PHTIP DISPOSABLE ISFET CATHETER

K102801 · E-Cath Co., Ltd. · FFX · Oct 26, 2010 · Gastroenterology, Urology

Device Facts

• Record ID: K102801
• Device Name: PHTIP DISPOSABLE ISFET CATHETER
• Applicant: E-Cath Co., Ltd.
• Product Code: FFX · Gastroenterology, Urology
• Decision Date: Oct 26, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1725
• Device Class: Class 2

Intended Use

The pHTip™ Disposable ISFET Catheter is a device used to measure intragastric and intraesophageal pH activity in the stomach or esophagus, by means of a flexible lead with ISFET pH electrodes that is introduced through the nose into the gastrointestinal tract. It is intended especially for gastro esophageal testing for the severity of acid reflux events. The device may include conductive rings for impedance studies, and may also include signal conditioning and amplifying equipment.

Device Story

The pHTip Disposable ISFET Catheter is a flexible probe inserted nasally into the gastrointestinal tract to measure pH activity in the stomach or esophagus. It utilizes ISFET (Ion-Sensitive Field-Effect Transistor) transducers to detect pH levels and may include conductive rings for impedance studies. The device connects to signal conditioning and amplifying equipment to process the signals. It is intended for use by trained healthcare personnel to assess the severity of acid reflux events. The output allows clinicians to evaluate gastroesophageal acid exposure, aiding in the diagnosis and management of reflux-related conditions.

Clinical Evidence

No clinical data was conducted or relied upon for this submission. Evidence consists of non-clinical bench testing, including functional validation under simulated use conditions, biocompatibility testing (ISO 10993-1), and EMC compliance (IEC 60601-1-2 + A1).

Technological Characteristics

Disposable catheter featuring ISFET pH electrodes and optional conductive rings for impedance monitoring. Includes signal conditioning and amplification components. Biocompatibility per ISO 10993-1; EMC compliance per IEC 60601-1-2 + A1.

Indications for Use

Indicated for patients requiring intragastric and intraesophageal pH monitoring to assess the severity of acid reflux events. Used via nasal insertion into the gastrointestinal tract.

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

• UniTip Pressure Sensor Catheter (K003580)
• High resolution GI catheter (K062222)

Submission Summary (Full Text)

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510(k) Number: _ Klo28C/

Date:

Page 1 of 2

# 510(k) Summary

#### Introduction

OCT 2 6 2010

This summary is intended to comply with requirements of the SMDA and 21CFR§807.92. FDA may make this summary available to the public within 30 days following a finding of substantial equivalence.

#### 510(k) Applicant

E-Cath Co. Ltd. Room 810, 8F, Argyle Center 688, Nathan Road Mong Kok, Hong Kong, China

# 510(k) Correspondent

Robert N. Clark, President and Senior Consultant Medical Device Regulatory Advisors, Inc. 4251 Kipling Street, Suite 565, Wheat Ridge, CO 80033 USA Tel: [phone] / Fax: [phone]

# Date Prepared

September 3, 2010

#### Trade Name of Device

pHTip Disposable ISFET Catheter

#### Classification Name

Gastrointestinal motility monitoring system

# 510(k) Classification

FDA Class II - FFX - Regulation 876.1725

#### Predicate Devices

- K003580 Unisensor AG. UniTip Pressure Sensor Catheter .
- K062222 Unisensor AG, High resolution GI catheter .

# Device Description and Intended Use

The pHTIP Disposable ISFET Catheter is a device used to measure pH activity in the stomach or esophagus by means of a probe with transducers, which is introduced through the nose into the gastrointestinal tract, and is intended especially for gastro esophageal testing for the severity of

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510(k) Number: _ K 102 80/

Date:

Page 2 of 2

acid reflux events. The device may include conductive rings for impedance studies, and may also include signal conditioning and amplifying equipment.

# Clinical and Non-Clinical Testing

E-cath Co. Ltd did not conduct, nor rely upon, clinical tests to determine substantial equivalence. Non-clinical bench testing was performed in order to validate the design against the company's specified design requirements.

# Biocompatibility

Biocompatibility testing was successfully completed on patient contacting materials according to standard ISO 10993-1.

# EMC Compliance

EMC compliance of the pHTip Disposable ISFET Catheter was successfully completed according to standard IEC 60601-1-2 + A1.

#### Functional Testing

Functionality of the pHTip Disposable ISFET Catheter was validated under simulated use conditions.

# Risk Management

This device has been designed to either completely eliminate or mitigate 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.

#### Substantial Equivalence

Based on the above, e-cath Co. Ltd. believes that the pHTip Disposable ISFET Catheter product is safe and effective when used as instructed by knowledgeable and trained personnel, and is substantially equivalent to the legally marketed predicate devices.

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Image /page/2/Picture/1 description: The image shows a logo for the Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission of promoting health, well-being, and human services. The text "DEPARTMENT OF HEALTH & HU..." is arranged in a circular fashion around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G60 Silver Spring, MD 20993-0002

E-Cath Co., Ltd. c/o Mr. Robert N. Clark President & Senior Consultant Medical Device Regulatory Advisors, Inc. 13605 West 7th Avenue GOLDEN CO 80401

OCT 2 5 2010

Re: K102801

> Trade/Device Name: pHTip™ Disposable ISFET Catheter Regulation Number: 21 CFR §876.1725

Regulation Name: Gastrointestinal motility monitoring system

Regulatory Class: II

Product Code: FFX and FFT

Dated: September 21, 2010

Received: September 27, 2010

#### Dear Mr. Clark:

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 Part 801); medical device reporting of medical device-related

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adverse events) (21 CFR 803); good manufacturing practice requirements 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 Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm161482.htm

Sincerely yours,

Hubert Lemmer MD

Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

OCT 2 6 2010

| 510(k) Number (if known): | K102801 |
|---------------------------|----------------------------------|
| Device Name: | pHTip™ Disposable ISFET Catheter |

Indications for Use:

The pHTip™ Disposable ISFET Catheter is a device used to measure intragastric and intraesophageal pH activity in the stomach or esophagus, by means of a flexible lead with ISFET pH electrodes that is introduced through the nose into the gastrointestinal tract. It is intended especially for gastro esophageal testing for the severity of acid reflux events. The device may include conductive rings for impedance studies, and may also include signal conditioning and amplifying equipment.

| Prescription Use<br>(Part 21 CFR 801 Subpart D) | X |
|-------------------------------------------------|---|
|-------------------------------------------------|---|

AND/OR

| Over-The-Counter Use<br>(21 CFR 801 Subpart C) | |
|------------------------------------------------|--|
|------------------------------------------------|--|

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Reproductive, Gastro-Renal, and Urological Devices

| 510(k) Number | K102801 |
|---------------|---------|
|---------------|---------|