(135 days)
Not Found
No
The description mentions a "pre-programmed diagnostic computer" and "new software," but there is no mention of AI, ML, or any learning or adaptive capabilities. The performance studies focus on pressure accuracy and equivalence to predicate devices, not on AI/ML performance metrics.
No.
The device is described as a measurement and monitoring device for physiological pressure, not one that treats or diagnoses a condition.
Yes.
The device's description states it "incorporate[s] a pressure transducer and an integrated pre-programmed diagnostic computer with liquid crystal display (LCD)." The repeated mention of "direct measurement of physiological pressure" for various medical procedures (thoracentesis, paracentesis, compartment pressure, epidural assist, arterial assist) also indicates its use in aiding diagnosis by providing specific physiological measurements.
No
The device description explicitly states it incorporates a pressure transducer, an integrated pre-programmed diagnostic computer, and a liquid crystal display (LCD), all of which are hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "direct measurement 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 description details a device that attaches to a needle or catheter to measure pressure in situ. It doesn't mention any interaction with biological samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting or measuring substances in biological samples.
- Providing information for diagnosis, monitoring, or screening based on sample analysis.
The device is clearly designed for direct physiological measurement within the body, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
DRS, DXG
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.
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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
13
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 220 | |
| Seattle, Washington 98102 | |
| Contact Person: | Justin Hulvershorn, MD, PhD |
| Chief Science Officer | |
| Phone: (206) 295-3372 | |
| Trade Names: | Compass™ GP |
| Compass™ Thoracentesis | |
| Compass™ Paracentesis | |
| Compass™ Compartment Pressure | |
| Compass™ Epidural Assist | |
| Compass™ Arterial Assist | |
| 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 |
1
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:
2
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.
3
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.
4
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
5
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) |
|---|
| Division of Cardiovascular Devices |
| 510(k) Number | K112203 |
|---|---|
| --------------- | --------- |
| Page | of |
|---|---|
| ------ | ---- |
Mirador Biomedical, Inc.
CONFIDENTIAL
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