(143 days)
The Compass™ CT disposable pressure transducer with integrated digital display is intended for direct measurement and monitoring of physiological pressure, including during the infusion of fluids and therapeutic and diagnostic agents.
The Compass™ CT Port disposable pressure transducer with integrated digital display is intended for direct measurement and monitoring of physiological pressure, including during the infusion of fluids and therapeutic and diagnostic agents.
The Compass CT and Compass CT Port 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 devices have a distal male luer fitting to connect to a needle or catheter, and a proximal female luer fitting that can be connected to accessory devices (e.g. syringes, caps, or infusion tubing). The devices 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. The Compass CT Port has an additional, sealed proximal port through which commercially available guidewires can be inserted during pressure measurement.
The Mirador Compass™ CT and CT Port are disposable pressure measurement and monitoring devices with an integrated digital display. The devices are intended for direct measurement and monitoring of physiological pressure, including during the infusion of fluids and therapeutic and diagnostic agents.
Here's an analysis of the acceptance criteria and the study proving the device meets them:
1. A table of acceptance criteria and the reported device performance
The provided document does not explicitly present a table of acceptance criteria with corresponding performance metrics like "Accuracy: X mmHg". Instead, it states that "The subject Compass CT and CT Port incorporate new software that allows for an extended pressure range. Therefore, all verification tests related to the software and pressure accuracy that were completed to support the substantial equivalence of the predicate Compass devices were re-executed for the subject Compass CT and CT Port. Pressure accuracy testing was completed per ANSI/AAMI BP22:1994(R)2006 and ISO 60601-2-34 310 Ed."
Without the specific results from the re-executed pressure accuracy testing, a direct table of acceptance criteria vs. reported performance cannot be created from the given text. However, the implicit acceptance criterion is adherence to the performance standards specified in ANSI/AAMI BP22:1994(R)2006 and ISO 60601-2-34 310 Ed for pressure accuracy.
The text states: "The results from this in vitro testing demonstrate that the technological and performance characteristics of the subject Compass CT and CT Port 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 did meet the internal design requirements and the standards cited.
Implicit Acceptance Criteria & Reported Performance:
| Acceptance Criteria Category | Standard/Requirement | Reported Device Performance |
|---|---|---|
| Pressure Accuracy | Per ANSI/AAMI BP22:1994(R)2006 and ISO 60601-2-34 310 Ed. | "The results from this in vitro testing demonstrate that the technological and performance characteristics of the subject Compass CT and CT Port meet defined design requirements and that they can perform in a manner equivalent to devices currently on the market used for measuring physiological pressure." (Implying successful conformance to the standards.) |
2. Sample size used for the test set and the data provenance
The document states "Pressure accuracy testing was completed per ANSI/AAMI BP22:1994(R)2006 and ISO 60601-2-34 310 Ed." These are in vitro testing standards.
- Sample size: The specific number of devices or measurements used in the pressure accuracy testing is not provided in the given text.
- Data provenance: The testing was in vitro (laboratory-based), rather than from a clinical setting. The country of origin of the data is not explicitly stated, but the manufacturer is Mirador Biomedical, Inc. in Seattle, Washington, USA, suggesting the testing likely occurred in the US or at a certified lab. The study is prospective in the sense that these specific tests were re-executed for the new software version.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This type of information (experts, ground truth establishment) is typically not applicable or reported for in vitro device performance testing where the ground truth is established by a calibrated reference standard (e.g., a highly accurate pressure calibrator). The performance is assessed against these known, precise values, not expert interpretation.
4. Adjudication method for the test set
Not applicable for in vitro performance testing against a calibrated reference standard.
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
- No MRMC study was done. This device is a direct pressure measurement device, not an AI-assisted diagnostic tool that would involve human readers interpreting images or data with and without AI.
- No AI component requiring human-in-the-loop performance measurement is described. The device incorporates an "integrated pre-programmed diagnostic computer" but this refers to its internal processing and display of pressure, not an AI for interpretation or assistance to a human reader.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the pressure accuracy testing conducted ("re-executed for the subject Compass CT and CT Port") is a form of standalone performance assessment. The performance of the device's internal pressure measurement and display system was evaluated independently (without human intervention in the measurement process itself, beyond operating the test equipment). The "algorithm" here refers to the software that processes the pressure sensor's input and drives the display.
