(192 days)
K0833784, K003759
Not Found
No
The description focuses on air-coupled pressure transduction and signal transmission, with no mention of AI or ML algorithms for data analysis or interpretation.
No
The device is purely a monitoring system for intracranial pressure (ICP), it does not provide any therapy or treatment.
Yes
Explanation: The device is indicated for "continuous monitoring of ICP" and obtains "direct measurement of ICP," which are diagnostic activities.
No
The device description explicitly details hardware components like a reusable patient/monitor interconnect cable, integrated Control and Catheter-Connect Modules, a pressure transducer, and pneumatic connections. It also mentions electrical safety and electromagnetic compatibility testing, which are relevant to hardware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "continuous monitoring of ICP" (Intracranial Pressure) by direct measurement from "subdural, parenchymal, or intraventricular locations." This involves measuring a physiological parameter within the body.
- Device Description: The device is described as a "patient/monitor interconnect cable with integrated Control and Catheter-Connect Modules." It works by "air-coupled pressure transduction" to measure pressure. This is a physical measurement of a physiological state.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens outside of the body, such as blood, urine, or tissue samples. IVDs are specifically designed for testing these types of samples to provide information about a person's health.
The device is clearly designed for in vivo (within the living body) measurement of intracranial pressure.
N/A
Intended Use / Indications for Use
The HICP200 is designed for use with any Hummingbird catheter. Together, they comprise a system that is indicated for use in those conditions where continuous monitoring of ICP is required. As dictated by clinical judgment, direct measurement of ICP may be obtained from the subdural, parenchymal, or intraventricular locations.
Product codes (comma separated list FDA assigned to the subject device)
GWM
Device Description
The HICP200 is a reusable patient/monitor interconnect cable with integrated Control and Catheter-Connect Modules. The principle of operation of the HICP200 and Hummingbird intracranial pressure catheter system is air-coupled pressure transduction.
The HICP200 Catheter-Connect Module houses the pressure transducer and provides a high-reliability pneumatic connection to the Hummingbird ICP catheter. The connector provides for audible and tactile feedback indicating a secure connection. The Intracranial Pressure (ICP) waveform is transduced in the Catheter-Connect Module and the analog signal is transmitted to the patient monitor, according to AAMI BP-22 standard protocol of 5u V/V/mmHg.
The HICP200 Control Module monitors the same ICP signal transmitted to the monitor to control and implement system air priming cycle requirements and user interface audio/visual system status.
The HICP200 is configured with a user-specified connector to interface with the patient monitor.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
subdural, parenchymal, or intraventricular
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)
The HICP200 design (including software) reflects the distillation of documented requirements analyses, including hazard analysis and the identification of risk mitigations. The hazard analysis was performed consistently with the company's risk management procedures. The software that controls the function of the device was developed according to the company's software development procedure RD-004, Software Lifecycle Process, which is based on the IEC 62304:2006 and FDA software-related guidance documents. The HICP200 was subjected to extensive design verification and validation testing, including functional and performance testing, to demonstrate its ability to perform effectively as a component of the system employed in the measurement of intracranial pressure (ICP). The HICP200 summary V&V test reports contain trace matrices linking individual test reports that contain evidence that the HICP200 conforms to product specifications and that demonstrate risk mitigation schemes have been implemented successfully. Included in these reports are the results of an independent laboratory testing for conformance with the requirements of IEC 60601, including electrical safety and electromagnetic compatibility. The HICP200 has been subjected to testing and demonstrates conformance with the requirements of AAMI NS 28, including absolute accuracy, accuracy over time, and the labeling requirements contained in the standard.
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.
K0833784, K003759
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).
0
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 20, 2016
Innerspace Neuro Solutions, Inc. Gary Frugard VP, Regulatory Affairs 1622 Edinger Ave Suite C Tustin, California 92780
Re: K161010
Trade/Device Name: HICP200 Patient/monitor Interconnect Cable Regulation Number: 21 CFR 882.1620 Regulation Name: Intracranial Pressure Monitoring Device Regulatory Class: Class II Product Code: GWM Dated: April 9, 2016 Received: September 19, 2016
Dear Gary Frugard:
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
1
the quality systems (OS) 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 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 yours,
| William J. | Digitally signed by William J. Heetderks -
DN: c=US, o=U.S. Government, ou=HHS,
ou=NIH, ou=People, |
|--------------|----------------------------------------------------------------------------------------------------------|
| Heetderks -A | 0.9.2342.19200300.100.1.1=0010149848
cn=William J. Heetderks -A
Date: 2016.10.20 12:27:38 -04'00' |
| for | Carlos L. Peña, PhD, MS |
|---|---|
| Director | |
| Division of Neurological | |
| and Physical Medicine Devices | |
| Office of Device Evaluation | |
| Center for Devices and Radiological Health |
Enclosure
2
Indications for Use
510(k) Number (if known) K161010
Device Name
HICP 200 Patient/Monitor Interconnect Cable
Indications for Use (Describe)
The HICP200 is designed for use with any Hummingbird catheter. Together, they comprise a system that is indicated for use in those conditions where continuous monitoring of ICP is required. As dictated by clinical judgment, direct measurement of ICP may be obtained from the subdural, parenchymal, or intraventricular locations.
| 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
HICP200 510(k)
InnerSpace Neuro Solutions, Inc.
