The Compass Cast and MAP disposable pressure transducer system with integrated digital display and wireless transmission capability is intended for direct measurement and monitoring of physiologic pressure, including during the infusion of fluids and therapeutic and diagnostic agents.

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.

The Compass CT Port device is being modified to add wireless Bluetooth capability to the point-of-use Compass Cast device, in order to allow for optional display of acquired pressure data and information to a separate display monitor. The modified product will consist of two components that are packaged separately, the compass Cast (Subject Device) and MAP (Monitor Accessory Plug - Accessory).

The Compass Cast (Subject Device) is a single-use, sterile pressure transducer that is physically identical to the predicate device Compass CT Port (510(k) K133624) with the exception of a slight modification to the main CT Port circuit board to accommodate the secondary Bluetooth radio board. All components and functionality of the main circuit board remain identical.

The MAP (Accessory) is a non-sterile, reusable monitor accessory plug that receives a digital pressure signal from the Compass Cast and converts the digital pressure signal to an analog output that is identical to the analog output of a traditional wired pressure transducer. There are two versions of the MAP device:

Wireless Pressure Receiver - GE Monitor (CWMG001-5)
Wireless Pressure Receiver Philips Monitor (CWMP001-5)

AI/ML Overview

The provided text describes information about the submission of the "Compass Cast and MAP System" for FDA clearance. However, it does not contain explicit acceptance criteria and device performance data in a tabular format, nor does it detail a study that proves the device meets specific performance criteria related to its core function of physiological pressure measurement beyond stating adherence to existing standards.

The document focuses heavily on demonstrating substantial equivalence to a predicate device (Compass CT Port) by highlighting the technological characteristics and the modifications made (addition of Bluetooth capability and a reusable Monitor Accessory Plug - MAP). Performance data mentioned primarily concerns safety aspects due to these modifications, such as sterility, EO residuals, and electromagnetic compatibility.

Therefore, many of the requested items cannot be fully answered from the provided text.

Based on the available information:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state a table of new acceptance criteria established for the Compass Cast and MAP system itself in terms of pressure measurement performance. Instead, it states that the device's fundamental pressure accuracy and functional performance are "identical" to the predicate device and "Meet or exceed ANSI/AAMI BP22:1994(R)2006".

The only "acceptance criteria" and "reported performance" directly stated are for safety and compatibility tests related to the new wireless functionality and sterilization.

Acceptance Criteria (Implied / Standard Adherence)	Reported Device Performance
Sterilization: Sterility Assurance Level (SAL) of 1 x 10^-6	Validated (in accordance with ANSI/AAMI/ISO 11135-1:2014)
EO Residuals: < 4 mg/device for EO, < 9 mg/device for EC	Testing performed; compliant with ANSI/AAMI/ISO 10993-7:2008 (implied passes, as "testing was performed" on worst-case model and is "in Compliance")
BET Testing: Endotoxin limit: 2.15 EU/Device	Kinetic Chromogenic Test Method validated; "in Compliance" with AAMI ANSI ST72:2011
EMC/Electrical Safety: Compliance with IEC 60601-1-2:2007	"Confirmed to be compliant" and "in Compliance"
Wireless Communication: Compliance with relevant standards (e.g., CFR 47, Part 15, subpart B; RSS-247)	"In Compliance"
Pressure Accuracy and Functional Performance: Meet or exceed ANSI/AAMI BP22:1994(R)2006	"Identical" to predicate, which meets/exceeds this standard. Explicit mention: -199 to -51 mm Hg: ±3% of reading -50 to +50 mm Hg: ±2 mm Hg 51 to 999 mm Hg: ±3% of reading
Zero Drift: ±1 mm Hg per 4 hours	"Identical" to predicate
Light Sensitivity: < 1 mm Hg	"Identical" to predicate

2. Sample size used for the test set and the data provenance

For the safety tests (sterilization, EO residuals, BET, EMC/Wireless), specific sample sizes are mentioned:

EO Residuals: "Three samples were processed through two routine (Cycle 20) sterilization cycles".
Other tests: Sample sizes are not explicitly stated for EMC/Wireless, Sterilization validation, or BET, beyond stating that testing was performed.
Pressure performance: No specific test set sample size is described for evaluating the pressure accuracy of the Compass Cast itself, as its performance is stated to be "identical" to the predicate. Therefore, any data provenance for such a study would refer to the predicate device development.

