The catheter probe is used to obtain a high resolution mapping of peristaltic activity or pressure within the organs of the gastrointestinal tract, and to allow storage of the corresponding data.

The device is manufactured in the basic model variations listed below:

High Resolution Gastrointestinal Catheter with up to 40 pressure sensors:
This model variation is intended for simple direct esophageal pressure, either at, above, or below the specific site of interest. Pressure information is provided at multiple sensor sites. Pressures may be measured continuously, at rest, or dynamically.
Gastrointestinal catheter, with pH sensors:
This model variation is the same as the High Resolution Gastrointestinal (GI) catheter described above, except that this model variation includes up to 7 pH sensors. PH probes are added to allow measurements of pH in the stomach and/or esophagus.
Gastrointestinal catheter, with sleeve:
This model variation is the same as the High Resolution Gastrointestinal (GI) catheter described above, except one or more of the pressure sensor sites will include a sleeve. The sleeve is added to broaden the pressure sensitive one for the sensor site, and reduce positioning sensitivity.
Gastrointestinal catheter, with impedance rings:
This model variation is the same as the High Resolution Gastrointestinal (GI) catheter described above, except it includes up to 14 conductive rings for impedance studies.
Gastrointestinal catheter, with lumen
This model variation is the same as the High Resolution Gastrointestinal (GI) catheter described above, except it includes a lumen.

Device Description

The Unisensor UniTip Gastrointestinal Pressure Sensor Catheter product line consists of multiple ultra-miniature solid-state pressure sensors, located at the distal end of a gastrointestinal catheter. pH sensors, silicon rubber sleeves, lumen, and conductive impedance rings, may also be included. There are scanning electronics for multiplexing the sensor signals, and an electrical connection located at the proximal end to carry the sensor element signals to an external gastrointestinal motility recording equipment. The UniTip GI catheters are produced in various lengths and catheter sizes.

This modification consists of increasing the maximum number of pressure sensor elements to 40. The closer proximity of the pressure sensor elements to each other allows for high-resolution mapping of pressures within the organs of the human gastrointestinal tract. This modification also increases the maximum number of pH sensors to 7, and the maximum number of impedence rings to 14.

AI/ML Overview

This 510(k) summary explicitly states that no clinical studies were conducted or relied upon to establish substantial equivalence for the Unisensor UniTip High Resolution GI Catheter. Therefore, the device's acceptance criteria and the study proving it meets them cannot be described in terms of a clinical performance study.

Instead, substantial equivalence was established based on bench testing, design comparisons, and adherence to recognized standards, primarily in the areas of biocompatibility and risk management.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Since no clinical performance study was conducted, direct acceptance criteria in terms of performance metrics (like sensitivity, specificity, accuracy) are not available from this document. The "acceptance criteria" here refer to the demonstration of safety and effectiveness through non-clinical means and similarity to predicate devices.

Acceptance Criterion (Implied)	Reported Device Performance/Evidence
Biocompatibility	Meets ISO 10993-1: The device's materials and design are evaluated to ensure biological compatibility, adhering to EN 30993-1/ISO 10993-1, "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing." This implies that the device is not expected to cause adverse biological reactions when in contact with the human body.
Risk Management	Health hazards eliminated or mitigated: A rigorous risk management program was applied during design to eliminate or mitigate known health hazards associated with device use. This means potential risks (e.g., electrical, mechanical, material-related) were identified and addressed.
Functional Equivalence to Predicate Devices	Increased sensor capabilities: The primary modification (increase to 40 pressure sensors, 7 pH sensors, 14 impedance rings) enhances functionality while maintaining the same fundamental principles of operation as the predicate devices (Unisensor AG, UniTip Pressure Sensor Catheter K003580 and Sierra Scientific Instruments, Inc., Motility Visualization System K031169). This suggests the core pressure sensing technology remains equivalent.
Intended Use Consistency	Same intended use as predicates: The device's intended use remains consistent with the predicate devices – obtaining high-resolution mapping of peristaltic activity/pressure and pH/impedance within the GI tract. The increased sensor count provides "high-resolution mapping" which is an enhancement to the existing known functionality.
Adherence to General Controls & Regulatory Requirements	Compliance with 21 CFR 807.92: The submission is intended to comply with requirements for 510(k) summaries. The FDA's letter confirms substantial equivalence, allowing marketing subject to general controls (e.g., annual registration, GMP, labeling, advertising prohibitions).

2. Sample size used for the test set and the data provenance

Sample Size: Not applicable. No clinical test set data was used or provided in the submission for performance evaluation.
Data Provenance: Not applicable. No clinical data origin (country, retrospective/prospective) is relevant as no clinical study was performed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No clinical test set and thus no ground truth derived from expert consensus were used to establish substantial equivalence.

4. Adjudication method for the test set

Not applicable. No clinical test set was used for performance evaluation, so no adjudication method was employed.

