(135 days)
The Compass™ GP disposable pressure transducer with integrated digital display is intended for direct measurement of physiological pressure.
The Compass™ Thoracentesis disposable pressure transducer with integrated digital display is intended for direct measurement of physiological pressure.
The Compass™ Paracentesis disposable pressure transducer with integrated digital display is intended for direct measurement of physiological pressure.
The Compass™ Compartment Pressure disposable pressure transducer with integrated digital display is intended for direct measurement of physiological pressure.
The Compass™ Epidural Assist disposable pressure transducer with integrated digital display is intended for direct measurement of physiological pressure.
The Compass™ Arterial Assist disposable pressure transducer with integrated digital display is intended for direct measurement of physiological pressure.
The Compass devices are disposable, point-of-use pressure measurement and monitoring devices that incorporate a pressure transducer and an integrated pre-programmed diagnostic computer with liquid crystal display (LCD). The Compass devices are designed to attach distally to an inserted needle or catheter, measure the pressure via an embedded pressure sensor, internally convert changes in pressure into electrical currents, and then display the resulting pressure via the integrated LCD.
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Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly present a table of acceptance criteria with corresponding performance results. However, it indicates that "Pressure accuracy testing was completed per ANSVAAMI BP22:1994(R)2006." The study concludes that "The results from this in vitro testing demonstrate that the technological and performance characteristics of the Compass devices meet defined design requirements and that they can perform in a manner equivalent to devices currently on the market used for measuring physiological pressure." This implies that the device met the accuracy requirements specified in the ANSVAAMI BP22:1994(R)2006 standard, which served as the acceptance criteria for pressure accuracy. Specific numerical values for the acceptance criteria and the device's performance against them are not provided in this summary.
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Sample Size for Test Set and Data Provenance:
The document describes "in vitro testing" without specifying a particular sample size for a test set in the context of a dataset of medical images or patient records. The testing performed focused on physical device performance, specifically pressure accuracy, rather than evaluating an algorithm on a clinical dataset. The data provenance is related to the physical testing of the device.
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Number of Experts and Qualifications for Ground Truth:
Not applicable. The study is a device performance test (pressure accuracy) and does not involve establishing ground truth by medical experts for a diagnostic or AI-driven task.
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Adjudication Method for Test Set:
Not applicable. The study is a device performance test and does not involve adjudication of expert interpretations for a test set.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is a disposable pressure transducer with an integrated digital display, not an AI system designed to assist human readers in interpreting medical images or data.
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Standalone (Algorithm Only) Performance Study:
The device itself (Compass™) is the standalone device. The testing described is of the device's performance, specifically its pressure accuracy and software functionality. It's not an algorithm in the sense of a software-only diagnostic tool that would typically undergo a standalone performance study in the context of AI. The performance of the integrated pre-programmed diagnostic computer is assessed as part of the overall device.
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Type of Ground Truth Used:
For the pressure accuracy testing, the "ground truth" would have been established by a reference standard pressure measurement device or system, as per the ANSVAAMI BP22:1994(R)2006 standard. This is a technical (metrological) ground truth rather than clinical ground truth (e.g., pathology, outcomes data, or expert consensus on a diagnosis).
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Sample Size for Training Set:
Not applicable. The device is a physical pressure transducer with integrated software, not an AI system requiring a training set in the machine learning sense. The software is described as "integrated pre-programmed diagnostic computer" and "new software," suggesting it was developed through traditional software engineering processes, not by training on a dataset.
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How Ground Truth for Training Set Was Established:
Not applicable, as there is no "training set" in the context of this device's development. The software was likely developed and verified against functional and performance requirements through established software development lifecycles and testing protocols.
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Image /page/0/Picture/2 description: The image shows the logo for Mirador Biomedical. The logo consists of the letters "MB" with a circle around them, followed by the words "Mirador Biomedical". The "B" in "Biomedical" is outlined.
SECTION 5: 510(k) SUMMARY
In accordance with the requirements of 21 CFR 807.92(c) Mirador Biomedical, Inc. (hereafter "Mirador") has prepared this 510(k) Summary to provide information supporting the substantial equivalence of the Mirador Compass™.
General Information:
| Date of Summary Preparation: | 26 July 2011 |
|---|---|
| Name and Address of Manufacturer: | Mirador Biomedical, Inc.2815 Eastlake Ave E. Suite 220Seattle, Washington 98102 |
| Contact Person: | Justin Hulvershorn, MD, PhDChief Science OfficerPhone: (206) 295-3372 |
| Trade Names: | Compass™ GPCompass™ ThoracentesisCompass™ ParacentesisCompass™ Compartment PressureCompass™ Epidural AssistCompass™ Arterial Assist |
| Common Name: | Disposable Pressure Transducer |
| Device Classification: | Extravascular Blood Pressure TransducerSingle-Function, Preprogrammed Diagnostic Computer |
| Classification Panel: | Cardiovascular |
| CFR Reference: | 870.2850870.1435 |
| Product Code: | DRSDXG |
| Device Class: | Class II |
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Device Description: The Compass devices are disposable, point-of-use pressure measurement and monitoring devices that incorporate a pressure transducer and an integrated pre-programmed diagnostic computer with liquid crystal display (LCD). The Compass devices are designed to attach distally to an inserted needle or catheter, measure the pressure via an embedded pressure sensor, internally convert changes in pressure into electrical currents, and then display the resulting pressure via the integrated LCD.
