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 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.

AI/ML Overview

The provided document describes the Zoe Medical Nightingale Monitoring System, a patient physiological monitor. Here's an analysis of its acceptance criteria and the studies performed:

1. Table of Acceptance Criteria and Reported Device Performance

The submission focuses on establishing substantial equivalence to a predicate device (Spacelabs Healthcare Vital Signs Monitoring System, K090556) rather than detailing specific numerical acceptance criteria for each physiological parameter. The acceptance criteria are broadly defined by compliance with applicable standards and demonstration that the device's performance meets its predetermined specifications.

Category	Acceptance Criteria (Implied)	Reported Device Performance and Compliance
Software	Designed and developed according to Zoe Medical processes; verified and validated.	Software was designed and developed in accordance with Zoe Medical software development processes, and was verified and validated. Test results indicated that the Nightingale Monitoring System complies with its predetermined specification.
Electrical Safety	Compliance with specified electrical safety standards (e.g., AAMI ES 60601-1:2005, IEC 60601-2-XX series).	Tested for patient safety in accordance with AAMI ES 60601-1:2005, ANSI/AAMI SP10:2002 / A1:2003, IEC 60601-1-4:2000, IEC 60601-1-8:2006, IEC 60601-2-27:2011, IEC 80601-2-30:2009, IEC 60601-2-34:2011, ISO 80601-2-55:2011, ISO 80601-2-56:2009, ISO 80601-2-61:2011, IEC 62366:2007, IEC 62304:2006. Test results indicated compliance with predetermined specification.
Electromagnetic Compatibility (EMC)	Compliance with IEC 60601-1-2:2007.	Tested for EMC in accordance with IEC 60601-1-2:2007. Test results indicated that the Nightingale Monitoring System complies with its predetermined specification.
Bench Performance	Compliance with Zoe Medical internal requirements and procedures; functional, environmental, and shipping/transportation performance.	Tested in accordance with Zoe Medical internal requirements and procedures. Test results indicated that the device complies with the predetermined requirements, including performance, functional, environmental, and shipping/transportation testing.

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

The document does not specify a separate "test set" in the context of device performance data beyond the compliance testing. The performance and safety validations were primarily based on engineering and laboratory testing against established standards and internal requirements. Therefore:

Sample Size: Not applicable in terms of a clinical dataset for a test set. The samples would be the physical devices and components undergoing the various safety and performance tests.
Data Provenance: The data comes from internal testing conducted by Zoe Medical, Inc., as part of their design and development processes. It is retrospective in the sense that the testing was completed before submission for clearance. The country of origin of this internal testing data is likely the USA (Topsfield, MA, where the company is located).

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

This information is not applicable. The device's performance is assessed against recognized industry standards and internal specifications, not against a "ground truth" established by experts in the typical sense of a clinical diagnostic study. The "ground truth" for electrical safety would be the requirements of the IEC 60601 series, and for EMC, the IEC 60601-1-2 standard. Internal engineering experts and certified testing laboratories would be involved in verifying compliance.

4. Adjudication Method for the Test Set

This is not applicable as there is no mention of a "test set" in the context of human interpretation or clinical data requiring adjudication. Compliance with standards is typically a pass/fail outcome based on measurements and observations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The submission relies on demonstrating substantial equivalence to a predicate device and compliance with relevant safety and performance standards for a physiological monitor, not on assessing the improvement of human readers with this AI-assisted technology. This device is a monitor, not an AI diagnostic tool.

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

This is not applicable. The Zoe Medical Nightingale Monitoring System is a physiological patient monitor, a hardware device with embedded software. Its performance is inherent to the device itself and its sensors, not a standalone algorithm in the AI sense. Its intended use involves healthcare professionals continuously monitoring the patient via the device.

7. The Type of Ground Truth Used

The "ground truth" for the performance and safety testing is based on:

Pre-determined specifications: Internal requirements established by Zoe Medical.
International and National Standards: Compliance with recognized standards such as AAMI ES 60601-1, IEC 60601-1-2, IEC 60601-2-XX series, ISO 80601-2-XX series, IEC 62366, and IEC 62304. These standards define acceptable levels of safety and performance for physiological monitors.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physiological monitor, not an AI/ML algorithm that requires a "training set" in the machine learning context. Its functionality is based on established engineering principles and signal processing, not on learning from a large dataset.

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

This information is not applicable, as there is no "training set."

