The Wireless Monitoring System is intended for use by health care professionals for routine surveillance of patient physiological parameters to include, pulse rate, respiratory rate and axillary temperature, in a hospital setting. Data is transmitted wirelessly to a central location. Notifications can be prospectively set to notify healthcare professionals to excursions outside of selected parameters.

The device is not intended to be used on critical care patients and is intended to supplement vital signs monitoring by healthcare professionals, not to replace current standards of care. The device is intended for use on general care patients and on patients who are 18 years of age or older.

Device Description

The proposed device consists of a patient patch with integrated temperature sensor, an electronic bridge and server software. The patch is attached to the patient and connected to existing monitoring leads to capture heart rate, respiration and body temperature. This data is wirelessly transmitted to a bridge. Multiple bridges can be installed in a hospital setting to capture signals in case the patient is moved or becomes ambulatory. Data from the patch is transmitted through a hard-wire connection to the nurses' station for surveillance. The healthcare practitioner can set limits on the patient data which in turn may trigger an alert.

AI/ML Overview

Here's a breakdown of the requested information based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary primarily focuses on non-clinical performance and equivalence to predicate devices, rather than explicit acceptance criteria with specific thresholds for accuracy or sensitivity/specificity typical of clinical performance studies for diagnostic devices. However, the comparative information table provides implicit acceptance criteria by stating "Same or similar" to the predicate devices for key physiological parameters.

Characteristic	Acceptance Criteria (based on predicate equivalence)	Reported Device Performance (New Device)
FCC Approval	Letter of approval	Yes
Frequency Range	911.38-918.59 (Mhz). FCC Part 15	Same or similar
Type of Device	Near-patient data collection	Disposable
Heart Rate	30 to 200 bpm	Same or similar
Axillary Temp	89.6° F – 111.2°F	Same or similar
Respiratory Rate	5 - 60 resp/min	Same or similar
HL7 Protocol	Communicate with HIS using HL7	Yes
Interval reporting	Range: 2-30 minute increments in 2 minute increments	Range: 2-30 minute increments in 2 minute increments
Battery power	Low power battery for near patient device	3.0 volts
Power for bridges	Bridges use AC Main for power	Yes
Notifications	System has programmable notifications	Yes
Telemetry	Transmissions between bridge and patch shall use ISM bands	Yes
Vital signs data	Provides: (1) heart rate, (2) Respiration rate, (3) Axillary temperature	Yes
Operating Paradigm	Uses: (1) Patient data collection device, (2) bridges, (3) Hospital servers	Yes
Biocompatibility	Pass ASTM 2475-05	Passes applicable tests and standards
Basic safety	Pass IEC 60601-1	Passes applicable tests and standards
EMC Compatibility	Pass IEC60601-1-2	Passes applicable tests and standards
Collateral Safety	Pass IEC 60601-1-1	Passes applicable tests and standards
Electrocardiographic equipment	Pass IEC 60601-2-27	Passes applicable tests and standards
Patient Monitoring	Pass IEC 60601-2-49	Passes applicable tests and standards
Degrees of Protection	Pass IEC 60529 IP 64	Passes applicable tests and standards
Human exposure to electromagnetic fields	Pass IEC 62311	Passes applicable tests and standards
IT Equipment	Pass IEC 60950-1	Passes applicable tests and standards
Animal welfare	Pass ISO 10993-2	Passes applicable tests and standards
Interactions with Blood	Pass ISO 10993-4	Passes applicable tests and standards
In Vitro Cytotoxicity	Pass ISO 10993-5	Passes applicable tests and standards
Irritation and Skin Sensitization	Pass ISO 10993-10	Passes applicable tests and standards
Systemic Toxicity	Pass ISO 10993-11	Passes applicable tests and standards
Sample Preparation	Pass ISO 10993-12	Passes applicable tests and standards
Leachable Substances	Pass ISO 10993-17	Passes applicable tests and standards
Chemical Characterization of Materials	Pass ISO 10993-18	Passes applicable tests and standards
Risk Management	Pass ISO 14971	Passes applicable tests and standards
Usability	Good usability (subjective user feedback)	"Good usability"; user interest
Wireless Functionality	Operate as designed and intended (no interference)	"Operated as designed and as intended"; no interference with hospital equipment

