SMARTPILL GI MONITORING SYSTEM

K053547 · The Smartpill Corporation · NYV · Jul 18, 2006 · Gastroenterology, Urology

Device Facts

• Record ID: K053547
• Device Name: SMARTPILL GI MONITORING SYSTEM
• Applicant: The Smartpill Corporation
• Product Code: NYV · Gastroenterology, Urology
• Decision Date: Jul 18, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1725
• Device Class: Class 2

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

Device Story

Ingestible capsule measures pH, pressure, and temperature throughout GI tract; transmits data via 434 MHz ASK modulated RF signal to patient-worn Data Receiver; data downloaded to PC for analysis. MotiliGI software performs automated analysis; generates printable report for physician review. Used in clinical settings; physician interprets output to assess gastric emptying time, total transit time, small-large bowel transit time, and motility indices. Assists in diagnosing gastroparesis and functional non-ulcer dyspepsia; provides objective physiological data to guide clinical management.

Clinical Evidence

Clinical testing conducted to validate indications for use; bench testing performed to verify accuracy and precision. Biocompatibility tested per ISO-10993 and USP <661>. Electrical safety verified per IEC 60601-1; EMC verified per IEC 60601-1-2. Results support intended use and clinical claims.

Technological Characteristics

Ingestible capsule with solid-state piezo-resistive pressure sensor, pH sensor, and temperature sensor. RF transmission at 434 MHz (ASK modulation). Patient-worn receiver; PC-based analysis software. Biocompatibility per ISO-10993 and USP <661>. Electrical safety per IEC 60601-1; EMC per IEC 60601-1-2.

Indications for Use

Indicated for patients with suspected delayed gastric emptying (gastroparesis), including idiopathic and diabetic gastroparesis and functional non-ulcer dyspepsia. Not for use in pediatric populations.

Regulatory Classification

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.

Predicate Devices

• Heidelberg pH Capsule and the Heidelberg Gold Medallion Gastro-intestinal pH Measurement System
• Unisensor UniTip Gastrointestinal Pressure Catheter

Submission Summary (Full Text)

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## 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 [phone] or [phone] 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 [phone] or [phone] 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 Corporation<br>847 Main Street<br>Buffalo, NY 14203 |
| CONTACT INFORMATION: | Phone: [phone], ext. 106<br>Fax: [phone] Fax<br>Email: [e-mail] |
| CONTACT PERSON: | Kathleen H. Selover<br>Director, Regulatory Affairs |
| DEVICE TRADE NAME: | SmartPill GI Monitoring System |
| DEVICE COMMON NAME: | Gastrointestinal pH and pressure monitoring<br>equipment |
| CLASSIFICATION NAME,<br>REGULATORY REFERENCE<br>AND PRODUCT CODE | Unclassified<br>Product Code: 78 NYV |
| PREDICATE DEVICE(S) | • Heidelberg pH Capsule and the Heidelberg Gold<br>Medallion Gastro-intestinal pH Measurement<br>System<br>• Unisensor UniTip Gastrointestinal Pressure<br>Catheter |

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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 AND<br>TECHNICAL COMPARISONS | The SmartPill Gl Monitoring System, as it applies to<br>pH measurements, is the same as the intended use of<br>the predicate, Heidelberg pH capsule and Monitoring<br>System. Both devices use an ingestible capsule<br>capable of measuring pH throughout the Gl tract to<br>provide a continuous data stream of measured pH<br>values.<br><br>The device is technically comparable to UniSensor<br>UniTop pressure catheter. Both use a solid state<br>piezo resistive pressure sensor for sensing pressure in<br>the gastrointestinal tract and transmit the sensed<br>signal to a receiving device. Display of contractile<br>patterns are similar. |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| PERFORMANCE<br>SUMMARY<br>SAFETY TESTING | The SmartPill Gl Monitoring System was tested in<br>multiple bench tests to verify the accuracy and<br>precision of the device. In addition, clinical testing<br>was conducted to validate the device's indications<br>for use. Results of these tests support the product's<br>intended use, indications for use, performance and<br>clinical claims. |
| BIOCOMPATIBILITY | All patient contacting materials were tested for<br>biocompatibility in accordance with ISO-10993, Part I<br>for a surface device that contacts breached or<br>compromised surfaces for prolonged contact and<br>plastic materials in accordance with USP <661>. |
| ELECTRICAL SAFETY | Electrical safety was conducted and found to meet<br>the requirements of IEC 60601-1 |
| ELECTROMAGNETIC<br>COMPATIBILITY | EMC testing was tested and found to meet the<br>requirements of IEC 60601-1-2 |