(259 days)
The mcompass Biofeedback Anorectal Manometry System is for use on patients requiring anorectal pressure studies and biofeedback therapy.
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
The provided text describes a 510(k) premarket notification for the mcompass Biofeedback Anorectal Manometry System (K143031). It focuses on demonstrating substantial equivalence to a predicate device (mcompass Anorectal Manometry System, K120088) rather than detailing specific acceptance criteria and a study to prove they are met in the same way one might for a novel AI device.
Therefore, the requested information, particularly regarding AI-specific criteria, sample sizes for test/training sets, expert adjudication methods, and MRMC studies, is not present in this document. This document pertains to the regulatory clearance of a physical medical device.
However, I can extract the information that is present regarding performance data and validation:
1. A table of acceptance criteria and the reported device performance
Since this is a 510(k) submission for substantial equivalence to an existing device, a direct "acceptance criteria" table with numerical performance targets similar to a novel AI algorithm's sensitivity/specificity is not explicitly stated. Instead, the "performance data" section focuses on demonstrating that the new device meets various safety and functional standards, and that its technological differences do not raise new questions of safety or effectiveness compared to the predicate.
| Category | Acceptance Criteria (Implied by Standards) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Complies with ISO 10993-5 (Cytotoxicity), ISO 10993-11 (Systemic Toxicity), ISO 10993-10 (Intracutaneous Injection Test, Sensitivity) for surface-contacting devices (<24 hours mucosal exposure). | Meets the specified ISO 10993 standards for Cytotoxicity (Elution Test & Neutral Red Uptake), Systemic Toxicity, Intracutaneous Injection Test (Irritation), and Kligman Maximization Test (Sensitivity). |
| Mechanical Testing | Meets standards for physical characteristics, system leak pressure, and burst pressure. | • Physical characteristics• System leak pressure• Burst pressure(All implicitly met as "Performance data" is listed and no deficiencies are noted.) |
| Electrical Safety and EMC | Complies with current standards for electrical safety and Electromagnetic Compatibility (EMC). | Meets current standards for electrical safety and EMC. |
| Software Verification and Validation | Complies with FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 2005). | Software verification and validation testing were conducted, and documentation was provided as recommended by the FDA guidance. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The submission focuses on device engineering, safety, and software validation rather than a clinical performance study with a test set of patient data.
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)
This information is not provided in the document. As mentioned, the submission doesn't detail a clinical performance study with a test set requiring expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
This information is not provided in the document. The device is not an AI-assisted diagnostic tool, but rather a system for anorectal manometry and biofeedback.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the device is not an algorithm performing a diagnostic task. It is a physical system with software for data collection, recording, and display. The software's performance was validated, but not as a "standalone algorithm" in the typical sense of AI product evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the software verification and validation, the "ground truth" would be defined by the software requirements and design specifications, with correctness verified through testing against expected outputs. For the device components, the ground truth is adherence to the specified engineering standards (e.g., ISO, electrical safety norms) and mechanical properties. There is no biological "ground truth" mentioned in the context of a clinical study in this document.
8. The sample size for the training set
This information is not provided in the document. This is not an AI device that would typically have a "training set" of patient data.
9. How the ground truth for the training set was established
This information is not provided in the document, as it is not applicable to this type of device submission.
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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 (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, LLC2718 Summer Street NEMinneapolis, MN 55413 |
|---|---|
| Contact Person: | Jim QuackenbushChief Executive OfficerTelephone: 763-244-1079Fax: 612-789-2708Email: 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 CFR876.1725) |
| 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 amanometry system for the measurement of anorectalpressures. It provides visual feedback (biofeedback) of themuscle action allowing the patient to modulate the activity ofthe anorectal muscles, thereby reeducating the pelvic floormuscles. It is used in a clinical setting and consists of a non-sterile disposable catheter (2-channel or 5-channel), apreviously cleared reusable RMD FOB (and related batterycharger), and software that resides on a tablet PC and thatcollects, records and displays the pressure data.Air-charged balloons are used to measure contractile pressuresof the anorectal canal and simulate a range of bowel fullnesslevels, in addition to measuring locational pressure at thedistal tip of the catheter. During the clinical procedure, thedistal end of the catheter is inserted in the anus/rectum of thepatient. The proximal end of the catheter is connected via anintegrated cable to the handheld RMD FOB which transmitsreal-time pressure data wirelessly to the mcompass softwareon 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 theTechnologicalCharacteristics withthe PredicateDevice: | The subject device is identical to the predicate device in thefollowing ways:• Each of the devices is intended to measure anorectalpressures.• Each of the devices has separate channels for measuringanal 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 isfilled with air and measures distal rectal locationalpressure.• Each of the devices has markings to indicate catheterinsertion depth.• Each of the devices is sold non-sterile.• Each of the devices is a single use device (not to besterilized or reused). |
| The following technological differences exist between thesubject 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 (mucosalmembranes) for a duration of less than 24 hours (limitedexposure) 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 10993-5Mechanical Testing | |
| • Physical characteristics | |
| • System leak pressure | |
| • Burst pressure | |
| Electrical safety and Electromagnetic Compatibility(EMC)The electrical components of the mcompass BiofeedbackAnorectal Manometry System meet the current standards forelectrical safety and EMC. | |
| Software Verification and Validation TestingSoftware verification and validation testing were conductedand documentation was provided as recommended by FDA'sGuidance for Industry and Staff, "Guidance for the Content ofPremarket Submissions for Software Contained in MedicalDevices" (May 2005). | |
| Conclusion: | The information submitted in this premarket notificationdemonstrates that the mcompass Biofeedback AnorectalManometry System performs as intended in the specified useconditions and supports the determination that the device issubstantially equivalent in principles of operation, technology,materials and indications for use to the predicate device listedabove. |
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§ 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).