When used in conjunction with a gastrointestinal manometric assembly (catheter), the Mark II CO2 Manometric Perfusion Pump & Mark II Manometric Perfusion Fump, 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 gastro-intestinal motility.
Contra-indications are considered, and the risk-bencht analysis is judged to favour performance of the manometric study, after measures have been taken to minimise all possible risks.

Device Description

The Mark II Manometric Perfusion Pump and the Mark II CO2 Flush Manometric Perfusion Pump are gas powered perfusion pumps designed to facilitate the monitoring and analysis of intragastrointestinal pressures. The Mark II Manometric Perfusion Pump and the Mark II CO2 Flush Manometric Perfusion Pump are comprised of a constant gas pressure delivery system and a constant flow constant pressure, multi-channel, perfusate system with the capacity to connect pressure transducers for monitoring intragastrointestinal pressures. The Mark II CO2 Flush Manometric Perfusion Pump has an addition CO2 gas circuit for facilitating the removal of air bubbles from the perfusate circuit prior to it clinical use. Both Manometric Perfusion Pump have been designed to be compatible with gastrointestinal motility catheters.

AI/ML Overview

The provided text describes a medical device, the "Mark II Manometric Perfusion Pump" and "Mark II CO2 Flush Manometric Perfusion Pump," and its substantial equivalence to a predicate device. However, it does not contain explicit acceptance criteria or a dedicated study section that proves the device meets specific performance metrics in a way that can be directly extracted and tabulated as requested.

The text primarily focuses on:

Device Description and Indications for Use: Explaining what the device is, what it does, and how it's intended to be used.
Substantial Equivalence Claim: Stating that it's equivalent to existing devices.
References to Prior Research: Citing scientific papers that support the concept of improved perfusion systems for manometry in general, and the benefits of pneumatically driven pumps. These are not direct studies of this specific Mark II device's acceptance criteria.

Here's an attempt to answer your questions based on the available information, with significant caveats where information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly provided in the given text. The document states:

"The Mark II Manometric Perfusion Pump has been tested and shown to enable accurate intergastrointestinal pressure measurements."

This is a general statement of performance, not a specific, quantifiable "acceptance criteria" with associated "reported device performance." The references provided are for the principles behind such devices, not the a study detailing the Mark II's direct performance against quantifiable criteria.

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

Not provided. The document references scientific papers, but these are not studies of the Mark II device's specific test set. For example, Arndorfer et al. (1977) studied a "hydraulic capillary infusion system," and Dent et al. (1977) studied a "pneumatically driven perfusion pump," neither of which are explicitly named as the "Mark II." Hebbard et al. (1997) is an abstract about high-resolution perfusion manometry generally.

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

Not provided.

4. Adjudication method for the test set

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 and Not provided. This device is a perfusion pump, not an AI-powered diagnostic tool requiring human reader interpretation in the context of AI assistance. The concept of "human readers improve with AI vs without AI assistance" does not apply here.

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

Not applicable and Not provided. This device is a mechanical perfusion pump, not an algorithm.

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

Not explicitly provided for the "Mark II" device. For the principles elucidated in the referenced papers (e.g., Arndorfer et al., 1977), the "ground truth" would likely be the accurate measurement of esophageal peristaltic pressure, which would be assessed by comparing the device's output against known physiological responses or established standards of accurate pressure measurement. However, this is inferential based on the type of device.

8. The sample size for the training set

Not applicable and Not provided. This is a hardware device, not a machine learning algorithm that requires a training set.

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

Not applicable and Not provided. This is a hardware device, not a machine learning algorithm.

Summary of what is present:

The document serves as a 510(k) summary, aiming to demonstrate substantial equivalence to existing predicate devices (e.g., The Pneumo-Hydraulic Capillary Infusion System Arndorfer Medical Specialties). This approach often relies on demonstrating that technical characteristics are similar and that the new device does not raise new questions of safety or effectiveness, rather than providing a detailed clinical study meeting specific, quantifiable acceptance criteria for this new device. The "Testing" section is extremely brief and general ("has been tested and shown to enable accurate intergastrointestinal pressure measurements") and refers to the scientific literature that likely informed the design principles of the device rather than directly presenting the results of a specific validation study against quantitative acceptance criteria for the Mark II pump itself.

