(259 days)
Not Found
No
The description focuses on pressure measurement, biofeedback, and data display. There is no mention of AI or ML in the device description, intended use, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The system is used for biofeedback therapy, which is a therapeutic intervention involving re-education of pelvic floor muscles and modulating muscle activity.
Yes
Explanation: The device is used for "anorectal pressure studies" and measures "anorectal pressures," which are diagnostic procedures to assess the function of the anorectal muscles. It collects, records, and displays pressure data to help understand a patient's condition.
No
The device description explicitly states it consists of a non-sterile disposable catheter, a reusable RMD FOB (and battery charger), and software. This includes significant hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition.
- Device Function: The mcompass Biofeedback Anorectal Manometry System directly measures physical pressures within the anorectal canal. It does not analyze biological specimens taken from the body.
- Intended Use: The intended use is for "anorectal pressure studies and biofeedback therapy," which involves direct physiological measurement and therapeutic intervention, not the analysis of biological samples.
- Device Description: The description details the use of a catheter inserted into the body to measure pressure, not the processing of a specimen.
Therefore, the device falls under the category of a medical device used for physiological measurement and therapy, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The mcompass Biofeedback Anorectal Manometry System is for use on patients requiring anorectal pressure studies and biofeedback therapy.
Product codes
KLA, HCC
Device Description
The mcompass Biofeedback Anorectal Manometry System is a manometry system for the measurement of anorectal pressures. It provides visual feedback (biofeedback) of the muscle action allowing the patient to modulate the activity of the anorectal muscles, thereby reeducating the pelvic floor muscles. It is used in a clinical setting and consists of a non-sterile disposable catheter (2-channel or 5-channel), a previously cleared reusable RMD FOB (and related battery charger), and software that resides on a tablet PC and that collects, records and displays the pressure data. Air-charged balloons are used to measure contractile pressures of the anorectal canal and simulate a range of bowel fullness levels, in addition to measuring locational pressure at the distal tip of the catheter. During the clinical procedure, the distal end of the catheter is inserted in the anus/rectum of the patient. The proximal end of the catheter is connected via an integrated cable to the handheld RMD FOB which transmits real-time pressure data wirelessly to the mcompass software on the PC
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anorectal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinical setting
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
Biocompatibility: The catheter is considered surface contacting (mucosal membranes) for a duration of less than 24 hours (limited exposure) and meets the following:
• Cytotoxicity (Elution Test) per ISO 10993-5
• Systemic Toxicity per ISO 10993-11
• Intracutaneous Injection Test (Irritation) per ISO 10993-10
• Kligman Maximization Test (Sensitivity) per ISO 10993-10
• Neutral Red Uptake Cytotoxicity Test per ISO 10993-5
Mechanical Testing:
• Physical characteristics
• System leak pressure
• Burst pressure
Electrical safety and Electromagnetic Compatibility (EMC): The electrical components of the mcompass Biofeedback Anorectal Manometry System meet the current standards for electrical safety and EMC.
Software Verification and Validation Testing: Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 2005).
Key Metrics
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).
