INTELLIVUE CLINICAL INFORMATION PORTFOLIO

K100272 · Philips Medical Systems · DXJ · Apr 14, 2010 · Cardiovascular

Device Facts

• Record ID: K100272
• Device Name: INTELLIVUE CLINICAL INFORMATION PORTFOLIO
• Applicant: Philips Medical Systems
• Product Code: DXJ · Cardiovascular
• Decision Date: Apr 14, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2450
• Device Class: Class 2
• Attributes: Software as a Medical Device

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. This device is indicated for use by health care providers whenever there is a need for generation of a patient record and computation of drug dosage.

Device Story

IntelliVue Clinical Information Portfolio (ICIP) is a software-only clinical information management system; collects, stores, and manages data from bedside devices and ancillary systems via direct or network connections. Used by healthcare providers in clinical environments (e.g., critical care) to generate patient records and compute drug dosages. Enhancements in Release E.0 include updated user interface, improved usability, and hospital IT requirement compliance. Output provided to clinicians for patient management and decision-making support. Benefits include streamlined data management, improved clinical workflow, and accurate drug dosage calculations.

Clinical Evidence

Bench testing only. Verification and validation activities included system-level tests, performance tests, and safety testing based on hazard analysis. Results demonstrated that the device meets all reliability requirements and performance claims consistent with the predicate device.

Technological Characteristics

Software-only clinical information management system. Connectivity via direct or network interfaces to bedside devices and ancillary systems. Operates as a data management and computation platform. No specific hardware materials or energy sources defined as it is a software-only product.

Indications for Use

Indicated for use by health care providers for patient record generation and drug dosage computation in clinical settings where data collection, storage, and management from bedside devices and ancillary systems are required.

Regulatory Classification

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.

Predicate Devices

• HP CareVue 9000 Clinical Information System (K992636)

Submission Summary (Full Text)

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September 1, 2023

Philips Medical Systems Teresa Schmidt Quality Assurance & Regulatory Engineer 3000 Minuteman Rd. Andover, Massachusetts 01810-1099

Re: K100272

Trade/Device Name: Intellivue Clinical Information Portfolio Regulation Number: 21 CFR 870.2450 Regulation Name: Medical cathode-ray tube display Regulatory Class: Class II Product Code: DXJ

Dear Teresa Schmidt:

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 April 14, 2010. 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

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

APR 1 4 2010

Philips Medical Systems c/o Ms. Teresa Schmidt Quality Assurance & Regulatory Engineer 3000 Minuteman Rd Andover, MA 01810-1099

Re: K100272

Trade/Device Name: Intellivue Clinical Information Portfolio Regulation Number: 21 CFR 870.2450 Regulation Name: Medical Cathode-Ray Tube Display Regulatory Class: Class II (two) Product Code: DXJ, NSX Dated: March 12, 2010 Received: March 15, 2010

Dear Ms. Schmidt:

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. Teresa Schmidt

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/ucm 1 1 5809.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/ReportalProblem/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 [phone] or [phone] or at its Internet address

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

Sincerely yours,

Pr Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation · Center for Devices and Radiological Health

Enclosure

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K100272 pg 1 of 1

Indications for Use

K100272 510 (k) Number (if known):

Device Name: IntelliVue Clinical Information Portfolio Release E.0

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. This device is indicated for use by health care providers whenever there is a need for generation of a patient record and computation of drug dosage.

AND/OR over-the-counter Use: Prescription Use: YES NO (21 CFR 807 Subpart C) (Part 21 CFFR 801 Subpart D)

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE)

W.M.H.

Page of

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number K1600272

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K100272 pg 1 of 3

## APR 1 4 2010

## 510K Summary

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 CFR 807-92(c).

- 1. The submitter of this pre-market notification is:
Teresa Schmidt Philips Medical Systems 3000 Minuteman Road Andover. MA 01810 United States

- Tel: [phone] Fax: [phone] Email: [e-mail]
This summary was prepared on December 18, 2009.

- 2. The name of the subject device is the Philips IntelliVue Clinical Information Portfolio Release E.O.
- 3. The trade name of the device the Philips IntelliVue Clinical Information Portfolio.
- 4. The common usual name is Clinical Information Management System.
- 5. Device Description: As with the predicate device, the proposed IntelliVue Clinical Information Portfolio (ICIP) is a software only product used for charting and data management. The proposed updated device targets functionality needed for critical care, enhances the user experience, and provide necessary updates to meet hospital IT requirements, as is found in the Philips IntelliVue Clinical Information Portfolio device (K992636). Enhancements for the Critical Care market derived from customer feedback will be added to device in order to meet customer requirements for imoroved usability. The purpose of this submission is to formally document the renaming of the product to the Philips IntelliVue Clinical Information Portfolio (ICIP) as well as to update the 510(k) filing to include updated technologies needed to meet current hospital IT requirements and improve usability for clinicians

| Device Panel | Classification | ProCode | Description |
|------------------|----------------|---------|-----------------------------------------------------|
| General Hospital | Not classified | LNX | Software, transmission and<br>storage, patient data |
| Cardiovascular | 870.2450, II | DXJ | Display, medical cathode ray<br>tube |

The Classification names are as follows:

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K 100272 pg 2 of 3

- 7. The modified device is substantially equivalent to the previously cleared HP Care Vue 9000 Clinical Information System: K992636 HP CAREVUE 9000 Clinical Information System
- 8. The major modifications are as follows:

The purpose of this submission is to formally document the renaming of the product to the Philips IntelliVue Clinical Information Portfolio (ICIP) as well as to update the 510(k) filing to include updated technologies needed to meet current hospital IT requirements and improve usability for clinicians.

- 9. Comparison with predicate:
Predicate Device : The predicate device is the HP CareVue 9000 Clinical Information System (K992636). Similarities: The predicate device and the subject device are similar with respect to the intended use and indications for use and fundamental scientific technology: 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. This device is indicated for use by health care providers whenever there is a need for generation of a patient record and computation of drug dosage. Additionally, ICIP Release E.0 contains all the main functionality of the predicate. Differences: There were enhancements to several of the core features such as report enhancements and simple configuration changes. There is a new user interface designed around more modern technologies, this makes the product more user friendly for clinicians, support and scalability. In conclusion, there are no changes to the intended use or in the Conclusion: fundamental scientific technology employed between the predicate device and the subject devices. Thus, in our opinion, given the substantial equivalence to the predicate devices, no new issues of safety or effectiveness are raised by this premarket notification.

- 10. The subject device has the same fundamental technological characteristics as the legally marketed predicate device.
- 11. Non-Clinical Testing: Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the subject devices with respect to the predicates. Testing involved system level tests, performance tests, and

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K100272 pg 3 of 3

safety testing from hazard analysis. Pass/Fail criteria were based on the specifications cleared for the predicate device, the specifications of the subject device and test results showed substantial equivalence.

- 12. Conclusions from Non-Clinical Testing: The results demonstrate that the Philips IntelliVue Clinical Information Portfolio Release E.0 meets all reliability requirements and performance claims and supports a determination of substantial equivalence.