Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on data management, display, and electronic record keeping. There is no mention of AI, ML, or any analytical capabilities beyond basic data processing and display. The performance studies are focused on software verification, validation, and risk analysis, not on the performance of an AI/ML algorithm.

Therapeutic

No
The device is a data management software designed for viewing and storing perinatal monitoring data. It does not actively provide therapy or treatment to the patient.

Diagnostic

No.

The device is a data managing software application that collects, processes, and saves monitoring data. It does not perform diagnostic functions, but rather provides an electronic medical record for viewing by qualified healthcare professionals. The documentation explicitly states that the user cannot solely depend on the system for monitoring data, implying it's not for diagnosis.

SaMD (Software as a Medical Device)

Yes

The device is explicitly described as "clinical data managing software applications" and the performance studies section states "Since the subject is a software only product...". While it interacts with bedside monitors and operates with off-the-shelf hardware, the device itself is presented as the software component.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use is to manage and display clinical data acquired from bedside monitors or manual input for monitoring pregnant women. It produces electronic medical records. This is focused on managing and presenting existing patient data, not on performing tests on biological samples to diagnose or monitor a condition.
Device Description: The device is described as a "clinical data managing software application." It collects, processes, and saves patient and clinical data from bedside monitors. It does not involve the analysis of biological specimens.
Lack of IVD Characteristics: There is no mention of the device being used with biological samples (blood, urine, tissue, etc.), reagents, or performing any kind of test or analysis on these samples.

IVD devices are specifically designed to perform tests on biological specimens to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device's function is to consolidate and display data from other medical devices and manual input.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Maternal Fetal Monitoring – Central Nurse System (hereinafter called "MFM-CNS") is a clinical data managing software application and is indicated for antepartum and intrapartum monitoring of pregnant women in a healthcare setting.

MFM-CNS is intended to manage perinatal monitoring data acquired from bedside monitors or manual input for viewing at the central nursing station. The system also produces an electronic medical record.

MFM-CNS has display fields for the following obstetric data:

□ patient demographics
□ provider notes
□ fetal heart rate (FHR)
□ uterine activity
□ fetal movement
□ maternal heart rate
SpO2
□ non-invasive blood pressure (NIBP)
□ respiratory rate
□ temperature
□ pulse rate

MFM-CNS Lite (hereinafter called "Lite") is a clinical data managing software application and is indicated for antepartum monitoring of pregnant women in a healthcare setting.

Lite is intended to manage antepartum-monitoring data acquired from bedside monitors and produce electronic medical records.

Lite has display fields for the following obstetric data:
□ patient demographics

□ provider notes
□ fetal heart rate (FHR)
□ uterine activity
□ fetal movement

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

HGM

Device Description

The MFM-CNS v3.91 and MFM-CNS Lite v1.1 are clinical data managing software applications. Both applications manage clinical data of fetal monitoring and uterine activity, and the MFM-CNS v3.91 additional monitors maternal vital signs. Data are automatically acquired from bedside monitors, for the purpose of collecting, processing and saving the patient and/or clinical data that is normally provided on record papers and/or separate bedside monitors. They provide electronic medical records and operate with off-the-shelf software and hardware.

The MFM-CNS v3.91 and MFM-CNS Lite v1.1 are intended to be used in hospital clinical areas such as monitor units, delivery room, etc. They are intended to be operated by or under guidance of qualified healthcare professionals, not intended for home healthcare environment. During monitoring, the user should check the results on the bedside monitor in person, even though they could observe the results on the MFM-CNS v3.91 and MFM-CNS Lite v1.1 system interface. The user cannot only depend on the MFM-CNS v3.91 and MFM-CNS Lite v1.1 system to obtain monitoring data, because whether the data provided by the system are accurate depends on the stability of the operating system, the performance of PC station and the network.

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

Not Found

Intended User / Care Setting

Qualified healthcare professionals in a healthcare setting (hospital clinical areas such as monitor units, delivery room, etc.)

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)

Non-clinical data:
Since the subject is a software only product, the following quality assurance measures were applied to the development of the MFM-CNS v3.91 and MFM-CNS Lite v1.1 to evaluate safety and effectiveness: 1. Risk analysis according to ISO 14971: 2007 2. Software life cycle management according to IEC 62304: 2006. The subject device passed all testing. 3. Bench testing was conducted per IEC 60601-1-8: 2006 (Medical electrical equipment General requirements for basic safety and essential performance - Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems), and all the results show pass.

Software Verification and Validation Testing:
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "major" level of concern, since a failure or latent flaw in the software could result in serious injury or death to the patient or operator.

Key results: The non-clinical performance testing showed that the subject devices are as safe and as effective as the predicate device.

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.

K143695

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.

