The Compass™ Vascular Access is a disposable pressure transducer with integrated digital display intended for direct measurement and monitoring of invasive blood pressure.
The Compass™ Lumbar Puncture is a disposable pressure transducer with integrated digital display intended for direct measurement and monitoring of intracranial pressure.

Device Description

The Compass is a disposable, point-of-use pressure measurement and monitoring device that incorporates a pressure transducer and an integrated pre-programmed diagnostic computer with liquid crystal display (LCD). The Compass is provided as two different models, each corresponding to a specific indication for use:

(1) The Compass Vascular Access (VA) is for invasive blood pressure measurement and monitoring during the insertion of vascular access devices.
(2) The Compass Lumbar Puncture (LP) is for intracranial pressure measurement and monitoring via lumbar puncture or intraventricular catheter.
Both models 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.
The Compass VA and Compass LP devices are identical except for two differences: 1) the measurement units in which the pressure is displayed on the LCD (mm Hg for blood pressure measurements with the Compass VA and cm H2O for intracranial pressure measurements with the Compass LP), and 2) the Compass VA blood pressure monitoring device has a proximal port through which commercially available guidewires can be inserted during pressure measurement.

AI/ML Overview

The provided 510(k) summary for the Mirador Compass™ device (K101518) describes the device, its indications for use, and the testing performed. However, it does not provide a specific table of acceptance criteria with corresponding reported device performance values in a side-by-side format as typically found in comprehensive performance studies for AI/CAD devices.

Instead, the documentation outlines various tests conducted and generally states that the device "meet defined design requirements" and can "perform in a manner equivalent to devices currently on the market."

Let's break down the information based on your requested points:

Acceptance Criteria and Reported Device Performance

The document describes several categories of testing, implying that the acceptance criteria are met if the device performs "per Mirador Biomedical's in-house test methods, protocols, and requirements or in accordance with applicable recognized standards by accredited outside laboratories," and that the results "demonstrate that the technological and performance characteristics... meet defined design requirements and that they can perform in a manner equivalent to devices currently on the market."

Due to the nature of the provided document, a specific table of acceptance criteria and reported device performance with numerical values cannot be fully constructed as the exact numerical acceptance limits and reported performance values are not explicitly stated for all tests. However, we can infer the categories of performance that were assessed.

Acceptance Criteria Category (Inferred)	Reported Device Performance (as stated in document)
Biocompatibility	Met ISO 10993-1 standards (cytotoxicity, hemolysis, acute systemic toxicity, intracutaneous reactivity, sensitization, pyrogenicity).
Functional Testing (General)	Met applicable functional testing per ANSI/AAMI BP22:1994(R)2006, ISO 594-1, and ISO 594-2.
Luer Fittings	Met defined design requirements.
Mechanical Strength and Durability	Met defined design requirements.
Power Switch	Met defined design requirements.
Dimensional and Weight Verification	Met defined design requirements.
Battery Life	Met defined design requirements.
Pressure Overrange Capability	Met defined design requirements.
Pressure Accuracy	Met defined design requirements. (In vivo study showed accurate measurement equivalent to predicate)
Drift, Temperature Error Band, Temperature Error Band of Sensitivity	Met defined design requirements.
Light Sensitivity	Met defined design requirements.
Frequency Response	Met defined design requirements.
Guidewire Testing (Compass VA)	Met defined design requirements.
Spillage	Met defined design requirements.
Safety	Met defined design requirements.
Simulated Use Testing (Vascular Access & Lumbar Puncture)	Met defined design requirements.
In vivo Performance	Compass VA and LP devices accurately measure and monitor labeled physiologic pressures (invasive blood pressure/intracranial pressure) in a manner equivalent to the predicate device.

Detailed Information on Studies and Ground Truth:

This device (Mirador Compass™) is a disposable pressure transducer with an integrated digital display and pre-programmed diagnostic computer. It is not an AI/CAD (Computer-Aided Detection/Diagnosis) system in the modern sense. Therefore, many of the typical questions for AI/CAD devices, such as those related to observer performance studies (MRMC), ground truth established by experts, adjudication methods, and training/test sets for AI models, are not applicable to this type of medical device.