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. The device is a "Gastrointestinal motility monitoring system" with physical sensors and electronics. It is not an AI-powered diagnostic imaging device that involves human readers interpreting results. Therefore, an MRMC study or AI assistance is not relevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This device is a sensor catheter system, not a standalone algorithm. Its function is to collect data, which is then interpreted by medical personnel using external recording equipment.

7. The type of ground truth used

Not applicable for a clinical performance evaluation. The "ground truth" for the device's efficacy is established through its physical function and robust engineering/bench testing validating its ability to accurately measure pressure, pH, and impedance, and its similarity to predicate devices that have established clinical utility. Biocompatibility standards serve as a "ground truth" for safety.

8. The sample size for the training set

Not applicable. This is a physical sensor device, not an AI/machine learning algorithm requiring a training set.

9. How the ground truth for the training set was established

Not applicable. As no training set was used, no ground truth needed to be established for it.

Summary

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510(k) Number: K0622222 Date: Page 1 of 2

510(k) Summary

MAR 1 5 2007

Introduction

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 & Holder

Unisensor AG Bahnstrasse 12a Attikon CH-8544 Switzerland

510(k) Correspondent

Robert N. Clark, President and Senior Consultant Medical Device Regulatory Advisors 13605 West 7th Ave., Golden, CO USA Tel: 303-234-9412 / Fax: 303-234-9413

Date Prepared

July 19, 2006

Proprietary Name of Device

UniTip High Resolution GI Catheter

Classification Name

Gastrointestinal motility monitoring system

510(k) Classification

Class II FFX

Device Description and Intended Use

This modification consists of increasing the maximum number of pressure sensor elements to 40. The closer proximity of the pressure sensor elements to each other allows for high-resolution

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510(k) Number: K0622222 Date: Date: Date: Date: Page 2 of 2

mapping of pressures within the organs of the human gastrointestinal tract. This modification also increases the maximum number of pH sensors to 7, and the maximum number of impedence rings to 14.

Predicate Devices

Unisensor AG, UniTip Pressure Sensor Catheter K003580

Sierra Scientific Instruments, Inc., Motility Visualization System K031169

Biocompatibility

The requirements of the following standards have been used in part to establish substantial equivalence:

EN 30993-1/ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing"

The company did not conduct, nor depend on, clinical studies in order to establish substantial equivalence.

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.

Unisensor AG believes that the UniTip High Resolution GI Catheter 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/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing the wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

AR 1 5 2007

Unisensor AG c/o Mr. Robert N. Clark Medical Device Regulatory Advisors 13605 West 7" Avenue GOLDEN CO 80401

Re: K062222

Trade/Device Name: Unitip High Resolution Catheter Regulation Number: 21 CFR §876.1725 Regulation Name: Gastrointestinal motility monitoring system Regulatory Class: II Product Code: FFX Dated: February 22, 2007 Received: February 26, 2007

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 indivious 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 Coometic 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 greeral controls provisions of the Act include requirements for annual registration, listing of devines, good manufacturing practice, labeling, and prohibitions against misbranding and adulter of on.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 899. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Image /page/2/Picture/10 description: The image is a circular logo or seal. The text "1906-2006" is at the top of the logo. The letters "FDA" are in the center of the logo, and the word "Centennial" is below the letters. The text around the edge of the circle is difficult to read.

Protecting and Promoting Public Health

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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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): _________________

Device Name:

Indications for Use:

The catheter probe is used to obtain a high resolution mapping of peristaltic activity or pressure within the organs of the gastrointestinal tract, and to allow storage of the corresponding data.

The device is manufactured in the basic model variations listed below:

1. High Resolution Gastrointestinal Catheter with up to 40 pressure sensors:
  This model variation is intended for simple direct esophageal pressure, either at, above, or below the specific site of interest. Pressure information is provided at multiple sensor sites. Pressures may be measured continuously, at rest, or dynamically.
1. Gastrointestinal catheter, with pH sensors:
  This model variation is the same as the High Resolution Gastrointestinal (GI) catheter described above, except that this model variation includes up to 7 pH sensors. PH probes are added to allow measurements of pH in the stomach and/or esophagus.

Over-The-Counter Use Prescription Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David h. Ingram

Division of Reproductive, Abdominal 510k) Num

l of 2

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1. Gastrointestinal catheter, with sleeve:
  This model variation is the same as the High Resolution Gastrointestinal (GI) catheter described above, except one or more of the pressure sensor sites will include a sleeve. The sleeve is added to broaden the pressure sensitive one for the sensor site, and reduce positioning sensitivity.
1. Gastrointestinal catheter, with impedance rings:
  This model variation is the same as the High Resolution Gastrointestinal (GI) catheter described above, except it includes up to 14 conductive rings for impedance studies.
1. Gastrointestinal catheter, with lumen
  This model variation is the same as the High Resolution Gastrointestinal (GI) catheter described above, except it includes a lumen.

Regulation Number and Section

§ 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).