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.

Device Description

The InSIGHT Model S980000 Gastrointestinal Motility system consists of three basic subsystems. These are: Signal conditioning and recording hardware, Analysis software, and Probes and transducers.

AI/ML Overview

The provided text does not contain a study that proves the device meets specific acceptance criteria in the manner requested. Instead, it describes a 510(k) Premarket Notification for the InSIGHT Model S980000 Gastrointestinal Motility System, which focuses on demonstrating substantial equivalence to previously marketed predicate devices rather than proving performance against specific acceptance criteria through a clinical study.

Here's an analysis based on the information provided, highlighting why many requested points cannot be answered:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Reported Device Performance	Comments
Safety	"designed to either completely eliminate or mitigate all known health hazards""performs as well as or better than the legally marketed predicate devices."	The document states the device meets UL 2601-1 for safety through internal and external lab testing. It doesn't provide specific quantitative safety metrics or criteria.
Effectiveness	"performs as well as or better than the legally marketed predicate devices."	Effectiveness is primarily claimed through substantial equivalence to predicate devices, implying similar diagnostic aid capabilities. No specific quantitative effectiveness criteria (e.g., sensitivity, specificity, accuracy for specific digestive motility disorders) are defined or reported.
Key Technological Characteristics are Equivalent to Predicate Devices	"The technological characteristics of the InSIGHT Model S980000 are the same as, or perform equivalently to, the predicate devices."	This is the core "acceptance criterion" for a 510(k) submission: demonstrating equivalence in design and performance to a legally marketed device. The document states this equivalency is met.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable / No information provided. The document explicitly states: "No formal clinical testing has been performed, nor is any believed to be necessary." Therefore, there is no test set or related data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable / No information provided. As no formal clinical testing was performed, there was no test set requiring expert ground truth establishment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable / No information provided. No test set, so no adjudication method.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable / No information provided. The device is a "Gastrointestinal Motility System" with analysis software, not explicitly an "AI" device as typically understood in the context of MRMC studies comparing human readers with and without AI. No such study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable / No information provided. While the system includes "analysis software," it explicitly states it "requires skilled interpretation by a physician to make a diagnosis." There is no indication of standalone performance testing of just the algorithm without a human in the loop. The "non-clinical testing" mentioned focuses on safety standards (UL 2601-1) and internal design specifications, not diagnostic performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable / No information provided. Since no formal clinical testing was performed to establish device performance against a diagnostic gold standard, no ground truth type is specified. The device's "effectiveness" is based on its functional equivalence to predicate devices which are already accepted diagnostic aids.

8. The sample size for the training set

Not applicable / No information provided. There's no mention of an "AI" or machine learning component that would involve a training set as often discussed in the context of acceptance criteria for diagnostic algorithms.

9. How the ground truth for the training set was established

Not applicable / No information provided. As there's no mention of a training set, the method for establishing its ground truth is not applicable.

Summary of the Study (or lack thereof) that Proves the Device Meets Acceptance Criteria:

The document describes a bench testing and design verification approach, not a clinical study. The primary "study" that supports the device meets its "acceptance criteria" (which are fundamentally about safety and substantial equivalence to predicate devices) involves:

Design Controls Procedures: Internal processes to ensure the device meets predefined specifications.
Compliance with UL 2601-1: Meeting a recognized standard for medical electrical equipment safety. This was achieved through a "planned combination of internal design testing to written protocols and outside laboratories."
Comparison to Predicate Devices: Demonstrating that the "technological characteristics... are the same as, or perform equivalently to, the predicate devices" (BioVIEW Model S960000 and Sandhill DMS). This comparison forms the basis of the "effectiveness" claim in the absence of clinical data.

In conclusion, this 510(k) submission primarily relies on demonstrating substantial equivalence to predicate devices and adherence to safety standards through non-clinical testing, rather than presenting results from a clinical study with defined performance acceptance criteria, test sets, or ground truth.

Summary

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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.

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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:

1. Design modifications.
1. Detection of hazard conditions and alerting of the user through alarms and visual indications.
1. Identification of any potentially undetectable health hazard conditions in the instruction manual and other device labeling.

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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.

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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

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Indications for Use

510(k) Number:

InSIGHT Model S980000 Gastrointestinal Motility System Device Name:

Indications for Use:

(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,

Radiological Devices
510(k) Number K984444

Regulation Number and Section

§ 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).