(75 days)
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.
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
This FDA 510(k) premarket notification (K100272) is for the Philips IntelliVue Clinical Information Portfolio Release E.0. It is a software-only product used for charting and data management, and the submission primarily focuses on renaming the product, updating technologies to meet current hospital IT requirements, and improving usability.
Based on the provided documents, it is important to note that this submission does not involve a clinical study to prove the device meets specific performance criteria related to diagnostic accuracy or clinical outcomes. Instead, it relies on demonstrating substantial equivalence to a predicate device (HP CareVue 9000 Clinical Information System, K992636) through non-clinical testing.
Therefore, many of the requested sections (e.g., sample size for test sets, expert adjudication, MRMC study, standalone performance, ground truth types) are not applicable as they pertain to clinical or diagnostic performance studies, which were not conducted for this submission.
Here's an analysis of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a software update and renaming submission, the "acceptance criteria" are related to maintaining the functionality, reliability, and safety of the previous version and meeting new IT and usability requirements. The reported performance is that these criteria were met through non-clinical testing.
| Acceptance Criteria Category | Description | Reported Device Performance |
|---|---|---|
| Functional Equivalence | The device (IntelliVue Clinical Information Portfolio Release E.0) must retain the core functionalities of the predicate device (HP CareVue 9000 Clinical Information System). | "ICIP Release E.0 contains all the main functionality of the predicate." |
| Intended Use Equivalence | The device must maintain the same intended use as the predicate device. | "The predicate device and the subject device are similar with respect to the intended use and indications for use." |
| Safety and Effectiveness | The updated device must not raise new issues of safety or effectiveness compared to the predicate device. | "In our opinion, given the substantial equivalence to the predicate devices, no new issues of safety or effectiveness are raised by this premarket notification." |
| Reliability and Performance Claims | The device must meet all reliability requirements and performance claims established for the device. Non-clinical testing (system level, performance, safety) demonstrated this. | "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." |
| Usability Enhancement | The new user interface and updated technologies should improve user experience and meet hospital IT requirements, making the product more user-friendly for clinicians, support, and scalability. | "There is a new user interface designed around more modern technologies, this makes the product more user friendly for clinicians, support and scalability." |
Regarding the study that proves the device meets the acceptance criteria:
The study that proves the device meets the acceptance criteria is described as Non-Clinical Testing.
- Type of Study: Verification, validation, and testing activities. This included system-level tests, performance tests, and safety testing from hazard analysis.
- Purpose: To establish the performance, functionality, and reliability characteristics of the subject device with respect to the predicate device.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable. This was a non-clinical software validation and verification study, not a study involving patient data or a specific "test set" of clinical cases in the way a diagnostic accuracy study would. The testing was against product specifications and the predicate device's performance.
- Data Provenance: Not applicable. No clinical data or patient data was involved in the testing described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable. Ground truth, in the context of clinical accuracy, was not established for this type of non-clinical software validation. The "ground truth" for this submission would be the functional and performance specifications of the software itself and the established performance of the predicate device.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set
- Adjudication Method: Not applicable. No clinical test set or human interpretation requiring adjudication was involved.
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
- MRMC Study: No. This submission does not involve AI or a diagnostic study requiring human reader assessment of cases.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance Study: No, not in the context of diagnostic or interpretive performance. The software's functionality was tested, but not its standalone performance in a clinical diagnostic sense. It is a clinical information management system, not a diagnostic algorithm.
7. The type of ground truth used
- Type of Ground Truth: The "ground truth" for this non-clinical testing was based on:
- The specifications cleared for the predicate device (HP CareVue 9000 Clinical Information System, K992636).
- The specifications of the subject device (Philips IntelliVue Clinical Information Portfolio Release E.0).
- Test results demonstrating adherence to these specifications and functional equivalence.
- Hazard analysis for safety testing.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This device is not an AI/ML algorithm that requires a "training set" of data in the conventional sense. The software development likely involved iterative testing and refinement, but not a distinct "training set" for model learning.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable, as there was no training set in the context of AI/ML development. The "ground truth" for the software's development and verification would have been its functional requirements and design specifications.
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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, 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
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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.
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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 (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 andstorage, patient data |
| Cardiovascular | 870.2450, II | DXJ | Display, medical cathode raytube |
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
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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.
-
- 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.
§ 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).