Summary

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K980946

Section 11 510(k) Summary of Safety and Effectiveness

Date prepared: 02 February 1998

Submitter: Dentsleeve Pty Ltd 56a/b Crn St Annes Place & Glen Osmond Road Parkside SA 5063, Australia Telephone: +61-8-8271 0744 +61-8-8271 0084 Facsimile: Marcus Tippett, Technical Consultant

Trade Name:	Mark II Manometric Perfusion PumpMark II CO2 Flush Manometric Perfusion Pump
Common Name:	Manometric perfusion pump
Classification Name:	Monitor, esophageal motility and tube

Substantial equivalence is claimed to the following devices:

The Pneumo-Hydraulic Capillary Infusion System Arndorfer Medical Specialties. 5656 Grove Terrace Greendale WI 53129 U.S.A.

Description

Indications

The Mark II Manometric Perfusion Pump is used to provide a low compliant fluid pathway to enable high fidelity dynamic intragastroesophageal pressured and analyzed in both pediatric and adult populations when used with a gastrointestinal motility catheter. The product is to be used on patients in the hospital environment under supervision of a trained physician.

Technological Characteristics

The Mark II Manometric Perfusion Pump is a medical gas cylinder powered perfusion pump. It has 6 to 24 perfusate channels with attachment squares to connect pressure transducers to each channel.

The Mark II CO2 Flush Manometric Perfusion Pump is a medical gas cylinder powered perfusion pump. It has 6 to 24 perfusate channels with attachment squares to connect pressure transducers to It also has a CO2 flush circuit to assist the removal of air from the perfusate circuit. each channel.

Testing

The Mark II Manometric Perfusion Pump has been tested and shown to enable accurate intergastrointestinal pressure measurements.

Other reports (scientific papers, validation of manometric equipment)

1. Ronald C Arndorfer, et al. Improved infusion system for intraluminal esophageal manometry. Gastroenterology 73:23-27, 1977 Depts. of Radiology and Medical College of Wisconsin and dept. of Engineering,
  Marquette University, Milwaukee, Wisconsin

Abstract

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An improved catheter infusion system is needed for esophageal intraluminal manometry. Using conventional syringe pump infusion systems undesirably rapid infusion rates of 6ml/min or more are often needed to achieve accurate recording of esophageal peristaltic pressure. These rapid baseline infusion rates are necessitated by the high compliance of syringe pump systems which causes substantial reduction in the infusion rate during dynamic pressure transients. In this study we tested a hydraulic capillary infusion system designed to have low compliance. This minimally compliant system yields accurate recording of esophageal peristaltic pressure at infusion rates of 0.6 ml/min or less. We believe that the hydraulic capillary infusion system is a useful tool for performing both clinical and investigative studies of esophageal motor function.

1. JJ Dent et al. A pneumatically driven pump for constant perfusion manometry. The Australian Journal of Experimental Biology and Medical Science, 55:293-298, 1977 Monash University Dept. of Medicine and dept. of Medical Physics, Austin Hospital Victoria Australia.

Abstract

Syringe pumps are almost universally used for constant perfusion oesophageal manometry, despite important technical limitations. A pneumatically driven perfusion pump has been designed specifically for oesophageal manometry. This pump requires less than one third the flow setting of a syringe pump to achieve a given rate of pressure rise. It is simple to operate and needs infrequent refilling. Nearly two years' practical experience with this pump has confirmed its superiority over the syringe pump for constant perfusion manometry.

1. Geoffrey S Hebbard et al. Assessment of gastrointestinal pressure gradients using high resolution perfusion manometry. Abstract, Digestive Diseases Week, Washington US, May 1997

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle head in profile, with three lines representing the feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES" are arranged in a circular pattern around the left side of the eagle. The letters "USA" are located on the right side of the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Public Health Service

JUN - 8 1998

Mr. Marcus Tippett Dentsleeve Pty, Ltd 56 A/B Glen Osmond RD. Parkside, South Australia Australia, 5063

Re: K980946

Mark II and Mark II CO2 Flush Manometric Perfusion Pump Dated: February 28, 1998 Received: March 13, 1998 Regulatory Class: II 21 CFR $876.1725/Product code: 78 FFX

Dear Mr. Tippett:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions, Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/odrh/dsmaldsmam.html".

Sincerely yours

Lillian Yin, Ph.D.

Director, Division of Reproductive, Abdominal. Ear. Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) number (if known):

K980946

Device Name:

Mark II CO2 Manometric Perfosion Pump & Mark II Manometric Perfusion Pump Product code: 78KLA

Indications For Use:

When information about patterns of gastrointestinal pressures is judged to be of importance for either determining appropriate patient management or for research studies into gastro-intestinal motility.
Contra-indications are considered, and the risk-bencht analysis is judged to favour performance of the manometric study, after measures have been taken to minimise all possible risks.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
Carly Y Newland for R. Gatling
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number	K980946
Prescription Use	OR Over-The-Counter Use ________
(Per 21 CFR 801.109)	(Optional Format 1-2-96)

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).