(405 days)
Not Found
No
The description details a pneumatic pump system controlled by a touchscreen and remote, measuring pressure and volume based on patient input. There is no mention of algorithms that learn or adapt from data to perform tasks like diagnosis or data analysis. The system records and displays data, but the interpretation and diagnosis are left to the healthcare professional.
No.
The device is used for diagnostic purposes to measure rectal capacity and sensation points, aiding in the diagnosis of anorectal disorders, rather than providing direct therapy or treatment.
Yes
The device aids in the diagnosis of anorectal disorders by determining hypersensitivity, hyposensitivity, or normal rectal sensations based on measured rectal capacity and volume at points of sensation, urge, and discomfort.
No
The device description clearly outlines hardware components including a pump unit with an air compressor, touch screen, rechargeable batteries, wireless remote control, and a disposable catheter with a balloon. While software is involved in operation and data collection, it is integral to and dependent on this physical 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 Rapid Barostat Bag Pump and Catheter system works by inflating a balloon inside the patient's rectum to measure physical responses (pressure and volume) and patient-reported sensations. This is a direct interaction with the patient's body, not a test performed on a sample taken from the body.
- Intended Use: The intended use is to measure rectal capacity and volume at different sensation points to aid in the diagnosis of anorectal disorders. This is achieved through a physical procedure, not by analyzing a biological sample.
Therefore, the device falls under the category of a medical device used for diagnosis, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
FFX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
rectum, anorectal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare professional
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/1 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" arranged around the perimeter. Inside the circle is a stylized symbol featuring three human profiles facing to the right, with flowing lines beneath them.
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.
1
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
2
Indications for Use
510(k) Number (if known)
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:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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Image /page/3/Picture/0 description: The image contains the logo for Mui Scientific. The logo consists of a circular design with a central black dot and four smaller white circles around the perimeter. To the right of the logo is the text "Mui Scientific" in a bold, serif typeface.
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 #33-34 |
| Mississauga, 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:
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
4
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.
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.
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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Image /page/5/Picture/0 description: The image shows a chemical structure diagram. The diagram depicts a central atom represented by a filled circle. Two other atoms, represented by open circles, are connected to the central atom via curved lines. The overall structure appears to be a simplified representation of a molecule or a chemical compound.
| 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 for | ||
| Use | 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. | The Barostat machine is a pneumatic | |
| device that indirectly measures the | ||
| muscle tone of a hollow organ by | ||
| inflating a barostat balloon and keeping | ||
| the pressure constant while measuring | ||
| the volume changes and rectal | ||
| capacity | ||
| Energy Source | Rechargeable Batteries, AC | |
| Source | AC Source | |
| Peripherals | Patient handheld device for | |
| recording points of | ||
| sensation/urge/discomfort | Patient handheld device for recording | |
| points of sensation/urge/discomfort | ||
| Software | Integrated into pump unit, with | |
| touch screen monitor | Requires a separate standalone | |
| computer | ||
| Pressure | ||
| Range | 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 measurement | |
| for rectal capacity and compliance | ||
| as the Predicate Device when | ||
| running the same RBB Protocol | Obtained the same measurement for | |
| rectal capacity and compliance as the | ||
| Submission Device when running the | ||
| same RBB Protocol | ||
| Software | ||
| Validation | Substantial equivalency | |
| demonstrated | Information not readily available by | |
| manufacturer. | ||
| Measurement | ||
| Accuracy | Substantial equivalency | |
| demonstrated | Information not readily available by | |
| manufacturer. | ||
| Measurement | ||
| Consistency | Substantial equivalency | |
| demonstrated | Information not readily available by | |
| manufacturer. |
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
6
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 for | ||
| Use | 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. | The Barostat Catheter 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. | ||
| 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, polyolefin | |
| balloon | Polyvinylchloride tubing, polyolefin | |
| balloon | ||
| Length | 100 cm | Various (100 cm standard) |
| Connector End | Female luer | Polyvinylchloride tubing (10 cm |
| length, OD 7.9 mm, ID 4.8 mm) | ||
| Number of uses | Single-use | Single-use and reusable models |
| Balloon Burst | ||
| and Leak Tests | Substantial equivalency | |
| demonstrated | 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
| Tensile
Strength Test of
Bonded/Glued
Catheter
Components | 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 |