The provenance for the safety tests is internal company testing ("Centurion Protocol# 17205-16"). No country of origin is specified for these tests. The nature of these tests is prospective for this device modification.

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

This information is not provided in the document. The regulatory submission relies on adherence to established consensus standards (e.g., ANSI/AAMI BP22, ISO 11135, IEC 60601-1-2), rather than a new study requiring expert ground truth for diagnostic accuracy.

4. Adjudication method for the test set

Not applicable, as no diagnostic accuracy study requiring expert adjudication is described in the provided text for the modified device. The compliance is against engineering and safety standards.

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

Not applicable. The device is a pressure transducer system, not an AI-assisted diagnostic tool.

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

A standalone performance evaluation would be the stated compliance to standards like ANSI/AAMI BP22 for pressure accuracy, and the safety/EMC standards. There is no algorithm in the AI sense for a standalone "algorithm only" performance. The device itself is the "standalone" component measuring pressure.

7. The type of ground truth used

For pressure accuracy and functional performance, the ground truth is based on established metrology reference standards and methods outlined in ANSI/AAMI BP22:1994(R)2006.
For sterilization, EO residuals, BET, and EMC, the ground truth is defined by the specific requirements and test methods detailed in the respective international and national standards (e.g., ANSI/AAMI/ISO 11135, ISO 10993-7, AAMI ANSI ST72, IEC 60601-1-2).

8. The sample size for the training set

Not applicable. This is not a machine learning/AI device, so there is no training set mentioned.

9. How the ground truth for the training set was established

Not applicable. There is no training set involved.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other to form a single, abstract shape.

Public Health Service

Food and Drug Administration

10903 New Hampshire Avenue Document Control Center - WO66-G609 November 22, 2016 Silver Spring, MD 20993-0002

Centurion Medical Products Corporation Matthew Price Director, Regulatory Affairs & Quality Assurance 100 Centurion Way Williamston, Michigan 48895

Re: K161408

Trade/Device Name: Compass Cast and MAP System Regulation Number: 21 CFR 870.2850 Regulation Name: Extravascular Blood Pressure Transducer Regulatory Class: Class II Product Code: DRS, DXG Dated: September 20, 2016 Received: September 22, 2016

Dear Matthew Price:

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 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 devicerelated 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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 vours.

Mude Jellman
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

510(k) Number (if known) K161408

Device Name

Compass Cast and MAP

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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FORM FDA 3881 (8/14)

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

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	510(k) Summary
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Centurion Medical Products Corporation 100 Centurion Way Williamston, MI 48895

Matthew K. Price Director of Regulatory Affairs and Quality Assurance Phone: (517) 546-5400 (517) 546-3356 Facsimile:

November 14, 2016

Traditional Compass Cast and MAP System Disposable Pressure Transducer

Extravascular Blood Pressure Transducer Single-Function, Preprogrammed Diagnostic Computer

ll 870.2850 870.1435

DRS / DXG

Cardiovascular

(1) Slight modification to the predicate Compass CT Port circuit board to accommodate an added secondary Bluetooth radio board that allows for wireless communication with the new Compass MAP. All modifications are internal to the Compass Cast, so that the external plastic housing and all other physical components of the device remain identical to the predicate Compass CT Port.
(2) Development of new Compass Monitor Accessory Plug (MAP), which is a reusable, non-sterile component that can be plugged into a compatible monitor and paired to the Compass Cast to then allow for complementary display of all pressure information on a separate monitor.

Predicate SE Device(s):

Manufacturer:

Date Summary Prepared:

Common Name of Device:

Trade Name (Proprietary Name):

Device Description Submission Type:

Classification Name:

Device Classification:

Classification Panel:

Reason for 510(k):

Regulation:

Product Code:

Contact:

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Description:

1. Wireless Pressure Receiver - GE Monitor (CWMG001-5)
1. Wireless Pressure Receiver Philips Monitor (CWMP001-5)

The MAP Accessory has not received prior 510(k) clearance.