Not Found

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

§ 884.2740 Perinatal monitoring system and accessories.

(a)
Identification. A perinatal monitoring system is a device used to show graphically the relationship between maternal labor and the fetal heart rate by means of combining and coordinating uterine contraction and fetal heart monitors with appropriate displays of the well-being of the fetus during pregnancy, labor, and delivery. This generic type of device may include any of the devices subject to §§ 884.2600, 884.2640, 884.2660, 884.2675, 884.2700, and 884.2720. This generic type of device may include the following accessories: Central monitoring system and remote repeaters, signal analysis and display equipment, patient and equipment supports, and component parts.(b)
Classification. Class II (performance standards).

Summary

0

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 6, 2017

Edan Instruments, Inc. % Doug Worth Sr.Dir.US RA/OA Edan Medical 1200 Crossman Ave, Suite 200 Sunnyvale, California 94089

Re: K171178

Trade/Device Name: Central Monitoring System MFM-CNS Lite v1.1 and MFM-CNS v3.91 Regulation Number: 21 CFR 884.2740 Regulation Name: Perinatal Monitoring System and Accessories Regulatory Class: Class II Product Code: HGM Dated: August 4, 2017 Received: August 7, 2017

Dear Doug Worth:

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.

1

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 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Benjamin R. Fisher -S

Benjamin R. Fisher, Ph.D. Director Division of Reproductive. Gastro-Renal. and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K171178

Device Name

Central Monitoring System MFM-CNS v3.91

Indications for Use (Describe)
--------------------------------	--

The Maternal Fetal Monitoring - Central Nurse System (hereinafter called "MFM-CNS") is a clinical data managing software application and is indicated for antepartum and intrapartum monitoring of pregnant women in a healthcare setting.

MFM-CNS is intended to manage perinatal monitoring data acquired from bedside monitors or manual input for viewing at the central nursing station. The system also produces an electronic medical record.

MFM-CNS has display fields for the following obstetric data:

□ patient demographics
□ provider notes
□ fetal heart rate (FHR)
□ uterine activity
□ fetal movement
□ maternal heart rate
SpO2
□ non-invasive blood pressure (NIBP)
□ respiratory rate
□ temperature
□ pulse rate

Type of Use (Select one or both, as applicable)
-------------------------------------------------

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

| X | Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

3

Indications for Use

510(k) Number (if known) K171178

Device Name

Central Monitoring System MFM-CNS Lite v1.1

Indications for Use (Describe)

MFM-CNS Lite (hereinafter called "Lite") is a clinical data managing software application and is indicated for antepartum monitoring of pregnant women in a healthcare setting.

Lite is intended to manage antepartum-monitoring data acquired from bedside monitors and produce electronic medical records.

Lite has display fields for the following obstetric data:

□ patient demographics

□ provider notes
□ fetal heart rate (FHR)
□ uterine activity
□ fetal movement

Type of Use (Select one or both, as applicable)

|X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

4

510(K) Summary

Prepared in accordance with the content and format regulatory requirements of 21 CFR Part 807.92

| 1. Submitter: | Edan Instruments, Inc.
#15 Jinhui Road, Jinsha Community,
Kengzi Sub-District, Pingshan District,
Shenzhen, 518122 P.R.China.
Tel: +86(0755) 26858736
Fax: +1 (408) 418-4059 |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person:
Preparing date: | Alice Yang
April 19, 2017 |
| 2. Device name and
classification: | Device Name: Central Monitoring System
Model: MFM-CNS v3.91, MFM-CNS Lite v1.1
Classification Name/ Product code:
884.2740 Perinatal monitoring system and accessories / HGM
Regulatory Class: Class II |
| 3. Predicate Device(s): | 1. EDAN Instrument, Inc. Central Monitoring System, model
MFM-CNS v3.82, K143695. The predicate device was not the subject
of a recall and no reference devices were used in this submission. |
| 4. Device Description: | MFM-CNS v3.91 and MFM-CNS Lite v1.1
The MFM-CNS v3.91 and MFM-CNS Lite v1.1 are clinical data
managing software applications. Both applications manage clinical
data of fetal monitoring and uterine activity, and the MFM-CNS v3.91
additional monitors maternal vital signs. Data are automatically
acquired from bedside monitors, for the purpose of collecting,
processing and saving the patient and/or clinical data that is normally
provided on record papers and/or separate bedside monitors. They
provide electronic medical records and operate with off-the-shelf |

software and hardware.

The MFM-CNS v3.91 and MFM-CNS Lite v1.1 are intended to be

5

used in hospital clinical areas such as monitor units, delivery room, etc. They are intended to be operated by or under guidance of qualified healthcare professionals, not intended for home healthcare environment. During monitoring, the user should check the results on the bedside monitor in person, even though they could observe the results on the MFM-CNS v3.91 and MFM-CNS Lite v1.1 system interface. The user cannot only depend on the MFM-CNS v3.91 and MFM-CNS Lite v1.1 system to obtain monitoring data, because whether the data provided by the system are accurate depends on the stability of the operating system, the performance of PC station and the network.

