NIGHTINGALE MONITORING SYSTEM

K130740 · Zoe Medical, Inc. · MWI · Jul 23, 2013 · Cardiovascular

Device Facts

• Record ID: K130740
• Device Name: NIGHTINGALE MONITORING SYSTEM
• Applicant: Zoe Medical, Inc.
• Product Code: MWI · Cardiovascular
• Decision Date: Jul 23, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2300
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Zoe Medical Nightingale Monitoring System is indicated for use in adult & pediatric patient populations. The Zoe Medical Nightingale Monitoring System facilitates the monitoring of: - ECG - - Impedance respiration - - Non-Invasive blood pressure - - Invasive blood pressure - - Body temperature - -Functional arterial oxygen saturation (SpO2) - -End-tidal & inspired CO2 The Zoe Medical Nightingale Monitoring System is a prescription device intended to be used by healthcare professionals in all areas of a healthcare facility.

Device Story

Nightingale Monitoring System (NMS) provides bedside (PPM3 monitor) and remote (MPC central station) physiological monitoring. Inputs: ECG, impedance respiration, NIBP, IBP, body temperature, SpO2, and CO2 (via Oridion Microstream). System processes these signals to display real-time waveforms and vital signs; provides 72-hour trending; supports up to 64 monitors at central station. Operated by healthcare professionals in clinical settings. Output used for patient status assessment and clinical decision-making. Benefits include continuous monitoring of critical physiological parameters to facilitate timely clinical intervention.

Clinical Evidence

No clinical data. Bench testing only, including performance, functional, environmental, and shipping/transportation testing. Electrical safety and EMC testing performed per AAMI ES 60601-1:2005, IEC 60601-1-2:2007, and related standards.

Technological Characteristics

Physiological patient monitor; portable; indoor use. Parameters: ECG, impedance respiration, NIBP, IBP, temp, SpO2, CO2. 8.4" display; push-knob/key interface. Power: Medical grade supply with internal Li-ion battery. Connectivity: Central station support for 64 monitors. Standards: IEC 60601-1-2:2007 (EMC), AAMI ES 60601-1:2005 (Safety). Ingress protection: IPX1. Software: Verified and validated per IEC 62304.

Indications for Use

Indicated for adult and pediatric patients requiring physiological monitoring of ECG, impedance respiration, NIBP, IBP, body temperature, SpO2, and end-tidal/inspired CO2. Prescription use only by healthcare professionals in healthcare facilities.

Regulatory Classification

Identification

A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.

Predicate Devices

• Spacelabs Healthcare Vital Signs Monitoring System (K090556)

Submission Summary (Full Text)

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| Company: | Zoe Medical, Inc.<br>460 Boston Street<br>Topsfield, MA 01983<br>Phone: [phone]<br>FAX: [phone] |
|--------------------------------|---------------------------------------------------------------------------------------------------------------|
| Establishment<br>Registration: | 3003294644 |
| Primary Contact: | James Chickering<br>Regulatory Affairs Manager |
| Date Prepared: | March 13, 2013 |
| Trade Name: | Zoe Medical Nightingale Monitoring System |
| Common Name: | Patient Physiological Monitor |
| Classification Name: | Monitor, Physiological Patient |
| Product Code: | MWI |
| Classification<br>Regulation: | 21 CFR 870.2300 |

#### Device Description

The Zoe Medical Nightingale Monitoring System (NMS) facilitates the monitoring of patient physiological parameters both at the bedside on the Nightingale PPM3 monitor and remotely on the Nightingale MPC central station. The physiological parameters monitored by the NMS include: ECG. impedance respiration, non-invasive blood pressure, invasive blood pressure, body temperature, functional arterial oxygen saturation (SpO2), and end-tidal & inspired CO2 (capnography). The Nightingale Monitoring System as described in this submission is a new device, and will be marketed as the next generation product superseding the original and previously cleared Zoe Medical NMS (K001775).

The part numbers for the four Nightingale PPM3 variants and their associated configurations are given below.

179-0003 NIGHTINGALE PPM3 (with NIBP, SPO2, ECG, and Temp)

179-1000 NIGHTINGALE PPM3 WITH IBP (with NIBP, SPO2, ECG, Temp, & IBP)

179-1001 NIGHTINGALE PPM3 WITH ETCO2 (with NIBP, SPO2, ECG, Temp, & Microstream ETCO2)

179-1002 NIGHTINGALE PPM3 (with NIBP, SPO2, ECG, Temp, IBP, & Microstream ETCO2)

The Nightingale MPC central station (171-0001) will be sold as an option available to all customers based on their needs.

