(75 days)
Not Found
No
The summary describes a software product for data collection, storage, and management, with enhancements focused on usability and IT requirements. There is no mention of AI or ML capabilities.
No.
This device is a software product for data collection, storage, and management, and computation of drug dosage, not for directly treating a medical condition.
No
The device is described as a software-only product for charting and data management, and its intended use is for data collection, storage, and management, as well as computation of drug dosage. It explicitly states it is "Intended for use in the data collection, storage, and management," not for diagnosing conditions.
Yes
The device description explicitly states that the proposed device is a "software only product" and the submission is primarily for renaming and updating technologies to meet IT requirements and improve usability, consistent with a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use focuses on data collection, storage, management, and computation of drug dosage based on data from independent bedside devices and ancillary systems. This is related to patient monitoring and information management, not the examination of specimens derived from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The device is described as a software-only product for charting and data management, enhancing user experience and meeting IT requirements. This aligns with a clinical information system, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, reagents, or providing diagnostic information based on laboratory tests.
Therefore, the device's function and purpose fall outside the scope of an In Vitro Diagnostic device.
N/A
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. 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.
Product codes (comma separated list FDA assigned to the subject device)
DXJ, NSX
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
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
health care providers
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)
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 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.
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
§ 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).
0
Image /page/0/Picture/0 description: The image contains two logos. On the left is the logo for the Department of Health & Human Services - USA, which features a stylized emblem with three figures. To the right of that is the logo for the U.S. Food & Drug Administration (FDA). The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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, Aneesh.Deoras@fda.hhs.gov.
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/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with a staff entwined by two snakes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
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.
2
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 (800) 638-2041 or (301) 796-7100 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).
-
- The submitter of this pre-market notification is:
Teresa Schmidt Philips Medical Systems 3000 Minuteman Road Andover. MA 01810 United States
- The submitter of this pre-market notification is:
-
Tel: 978-659-2220 Fax: 978-685-5624 Email: teresa.schmidt@philips.com
This summary was prepared on December 18, 2009. -
- The name of the subject device is the Philips IntelliVue Clinical Information Portfolio Release E.O.
-
- The trade name of the device the Philips IntelliVue Clinical Information Portfolio.
-
- The common usual name is Clinical Information Management System.
-
- 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 |
| storage, patient data | |||
| Cardiovascular | 870.2450, II | DXJ | Display, medical cathode ray |
| tube |
The Classification names are as follows:
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K 100272 pg 2 of 3
-
- The modified device is substantially equivalent to the previously cleared HP Care Vue 9000 Clinical Information System: K992636 HP CAREVUE 9000 Clinical Information System
-
- 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.
-
- 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.
- Comparison with predicate:
-
- The subject device has the same fundamental technological characteristics as the legally marketed predicate device.
-
- 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
6
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.
-
- 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.