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size:
- Usability Testing: The summary does not specify the exact number of participants for the usability testing. It mentions "participants" in the context of user opinions.
- Wireless Testing: The summary does not provide a specific sample size (e.g., number of patients, devices, or test points) for the wireless testing.
Data Provenance:
- Usability Testing: Conducted at "The University of Texas at Arlington."
- Wireless Testing: Conducted at "Palomar Pomerado Hospital."
- The studies appear to be prospective as they are described as "testing" of the new device's operation and usability.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Usability Testing: "Staff opinions were positive with participants showing an interest in using the proposed device." No specific number of experts or their qualifications for establishing a "ground truth" on usability are provided, as usability is often assessed through user feedback rather than expert ground truth.
Wireless Testing: "Testing for EMI and other parameters were monitored and recorded." No specific number of experts or their qualifications for interpreting these technical results are provided. The "ground truth" here is the measurement data itself against predefined technical standards.

4. Adjudication Method for the Test Set

No formal adjudication method (e.g., 2+1, 3+1) is mentioned for either the usability or wireless performance testing. The reported results are summaries of observations and measurements.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

No MRMC study was done. This device is a physiological monitoring system, not an AI-assisted diagnostic imaging device that typically uses human readers. The clinical studies focused on usability and wireless functionality, not on improving human reader performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This device is not an algorithm-only device. It is a hardware system that collects and transmits physiological data for healthcare professionals to monitor. The "standalone" performance in this context would refer to its technical accuracy and reliable data transmission, which were broadly addressed by technical testing and wireless performance checks, not an AI algorithm.

7. The Type of Ground Truth Used

Non-Clinical (Technical/Performance) Tests: The ground truth for these tests would be the established performance standards (e.g., IEC, ISO, FCC) against which the device's technical specifications and measurements were compared.
Usability Testing: The "ground truth" was subjective user feedback and observation of the system's operation as intended.
Wireless Testing: The "ground truth" was direct measurement of wireless transmission parameters and observation of interference, compared against expected operational norms.
No pathology or outcomes data was used as ground truth because this device is for surveillance of physiological parameters, not for diagnosis based on pathology or for evaluating clinical outcomes directly tied to a specific diagnostic accuracy.

8. The Sample Size for the Training Set

Not applicable. The device described is a hardware and software system for physiological monitoring, not a machine learning or AI model that requires a "training set" in the conventional sense. The development likely involved engineering design, testing, and refinement, but not machine learning training on a dataset.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As stated above, there is no mention of a "training set" for machine learning algorithms in this 510(k) summary.

Summary

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K110809

510(k) SUMMARY

A Summary of 510(k) Safety and Effectiveness Information in Accordance with the

Requirements of 21 CFR 807.92.