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#### Intended Use

The Zoe Medical Nightingale Monitoring System is indicated for use in adult & pediatric patient populations.

The Zoe Medical Nightingale Monitoring System facilitates the monitoring of:

- ECG -
- Impedance respiration -
- Non-Invasive blood pressure -
- Invasive blood pressure -
- Body temperature -
- -Functional arterial oxygen saturation (SpO2)
- -End-tidal & inspired CO2

The Zoe Medical Nightingale Monitoring System is a prescription device intended to be used by healthcare professionals in all areas of a healthcare facility.

## Substantial Equivalence

The Nightingale Monitoring System utilizes the same Zoe Medical and Oridion Medical components utilized in the primary predicate device, the Spacelabs Healthcare Vital Signs Monitoring System (K090556).

| Characteristic | Zoe Medical Nightingale<br>Monitoring System<br>(this submission) | Spacelabs Healthcare élance<br>Vital Signs Monitoring<br>System<br>(K090556) | Discussion of<br>Differences |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|
| Intended Use | The Zoe Medical Nightingale<br>Monitoring System is indicated for<br>use in adult & pediatric patient<br>populations.<br><br>The Zoe Medical Nightingale<br>Monitoring System facilitates the<br>monitoring of:<br>- ECG<br>- Impedance respiration<br>- Non-Invasive blood pressure<br>- Invasive blood pressure<br>- Body temperature<br>- Functional arterial oxygen<br>saturation (SpO2)<br>- End-tidal & inspired CO2<br><br>The Zoe Medical Nightingale<br>Monitoring System is a<br>prescription device intended to be<br>used by healthcare professionals<br>in all areas of a healthcare facility. | The Spacelabs élance Vital<br>Signs Monitor is indicated for<br>use in patient populations for:<br>- Adult<br>- Pediatric<br><br>The Spacelabs élance Vital<br>Signs Monitor facilitates the<br>monitoring of:<br>- ECG with arrhythmia<br>detection<br>- Respiration<br>- Non-Invasive blood pressures<br>- Invasive blood pressures<br>- Body temperature<br>- Functional arterial oxygen<br>saturation<br>- Expired and/or inspired CO2<br><br>The Spacelabs élance Vital<br>Signs Monitor is a prescription<br>device intended to be used by<br>healthcare professionals in all<br>areas of a healthcare facility. | Nightingale not<br>intended for<br>arrhythmia<br>monitoring |
| Characteristic | Zoe Medical Nightingale<br>Monitoring System<br>(this submission) | Spacelabs Healthcare élance<br>Vital Signs Monitoring<br>System<br>(K090556) | Discussion of<br>Differences |
| Parameters | ECG, impedance respiration, non-<br>invasive blood pressure, invasive<br>blood pressure, body<br>temperature, functional arterial<br>oxygen saturation (SpO2), end-<br>tidal & inspired CO2 (Oridion<br>Microstream®). | Same | Optional<br>arrhythmia<br>components not<br>included in<br>Nightingale |
| Number of<br>Waveforms | 3 or 5 | Same | |
| User Interface | Push knob and dedicated keys | Touch screen | PPM3 meets<br>intended use |
| Alarm Levels | 3 per IEC 60601-1-8 | Same | |
| Operating Modes | Continuous | Same | |
| Trending | 72 hours | Same | |
| Size | 286 W x 182 H x 83 D (mm) w/<br>8.4" display | 252 W x 193 H x 70 D w/ 10.2"<br>display or 291 W x 221 H x 70<br>D (12.1" display) | PPM3<br>represents a<br>slimmed down<br>design |
| Electrical | Medical grade power supply with<br>internal lithium-ion battery | Same | |
| Equipment Type | Portable, Indoor Use Only | Same | |
| Ingress<br>Protection | IPX1 | Same | |
| Operating<br>Conditions | 0 to 40°C (32 to 104°F)<br>15 to 90% RH, non-condensing<br>0 to 4572 m (0 to 15,000') | Same | |
| Storage<br>Conditions | -20 to 60°C (-4 to 140°F)<br>15 to 95%, non-condensing<br>0 to 12192 m (0 to 40,000') | Same | |
| Electromagnetic<br>Compatibility | Meets IEC 60601-1-2:2007 | Same | |
| Central Station | Support for 64 monitors;<br>Parameters: ECG, Respiration,<br>NIBP, IBP, Temp, SpO2, EtCO2,<br>FiCO2; Alarming with Logging;<br>Printed Vital Sign, Summary,<br>Trend Reports | Same | |

