Philips CS770 IntelliSpace Critical Care and Anesthesia

• K Number: K151366
• Device Name: Philips CS770 IntelliSpace Critical Care and Anesthesia
• Manufacturer: PHILIPS MEDICAL SYSTEMS
• Date Cleared: 2015-10-30 ( 162 days)
• Product Code: DXJ
• Regulation Number: 870.2450

Intended Use

Intended for use in the data collection, storage, and management with independent bedside devices, and ancillary systems that are connected either directly or through networks. The device is indicated for use whenever there is a need for generation of a patient record and computation of drug dosage in all areas patient care is given in the hospital, including critical care and anesthesia areas.

Device Description

The CS770 IntelliSpace Critical Care and Anesthesia software (Release H.O), a modified version of the IntelliVue Clinical Information Portfolio which was last cleared under premarket notification number K100272. ICCA is a software only product used for charting and data management, offers clinical decision and clinical workflow support for critical care environments, intra-operative anesthesia, and the anesthesia-critical care continuum. Integrating information from patient vital sign monitors and ancillary bedside devices, hospital systems such as CPOE and laboratory, and clinical documentation, ICCA uses advisories and evidence-based medicine bundles to provide information to clinicians. In addition ICCA provides a powerful Data Analysis and Reporting (DAR) database and reporting toolset for the critical care and anesthesia environments.

Predicate Devices

K100272

Reference Devices

K100272

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a software system for data collection, storage, management, and clinical workflow support, but it does not mention any AI or ML capabilities. The focus is on integrating data and providing advisories based on evidence-based medicine bundles, which is typically rule-based logic, not AI/ML.

Therapeutic

No.
The device is a software product for data collection, storage, and management, and offers clinical decision and workflow support; it does not directly treat or diagnose a disease or condition.

Diagnostic

No

The device is described as a software product for data collection, storage, and management, and for providing clinical decision and workflow support. Its functions include generating patient records, computing drug dosages, and integrating information from various sources to provide information to clinicians. These activities support clinical care and management but do not inherently involve making a medical diagnosis.

SaMD (Software as a Medical Device)

Yes

The device description explicitly states that the CS770 IntelliSpace Critical Care and Anesthesia software is a "software only product". While it integrates data from hardware devices and systems, the device itself, as described in the 510(k) summary, is solely the software component.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use/Indications for Use: The intended use focuses on data collection, storage, management, patient record generation, and drug dosage computation. These are all related to managing patient information and clinical workflow, not performing tests on biological samples to diagnose or monitor a disease or condition.
• Device Description: The description clearly states it's a software-only product for charting, data management, clinical decision support, and workflow support. It integrates data from various sources but doesn't perform any diagnostic tests itself.
• Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing chemical or biological reactions, or providing diagnostic results based on such analysis.

IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is entirely focused on managing and utilizing existing patient data and supporting clinical processes.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Intended for use in the data collection, storage, and management with independent bedside devices, and ancillary systems that are connected either directly or through networks. The device is indicated for use whenever there is a need for generation of a patient record and computation of drug dosage in all areas patient care is given in the hospital, including critical care and anesthesia areas.

Product codes

DXJ, NSX

Device Description

The CS770 IntelliSpace Critical Care and Anesthesia software (Release H.O), a modified version of the IntelliVue Clinical Information Portfolio which was last cleared under premarket notification number K100272. ICCA is a software only product used for charting and data management, offers clinical decision and clinical workflow support for critical care environments, intra-operative anesthesia, and the anesthesia-critical care continuum. Integrating information from patient vital sign monitors and ancillary bedside devices, hospital systems such as CPOE and laboratory, and clinical documentation, ICCA uses advisories and evidence-based medicine bundles to provide information to clinicians. In addition ICCA provides a powerful Data Analysis and Reporting (DAR) database and reporting toolset for the critical care and anesthesia environments.

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

Hospital, including critical care and anesthesia areas.

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)

Verification, validation, and testing activities, where required to establish the performance, functionality, and reliability characteristics of the new device with respect to the predicate are performed. Testing involved system level tests, performance tests, and peformance testing from hazard analysis. Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K100272

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 870.2450 Medical cathode-ray tube display.

(a)
Identification. A medical cathode-ray tube display is a device designed primarily to display selected biological signals. This device often incorporates special display features unique to a specific biological signal.(b)
Classification. Class II (performance standards).

Summary

0

Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is blue and white.

