The Philips IntelliSpace Perinatal Obsterical Information Management System is indicated for obsterior and after pregnancy, who require monitoring in a healthcare setting.

The Philips IntelliSpace Perinatal system provides:

Basic and advanced fetal trace alarming for both antepartum and intrapartum patients.
Central monitoring of maternal alarming.
Documentation capabilities and data storage.
Viewing and alarming of patient physiologic data, at remote locations, via the healthcare facility Remote Desktop Session (RDS).
An interface to launch the Philips IntelliVue XDS Remote viewing and operating of compatible patient monitors.

Device Description

The Philips IntelliSpace Perinatal Rev. K.00 is a patient-oriented, departmental information management system for the obstetrical care environment. It covers OB care in so far as it is relevant for GYN visits, pregnancy, labor, birth and newborn documentation. It combines surveillance and alarming with comprehensive patient documentation and data storage into one system that covers the continuum of obstetrical care across one or more pregnancies, from the first antepartum visit until delivery and discharge.

AI/ML Overview

The provided document is a 510(k) summary for the Philips IntelliSpace Perinatal Revision K.00. This document describes the device, its intended use, and the testing performed to demonstrate its substantial equivalence to a predicate device.

However, it does not contain details about specific acceptance criteria related to a performance study (e.g., accuracy, sensitivity, specificity) for an AI/ML-based device. The document primarily focuses on non-clinical verification and validation (V&V) activities for software modifications and does not describe a clinical performance study with human readers or an algorithm-only standalone performance study.

Therefore, I cannot populate the requested table and answer many of the questions directly from the provided text. The information given is at a higher level, focusing on regulatory compliance for a software system that manages obstetrical information and integrates with other monitoring devices, rather than a diagnostic AI algorithm with quantifiable performance metrics.

Here is what I can extract and infer based on the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that "All specified pass/fail criteria have been met" for the nonclinical V&V activities. However, it does not specify what those exact performance criteria are in terms of numerical metrics (e.g., sensitivity, specificity, accuracy) for an AI/ML component. The "performance" described is about the functionality and safety of the software modification, not a diagnostic accuracy metric.

Acceptance Criterion Type	Specific Criterion (If available in document)	Reported Device Performance (If available in document)
Functionality	Correctly hand over start-up parameters to XDS software	Met: "conducted tests demonstrate that start-up parameters provided by the modified IntelliSpace Perinatal software are correctly handed over to the XDS software"
	Correct operation of patient monitors via XDS	Met: "compatible IntelliVue patient monitors can be correctly operated via the XDS software."
Safety	Effectiveness of implemented risk mitigation measures	Met: "Test results confirmed the effectiveness of implemented risk mitigation measures."
General V&V	All specified pass/fail criteria	Met: "All specified pass/fail criteria have been met."

2. Sample size used for the test set and the data provenance:

Sample Size: Not explicitly stated as this was a software engineering V&V activity, not a clinical trial or performance study on a specific dataset. The tests were likely performed on a simulated environment or
test cases designed to validate software functionality.
Data Provenance: Not applicable in the context of a "test set" for an AI/ML performance study. The testing was of the software's functionality and safety, not its diagnostic accuracy on patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

Not applicable. The document describes software verification and validation, which typically involves software engineers and quality assurance professionals, not clinical experts establishing ground truth for diagnostic outputs.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. As no clinical ground truth was established by experts for a test set, no adjudication method was mentioned.

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:

No MRMC study was performed or described. The document explicitly states: "Therefore, a clinical study was not needed for the changes provided with the Philips IntelliSpace Perinatal Obstetrical Information Management System software revision Rev.K.00." The modifications were software updates related to integration and data management, not an AI assisting human readers in diagnosis.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

No standalone algorithm performance study was performed or described. The device is a perinatal information management system, not a standalone diagnostic AI algorithm. Its function is to provide "Basic and advanced fetal trace alarming," "Central monitoring of maternal alarming," and "Documentation capabilities and data storage." These are system functions, not typically evaluated as a "standalone algorithm" in the same way a diagnostic AI would be. The closest described is functional testing of the software's ability to hand off data and control.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable. The ground truth in this context refers to the expected behavior and output of the software functions as defined by the system requirements and design specifications, not clinical markers. This is a V&V process for software, where "ground truth" would be software specifications and expected functional outcomes.

8. The sample size for the training set:

Not applicable. The document describes the V&V of a non-AI software system; there is no mention of a training set as would be found with an AI/ML model.

9. How the ground truth for the training set was established:

Not applicable, as no training set was used or mentioned.

