MCOMPASS ANORECTAL MANOMETRY SYSTEM

K120088 · Medspira, LLC · KLA · Mar 29, 2012 · Gastroenterology, Urology

Device Facts

• Record ID: K120088
• Device Name: MCOMPASS ANORECTAL MANOMETRY SYSTEM
• Applicant: Medspira, LLC
• Product Code: KLA · Gastroenterology, Urology
• Decision Date: Mar 29, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1725
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The mcompass Anorectal Manometry System is for use on patients requiring anorectal pressure studies.

Device Story

mcompass Anorectal Manometry System measures anorectal pressures in clinical settings. System components: non-sterile disposable catheter, reusable RMD FOB (handheld unit), and tablet PC software. Procedure: distal end of catheter inserted into patient's anus/rectum; proximal end connects to RMD FOB; RMD FOB transmits real-time pressure data wirelessly to tablet PC. Catheter features: four small air-charged radial balloons for anorectal canal contractile pressure measurement; one distal balloon for bowel fullness simulation and locational pressure measurement. Software collects, records, and displays pressure data for clinician review. Output assists healthcare providers in assessing anorectal function and making clinical decisions regarding patient motility disorders.

Clinical Evidence

No clinical data. Evidence based on bench testing, including mechanical, electrical, and biocompatibility testing (ISO 10993-5, -10, -11, -12; EN 60601-1-2; IEC 60601-1; EN 60601-1-4).

Technological Characteristics

System includes non-sterile disposable catheter with five air-charged balloons, reusable handheld RMD FOB, and tablet PC. Connectivity: wireless transmission from FOB to PC. Standards: ISO 10993 (biocompatibility), IEC 60601-1 (safety), EN 60601-1-2 (EMC), EN 60601-1-4 (programmable electrical medical systems).

Indications for Use

Indicated for patients requiring anorectal pressure studies.

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

• Latitude Ano-Rectal Pressure Catheter (K022023)
• Latitude Directional Anorectal Manometry Catheter (510(k) number not available)
• uroNIRS 2000 (K082701)
• Manoscan 360AR (K031169)

Submission Summary (Full Text)

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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: | Medspira<br>2718 Summer Street NE<br>Minneapolis, MN 55413 |
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| Contact Person: | Jim Quackenbush<br>Chief Executive Officer<br>Telephone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Date Prepared: | October 28, 2011 |
| Trade Name: | mcompass™ Anorectal Manometry System |
| Common Name: | Gastrointestinal monitoring system |
| Classification: | Class II, Gastrointestinal motility monitoring system (21 CFR<br>876.1725) |
| Product Code: | KLA |
| Predicate Device(s): | Latitude Ano-Rectal Pressure Catheter (K022023) Latitude Directional Anorectal Manometry Catheter<br>(510(k) number not available) uroNIRS 2000 (K082701) Manoscan 360AR (K031169) |
| Device Description: | The mcompass device is a manometry system for the<br>measurement of anorectal pressures. It is used in a clinical<br>setting and consists of a non-sterile disposable catheter, a<br>reusable RMD FOB, and software that resides on a tablet PC<br>that collects, records and displays data.<br>During the clinical procedure, the distal end of the catheter is<br>inserted in the anus/rectum of the patient. The proximal end of<br>the catheter is connected via an integrated cable to the handheld<br>RMD FOB which transmits real-time pressure data wirelessly to<br>the mcompass software on the PC.<br>Pressures are measured via four small, air-charged, radial<br>balloons evenly spaced around the distal circumference of the<br>catheter and a fifth larger balloon, positioned near the distal tip.<br>The four small balloons measure radial contractile pressures of<br>the anorectal canal while the most distal balloon is used to<br>simulate a range of bowel fullness levels, in addition to<br>measuring locational pressure. |
| Intended Use: | The mcompass Anorectal Manometry System is for use on<br>patients requiring anorectal pressure studies. |

Medspira, LLC

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| Functional and<br>Safety Testing: | To verify that device design met it's functional and performance<br>requirements, representative samples of the device underwent<br>mechanical, electrical, and biocompatibility testing in<br>accordance with the applicable industry standards listed below:<br>ISO 10993-5 (2009) Biological Evaluation of<br>Medical Devices - Part 5: Tests for Vitro<br>Cytotoxicity ISO 10993-12 (2007) Biological Evaluation of<br>Medical Devices - Part 12: Sample Preparation and<br>Reference Materials ISO 10993-10 (2010) Biological Evaluation of<br>Medical Devices - Part 10: Tests for Irritation and<br>Skin Sensitization ISO 10993-11 (2006) Biological Evaluation of<br>Medical Devices - Part 11: Tests for Systemic<br>Toxicity EN 60601-1-2 (2001) Medical Electrical Equipment<br>- Part 1: General Requirements for Safety, 2:<br>Collateral Standard: Electromagnetic Compatibility -<br>Requirements and Tests IEC 60601-1 (1988) Medical electrical equipment -<br>Part 1: general requirements for safety (+A1:1991<br>and A2:1995) EN 60601-1-4 (2000) Medical Electrical Equipment<br>- Part 1-4: General Requirements for Collateral<br>Standard: Programmable Electrical Medical Systems |
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| Conclusion: | The information submitted in this premarket notification<br>supports the determination that the Medspira mcompass<br>Anorectal Manometry System is substantially equivalent in<br>principles of operation, technology, materials and indications for<br>use 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 [phone] or [phone] 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) | |
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| Division of Reproductive, Gastro-Renal, and Urological Devices | |
| 510(k) Number | K120088 |

Medspira, LLC

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