The Mediplus Single Use GI Manometry Catheter is intended for water-perfused manometry of the GI tract. The Mediplus Single Use & Manometry Catheter is inducation for use when measurements of gastrointestinal tract pressures are needed for the diagnosis of suspected gastrointestinal disonders : - Investigation of gastrantestinal diseases - motility dison - Swallowing disorders - Refury disorders - Gastric and intestine disorders - Coloniec and anorectal disorders

Device Description

Mediblus GI Motility Manometric Catheters are design for the monitoring of gastrointestinal pressure. They are designed to be used with a manometric infusion pump. The major structure of the Mediplus Manometric Catheter is a multi-lumen PVC tube. The catheters are designed with variations of the configuration of the channels (depending on the model and application). The catheter facilitates the measurement of pressure at a fixed number of points along the upper gastro-intestinal tract when correctly installed to water perfusion manometry transducer equipment. Measurement is accomplished by perfusion of water through each catheter lumen. Each column of water transmits pressure to a transducer. The equipment terminates in a pressure transducer and 3-way tap.

AI/ML Overview

The provided text is a 510(k) Premarket Notification for a Mediplus Single Use GI Manometry Catheter. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria based on performance metrics like accuracy, sensitivity, or specificity of a diagnostic algorithm.

Therefore, much of the requested information regarding acceptance criteria, reported performance, sample sizes, expert involvement, and ground truth for a diagnostic AI device is not applicable to this submission. This is a medical device, specifically a catheter, not an AI or diagnostic algorithm, and its approval relies on demonstrating that it is as safe and effective as legally marketed predicate devices, not on specific performance metrics established through clinical studies in the same way an AI diagnostic would be.

Here's an analysis based on the provided document:

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: The primary "acceptance criterion" for this 510(k) submission is substantial equivalence to existing legally marketed predicate devices. This means that the device must be as safe and effective as a predicate device, and it must have the same intended use and technological characteristics, or if there are differences, those differences must not raise new questions of safety or effectiveness.
- The document explicitly states: "The Mediplus GI Monitoring Catheter is technologically equivalent to both predicate devices in design and physical characteristics. Like the Arndorfer catheter, it is made of PVC, which has been used historically for intubations."
- It also states: "The Mediplus GI Manometry Catheter has been tested for biocompatibility and meets the requirements of ISO 10993 and USFDA 510(k) Memorandum - # K95-1for the intended use of the device."
Reported Device Performance: The document does not provide quantitative performance metrics (e.g., accuracy, sensitivity, specificity, or precision of pressure measurements) in the way a diagnostic algorithm would. Instead, its "performance" is demonstrated by its inherent properties and by showing it meets safety standards equivalent to predicate devices.
- Biocompatibility: Meets ISO 10993 and USFDA 510(k) Memorandum - # K95-1.
- Material: Made of PVC, "which has been used historically for intubations" (implying established safety and effectiveness).
- Function: Designed for "monitoring of gastrointestinal pressure" by transmitting pressure via water perfusion to a transducer. The functional performance is implicitly considered equivalent to the predicate devices.

2. Sample Size Used for the Test Set and Data Provenance:

Not applicable. This submission does not involve a "test set" of diagnostic data for performance evaluation in the context of an algorithm. The evaluation is based on device design, materials, and safety testing on the device itself, not on patient data for diagnostic accuracy.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Not applicable. As there is no test set of diagnostic data, there are no experts establishing ground truth in this context. The "ground truth" here relates to the safety and functional equivalence of the device, which is evaluated by the FDA based on the manufacturer's submission and predicate device comparison.

4. Adjudication Method for the Test Set:

Not applicable. No test set or expert adjudication process is detailed in this type of 510(k) submission for a physical medical device.

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. This is a physical medical device (catheter) and does not involve AI or human readers for diagnostic interpretation. Such a study would be relevant for an AI-powered diagnostic tool, not for this device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. This device is not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

For this device, the "ground truth" for evaluation primarily centers on device safety standards, material properties, and functional principles proven safe and effective by predicate devices.
- Biocompatibility: Demonstrated by testing against ISO 10993 and USFDA 510(k) Memorandum - # K95-1.
- Material Equivalence: PVC is a historically used material, forming a basis of known safety.
- Functional Equivalence: The design for water-perfused manometry, transmitting pressure to a transducer, is considered functionally equivalent to the predicate devices.

