OB TRACEVUE OBSTETRICAL INFORMATION MANAGEMENT SYSTEM WITH RELEASE F.00

K081203 · Philips Medizin Systeme Boeblingen GmbH · HGM · May 28, 2008 · Obstetrics/Gynecology

Device Facts

• Record ID: K081203
• Device Name: OB TRACEVUE OBSTETRICAL INFORMATION MANAGEMENT SYSTEM WITH RELEASE F.00
• Applicant: Philips Medizin Systeme Boeblingen GmbH
• Product Code: HGM · Obstetrics/Gynecology
• Decision Date: May 28, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 884.2740
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The Philips OB TraceVue Obstetrical Information Management System indicated for use in healthcare facilities by healthcare 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.

Device Story

Obstetrical information management system; acquires/presents patient data for labor monitoring in hospitals/clinics. Inputs: patient demographic data, fetal/maternal traces, clinical notes. Operation: central station/bedside surveillance; provides antepartum/intrapartum alarming; stores data to optical disk for permanent records. Operated by healthcare professionals (nurses, physicians). Output: visual display of traces/alerts; documentation of monitor information. Clinical decision-making: alerts user to suspicious traces; clinician retains final decision-making authority. Benefit: comprehensive surveillance/documentation of labor.

Clinical Evidence

Bench testing only. Verification and validation activities included system-level tests, performance tests, and hazard analysis. Pass/Fail criteria based on predicate specifications. Results confirmed substantial equivalence.

Technological Characteristics

Obstetrical information management software (Rev. F.00). Modular implementation for antepartum/intrapartum surveillance. Data storage via optical disk. Non-contact device. Connectivity: central station and bedside network integration.

Indications for Use

Indicated for patients in OB/GYN departments requiring continuous obstetrical surveillance. Used by healthcare professionals in hospitals/clinics for antepartum and intrapartum monitoring. Prescription only; not for direct patient contact.

Regulatory Classification

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.

Predicate Devices

• Philips OB TraceVue (K970456)

Submission Summary (Full Text)

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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.

K081203

MAY 28 2008

1. 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: [e-mail]

This summary was prepared on April 22nd, 2008.

- 2. 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<br>Gynecological<br>Monitoring Devices | §884.2740, II | HGM | Perinatal monitoring system<br>and accessories |

- 3. 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.

- 6. The modified device has the same technological characteristics as the legally marketed predicate device.

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- 7. 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 [phone] or [phone] 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