(186 days)
No
The description focuses on pressure measurement, digital display, wireless transmission (Bluetooth), and basic signal conversion. There is no mention of algorithms for data analysis, pattern recognition, or decision support that would typically indicate AI/ML. The "pre-programmed diagnostic computer" likely refers to basic processing for displaying pressure readings, not advanced AI/ML capabilities.
No
The device is described as a system for "direct measurement and monitoring of physiologic pressure." It measures pressure, but it does not apply any form of therapy itself.
Uncertain
The device performs "direct measurement and monitoring of physiologic pressure." While monitoring often supports diagnosis, the provided text does not explicitly state that the device itself performs a diagnostic interpretation of the pressure data. It mentions an "integrated pre-programmed diagnostic computer" in the Device Description, but the "Intended Use" focuses on measurement and monitoring. It measures the pressure, converts changes to electrical currents, and displays the pressure, but doesn't explicitly state that it diagnoses based on that pressure.
No
The device description explicitly states that the device incorporates a pressure transducer, an integrated pre-programmed diagnostic computer with liquid crystal display (LCD), and an embedded pressure sensor. It also mentions a circuit board and a battery. These are all hardware components, making it a hardware device with integrated software, not a software-only medical device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is for "direct measurement and monitoring of physiologic pressure". This involves measuring a physiological parameter 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 resulting pressure. It connects to needles or catheters, which are used to access the body directly.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or performing tests on specimens outside of the body.
IVDs are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device measures a physical parameter (pressure) directly within the body.
N/A
Intended Use / Indications for Use
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.
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.
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)
The MAP Accessory has not received prior 510(k) clearance.
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 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
§ 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/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.
1
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
2
| 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)
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.
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)
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3
| 510(k) Summary | |
|---|---|
| -- | ---------------- |
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:
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.
4
Description:
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)
The MAP Accessory has not received prior 510(k) clearance.
Indications for Use:
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.
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.
5
| Design / Technological
Characteristic | Predicate Compass CT Port | Subject Compass Cast
(and MAP only as applicable) |
|----------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | 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. | 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. |
| Regulatory History | K133624 | K161408 |
| Classification Panel | Cardiovascular | Identical |
| Classification Name | Extravascular Pressure Transducer
and Single-Function, Preprogrammed
Diagnostic Computer | Identical |
| Device Class | Class II (21 CFR 870.2850 and
870.1435) | Identical |
| Device Code | DRS and DXG | Identical |
| General Technological
Design | Designed as a pressure transducer
with an integrated digital display to
allow for "point of use"
measurement and monitoring of
physiological pressures. | Identical
(but also incorporates wireless Bluetooth
capability for display to compatible
monitor via new Compass MAP
component) |
| Wireless Low Energy
Bluetooth Capability via
Compass MAP | No | Yes |
| Luer Connections | Proximal male and distal female luer
tested per ISO 594-1 ISO 594-2 | Identical |
| Pressure Sensing Element | Piezoresistive bridge transducer
tested per ANSI/AAMI
BP22:1994(R)2006 | Identical |
| Pressure Accuracy and
Functional Performance | Meet or exceed ANSI/AAMI
BP22:1994(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 Hg
51 to 999 mm Hg: ±3% of reading | Identical |
| Guidewire Port | Yes | Identical |
| Zero Drift | ±1 mm Hg per 4 hours | Identical |
| Light Sensitivity |