device is classified (sec above) into other existing major regulations affecting your Approval), if may be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA
device can be found in the Code of Federal Regulations, Title 21, Parls 800 Port device can be found in the Sodo of the Code of the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that Please be advised that PDA 's issualled of a successions lies with other requirements of the Act of all FDA has made a delemination that your do receives was agencies. You must comply with all the rederal statues and regulations administered of ourse and listing (2 CFR Part 807); labeling areams (OS Act s requirements, including, but not mined to regulation the quality systems (QS)
(21 CFR Part 801); good manufacturing practice requirements as set for the positions (21 CFR Part 801), good manufacturing practice the electronic product radiation control provisions
regulation (21 CFR Part 820); and if applicable, the electronic product rad (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 Section 5 I0(k) This letter will allow you to begin marketing your device of your device of your device to a legally
premarket notification. The FDA indian if your device and this ocruits premarket notification. The FDA inding of substantial equive 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
r in the may of the follow following sumbers, based on the regulation num If you desire specific advice for your device on our labeling regulations.
contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation entitled, "Misoration on your responsibilities under the Act from the 807.97). You may obtain other general information on your responsibility of the number (800)
Division of Small Manufacturers, International and Consumer Assistance at its to DIVIsion of Binan Man......................................................................................................................................................... 056-2041 or (2 gov/cdrh/industry/support/index.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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## Indications for Use
510(k) Number (if known):
K052338
Device Name:
Solar GI including CIM-AUX module
Indications For Use:
The Solar GI system is intended to record, store, view and analyse pressure, EMG,
anywhere in the state in the successions william innut dovice data on-line anywhere in The Solar Gl system is intended to record, store, wew and data on-line anywhere in the
swallow and respiration and various antemant dudenmenting of oddi. swallow and respiration and valious auxinal y mpara ovloodenum, sphincter of oddi,
gastrointestinal tract (pharynx, esophagus, stomach, duodenum, sphincter of oddi, gastrointestinal tract (pharynx, esophagus, stomaon, adocuments |
small bowel, colon and anorectal area including rectum and pelvio floor) to assist in the small bower, color and anorestal drou installing wallowing disorders.
diagnosis and evaluation of gastrointestinal and swallowing disorders.
Designated catheters and accessories are required for measurement in each specific area.
Yes Prescription Use (Part 21 CFR 801 Subpart D) AND/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)
Nancy C. Brogdon
Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
No
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.
