(78 days)
The mcompass Anorectal Manometry System is for use on patients requiring anorectal pressure studies.
The mcompass device is a manometry system for the measurement of anorectal pressures. It is used in a clinical setting and consists of a non-sterile disposable catheter, a reusable RMD FOB, and software that resides on a tablet PC that collects, records and displays data. 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. Pressures are measured via four small, air-charged, radial balloons evenly spaced around the distal circumference of the catheter and a fifth larger balloon, positioned near the distal tip. The four small balloons measure radial contractile pressures of the anorectal canal while the most distal balloon is used to simulate a range of bowel fullness levels, in addition to measuring locational pressure.
The Medspira mcompass™ Anorectal Manometry System did not report specific acceptance criteria or detailed study results in the provided document. The submission is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting full clinical trial data with predefined acceptance criteria.
The information provided describes the device, its intended use, predicate devices, and the types of testing performed to ensure its functional and performance requirements.
Here's a breakdown of the available information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria:
Specific quantitative acceptance criteria (e.g., accuracy thresholds, sensitivity/specificity targets) for the device's clinical performance are not explicitly stated in the provided document. The submission focuses on compliance with general functional, safety, and performance requirements through various standards.
Reported Device Performance:
The document states that "representative samples of the device underwent mechanical, electrical, and biocompatibility testing in accordance with the applicable industry standards." However, the quantitative results or specific performance metrics from these tests (e.g., exact pressure measurement accuracies, reliability figures) are not provided. The conclusion is simply that the device design "met its functional and performance requirements" and is "substantially equivalent" to predicate devices.
2. Sample Size for Test Set and Data Provenance
No information regarding a "test set" in the context of clinical performance or algorithm evaluation is provided. The functional and safety testing mentioned likely refers to laboratory-based engineering and safety tests rather than a clinical study test set for assessing diagnostic or prognostic performance. Therefore, sample size for a test set and data provenance (country of origin, retrospective/prospective) are not applicable or not reported.
3. Number of Experts and Qualifications for Ground Truth
No information regarding a clinical study involving human experts to establish ground truth is provided. The device is a measurement system, and its "ground truth" would typically relate to the accuracy of its physical measurements against known standards, which is addressed by the functional and performance testing mentioned.
4. Adjudication Method
As no clinical study with human interpretation or expert-based ground truth is described, adjudication methods are not applicable or not reported.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study is mentioned. This device is a measurement system, not an AI-assisted diagnostic tool that would typically involve human readers interpreting output.
6. Standalone (Algorithm Only) Performance Study
The document does not describe an "algorithm only" performance study in the context of AI. The device includes software that "collects, records and displays data," implying a user interface for clinicians. The performance described relates to the accuracy of pressure measurements by the system as a whole.
7. Type of Ground Truth Used
For the functional and performance testing mentioned:
- Physical standards/calibrations: The "ground truth" for pressure measurements would be established through calibrated pressure sources and other physical reference standards used during the mechanical and electrical testing.
- Industry standards: Biocompatibility testing relies on established biological evaluation standards (ISO 10993 series).
8. Sample Size for Training Set
The document does not describe the use of machine learning algorithms requiring a "training set" in the context of AI. The software primarily handles data collection, recording, and display. Therefore, sample size for a training set is not applicable or not reported.
9. How Ground Truth for Training Set Was Established
As no training set for a machine learning algorithm is mentioned, this information is not applicable or not reported.
In summary: The provided document is a 510(k) summary for a medical device that measures anorectal pressures. It demonstrates substantial equivalence through compliance with safety and performance standards rather than presenting detailed clinical performance data with specific acceptance criteria, clinical study designs, or AI-specific evaluation metrics. The "study" referenced refers to laboratory-based functional, electrical, and biocompatibility testing against recognized industry standards.