September 1, 2023

Philips Medical Systems Kristen Phillips, RHIA, CTFL Regulatory Affairs Specialist 3000 Minuteman Road, MS 4304 Andover, Massachusetts 01810

Re: K151366

Trade/Device Name: CS770 IntelliSpace Critical Care and Anesthesia, Release H.0 Regulation Number: 21 CFR 870.2450 Regulation Name: Medical Cathode-ray Tube Display Regulatory Class: Class II Product Code: DXJ

Dear Kristen Phillips:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated October 30, 2015. Specifically, FDA is updating this SE Letter to remove the secondary product code NSX as an administrative correction.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter, please contact Aneesh Deoras, OHT2: Office of Cardiovascular Devices, 240-402-4363, [e-mail].

Sincerely,

Aneesh S. Deoras -S

for

Jennifer Shih Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

1

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of a human face in profile, with three stylized lines representing the nose, mouth, and chin.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 30, 2015

Philips Medical Systems Kristen Phillips, RHIA, CTFL Regulatory Affairs Specialist 3000 Minuteman Road, MS 4304 Andover, Massachusetts 01810-1099

Re: K151366

Trade/Device Name: CS770 IntelliSpace Critical Care and Anesthesia, Release H.0 Regulation Number: 21 CFR 870.2450 Regulation Name: Medical cathode-ray tube display Regulatory Class: II Product Code: DXJ. NSX Dated: September 29, 2015 Received: October 2, 2015

Dear Ms. Phillips:

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.

2

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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours, Tina Kiang -S

for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

3

Indications for Use

510(k) Number (if known) K151366

Device Name

CS770 IntelliSpace Critical Care and Anesthesia, Release H.0

Indications for Use (Describe)

Intended for use in the data collection, storage, and management with independent bedside devices, and ancillary systems that are connected either directly or through networks. The device is indicated for use whenever there is a need for generation of a patient record and computation of drug dosage in all areas patient care is given in the hospital, including critical care and anesthesia areas.

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.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

4

Image /page/4/Picture/1 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The word is centered and takes up most of the frame.

Connected Care Solutions Quality & Regulatory Group 3000 Minuteman Road Mailstop 4304 Andover, MA 01810 Tel: [phone] Fax: [phone]

510(k) SUMMARY

This summary of 510(k) information is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 CFR §807.92.

Reference 510(k) Number: K151366 CS770 IntelliSpace Critical Care and Anesthesia, Release H.0

• 1. The submitter of this premarket notification is:
     Kristen Phillips Regulatory Affairs Specialist Philips Medical Systems 3000 Minuteman Road, MS 4304 Andover, Massachusetts 01810-1099 Tel: [phone] Fax: [phone] e-mail: [e-mail]

This summary was prepared on 29 October 2015.

• 2. The name and classification of the device:
     Trade Name: CS770 IntelliSpace Critical Care and Anesthesia, Release H.O. Common name: Clinical Information Management System Classification:

Classification	ProCode	Description
870.2450, II	DXJ	Display, Cathode-Ray Tube, Medical
Secondary Prod Code:
	NSX	Software, transmission and storage, patient data

• 3. Device Description:
     The CS770 IntelliSpace Critical Care and Anesthesia software (Release H.O), a modified version of the IntelliVue Clinical Information Portfolio which was last cleared under premarket notification number

5

K100272. ICCA is a software only product used for charting and data management, offers clinical decision and clinical workflow support for critical care environments, intra-operative anesthesia, and the anesthesia-critical care continuum. Integrating information from patient vital sign monitors and ancillary bedside devices, hospital systems such as CPOE and laboratory, and clinical documentation, ICCA uses advisories and evidence-based medicine bundles to provide information to clinicians. In addition ICCA provides a powerful Data Analysis and Reporting (DAR) database and reporting toolset for the critical care and anesthesia environments.

• 4. The CS770 IntelliSpace Critical Care and Anesthesia, Release H.O software is substantially equivalent to the previously cleared IntelliVue Clinical Information Portfolio, Release E.0 marketed pursuant to K100272.
• 5. Indications for Use

The device has an updated Indications for Use and Intended Use Statement: Intended for use in the data collection, storage, and management with independent bedside devices, and ancillary systems that are connected either directly or through networks. The device is indicated for use whenever there is a need for generation of a patient record and computation of drug dosage in all areas patient care is given in the hospital, including critical care and anesthesia areas.

• 6. The major modifications are as follows:
     The purpose of this submission is to formally document the renaming of the product to the Philips CS770 IntelliSpace Critical Care and Anesthesia (ICCA) as well as to update the 510(k) filing to include the following software changes:

Medical Reference capability

Third party medical reference information will be displayed to the end user at the time of entering an order. Depending on the configuration, the end user may be given the opportunity to review the medical reference information provided and cancel or modify the order.

Patient Data Security

Patient data security is being enhanced in relation to controlling and tracking of users actions when they access restricted patient records.

