The Rapid Barostat Bag Pump and Catheter are used together for the inflation of a barostat balloon to measure rectal capacity, as well as rectal volume at points of sensation, urge, and discomfort, to determine hypersensitivity, hyposensitivity, or normal rectal sensations. These determinations aid in the diagnosis of anorectal disorders, such as fecal incontinence and constipation.

Device Description

The Rapid Barostat Bag system consists of a pump unit and a disposable catheter. The pump uses an air compressor pneumatic system and is operated through a touch screen. It is electrically powered by rechargeable batteries and is wirelessly connected to a peripheral remote control for the patient to input different levels of sensation during the study. The catheter is made up of single-lumen PVC tubing with a plastic non-compliant barostat balloon at the distal end, and a female luer at the proximal end. The balloon end of the catheter is inserted into a patient's rectum, and the luer end is connected to the pump.

The study, also known as RBB Protocol, consists of two or more rounds of inflation and deflation of the catheter. The first round will inflate the balloon to the set internal pressure of 40 mmHg to determine the maximum volume of the rectum. The second round of inflation will be used to determine the volumetric points of sensation, urge, and discomfort associated with the patient's rectum. During the study, the pump will push air through the catheter tubing into the barostat balloon at a constant rate of 2 mL/sec, while displaying the fluctuating pressure within the balloon onto the pump's touch screen display. When the patient begins to feel the sensation of the inflated balloon, they would push the "sensation" button on the remote control to transmit a signal to the pump. The inflation volume and pressure will be recorded at that point of reference. The pump will continue to inflate the balloon for the patient to report the point of the feeling of urge, and then discomfort, and the data points are collected and stored in the systems internal memory. Upon pressing the discomfort indicator button, the system will automatically stop the inflow of air into the balloon and begin to rapidly deflate the balloon at 3 mL/sec. By extrapolating the volume and pressure measurements recorded within the barostat balloon, the pump will be able to provide the healthcare professional with clearer data for a more accurate diagnosis of anorectal functions and rectum disorder.

AI/ML Overview

The provided text describes the Mui Scientific Rapid Barostat Bag (RBB) Pump and Catheter System, detailing its intended use, design, and a comparison to predicate devices to demonstrate substantial equivalence. The document is primarily a 510(k) Summary for regulatory purposes.

Based on the provided information, here's a breakdown of the acceptance criteria and the study that proves the device meets those criteria:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail format typical of a rigorous study. Instead, it describes performance in relation to a predicate device to demonstrate "substantial equivalence." The key performance metrics and their comparison are:

Feature/Metric	Acceptance Criteria (Implied by Predicate Performance)	Reported Device Performance (RBB Pump and Catheter)
RBB Pump:
Indications for Use	Measure rectal capacity, as well as rectal volume at points of sensation, urge, and discomfort, to determine hypersensitivity, hyposensitivity, or normal rectal sensations. These determinations aid in the diagnosis of anorectal disorders, such as fecal incontinence and constipation. (Predicate's general indication is "indirectly measures the muscle tone of a hollow organ")	The Rapid Barostat Bag Pump and Catheter are used together for the inflation of a barostat balloon to measure rectal capacity, as well as rectal volume at points of sensation, urge, and discomfort, to determine hypersensitivity, hyposensitivity, or normal rectal sensations. These determinations aid in the diagnosis of anorectal disorders, such as fecal incontinence and constipation.
Pressure Range	0 to 60 mmHg	0 to 40 mmHg
Airflow Rate	2 to 25 mL/sec	1.5 to 3 mL/sec
Performance	Obtained the same measurement for rectal capacity and compliance as the Submission Device when running the same RBB Protocol.	Obtained the same measurement for rectal capacity and compliance as the Predicate Device when running the same RBB Protocol.
Software Validation	Information not readily available by manufacturer (for predicate)	Substantial equivalency demonstrated.
Measurement Accuracy	Information not readily available by manufacturer (for predicate)	Substantial equivalency demonstrated.
Measurement Consistency	Information not readily available by manufacturer (for predicate)	Substantial equivalency demonstrated.
RBB Catheter:
Indications for Use	Must be used in conjunction with a Barostat machine to indirectly measure the muscle tone of a hollow organ by inflating a barostat balloon and keeping the pressure constant while measuring the volume changes. Also measures rectal capacity.	The Rapid Barostat Bag Pump and Catheter are used together for the inflation of a barostat balloon to measure rectal capacity, as well as rectal volume at points of sensation, urge, and discomfort, to determine hypersensitivity, hyposensitivity, or normal rectal sensations. These determinations aid in the diagnosis of anorectal disorders, such as fecal incontinence and constipation.
Catheter OD	Various	5.2 mm
Lumen ID	Various	3.2 mm
Balloon Details	Various volumes (150 mL - 1000 mL), various lengths	700 mL, 10 cm in length
Material	Polyvinylchloride tubing, polyolefin balloon	Polyvinylchloride tubing, polyolefin balloon
Length	Various (100 cm standard)	100 cm
Connector End	Polyvinylchloride tubing (10 cm length, OD 7.9 mm, ID 4.8 mm)	Female luer
Number of uses	Single-use and reusable models	Single-use
Balloon Burst/Leak Tests	Substantial equivalency demonstrated	Substantial equivalency demonstrated.
Tensile Strength Test	Substantial equivalency demonstrated	Substantial equivalency demonstrated.
Biocompatibility	Passed Cytotoxicity, Irritation, and Sensitization tests	Passed Cytotoxicity, Irritation, and Sensitization tests.
Shelf Life	2 years	2 years.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

