BIRTHNET II PERINATAL PATIENT DATA MANAGEMENT SYSTEM

• K Number: K965008
• Device Name: BIRTHNET II PERINATAL PATIENT DATA MANAGEMENT SYSTEM
• Manufacturer: SPACELABS MEDICAL, INC.
• Date Cleared: 1997-12-16 ( 365 days)
• Product Code: HGM
• Regulation Number: 884.2740
• Type: Traditional
• Panel: Obstetrics/Gynecology
• Reference & Predicate Devices: K960109 , K893981
• Predicate For: K980719

Intended Use

The BirthNet™ II Perinatal Patient Data Management System is designed for use in the following functions:
a) Collect fetal monitor data for the purpose of central surveillance. Iocal surveillance. review, annotation, and for archiving data for long storage.
b) Report alert conditions generated by the AMS fetal monitors or the AMS computer interface module (CIM).
c) Collect physiological, maternal and fetal data directly from physiological monitors and append such data to the proper patient database table.
d) Feed back selected data items to the AMS fetal monitor for the purpose of printing such data on the fetal monitor strip in real time.
e) Enable manual patient data entry into the system for the purpose of charting.
f) Assemble and display selected data in a summary format of r more efficient review capability by the care giver.
g) Validate data entry when applicable to ensure data integrity.
h) Print pre-formatted reports on individual patients
i) Reproduce fetal monitor records from storage to a printer or an AMS UR10 (stripped down fetal monitor) recorder.
j) Transmit selected items from the database via fax.
k) Enable authorized (password) care giver to access the system remotely.
l) Generate an audit trail for all transactions.
m) Generate statistics reports for quality assurance.
n) Facilitate the generation of a birth certificate by providing pertinent patient data acquired by the system.

Device Description

The BirthNet TM II Perinatal Patient Data Management System is a comprehensive on-line, real-time information system to collect, display, and store physiological (e.g. fetal heart rate and uterine activity) data and other pertinent patient medical information. Designed specifically for pregnancy, delivery, and early neonatal care, medical personnel can review the status and management of each patient form any hospital based workstation. The primary function of the BirthNet TM II Perinatal Patient Data Management System is to automatically receive and record physiological monitoring data, and correlate this data with health care practitioner supplied data such as medicinal administrations, and recognized physical and physiological conditions. The BirthNet ™ II Perinatal Patient Data Management System is also designed to interface with all AMS fetal monitors and most all fetal and maternal physiological monitors presently available. Patient information can be archived onto optical disks for long-term storage. Aggregate statistical reports can also be generated.

AI/ML Overview

The provided text is a 510(k) summary for the Advanced Medical Systems BirthNet™ II Perinatal Patient Data Management System. It states that the device has undergone "extensive safety testing" and "extensive performance testing prior to release," with "Final testing for the system includes a comprehensive validation of the entire system requirements." However, it does not provide specific details about the acceptance criteria, the study design, or the results that prove the device meets any specific criteria.

Therefore, I cannot populate the requested tables and sections with factual information from the given input. The document focuses on establishing substantial equivalence to predicate devices and describes the device's functions and classification, but it does not detail performance metrics or study specifics like sample sizes, ground truth establishment, or expert qualifications.

Based on the provided text, the following information is NOT available:

• A table of acceptance criteria and the reported device performance: No specific performance metrics or acceptance criteria are listed.
• Sample size used for the test set and the data provenance: No details on testing sample sizes or data origin are provided.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
• Adjudication method for the test set: Not mentioned.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not mentioned.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not mentioned.
• The type of ground truth used: Not mentioned.
• The sample size for the training set: Not mentioned (as this is a data management system, not typically an AI/machine learning algorithm with distinct training/test sets in the modern sense).
• How the ground truth for the training set was established: Not mentioned.

The document generally states: "The BirthNet™ II Perinatal Patient Data Management System has been subject to extensive safety testing and will be subject to extensive performance testing prior to release. Final testing for the system includes a comprehensive validation of the entire system requirements." This is a general statement about testing without specifics.

Summary

{0}------------------------------------------------

K965008 4/2

510(k) Summary

Advanced Medical Systems BirthNet ™ II Perinatal Patient Data Management System

1 1 6 1 12

DEC 16 1997

1. Submitter's Name:	Advanced Medical Systems, Inc. 925 Sherman Avenue Hamden, CT 06514
Telephone:	[phone]
Facsimile:	[phone]

BirthNet TM II Perinatal Patient Data Management System 2. Name of Device

Classification:

The BirthNet TM II Perinatal Patient Data Management System is classified under Perinatal Monitoring System and Accessories which has been classified as a Class II device, in accordance to 21 CFR 884.2740.