Indications for Use:

Summary of Technological Characteristics between Subject and Predicate Device:

The Compass Cast and MAP system retain the same fundamental scientific technology as the predicate device. The intended use is identical as well as the operating principles at the point of use with the compass Cast – direct measurement of physiological pressure, including during the infusion of fluids and therapeutic and diagnostic agents.

ldentical to the predicate Compass CT Port, the Compass Cast remains a single-use, sterile pressure transducer that is physically identical to the Compass CT Port from 510(k) K133624 except for: (1) a secondary, internal circuit board that gives the modified device wireless (low energy Bluetooth) capability, and (2) a slightly thicker battery to provide increased capacity due to the added wireless transmission functionality. The Compass Cast device thus incorporates the exact physical elements (including a coin cell battery) contained in the predicate Compass CT Port except for some slight modifications to the main predicate Compass CT Port circuit board changes were necessary to accommodate the added secondary Bluetooth radio board, but all components and functionality of the main circuit board remain identical. The Compass Cast and MAP do not transmit any patient identifying data; they simply transmit pressure data that has no patient identifiers. The Bluetooth capability allows the pressure data to be freely viewable on the monitors in the patient room without the use of a wire connection. Lastly, while the Compass Cast uses a thicker coin cell battery compared to the predicate Compass CT Port (specifically, it uses a CR1632 instead of a CR1616) to account for the added wireless transmission functionality drawing more power from the battery, the nominal voltage of the two batteries remains identical (3V).

Following is a side by side comparison of the features of the subject and predicate device.

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Design / TechnologicalCharacteristic	Predicate Compass CT Port	Subject Compass Cast(and MAP only as applicable)
Indications for Use	The Compass CT Port disposablepressure transducer with integrateddigital display is intended for directmeasurement and monitoring ofphysiological pressure, includingduring the infusion of fluids andtherapeutic and diagnostic agents.	The Compass Cast and MAP disposablepressure transducer system withintegrated digital display and wirelesstransmission capability is intended fordirect measurement and monitoring ofphysiologic pressure, including during theinfusion of fluids and therapeutic anddiagnostic agents.
Regulatory History	K133624	K161408
Classification Panel	Cardiovascular	Identical
Classification Name	Extravascular Pressure Transducerand Single-Function, PreprogrammedDiagnostic Computer	Identical
Device Class	Class II (21 CFR 870.2850 and870.1435)	Identical
Device Code	DRS and DXG	Identical
General TechnologicalDesign	Designed as a pressure transducerwith an integrated digital display toallow for "point of use"measurement and monitoring ofphysiological pressures.	Identical(but also incorporates wireless Bluetoothcapability for display to compatiblemonitor via new Compass MAPcomponent)
Wireless Low EnergyBluetooth Capability viaCompass MAP	No	Yes
Luer Connections	Proximal male and distal female luertested per ISO 594-1 ISO 594-2	Identical
Pressure Sensing Element	Piezoresistive bridge transducertested per ANSI/AAMIBP22:1994(R)2006	Identical
Pressure Accuracy andFunctional Performance	Meet or exceed ANSI/AAMIBP22:1994(R)2006	Identical
Power Source	3 V DC from internal lithium battery	Identical
External Cable	None	Identical
Fluid Path Materials	USP Class VI polycarbonate	Identical
Display	Integrated LCD	Identical
Display Range – Max	1,198 mm Hg (-199 to +999 mm Hg)	Identical
Accuracy	-199 to -51 mm Hg: ±3% of reading-50 to +50 mm Hg: ±2 mm Hg51 to 999 mm Hg: ±3% of reading	Identical
Guidewire Port	Yes	Identical
Zero Drift	±1 mm Hg per 4 hours	Identical
Light Sensitivity	< 1 mm Hg	Identical

Table 1: Summary of Design and Technological Characteristics for the Predicate Compass Device (K133624) and the Subject Compass Cast and MAP (Modified)

Biocompatible

Single-use only

Sterilization

Yes

Ethylene Oxide

Identical

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Performance Data:

The results of performance testing demonstrate that the functionality, integrity, and safety and effectiveness of the Compass Cast and MAP System are sufficient for its intended use and support a determination of substantial equivalence.

