(111 days)
Not Found
No
The summary does not mention AI, ML, or related terms, nor does it describe features or processes typically associated with these technologies (e.g., image processing, training/test sets, performance metrics like AUC). The focus is on data recording, storage, viewing, and analysis of physiological signals.
No
The device is intended to assist in diagnosis and evaluation, not to treat.
Yes
The 'Intended Use / Indications for Use' section explicitly states that the system is "to assist in the diagnosis and evaluation of gastrointestinal and swallowing disorders," which is the primary function of a diagnostic device.
No
The intended use 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 involves measurements taken directly within the patient's body using catheters and accessories, not on samples taken from the body.
Therefore, the Solar GI system is a medical device used for in vivo (within the living body) measurements and analysis, 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 auxillary 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. Designated catheters and accessories are required for measurement in each specific area.
Product codes
FFX
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastrointestinal tract (pharynx, esophagus, stomach, duodenum, sphincter of oddi, small bowel, colon and anorectal area including rectum and pelvic floor)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 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).
0
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.
1
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
2
Indications for Use
510(k) Number (if known):
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