Indications for Use: Consistent with the above device description, the Compass family of devices possesses the following indications for use:
The Compass™ GP disposable pressure transducer with integrated digital display is intended for direct measurement of physiological pressure.
The Compass™ Thoracentesis disposable pressure transducer with integrated digital display is intended for direct measurement of physiological pressure.
The Compass™ Paracentesis disposable pressure transducer with integrated digital display is intended for direct measurement of physiological pressure.
The Compass™ Compartment Pressure disposable pressure transducer with integrated digital display is intended for direct measurement of physiological pressure.
The Compass™ Epidural Assist disposable pressure transducer with integrated digital display is intended for direct measurement of physiological pressure.
The Compass™ Arterial Assist disposable pressure transducer with integrated digital display is intended for direct measurement of physiological pressure.
Substantially Equivalent Predicate Devices: The Compass devices are substantially equivalent to the following legally marketed devices with respect to classification, design principles and/or indications for use:
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7/3
Device Testing: The subject Compass products are new Compass models in an existing Mirador product line of disposable pressure sensors with integrated digital displays. The new Compass device models incorporate the exact physical elements (e.g. housing. electronics) contained in the predicate Mirador products (e.g. the Compass Vascular Access that was the subject of 510(k) K101518 & K103715), except for a modified LCD display.
All packaging materials, methods and processes and the sterilization process are identical to the predicate Compass VA device. Therefore, all prior packaging, sterilization, and shelf life testing of the predicate Compass device remain applicable to the subject Compass devices.
With respect to device performance, given the similarities in design and mechanical operation, tests completed on the predicate Compass VA and included previously in support of predicate Mirador 510(k) K101518 and K103715 have been used to verify design requirements for the subject Compass devices. However, the subject Compass devices include a modified LCD that allows for an extended pressure range and incorporates new software. Therefore, all verification tests related to the software and pressure accuracy that were completed to support the substantial equivalence of the predicate Compass VA were re-executed for the subject Compass devices. Pressure accuracy testing was completed per ANSVAAMI BP22:1994(R)2006.
The results from this in vitro testing demonstrate that the technological and performance characteristics of the Compass devices meet defined design requirements and that they can perform in a manner equivalent to devices currently on the market used for measuring physiological pressure.
Conclusion (Statement of Equivalence): The data and information presented within this submission support a determination of substantial equivalence, and therefore market clearance of the subject Compass devices.
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Image /page/3/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 wings. The eagle is facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
DEC 1 4 2011
Mirador Biomedical, Inc. c/o Justin Hulvershorn, MD, PhD Chief Science Officer 2815 Eastlake Ave. E., Suite 220 Seattle, WA 98102
Re: K112203
Trade/Device Names: Mirador Compass Digital Pressure Transducers consisting of the following 6 models:
Compass™ GP Compass™ Thoracentesis Compass™ Paracentesis Compass™ Compartment Pressure Compass™ Epidural Assist Compass™ Arterial Assist Regulatory Number: 21 CFR 870.2850 Regulation Name: Extravascular Blood Pressure Transducer Regulatory Class: Class II (Two) Product Code: DRS, DXG Dated: November 9, 2011 Received: November 14, 2011
Dear Dr. Hulvershorn:
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.
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Page 2 - Justin Hulvershorn, MD, PhD
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 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 CDRH3'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.
Sincerely yours.
M. A. Hillenbrand
, Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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SECTION 4: INDICATIONS FOR USE
KI/2203 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Names: Compass™ GP Compass™ Thoracentesis Compass™ Paracentesis
Compass™ Compartment Pressure Compass™ Epidural Assist Compass™ Arterial Assist
Indications for Use:
The Compass™ GP disposable pressure transducer with integrated digital display is intended for direct measurement of physiological pressure.
The Compass™ Thoracentesis disposable pressure transducer with integrated digital display is intended for direct measurement of physiological pressure.
The Compass™ Paracentesis disposable pressure transducer with integrated digital display is intended for direct measurement of physiological pressure.
The Compass™ Compartment Pressure disposable pressure transducer with integrated digital display is intended for direct measurement of physiological pressure.
The Compass™ Epidural Assist disposable pressure transducer with integrated digital display is intended for direct measurement of physiological pressure.
The Compass™ Arterial Assist disposable pressure transducer with integrated digital display is intended for direct measurement of physiological pressure. ﺴﺴﺴ
Prescription Use X Presertphon Ose
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) |
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| Division of Cardiovascular Devices |
| 510(k) Number | K112203 |
|---|---|
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Mirador Biomedical, Inc.
CONFIDENTIAL
Page 16 of 357
§ 870.2850 Extravascular blood pressure transducer.
(a)
Identification. An extravascular blood pressure transducer is a device used to measure blood pressure by changes in the mechanical or electrical properties of the device. The proximal end of the transducer is connected to a pressure monitor that produces an analog or digital electrical signal related to the electrical or mechanical changes produced in the transducer.(b)
Classification. Class II (performance standards).