COMPASS VASCULAR ACCESS; COMPASS LUMBAR PUNCTURE

K101518 · Mirador Biomedical, Inc. · DRS · Oct 13, 2010 · Cardiovascular

Device Facts

• Record ID: K101518
• Device Name: COMPASS VASCULAR ACCESS; COMPASS LUMBAR PUNCTURE
• Applicant: Mirador Biomedical, Inc.
• Product Code: DRS · Cardiovascular
• Decision Date: Oct 13, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2850
• Device Class: Class 2

Intended 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.

Device Story

Compass is a disposable, point-of-use pressure measurement device. It attaches distally to an inserted needle or catheter. It uses an embedded pressure sensor to measure physiologic pressure, converts pressure changes into electrical currents, and displays the value on an integrated LCD. The Vascular Access (VA) model displays mmHg and includes a proximal port for guidewire insertion; the Lumbar Puncture (LP) model displays cmH2O. Used by clinicians in clinical settings to provide real-time pressure data during invasive procedures. Output allows immediate monitoring of blood or intracranial pressure, aiding clinical decision-making during needle/catheter placement.

Clinical Evidence

Bench testing included biocompatibility (ISO 10993-1), functional testing (ANSI/AAMI BP22:1994(R)2006, ISO 594-1/2), electrical/EMC, and simulated use. In vivo animal study (swine model) compared Compass VA/LP performance against the Shenzhen DPT predicate for arterial, venous, and intracranial pressure measurements. Results demonstrated accurate measurement and monitoring equivalent to the predicate device.

Technological Characteristics

Disposable pressure transducer with integrated LCD. Materials tested per ISO 10993-1. Sensing principle: embedded pressure sensor converting pressure to electrical current. VA model includes proximal port for guidewires. Connectivity: standalone. Power: battery-operated. Standards: ANSI/AAMI BP22:1994(R)2006, ISO 594-1, ISO 594-2.

Indications for Use

Indicated for direct measurement and monitoring of invasive blood pressure (Vascular Access model) or intracranial pressure (Lumbar Puncture model) in patients requiring such monitoring during vascular access or lumbar puncture/intraventricular catheter procedures.

Regulatory Classification

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.

Predicate Devices

• Shenzhen Disposable Pressure Transducer (K091408)
• Vigileo APCO/Oximetry Monitor and DDPT (K043065)
• Stryker Intra-Compartmental Pressure Monitor System (K844214)

Submission Summary (Full Text)

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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.<br>2815 Eastlake Ave Suite 300<br>Seattle, Washington 98102 |
| Contact Person: | Justin Hulvershorn, MD, PhD<br>Chief Science Officer<br>Phone: [phone] |
| Trade Names: | CompassTM Vascular Access<br>CompassTM Lumbar Puncture |
| Common Name: | Disposable Pressure Transducer |
| Device Classification: | Extravascular Blood Pressure Transducer<br>Single-Function, Preprogrammed Diagnostic Computer |
| Classification Panel: | Cardiovascular |
| CFR Reference: | 870.2850<br>870.1435 |
| Product Code: | DRS<br>DXG |
| Device Class: | Class II |

Mirador Biomedical, Inc.

510(k) SUMMARY

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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 [phone] or [phone] 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) | |
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| Division of Cardiovascular Devices | |

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

CONFIDENTIAL

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