MEDIPLUS SINGLE USE LOWER GI MANOMETRY CATHETER

K031617 · Mediplus , Ltd. · KLA · Jan 16, 2004 · Gastroenterology, Urology

Device Facts

• Record ID: K031617
• Device Name: MEDIPLUS SINGLE USE LOWER GI MANOMETRY CATHETER
• Applicant: Mediplus , Ltd.
• Product Code: KLA · Gastroenterology, Urology
• Decision Date: Jan 16, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1725
• Device Class: Class 2

Intended Use

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

Device Story

Multilumen PVC catheter for anorectal canal pressure monitoring; used with external manometric infusion pump and pressure transducer equipment. Device facilitates pressure measurement at fixed points along anorectal tract via water perfusion through catheter lumens; each water column transmits pressure to external transducer. Used by trained physicians in clinical settings to assist in diagnosing colonic and anorectal disorders. Single-use design.

Clinical Evidence

Bench testing only. Biocompatibility testing performed in accordance with ISO 10993 and USFDA 510(k) Memorandum #K951.

Technological Characteristics

Multilumen PVC tube; water-perfused sensing principle; connects to external manometric infusion pump and pressure transducer equipment; single-use; biocompatible per ISO 10993.

Indications for Use

Indicated for use by a trained physician when measurements of gastrointestinal tract pressures are needed to assist in the diagnosis of suspected colonic and anorectal disorders.

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

• Medtronic Zinectics anorectal water perfused manometry catheter

Submission Summary (Full Text)

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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<br>(21 CFR 876.1725) | |
| 1.4 Product Code | 78KLA | |
| 1.5 Applicant | Mediplus Limited | |
| 1.6 Address | Unit 7<br>The Gateway Centre<br>Coronation Road<br>Cressex Business Park<br>High Wycombe<br>Bucks<br>HP12 3SU<br>United Kingdom<br>Telephone: [phone]<br>Fax: [phone] | |
| 1.7 Submission Correspondent | Dr. Norman Estrin<br>Estrin Consulting Group Inc<br>9109 Copenhaver Drive<br>Potomac, MD20854<br>USA<br>Telephone: [phone]<br>Fax: [phone] | |
| 1.8 Date of Preparation | January 9, 2004 | |
| 1.9 Predicate Device | Medtronic Zinectics anorectal water perfused<br>manometry catheter | |

:

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K031617
Page 2 of 2

#### 1.10 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.

#### 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

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.

#### 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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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 | [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 Additionally, for questions on the proguent an a more the regulation entitled, "Misbranding
Office of Compliance at [phone]. "Also, possess and since of the researcel Ottice of Compliance at [phone]. 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 [phone] 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)

OR

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

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