5. Indications for Use MFM-CNS v3.91:

The Maternal Fetal Monitoring – Central Nurse System (hereinafter called "MFM-CNS") is a clinical data managing software application and is indicated for antepartum and intrapartum monitoring of pregnant women in a healthcare setting.

MFM-CNS is intended to manage perinatal monitoring data acquired from bedside monitors or manual input for viewing at the central nursing station. The system also produces an electronic medical record.

MFM-CNS has display fields for the following obstetric data: patient demographics provider notes fetal heart rate (FHR) uterine activity fetal movement maternal heart rate SpO2 non-invasive blood pressure (NIBP) respiratory rate temperature pulse rate

MFM-CNS Lite v1.1:

MFM-CNS Lite (hereinafter called "Lite") is a clinical data managing software application and is indicated for antepartum monitoring of pregnant women in a healthcare setting.

Lite is intended to manage antepartum-monitoring data acquired from

6

bedside monitors and produce electronic medical records. Lite has display fields for the following obstetric data: patient demographics provider notes fetal heart rate (FHR) uterine activity fetal movement

6. Predicate Device Comparison

The subject device shares the same characteristics in most items with the predicate device except in the following aspects:

| Item | MFM-CNS
v3.82 | MFM-CNS v3.91 | MFM-CNS Lite v1.1 | |
|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Manufacturer/K# | EDAN
Instruments/
K143695 | EDAN
Instruments/N/A | EDAN
Instruments/N/A | SE |
| | Indication for Use | | | |
| | MFM-CNS
v3.82 | MFM-CNS v3.91 | MFM-CNS Lite v1.1 | |
| Indication for Use | The Maternal
Fetal Monitoring
– Central Nurse
System
(hereinafter
called
"MFM-CNS") is
a clinical data
managing
software
application and is
indicated for
antepartum and
intrapartum
monitoring of
pregnant women
in a healthcare | The Maternal Fetal
Monitoring –
Central Nurse
System (hereinafter
called
"MFM-CNS") is a
clinical data
managing software
application and is
indicated for
antepartum and
intrapartum
monitoring of
pregnant women in
a healthcare setting.
The MFM-CNS is
intended to manage
perinatal | MFM-CNS Lite
(hereinafter called
"Lite") is a clinical
data managing
software application
and is indicated for
antepartum monitoring
of pregnant women in
a healthcare setting.
MFM-CNS Lite is
intended to manage
antepartum-monitoring
data acquired from
bedside monitors and
produce electronic
medical records.
The MFM-CNS Lite
has display fields for | Different |
| | | | | |
| | setting. | monitoring data | the following obstetric | |
| | The MFM-CNS | acquired from | data: | |
| | is intended to | bedside monitors or | Patient demographics, | |
| | manage perinatal | manual input for | provider notes, fetal | |
| | monitoring data | viewing at the | heart rate (FHR),
uterine activity, fetal | |
| | acquired from | central nursing | movement. | |
| | bedside monitors | station. The system | | |
| | or manual input | also produces an | | |
| | for viewing at the | electronic medical | | |
| | central nursing | record. | | |
| | station. The | The MFM-CNS has | | |
| | | display fields for | | |
| | system also | the following | | |
| | produces an | obstetric data: | | |
| | electronic | patient | | |
| | medical record. | demographics, | | |
| | The MFM-CNS | provider notes, fetal
heart rate (FHR), | | |
| | has display fields | uterine activity, etc. | | |
| | for the following | | | |
| | obstetric data: | | | |
| | patient
demographics, | | | |
| | provider notes, | | | |
| | fetal heart rate | | | |
| | (FHR), uterine | | | |
| | activity (via | | | |
| | tocodynamometry | | | |
| | or IUP), etc. | | | |
| | | Classification | | |
| Classified as per | | | | |
| FDA regulation | Class II | Class II | Class II | Same |
| | | Network and Hardware | | |
| | Off-the-shelf | Off-the-shelf | Off-the-shelf | |
| Hardware | computers and | computers and | computers and | Same |
| | accessories | accessories | accessories | |
| Network | | | | |
| connecting to | Ethernet | Ethernet | Ethernet | Same |
| bedside monitor | | | | |

