(29 days)
Not Found
No
The description focuses on the physical device, its function (measuring pH and potentially impedance), and signal conditioning. There is no mention of data analysis, interpretation, or any algorithms that would suggest AI/ML is being used. The performance studies section also only mentions bench testing, not clinical studies that might involve complex data analysis.
No
The device is used to measure pH activity for diagnostic purposes, specifically for gastroesophageal testing to determine the severity of acid reflux events, rather than to treat a condition.
Yes
The device is used to measure intragastric and intraesophageal pH activity and severity of acid reflux events, which are diagnostic indicators for gastroesophageal issues.
No
The device description explicitly mentions hardware components such as a flexible lead with ISFET pH electrodes, conductive rings for impedance studies, and signal conditioning and amplifying equipment. This indicates it is a physical medical device with integrated hardware, not a software-only device.
Based on the provided information, the pHTip™ Disposable ISFET Catheter is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The pHTip™ device is introduced directly into the gastrointestinal tract to measure pH in situ (within the body). It does not analyze a sample taken from the body.
- The intended use describes direct measurement within the stomach or esophagus. This is an in vivo measurement, not an in vitro (in glass/outside the body) measurement.
Therefore, the device falls outside the definition of an IVD.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
FFX and FFT
Device Description
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 acid reflux events. The device may include conductive rings for impedance studies, and may also include signal conditioning and amplifying equipment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
stomach or esophagus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
knowledgeable and trained personnel
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)
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.
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.
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
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: +1 (303) 463-0900 / Fax: +1 (303) 558-3833
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
1
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.
2
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
3
Page 2
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 (800) 638-2041 or (301) 796-7100 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
4
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
| (Part 21 CFR 801 Subpart D) | X |
|---|---|
| ------------------------------------------------- | --- |
AND/OR
| Over-The-Counter Use
| (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 |
|---|---|
| --------------- | --------- |