8. The Sample Size for the Training Set:

Not applicable. As this is not an AI/algorithm, there is no "training set."

9. How the Ground Truth for the Training Set Was Established:

Not applicable. No training set exists for this type of device submission.

In summary: The provided document is a 510(k) premarket notification for a Class II medical device (GI Manometry Catheter). Its approval is based on demonstrating substantial equivalence to existing predicate devices regarding intended use, technological characteristics, and safety considerations (like biocompatibility and material choice), rather than clinical performance metrics typically associated with diagnostic algorithms or AI-driven systems. Therefore, most of the questions relating to performance studies of an AI model are not relevant to this specific document.

Summary

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Mediplus, Ltd. 510(k) Premarket Notification GI Manometery Catheter

Premarket Notification [510(k)] Summary 8.0

SMDA 510(K) Summary [as required by Section 80792(c)]

Trade Name:	Mediplus Esophageal Manometery Catheter
Common Name	Esophageal Manometery Catheter
Classification Name:	Gastrointestinal motility monitoring catheter(21 CFR 876.1725)
Applicant:	Mediplus Ltd.
Address:	37-39 Baker StreetHigh WycombeBuckinghamshireHP11 2RXUnited KingdomTelephone: +44 1494 551200Fax: +44 1494 536333
SubmissionCorrespondent:	Ms. Elizabeth M. Paul541 Moreno Circle NESt. Petersburg, FL 33703Telephone: 727.525.1247Email: epaul@tampabay.rr.com
Date of Preparation:	November 5, 2001
Legally MarketedDevices to whichMediplus claimsEquivalence to:	Arndorfer Esophageal Manometry Catheter andDentsleeve Manometric Multilumen Extrusion

Device Description:

The catheters are designed with variations of the configuration of the channels (depending on the model and application). The catheter facilitates the measurement of pressure at a fixed number of points along the upper gastro-intestinal tract when correctly installed to water perfusion manometry transducer equipment. Measurement is accomplished by perfusion of water through each catheter lumen. Each column of water transmits pressure to a transducer. The equipment terminates in a pressure transducer and 3-way tap.

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Intended Use

The Mediplus Single Use GI Manometry Catheter is intended for water-perfused manometry of the GI tract.

Technological Characteristics

The Mediplus GI Monitoring Catheter is technologically equivalent to both predicate devices in design and physical characteristics. Like the Arndorfer catheter, it is made of PVC, which has been used historically for intubations.

Testing and Safety

The Mediplus GI Manometry Catheter has been tested for biocompatibility and meets the requirements of ISO 10993 and USFDA 510(k) Memorandum - # K95-1for the intended use of the device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the department's name encircling an abstract symbol. The symbol resembles a stylized caduceus, featuring a staff with three wavy lines instead of snakes. The overall design is simple and monochromatic, rendered in black and white.

Public Health Service

AUG 0 5 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mediplus, Ltd. c/o Ms. Elizabeth M. Paul Submission Correspondent RQA Compliance 541 Moreno Circle NE ST. PETERSBURG FL 33703 Re: K013704 · Trade/Device Name: Mediplus Single Use GI Manometry Catheters - Models 2244-1, 2244-8, 2280, 2235 & 2135 Regulation Number: 21 CFR 876.1725 Regulation Name: Gastrointestinal motility monitoring system Regulatory Class: II Product Code: 78 KLA Dated: May 1, 2002 Received: May 7, 2002

Dear Ms. Paul:

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.

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); 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.

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Page 2

This letter will allow you to begin marketing your device as described in your 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:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.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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Page I of I

510(k) Number (if known): K013704

Device Name: MEDI PLUS SINGLE USE GI MANOMETRY CATHETER Indications For Use:

The Mediplus Single Use & Manometry Catheter is inducation for use when measurements of gastrointestinal tract pressures are needed for the diagnosis of suspected gastrointestinal disonders :

Investigation of gastrantestinal diseases
motility dison
Swallowing disorders
Refury disorders
Gastric and intestine disorders
Coloniec and anorectal disorders

This product is for use by a trained physician.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	✓	OR	Over-The-Counter Use	__
(Per 21 CFR 801.109)			(Optional Format 1-2-96)

(Division Sign-Off)

Division of...

[Signature]

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).