(87 days)
SmartPill GI Monitoring System and pH.p Capsule, version 1.2, Konsyl Sitzmarks
Not Found
No
The description focuses on sensing and recording physical parameters (pH, pressure, temperature) and performing automated data analysis to calculate transit times and motility indices. There is no mention of AI or ML algorithms being used for interpretation, diagnosis, or any other function beyond standard data processing.
No
This device is a diagnostic tool that measures gastrointestinal transit times to aid in evaluating motility disorders; it does not directly treat or alleviate a medical condition.
Yes
Explanation: The device measures transit times and other parameters (pH, pressure) within the GI tract to evaluate motility disorders. This information is used by physicians to aid in the diagnosis of conditions like gastroparesis and to differentiate types of constipation.
No
The device description clearly states that the system includes an ingestible capsule with sensors, a patient-worn Data Receiver, and a PC for analysis, indicating significant hardware components beyond just software.
Based on the provided information, the SmartPill GI Monitoring System is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the body. IVDs typically involve testing biological samples like blood, urine, tissue, or other bodily fluids outside of the body to diagnose or monitor conditions.
- The SmartPill operates within the body. The SmartPill is an ingestible capsule that measures parameters (pH, pressure, temperature) inside the gastrointestinal tract as it travels through. The data is transmitted wirelessly and analyzed externally, but the measurements themselves are taken in vivo.
The SmartPill is a medical device used for in vivo measurement and monitoring of physiological parameters within the GI tract to aid in the diagnosis and evaluation of motility disorders. This falls under the category of a diagnostic medical device, but not specifically an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The SmartPill GI Monitoring System measures whole gut and regional gut (stomach, small bowel, and colon) transit times. Measurements of gastrointestinal tract transit times are used for evaluating motility disorders.
Gastric transit time (gastric emptying time, GET) is indicated for the evaluation of patients with suspected gastroparesis. Delayed gastric emptying is implicated in such disorders as idiopathic and diabetic gastroparesis and functional non-ulcer dyspepsia
Colonic transit time (CTT) is indicated for the evaluation of colonic transit in patients with chronic constipation and used to aid in differentiating slow and normal transit constipation. Combined small and large bowel transit time (SLBTT) is used as a surrogate measure of colonic transit in patients with chronic constipation when colonic transit time alone cannot be determined.
The System measures pH, pressure, and temperature throughout the GI tract. Pressure contraction data from the antrum and duodenum can be used to calculate motility indices.
Not for use in pediatric patients.
Product codes (comma separated list FDA assigned to the subject device)
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 aid in the evaluation of gastrointestinal motility diseases and conditions. 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. MotiliGIT™ Software performs data analyses automatically and provides the physician with a printable report containing regional gut transit times: GET - Gastric emptying (transit) time SBTT - Small bowel transit time SLBTT - Combined small and large bowel transit time CTT - Colonic transit time WGTT - whole gut transit time
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
整個胃腸道
Indicated Patient Age Range
Not for use in pediatric patients.
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 performance of 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.
Two prospective clinical studies were performed with the device. The first study established cutoff values for colonic and combined small large bowel transit time and the second study validated the cutoff values in symptomatic constipated patients.
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.
SmartPill GI Monitoring System and pH.p Capsule, version 1.2, Konsyl Sitzmarks
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
Image /page/0/Picture/0 description: The image shows a partial logo on the left and the word "DEPARTMENT" on the right. The logo includes the words "HUMAN SERVICES-USA" arranged in a circular fashion. Below the word "DEPARTMENT" is a horizontal line.
DEPARTMENT OF HEALTH & HUMAN SERVICES
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: K092342
Trade/Device Name: SmartPill GI Monitoring System, Version 2.0 Regulation Number: 21 CFR 876.1725 Regulation Name: Gastrointestinal motility monitoring system Regulatory Class: II Product Code: NYV Dated: July 29, 2009 Received: August 4, 2009
Dear Ms. Selover:
This letter corrects our substantially equivalent letter of October 30, 2009.
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. Insting 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 electronic product 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/ReportalProblem/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 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.
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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SMARTPILL CORPORATION 510(K) SUBMISSION - SECTION 4 SMARTPILL GI MONITORING SYSTEM, VERSION 2.0
SECTION 4: INDICATIONS FOR USE STATEMENT
510(k) Number: not assigned
Device Name: SmartPill GI Monitoring System, version 2.0
Indications for Use:
The SmartPill GI Monitoring System measures whole gut and regional gut (stornach, small bowel, and colon) transit times. Measurements of gastrointestinal tract transit times are used for evaluating motility disorders.