• The AMS BirthNet TM II Perinatal Patient Data 3. Predicate Devices: Management System is substantial equivalent to the Quantitative Sentinel Perinatal, as described in K960109; and the Air Shield WatchChild as described in K893981.
• The BirthNet TM II Perinatal Patient Data Management System is a comprehensive on-4. line, real-time information system to collect, display, and store physiological (e.g. fetal heart rate and uterine activity) data and other pertinent patient medical information. Designed specifically for pregnancy, delivery, and early neonatal care, medical personnel can review the status and management of each patient form any hospital based workstation. The primary function of the BirthNet TM II Perinatal Patient Data Management System is to automatically receive and record physiological monitoring data, and correlate this data with health care practitioner supplied data such as medicinal administrations, and recognized physical and physiological conditions.

The BirthNet ™ II Perinatal Patient Data Management System is also designed to interface with all AMS fetal monitors and most all fetal and maternal physiological monitors presently available. Patient information can be archived onto optical disks for long-term storage. Aggregate statistical reports can also be generated.

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• 5. The BirthNet TM II Perinatal Patient Data Management System is designed for use to capture, display, and manage physiological obstetrical and fetal patient data. It is intended to permit the real-time monitoring of multiple obstetrical and fetal patients simultaneously, and to correlate non-monitored patient data with monitored physiological parameters.
• 6. The BirthNet™ II Perinatal Patient Data Management System software is manufactured by conventional CD-ROM replication from an authenticated master image under configuration control. The interface modules are comprised of surface mounted printed circuit boards and manufactured in a conventional manner. The installed software is validated prior to release and functionally tested at installation using validated test software.
• 7. The BirthNet TM II Perinatal Patient Data Management System has been subject to extensive safety testing and will be subject to extensive performance testing prior to release. Final testing for the system includes a comprehensive validation of the entire system requirements. Safety tests have been performed to ensure the device complies to all applicable industry and safety standards.

In conclusion, the BirthNet ™ II Perinatal Patient Data Management System is as safe and effective as the predicate devices and raises no new issues.

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Image /page/2/Picture/0 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 16 1997

Mr. Anthony Calderoni Vice President Advanced Medical System, Inc. 925 Sherman Avenue Hamden, Connecticut 06514

Re: K965008

BirthNet™ II Perinatal Patient Data Management System Dated: September 24, 1997 Received: September 29, 1997 Regulatory class: II 21 CFR §884.2740/Product code: 85 HGM

Dear Mr. Calderoni:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Revolations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Ouality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements conceming your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you might have under sections 531 the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510/k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed bredicate 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for question and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours.

Willian Yu
Lillian Yiu, Ph.D.

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K965008

Device Name: BirthNet™ II Perinatal Patient Data Management System Indications for Use:

The BirthNet™ II Perinatal Patient Data Management System is designed for use in the following functions:

• a) Collect fetal monitor data for the purpose of central surveillance. Iocal surveillance. review, annotation, and for archiving data for long storage.
• b) Report alert conditions generated by the AMS fetal monitors or the AMS computer interface module (CIM).
• c) Collect physiological, maternal and fetal data directly from physiological monitors and append such data to the proper patient database table.
• d) Feed back selected data items to the AMS fetal monitor for the purpose of printing such data on the fetal monitor strip in real time.
• e) Enable manual patient data entry into the system for the purpose of charting.
• f) Assemble and display selected data in a summary format of r more efficient review capability by the care giver.
• g) Validate data entry when applicable to ensure data integrity.
• h) Print pre-formatted reports on individual patients
• Reproduce fetal monitor records from storage to a printer or an AMS UR10 (stripped i) down fetal monitor) recorder.
• Transmit selected items from the database via fax. i)
• k) Enable authorized (password) care giver to access the system remotely.
• ﮯ Generate an audit trail for all transactions.
• m) Generate statistics reports for quality assurance.
• n) Facilitate the generation of a birth certificate by providing pertinent patient data acquired by the system.

(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Robert R. Sathing/
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number K96 5008

OR

Prescription Use
(Per 21 CFR 801.109) ✓

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 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).