7. The type of ground truth used
The ground truth for the pressure accuracy testing would be established by calibrated reference standards. This typically involves highly accurate, independently verified pressure transducers or calibrators against which the device's measurements are compared.
8. The sample size for the training set
The concept of a "training set" is not relevant here as this is not an AI/machine learning device that learns from data. It's a measurement device with a pre-programmed diagnostic computer.
9. How the ground truth for the training set was established
Not applicable as there is no training set mentioned or implied for this type of device.
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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™ CT and CT Port.
General Information:
| Date of Summary Preparation: | November 20, 2013 |
|---|---|
| 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™ CT PortCompass™ CT |
| 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 |
Mirador Biomedical, Inc.
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Device Description: The Compass CT and Compass CT Port 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 devices have a distal male luer fitting to connect to a needle or catheter, and a proximal female luer fitting that can be connected to accessory devices (e.g. syringes, caps, or infusion tubing). The devices 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. The Compass CT Port has an additional, sealed proximal port through which commercially available guidewires can be inserted during pressure measurement.
Indications for Use: Consistent with the above device description, the devices possess the following indications for use:
The Compass™ CT disposable pressure transducer with integrated digital display is intended for direct measurement and monitoring of physiological pressure, including during the infusion of fluids and therapeutic and diagnostic agents.
The Compass™ CT Port disposable pressure transducer with integrated digital display is intended for direct measurement and monitoring of physiological pressure, including during the infusion of fluids and therapeutic and diagnostic agents.
Substantially Equivalent Predicate Devices: The Compass CT and CT Port devices are substantially equivalent to the following legally marketed devices with respect to classification, design principles, and/or indications for use:
Device Testing: The subject Compass CT and CT Port are new Compass models in an existing Mirador product line of disposable pressure sensors with integrated digital displays. The Compass CT device incorporates the exact physical elements (e.g. plastic housing, electronics) contained in the predicate Compartment Pressure device except for a male luer lock on the distal end of the CT device. The Compass CT Port device (which adds a guidewire port) incorporates the exact physical elements contained in the predicate Compass Vascular Access Port except for a male luer lock on the CT Port device.
All applicable functional and biocompatibility testing has been performed on the new male luer lock.
All packaging materials, methods and processes and the sterilization process are identical to the predicate Compartment Pressure and Vascular Access Port device. Therefore, all prior packaging, sterilization, and shelf life testing of the predicate Compass devices remain applicable to the subject Compass CT and CT Port devices.
Mirador Biomedical, Inc.
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With respect to device performance, given the similarities in design and mechanical operation, tests completed on the predicate Compartment Pressure and Compass Vascular Access Port and included previously in support of Mirador 510(k)s K112203 and K101518 have been used to verify design requirements for the subject Compass CT and CT Port devices. However, the subject Compass CT and CT Port devices incorporate new software that allows for an extended pressure range. Therefore, all verification tests related to the software and pressure accuracy that were completed to support the substantial equivalence of the predicate Compass devices were re-executed for the subject Compass CT and CT Port. Pressure accuracy testing was completed per ANSI/AAMI BP22:1994(R)2006 and ISO 60601-2-34 310 Ed..
The results from this in vitro testing demonstrate that the technological and performance characteristics of the subject Compass CT and CT Port 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 CT and CT Port.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
April 18, 2014
Mirador Biomedical, Inc. c/o Justin Hulvershorn, MD, PhD Chief Science Officer 2815 Eastlake Ave. E Suite 220 Seattle, WA 98102
Re: K133624
Trade/Device Names: Compass™ CT and Compass™ CT Port Regulatory Number: 21 CFR 870.2850 Regulation Name: Extravascular Blood Pressure Transducer Regulatory Class: Class II (Two) Product Code: DRS, DXG Dated: March 7, 2014 Received: March 11, 2014
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. 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
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Page 2 - Justin Hulvershorn, MD, PhD
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/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.
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for 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
510(k) Number (if known): K133624
Device Names: Compass™ CT Compass™ CT Port
Indications for Use:
The Compass™ CT disposable pressure transducer with integrated digital display is intended for direct measurement and monitoring of physiological pressure, including during the infusion of fluids and therapeutic and diagnostic agents.
The Compass™ CT Port disposable pressure transducer with integrated digital display is intended for direct measurement and monitoring of physiological pressure, including during the infusion of fluids and therapeutic and diagnostic agents.
Prescription Use X (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)
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Mirador Biomedical, Inc.
CONFIDENTIAL
§ 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).