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.

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.

AI/ML Overview

The provided text describes the HICP200 Patient/Monitor Interconnect Cable and its substantial equivalence to predicate devices, focusing on regulatory affairs and technical specifications rather than a detailed device performance study with specific acceptance criteria and outcome metrics typical for clinical trials or AI/algorithm performance.

Therefore, much of the requested information (items 1, 2, 3, 4, 5, 6, 7, 8, 9) is not explicitly available in the provided document, as it pertains to a 510(k) submission for a Class II medical device, which typically relies on demonstrating substantial equivalence to a legally marketed predicate device through technical and performance testing rather than a comparative effectiveness study or a standalone algorithm performance study with ground truth.

However, I can extract information related to the performance data and testing mentioned:

1. Table of acceptance criteria and the reported device performance:

The document lists standards the device conforms to, which imply certain performance criteria, but does not provide a table with specific pass/fail values or reported device performance metrics against those values. Instead, it states the device "demonstrates conformance" to these standards.

Acceptance Criteria (Implied by Standards Conformance)	Reported Device Performance
AAMI NS 28:1988/(R)2010 Intracranial Pressure Monitoring Devices:
- Absolute accuracy	Conforms to requirements
- Accuracy over time	Conforms to requirements
- Labeling requirements	Conforms to requirements
IEC 60601-1-2:2007 + ISH1:2010 (Electromagnetic compatibility)	Conforms to requirements
EN 60601-1-2:2007 + CORR1:2010 (Electromagnetic compatibility)	Conforms to requirements
IEC 60601-1:2005 + A1:2012 (Basic safety and essential performance)	Conforms to requirements
AAMI/ANSI ES 60601-1:2005/(R)2012 + A1:2012. C1:2009/(R)2012 and A2:2010/(R)2012 (Basic safety and essential performance)	Conforms to requirements
EN 60601-1:2006 + A1:2013 (Basic safety and essential performance)	Conforms to requirements

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

Sample Size: Not specified for any of the performance tests. The document refers to "extensive design verification and validation testing, including functional and performance testing," but does not quantify the sample sizes for these tests.
Data Provenance: Not specified. The testing was conducted by the company ("extensive design verification and validation testing") and an "independent laboratory" for IEC 60601 compliance. It is not a clinical study on patients, but rather engineering verification and validation testing of the device itself.

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

This is not applicable as the document describes device performance testing against engineering specifications and industry standards, not a study involving interpretation of clinical data by experts to establish a ground truth.

4. Adjudication method for the test set:

Not applicable for this type of device performance testing.

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. This is a cable for an intracranial pressure monitoring system, not an AI/imaging diagnostic device that would involve human readers.

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

Not applicable. The HICP200 is a hardware component with integrated software, not a standalone algorithm. Its performance is evaluated as part of the overall system functionality.

7. The type of ground truth used:

For the performance data mentioned, the "ground truth" would be the established scientific and engineering principles and the specified parameters within the referenced standards (e.g., AAMI NS 28 for accuracy, IEC 60601 for safety and EMC). The device's measurements and behavior are compared against these known, precise benchmarks.

8. The sample size for the training set:

Not applicable, as this is hardware and embedded system development, not a machine learning model that requires a training set. The software development procedure RD-004 is based on IEC 62304:2006 and FDA software-related guidance documents, implying software validation rather than training data.

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

Not applicable, for the same reason as point 8.

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 seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure embracing a bird, which is a symbol of care and protection.

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

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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=0010149848cn=William J. Heetderks -ADate: 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

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Indications for Use

510(k) Number (if known) K161010

Device Name

HICP 200 Patient/Monitor Interconnect Cable

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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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 CTustin, CA 92780Tel: 877-486-2473 ext. 108Fax: 888/391-5238
Company Representative:	Gary G. FrugardVP, Regulatory Affairs/Quality AssuranceContact phone: 949-683-1642Email: 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:

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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 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.

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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 (AirManagement System)(Trilogy K083378)	Predicate Device, Aesculap-SpiegelbergBrain 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 withsoftware control	Electromechanical withsoftware control	YES
Intracranial Access	Parenchymal catheters:H110MR, K083378H510MR, K083378H710MR, K083378Ventricular catheters:H210MR, K083378H310, K013705H410MR, K083378H610MR, K083378Subdural catheter:H910MR, K113088	Probes numbered 1through 3 for subdural,parenchymal andintraventricular access	Parenchymal catheters:H110MR, K083378H510MR, K083378H710MR, K083378Ventricular catheters:H210MR, K083378H310, K013705H410MR, K083378H610MR, K083378Subdural catheter:H910MR, K113088	YES
ICP Display	Hospital Monitor	Aesculap-SpiegelbergMonitor	Hospital Monitor	YES
Transducer Location	Main cable housing	Aesculap-SpiegelbergMonitor	Catheter-ConnectModule	YES
Priming Actuator Location	Main cable housing	Aesculap-SpiegelbergMonitor	Control Module	YES
Sensor Location	Air bladder located onthe body of the catheter	Air-pouch located on thetip of the probe	Air bladder located onthe 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 toAtmospheric	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

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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.

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. 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.

Regulation Number and Section

§ 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).