(210 days)
The SmartPill GI Monitoring System is indicated for use in evaluating patients with suspected delayed gastric emptying (gastroparesis).
The SmartPill GI Monitoring System measures pH, pressure and temperature throughout the gastrointestinal tract. These physiological measurements are used to determine gastric emptying time (GET), total transit time (TTT), and combined small-large bowel transit time (SLBTT). In addition, pressure contraction patterns from the antrum and duodenum are used to calculate motility indices.
Delayed gastric emptying is implicated in such disorders as idiopathic and diabetic gastroparesis and functional non-ulcer dyspepsia.
Not for use in pediatric populations
The SmartPill GI Monitoring System senses and records pH and pressure measurements from the entire length of the gastrointestinal tract for use by physicians to evaluate patients with delayed gastric emptying. Sensors on board an ingestible capsule measure pH and pressure as the capsule travels the length of the GI tract. Measurements are transmitted from the capsule within the GI tract via ASK modulated RF signal at 434 MHz to a patient-worn Data Receiver and subsequently downloaded to PC for analysis and review. MotiliGI™ Software performs data analyses automatically and provides the physician with a printable report containing gastric emptying time, motility index, and total transit time.
The provided document is a 510(k) summary for the SmartPill GI Monitoring System (K053547). It outlines the device's intended use, comparison to predicate devices, and a high-level summary of performance testing. However, it does not provide specific acceptance criteria or detailed results of the study that proves the device meets those criteria.
Here's an analysis based on the available information, highlighting what is present and what is missing based on your request:
The SmartPill GI Monitoring System is indicated for evaluating patients with suspected delayed gastric emptying (gastroparesis). It measures pH, pressure, and temperature throughout the gastrointestinal tract to determine gastric emptying time (GET), total transit time (TTT), and combined small-large bowel transit time (SLBTT). It also uses pressure contraction patterns to calculate motility indices.
1. A table of acceptance criteria and the reported device performance
This information is not explicitly provided in the document. The "PERFORMANCE SUMMARY SAFETY TESTING" section states: "The SmartPill GI Monitoring System was tested in multiple bench tests to verify the accuracy and precision of the device. In addition, clinical testing was conducted to validate the device's indications for use. Results of these tests support the product's intended use, indications for use, performance and clinical claims."
However, specific quantitative acceptance criteria (e.g., "GET measurement must be within X% of a reference standard") and the corresponding performance achieved (e.g., "achieved Y% accuracy for GET") are not detailed.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document mentions "clinical testing was conducted to validate the device's indications for use" but does not specify the sample size for this clinical testing. It also does not mention the data provenance (e.g., country of origin) or whether the data was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not provided in the document. The method for establishing ground truth is not detailed, nor are the experts involved or their qualifications.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
The SmartPill GI Monitoring System is a diagnostic device that measures physiological parameters, not an AI-assisted diagnostic tool that humans interpret. Therefore, an MRMC comparative effectiveness study involving human readers with/without AI assistance is not applicable in this context and was not mentioned. The device's output (gastric emptying time, etc.) is reported to the physician, who then uses this information for evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is a "standalone" system in the sense that the capsule collects data and the "MotiliGI™ Software performs data analyses automatically and provides the physician with a printable report containing gastric emptying time, motility index, and total transit time." This implies an algorithm-only analysis of the collected data. The document states "clinical testing was conducted to validate the device's indications for use," which would assess the accuracy of these automated measurements against clinical reality, serving as a standalone performance evaluation. However, specific performance metrics are not reported.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The document states that the system's measurements "are used to determine gastric emptying time (GET), total transit time (TTT), and combined small-large bowel transit time (SLBTT)" and that "pressure contraction patterns from the antrum and duodenum are used to calculate motility indices." The clinical testing was done "to validate the device's indications for use" in evaluating "suspected delayed gastric emptying (gastroparesis)." This implies that the ground truth for validation would likely involve established diagnostic methods for delayed gastric emptying, potentially including gastric emptying scintigraphy (GES) or other recognized clinical assessments for gastroparesis. However, the specific type of ground truth used is not explicitly stated.
8. The sample size for the training set
The document does not provide any information about a "training set" or its sample size. This suggests that the device's algorithms were either developed based on established physiological principles and perhaps small internal validation, or this detail was not considered necessary for this 510(k) summary.
9. How the ground truth for the training set was established
Since no training set is mentioned, this information is not provided.
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with a more abstract and flowing design.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Ms. Kathleen H. Selover Director, Regulatory Affairs and Quality The SmartPill Corporation 847 Main Street Buffalo, New York 14203-1109
JAN 1 0 2017
Re: K053547
Trade/Device Name: SmartPill GI Monitoring System Regulation Number: 21 CFR 876.1725 Regulation Name: Gastrointestinal motility monitoring system Regulatory Class: II Product Code: NYV Dated: May 18, 2006 Received: May 18, 2006
Dear Ms. Selover:
This letter corrects our substantially equivalent letter of July 18, 2006.
