(30 days)
Not Found
No
The document describes a system for gathering, storing, presenting, and alarming on obstetrical patient data. It explicitly states that the system "can alert the user to suspicious traces, but leaves the decision about what action to take to the clinician." There is no mention of AI, ML, or any related technologies in the description or the "Mentions AI, DNN, or ML" section. The performance studies focus on equivalence to a predicate device and meeting functional requirements, not on the performance of an AI/ML algorithm.
No
The device is an information management system for obstetrical surveillance, designed to gather, store, and present patient information and documentation; it does not directly treat or diagnose a condition.
No
The device is described as an "Information Management System" that acquires, presents, gathers, stores, and documents patient information (surveillance). While it can alert to "suspicious traces," it explicitly states that it "leaves the decision about what action to take to the clinician," indicating it does not provide a diagnosis. Its physiological purpose is indirect, focused on information management rather than direct diagnostic assessment.
Yes
The device description explicitly states "The Philips OB TraceVue Obstetrical Information Management System SW Revision F.00," indicating it is a software revision. The focus is on acquiring, presenting, and storing patient information and providing alerts, which are typical software functions. There is no mention of hardware components being part of the device itself, only that it is used in conjunction with patient monitors.
Based on the provided information, the Philips OB TraceVue Obstetrical Information Management System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The description of the Philips OB TraceVue system clearly states its purpose is for "comprehensive obstetrical surveillance of patients" and to "gather and store patient information and to document to relevant monitor information (surveillance) of patients in OB and GYN". It focuses on monitoring and managing patient data, not analyzing biological samples.
- The device is not intended to contact the patient. While some IVD devices might not directly contact the patient (e.g., analyzers), their function is still based on analyzing patient specimens. This device's function is based on receiving and processing data from other sources (likely patient monitoring equipment).
- The intended use and device description focus on data management, surveillance, and alarming based on physiological data. This aligns with the function of a patient information management system, not an IVD.
Therefore, the Philips OB TraceVue Obstetrical Information Management System falls under the category of a patient information management system or a clinical decision support system, rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Philips OB TraceVue Obstetrical Information Management System indicated for use in healthcare facilities by healthcare i s professionals whenever there is a need for comprehensive obstetrical surveillance of patients at central station, all bedsides, nurses' lounges, physicians' lounges and offices.
The Philips OB TraceVue Obstetrical Information Management System allows easy-to-use patient surveillance in hospitals. It is easy to expand and the highly modular implementation offers antepartum and intrapartum alarming and optional storage.
The specific medical indication for use of this device is:
- . This device is a prescription device.
- This device is not intended to contact the patient.
- This device is used continuously in Obstetrical Gynecological departments (OB/GYN).
- Basic and advanced fetal trace alarming for both antepartum and intrapartum applications.
- The physiological purpose is indirect. The device is intended gather and store patient information and to document to relevant monitor information (surveillance) of patients in OB and GYN, as needed by care providers.
Product codes (comma separated list FDA assigned to the subject device)
HGM
Device Description
The name of the device is the Philips OB TraceVue Obstetrical Information Management System SW Revision F.00. The modification is the introduction of Revision F.00 software for the Philips OB TraceVue Rev.F.00 Obstetrical Information Management System.
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
healthcare professionals / healthcare facilities (central station, all bedsides, nurses' lounges, physicians' lounges and offices), hospitals
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 establish the performance and functionality characteristics of the modified device with respect to the predicate device. Testing involved system level tests, performance tests, and safety testing from the hazard analysis. Pass/Fail criteria were based on the specifications cleared for the predicate device. The test results showed substantial equivalence. The results demonstrate that the Philips OB TraceVue Obstetrical Information Management System SW Rev.F.00 meets all functionality requirements and performance claims.
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
§ 884.2740 Perinatal monitoring system and accessories.