Submitter Information
Name	Frank Pokrop
Address	CareFusion Inc., 3750 Torrey View Court. San Diego, Ca 92130
Phone number	Work - (858) 617-4364.Cell: (858) 245-8197
Fax number	(858) 617-6735
EstablishmentRegistrationNumber	2016493
Name of contactperson	Frank Pokrop
Date prepared	March 15, 2011
Name of device
Trade or proprietaryname	Trade name is still being determined
Common or usualname	Wireless Monitoring System
Classification name	Cardiovascular Monitoring Devices
Classification panel	Cardiovascular
Regulation	21 CFR Part 870.2910
Product Code(s)	DRG
Legally marketeddevice(s) to whichequivalence is claimed	(1) Philips Intellivue Patient Monitor. 510(k) #: K052961(2) Nihon Koden Multiple Patient Receiver. 510(k) #: K071058,
Reason for 510(k)submission	New device.
Device description	The proposed device consists of a patient patch with integratedtemperature sensor, an electronic bridge and server software. Thepatch is attached to the patient and connected to existing monitoringleads to capture heart rate, respiration and body temperature. Thisdata is wirelessly transmitted to a bridge. Multiple bridges can beinstalled in a hospital setting to capture signals in case the patient ismoved or becomes ambulatory.Data from the patch is transmitted through a hard-wire connection tothe nurses' station for surveillance. The healthcare practitioner canset limits on the patient data which in turn may trigger an alert.
Intended use of the device	General surveillance of non-critical acre patients who are at least 18 years of age.
Indications for use	The Wireless Monitoring System is intended for use by health care professionals for routine surveillance of patient physiological parameters to include, pulse rate, respiratory rate and axillary temperature, in a hospital setting. Data is transmitted wirelessly to a central location. Notifications can be prospectively set to notify healthcare professionals to excursions outside of selected parameters.The device is not intended to be used on critical care patients and is intended to supplement vital signs monitoring by healthcare professionals, not to replace current standards of care. The device is intended for use on general care patients and on patients who are 18 years of age or older.

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Summary of the technological characteristics of the device compared to the predicate device

Characteristic	New Device	Predicate [Device Name][510(k) number]
Central monitoring of remotelytransmitted patient data	Yes	Philips Intellivue Patient Monitor. K052961
		Nihon Koden Multiple Patient Monitor. K071058
Uses existing sources ofphysiological data	Yes	Philips Intellivue Patient Monitor. K052961
		Nihon Koden Multiple Patient Monitor. K071058
Programmable alert settingsand limits	Yes	Philips Intellivue Patient Monitor. K052961
		Nihon Koden Multiple Patient Monitor. K071058
Data sent to central server	Yes	Philips Intellivue Patient Monitor. K052961
		Nihon Koden Multiple Patient Monitor. K071058
Monitors heart rate	Yes	Philips Intellivue Patient Monitor. K052961
		Nihon Koden Multiple Patient Monitor. K071058
Monitors respiration	Yes	Philips Intellivue Patient Monitor. K052961
		Nihon Koden Multiple Patient Monitor. K071058
Monitors body or axillarytemperature	Yes	Philips Intellivue Patient Monitor. K052961
		Nihon Koden Multiple Patient Monitor. K071058
Can be used with a generalhospital patient population	Yes	Philips Intellivue Patient Monitor. K052961
		Nihon Koden Multiple Patient Monitor. K071058
Monitors multiple patients	Yes	Philips Intellivue Patient Monitor. K052961
		Nihon Koden Multiple Patient Monitor. K071058

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Uses both AC Main and battery power	Yes	Philips Intellivue Patient Monitor. K052961 Nihon Koden Multiple Patient Monitor. K071058
-------------------------------------	-----	-------------------------------------------------------------------------------------------	--

PERFORMANCE DATA

SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF
SUBSTANTIAL EQUIVALENCE*

Performance Test Summary-New Device

Characteristic	Standard/Test/FDA Guidance	Results Summary
1. Packaging - biocompatibility	ASTM 2475-05	The proposed device passes the applicable tests and standards.
2. Basic safety	IEC 60601-1
3. EMC Compatiblity	IEC60601-1-2
4. Collateral Safety	IEC 60601-1-1
5. Electrocardiographic equipment	IEC 60601-2-27
6. Patient Monitoring	IEC 60601-2-49
7. Degrees of Protection	IEC 60529 IP 64
8. Human exposure to electromagnetic fields	IEC 62311
9. IT Equipment	IEC 60950-1
10. Animal welfare	ISO 10993-2
11. Interactions with Blood	ISO 10993-4
12. In Vitro Cytotoxicity	ISO 10993-5
13. Irritation and Skin Sensitization	ISO 10993-10
14. Systemic Toxicity	ISO 10993-11
15. Sample Preparation	ISO 10993-12
16. Leachable Substances	ISO 10993-17
17. Chemical Characterization of Materials	ISO 10993-18
18. Risk Management	ISO 14971