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 Parts 801 and 809 ); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements
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Page 2 - Ms. Kathleen H. Selover
as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the as set form in and radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809] ), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Tou may of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Benjamin R. Fisher -S
Benjamin Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Response to FDA Request for Additional. Information FOR K053547 DATED March 24, 2006
5/17/2006
SECTION 16
Indications for Use Statement
510(k) Number, if known: K05354Z
Device Name: SmartPill GI Monitoring System
Indications for Use:
The SmartPill GI Monitoring System is indicated for use in evaluating patients with suspected delayed gastric emptying (gastroparesis).
The SmartPill GI Monitoring System measures pH, pressure and temperature The SmartPill Of Montoning System measurements are and masurements are throughout the gastromics time (GET), total transit time (GET), total transit time (TTT), and used to determine gastric emplying this (SLBTT). In addition, pressure Combined shaketarge bower cransit time (S) (S) (S) (S) (S) (S) (Calculate motility indices.
Delayed gastric emptying is implicated in such disorders as idiopathic and Detayed gastroparesis and functional non-ulcer dyspepsia.
Not for use in pediatric populations
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-the-Counter Use _
(Per 21CFR 801.109)
Doucuc hoadon
Division Sion-Off Division of Renmout ive. Ahdon and Radiological Devi
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JUL 1 8 2006
Page 1 of 3
510(k) Summary
.
:
| DATE OF SUMMARY: | July 7, 2006 |
|---|---|
| MANUFACTURER: | The SmartPill Corporation847 Main StreetBuffalo, NY 14203 |
| CONTACT INFORMATION: | Phone: 716.882.0701, ext. 106Fax: 716.882.0706 FaxEmail: kselover@smartpillcorp.com |
| CONTACT PERSON: | Kathleen H. SeloverDirector, Regulatory Affairs |
| DEVICE TRADE NAME: | SmartPill GI Monitoring System |
| DEVICE COMMON NAME: | Gastrointestinal pH and pressure monitoringequipment |
| CLASSIFICATION NAME,REGULATORY REFERENCEAND PRODUCT CODE | UnclassifiedProduct Code: 78 NYV |
| PREDICATE DEVICE(S) | • Heidelberg pH Capsule and the Heidelberg GoldMedallion Gastro-intestinal pH MeasurementSystem• Unisensor UniTip Gastrointestinal PressureCatheter |
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510(K) Summary K053547 Page 2 of 3 The SmartPill GI Monitoring System senses and Product records pH and pressure measurements from the DESCRIPTION entire length of the gastrointestinal tract for use by physicians to evaluate patients with delayed gastric emptying. Sensors on board an ingestible capsule measure pH and pressure as the capsule travels the length of the GI tract. Measurements are transmitted from the capsule within the GI tract via ASK modulated RF signal at 434 MHz to a patient-worn Data Receiver and subsequently downloaded to PC for analysis and review. MotiliGI™ Software performs data analyses automatically and provides the physician with a printable report containing gastric emptying time, motility index, and total transit time. The SmartPill GI Monitoring System is indicated for INTENDED USE INDICATIONS FOR USE use in evaluating patients with suspected delayed gastric emptying (gastroparesis). The SmartPill GI Monitoring System measures pH, pressure and temperature throughout the gastrointestinal tract. These physiological measurements are used to determine gastric emptying time (GET), total transit time (TTT), and combined small-large bowel transit time (SLBTT). In addition, pressure contraction patterns from the antrum and duodenum are used to calculate motility indices. Delaved gastric emptving is implicated in such disorders as idiopathic and diabetic gastroparesis and functional non-ulcer dyspepsia.
Not for use in pediatric populations
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510(K) Summary
K053547
Page 3 of 3
:
| PHYSICAL ANDTECHNICAL COMPARISONS | The SmartPill Gl Monitoring System, as it applies topH measurements, is the same as the intended use ofthe predicate, Heidelberg pH capsule and MonitoringSystem. Both devices use an ingestible capsulecapable of measuring pH throughout the Gl tract toprovide a continuous data stream of measured pHvalues.The device is technically comparable to UniSensorUniTop pressure catheter. Both use a solid statepiezo resistive pressure sensor for sensing pressure inthe gastrointestinal tract and transmit the sensedsignal to a receiving device. Display of contractilepatterns are similar. |
|---|---|
| PERFORMANCESUMMARYSAFETY TESTING | The SmartPill Gl Monitoring System was tested inmultiple bench tests to verify the accuracy andprecision of the device. In addition, clinical testingwas conducted to validate the device's indicationsfor use. Results of these tests support the product'sintended use, indications for use, performance andclinical claims. |
| BIOCOMPATIBILITY | All patient contacting materials were tested forbiocompatibility in accordance with ISO-10993, Part Ifor a surface device that contacts breached orcompromised surfaces for prolonged contact andplastic materials in accordance with USP <661>. |
| ELECTRICAL SAFETY | Electrical safety was conducted and found to meetthe requirements of IEC 60601-1 |
| ELECTROMAGNETICCOMPATIBILITY | EMC testing was tested and found to meet therequirements of IEC 60601-1-2 |
§ 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).