Image /page/3/Picture/2 description: The image shows the logo for innerspace neuro SOLUTIONS. The word "innerspace" is written in a stylized font, with the letters connected. To the right of "innerspace" is the word "neuro" in a smaller, simpler font. Below the two words is the word "SOLUTIONS" in a smaller, gray font. Above and to the right of the words is a graphic of a bird.
1622 Edinger Ave., Ste. C., Tustin, CA 92780 Phone 877-486-2473 Fax: 888-391-5238
510(k) Summary for the HICP200 Patient/Monitor Interconnect Cable
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
| SUBMITTER | |
|---|---|
| Company: | InnerSpace Neuro Solutions, Inc. |
| 1622 Edinger Avenue, Suite C | |
| Tustin, CA 92780 | |
| Tel: 877-486-2473 ext. 108 | |
| Fax: 888/391-5238 | |
| Company Representative: | Gary G. Frugard |
| VP, Regulatory Affairs/Quality Assurance | |
| Contact phone: 949-683-1642 | |
| Email: GGFandA@msn.com | |
| Date 510(k) Prepared: | April 9, 2016 |
| DEVICE | |
| Trade Name: | HICP200 Patient/Monitor Interconnect Cable |
| Common Name: | Patient/Monitor Interconnect Cable |
| Classification Name: | Device, Monitoring, Intracranial Pressure |
| Classification Panel: | Neurology |
| Product Code: | GWM |
| CFR Section: | 882.1620 |
| Classification: | Class II |
III. PREDICATE DEVICE
HICP200 Patient/Monitor Interconnect Cable is substantially equivalent to the following currently marketed devices:
4
- InnerSpace Medical Air Management System (AMS) as described in the Trilogy, K0833784
- Aesculap-Spiegelberg Brain Pressure Monitor, K003759 ●
These predicates have not been subject to a design-related recall.
IV. DEVICE DESCRIPTION
The HICP200 is a reusable patient/monitor interconnect cable with integrated Control and Catheter-Connect Modules. The principle of operation of the HICP200 and Hummingbird intracranial pressure catheter system is air-coupled pressure transduction.
The HICP200 Catheter-Connect Module houses the pressure transducer and provides a high-reliability pneumatic connection to the Hummingbird ICP catheter. The connector provides for audible and tactile feedback indicating a secure connection. The Intracranial Pressure (ICP) waveform is transduced in the Catheter-Connect Module and the analog signal is transmitted to the patient monitor, according to AAMI BP-22 standard protocol of 5u V/V/mmHg.
The HICP200 Control Module monitors the same ICP signal transmitted to the monitor to control and implement system air priming cycle requirements and user interface audio/visual system status.
The HICP200 is configured with a user-specified connector to interface with the patient monitor.
V. INDICATIONS FOR USE:
The HICP200 is designed for use with any Hummingbird catheter. Together, they comprise a system that is indicated for use in those conditions where continuous monitoring of intracranial pressure (ICP) is required. As dictated by clinical judgment, direct measurement of ICP may be obtained from the subdural, parenchymal, or intraventricular locations.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The HICP200 is substantially equivalent to the AMS (Air Management System) cable component of the Trilogy (K083378). Both are air-coupled pressure transduction devices, which require precise control of the system air volume. This is usually controlled by a priming mechanism that first evacuates the system and then introduces a defined volume of air. The HICP200 automates the priming process, whereas the AMS requires manual priming which is performed by hospital personnel on a periodic basis. The electromechanical priming mechanism is housed in the Control Module of the cable. The HICP200 is also substantial equivalent to the Aesculap-Spiegelberg Brain Pressure Monitor (K003759), which is also an aircoupled pressure transduction device; however with the Aesculap-Speigelberg device, the priming mechanism is located in the monitor housing.
1 In K083378 the Trilogy catheter is also referred to as the Synergy catheter.
5
A detailed listing of substantially equivalent elements are provided in the table below.