RBB Pump: A "comparison test was performed to demonstrate that the RBB Pump can measure the same results as the Barostat when both machines are running the same RBB Protocol." The sample size for this test set is not specified. The document does not provide information on the country of origin of the data or whether it was retrospective or prospective, implying it was likely an internal lab-based performance comparison.
RBB Catheter: Various tests (Balloon Burst/Leak, Tensile Strength, Biocompatibility, Shelf Life) were performed. The sample sizes for these tests are not specified. The data provenance (country, retrospective/prospective) is not provided, suggesting these were internal lab tests for the device itself.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. The tests performed are engineering/performance comparison tests against a predicate device, not diagnostic studies requiring clinical ground truth established by experts. The "ground truth" for the pump comparison was the measurements obtained by the predicate device under the same protocol. For the catheter, it was the results of standardized material and safety tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. The studies described are performance comparisons of medical devices, not clinical studies involving expert adjudication of patient data.

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. This document describes a medical device (pump and catheter) for physiological measurement, not an AI or imaging diagnostic tool. Therefore, an MRMC study or assessment of human reader improvement with AI assistance is irrelevant to this submission.

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

The primary study mentioned for the RBB Pump is a "comparison test" between the new device and the predicate device, both performing the "same RBB Protocol." This implies a standalone performance test of the new device against the predicate, likely in a controlled environment. The document states: "A comparison test was performed to demonstrate that the RBB Pump can measure the same results as the Barostat when both machines are running the same RBB Protocol." This focuses on the device's inherent measurement capabilities.

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

RBB Pump: The "ground truth" was a direct comparison of measurements obtained by the proposed RBB Pump against those obtained by the legally marketed predicate device (Distender Series II Barostat) when both were running the "same RBB Protocol." This is a performance equivalence ground truth, not a clinical diagnostic ground truth.
RBB Catheter: The ground truth for catheter-related tests (burst, leak, tensile, biocompatibility, shelf life) was established by demonstrating equivalence to the predicate's performance or compliance with recognized standards (e.g., biocompatibility standards like those for Cytotoxicity, Irritation, and Sensitization).

8. The sample size for the training set

Not applicable. This device is not an AI/machine learning model, so there is no "training set."

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

Not applicable, as there is no training set for this device.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 14, 2017

Mui Scientific Tammy Mui Operations Manager 145 Traders Blvd. East, Unit #33-34 Mississauga, ON L4Z 3L3 Canada

Re: K160287

Trade/Device Name: Rapid Barostat Bag (RBB) Pump and Catheter Regulation Number: 21 CFR§ 876.1725 Regulation Name: Gastrointestinal Motility Monitoring System Regulatory Class: II Product Code: FFX Dated: January 23, 2017 Received: January 26, 2017

Dear Tammy Mui:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

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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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Joyce M. Whang-S

for

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K160287

Device Name Rapid Barostat Bag (RBB) Pump and Catheter

Indications for Use (Describe)

The Rapid Barostat Bag Pump and Catheter are used together for the inflation of a barostat balloon to measure rectal capacity, as well as rectal volume at points of sensation, urge, and discomfort, to determine hypersensitivity, byposensitivity, or normal rectal sensations. These determinations aid in the diagnosis of anorectal disorders, such as fecal incontinence and constipation.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the i he to review instructions, search existing data sources, gather and maintain the data needed and complete time to review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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145 Traders Blvd. E., Unit #34, Mississauga, ON, Canada, L4Z 3L3 Tel: (905) 890-5525 Toll Free: 1-800-303-6611 Fax: (905) 890-3523 Website: www.muiscientific.com Email: mail@muiscientific.com

