(29 days)
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.
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.
The provided 510(k) summary for the pHTip™ Disposable ISFET Catheter states that no clinical tests were conducted or relied upon to determine substantial equivalence. Instead, non-clinical bench testing was performed to validate the design against the company's specified design requirements. This means the information requested about acceptance criteria and study details tied to human clinical performance will not be available in this document.
Here's the information explicitly stated or inferred from the document:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of specific acceptance criteria or quantitative performance metrics from the non-clinical bench testing. It broadly states that "Non-clinical bench testing was performed in order to validate the design against the company's specified design requirements" and "Functionality of the pHTip Disposable ISFET Catheter was validated under simulated use conditions."
Therefore, we cannot populate this table with specific values.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
Not applicable, as no clinical studies were performed. The non-clinical bench testing details (sample size, data provenance) are not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable, as no clinical studies were performed and thus no ground truth established by experts in a clinical context. For non-clinical bench testing, the "ground truth" would likely be based on calibrated reference measurements, but details are not provided.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable, as no clinical studies were performed requiring adjudication of expert interpretations.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable, as this is solely a medical device for measuring pH, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This refers to the device itself as a standalone measurement tool. The document implies that the device's functionality was tested in stand-alone mode during non-clinical bench testing, but no specific performance metrics are provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical bench testing, the "ground truth" for pH measurements would typically be established by calibrated reference solutions or systems. However, the document does not explicitly state this.
8. The sample size for the training set
Not applicable, as this device primarily relies on physical and chemical principles for measurement, not an AI model requiring a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no AI model or training set mentioned for this device.
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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: +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
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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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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
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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(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 |
|---|---|
| --------------- | --------- |
§ 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).