1. Sample sized used for the test set and the data provenance:

In vitro (Bench) Testing: The document lists several in vitro tests (Luer Fittings, Mechanical Strength, Power Switch, etc.). The sample sizes for each of these component-level or functional tests are not specified in the summary.
In vivo Animal Study: The "in vivo animal study" used a swine model. The specific number of animals or the number of measurements taken is not provided.
Data Provenance: The in vitro tests were conducted by "Mirador Biomedical's in-house test methods, protocols, and requirements or in accordance with applicable recognized standards by accredited outside laboratories." The animal study was conducted in a swine model. The country of origin for the animal study is not specified, but the manufacturer is US-based (Seattle, Washington).

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable for this type of device. The device's performance is measured against physical standards, calibrated equipment, and physiological measurements in an animal model, not against human expert interpretations of images or data that require adjudication for ground truth.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. As this is not an AI/CAD device based on expert interpretation, no adjudication method was used.

4. 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 measurement tool, not an AI assistance tool for human interpretation.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

The device itself is a "standalone" measurement device in that it directly measures and displays pressure. However, it's not an "algorithm-only" standalone performance test in the context of AI/CAD where the algorithm's output is being evaluated for accuracy without human input. Its performance was assessed through direct physical and physiological measurements.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

In vitro Tests: Ground truth would be established by reference standards, calibrated measurement equipment, and specified engineering tolerances as defined by design requirements and industry standards (e.g., ANSI/AAMI BP22, ISO 594-1/2).
In vivo Animal Study: Ground truth for pressure measurements would be established by direct physiological measurements from the swine model, likely using a highly accurate reference pressure transducer or established invasive pressure monitoring techniques, against which the Compass device's readings are compared. The summary explicitly states that a "predicate Shenzhen DPT pressure sensor was used for relative comparison."

7. The sample size for the training set:

Not applicable. This device is not an AI/Machine Learning diagnostic system that undergoes a "training" phase with a dataset.

8. How the ground truth for the training set was established:

Not applicable, as there is no training set for an AI model.

In summary, the K101518 submission for the Mirador Compass™ device demonstrates substantial equivalence through extensive bench testing and an in vivo animal study against established standards and a predicate device. The information provided aligns with typical submissions for Class II measurement devices, rather than AI-driven diagnostic tools.

Summary

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K101518

OCT 1 3 2010

Image /page/0/Picture/2 description: The image shows the logo for Mirador Biomedical. The logo consists of the letters "MB" with a stylized design around them. To the right of the letters is the company name, "Mirador Biomedical", written in a simple, sans-serif font. The word "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:	June 1, 2010
Name and Address of Manufacturer:	Mirador Biomedical, Inc.2815 Eastlake Ave Suite 300Seattle, Washington 98102
Contact Person:	Justin Hulvershorn, MD, PhDChief Science OfficerPhone: (206) 295-3372
Trade Names:	CompassTM Vascular AccessCompassTM Lumbar Puncture
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.

510(k) SUMMARY

Page 18 of 716

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Device Description: The Compass is a disposable, point-of-use pressure measurement and monitoring device that incorporates a pressure transducer and an integrated pre-programmed diagnostic computer with liquid crystal display (LCD). The Compass is provided as two different models, each corresponding to a specific indication for use:

(1) The Compass Vascular Access (VA) is for invasive blood pressure measurement and monitoring during the insertion of vascular access devices.
(2) The Compass Lumbar Puncture (LP) is for intracranial pressure measurement and monitoring via lumbar puncture or intraventricular catheter.

Both models 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.

The Compass VA and Compass LP devices are identical except for two differences: 1) the measurement units in which the pressure is displayed on the LCD (mm Hg for blood pressure measurements with the Compass VA and cm H2O for intracranial pressure measurements with the Compass LP), and 2) the Compass VA blood pressure monitoring device has a proximal port through which commercially available guidewires can be inserted during pressure measurement.