Comparative Performance Information Summary

Characteristic	Requirement	New Device	Predicate Device
FCC Approval	Letter of approval	Yes	Yes
Frequency Range	911.38-918.59 (Mhz). FCC Part 15	Same or similar	Same or similar
Type of Device	Near-patient data collection	Disposable	Non-disposable
Heart Rate	30 to 200 bpm	Same or similar	Same or similar
Axillary temp	89.6° F – 111.2°F	Same or similar	Same or similar
Respiratory rate	5 - 60 resp/min	Same or similar	Same or similar
HL7 Protocol	Communicate with HIS using HL7	Yes	Yes

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Interval reporting	Data reporting can be programmed	Range: 2-30 minuteincrements in 2 minuteincrements	Same or similar
Battery power	Low power battery for near patient device	3.0 volts	Same or similar
Power for bridges	Bridges use AC Main for power	yes	Same or similar
Notifications	System has programmable notifications	Yes	Yes
Telemetry	Transmissions between bridge and patch shalluse ISM bands	Yes	Same or similar
Vital signs data	Provides: (1) heart rate, (2) Respiration rate,(3) Axillary temperature	Yes	- Same or similarPredicate deviceshave thesecapabilities andmore
Operating Paradigm	Uses: (1) Patient data collection device, (2)bridges, (3) Hospital servers	Yes	Same or similar

SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION

Clinical Performance Data/Information

(1) Clinical testing was not performed with this device.
(2) Usability testing at a user site.

The University of Texas at Arlington showed that the proof of concept and the proof of operating principles were both found to be valid, the system operated and functioned as planned, staff opinions were positive with participants showing an interest in using the proposed device.

a. "The study execution went smoothly and it afforded the opportunity to conduct a realistic and rather rigorous test of system usability.
b. Based on the collective data analysis the system is considered to have good usability."
(3) Performance testing a user site.

Wireless testing at Palomar Pomerado Hospital showed that the device's wireless features operated as designed and as intended. Testing for EMI and other parameters were monitored and recorded. Attached reports show safe and effective levels of operation without harming the patient along with acceptable levels of performance. From the report:

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a. "The System Patch and Bridge did not interfere with any wireless equipment provided by the hospital for the testing.
b. Further no in hospital equipment noise or interference had any impact on the operation of the System." .

CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA

The device was found to be safe and effective and it operated as intended in user environments.

*Although a table format is shown and recommended, use whatever format is appropriate for your medical device or in vitro diagnostic product.

** Insert as many lines as necessary

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Image /page/5/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized design featuring three curved lines that resemble an abstract representation of a human figure or a symbol related to health and well-being.

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

JUL - 5 2011

CareFusion, Inc. c/o Mr. Frank Pokrop Director, Regulatory Affairs 3750 Torrey View Court San Diego, CA 92130

Re: K110809

Trade/Device Name: Wireless Monitoring System Regulatory Number: 21 CFR 870.2910 Regulation Name: Radiofrequency physiological signal transmitter and receiver Regulatory Class: II (two) Product Code: DRG Dated: June 3, 2011 Received: June 6, 2011

Dear Mr. Pokrop:

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 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

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Page 2 - Mr. Frank Pokrop

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 (reporting of medical device-related 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/MédicalDevices/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.

Sincerely yours,

Bram D. Zuckerman, M.D.

Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Wireless Monitoring System

Prescription Use _ XXX_ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter use (21 CFR Part 801 Subpart C)

(PLEASE DO NO WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEFDED)

Division Sig
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Cardiovascular Devices
K110809

Regulation Number and Section

§ 870.2910 Radiofrequency physiological signal transmitter and receiver.

(a)
Identification. A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.(b)
Classification. Class II (performance standards).