Summary of Technological Characteristics, Including the Related Components that Comprise the ICP Pressure Monitoring System
| | Predicate Device, AMS (Air
Management System)
(Trilogy K083378) | Predicate Device, Aesculap-Spiegelberg
Brain Pressure Monitor
(K003759) | HICP200 | S/E |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|
| Indication for Use | ICP Monitoring | ICP Monitoring | ICP Monitoring | YES |
| Principle of Operation | Air coupled pressure transduction | Air coupled pressure transduction | Air coupled pressure transduction | YES |
| Mechanism of Control | Electromechanical | Electromechanical with
software control | Electromechanical with
software control | YES |
| Intracranial Access | Parenchymal catheters:
H110MR, K083378
H510MR, K083378
H710MR, K083378
Ventricular catheters:
H210MR, K083378
H310, K013705
H410MR, K083378
H610MR, K083378
Subdural catheter:
H910MR, K113088 | Probes numbered 1
through 3 for subdural,
parenchymal and
intraventricular access | Parenchymal catheters:
H110MR, K083378
H510MR, K083378
H710MR, K083378
Ventricular catheters:
H210MR, K083378
H310, K013705
H410MR, K083378
H610MR, K083378
Subdural catheter:
H910MR, K113088 | YES |
| ICP Display | Hospital Monitor | Aesculap-Spiegelberg
Monitor | Hospital Monitor | YES |
| Transducer Location | Main cable housing | Aesculap-Spiegelberg
Monitor | Catheter-Connect
Module | YES |
| Priming Actuator Location | Main cable housing | Aesculap-Spiegelberg
Monitor | Control Module | YES |
| Sensor Location | Air bladder located on
the body of the catheter | Air-pouch located on the
tip of the probe | Air bladder located on
the body of the catheter | YES |
| Precise Priming Volume | Yes (.03 cc) | Yes (.05-.1 cc) | Yes (.1 cc) | YES |
| Reference to a Set Pressure | Yes - Relative to
Atmospheric | Yes – Atmospheric | Yes - Atmospheric | YES |
| Priming Actuation | Manual | Automatic, Electronic | Automatic, Electronic | YES |
| Priming Frequency | Manual, per IFU | Once every hour | Once every hour | YES |
| System Leak Detection | Yes | Yes | Yes | YES |
VII. PERFORMANCE DATA
The HICP200 design (including software) reflects the distillation of documented requirements analyses, including hazard analysis and the identification of risk mitigations. The hazard analysis was performed consistently with the company's risk
6
management procedures. The software that controls the function of the device was developed according to the company's software development procedure RD-004, Software Lifecycle Process, which is based on the IEC 62304:2006 and FDA software-related guidance documents. The HICP200 was subjected to extensive design verification and validation testing, including functional and performance testing, to demonstrate its ability to perform effectively as a component of the system employed in the measurement of intracranial pressure (ICP). The HICP200 summary V&V test reports contain trace matrices linking individual test reports that contain evidence that the HICP200 conforms to product specifications and that demonstrate risk mitigation schemes have been implemented successfully. Included in these reports are the results of an independent laboratory testing for conformance with the requirements of IEC 60601, including electrical safety and electromagnetic compatibility. The HICP200 has been subjected to testing and demonstrates conformance with the requirements of AAMI NS 28, including absolute accuracy, accuracy over time, and the labeling requirements contained in the standard. The standards to which the HICP200 conforms are referenced below.
- IEC 60601-1-2:2007 + ISH1:2010 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility - Requirements and tests
- EN 60601-1-2:2007 + CORR1:2010 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility - Requirements and tests
- . IEC 60601-1:2005 + A1:2012 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
- . AAMI/ANSI ES 60601-1:2005/(R)2012 + A1:2012. C1:2009/(R)2012 and A2:2010/(R)2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- EN 60601-1:2006 + A1:2013 Medical electrical equipment Part 1: General ● requirements for basic safety and essential performance
- ANSI/AAMI NS 28:1988/(R)2010 Intracranial Pressure Monitoring Devices ●
The results indicate that the HICP200 presents no new issues of safety when compared to the predicate devices.
VIII. CONCLUSIONS
Evaluation of Substantial Equivalence Conclusion: Based on the principles of operation and the information contained in the Summary of Technological Characteristics table and performance data described above, it is concluded that:
- The devices have the same intended use and indications for use. .
- . The devices employ comparable air management either by manual actuation or automatically by electromechanical means controlled by software.
- . The HICP200 and the AMS are components of a system that use the same catheters and that system is substantially equivalent to the Aesculap-Spiegelberg system.
7
- . The devices perform in a similar manner and are suitable for the designated indications for use.
The sponsor believes that the data submitted for the HICP200 constitutes valid scientific evidence to support the determination that the HICP200 is as safe and effective as the predicate devices.