(210 days)
Not Found
No
The description focuses on sensing and recording physiological measurements (pH, pressure, temperature) and performing automatic data analysis to calculate specific metrics (gastric emptying time, motility index, total transit time). There is no mention of AI, ML, or related concepts in the provided text.
No
The device measures physiological parameters to aid in diagnosis, rather than directly treating a condition.
Yes
The device is indicated for use in evaluating patients with suspected delayed gastric emptying and measures physiological parameters to determine various transit times and motility indices, which are used to aid in the diagnosis of certain disorders.
No
The device description clearly states that the system includes an ingestible capsule with sensors and a patient-worn Data Receiver, which are hardware components.
Based on the provided information, the SmartPill GI Monitoring System is an In Vitro Diagnostic (IVD) device.
Here's why:
- It measures physiological parameters (pH, pressure, temperature) from within the body. While the measurements are taken in vivo (inside the body), the analysis and interpretation of these measurements to determine conditions like gastric emptying time and motility indices are performed in vitro (outside the body) using the MotiliGI™ Software.
- It is used to evaluate a patient's condition (suspected delayed gastric emptying). The system provides data that physicians use to diagnose or assess a specific medical condition.
- The analysis of the data is performed on a PC using software. This is a key characteristic of many IVD devices, where a sample (in this case, the recorded physiological data) is analyzed outside the body to provide diagnostic information.
While the capsule is ingested and takes measurements internally, the diagnostic value comes from the analysis of the collected data, which happens externally. This aligns with the definition of an IVD device, which is used to examine specimens derived from the human body to provide information for diagnostic purposes. In this case, the "specimen" is the collected physiological data.
N/A
Intended Use / 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 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
Product codes
NYV
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Gastrointestinal tract
Indicated Patient Age Range
Not for use in pediatric populations
Intended User / Care Setting
Physicians
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
• Heidelberg pH Capsule and the Heidelberg Gold Medallion Gastro-intestinal pH Measurement System, • Unisensor UniTip Gastrointestinal Pressure Catheter
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/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
1
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
2
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
3
JUL 1 8 2006
Page 1 of 3
510(k) Summary
.
:
| DATE OF SUMMARY: | July 7, 2006 |
|---|---|
| MANUFACTURER: | The SmartPill Corporation |
| 847 Main Street | |
| Buffalo, NY 14203 | |
| CONTACT INFORMATION: | Phone: 716.882.0701, ext. 106 |
| Fax: 716.882.0706 Fax | |
| Email: kselover@smartpillcorp.com | |
| CONTACT PERSON: | Kathleen H. Selover |
| Director, Regulatory Affairs | |
| DEVICE TRADE NAME: | SmartPill GI Monitoring System |
| DEVICE COMMON NAME: | Gastrointestinal pH and pressure monitoring |
| equipment | |
| CLASSIFICATION NAME, | |
| REGULATORY REFERENCE | |
| AND PRODUCT CODE | Unclassified |
| Product Code: 78 NYV | |
| PREDICATE DEVICE(S) | • Heidelberg pH Capsule and the Heidelberg Gold |
| Medallion Gastro-intestinal pH Measurement | |
| System | |
| • Unisensor UniTip Gastrointestinal Pressure | |
| Catheter |
4
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
5
510(K) Summary
K053547
Page 3 of 3
:
| PHYSICAL AND
TECHNICAL COMPARISONS | The SmartPill Gl Monitoring System, as it applies to
pH measurements, is the same as the intended use of
the predicate, Heidelberg pH capsule and Monitoring
System. Both devices use an ingestible capsule
capable of measuring pH throughout the Gl tract to
provide a continuous data stream of measured pH
values.
The device is technically comparable to UniSensor
UniTop pressure catheter. Both use a solid state
piezo resistive pressure sensor for sensing pressure in
the gastrointestinal tract and transmit the sensed
signal to a receiving device. Display of contractile
patterns are similar. |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| PERFORMANCE
SUMMARY
SAFETY TESTING | The SmartPill Gl 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. |
| BIOCOMPATIBILITY | All patient contacting materials were tested for
biocompatibility in accordance with ISO-10993, Part I
for a surface device that contacts breached or
compromised surfaces for prolonged contact and
plastic materials in accordance with USP . |
| ELECTRICAL SAFETY | Electrical safety was conducted and found to meet
the requirements of IEC 60601-1 |
| ELECTROMAGNETIC
COMPATIBILITY | EMC testing was tested and found to meet the
requirements of IEC 60601-1-2 |