Summary

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Company:	Zoe Medical, Inc.460 Boston StreetTopsfield, MA 01983Phone: (978) 887-1410FAX: (978) 887-1406
EstablishmentRegistration:	3003294644
Primary Contact:	James ChickeringRegulatory 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
ClassificationRegulation:	21 CFR 870.2300

Device Description

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 NightingaleMonitoring System(this submission)	Spacelabs Healthcare élanceVital Signs MonitoringSystem(K090556)	Discussion ofDifferences
Intended Use	The Zoe Medical NightingaleMonitoring System is indicated foruse in adult & pediatric patientpopulations.The Zoe Medical NightingaleMonitoring System facilitates themonitoring of:- ECG- Impedance respiration- Non-Invasive blood pressure- Invasive blood pressure- Body temperature- Functional arterial oxygensaturation (SpO2)- End-tidal & inspired CO2The Zoe Medical NightingaleMonitoring System is aprescription device intended to beused by healthcare professionalsin all areas of a healthcare facility.	The Spacelabs élance VitalSigns Monitor is indicated foruse in patient populations for:- Adult- PediatricThe Spacelabs élance VitalSigns Monitor facilitates themonitoring of:- ECG with arrhythmiadetection- Respiration- Non-Invasive blood pressures- Invasive blood pressures- Body temperature- Functional arterial oxygensaturation- Expired and/or inspired CO2The Spacelabs élance VitalSigns Monitor is a prescriptiondevice intended to be used byhealthcare professionals in allareas of a healthcare facility.	Nightingale notintended forarrhythmiamonitoring
Characteristic	Zoe Medical NightingaleMonitoring System(this submission)	Spacelabs Healthcare élanceVital Signs MonitoringSystem(K090556)	Discussion ofDifferences
Parameters	ECG, impedance respiration, non-invasive blood pressure, invasiveblood pressure, bodytemperature, functional arterialoxygen saturation (SpO2), end-tidal & inspired CO2 (OridionMicrostream®).	Same	Optionalarrhythmiacomponents notincluded inNightingale
Number ofWaveforms	3 or 5	Same
User Interface	Push knob and dedicated keys	Touch screen	PPM3 meetsintended 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/8.4" display	252 W x 193 H x 70 D w/ 10.2"display or 291 W x 221 H x 70D (12.1" display)	PPM3represents aslimmed downdesign
Electrical	Medical grade power supply withinternal lithium-ion battery	Same
Equipment Type	Portable, Indoor Use Only	Same
IngressProtection	IPX1	Same
OperatingConditions	0 to 40°C (32 to 104°F)15 to 90% RH, non-condensing0 to 4572 m (0 to 15,000')	Same
StorageConditions	-20 to 60°C (-4 to 140°F)15 to 95%, non-condensing0 to 12192 m (0 to 40,000')	Same
ElectromagneticCompatibility	Meets IEC 60601-1-2:2007	Same
Central Station	Support for 64 monitors;Parameters: ECG, Respiration,NIBP, IBP, Temp, SpO2, EtCO2,FiCO2; Alarming with Logging;Printed Vital Sign, Summary,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, andtherefore this section does not apply to the monitor itself.
Shelf Life Testing	The Nightingale Monitoring System does not have a shelf life, andtherefore this section does not apply to the monitor itself.
Biocompatibility Testing	The Nightingale Monitoring System has no patient contact materials,and therefore this section does not apply to the monitor itself.
Software Testing	Software for the Nightingale Monitoring System was designed anddeveloped in accordance with Zoe Medical software developmentprocesses, and was verified and validated. Test results indicated thatthe Nightingale Monitoring System complies with its predeterminedspecification.
Electrical Safety	The Nightingale Monitoring System was tested for patient safety inaccordance with the following applicable standards:• AAMI ES 60601-1:2005• ANSI/AAMI SP10:2002 / A1:2003• IEC 60601-1-4:2000• IEC 60601-1-8:2006• IEC 60601-2-27:2011• IEC 80601-2-30:2009• IEC 60601-2-34:2011• ISO 80601-2-55:2011• ISO 80601-2-56:2009• ISO 80601-2-61:2011• IEC 62366:2007• IEC 62304:2006Test results indicated that the Nightingale Monitoring System complieswith its predetermined specification.
ElectromagneticCompatibility Testing	The Nightingale Monitoring System was tested for EMC in accordancewith IEC 60601-1-2:2007. Test results indicated that the NightingaleMonitoring System complies with its predetermined specification.
Performance Testing -Bench	The Nightingale Monitoring System was tested in accordance with ZoeMedical internal requirements and procedures, and test resultsindicated that the device complies with the predetermined requirements.This testing includes performance and functional, environmental, andshipping and transportation testing.
Performance Testing -Animal	Animal performance testing was not performed and is not necessary todemonstrate safety and effectiveness of the Nightingale MonitoringSystem.
Performance Testing -Clinical	Clinical performance testing was not performed and is not necessary todemonstrate safety and effectiveness of the Nightingale MonitoringSystem.

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 (800) 638-2041 or (301) 796-7100 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.

Regulation Number and Section

§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).

(a)
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.(b)
Classification. Class II (performance standards).