(29 days)
Not Found
No
The provided text describes a Manometric Perfusion Pump used in conjunction with a catheter for gastrointestinal manometry. The description focuses on the device's function in measuring gastrointestinal pressures and does not mention any AI or ML capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No.
The device is used for diagnostic purposes to obtain information about gastrointestinal pressures, not for treating a condition.
Yes
The device is used where "gastrointestinal manometry is indicated," which gathers "information about patterns of gastrointestinal pressures" to "determin[e] appropriate patient management or for research studies into gastrointestinal motility." This describes a diagnostic purpose.
No
The device is described as a "Manometric Perfusion Pump" and is used "in conjunction with a gastrointestinal manometric assembly (catheter)". This description strongly implies a physical hardware component (the pump) that interacts with a catheter, which is not consistent with a software-only device. The predicate device is also a "Manometric Perfusion Pump", further supporting the presence of hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device is a "Manometric Perfusion Pump" used "in conjunction with a gastrointestinal manometric assembly (catheter)". Its purpose is to facilitate the measurement of "patterns of gastrointestinal pressures".
- Lack of Sample Analysis: There is no mention of the device analyzing biological samples taken from the patient. It is used in vivo (within the body) to measure physiological parameters.
- Intended Use: The intended use describes its role in gastrointestinal manometry, which is a procedure to measure pressure within the gastrointestinal tract. This is a physiological measurement, not an in vitro diagnostic test.
Therefore, the Manometric Perfusion Pump is a medical device used for physiological measurement in vivo, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
When used in conjunction with a gastrointestinal manometric assembly (catheter), the Manometric Perfusion Pump can be used where gastrointestinal manometry is indicated when the following conditions are satisfied: 1) When information about patterns of gastrointestinal pressures is judged to be of importance for either determining appropriate patient management or for research studies into gastrointestinal motility. 2) Contraindications are considered, and the risk-benefit analysis is judged to favor performance of the manometric study, after measures have been taken to minimize all possible risks.
Product codes
78 FFX
Device Description
When used in conjunction with a gastrointestinal manometric assembly (catheter), the Manometric Perfusion Pump can be used where gastrointestinal manometry is indicated when the following conditions are satisfied: 1) When information about patterns of gastrointestinal pressures is judged to be of importance for either determining appropriate patient management or for research studies into gastrointestinal motility. 2) Contraindications are considered, and the risk-benefit analysis is judged to favor performance of the manometric study, after measures have been taken to minimize all possible risks.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastrointestinal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The user must be qualified in gastrointestinal diagnostic procedures, trained in the use of manometric perfusion pumps and recording equipment; trained in the insertion and use of gastrointestinal manometry catheters; and must be familiar with all labeling and instructions for use associated with the device.
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 company did not conduct, nor depend on, clinical studies in order to establish substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
OCT 1 9 2001
PAGE 1 OF 2
K013154
510(k) Summarv
Introduction
This 510(k) Summary document is intended to comply with the requirements of the SMDA and 21CFR§807.92. FDA may make this summary available to the public within 30 days following a finding of substantial equivalence.
510(k) Submitted by
Dentsleeve Pty Ltd 41 Goodwood Road Wayville, South Australia Australia 5034
USA Submission Correspondent
Robert N. Clark Medical Device Regulatory Advisors Tel: 303-234-9412 / Fax: 303-234-9413
Date Prepared
September 19, 2001
Trade Name of Device
Mark II / Mark III Manometric Perfusion Pump
Common Name of Device
Manometric Perfusion Pump
Classification Name
System, Gastrointestinal Motility (Electrical)
510(k) Classification
21CFR§876.1725 Class II
Device Description and Intended Use
When used in conjunction with a gastrointestinal manometric assembly (catheter), the Manometric Perfusion Pump can be used where gastrointestinal manometry is indicated when the following conditions are satisfied: 1) When information about patterns of gastrointestinal pressures is judged to be of importance for either determining appropriate patient management or for research studies into gastrointestinal motility. 2) Contraindications are considered, and the risk-benefit analysis is judged to favor performance of the manometric study, after measures have been taken to minimize all possible risks.
