(210 days)
Sensometrics Software is intended for use by a qualified nurse or physician to display variables from existing legally marketed primary measuring devices used to monitor neurosurgical and neurological patients. The parameters displayed by the Sensometrics Software include intracranial pressure, arterial blood pressure, oxygen, core/cerebral temperature, and these are continuously trended in charts. The presentation of both measured parameters and the relationships between them is intended as an adjunct to the information provided by existing primary monitors. The Sensometrics® Software should not be used alone as the sole basis for decisions as to diagnosis or therapy.
Sensometrics® Software is a secondary display system that collects together on a single large color display screen the measured pressure variables relevant to the multimodality monitoring of the patient in a neurosurgical intensive care unit. It receives digital inputs from primary monitors used in the measurement of intracranial pressure, arterial blood pressure and cerebral temperature. The Sensometrics® Software displays the measured and derived variables in digital trace form and can store and display trends over periods of up to 240 hours.
Here's an analysis of the provided text regarding the Sensometrics® Software's acceptance criteria and the study that proves its performance:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state numerical acceptance criteria for the Sensometrics® Software in terms of accuracy or precision. Instead, the "acceptance criteria" are implied by the objective of demonstrating equivalence to predicate devices and performing "according to specifications." The reported performance is a qualitative statement of equivalence.
| Parameter/Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Displayed Variables | Must accurately display intracranial pressure, arterial blood pressure, oxygen, core/cerebral temperature as trended charts. | Displays intracranial pressure, arterial blood pressure, oxygen, core/cerebral temperature, continuously trended in charts. |
| Equivalence to Predicate Devices | Variables computed must be equivalent to those from primary measuring devices (NeuroSystems 1 Monitor, Phillips IntelliVue Mp40, Integra MPM-1). | "The test results show that the parameters computed by Sensometrics software are equivalent to the predicate devices." (Specifically for Mean ICP, Mean ABP, systolic pressure output, diastolic pressure output, and cerebral temperature output). |
| Intended Use | Must function as an adjunct display system for primary monitors, not as a sole basis for diagnosis or therapy. | "Sensometrics® Software is intended for use by a qualified nurse or physician to display variables from existing legally marketed primary measuring devices... The presentation of both measured parameters and the relationships between them is intended as an adjunct to the information provided by existing primary monitors. The Sensometrics® Software should not be used alone as the sole basis for decisions as to diagnosis or therapy." |
| Design/Technology | Software installed on a PC, connected via RJ45/RS232 cable to primary monitors. | "Software installed on a PC connected via a RJ45/RS232 cable to primary monitors." |
| Internal Testing | Must perform according to specifications following module/unit, subsystem, integration, V&V, and final acceptance testing. | "The device performed according to specifications" across module/unit testing, subsystem testing, integration test, verification and validation testing, and final acceptance testing. |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions a "performance comparison test" where the Sensometrics® Software was compared with the Phillips and Integra devices. However, it does not specify the sample size used for this test set (e.g., number of patients, number of data points).
The data provenance is also not explicitly stated. It's not clear where this performance comparison test was conducted (country of origin) or if the data was collected retrospectively or prospectively.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not mention the use of experts to establish ground truth for the test set. The comparison test seems to rely on the outputs of the predicate devices themselves as the reference for "equivalence."
4. Adjudication Method for the Test Set:
No adjudication method is described, as the ground truth appears to be established by the predicate devices rather than human expert consensus.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
No, an MRMC comparative effectiveness study was not done. The study described is a performance comparison between the software and primary measuring devices, not a study evaluating human reader performance with and without AI assistance. Therefore, no effect size of human readers improving with AI vs. without AI assistance is provided.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
Yes, a standalone performance evaluation was done in the sense that the "Sensometrics® Software" itself was compared directly to the predicate devices' outputs. The software's performance describes its ability to compute and display parameters in a way that is equivalent to existing primary monitors. The intended use emphasizes it's an adjunct and not for sole diagnosis, but the performance testing described is of the algorithm/software's output.
7. The Type of Ground Truth Used:
The ground truth used for the performance comparison test was the measurements/outputs from the legally marketed predicate devices (Phillips IntelliVue Mp40 and Integra MPM-1). The assumption is that these predicate devices are accurate and provide reliable measurements for Mean ICP, Mean ABP, systolic pressure output, diastolic pressure output, and cerebral temperature output.
8. The Sample Size for the Training Set:
The document does not specify a sample size for a training set. The software's development life cycle included various levels of testing (Module/Unit, Subsystem, Integration, V&V, Final Acceptance), but there is no mention of a separate training phase or dataset in the context of machine learning, which the Sensometrics® Software submission does not appear to be. It's a display system, not an AI/ML algorithm that requires a training set in the typical sense.
9. How the Ground Truth for the Training Set Was Established:
As there is no explicit mention of a training set in the context of typical machine learning models (which this device is not presented as), there is no information provided on how ground truth for a training set was established. The software's "specifications" and the outputs of the primary monitors serve as the reference points for its design and verification.
