mcompass Biofeedback Anorectal Manometry System

K143031 · Medspira, LLC · KLA · Jul 7, 2015 · Gastroenterology, Urology

Device Facts

• Record ID: K143031
• Device Name: mcompass Biofeedback Anorectal Manometry System
• Applicant: Medspira, LLC
• Product Code: KLA · Gastroenterology, Urology
• Decision Date: Jul 7, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The mcompass Biofeedback Anorectal Manometry System is for use on patients requiring anorectal pressure studies and biofeedback therapy.

Device Story

System measures anorectal pressures; provides visual biofeedback to patient for pelvic floor muscle reeducation. Components: non-sterile disposable 2-channel or 5-channel catheter; reusable RMD FOB (handheld transmitter); tablet PC with software. Procedure: catheter inserted into anus/rectum; air-charged balloons measure contractile pressures and simulate bowel fullness; locational pressure measured at distal tip. Catheter connects to RMD FOB; data transmitted wirelessly to tablet PC. Software collects, records, and displays real-time pressure data. Used in clinical settings by healthcare providers. Visual feedback allows patients to modulate muscle activity; aids in treating anorectal dysfunction.

Clinical Evidence

Bench testing only. Includes biocompatibility (ISO 10993-5, -10, -11), mechanical testing (physical characteristics, system leak pressure, burst pressure), electrical safety, and electromagnetic compatibility (EMC). Software verification and validation conducted per FDA guidance.

Technological Characteristics

Air-charged (air-filled) measurement balloons; urethane rectal balloon. 2-channel or 5-channel disposable catheter. Wireless transmission via RMD FOB to tablet PC. Non-sterile, single-use. Biocompatibility per ISO 10993. Electrical safety and EMC compliance.

Indications for Use

Indicated for patients requiring anorectal pressure studies and biofeedback therapy for pelvic floor muscle reeducation.

Regulatory Classification

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.

Predicate Devices

• mcompass Anorectal Manometry System (K120088)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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<br>2718 Summer Street NE<br>Minneapolis, MN 55413 |
|----------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jim Quackenbush<br>Chief Executive Officer<br>Telephone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| 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<br>876.1725) |
| Regulatory Class: | II |
| Product Code: | KLA, HCC |
| Predicate Device: | mcompass Anorectal Manometry System (K120088)<br>This device has not been subject to a design-related recall. |
| Device Description: | The mcompass Biofeedback Anorectal Manometry System is a<br>manometry system for the measurement of anorectal<br>pressures. It provides visual feedback (biofeedback) of the<br>muscle action allowing the patient to modulate the activity of<br>the anorectal muscles, thereby reeducating the pelvic floor<br>muscles. It is used in a clinical setting and consists of a non-<br>sterile disposable catheter (2-channel or 5-channel), a<br>previously cleared reusable RMD FOB (and related battery<br>charger), and software that resides on a tablet PC and that<br>collects, records and displays the pressure data.<br>Air-charged balloons are used to measure contractile pressures<br>of the anorectal canal and simulate a range of bowel fullness<br>levels, in addition to measuring locational pressure at the<br>distal tip of the catheter. During the clinical procedure, the<br>distal end of the catheter is inserted in the anus/rectum of the<br>patient. The proximal end of the catheter is connected via an<br>integrated cable to the handheld RMD FOB which transmits<br>real-time pressure data wirelessly to the mcompass software<br>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<br>Technological<br>Characteristics with<br>the Predicate<br>Device: | The subject device is identical to the predicate device in the<br>following ways:<br>• Each of the devices is intended to measure anorectal<br>pressures.<br>• Each of the devices has separate channels for measuring<br>anal canal pressures and distal rectal pressures.<br>• Each of the devices uses air-charged (i.e. air-filled)<br>measurement balloons.<br>• Each of the devices has a urethane rectal balloon that is<br>filled with air and measures distal rectal locational<br>pressure.<br>• Each of the devices has markings to indicate catheter<br>insertion depth.<br>• Each of the devices is sold non-sterile.<br>• Each of the devices is a single use device (not to be<br>sterilized or reused). |
| | The following technological differences exist between the<br>subject device and the predicate device:<br>• Configuration of the measurement balloons<br>• Rectal balloon positioning<br>• Working length<br>• Biofeedback User software |
| Performance Data: | Biocompatibility |
| | The catheter is considered surface contacting (mucosal<br>membranes) for a duration of less than 24 hours (limited<br>exposure) and meets the following:<br>• Cytotoxicity (Elution Test) per ISO 10993-5<br>• Systemic Toxicity per ISO 10993-11<br>• Intracutaneous Injection Test (Irritation) per ISO 10993-<br>10<br>• Kligman Maximization Test (Sensitivity) per ISO 10993-<br>10<br>• Neutral Red Uptake Cytotoxicity Test per ISO 10993-5<br>Mechanical Testing |
| | • Physical characteristics<br> |
| | • System leak pressure<br> |
| | • Burst pressure |
| | Electrical safety and Electromagnetic Compatibility<br>(EMC)<br>The electrical components of the mcompass Biofeedback<br>Anorectal Manometry System meet the current standards for<br>electrical safety and EMC. |
| | Software Verification and Validation Testing<br>Software verification and validation testing were conducted<br>and documentation was provided as recommended by FDA's<br>Guidance for Industry and Staff, "Guidance for the Content of<br>Premarket Submissions for Software Contained in Medical<br>Devices" (May 2005). |
| Conclusion: | The information submitted in this premarket notification<br>demonstrates that the mcompass Biofeedback Anorectal<br>Manometry System performs as intended in the specified use<br>conditions and supports the determination that the device is<br>substantially equivalent in principles of operation, technology,<br>materials and indications for use to the predicate device listed<br>above. |

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