7

8

	Software
User Access /
Authentication	16 client	32 client	1 client	Different
Display	Fetal heart rate,
TOCO, maternal
vital signs,
patient
demography data,
and notes.
Providing the
means to display
multiple beds
simultaneously.	Fetal heart rate,
TOCO, maternal
vital signs, patient
demography data,
and notes.
Providing the
means to display
multiple beds
simultaneously.	Fetal heart rate,
TOCO, patient
demography data, and
notes.
Providing the means to
display multiple beds
simultaneously.	Different
Supporting beds	32	128	6	Different
Print	Print (locally or
remotely) CTG
and patient
records.	Print (locally or
remotely) CTG and
patient records.	Print (locally) CTG
and patient records.	Different
Archive	CTG and
maternal vital
signs.
Providing the
ability to archive
files to a
secondary or
tertiary storage
medium (i.e.
optical disk).
Saving data
automatically.	CTG and maternal
vital signs.
Providing the
ability to archive
files to a secondary
or tertiary storage
medium (i.e. optical
disk).
Saving data
automatically.	CTG.
Providing the ability to
archive files to a
secondary or tertiary
storage medium (i.e.
optical disk).
Saving data
automatically.	Different
Alarm	Visual alerts of
fetal/maternal
monitor such as
out-of-limit heart
rate or poor
signal quality.	Visual alerts of
fetal/maternal
monitor such as
out-of-limit heart
rate or poor signal
quality.	Visual alerts of fetal
monitor such as poor
signal quality.	Different
Electronic patient
record	Interfaces with
HL7 patient
record systems
for data	Interfaces with HL7 patient record
systems for data
acquisition	Interfaces with the
Gerätedatenträger
-Transfer (GDT)
patient record systems	Different
	acquisition,
viewing and
storage of
electronic patient
record.	viewing and storage
of electronic patient
record.	for data acquisition,
viewing and storage of
electronic patient
record.
Notes	Providing the
user the ability to
enter comments
and specific data.	Providing the user
the ability to enter
comments and
specific data.	Providing the user the
ability to enter
comments and specific
data.	Same
CTG	The MFM-CNS
can analyze
signal loss,
contractions,
basal heart rate,
accelerations,
decelerations,
short term
variation, long
term variation
and other
parameters.	The MFM-CNS can
analyze signal loss,
contractions, basal
heart rate,
accelerations,
decelerations, short
term variation, long
term variation and
other parameters.	The MFM-CNS Lite
can analyze signal
loss, contractions,
basal heart rate,
accelerations,
decelerations, short
term variation, long
term variation and
other parameters.	Same
NICHD	The MFM-CNS
can analyze FHR
baseline and its
scope, FHR
baseline variation
and its scope,
acceleration
number, early
deceleration, late
deceleration,
variable
deceleration,
prolonged
deceleration, sine
curve and other
parameters.	The MFM-CNS can
analyze FHR
baseline and its
scope, FHR
baseline variation
and its scope,
acceleration
number, early
deceleration, late
deceleration,
variable
deceleration,
prolonged
deceleration, sine
curve and other
parameters.	The MFM-CNS Lite
can analyze FHR
baseline and its scope,
FHR baseline variation
and its scope,
acceleration number,
early deceleration, late
deceleration, variable
deceleration,
prolonged
deceleration, sine
curve and other
parameters.	Same
Remote Access	Review
fetal/maternal
monitor data	Review
fetal/maternal	Local Access	Different
		TCP/IP.	TCP/IP.
Storage capacity		100 thousand
records	Capacity depends
on the size of the
hard disk	Capacity depends on
the size of the hard
disk	Different
Windows OS
Support		XP、Win7、
Win8.1	XP、Win7、Win8.1、
Win10	XP、Win7、Win8.1、
Win10	Different
	Standards compliance
		IEC 62304	IEC 62304	IEC 62304
Detail		IEC 62366	IEC 62366	IEC 62366	Same

9

10

As seen in the comparison tables, the subject and predicate devices have similar design features and performance specifications. The technological differences between the subject and predicate devices do not raise different questions of safety or effectiveness.

7. Performance Data:

Non-clinical data:

Since the subject is a software only product, the following quality assurance measures were applied to the development of the MFM-CNS v3.91 and MFM-CNS Lite v1.1 to evaluate safety and effectiveness: 1. Risk analysis according to ISO 14971: 2007

Software life cycle management according to IEC 62304: 2006. The subject device passed all testing.
Bench testing was conducted per IEC 60601-1-8: 2006 (Medical electrical equipment General requirements for basic safety and essential performance - Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems), and all the results show pass.

Software Verification and Validation Testing

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "major" level of concern, since a failure or latent flaw in the software could result in serious injury or death to the patient or operator.

Summarv

The non-clinical performance testing showed that the subject devices are as safe and as effective as the predicate device.

8. Conclusion

The non-clinical data and software verification and validation demonstrate that MFM-CNS v3.91 and MFM-CNS Lite v1.1 are substantially equivalent to the predicate device