(a)
Identification. A perinatal monitoring system is a device used to show graphically the relationship between maternal labor and the fetal heart rate by means of combining and coordinating uterine contraction and fetal heart monitors with appropriate displays of the well-being of the fetus during pregnancy, labor, and delivery. This generic type of device may include any of the devices subject to §§ 884.2600, 884.2640, 884.2660, 884.2675, 884.2700, and 884.2720. This generic type of device may include the following accessories: Central monitoring system and remote repeaters, signal analysis and display equipment, patient and equipment supports, and component parts.(b)
Classification. Class II (performance standards).
0
510 (k) 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 C.F.R. §807.92.
MAY 28 2008
- The submitter of this premarket notification is: Michael Asmalsky Philips Medizin Systeme Boeblingen GmbH Hewlett-Packard-Str. 2 D-71034 Boeblingen, Germany Tel: ++49 7031 463-1277 Fax: ++49 7031 463-2442 e-mail: michael.asmalsky@philips.com
This summary was prepared on April 22nd, 2008.
-
- The name of the device is the Philips OB TraceVue Obstetrical Information Management System SW Revision F.00. Classification names are as follows:
| Device Panel | Classification | ProCode | Description |
|---|---|---|---|
| Obstetrical and | |||
| Gynecological | |||
| Monitoring Devices | §884.2740, II | HGM | Perinatal monitoring system |
| and accessories |
-
- The modified device is substantially equivalent to the previously cleared Philips devices marketed pursuant to K970456.
- The modification is the introduction of Revision F.00 software 4 . for the Philips OB TraceVue Rev.F.00 Obstetrical Information Management System.
The modified device has the same intended use as the legally 5. marketed predicate device. They are intended to acquire and present patient information. They are designed to help the user to monitor and chart the labor of patients in the hospital or clinic. They can alert the user to suspicious traces, but leaves the decision about what action to take to the clinician. All patient related data, such as demographic data, traces, and notes can be stored to optical disk to ensure a complete, permanent record of patient data.
-
- The modified device has the same technological characteristics as the legally marketed predicate device.
1
K08120, gezofz
-
- Verification, validation, and testing activities establish the performance and functionality characteristics of the modified · device with respect to the predicate device. Testing involved system level tests, performance tests, and safety testing from the hazard analysis. Pass/Fail criteria were based on the specifications cleared for the predicate device. The test results showed substantial equivalence. The results demonstrate that the Philips OB TraceVue Obstetrical Information Management System SW Rev.F.00 meets all functionality requirements and performance claims.
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 8 2008
Mr. Michael Asmalsky Quality & Regulatory Affairs Philips Medizin Systeme Böblingen GmbH Hewlett-Packard-Str. 2, D-71034 Böblingen GERMANY
Re: K081203
Trade/Device Name: The Philips OB TraceVue Obstetrical Information Management System Rev.F.00
Regulation Number: 21 CFR 884.2740
Regulation Name: Perinatal monitoring system and accessories Regulatory Class: II Product Code: HGM Dated: April 23, 2008
Received: April 28, 2008
Dear Mr. Asmalsky:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
3
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CCDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Peporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html.
Sincerely yours,
Nancy Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K 08/203
Device Name: The Philips OB TraceVue Obstetrical Information Management System Rev.F.00
Indications for Use :
Indications for Use
The Philips OB TraceVue Obstetrical Information Management System indicated for use in healthcare facilities by healthcare i s professionals whenever there is a need for comprehensive obstetrical surveillance of patients at central station, all bedsides, nurses' lounges, physicians' lounges and offices.
The Philips OB TraceVue Obstetrical Information Management System allows easy-to-use patient surveillance in hospitals. It is easy to expand and the highly modular implementation offers antepartum and intrapartum alarming and optional storage.
The specific medical indication for use of this device is:
- . This device is a prescription device.
- This device is not intended to contact the patient. �
- This device is � used continuously in Obstetrical Gynecological departments (OB/GYN).
:
- Basic and advanced fetal trace alarming for both antepartum and intrapartum applications.
- The physiological purpose is indirect. The device is intended gather and store patient information and to document to relevant monitor information (surveillance) of patients in OB and GYN, as needed by care providers.
Prescription Use yes___________________________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
Over-The-Counter Use No (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE
IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hals Reum