## Table 1. Comparison of the Subject and Predicate Devices

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| Category | Testing Summary |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sterilization Validation | The Nightingale Monitoring System is not sterilized or sterilizable, and<br>therefore this section does not apply to the monitor itself. |
| Shelf Life Testing | The Nightingale Monitoring System does not have a shelf life, and<br>therefore this section does not apply to the monitor itself. |
| Biocompatibility Testing | The Nightingale Monitoring System has no patient contact materials,<br>and therefore this section does not apply to the monitor itself. |
| Software Testing | Software for the Nightingale Monitoring System was designed and<br>developed in accordance with Zoe Medical software development<br>processes, and was verified and validated. Test results indicated that<br>the Nightingale Monitoring System complies with its predetermined<br>specification. |
| Electrical Safety | The Nightingale Monitoring System was tested for patient safety in<br>accordance with the following applicable standards:<br>• AAMI ES 60601-1:2005<br>• ANSI/AAMI SP10:2002 / A1:2003<br>• IEC 60601-1-4:2000<br>• IEC 60601-1-8:2006<br>• IEC 60601-2-27:2011<br>• IEC 80601-2-30:2009<br>• IEC 60601-2-34:2011<br>• ISO 80601-2-55:2011<br>• ISO 80601-2-56:2009<br>• ISO 80601-2-61:2011<br>• IEC 62366:2007<br>• IEC 62304:2006<br>Test results indicated that the Nightingale Monitoring System complies<br>with its predetermined specification. |
| Electromagnetic<br>Compatibility Testing | The Nightingale Monitoring System was tested for EMC in accordance<br>with IEC 60601-1-2:2007. Test results indicated that the Nightingale<br>Monitoring System complies with its predetermined specification. |
| Performance Testing -<br>Bench | The Nightingale Monitoring System was tested in accordance with Zoe<br>Medical internal requirements and procedures, and test results<br>indicated that the device complies with the predetermined requirements.<br>This testing includes performance and functional, environmental, and<br>shipping and transportation testing. |
| Performance Testing -<br>Animal | Animal performance testing was not performed and is not necessary to<br>demonstrate safety and effectiveness of the Nightingale Monitoring<br>System. |
| Performance Testing -<br>Clinical | Clinical performance testing was not performed and is not necessary to<br>demonstrate safety and effectiveness of the Nightingale Monitoring<br>System. |

## Table 2. Performance Testing of the Nightingale Monitoring System

# Conclusion

Based upon a comparison of devices and performance testing results, the Zoe Medical Nightingale Monitoring System is substantially equivalent to the predicate device.

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the department's name written around the perimeter. Inside the circle is an abstract symbol that resembles a stylized eagle or bird in flight.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20995-00012

July 23, 2013

Zoe Medical, Inc. c/o Mr. James Chickering Regulatory Affairs Manager 460 Boston Street Topsfield, MA 01983

Re: K130740

Trade/Device Name: Nightingale Monitoring System Regulatory Number: 21 CFR 870.2300 Regulation Name: Physiological Patient Monitor (without arrhythmia detection or alarms) Regulatory Class: II (two) Product Code: 74 MWI Dated: April 21, 2013 Received: April 24, 2013

Dear Mr. Chickering:

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

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Page 2 - Mr. James Chickering

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/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.

for

Sincerely yours,

Owen-Paris-S

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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K130740

# Indications for Use

510(k) Number: _

Device Name:

## Zoe Medical Nightingale Monitoring System

Indications for Use:

The Zoe Medical Nightingale Monitoring System is indicated for use in adult & pediatric patient populations.

The Zoe Medical Nightingale Monitoring System facilitates the monitoring of:

- ECG -
- Impedance respiration -
- Non-Invasive blood pressure -
- Invasive blood pressure -
- Body temperature "
- Functional arterial oxygen saturation (SpO2) -
- -End-tidal & inspired CO2

The Zoe Medical Nightingale Monitoring System is a prescription device intended to be used by healthcare professionals in all areas of a healthcare facility.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Digitally signed by
Owen R. Faris -5
Date: 2013.07.23
16:23:12 -04'00'

Zoe Medical, Inc.