(78 days)
Not Found
No
The summary describes a system for measuring and displaying pressure data, with no mention of AI, ML, or any analytical capabilities beyond data collection and display.
No
The device is described as a manometry system for measurement and display of data, specifically for anorectal pressure studies. It does not provide any form of treatment or therapy.
Yes
Explanation: The device is used for "anorectal pressure studies" and measures "anorectal pressures," which are diagnostic procedures to assess conditions related to the anorectal canal.
No
The device description explicitly states it consists of a non-sterile disposable catheter and a reusable RMD FOB, in addition to the software. These are hardware components essential to the device's function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body ("in vitro").
- Device Function: The mcompass Anorectal Manometry System directly measures pressures within the anorectal canal inside the patient's body. It involves inserting a catheter into the anus/rectum.
- Lack of Sample Analysis: The description does not mention the analysis of any biological samples taken from the patient. The device is measuring a physical parameter (pressure) directly within the body.
Therefore, the mcompass Anorectal Manometry System is a medical device used for physiological measurement in vivo, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The mcompass Anorectal Manometry System is for use on patients requiring anorectal pressure studies.
Product codes (comma separated list FDA assigned to the subject device)
KLA
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anus/rectum
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Used in a 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
To verify that device design met it's functional and performance requirements, representative samples of the device underwent mechanical, electrical, and biocompatibility testing in accordance with the applicable industry standards listed below:
ISO 10993-5 (2009) Biological Evaluation of Medical Devices - Part 5: Tests for Vitro Cytotoxicity
ISO 10993-12 (2007) Biological Evaluation of Medical Devices - Part 12: Sample Preparation and Reference Materials
ISO 10993-10 (2010) Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization
ISO 10993-11 (2006) Biological Evaluation of Medical Devices - Part 11: Tests for Systemic Toxicity
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 (+A1:1991 and A2:1995)
EN 60601-1-4 (2000) Medical Electrical Equipment - Part 1-4: General Requirements for Collateral Standard: Programmable Electrical Medical Systems
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Latitude Ano-Rectal Pressure Catheter (K022023), Latitude Directional Anorectal Manometry Catheter (510(k) number not available), uroNIRS 2000 (K082701), Manoscan 360AR (K031169)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
0
K120088
PAGE 1 OF 2
MAR 2 9 2012
.
:
5.0 510(k) Summary ﺗ
.
| Submitter: | Medspira
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 28, 2011 |
| Trade Name: | mcompass™ Anorectal Manometry System |
| Common Name: | Gastrointestinal monitoring system |
| Classification: | Class II, Gastrointestinal motility monitoring system (21 CFR
876.1725) |
| 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 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. |
| Intended Use: | The mcompass Anorectal Manometry System is for use on
patients requiring anorectal pressure studies. |
Medspira, LLC
.
Page 19 of 102
1
| Functional and
Safety Testing: | To verify that device design met it's functional and performance
requirements, representative samples of the device underwent
mechanical, electrical, and biocompatibility testing in
accordance with the applicable industry standards listed below:
ISO 10993-5 (2009) Biological Evaluation of
Medical Devices - Part 5: Tests for Vitro
Cytotoxicity ISO 10993-12 (2007) Biological Evaluation of
Medical Devices - Part 12: Sample Preparation and
Reference Materials ISO 10993-10 (2010) Biological Evaluation of
Medical Devices - Part 10: Tests for Irritation and
Skin Sensitization ISO 10993-11 (2006) Biological Evaluation of
Medical Devices - Part 11: Tests for Systemic
Toxicity 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 (+A1:1991
and A2:1995) EN 60601-1-4 (2000) Medical Electrical Equipment - Part 1-4: General Requirements for Collateral
Standard: Programmable Electrical Medical Systems |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion: | The information submitted in this premarket notification
supports the determination that the Medspira mcompass
Anorectal Manometry System is substantially equivalent in
principles of operation, technology, materials and indications for
use to the predicate devices listed above. |
:
·
·
:
Medspira, LLC
・
. .
ﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ
Page 20 of 102
.
2
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
3
Page 2-
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
4
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
Page 18 of 102