HORIZON PERINATAL CARE SURVEILLANCE AND ARCHIVAL MODEL VERSON 4.0

K102263 · Mckesson Information Solutions, LLC · HGM · May 5, 2011 · Obstetrics/Gynecology

Device Facts

• Record ID: K102263
• Device Name: HORIZON PERINATAL CARE SURVEILLANCE AND ARCHIVAL MODEL VERSON 4.0
• Applicant: Mckesson Information Solutions, LLC
• Product Code: HGM · Obstetrics/Gynecology
• Decision Date: May 5, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.2740
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

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.

Device Story

Central monitoring system for obstetrical and fetal patients; interfaces with fetal and maternal monitors to collect physiological data; displays and archives patient information; enables electronic documentation of labor progress; provides remote access for caregivers. Used in healthcare facilities by clinicians to monitor multiple patients simultaneously; facilitates clinical decision-making through centralized observation and data storage.

Clinical Evidence

Bench testing only. Verification and validation testing performed to ensure system met specifications and performed as intended.

Technological Characteristics

Software-based system running on off-the-shelf servers and workstations. Uses 100 Mbps Ethernet networking. Interfaces with industry-standard fetal monitors and hospital information systems.

Indications for Use

Indicated for fetal surveillance, monitoring of labor progress, display, and archiving of obstetrical patient data in a healthcare facility. Provides remote access to the system for caregivers.

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

• LMS Medical Systems, Ltd., CALM (K980719)

Submission Summary (Full Text)

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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: [phone] Facsimile: [phone]

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 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.

#### Technological Characteristics

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.

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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 [phone] or [phone] 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:

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

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