(210 days)
Not Found
No
The description focuses on displaying and trending existing physiological data from primary monitors, with no mention of AI/ML algorithms for analysis or interpretation.
No
The device is a secondary display system that collects and displays variables from primary measuring devices; it is intended as an adjunct to information provided by existing primary monitors and should not be used as the sole basis for decisions on diagnosis or therapy. It does not exert any direct therapeutic action.
No
The Sensometrics Software is described as a "secondary display system" that presents data from existing primary measuring devices. Its function is to "display variables" and "continuously trend in charts" parameters like intracranial pressure and arterial blood pressure. The "Intended Use" explicitly states it should not be used alone "as the sole basis for decisions as to diagnosis or therapy," indicating it is an adjunct tool for monitoring rather than a device that makes a diagnosis.
Yes
The device description explicitly states "Sensometrics® Software is a secondary display system" and details its function as receiving digital inputs and displaying variables. There is no mention of any hardware component being part of the device itself, only that it receives data from existing primary measuring devices.
Based on the provided information, the Sensometrics Software is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Sensometrics Software's function: The Sensometrics Software receives digital inputs from existing legally marketed primary measuring devices that monitor physiological parameters like intracranial pressure, arterial blood pressure, oxygen, and temperature. It then displays and trends these parameters.
- No sample analysis: The software does not analyze samples taken from the human body. It processes data from devices that are already measuring physiological parameters in vivo (within the body).
Therefore, the Sensometrics Software falls under the category of a medical device that processes and displays data from other medical devices, rather than an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
GWM
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.
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
qualified nurse or physician / neurosurgical intensive care unit
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)
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.
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
§ 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).
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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 | Sensometrics | ||
| Software | NeuroSystems 1 | ||
| Monitor, K050702 | Phillips IntelliVue | ||
| Mp40, Integra MPM-1 | |||
| 510(k) No. | K101133 | K050702 | K032858, K962928 |
| Technology | Intracranial pressure | ||
| monitoring device | Same | Same. | |
| 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 | Same | Same except these | |
| devices are the primary | |||
| measuring devices | |||
| diagnosis or therapy. | |||
| Variables | |||
| measured | The measured | ||
| parameters are | |||
| described above in | |||
| detail. All parameters | |||
| have their origin | |||
| from the measured | |||
| signal which is | |||
| equivalent to the | |||
| predicate device. | Same but might have | ||
| different presentation | |||
| policy with regard to | |||
| pressure parameters | |||
| presented. | Same | ||
| Design: | Software installed on | ||
| a PC connected via a | |||
| RJ45/RS232 cable to | |||
| primary monitors | Monitor connected to | ||
| primary monitors | Primary Monitor | ||
| Data Storage | Dynamic and limit | ||
| depends on | |||
| configuration | 1, 2, 8 or 24 hrs. | Unknown | |
| Trace Form | Digital | Analog or digital | Analog or digital |
.
. .
2
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.
3
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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.
4
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
5
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