The Mediplus Single Use Anorectal GI Manometry catheter is indicated for use when measurements of gastrointestinal tract pressures are needed to assist in the diagnosis of suspected colonic and anorectal disorders. The product is for use by a trained physician.

Device Description

Mediplus Single Use Anorectal GI Manometry Catheters are designed for the monitoring of anorectal canal pressure. They are designed to be used with a manometric infusion pump. The major structure of the Mediplus Anorectal GJ Manometry Catheter is a multilumen 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 anorectal gastrointestinal 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 describes a 510(k) premarket notification for the "Mediplus Single Use Anorectal Manometry Catheter." This document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific performance acceptance criteria.

While the document states that the device has been tested for biocompatibility and meets the requirements of ISO 10993 and USFDA 510(k) Memorandum - # K951 for the intended use, it does not provide a table of acceptance criteria for specific performance metrics (e.g., pressure accuracy, flow rates, durability) or a study report detailing how those criteria were met.

Therefore, many of the requested details about performance studies, sample sizes, ground truth establishment, and expert involvement are not available in the provided text.

Based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Biocompatibility: Meet requirements of ISO 10993	Device has been tested for biocompatibility and meets the requirements of ISO 10993.
510(k) Memorandum: Meet requirements of USFDA 510(k) Memorandum - # K951 for intended use	Device has been tested and meets the requirements of USFDA 510(k) Memorandum - # K951 for the intended use.
Technological Characteristics: Technologically equivalent to predicate device in design and physical characteristics.	The Mediplus Single Use Anorectal GI Manometry is technologically equivalent to the predicate device in design and physical characteristics. It is made of PVC, like the predicate device.
Functional Performance (e.g., pressure measurement accuracy):	Not explicitly stated or quantified in this document. The document describes the device's function to "facilitates the measurement of pressure." However, no performance metrics (e.g., accuracy, precision, range) or their acceptance criteria are provided.

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

Not provided. The document states testing was done for biocompatibility and 510(k) memorandum requirements, but does not specify sample sizes or data provenance for these tests. This is a 510(k) submission, which primarily focuses on substantial equivalence rather than detailed clinical performance studies often submitted for PMAs.

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

Not applicable/Not provided. The type of testing mentioned (biocompatibility, technological equivalence) does not typically involve expert review for ground truth in the same way clinical diagnostic device studies would.

4. Adjudication method for the test set:

Not applicable/Not provided.

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 device is an anorectal manometry catheter, not an AI-powered diagnostic imaging device. No MRMC study was done.

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

Not applicable. This is a medical device, not a standalone AI algorithm. It is used by a "trained physician."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

For biocompatibility, the ground truth would be established by validated test methods and standards (e.g., ISO 10993).
For technological characteristics, the ground truth is the specifications and materials of the predicate device.
No other ground truth relevant to clinical performance is discussed.

8. The sample size for the training set:

Not applicable/Not provided. There is no mention of a "training set" as this is not an AI/machine learning device.

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

Not applicable/Not provided.

Summary

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Image /page/0/Picture/0 description: The image shows the word "mediplus" in a bold, sans-serif font. The word is split across two lines, with "medi" on the first line and "plus" on the second line. There is a line underneath the word "medi".

K031617

Page 1 of 2

'JAN 1 6 2004

Premarket Notification [510(k)] Summary
[as required by Section 80792(c)]
1.1 Trade Name	Mediplus Single Use Anorectal Manometry Catheter
1.2 Common Name	Anorectal GI manometry catheter
1.3 Classification Name	gastrointestinal motility monitoring catheter(21 CFR 876.1725)
1.4 Product Code	78KLA
1.5 Applicant	Mediplus Limited
1.6 Address	Unit 7The Gateway CentreCoronation RoadCressex Business ParkHigh WycombeBucksHP12 3SUUnited KingdomTelephone: +44 (0) 1494 551200Fax: +44 90) 1494 536333
1.7 Submission Correspondent	Dr. Norman EstrinEstrin Consulting Group Inc9109 Copenhaver DrivePotomac, MD20854USATelephone: 301 279 2899Fax: 301 294 0126
1.8 Date of Preparation	January 9, 2004
1.9 Predicate Device	Medtronic Zinectics anorectal water perfusedmanometry catheter

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K031617
Page 2 of 2

1.10 Device Description

1.11 Intended Use

The Mediplus Single Use Anorectal Gl Manometry Catheter is intended for waterperfused manometry of the anorectal GI tract.

1.12 Indications for Use

1.13 Technological Characteristics

The Mediplus Single Use Anorectal GI Manometry is technologically equivalent to the predicate device in design and physical characteristics. Like the Medtronic Zinectics anorectal water perfused manometry catheter, it is made of PVC, which has been used historically for intubations.

1.14 Testing and Safety

The Mediplus Single Use Anorectal GI Manometry has been tested for biocompatibility and meets the requirements of ISO 10993 and USFDA 510(k) Memorandum - # K951 for the intended use of the device.

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Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 6 2004

Mediplus Ltd. c/o Norman F. Estrin, Ph.D., RAC President Estrin Consulting Group, Inc. 9109 Copenhaven Drive POTOMAC MD 20854

Re: K031617

K091017
Trade/Device Name: MEDIPLUS® Single Use Anorectal GI Manometry Catheter Regulation Number: 21 CFR §876.1725 Regulation Name: Gastrointestinal motility monitoring system Regulatory Class: II Product Code: 78 KLA Dated: October 23, 2003 Received: October 24, 2003

Dear Dr. Estrin:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave rowed for a we 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 I ou may, therefere, misions 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 (sec above) into cither 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 I rouse of a researce a determination that your device complies with other requirements of the Act that I Dr Asso Internand regulations administered by other Federal agencies. You must or any Featur stabates 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 (21 CFR Party as the 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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This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will allow you to begin marketing your antial equivalence of your device to a legally premarket notitication. The FDA miding of sacsamia equivalian of this, 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 If you desire specific advice for your device on our labourg numbers, based on the regulation number at the top of the 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 Additionally, for questions on the proguent an a more the regulation entitled, "Misbranding
Office of Compliance at (301) 594-4639. "Also, possess and since of the researcel Ottice of Compliance at (501) 594-4057. 7150, production of Courth of Complex of Sma by reference to premarket notification (21 cc r = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = information on your responsibilities under the reach its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its toll-drivers (demoment Manufacturers, International and Collsamer Passement Passement of Schools of Schamain.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

Page 2

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510(k) Number: K031617

Device Name:

Mediplus single use anorectal GI manometry catheter

Indications for Use:

The Mediplus single use anorectal GI manometry catheter is intended for use The Mediplus single use anotected on the pressures are needed to assist in
when measurements of gastrointestinal traces atches are . The product is when measurements of gastromics interpressured on the product is for use by a trained physician.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X
(Per 21 CFR 801.109)

Over-the-Counter Use

(Optional Formar 1-2-96)

David K. Syverson
Under Sign Off

(Division Sign-Off) (Division Sign-Ont)
Division of Reproductive, Abdominal, Division of Radiological Devices 510(k) Number J

= 11

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).