Gastric transit time (gastric emptying time, GET) is indicated for the evaluation of patients with suspected gastroparesis. Delayed gastric emptying is implicated in such disorders as idiopathic and diabetic gastroparesis and functional non-ulcer dyspepsia
Colonic transit time (CIT) is indicated for the evaluation of colonic transit in patients with chronic constipation and used to aid in differentiating slow and normal transit constipation. Combined small and large bowel transit time (SLBTT) is used as a surrogate measure of colonic transit in patients with chronic constipation when colonic transit time alone cannot be determined.
The System measures pH, pressure, and temperature throughout the GI tract. Pressure contraction data from the antrum and duodenum can be used to calculate motility indices.
Not for use in pediatric patients.
X Prescription Use
OR
(Per 21CFR 801.109) Over-the-Counter Use _
Concurrence of CDRH, Office of Device Evaluation (ODE)
thom N. Vta
Division of Reproductive. Abdomi and Radiological Devi
Radiological Devices,
510(k) Number K092342
3
510(k) Submission, Section 5
Page 1 of 3
K092342
SMARTPILL CORPORATION 510(K) SUBMISSION - SECTION 5 SMARTPILL GI MONITORING SYSTEM, VERSION 2.0
SECTION 5: 510(K) SUMMARY
Date of Summary:
OCT 9 2008
| 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
Vice President, Regulatory Affairs and Quality
Assurance |
| Device Trade Name: | SmartPill GI Monitoring System, version 2.0 |
| Device Common Name: | Gastrointestinal Motility System, Capsule |
| Trade/Device Name
Regulatory Class Regulation
Number
Product code
Predicate Device(s) | SmartPill GI Monitoring System, version 2.0
Unclassified
None
NYV
SmartPill GI Monitoring System and pH.p Capsule,
version 1.2
Konsyl Sitzmarks |
| Product
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 aid in the
evaluation of gastrointestinal motility diseases and conditions.
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. MotiliGIT™ Software performs data
analyses automatically and provides the physician with a
printable report containing regional gut transit times:
GET - Gastric emptying (transit) time
SBTT - Small bowel transit time
SLBTT - Combined small and large bowel transit time
CTT - Colonic transit time
WGTT - whole gut transit time |
| Intended Use
Indications for Use | The SmartPill GI Monitoring System measures whole gut and
regional gut (stomach, small bowel, and colon) transit times.
Measurements of gastrointestinal tract transit times are used
for evaluating motility disorders.
Gastric transit time (gastric emptying time, GET) is indicated
for the evaluation of patients with suspected gastroparesis.
Delayed gastric emptying is implicated in such disorders as
idiopathic and diabetic gastroparesis and functional non-ulcer
dyspepsia
Colonic transit time (CTT) is indicated for the evaluation of
colonic transit in patients with chronic constipation and used
to aid in differentiating slow and normal transit constipation.
Combined small and large bowel transit time (SLBTT) is used
as a surrogate measure of colonic transit in patients with
chronic constipation when colonic transit time alone cannot
be determined.
The System measures pH, pressure, and temperature
throughout the GI tract. Pressure contraction data from the
antrum and duodenum can be used to calculate motility
indices.
Not for use in pediatric patients. |
| Physical and
Technical Comparisons | Comparison to SmartPill GI Monitoring System: Version 2.0 of the
system is similar to Version 1.1; differences include an
enhanced user interface for reviewing and analyzing the test
and an expanded indications for use. Technical features of the
two devices are, the same.
Comparison to Sitzmarks: Version 2.0 of the system is technically
different from Sitzmarks, however, the two devices share the
indication for use of measuring and using colonic transit time
to evaluate patients with chronic (severe) constipation. |
| Performance
Summary | The performance of 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. |
| Safety Testing | |
| 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 . Results of biocompatibility
testing indicate that patient contacting materials are non-
sensitizing, non-toxic, and non-irritating when used as
directed. |
| Electrical Safety | Electrical safety was conducted and the system found to meet
the requirements of IEC 60601-1 |
| Electromagnetic
Compatibility
Clinical Performance
Testing | EMC testing was tested and the system found to meet the requirements of IEC 60601-1-2 Two prospective clinical studies were performed with the device. The first study established cutoff values for colonic and combined small large bowel transit time and the second study validated the cutoff values in symptomatic constipated patients. |
SmartPill GI Monitoring System and pH.p Capsule, version 2.0 is substantially equivalent to SmartPill GI Monitoring System, version 1.2 and Konsyl Sirzmarks.
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