WIRELESS MONITORING SYSTEM

K110809 · Carefusion 303, Inc. · DRG · Jul 5, 2011 · Cardiovascular

Device Facts

• Record ID: K110809
• Device Name: WIRELESS MONITORING SYSTEM
• Applicant: Carefusion 303, Inc.
• Product Code: DRG · Cardiovascular
• Decision Date: Jul 5, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2910
• Device Class: Class 2

Intended 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.

Device Story

Wireless Monitoring System consists of a disposable patient patch with integrated temperature sensor, electronic bridge, and server software. Patch attaches to patient, connects to existing leads to capture heart rate, respiration, and axillary temperature. Data transmits wirelessly to bridge; multiple bridges installed in hospital environment to support patient mobility. Bridge transmits data via hard-wire to nurses' station for surveillance. Healthcare practitioners set parameter limits; system triggers alerts for excursions. Used in hospital settings by healthcare professionals to supplement standard vital signs monitoring. Benefits include continuous surveillance of general care patients, enabling timely response to physiological changes.

Clinical Evidence

No clinical trials performed. Evidence consists of usability testing at a user site (University of Texas at Arlington) and wireless performance testing at a hospital (Palomar Pomerado Hospital). Usability study confirmed proof of concept, operating principles, and positive staff feedback. Wireless testing confirmed system operated as designed without interference from or to hospital equipment. Bench testing included biocompatibility (ISO 10993), electrical safety (IEC 60601-1), and EMC (IEC 60601-1-2).

Technological Characteristics

Disposable patient patch with integrated temperature sensor; electronic bridge; server software. Sensing: heart rate, respiration, axillary temperature. Connectivity: wireless transmission (ISM bands, 911.38-918.59 MHz) to bridge, hard-wired to central server. Power: 3.0V battery (patch), AC main (bridge). Standards: ASTM 2475-05 (packaging), IEC 60601-1 (safety), IEC 60601-1-2 (EMC), IEC 60529 IP 64 (protection), ISO 10993 series (biocompatibility).

Indications for Use

Indicated for routine surveillance of pulse rate, respiratory rate, and axillary temperature in non-critical, general care hospital patients aged 18 years or older. Not for use on critical care patients.

Regulatory Classification

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.

Predicate Devices

• Philips Intellivue Patient Monitor (K052961)
• Nihon Koden Multiple Patient Receiver (K071058)

Submission Summary (Full Text)

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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 - [phone].<br>Cell: [phone] |
| Fax number | [phone] |
| Establishment<br>Registration<br>Number | 2016493 |
| Name of contact<br>person | Frank Pokrop |
| Date prepared | March 15, 2011 |
| Name of device | |
| Trade or proprietary<br>name | Trade name is still being determined |
| Common or usual<br>name | Wireless Monitoring System |
| Classification name | Cardiovascular Monitoring Devices |
| Classification panel | Cardiovascular |
| Regulation | 21 CFR Part 870.2910 |
| Product Code(s) | DRG |
| Legally marketed<br>device(s) to which<br>equivalence is claimed | (1) Philips Intellivue Patient Monitor. 510(k) #: K052961<br>(2) Nihon Koden Multiple Patient Receiver. 510(k) #: K071058, |
| Reason for 510(k)<br>submission | New device. |
| Device description | The proposed device consists of a patient patch with integrated<br>temperature sensor, an electronic bridge and server software. The<br>patch is attached to the patient and connected to existing monitoring<br>leads to capture heart rate, respiration and body temperature. This<br>data is wirelessly transmitted to a bridge. Multiple bridges can be<br>installed in a hospital setting to capture signals in case the patient is<br>moved or becomes ambulatory.<br>Data from the patch is transmitted through a hard-wire connection to<br>the nurses' station for surveillance. The healthcare practitioner can<br>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.<br>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]<br>[510(k) number] |
|------------------------------------------------------------|------------|-----------------------------------------------|
| Central monitoring of remotely<br>transmitted patient data | Yes | Philips Intellivue Patient Monitor. K052961 |
| | | Nihon Koden Multiple Patient Monitor. K071058 |
| Uses existing sources of<br>physiological data | Yes | Philips Intellivue Patient Monitor. K052961 |
| | | Nihon Koden Multiple Patient Monitor. K071058 |
| Programmable alert settings<br>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<br>temperature | Yes | Philips Intellivue Patient Monitor. K052961 |
| | | Nihon Koden Multiple Patient Monitor. K071058 |
| Can be used with a general<br>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 |

'

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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 minute<br>increments in 2 minute<br>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<br>use ISM bands | Yes | Same or similar |
| Vital signs data | Provides: (1) heart rate, (2) Respiration rate,<br>(3) Axillary temperature | Yes | - Same or similar<br><br>Predicate devices<br>have these<br>capabilities and<br>more |
| Operating Paradigm | Uses: (1) Patient data collection device, (2)<br>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 [phone] or [phone] 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

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 |