Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard vital signs monitoring system and does not mention any AI or ML capabilities.

Therapeutic

No
The device is described as a "Monitoring System" that "facilitates the monitoring of patient physiological parameters". Its functions are solely to measure and display physiological data (e.g., ECG, blood pressure, temperature, SpO2, CO2), not to treat, alleviate, or cure a disease or condition.

Diagnostic

No

The device is a monitoring system that measures physiological parameters. While these measurements can be used by healthcare professionals for diagnosis, the device itself is not explicitly stated to provide a diagnostic output or interpretation. Its primary function is "facilitates the monitoring of."

SaMD (Software as a Medical Device)

No

The device description explicitly mentions hardware components like the "Nightingale PPM3 monitor" and the "Nightingale MPC central station," along with specific part numbers for different hardware configurations.

IVD (In Vitro Diagnostic)

Based on the provided information, the Zoe Medical Nightingale Monitoring System is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
Device Function: The Zoe Medical Nightingale Monitoring System directly monitors physiological parameters from the patient's body (ECG, respiration, blood pressure, temperature, SpO2, CO2). It does not analyze specimens taken from the body.
Intended Use: The intended use describes monitoring patient physiological parameters, not analyzing biological samples.

Therefore, the device falls under the category of patient monitoring equipment, not In Vitro Diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

MWI

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.

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

adult & pediatric patient populations.

Intended User / Care Setting

healthcare professionals in all areas of a healthcare facility.

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)

Software Testing: Software for the Nightingale Monitoring System 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: The Nightingale Monitoring System was tested for patient safety in accordance 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 62304:2006. Test results indicated that the Nightingale Monitoring System complies with its predetermined specification.

Electromagnetic Compatibility Testing: The Nightingale Monitoring System was tested for EMC in accordance with IEC 60601-1-2:2007. Test results indicated that the Nightingale Monitoring System complies with its predetermined specification.

Performance Testing - Bench: The Nightingale Monitoring System was tested in accordance with Zoe Medical internal requirements and procedures, and test results indicated that the device complies with the predetermined requirements. This testing includes performance and functional, environmental, and shipping and transportation testing.

Performance Testing - Animal: Animal performance testing was not performed and is not necessary to demonstrate safety and effectiveness of the Nightingale Monitoring System.

Performance Testing - Clinical: Clinical performance testing was not performed and is not necessary to demonstrate safety and effectiveness of the Nightingale Monitoring System.

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

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K090556

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K001775

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

Summary

0

| Company: | Zoe Medical, Inc.
460 Boston Street
Topsfield, MA 01983
Phone: (978) 887-1410
FAX: (978) 887-1406 |
|--------------------------------|---------------------------------------------------------------------------------------------------------------|
| Establishment
Registration: | 3003294644 |
| Primary Contact: | James Chickering
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
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.

1

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
Monitoring System
(this submission) | Spacelabs Healthcare élance
Vital Signs Monitoring
System
(K090556) | Discussion of
Differences |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|
| 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. | The Spacelabs élance Vital
Signs Monitor is indicated for
use in patient populations for:

Adult
Pediatric

The Spacelabs élance Vital
Signs Monitor facilitates the
monitoring of:

ECG with arrhythmia
detection
Respiration
Non-Invasive blood pressures
Invasive blood pressures
Body temperature
Functional arterial oxygen
saturation
Expired and/or inspired CO2

Table 1. Comparison of the Subject and Predicate Devices

2

3

Category	Testing Summary
Sterilization Validation	The Nightingale Monitoring System is not sterilized or sterilizable, and
therefore this section does not apply to the monitor itself.
Shelf Life Testing	The Nightingale Monitoring System does not have a shelf life, and
therefore 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 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	The Nightingale Monitoring System was tested for patient safety in
accordance 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 62304:2006
Test results indicated that the Nightingale Monitoring System complies
with its predetermined specification.
Electromagnetic
Compatibility Testing	The Nightingale Monitoring System was tested for EMC in accordance
with IEC 60601-1-2:2007. Test results indicated that the Nightingale
Monitoring System complies with its predetermined specification.
Performance Testing -
Bench	The Nightingale Monitoring System was tested in accordance with Zoe
Medical internal requirements and procedures, and test results
indicated that the device complies with the predetermined requirements.
This testing includes performance and functional, environmental, and
shipping and transportation testing.
Performance Testing -
Animal	Animal performance testing was not performed and is not necessary to
demonstrate safety and effectiveness of the Nightingale Monitoring
System.
Performance Testing -
Clinical	Clinical performance testing was not performed and is not necessary to
demonstrate safety and effectiveness of the Nightingale Monitoring
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.

4

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

5

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

6

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.