(350 days)
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No
The summary does not mention AI, ML, deep learning, or any related terms, nor does it describe features typically associated with AI/ML analysis (e.g., automated interpretation, predictive modeling based on complex patterns). The analysis described is standard for physiological data.
No
The device is intended to "record, store, view and analyse pressure, EMG, swallow and respiration and various auxiliary input device data... to assist in the diagnosis and evaluation of gastrointestinal and swallowing disorders." This describes a diagnostic device, not a therapeutic one. It gathers data for diagnosis, rather than treating a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is intended "to assist in the diagnosis and evaluation of gastrointestinal and swallowing disorders."
No
The description explicitly states that "Designated catheters and accessories are required for measurement," indicating the device relies on hardware components beyond just software.
Based on the provided information, the Solar GI system is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Solar GI system function: The description states the Solar GI system records, stores, views, and analyzes pressure, EMG, swallow, and respiration data on-line anywhere in the gastrointestinal tract. This indicates it's a system that measures physiological parameters directly within the body using catheters and accessories.
Therefore, the Solar GI system is an in vivo diagnostic device, not an in vitro diagnostic device.
N/A
Intended Use / 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, sphirycter of oddi, small bowel, colon and anorectal area including rectum and pelvic flor) to assist in the diagnosis and evaluation of gastrointestinal and swallowing disorders. Designated catheters and accessories are required for measurement in each specific area.
Product codes
78 FFX
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
pharynx, esophagus, stomach, duodenum, sphirycter of oddi, small bowel, colon and anorectal area including rectum and pelvic flor
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 876.1725 Gastrointestinal motility monitoring system.
(a)
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.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem consisting of three stylized, overlapping shapes that resemble birds in flight. The emblem is black, and the text is also black.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 9 2004
Ms. Karin Ogink-Somhorst Quality Assurance and Regulatory Affairs Manager Medical Measurement Systems, B.V. Colosseum 25, 7521 PV Enschede P.O. Box 580, 7500 AN Enschede THE NETHERLANDS
Re: K031084
Trade/Device Name: Solar GI Regulation Number: 21 CFR §876.1725 Regulation Name: Gastrointestinal motility monitoring system Regulatory Class: II Product Code: 78 FFX Dated: December 19, 2003 Received: December 22, 2003
Dear Ms. Ogink-Somhorst:
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, Or ve 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 af 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 100-1050.
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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 Office of Compliance at one of the following numbers, based on the regulation number at the top of the 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" (21CFR Part 807.97) you may obtain. 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/dsmaldsmamain.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): K031084
Device Name: Solar Gl
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, sphirycter of oddi, small bowel, colon and anorectal area including rectum and pelvic flor) to assist in the diagnosis and evaluation of gastrointestinal and swallowing disorders.
Designated catheters and accessories are required for measurement in each specific area.
Yes Prescription Use (Parl 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ (21 CFR 807 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 Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number
Page 1 of
No