March 14, 2017

510(k) Summary

Rapid Barostat Bag (RBB) Pump and Catheter System RE:

Summary prepared by:

Contact person:	Tammy Mui
Title:	Operations manager
Manufacturer:	H&A Mui Enterprises, o/a Mui Scientific
Address:	145 Traders Blvd. East, Unit #33-34Mississauga, Ontario, Canada L4Z 3L3
Phone:	(905) 890-5525
Fax:	(905) 890-3523
Email:	tammy.mui@muiscientific.com

Trade name:	Rapid Barostat Bag (RBB) Pump and Catheter System
Common name:	Barostat pump and catheters
Classification name:	Gastrointestinal motility system
Regulation:	21 CFR§ 876.1725
Product Code:	FFX
510(k) submission #:	K160287

This 510(k) Summary is for the Rapid Barostat Bag Pump and Catheter System

Indications for Use:

Device Description:

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Mui Scientit

145 Traders Blvd. E., Unit #34, Mississauga, ON, Canada, L4Z 3L3 Tel: (905) 890-5525 Toll Free: 1-800-303-6611 Fax: (905) 890-3523 Website: www.muiscientific.com Email: mail@muiscientific.com

distal end, and a female luer at the proximal end. The balloon end of the catheter is inserted into a patient's rectum, and the luer end is connected to the pump.

Predicate Device:

We are claiming equivalence to the following predicates:

Product Name	510(k) Number	Manufacturer
Distender Series II Barostat	K991288	G&J Electronics
Barostat Catheters	K973844	Mui Scientific

Substantial Equivalence for RBB Pump:

The Distender Series II Barostat machine is designed to perform a large range of isobaric and isochoric protocols along the gastrointestinal system, including the rectum. Common Barostat protocols, such as the Ascending Methods of Limit (AML) Tests and the Random Isobaric (RND) Tests, often require the Barostat to generate air at a high airflow rate (ex. generate 250 mL in 10 Seconds). Other protocols, such as the RBB Protocol, require the Barostat to generate air at low airflow rate (ex. 2 mL/sec). Users can manually fine-tune the Barostat's airflow rate from 2 mL/sec up to 25 mL/sec through the changing of the Barostat's Software and Hardware configuration.

Due to its freedom of configuration, the Barostat can be designed to perform a great variety of protocols, including the RBB Protocol can be implemented into the Barostat through its Protocol Plus Deluxe software. A comparison test was performed to demonstrate that the RBB Pump can measure the same results as the Barostat when both machines are running the same RBB Protocol. Based on the test result, the RBB Pump is capable of measuring the same results as the barostat, concluding that the RBB Pump is substantially equivalent to the Distender Series II Barostat. Below, please find a comparison table of our RBB pump with the predicate:

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	Submission Device	Predicate Device
Product Name	Rapid Barostat Bag Pump	Distender Series II Barostat
510(k) Holder	Submitter: Mui Scientific	G&J Electronics
510(k) Number	K160287	K991288
Indications forUse	The Rapid Barostat Bag Pump andCatheter are used together for theinflation of a barostat balloon tomeasure rectal capacity, as well asrectal volume at points ofsensation, urge, and discomfort, todetermine hypersensitivity,hyposensitivity, or normal rectalsensations. These determinationsaid in the diagnosis of anorectaldisorders, such as fecalincontinence and constipation.	The Barostat machine is a pneumaticdevice that indirectly measures themuscle tone of a hollow organ byinflating a barostat balloon and keepingthe pressure constant while measuringthe volume changes and rectalcapacity
Energy Source	Rechargeable Batteries, ACSource	AC Source
Peripherals	Patient handheld device forrecording points ofsensation/urge/discomfort	Patient handheld device for recordingpoints of sensation/urge/discomfort
Software	Integrated into pump unit, withtouch screen monitor	Requires a separate standalonecomputer
PressureRange	0 to 40 mmHg	0 to 60 mmHg
Airflow Rate	1.5 to 3 mL/sec	2 to 25 mL/sec
Performance	Obtained the same measurementfor rectal capacity and complianceas the Predicate Device whenrunning the same RBB Protocol	Obtained the same measurement forrectal capacity and compliance as theSubmission Device when running thesame RBB Protocol
SoftwareValidation	Substantial equivalencydemonstrated	Information not readily available bymanufacturer.
MeasurementAccuracy	Substantial equivalencydemonstrated	Information not readily available bymanufacturer.
MeasurementConsistency	Substantial equivalencydemonstrated	Information not readily available bymanufacturer.

