Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard wireless monitoring system with data transmission and user-defined alerts. There is no mention of AI, ML, or any algorithms that learn or adapt.

Therapeutic

No
The device is a monitoring system that collects physiological parameters for surveillance, not to treat or alleviate a disease or condition.

Diagnostic

No

The device is intended for "routine surveillance of patient physiological parameters" and "to supplement vital signs monitoring," not to diagnose conditions. Notifications are for "excursions outside of selected parameters," which is monitoring, not diagnosis.

SaMD (Software as a Medical Device)

No

The device description explicitly states it consists of a "patient patch with integrated temperature sensor, an electronic bridge and server software," indicating the presence of hardware components in addition to software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
Device Function: The described device is a Wireless Monitoring System that measures physiological parameters (pulse rate, respiratory rate, axillary temperature) directly from the patient's body using a patch and existing monitoring leads. It transmits this data wirelessly for surveillance.
Lack of Sample Analysis: The device does not involve the collection or analysis of any biological samples from the patient. It directly measures vital signs from the body surface.

Therefore, because the device operates by directly monitoring physiological parameters from the patient's body rather than analyzing samples taken from the body, it falls outside the scope of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes

DRG

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

18 years of age or older.

Intended User / Care Setting

health care professionals / hospital setting

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE*
Performance Test Summary-New Device

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

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:
- 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K052961, K071058

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

0

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
Establishment
Registration
Number	2016493
Name of contact
person	Frank Pokrop
Date prepared	March 15, 2011
Name of device
Trade or proprietary
name	Trade name is still being determined
Common or usual
name	Wireless Monitoring System
Classification name	Cardiovascular Monitoring Devices
Classification panel	Cardiovascular
Regulation	21 CFR Part 870.2910
Product Code(s)	DRG
Legally marketed
device(s) to which
equivalence 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 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.
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.

.

1

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 remotely
transmitted patient data | Yes | Philips Intellivue Patient Monitor. K052961 |
| | | Nihon Koden Multiple Patient Monitor. K071058 |
| Uses existing sources of
physiological data | Yes | Philips Intellivue Patient Monitor. K052961 |
| | | Nihon Koden Multiple Patient Monitor. K071058 |
| Programmable alert settings
and 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 axillary
temperature | Yes | Philips Intellivue Patient Monitor. K052961 |
| | | Nihon Koden Multiple Patient Monitor. K071058 |
| Can be used with a general
hospital 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 |

'

2

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

3

| Interval reporting | Data reporting can be programmed | Range: 2-30 minute
increments in 2 minute
increments | 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 shall
use ISM bands | Yes | Same or similar |
| Vital signs data | Provides: (1) heart rate, (2) Respiration rate,
(3) Axillary temperature | 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:

4

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

5

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

6

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

7

Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Wireless Monitoring System

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.

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