Horizon Perinatal Care Surveillance and Archival System is intended for use as a central monitoring system, providing fetal surveillance and monitoring of multiple obstetrical and fetal patients simultaneously and to correlate pertinent patient observations of physiological parameters.

Horizon Perinatal Care Surveillance and Archival's indications for use are:

. Interfaces with fetal and maternal monitors to provide fetal surveillance, monitoring of labor progress, display and archiving functions
. Allow care givers to electronically document and store patient information on obstetrical patients in a health care facility; and
. Provides remote access to the HPC S&A system.

Device Description

The Horizon Perinatal Care Surveillance and Archival System consists of the Horizon Perinatal Care Surveillance and Archival software, which runs on standard "off-the-shell" hardware components (e.g., servers and workstations). Horizon Perinatal Care Surveillance and Archival uses standard 100 Mbps Ethernet networking technology and is coupled to industry standard fetal monitors that are legally marketed under FDA regulations. Each fetal monitor is attached to a networked computer. Horizon Perinatal Care Surveillance and Archival is able to interface with other pertinent hospital information systems.

AI/ML Overview

The provided 510(k) summary for the "McKesson Information Solutions, LLC's Horizon Perinatal Care Surveillance and Archival System" does not contain detailed information about specific acceptance criteria, a quantitative study proving performance against those criteria, or the methodology typically associated with a clinical validation study for an AI-powered device.

Instead, the summary emphasizes verification and validation testing to ensure the system met specifications and performed as intended, leading to a determination of substantial equivalence with a predicate device (LMS Medical Systems, Ltd., CALM (K980719)).

Here's a breakdown of the information that can be extracted, and what is missing based on your request:

1. A table of acceptance criteria and the reported device performance

Not provided in the document. The document states: "Verification and validation testing was performed on Horizon Perinatal Care Surveillance and Archival to ensure it met all specifications. The system was further validated to ensure that it performs as intended. In all instances, Horizon Perinatal Care Surveillance and Archival System functioned as intended and the results observed demonstrate substantial equivalence with the predicate device."

This indicates that internal specifications were met, and functional testing was successful, but specific quantitative performance metrics against defined acceptance criteria (e.g., sensitivity, specificity, accuracy for a detection task, or specific timing/latency metrics for a surveillance system) are not included.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not provided. The document describes "verification and validation testing" but does not detail the nature, size, or provenance of any test sets used.

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 provided. Given that this device is a "Perinatal Care Surveillance and Archival System" rather than an AI diagnostic tool, the concept of "ground truth" established by experts for a test set in the conventional sense (e.g., for disease detection) is likely not applicable or not presented in this summary. The validation would have focused on functional correctness, data integrity, and adherence to specifications.

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

Not provided.

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

Not applicable/Not mentioned. This device is a "Surveillance and Archival System," not an AI-powered diagnostic or decision support tool meant to be used by human readers in a comparative effectiveness study. Its primary function is to interface with monitors, display data, document, and archive.

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

Not applicable/Not mentioned in the context of an AI algorithm. The system's performance would be evaluated on its ability to correctly acquire, display, and archive data from medical devices, not on a standalone diagnostic algorithm's performance.

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

Not specified in the context of clinical "ground truth" for a diagnostic task. The "ground truth" for this system would likely relate to the accuracy of data acquisition, display, and archiving compared to the source data from the fetal and maternal monitors, or to the expected behavior of a properly functioning software system.

8. The sample size for the training set

Not applicable. This device is described as a software system running on "off-the-shell" hardware, performing functions of surveillance, monitoring, display, and archiving. It is not presented as an AI/ML device that requires a training set in the typical sense for learning patterns or making predictions.

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

Not applicable, as there is no indication of a training set for an AI/ML model for this device.