Substantial Equivalence for RBB Catheter:

The Rapid Barostat Bag Catheter is similar to barostat catheters currently manufactured by Mui Scientific in that they are made of the same tubing and balloon material, are assembled following similar procedures, and are also inflated with air for volume measurements of hollow organs within the gastrointestinal system.

The RBB Catheter is constructed with a single-lumen polyvinylchloride tubing, a 700 mL non-compliant polyolefin balloon at the distal end, and a polycarbonate luer at the proximal end (for connection to the RBB pump). The total catheter length is 100 cm, with the balloon length

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Mui Scientifi

145 Traders Blvd. E., Unit #34, Mississauga, ON, Canada, L4Z 3L3 Tel: (905) 890-5525 Toll Free: 1-800-303-6611 Fax: (905) 890-3523 Website: www.muiscientific.com Email: mail@muiscientific.com

being 10 cm. The balloon is secured with silk sutures and UV light cure glue. Inflation/deflation of the barostat balloon as well as pressure readings within the balloon are all conducted within the same single-lumen tubing.

The barostat catheters used with the Distender Series II Barostat machine are also manufactured by Mui Scientific (#K973844). These catheters are also made up of Polyvinylchloride tubing, with a non-compliant polyolefin balloon secured at the distal end. At the proximal end, instead of a polycarbonate luer, there is just a step up to a larger diameter polyvinylchloride tubing, approx. 6cm in length (for connection to a barb fitting on the Distender Series machine). Depending on the organ being measured, the barostat balloons can range in volume from 150mL - 1000mL. The length of the tubing can also vary, but standard is 100cm. These barostat catheters made specifically for the Distender Series II Barostat machine are also dual lumened, dedicating one lumen for balloon inflation only, and the second lumen for pressure measurement only.

Both RBB Catheter and barostat catheter have been tested to have a shelf life of two years and have passed the Cytotoxicity test, Irritation test, and Sensitization test for Biocompatibility. Below, please find a comparison table of our RBB Catheter with the predicate:

	Submission Device	Predicate Device
Product Name	RBB Catheter	Barostat Catheter
510(k) Holder	Submitter: Mui Scientific	G&J Electronics
510(k) Number	K160287	K973844
Indications forUse	The Rapid Barostat Bag Pump andCatheter are used together for theinflation of a barostat balloon tomeasure rectal capacity, as well asrectal volume at points of sensation,urge, and discomfort, to determinehypersensitivity, hyposensitivity, ornormal rectal sensations. Thesedeterminations aid in the diagnosisof anorectal disorders, such as fecalincontinence and constipation.	The Barostat Catheter must be usedin conjunction with a Barostatmachine to indirectly measure themuscle tone of a hollow organ byinflating a barostat balloon andkeeping the pressure constant whilemeasuring the volume changes. Alsomeasures rectal capacity.
Catheter OD	5.2 mm	Various
Lumen ID	3.2 mm	Various
Balloon Details	700 mL, 10 cm in length	Various volumes (150 mL - 1000 mL),various lengths
Material	Polyvinylchloride tubing, polyolefinballoon	Polyvinylchloride tubing, polyolefinballoon
Length	100 cm	Various (100 cm standard)
Connector End	Female luer	Polyvinylchloride tubing (10 cmlength, OD 7.9 mm, ID 4.8 mm)
Number of uses	Single-use	Single-use and reusable models
Balloon Burstand Leak Tests	Substantial equivalencydemonstrated	Substantial equivalency demonstrated

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145 Traders Blvd. E., Unit #34, Mississauga, ON, Canada, L4Z 3L3 Tel: (905) 890-5525 Toll Free: 1-800-303-6611 Fax: (905) 890-3523 Website: www.muiscientific.com Email: mail@muiscientific.com

TensileStrength Test ofBonded/GluedCatheterComponents	Substantial equivalencydemonstrated	Substantial equivalency demonstrated
Biocompatibility	Passed Cytotoxicity, Irritation, andSensitization tests	Passed Cytotoxicity, Irritation, andSensitization tests
Shelf Life	2 years	2 years

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).