Summary of what the document does convey regarding validation:

The modifications to the Philips IntelliSpace Perinatal system (Revision K.00) are primarily software-based, focusing on:
- Launching the Philips IntelliVue XDS Application for remote access to patient monitors.
- Adapting web TS client resolution for mobile devices.
- Adding configurable columns to electronic chalkboards.
- Providing additional options for documentation and reporting.
- HL7-based interfacing with ADT systems.
- Updating Windows Server compatibility.
- Adding more supported HL7-IHE profiles.
- Introducing roles and permission-based patient data access control.
- Adjusting alarm sound pressure levels.
- Adjusting system scalability (fetal monitors and client sessions).
Nonclinical V&V activities were performed:
- Safety and Performance testing according to ANSI/AAMI/IEC 62304:2006.
- Tests required by Hazard Analysis.
- Functional tests of the modified software, including the new XDS launch feature, based on FDA guidance for software in medical devices.
- The software was categorized as having a "MAJOR" level of concern.
Conclusion from V&V: The tests demonstrated that start-up parameters are correctly handed over to XDS, and patient monitors can be operated via XDS. All pass/fail criteria were met.
Clinical Data: "a clinical study was not needed" because the "similarities and differences... were determined not to have a significant impact on the device's performance, the clinical performance, and the actual use scenarios."

In essence, this document is a regulatory submission for a software update to an existing information management system, not a submission for a novel AI/ML diagnostic tool requiring a performance study against a clinical ground truth.

Summary

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September 10, 2018

Philips Medizin Systeme Böeblingen GmbH Christoph Krause Senior Regulatory Affairs Manager Hewlett-Packard-Str.-2 Boeblingen, Baden-Wūrttemberg D-71034 Germany

Re: K173941

Trade/Device Name: Philips IntelliSpace Perinatal Revision K.00 Regulation Number: 21 CFR§ 884.2740 Regulation Name: Perinatal monitoring system and accessories Regulatory Class: II Product Code: HGM, DSJ Dated: July 2, 2018 Received: July 12, 2018

Dear Christoph Krause:

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 mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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.

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Sharon M. Andrews -S

for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number

K173941

Device Name Philips IntelliSpace Perinatal Revision K.00

Indications for Use

The Philips IntelliSpace Perinatal Obsterical Information Management System is indicated for obsterior and after pregnancy, who require monitoring in a healthcare setting.

The Philips IntelliSpace Perinatal system provides:

Basic and advanced fetal trace alarming for both antepartum and intrapartum patients.
· Central monitoring of maternal alarming.
· Documentation capabilities and data storage.

• Viewing and alarming of patient physiologic data, at remote locations, via the healthcare facility Remote Desktop Session (RDS).

• An interface to launch the Philips IntelliVue XDS Remote viewing and operating of compatible patient monitors.

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

[X | Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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			510(k) Summary for K173941
807.92(a)(1)	Owner's name	Philips Medizin Systeme
	Address, Phoneand faxnumbers	Hewlett-Packard-Str. 2D-71034 BöblingenTel.: ++49 7031 463 1734Fax.: ++49 7031 2442
	Name ofcontact person	Christoph Krause,e-mail: christoph.krause@philips.com
	Date	September 6, 2018
807.92(a)(2)	Name of thedevice	Proprietary name: Philips IntelliSpace Perinatal Rev. K.00Common name: Obstetrical Information Management System
	Regulationname, Productcode		Device Panel	RegulationNumber,Class	ProCode	Regulation Name
			Obstetrical andgynecological devices	§884.2740, II	HGM	Perinatal monitoring systemand accessories
			Cardiovascular devices	§870.1100, II	DSJ	Blood pressure alarm
807.92.(a)(3)	Identificationof legallymarketedpredicatedevice	Primary Predicate: K100420, Philips OB TraceVue Obstetrical Information ManagementSystem, Software Revision G.00. This predicate has not been subject to a design-relatedrecall.Reference Device: K141015, IntelliVue Patient Monitors (MX400, MX450, and MX500) withPhilips XDSReference Device: K082633, IntelliVue Patient Monitor, IntelliVue XDS, Models MP2, MP5,MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90The predicate and reference devices have not been subject to a design related recall.
807.92(a)(4)	Description ofthe device	Device design and identificationThe Philips IntelliSpace Perinatal Rev. K.00 is a patient-oriented, departmental informationmanagement system for the obstetrical care environment. It covers OB care in so far as it isrelevant for GYN visits, pregnancy, labor, birth and newborn documentation.It combines surveillance and alarming with comprehensive patient documentation and datastorage into one system that covers the continuum of obstetrical care across one or morepregnancies, from the first antepartum visit until delivery and discharge.