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K120088
PAGE 1 OF 2
MAR 2 9 2012
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5.0 510(k) Summary ﺗ
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| Submitter: | Medspira2718 Summer Street NEMinneapolis, MN 55413 |
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| Contact Person: | Jim QuackenbushChief Executive OfficerTelephone: 763-244-1079Fax: 612-789-2708Email: jquackenbush@medspira.com |
| Date Prepared: | October 28, 2011 |
| Trade Name: | mcompass™ Anorectal Manometry System |
| Common Name: | Gastrointestinal monitoring system |
| Classification: | Class II, Gastrointestinal motility monitoring system (21 CFR876.1725) |
| Product Code: | KLA |
| Predicate Device(s): | Latitude Ano-Rectal Pressure Catheter (K022023) Latitude Directional Anorectal Manometry Catheter(510(k) number not available) uroNIRS 2000 (K082701) Manoscan 360AR (K031169) |
| Device Description: | The mcompass device is a manometry system for themeasurement of anorectal pressures. It is used in a clinicalsetting and consists of a non-sterile disposable catheter, areusable RMD FOB, and software that resides on a tablet PCthat collects, records and displays data.During the clinical procedure, the distal end of the catheter isinserted in the anus/rectum of the patient. The proximal end ofthe catheter is connected via an integrated cable to the handheldRMD FOB which transmits real-time pressure data wirelessly tothe mcompass software on the PC.Pressures are measured via four small, air-charged, radialballoons evenly spaced around the distal circumference of thecatheter and a fifth larger balloon, positioned near the distal tip.The four small balloons measure radial contractile pressures ofthe anorectal canal while the most distal balloon is used tosimulate a range of bowel fullness levels, in addition tomeasuring locational pressure. |
| Intended Use: | The mcompass Anorectal Manometry System is for use onpatients requiring anorectal pressure studies. |
Medspira, LLC
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| Functional andSafety Testing: | To verify that device design met it's functional and performancerequirements, representative samples of the device underwentmechanical, electrical, and biocompatibility testing inaccordance with the applicable industry standards listed below:ISO 10993-5 (2009) Biological Evaluation ofMedical Devices - Part 5: Tests for VitroCytotoxicity ISO 10993-12 (2007) Biological Evaluation ofMedical Devices - Part 12: Sample Preparation andReference Materials ISO 10993-10 (2010) Biological Evaluation ofMedical Devices - Part 10: Tests for Irritation andSkin Sensitization ISO 10993-11 (2006) Biological Evaluation ofMedical Devices - Part 11: Tests for SystemicToxicity EN 60601-1-2 (2001) Medical Electrical Equipment- Part 1: General Requirements for Safety, 2:Collateral Standard: Electromagnetic Compatibility -Requirements and Tests IEC 60601-1 (1988) Medical electrical equipment -Part 1: general requirements for safety (+A1:1991and A2:1995) EN 60601-1-4 (2000) Medical Electrical Equipment- Part 1-4: General Requirements for CollateralStandard: Programmable Electrical Medical Systems |
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| Conclusion: | The information submitted in this premarket notificationsupports the determination that the Medspira mcompassAnorectal Manometry System is substantially equivalent inprinciples of operation, technology, materials and indications foruse to the predicate devices listed above. |
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Medspira, LLC
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle's head is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Medspira, LLC % Mr. William Sammons Sr. Project Engineer, Sr. Reviewer - Medical Devices Intertek Testing Services 2307 East Aurora Rd. Unit B7 TWINSBURG OH 44087
MAR 2 9 :2012
Re: K120088
Trade/Device Name: mcompass™ Anorectal Manometry System Regulation Number: 21 CFR§ 876.1725 Regulation Name: Gastrointestinal motility monitoring system Regulatory Class: II Product Code: KLA Dated: March 9, 2012 Received: March 14, 2012
Dear Mr. Sammons:
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. 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
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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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerély vours,
Sincerely yours,
Benjamin K-twka
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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4.0 Indications for Use Statement
Device Name: mcompass™ Anorectal Manometry System
Indications for Use:
The mcompass Anorectal Manometry System is for use on patients requiring anorectal pressure studies.
Prescription Use X (21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Gastro-Renal, and Urological Devices | |
| 510(k) Number | K120088 |
Medspira, LLC
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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).