(30 days)
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.
The Philips OB TraceVue Obstetrical Information Management System SW Revision F.00. The modified device has the same intended use as the legally 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.
Please note that the provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with specific acceptance criteria and performance metrics for the modified device. Therefore, much of the requested information, particularly quantitative data on device performance, sample sizes for specific tests, and expert involvement, is not explicitly stated in this document.
Here's an analysis based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Functionality requirements per specifications of the predicate device | "Meets all functionality requirements" |
| Performance claims per specifications of the predicate device | "Meets all ... performance claims" |
| Safety requirements per hazard analysis | Confirmed through "safety testing from the hazard analysis" |
| Demonstrate substantial equivalence to K970456 | "Test results showed substantial equivalence." |
| Pass/Fail criteria based on predicate device specifications | "Pass/Fail criteria were based on the specifications cleared for the predicate device." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document refers to "system level tests, performance tests, and safety testing," but does not provide details on the number of cases, patient data, or other samples used in these tests.
- Data Provenance: Not specified. It's unclear if the testing involved real patient data, simulated data, or a combination, nor is the country of origin or whether it was retrospective or prospective data mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not provided in the 510(k) summary. The document does not describe the establishment of a "ground truth" for a test set in the context of clinical validation, as its primary focus is on demonstrating equivalence based on engineering and system-level testing.
4. Adjudication Method for the Test Set
- This information is not provided. Given that the testing described seems to be more focused on technical verification and validation against predicate specifications rather than a clinical trial requiring consensus ground truth, an adjudication method for a test set is not mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done according to this 510(k) summary. The document focuses on demonstrating substantial equivalence of a software revision, not on evaluating the improvement in human reader performance with or without AI assistance. The device is described as an "information management system" that can "alert the user to suspicious traces, but leaves the decision about what action to take to the clinician." This suggests its primary role is data presentation and alerts, not a diagnostic aid requiring an MRMC study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- While the document mentions the device can "alert the user to suspicious traces," it explicitly states it "leaves the decision about what action to take to the clinician." This indicates it is not intended to operate as a standalone diagnostic algorithm. The described "verification, validation, and testing activities" are for the overall system's functionality and performance against predicate specifications, not for a standalone algorithmic performance. Therefore, a standalone performance study in the sense of an algorithm making a definitive diagnosis or decision is not applicable/not reported.
7. The Type of Ground Truth Used
- As the study described is primarily focused on software verification, validation, and demonstrating substantial equivalence to a predicate device's specifications, the concept of "ground truth" in the context of clinical outcomes, pathology, or expert consensus (as would be used in a diagnostic AI study) is not applicable and not detailed. The "ground truth" for the tests mentioned would likely be the expected system behavior and output as defined by the device's functional and performance specifications, rather than clinical ground truth.
8. The Sample Size for the Training Set
- This information is not provided and is likely not relevant, as the device is a software revision of an information management system, not explicitly an AI/ML-based diagnostic algorithm that undergoes a distinct training phase on a dataset separate from testing.
9. How the Ground Truth for the Training Set Was Established
- As there's no mention of a "training set" in the context of an AI/ML model, this information is not provided and is not applicable to the type of device and study described.
Summary of the Study that Proves the Device Meets the Acceptance Criteria:
The study described is focused on demonstrating substantial equivalence of the Philips OB TraceVue Obstetrical Information Management System SW Revision F.00 to its previously cleared predicate device (K970456). The studies performed included:
- System-level tests: To ensure the entire system functions as intended.
- Performance tests: To verify that the system meets its operational specifications.
- Safety testing from the hazard analysis: To confirm identified hazards are mitigated and the device performs safely.
The acceptance criteria for these tests were "based on the specifications cleared for the predicate device," and the pass/fail criteria were similarly linked. The results reported were that the tests "showed substantial equivalence" and that the device "meets all functionality requirements and performance claims."
In essence, the study was a technical verification and validation effort to confirm that the new software revision maintained the same safety and effectiveness characteristics as the legally marketed predicate device, rather than a clinical trial establishing new performance benchmarks for a novel diagnostic algorithm.
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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 andGynecologicalMonitoring Devices | §884.2740, II | HGM | Perinatal monitoring systemand 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.
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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.
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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.
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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
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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
§ 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).