Summary of Testing: Sterilization

The Compass Cast will be available only in sterile product will be sterilized using ethylene oxide. The sterilization method was validated and performed in accordance with ANSI/AAMI/ISO 11135-1:2014, Sterilization of health care products – Ethylene oxide - Requirement, validation and routine control of a sterilization process for medical devices. A sterility assurance level of 1 x 10 ° has been validated for this product.

The Compass MAP will be sold non-sterile, reusable, as an accessory to the Compass Cast.

EO Residuals

Ethylene Oxide Residual testing was performed in accordance with ANSI/AAMI/ISO 10993-7:2008. Testing was performed (Centurion Protocol# 17205-16) on product code CLCK001 (Compass Vascular Access Lock) as this model was selected as a "worst case" representative for the Compass family of products. The Compass Vascular Access Lock is identical in physical construction to the Compass Cast with the exception of the electronics. A second circuit board is attached perpendicular to the main PCB in the Compass Cast to allow for wireless transmission capability. However, this additional component is contained within the device's housing and has no impact on sterility.

Three samples were processed through two routine (Cycle 20) sterilization cycles for a total of eight (8) hours exposure and subjected to 24 hours of forced heated aeration. The duration of contact for the Compass product is <8 hours. As a result, a simulated use extraction was performed at body temperature (37°C) for a duration of 8 hours. The proposed limits as defined in in ANSI/AAMI/ISO 10993-7:2008 are 4 mg/device for EO and 9 mg/device for EC.

BET Testing

The Kinetic Chromogenic Test Method has been validated as the test method for determining the presence of bacterial endotoxins on the Compass family of devices. The Endotoxin limit applied to the Compass Products is 2.15 EU/Device (0.06 EU/ml). The selected endotoxin limit is based on the potential contact with Cerebrospinal Fluid in accordance with AAMI ANSI ST72:2011.

Electromagnetic Compatibility/Electrical Safety

EMC and Wireless Communication Testing were performed on the Compass Cast and MAP system due to the modification to incorporate a low energy Bluetooth communication. A slight modification was made to the Compass CT Port circuit board to accommodate a secondary Bluetooth radio board that enables wireless communication. A thicker coin cell battery was also added to provide increased capacity. The Compass monitor accessory plug (MAP) was developed as a reusable, non-sterile component that can be plugged into a monitor and paired to the Compass Cast device to allow the pressure information to be viewed on a separate monitor. The Compass Cast and MAP were evaluated for electromagnetic compatibility and safety in accordance with IEC 60601-1-2:2007 and confirmed to be compliant. The results demonstrate that the Compass Cast and MAP, when transported, stored, installed, operated in normal use, and maintained according to the instructions of the manufacturer, cause no safety hazard which could reasonably be foreseen and which is not connected with its intended application, in normal condition and in single fault condition.

Refer to Table 2 for applicable test references.

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		TABLE 2: Test References
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Standard	Results
IEC 60601-1-2:2007 Third Edition, Medical electrical equipment –Part 1-2: General requirements for basic safety and essentialperformance - collateral standard: Electromagnetic compatibility –Requirements and tests	In Compliance
Safety Code 6; HC Pub: 091029; KDB447498	In Compliance
Federal Register CFR 47, Part 15, subpart B:2007 RadiatedEmissions, Part 15.109(b), Class A	In Compliance
RSS-247 - Digital Transmission systems (DTSs), Frequency HoppingSystems (FHSs) and Licence-Exempt Local Area Network (LE-LAN)Devices; RSS-Gen, General Requirement and Information for theCertification of Radio Apparatus	In Compliance
ANSI/AAMI/ISO 11135: 2014 Sterilization of health-care products –Ethylene oxide-Requirements for the development, validation androutine control of a sterilization process for medical devices	In Compliance
ANSI/AAMI/ISO 10993-7:2008(R)2012, Biological Evaluation ofMedical Devices - Part 7, Ethylene Oxide Residuals	In Compliance
General Principles of Software Validation; Final guidance forIndustry and FDA Staff (January 2002)	In Compliance
AAMI ANSI BP22:1994 (R) 2011 Blood Pressure Transducers	In Compliance
AAMI ANSI ST72:2011 Bacterial endotoxins – Test methods, routinemonitoring, and alternatives to batch testing	In Compliance

Standards Data Reports for 510(k) (FORM 3654) are attached for the applicable standards referenced above.

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).