MEDIPLUS SINGLE USE GI MANOMETRY CATHETER

K013704 · Mediplus , Ltd. · KLA · Aug 5, 2002 · Gastroenterology, Urology

Device Facts

• Record ID: K013704
• Device Name: MEDIPLUS SINGLE USE GI MANOMETRY CATHETER
• Applicant: Mediplus , Ltd.
• Product Code: KLA · Gastroenterology, Urology
• Decision Date: Aug 5, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1725
• Device Class: Class 2

Intended Use

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

Device Story

Mediplus GI Manometry Catheter; multi-lumen PVC tube; used for water-perfused manometry of GI tract. Input: water perfusion through catheter lumens; pressure transmitted to external transducer and 3-way tap. Output: pressure measurements at fixed points along upper GI tract. Used in clinical setting by trained physician. Facilitates diagnosis of motility, swallowing, reflux, gastric, intestinal, colonic, and anorectal disorders. Single-use device.

Clinical Evidence

Bench testing only. Biocompatibility testing performed in accordance with ISO 10993 and USFDA 510(k) Memorandum #K95-1.

Technological Characteristics

Multi-lumen PVC tube; water-perfused sensing principle; connects to external water perfusion manometry transducer equipment; single-use; biocompatible per ISO 10993.

Indications for Use

Indicated for patients requiring gastrointestinal tract pressure measurements for diagnosis of suspected disorders, including motility, swallowing, reflux, gastric, intestinal, colonic, and anorectal disorders. For use by trained physicians.

Regulatory Classification

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.

Predicate Devices

• Arndorfer Esophageal Manometry Catheter
• Dentsleeve Manometric Multilumen Extrusion

Submission Summary (Full Text)

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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<br>(21 CFR 876.1725) |
| Applicant: | Mediplus Ltd. |
| Address: | 37-39 Baker Street<br>High Wycombe<br>Buckinghamshire<br>HP11 2RX<br>United Kingdom<br>Telephone: [phone]<br>Fax: [phone] |
| Submission<br>Correspondent: | Ms. Elizabeth M. Paul<br>541 Moreno Circle NE<br>St. Petersburg, FL 33703<br>Telephone: [phone]<br>Email: [e-mail] |
| Date of Preparation: | November 5, 2001 |
| Legally Marketed<br>Devices to which<br>Mediplus claims<br>Equivalence to: | Arndorfer Esophageal Manometry Catheter and<br>Dentsleeve Manometric Multilumen Extrusion |

## 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.

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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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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 | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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.

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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) | |

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