Summary of what the document does provide:

Intended Use: Central monitoring system for fetal surveillance and monitoring of multiple obstetrical and fetal patients, correlating physiological parameters.
Indications for Use: Interfaces with fetal/maternal monitors, provides surveillance, monitors labor progress, displays and archives functions; allows electronic documentation and storage of patient information; provides remote access.
Technological Characteristics: Software running on standard hardware, uses standard Ethernet, interfaces with industry-standard, legally marketed fetal monitors, and can interface with other hospital information systems.
Predicate Device: LMS Medical Systems, Ltd., CALM (K980719).
Performance Claim: "In all instances, Horizon Perinatal Care Surveillance and Archival System functioned as intended and the results observed demonstrate substantial equivalence with the predicate device."
Basis for Substantial Equivalence: Same intended use, indications for use, technological characteristics, and principles of operation as the predicate. Minor technological differences raise no new safety/effectiveness issues. Verification and validation testing demonstrated it functioned as intended.

The document focuses on the functional verification and validation of a software system against its specifications and its similarity to a predicate device, rather than a clinical performance study with specific quantitative acceptance criteria typically seen for AI/ML diagnostic or predictive devices.

Summary

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K102263.
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MAY = 5 2011

510(k) SUMMARY

McKesson Information Solutions, LLC's Horizon Perinatal Care Surveillance and Archival System

McKesson Information Solutions, LLC 11000 Westmoor Circle Suite 125 Westminster, CO 80021

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Contact Person: Louise Smith, Director Regulatory Assessment & Compliance Operations Phone: (404)338-3519 Facsimile: (404)338-5138

Date Prepared: August 6, 2010

Proprietary / Trade Name: Horizon Perinatal Care Surveillance and Archival System Common or Usual Name: Perinatal monitoring systems and accessories Classification Name: Perinatal monitoring system and accessories, 21 C.F.R. § 884.2740 Product code: HGM Device Class: 11 Predicate Device: LMS Medical Systems, Ltd., CALM (K980719)

Intended Use / Indications for Use:

Horizon Perinatal Care Surveillance and Archival's indications for use are:

. Interfaces with fetal and maternal monitors to provide fetal surveillance, monitoring of labor progress, display and archiving functions
. Allow care givers to electronically document and store patient information on obstetrical patients in a health care facility; and
. Provides remote access to the HPC S&A system.

Technological Characteristics

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Performance Data

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Verification and validation testing was performed on Horizon Perinatal Care Surveillance and Archival to ensure it met all specifications. The system was further validated to ensure that it performs as intended. In all instances, Horizon Perinatal Care Surveillance and Archival System functioned as intended and the results observed demonstrate substantial equivalence with the predicate device.

Substantial Equivalence

The Horizon Perinatal Care Surveillance and Archival System has the same intended use, indications for use, technological characteristics, and principles of operation as its predicate device. The minor technological differences between Horizon Perinatal Care Surveillance and Archival System and its predicate device raise no new issues of safety or effectiveness. Verification and validation testing demonstrate that Horizon Perinatal Care Surveillance and Archival System functioned as intended. Thus, Horizon Perinatal Care Surveillance and Archival is substantially equivalent.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing the bird's body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

MAY - 5 2011

McKesson Information Solutions LLC c/o Steven B: Datloff, M.D., J.D. Partner Hogan Lovells US LLP 1835 Market Street, 29th Floor PHILADELPHIA PA 19103

Re: K102263

Trade Name: Horizon Perinatal Care Surveillance and Archival System Regulation Number: 21 CFR §884.2740 Regulation Name: Perinatal monitoring system and accessories Regulatory Class: II Product Code: HGM Dated: April 29, 2011 Received: May 2, 2011

Dear Dr. Datloff:

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. 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. 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

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adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance,

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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Hubert Lehman MD

Herbert P. Lerner, M.D., Director (Acting) 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 Statement

KI02263 510(k) Number (if known):

Device Name: Horizon Perinatal Care Surveillance and Archival System

Intended Use:

Indications for Use:

. Interfaces with fetal and maternal monitors to provide fetal surveillance, monitoring of labor progress, display and archiving functions
Allow care givers to electronically document and store patient information on obstetrical . patients in a health care facility; and
. Provides remote access to the HPC S&A system.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Tom Whing

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(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K102263

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).