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		Environment of useThe Philips IntelliSpace Perinatal Obstetrical Information Management System is intendedto be used in a healthcare facility environment within the Obstetrical/Gynecological(OB/GYN) department.Principle of operationIntelliSpace Perinatal is Software that is installed on a computer-based network system forobstetrical surveillance, alarming, and patient data management.Key options include patient data storage to a network location; an External Server used, for
		example, to facilitate forms-based patient records and statistical reporting; an optional HL7link for Admission Discharge Transfer (ADT) messages and ORU (IntelliSpace Perinatalnotes) messages; and an optional access via RDS.
		Key performance specifications/device characteristicsThe Philips IntelliSpace Perinatal Obstetrical Information Management System can bedeployed as standalone or network based server client installations. It is intended to beinstalled on customer supplied compatible off-the-shelf information technology equipment,that meet the technical requirements as specified by Philips.Operating System:
		Servers – Windows Server 2012 R2 Clients – Windows 10 LTSB 2016 HL7:
		Compliance with ANSI Health Level 7 (HL7) specification 2.5 System Scalability: Fetal monitors per system (maximum): 250 Client sessions per system (maximum): 300
807.92(a)(5)	Indications forUse	Indications for Use for the subject deviceThe Philips IntelliSpace Perinatal Obstetrical Information Management System is indicatedfor obstetric patients during and after pregnancy, who require monitoring in a healthcaresetting. The Philips IntelliSpace Perinatal system provides: Basic and advanced fetal trace alarming for both antepartum and intrapartum patients. Central monitoring of maternal alarming. Documentation capabilities and data storage. Viewing and alarming of patient physiologic data, at remote locations, via the healthcare facility Remote Desktop Session (RDS). An interface to launch the Philips IntelliVue XDS Remote Display for remote viewing and operating of compatible patient monitors.
		Indications for Use for the predicate deviceThe Philips OB TraceVue Obstetrical Information Management System is indicated forobstetric patients during and after pregnancy, who require monitoring in a healthcaresetting. The Philips OB TraceVue provides: Basic and advanced fetal trace alarming for both antepartum and intrapartum patients. Central monitoring of maternal alarming.
		Documentation capabilities and data storage. Viewing and alarming of patient physiologic data, at remote locations, via the healthcare facility web access (intranet/internet). The Indications for Use for the subject device Philips IntelliSpace Perinatal Obstetrical Information Management System rev.K.00 is the same as for the predicate device Philips IntelliSpace Perinatal Obstetrical Information Management System rev.G except for the final bullet point, which also includes remote viewing and operating of patient monitors enabled by launching XDS from within Philips IntelliSpace Perinatal. editorial changes of the product name and the terminology of the manufacturer of RDS technology Microsoft Corporation. The subject and predicate device have the same intended use.
807.92(a)(6)	Technologicalsimilarities anddifferences tothe PredicateDevice	The fundamental scientific technology employed in the operation of the Philips IntelliSpace Perinatal Obstetrical Information Management System software revision Rev.K.00 has not changed from that of the predicate devices. The device has been modified in order to support the new feature of launching XDS Remote Display application.ModificationsThe modifications of the Philips IntelliSpace Perinatal Obstetrical Information Management System, software revision Rev.K.00 are software modifications only and cover: The launch of Philips IntelliVue XDS Application in order to allow the user to remotely access IntelliVue Patient monitors by using XDS remote display. The web TS client resolution has been adopted to standard mobile device screens Electronic chalkboards have more configurable columns Additional options for documentation and reporting are provided (more print outs statistics profiles, default reports, storage options etc.) HL7-based Interfacing with automated inbound to hospital ADT system Windows Server have been updated to Windows 7/10/Server2012) Addition of more supported HL7-IHE profiles Introduction of roles and permission based patient data access control Adjustment of alarm sound pressure levels System Scalability adjusted to Fetal monitors per system (maximum): 250 Client sessions per system (maximum): 300 All other measurements parameters that contain signal acquisition and/or physiological algorithms are unchanged in this Premarket Notification. These differences in technological characteristics do not raise different questions of safety and effectiveness.
807.92(b)(1)	BriefDescriptionNonclinicalData	The modified IntelliSpace Perinatal Software rev.K.00 has been subject to the following nonclinical V&V activities: Safety and Performance testing was done according to ANSI/AAMI/IEC 62304:2006.
		Tests as required by Hazard Analysis. All specified pass/fail criteria have been met. Test results confirmed the effectiveness of implemented risk mitigation measures. Functional tests of the modified software including the newly added feature of launching the XDS Remote Display feature, based on General Principles of Software Validation; Final Guidance for Industry and FDA Staff, January 2002 Guidance for FDA Reviewers and Industry, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", May 11, 2005. Testing was conducted for software categorized as having a “MAJOR” level of concern. The conducted tests demonstrate that start-up parameters provided by the modified IntelliSpace Perinatal software are correctly handed over to the XDS software and that the compatible IntelliVue patient monitors can be correctly operated via the XDS software.All specified pass/fail criteria have been met.
807.92.(b)(2)	BriefDescriptionClinical Data	The similarities and differences between the subject device and the predicate device (see section 5), in particular the modifications to the predicate device, were determined not to have a significant impact on the device's performance, the clinical performance, and the actual use scenarios.Therefore, a clinical study was not needed for the changes provided with the Philips IntelliSpace Perinatal Obstetrical Information Management System software revision Rev.K.00.
807.92(b)(3)	Conclusionsdrawn fromthe nonclinical& clinical tests(discussedabove)	The successful V&V tests demonstrate that the device is as safe and effective and is therefore substantially equivalent to the legally marketed Philips OB TraceVue Obstetrical Information Management System Rev. G.00 (K100420).

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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).