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name in a circular arrangement around a stylized caduceus symbol. The caduceus is represented by three intertwined human profiles facing right. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 7, 2015
Medspira, LLC Jim Quackenbush CEO 2718 Summer Street N.E. Minneapolis, MN 55413
Re: K143031
Trade/Device Name: mcompass Biofeedback Anorectal Manometry System Regulation Number: 21 CFR §876.1725 Regulation Name: Gastrointestinal motility monitoring system Regulatory Class: II Product Code: KLA, HCC Dated: Mav 27, 2015 Received: June 1, 2015
Dear Jim Quackenbush,
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,
Benjamin R. Fisher -S
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) K143031
Device Name
mcompass Biofeedback Anorectal Manometry System
Indications for Use (Describe)
The mcompass Biofeedback Anorectal Manometry System is for use on patients requiring anorectal pressure studies and biofeedback therapy.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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5.0 510(k) Summary
| Submitter: | Medspira, LLC
2718 Summer Street NE
Minneapolis, MN 55413 |
|----------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jim Quackenbush
Chief Executive Officer
Telephone: 763-244-1079
Fax: 612-789-2708
Email: jquackenbush@medspira.com |
| Date Prepared: | October 17, 2014 |
| Trade Name: | mcompass™ Biofeedback Anorectal Manometry System |
| Common Name: | Gastrointestinal monitoring system |
| Classification Name: | Gastrointestinal motility monitoring system (21 CFR
876.1725) |
| Regulatory Class: | II |
| Product Code: | KLA, HCC |
| Predicate Device: | mcompass Anorectal Manometry System (K120088)
This device has not been subject to a design-related recall. |
| Device Description: | The mcompass Biofeedback Anorectal Manometry System is a
manometry system for the measurement of anorectal
pressures. It provides visual feedback (biofeedback) of the
muscle action allowing the patient to modulate the activity of
the anorectal muscles, thereby reeducating the pelvic floor
muscles. It is used in a clinical setting and consists of a non-
sterile disposable catheter (2-channel or 5-channel), a
previously cleared reusable RMD FOB (and related battery
charger), and software that resides on a tablet PC and that
collects, records and displays the pressure data.
Air-charged balloons are used to measure contractile pressures
of the anorectal canal and simulate a range of bowel fullness
levels, in addition to measuring locational pressure at the
distal tip of the catheter. During the clinical procedure, the
distal end of the catheter is inserted in the anus/rectum of the
patient. The proximal end of the catheter is connected via an
integrated cable to the handheld RMD FOB which transmits
real-time pressure data wirelessly to the mcompass software
on the PC |
| Indications for Use: | The mcompass Biofeedback Anorectal Manometry System is |
| | for use on patients requiring anorectal pressure studies and |
| | biofeedback therapy. |
| Comparison of the
Technological
Characteristics with
the Predicate
Device: | The subject device is identical to the predicate device in the
following ways:
• Each of the devices is intended to measure anorectal
pressures.
• Each of the devices has separate channels for measuring
anal canal pressures and distal rectal pressures.
• Each of the devices uses air-charged (i.e. air-filled)
measurement balloons.
• Each of the devices has a urethane rectal balloon that is
filled with air and measures distal rectal locational
pressure.
• Each of the devices has markings to indicate catheter
insertion depth.
• Each of the devices is sold non-sterile.
• Each of the devices is a single use device (not to be
sterilized or reused). |
| | The following technological differences exist between the
subject device and the predicate device:
• Configuration of the measurement balloons
• Rectal balloon positioning
• Working length
• Biofeedback User software |
| Performance Data: | Biocompatibility |
| | The catheter is considered surface contacting (mucosal
membranes) for a duration of less than 24 hours (limited
exposure) and meets the following:
• Cytotoxicity (Elution Test) per ISO 10993-5
• Systemic Toxicity per ISO 10993-11
• Intracutaneous Injection Test (Irritation) per ISO 10993-
10
• Kligman Maximization Test (Sensitivity) per ISO 10993-
10
• Neutral Red Uptake Cytotoxicity Test per ISO 10993-5
Mechanical Testing |
| | • Physical characteristics
|
| | • System leak pressure
|
| | • Burst pressure |
| | Electrical safety and Electromagnetic Compatibility
(EMC)
The electrical components of the mcompass Biofeedback
Anorectal Manometry System meet the current standards for
electrical safety and EMC. |
| | Software Verification and Validation Testing
Software verification and validation testing were conducted
and documentation was provided as recommended by FDA's
Guidance for Industry and Staff, "Guidance for the Content of
Premarket Submissions for Software Contained in Medical
Devices" (May 2005). |
| Conclusion: | The information submitted in this premarket notification
demonstrates that the mcompass Biofeedback Anorectal
Manometry System performs as intended in the specified use
conditions and supports the determination that the device is
substantially equivalent in principles of operation, technology,
materials and indications for use to the predicate device listed
above. |
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