1
Comparison to Predicate Devices
The device is equivalent in safety and performance to prior legally marketed devices. In particular it is equivalent to:
PAGE 2 OF 2
K980946 - Mark II / Mark II CO2 Flush Manometric Perfusion Pump, manufactured by Dentsleeve Pty Ltd.
Recognized Standards
The requirements of the following standards have been used in part to establish substantial equivalence:
IEC 601-1 (1988) Medical Electrical Equipment - Part 1: General Requirements for Safety; including Amendment 1 (1991) & Amendment 2 (1995).
IEC 601-1-2 (1993) Medical Electrical Equipment - Part 1: General Requirements for Safety; Electromagnetic Compatibility - Requirements and Tests
Clinical Testing
The company did not conduct, nor depend on, clinical studies in order to establish substantial equivalence.
Risk Management
This device has been designed to either completely eliminate or mitigate all known health hazards associated with the use of the device. Health hazard risk reduction has been accomplished by rigorous application of a risk management program. One or more of the following means (in order of preference) was used to implement mitigation of health hazards identified by the risk management program:
- Design modifications. 1.
- Detection of hazard conditions and alerting of the user. 2.
-
- Identification of any potentially undetectable health hazard conditions in the instructions for use or other device labeling.
The user must be qualified in gastrointestinal diagnostic procedures, trained in the use of manometric perfusion pumps and recording equipment; trained in the insertion and use of gastrointestinal manometry catheters; and must be familiar with all labeling and instructions for use associated with the device. The company believes many device health hazards are due to user error and failure to follow instructions for use.
Dentsleeve Pty Ltd believes that the Mark II / Mark III Manometric Perfusion Pump products are safe and effective when used as instructed by knowledgeable and trained personnel, and perform as well as or better than the legally marketed predicate devices.
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, which is a traditional symbol of medicine and healthcare. The symbol features a staff with two snakes entwined around it, and a pair of wings at the top.
OCT 1 9 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dentsleeve Pty. Ltd. c/o Mr. Robert N. Clark Medical Device Regulatory Advisors 13605 West 7th Avenue GOLDEN CO 80401-4604 Re: K013154
Trade/Device Name: Mark II / Mark III Manometric Perfusion Pump Regulation Number: 21 CFR §876.1725 Regulation Name: Gastrointestinal motility monitoring system Regulatory Class: II Product Code: 78 FFX Dated: September 17, 2001 Received: September 20, 2001
Dear Mr. Clark:
De have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enorosale) to regally the enactment date of the Medical Device Amendments, or to conninered price to May 20, 1978, ins easonance with the provisions of the Federal Food, Drug, devices that have ocon require approval of a premarket approval application (PMA). and Cosmetic Act (710t) that to not requent of the general controls provisions of the Act. The I ou may, dicierore, market and act include requirements for annual registration, listing of general controls profises in a prohibitions against misbranding against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it your device is classified (800 a00 v) ... 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 that FDA has made a determination that your device complies with other requirements of the Act that I Dri has made a sold regulations administered by other Federal agencies. You must or any I oderal surates and registments, including, but not limited to: registration and listing Compry with and rice broquientends, as 801); good manufacturing practice requirements as set (21 CFR Part 807), adoming (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 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 Cbrogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number: _______________________________________________________________________________________________________________________________________________________________
Device Name:
Mark II / Mark III Manometric Perfusion Pump
Indications for Use:
When used in conjunction with a gastrointestinal manometric assembly (catheter), the Manometric Perfusion Pump can be used where gastrointestinal manometry is indicated when the following conditions are satisfied:
-
When information about patterns of gastrointestinal pressures is judged to be of importance for either determining appropriate patient management or for research studies into gastrointestinal motility.
-
Contraindications are considered, and the risk-benefit analysis is judged to favor performance of the manometric study, after measures have been taken to minimize all possible risks.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
| Nancy C Bragdon | |
|---|---|
| (Division Sign-Off) | |
| Division of Reproduction and Radiological Devices | |
| 510(k) Number | K013154 |