(326 days)
This question cannot be answered from the given input. The "Predicate Device(s)" section explicitly states "Not Found".
Not Found
No
The summary does not mention AI, ML, deep learning, or any related terms, and the description of the device's function focuses on standard motility measurements and analysis software requiring physician interpretation.
No
The device is used to document, aid in diagnosing, and measure functions related to motility disorders and reflux events. It does not directly treat or provide therapy for these conditions.
Yes
Explanation: The device is explicitly stated to be an "aid in documenting and diagnosing digestive motility disorders" and can be used for "esophageal, biliary, and anorectal motility studies," which are diagnostic procedures. Additionally, the Accessory Model MII is intended to "aid in differentiating acid vs. non-acid reflux events" and "measure motor function," further indicating its diagnostic purpose.
No
The description explicitly states the system "includes analysis software" but also mentions "Accessory Model MII" which is described as a "component" and is used with a "pH probe" and for "intraluminal impedance recording," indicating hardware components are part of the system.
Based on the provided information, the InSight Model S980000 Gastrointestinal Motility System is an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states it's an "aid in documenting and diagnosing digestive motility disorders." This involves analyzing physiological data (motility and impedance/pH) collected from within the body to provide information for diagnosis.
- Accessory Model MII: The description of the Accessory Model MII further supports this by mentioning its use in differentiating acid vs. non-acid reflux events and measuring motor function by intraluminal impedance recording. These are diagnostic measurements.
- Requires Skilled Interpretation: While the system includes analysis software, it explicitly states it "requires skilled interpretation by a physician to make a diagnosis." This is typical of IVD devices where the technology provides data and analysis, but the final diagnosis is made by a qualified healthcare professional.
IVD devices are defined as those intended for use in the collection, preparation, and examination of specimens taken from the human body for the purpose of providing information for the diagnosis, treatment, or prevention of disease. While this system doesn't directly examine specimens in the traditional sense (like blood or tissue), it collects and analyzes physiological data from within the body to aid in diagnosis, which falls under the scope of IVD.
N/A
Intended Use / Indications for Use
The InSight Model S980000 Gastrointestinal Motility System is intended for use by gastroenterologists, surgeons, and medically trained personnel as an aid in documenting and diagnosing digestive motility disorders. It may be used for esophageal, biliary, and anorectal motility studies. The system includes analysis software, but requires skilled interpretation by a physician to make a diagnosis.
The Accessory Model MII, when used in conjunction with a pH probe, can he used as an aid in differentiating acid versus non-acid reflux events. In addition, the Accessory Model MIT is intended to measure motor function of the proximal gastrointestinal tract including swallow effectiveness and directional bolus transport by means of intraluminal impedance recording.
The Accessory Model MII component of the InSight Gastrointestinal Motility System is not intended for use in biliary studies.
Product codes
78 FFX
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
esophageal, biliary, anorectal, proximal gastrointestinal tract
Indicated Patient Age Range
Not Found
Intended User / Care Setting
gastroenterologists, surgeons, and medically trained personnel
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 the logo for the Department of Health & Human Services (HHS). The logo features a stylized image of an eagle's head in profile, with three parallel lines extending from the back of the head to suggest feathers or wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN = 7 2002
Sandhill Scientific, Inc. c/o Mr. Lewis W. Ward L. W. Ward and Associates, Inc. 4655 Kirkwood Court BOULDER CO 80301
Re: K012232 Trade/Device Name: Sandhill Scientific InSight Model S980000 with Accessory Model MII Regulation Number: 21 CFR §876.1725 Regulation Name: Gastrointestinal Motility Monitoring System Regulatory Class: II Product Code: 78 FFX Dated: March 3. 2002 Received: March 11, 2002
Dear Mr. Ward:
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 Cbrogdon
Nancy C. Brogdon Director. Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Initial 510(k): K012232
Device Name: InSight Model 980000 Gastrointestinal Motility System with Accessory Model MII
Indications for Use:
The InSight Model S980000 Gastrointestinal Motility System is intended for use by gastroenterologists, surgeons, and medically trained personnel as an aid in documenting and diagnosing digestive motility disorders. It may be used for esophageal, biliary, and anorectal motility studies. The system includes analysis software, but requires skilled interpretation by a physician to make a diagnosis.
The Accessory Model MII, when used in conjunction with a pH probe, can he used as an aid in differentiating acid vs. non-acid reflux events. In addition, the Accessory Model MIT is intended to measure motor function of the proximal gastrointestinal tract including swallow effectiveness and directional bolus transport by means of intraluminal impedance recording,
The Accessory Model MII component of the InSight Gastrointestinal Motility System is not intended for use in biliary studies.
(PLEASE! DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X (Fer 21 CFR 801.109)
OR Over-the-Counter Use
Daniel h. Lyon
(Division Sign-Off Division of Reprodu and Radiological Devi 510(k) Number