(28 days)
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the description of the device and its intended use do not suggest the presence of AI/ML. The analysis software is mentioned, but without further detail, it's likely standard signal processing and analysis, not AI/ML.
No.
The device is strictly for diagnosing motility disorders and does not provide any therapeutic intervention.
Yes
The device is described as "an aid in documenting and diagnosing digestive motility disorders" and explicitly states it is used to "make a diagnosis," which are functions of a diagnostic device.
No
The device description explicitly states that the system consists of three basic subsystems, including "Signal conditioning and recording hardware" and "Probes and transducers," in addition to the analysis software. This indicates the device is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis.
- The description of the InSIGHT Model S980000 Gastrointestinal Motility System indicates it is used for esophageal motility and anorectal motility studies. These studies involve measuring the movement and pressure within the gastrointestinal tract in vivo (within the body) using probes and transducers.
- The system analyzes signals from these in vivo measurements, not from in vitro analysis of bodily specimens.
Therefore, the InSIGHT Model S980000 Gastrointestinal Motility System is a device used for physiological measurement and analysis in vivo, not an in vitro diagnostic device.
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 motility, anorectal motility and biliary studies. The system includes analysis software, but requires skilled interpretation by a physician to make a diagnosis.
Product codes (comma separated list FDA assigned to the subject device)
78 FFX, 78 KLA
Device Description
The InSIGHT Model S980000 Gastrointestinal Motility system consists of three basic subsystems. These are:
- Signal conditioning and recording hardware
- Analysis software
- Probes and transducers
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
esophageal, anorectal, biliary
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)
No formal clinical testing has been performed, nor is any believed to be necessary.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
Summary of Safety and Effectiveness
Introduction
The Safe Medical Device Act (SMDA) of 1990 requires that in addition to other information submitted in a 510(k), medical device manufacturers submit a summary of information regarding safety and effectiveness for the device subject to the 510(k). The summary is to include detailed information regarding adverse health effects of the device. This Summary of Safety and Effectiveness document is intended to comply with the SMDA requirement. FDA will make this summary available to the public within 30 days following a finding of substantial equivalence.
510(k) Submitted by
Sandhill Scientific, Inc. 8955 S. Ridgeline Blvd., #500 Highlands Ranch, CO 80126
USA Contact Person
Linda L. Diederich, MT-ASCP VP of Marketing & Customer Relations Tel: 303-470-7020 / Fax: 303-470-2975
Date Prepared
December 5, 1998
Trade Name of Device
InSIGHT Model S980000
Common Name of Device
Gastrointestinal Motility System
Classification Name
System, Gastrointestinal Motility (Electrical)
510(k) Classification
Class II
Comparison to Predicate Devices
The InSIGHT Model S980000 is a modified device with features equivalent in safety and performance to those included on prior legally marketed devices manufactured by Sandhill Scientific. The InSIGHT Model S980000 is Substantially Equivalent to:
K961056, BioVIEW Model S960000, Manufactured by Sandhill Scientific, Inc.
K821588, Sandhill DMS, Manufactured by Sandhill Scientific, Inc.
1
Device Description and Intended 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 motility, anorectal motility and biliary studies. The system includes analysis software, but requires skilled interpretation by a physician to make a diagnosis.
Technological Characteristics
The InSIGHT Model S980000 Gastrointestinal Motility system consists of three basic subsystems. These are:
Signal conditioning and recording hardware
This subsystem includes the hardware that amplifies the transduced signals for recording, provides electrical isolation for safety, and processes the signals for subsequent analysis.
Analysis software
The software displays the waveforms, shows the analyzed results and incorporates these results into reports.
Probes and transducers
These are used to generate the signal that is recorded. Sandhill does not manufacture the transducers and probes that are intended for use with the system, but these carry the manufacturers' approval to market and meet the manufacturers' safety requirements for their use.
The technological characteristics of the InSIGHT Model S980000 are the same as, or perform equivalently to, the predicate devices.
Applicable Standards and Non-Clinical Testing
In compliance with the company's Design Controls procedures, the InSIGHT Model S980000 has been designed to meet the requirements of the following standard:
UL 2601-1: Standard for Medical Electrical Equipment, Part 1: General Requirements for Safety
Certification of the design to the above standards and the device design specifications is through a planned combination of internal design testing to written protocols and outside laboratories. No formal clinical testing has been performed, nor is any believed to be necessary.
Potential Adverse Health Effects
The InSIGHT Model S980000 has been designed to either completely eliminate or mitigate all known health hazards associated with the use of the device. Health hazard risk reduction has been accomplished by rigorous application of a risk management program. One or more of the following means (in order of preference) was used to implement mitigation of health hazards identified by the risk management program:
-
- Design modifications.
-
- Detection of hazard conditions and alerting of the user through alarms and visual indications.
-
- Identification of any potentially undetectable health hazard conditions in the instruction manual and other device labeling.
2
The user must be qualified in gastrointestinal motility diagnostic procedures, trained in the use of the system, and must be familiar with all labeling and instructions for use associated with the equipment. Many device injuries are due to user error and failure to follow the instructions for use. The user of the device is advised to thoroughly understand the use of the equipment, and familiarize themselves with the location and function of all controls and alarms prior to using the equipment.
Sandhill Scientific believes that the InSIGHT Model S980000 is safe and effective when used as instructed by knowledgeable and trained personnel, and performs as well as or better than the legally marketed predicate devices.
3
Image /page/3/Picture/16 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The seal is black and white and appears to be a scanned image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 1 1999
Linda L. Diederich, MT-ASCP Vice President, Marketing and Customer Relations Sandhill Scientific, Inc. 8955 Ridgeline Blvd., #500 Highlands Ranch, Colorado 80126
Re: K984444 InSIGHT Model S980000 Gastrointestinal Motility System Dated: December 11, 1998 Received: December 14, 1998 Regulatory class: II 21 CFR §876.1725/Product code: 78 FFX 21 CFR §876.1725/Product code: 78 KLA
Dear Ms. Diederich:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21. Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
J J J
Capt. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number:
InSIGHT Model S980000 Gastrointestinal Motility System Device Name:
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 motility and anorectal motility studies. The system includes analysis software, but requires skilled interpretation by a physician to make a diagnosis.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
ﺴﺴﻢ Prescription Use (Per 21 CFR 801.109)
Over-The-Counter Use
ion Sign-Off) Division of Reproductive, Abdominal, ENT,
OR
Radiological Devices
510(k) Number K984444