Formulary Upload

A new tool launched from ICCA's system management tools which allows the following functions:

• · Exporting ICCA configuration into XML files
• Importing XML files into an existing ICCA system

User Interface (UI) Streamlining

The UI enhancements introduce a new "look" to the patient chart container (the parent window that hosts patient data), Patient Census, Notes and Forms. Preexisting chart functionality is retained with some minor exceptions; the user's navigation has been modified and the previous menu approach is replaced with an industry-standard ribbon approach. The new UI involves implementing

6

a ribbon that replaces most of the menu and toolbar commands (available from the chart, census, and personal organizer), a user login / logout area, a notification area (for reminder, advisory, notification icons), and a patient area (for the patient picker and infostrip) which is only visible from the patient chart. The core chart functionality (flowsheet) remains the same as in prior releases.

Discharge Management Report

Enhance the discharge document to accommodate more data points, customization and capture data available in the record at the time the report is generated.

Medication Order co-signing

In many clinical environments, there is a list of drugs that the customer considers to be restricted and need two clinical approvals for ordering of the drug. ICCA supports:

• Configurable list of drugs that need the co-signing
• Holding the order release until one additional clinician has approved the original order. No interventions are generated until additional clinician approves the order.
• Allow the customer to designate specific users who have co-signing authority
• Modify the existing order workflow to present a co-signing authentication/opportunity for the end user.
• Log and traceability on all activities related to co-signing in orders audit trail
• Configuration is done as a check box on the drug in the pharmacy product editor
• Generate a reminder icon, an update to the reminder document
• If the user has cosign permission, it is configurable if the order can continue or be held.
• · Co-sign exists whenever the order is created or modified.
• Co-sign impacts all types of orders that uses that drug.
• Inbound interfaces are not impacted
• Comparative Predicate Device Subject Device CS770 IntelliSpace Critical Care and Characteristic IntelliVue Clinical Information Portfolio, Release E.0 Anesthesia, Release H.O IntelliVue Clinical Information Portfolio, Device Name CS770 IntelliSpace Critical Care and Release E.O Anesthesia, Release H.O The below indications for use have been updated to include the implied use in the name for critical care and anesthesia areas. Intended Use Intended for use in the data collection, Intended for use in the data collection, storage, and management with storage, and management with independent bedside devices, and ancillary independent bedside devices, and systems that are connected either directly ancillary systems that are connected or through networks. either directly or through networks. The device is indicated for use whenever The device is indicated for use whenever Indications for use there is a need for generation of a patient there is a need for generation of a patient record and computation of drug dosage. record and computation of drug dosage in all areas patient care is given in the
• 7. Comparison with predicate:

7

| Comparative
Characteristic | Predicate Device
IntelliVue Clinical Information Portfolio,
Release E.O | Subject Device
CS770 IntelliSpace Critical Care and
Anesthesia, Release H.O |
|---------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| Population | No direct patient connection. As this
software is only intended for use in data
collection, storage, and management; the
performance of the software does not
change with different patient populations. | Same |
| Environment | Hospital | Same |
| Operating Principle | Data Management (charting and
reporting) | Same; with the addition of the Patient
Analytics Platform option. |
| Electronic Patient
Record | Configurable Patient Record usually
consisting of Flowsheets, Notes and Forms,
Medication Administration Record, Patient
Summary, History and Physical, Worklist,
procedure and diagnosis coding | Same; with UI enhancements, Discharge
Management report and Medication co-sign. |
| Census | Patient Census screen showing patient
status | Same |
| Configuration
Editors | A set of configuration editors are provided
that allow trained personnel to configure
the Patient Record documents and
reports. Programming language skill not
required. | Same, plus ability to import/export
configuration (known as Formulary
Upload) |
| Reporting Capability | Generate paper copy reports for the
patient record, including audit trail. | Same |
| Drug Calculator | Present | Same |
| Calculations Engine
& Clinical Advisories | Present | Same Calculations Engine with same
clinical advisories; added Deep Vein
Thrombosis advisory. |
| Alarm functionality | None | Same |
| Measurement
functionality | None | None |
| Technology | ICIP follows deployment model similar to
Microsoft technologies such as clustering.
ICIP was designed to be a cost effective
solution which handles single unit,
standalone starter configurations to large
scale, multi-unit installations.
Reference the ICIP Architecture Overview
in Appendix A, ICIP System Architecture
Enterprise View diagram in Appendix B
and the 865209 IntelliVue Clinical
Information Portfolio Release E.00
Technical Data Sheet in Appendix C. | Same |
| Comparative | Predicate Device | Subject Device |
| Characteristic | IntelliVue Clinical Information Portfolio, | CS770 IntelliSpace Critical Care and |
| | Release E.O | Anesthesia, Release H.O |
| | Windows Server 2008, Enterprise Edition;
SQL Server 2008 | Windows Server 2008 R2, Enterprise
Edition;
Windows Server 2012 R2, Enterprise
Edition;
SQL Server 2008 R2/2012, Enterprise
Edition |
| Programming
language | Microsoft .NET C# | Same |
| Remote Service
Network capability | To gain remote access, the user can run
Remote Desktop client, or Terminal Server
sessions on any appropriately configured
Windows Terminal Server Host. | Same |
| Interfaces/Data
Acquisition - Philips
Monitoring System | HL7 interface from Philips Information
Center server | Same |
| Interfaces/Data
Acquisition | Device Link II (K041942) and DataCapsule
Information using Ethernet LAN standard
protocol to interface with other hospital
networks. | Same, plus IntelliBridge System |
| Interfaces/Hospital
Information System

