(143 days)
Not Found
No
The description mentions a "pre-programmed diagnostic computer" and "new software that allows for an extended pressure range," but there is no mention of AI or ML algorithms, training data, or performance metrics typically associated with AI/ML. The device appears to be a standard pressure transducer with digital display and basic processing.
No
The device is intended for direct measurement and monitoring of physiological pressure, not for providing therapy.
Yes
The "Intended Use" states "direct measurement and monitoring of physiological pressure" and mentions "therapeutic and diagnostic agents," which implies a diagnostic function. Additionally, the "Device Description" mentions an "integrated pre-programmed diagnostic computer."
No
The device description explicitly states it incorporates a pressure transducer, an integrated pre-programmed diagnostic computer with liquid crystal display (LCD), and physical luer fittings, indicating it is a hardware device with embedded software, not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "direct measurement and monitoring of physiological pressure." This involves measuring pressure within the body, not analyzing samples taken from the body (like blood, urine, or tissue).
- Device Description: The device measures pressure via an embedded sensor and displays the result. It connects directly to a needle or catheter inserted into the body. This is a direct physiological measurement, not an in vitro test.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device measures a physiological parameter directly within the body.
N/A
Intended Use / 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.
Product codes
DRS, DXG
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
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.
Key Metrics
Not Found
Predicate Device(s)
Compass Compartment Pressure K112203, Compass Vascular Access Port K101518
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/2 description: The image shows the logo for Mirador Biomedical. The logo consists of the letters "MB" in a stylized font, with a circle around the letters. To the right of the letters is the word "Mirador Biomedical" in a sans-serif font. The logo is black and white.
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 220 | |
| Seattle, Washington 98102 | |
| Contact Person: | Justin Hulvershorn, MD, PhD |
| Chief Science Officer | |
| Phone: (206) 295-3372 | |
| Trade Names: | Compass™ CT Port |
| Compass™ CT | |
| Common Name: | Disposable Pressure Transducer |
| Device Classification: | Extravascular Blood Pressure Transducer |
| Single-Function, Preprogrammed Diagnostic Computer | |
| Classification Panel: | Cardiovascular |
| CFR Reference: | 870.2850 |
| 870.1435 | |
| Product Code: | DRS |
| DXG | |
| Device Class: | Class II |
Mirador Biomedical, Inc.
1
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.
2
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.
3
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.
Image /page/4/Picture/6 description: The image shows the text "Sincerely yours," at the top. Below the text is a logo that appears to be for the FDA. The logo is a stylized design with the letters "FDA" prominently displayed.
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
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