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K101133, Sensometrics® Software - Response November 16, 2010
Attachment C
NDV 1 9 2010
510(k) Summary
Submitter: dPCom AS
Address: Solveien 29 C, N-1177 Oslo, Norway Postal: Pb 14, Bekkelagshøgda, N-1109 Oslo, Norway Phone: +47 22 95 82 77
Contact Information: Constance Bundy C. G. Bundy Associates, Inc. 435 Rice Creek Terrace Fridley, MN 55432
Submission Date: April 16, 2010, Revised November 12, 2010
Device Name and Classification: Sensometrics® Software, Intracranial Pressure Monitoring Device, Class II, 21 CFR 882.1620 Product Code: GWM
Equivalent Device Identification: NeuroSystems 1™ Monitor, K050702, Integra MPM-1 Monitor, K962928, Phillips IntelliVue Mp40, K032858
Device Description: Sensometrics® Software is a secondary display system that collects together on a single large color display screen the measured pressure variables relevant to the multimodality monitoring of the patient in a neurosurgical intensive care unit. It receives digital inputs from primary monitors used in the measurement of intracranial pressure, arterial blood pressure and cerebral temperature. The Sensometrics® Software displays the measured and derived variables in digital trace form and can store and display trends over periods of up to 240 hours.
Intended Use: Sensometrics® Software is intended for use by a qualified nurse or physician to display variables from existing legally marketed primary measuring devices used to monitor neurosurgical and neurological patients. The parameters displayed by the Sensometrics® Software include intracranial pressure, arterial blood pressure, oxygen, core/cerebral temperature, and these are continuously trended in charts. The presentation of both measured parameters and the relationships between them is intended as an adjunct to the information provided by existing primary monitors. The Sensometrics Software should not be used alone as the sole basis for decisions as to diagnosis or therapy.
Summary of Substantial Equivalence: Sensometrics® Software is similar in design, intended use and performance to the NeuroSystems device. It has the same intended use in that it is an adjunct to primary measuring devices. There are no major differences between the two devices. Sensometrics Software is also substantially equivalent to the Phillips and Integra device. All three devices have the same outputs. No new issues of safety or effectiveness are introduced by using this device.
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K101133, Sensometrics® Software -- Response November 16, 2010
・
Comparison Table
:
| Parameter | Proposed device | Predicate Device 1 | Predicate Devices 2 & 3 |
|---|---|---|---|
| Identification | SensometricsSoftware | NeuroSystems 1Monitor, K050702 | Phillips IntelliVueMp40, Integra MPM-1 |
| 510(k) No. | K101133 | K050702 | K032858, K962928 |
| Technology | Intracranial pressuremonitoring device | Same | Same. |
| Intended Use | Sensometrics®Software is intendedfor use by a qualifiednurse or physician todisplay variablesfrom existing legallymarketed primarymeasuring devicesused to monitorneurosurgical andneurological patients.The parametersdisplayed by theSensometrics®Software includeintracranial pressure,arterial bloodpressure, oxygen,core/cerebraltemperature, andthese arecontinuously trendedin charts. Thepresentation of bothmeasured parametersand the relationshipsbetween them isintended as anadjunct to theinformation providedby existing primarymonitors. TheSensometrics®Software should notbe used alone as thesole basis for | Same | Same except thesedevices are the primarymeasuring devices |
| diagnosis or therapy. | |||
| Variablesmeasured | The measuredparameters aredescribed above indetail. All parametershave their originfrom the measuredsignal which isequivalent to thepredicate device. | Same but might havedifferent presentationpolicy with regard topressure parameterspresented. | Same |
| Design: | Software installed ona PC connected via aRJ45/RS232 cable toprimary monitors | Monitor connected toprimary monitors | Primary Monitor |
| Data Storage | Dynamic and limitdepends onconfiguration | 1, 2, 8 or 24 hrs. | Unknown |
| Trace Form | Digital | Analog or digital | Analog or digital |
.
. .
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Summary of Testing:
Sensometrics® Software has undergone testing on several levels:
Module/Unit testing
· Subsystem testing
Integration test
Verification and validation testing throughout the development life cycle
Final acceptance testing of the final product
The device performed according to specifications.
The Software was also compared with the Phillips and Integra devices in a performance comparison test. The test objective was to compare Mean ICP, Mean ABP, systolic pressure output, diastolic pressure output and cerebral temperature output between the three devices. The test results show that the parameters computed by Sensometrics software are equivalent to the predicate devices.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
dPCom AS c/o Ms. Constance G. Bundy C.G. Bundy Associates, Inc. 435 Rice Ccreek Terrace NE Fridley, MN 55432
NOV 1 9 2010
Re: K101133
Trade/Device Name: Sensometrics® Software Regulation Number: 21 CFR 882.1620 Regulation Name: Intracranial Pressure Monitoring Device Regulatory Class: Class II Product Code: GWM Dated: August 25, 2010 Received: August 31, 2010
Dear Ms. Bundy:
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.
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Page 2 - Ms. Constance G. Bundy
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.
Erich Fromm fr
Malvina B. Eydelman, M.D Director Division of Ophthalmic. Neurological. and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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dPCom AS Oslo, Norway
Indications for Use
510(k) Number (if known):
Device Name: Sensometrics® Software
Indications For Use:
Sensometrics Software is intended for use by a qualified nurse or physician to display variables from existing legally marketed primary measuring devices used to monitor neurosurgical and neurological patients. The parameters displayed by the Sensometrics Software include intracranial pressure, arterial blood pressure, oxygen, core/cerebral temperature, and these are continuously trended in charts. The presentation of both measured parameters and the relationships between them is intended as an adjunct to the information provided by existing primary monitors. The Sensometrics® Software should not be used alone as the sole basis for decisions as to diagnosis or therapy.
Prescription Use X
AND/OR Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Michael Hoffmann
Page 1 of
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
101133
510(k) Number
3
§ 882.1620 Intracranial pressure monitoring device.
(a)
Identification. An intracranial pressure monitoring device is a device used for short-term monitoring and recording of intracranial pressures and pressure trends. The device includes the transducer, monitor, and interconnecting hardware.(b)
Classification. Class II (performance standards).