(238 days)
K951
K951
No
The description focuses on a physical catheter and its function in measuring pressure, with no mention of AI/ML for data analysis or interpretation.
No
The device is used for diagnosis by measuring pressures in the gastrointestinal tract, not for treatment.
Yes
The device is indicated for use when measurements of gastrointestinal tract pressures are needed to assist in the diagnosis of suspected colonic and anorectal disorders.
No
The device description clearly states it is a physical catheter made of a multilumen PVC tube, designed to be used with a manometric infusion pump and pressure transducers. This indicates it is a hardware device, not software-only.
Based on the provided information, the Mediplus Single Use Anorectal GI Manometry Catheter is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the body (like blood, urine, tissue). This device is inserted into the body to measure pressure directly within the anorectal GI tract.
- The intended use is to measure pressure in vivo (within a living organism). IVDs perform tests in vitro (in a lab setting, outside the body).
- The device description focuses on the physical structure and how it interacts with pressure transducers. It doesn't describe any reagents, assays, or analytical processes typically associated with IVDs.
- The performance studies mentioned are related to biocompatibility and meeting regulatory standards for medical devices, not analytical performance metrics common for IVDs (like sensitivity, specificity, etc.).
Therefore, this device is a medical device used for physiological measurement in vivo, not an IVD.
N/A
Intended Use / Indications for Use
The Mediplus Single Use Anorectal Gl Manometry Catheter is intended for waterperfused manometry of the anorectal GI tract.
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.
Product codes
78KLA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anorectal GI tract, anorectal canal, anorectal gastrointestinal tract
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Medtronic Zinectics anorectal water perfused manometry catheter
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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".
- 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 7 | |
| The Gateway Centre | ||
| Coronation Road | ||
| Cressex Business Park | ||
| High Wycombe | ||
| Bucks | ||
| HP12 3SU | ||
| United Kingdom | ||
| Telephone: +44 (0) 1494 551200 | ||
| Fax: +44 90) 1494 536333 | ||
| 1.7 Submission Correspondent | Dr. Norman Estrin | |
| Estrin Consulting Group Inc | ||
| 9109 Copenhaver Drive | ||
| Potomac, MD20854 | ||
| USA | ||
| Telephone: 301 279 2899 | ||
| Fax: 301 294 0126 | ||
| 1.8 Date of Preparation | January 9, 2004 | |
| 1.9 Predicate Device | Medtronic Zinectics anorectal water perfused | |
| manometry catheter |
:
1
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.
2
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.
3
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
4
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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