• Inputs | ICIP interfaces to other hospital systems
  through Health Level 7 (HL7). | Same |
  | Interfaces/Hospital
  Information
  Systems - Output | Patient Data export; Document Export | Same |
  | Auto-Charting | Automatically stored device data without
  user intervention | Same |
  | Data Analysis and
  Reporting | DAR provides users a location to query and
  develop patient data reports without
  impacting the performance of the ICCA
  charting systems. | Same |
  | Medical Reference | N/A | Third party medical reference information
  displayed to user. |
  | User Access &
  Patient Data
  Security | User Authentication services and user
  roles to include logging for audit trail
  information. | Individual Patient lock, Break glass (user
  emergency access with logging) and
  enhanced logging information. |

8

• 8. The technological characteristic changes of this device are the design changes as follows:
  • The electronic patient record is the same with additional UI enhancements, Discharge . Management report and medication co-sign.
  • The configuration editors are the same plus the ability to import/export formulary configuration ●
  • . The Calculations Engine & Clinical Advisories are the same with the addition of the Deep Vein Thrombosis advisory.

9

• The operating system did not include a design change, however the device is verified for compatibility with the updated versions of Windows (as listed in the table above)
• . The Interfaces/Data acquisition in the devices are the same with the addition of interfacing with IntelliBridge System.
• The device has added a third party medical reference display.
• . The user access & patient data security is the same with the addition of enhanced logging, individual patient lock and user emergency access with logging.
• 9. Standards and Guidance used:

| Standard
Number & Date | Standard Title | Recognition
Number |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------|-----------------------|
| ISO 15223-1:
2012 | Medical devices -- Symbols to be used
with medical device labels, labeling and
information to be supplied | 5-90 |
| IEC 62304: 2006 | Medical device software. Software
lifecycle processes | 13-32 |
| AAMI/ANSI/IEC
62366:
2007/(R)2013 | Medical devices. Application of usability
engineering to medical devices | 5-67 |

The following FDA documents were used for guidance:

• "The New 510(k) Paradigm, Alternate Approaches to Demonstrating Substantial Equivalence O in Premarket Notifications", issued March 20, 1998.
• O "Guidance for Industry and FDA Staff, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", issued May 11, 2005.
• "Guidance for FDA Reviewers and Compliance on Off-The-Shelf Software Use in Medical O Devices", issued September 9, 1999.
• "Guidance for Industry: Cybersecurity for Networked Medical Devices Containing Off-the- O Shelf (OTS) Software" issued January 14, 2005.
• "Guidance for Industry and Food and Drug Administration Staff; The 510(k) Program: O Evaluating Substantial Equivalence in Premarket Notifications [510(k)]", Document issued on: July 28, 2014
• "Use of Standards in Substantial Equivalence Determinations", March 12, 2000. O
• "Guidance for Industry", Alternative to Certain Prescription Device Labeling Requirements, O issued January 21, 2000.
• O "Guidance for Industry and FDA Staff, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", issued May 11, 2005. "General Principles of Software Validation; Final Guidance for Industry and FDA Staff", January 11, 2002

10

• "Guidance for Industry and Food and Drug Administration Staff"; Content of Premarket O Submissions for Management of Cybersecurity in Medical Devices, Document Issued on: October 2, 2014
• o "Guidance for Industry and Food and Drug Administration Staff, Mobile Medical Applications"; Document issued on: September 25, 2013
• 10. Non-clinical Testing:

Verification, validation, and testing activities, where required to establish the performance, functionality, and reliability characteristics of the new device with respect to the predicate are performed. Testing involved system level tests, performance tests, and peformance testing from hazard analysis. Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence.

• 11. Conclusions from Non-clinical testing:
      The CS770 IntelliSpace Critical Care and Anesthesia, Release H.O software meets all reliability requirements and performance claims; this supports a determination of substantial equivalence.