Indications for Use: Consistent with the above device description, the Compass VA and Compass LP devices respectively possess the following indications for use:

. The Compass™ Vascular Access is a disposable pressure transducer with integrated digital display intended for direct measurement and monitoring of invasive blood pressure.
The Compass™ Lumbar Puncture is a disposable pressure transducer with integrated digital display intended for direct measurement and monitoring of intracranial pressure.

Substantially Equivalent Predicate Devices: The Compass VA and Compass LP are substantially equivalent to the following legally marketed devices with respect to classification, design principles and/or indications for use:

Shenzhen Disposable Pressure Transducer K091408 ●
Vigileo APCO/Oximetry Monitor and DDPT K043065 .
Stryker Intra-Compartmental Pressure Monitor System K844214 .

Device Testing: Performance testing of the Compass VA and Compass LP devices included in vitro (bench), biocompatibility, packaging, sterilization, software validation, electrical/EMC, and in vivo animal.

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All testing was completed per Mirador Biomedical's in-house test methods, protocols, and requirements or in accordance with applicable recognized standards by accredited outside laboratories.

Biocompatibility testing was completed per ISO 10993-1 and included cytotoxicity, hemolysis, acute systemic toxicity, intracutaneous reactivity, sensitization and pyrogenicity.

With respect to device performance, this included, but was not limited to, applicable functional testing per ANSI/AAMI BP22:1994(R)2006, ISO 594-1 and ISO 594-2. A listing of all in vitro performance testing is as follows:

Luer Fittings ●
Mechanical Strength and Durability .
. Power Switch
Dimensional and Weight Verification ●
Battery Life .
. Pressure Overrange Capability
Pressure Accuracy
Drift, Temperature Error Band, and Temperature Error Band of Sensitivity .
. Light Sensitivity
. Frequency Response
Guidewire Testing .
Spillage
Safety .
Simulated Use Testing Vascular Access ●
Simulated Use Testing Lumbar Puncture .

The results from this in vitro testing demonstrate that the technological and performance characteristics of the Compass VA and Compass LP devices meet defined design requirements and that they can perform in a manner equivalent to devices currently on the market used for measuring and monitoring invasive blood pressure and intracranial pressure.

The in vivo animal study was completed using a swine model and assessed performance of the Compass VA to measure arterial and venous blood pressures and the Compass LP to measure intracranial pressures via lumbar puncture. The predicate Shenzhen DPT pressure sensor was used for relative comparison. The results of this study demonstrate that the Compass VA and Compass LP devices can each be used as intended to accurately measure and monitor their labeled physiologic pressures (i.e., invasive blood pressure of intracranial pressure) in a manner equivalent to the predicate device.

Conclusion (Statement of Equivalence): The data and information presented within this submission support a determination of substantial equivalence, and therefore market clearance of Compass VA and Compass LP devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three lines representing its wings and tail feathers. The eagle is positioned above a wavy line, possibly representing water. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

OCT 1 3 2010

Mirador Biomedical, Inc. c/o Dr. Justin Hulvershorn Chief Science Officer 2815 Eastlake Avenue Suite 300 Seattle, WA 98102

Re: K101518

Trade/Device Name: Compass Vascular Access and Compass Lumbar Puncture Regulation Number: 21 CFR 870.2850 Regulation Name: Extravascular Blood Pressure Transducer Regulatory Class: Class II (two) Product Code: DRS, DXG Dated: August 24, 2010 Received: August 25, 2010

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.

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.

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Page 2 - Dr. Justin Hulvershorn

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 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

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):

Device Names: Compass™ Vascular Access Compass™ Lumbar Puncture

Indications for Use:

The Compass™ Vascular Access is a disposable pressure transducer with integrated digital display intended for direct measurement and monitoring of invasive blood pressure.

10/5

The Compass™ Lumbar Puncture is a disposable pressure transducer with integrated digital display intended for direct measurement and monitoring of intracranial pressure.

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)

(Division Sign-Off)
Division of Cardiovascular Devices

10(k) Number	K101518
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Page	1 of 1
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Mirador Biomedical, Inc.

CONFIDENTIAL

Page 17 of 716

Regulation Number and Section

§ 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).