F6/F9 Fetal & Maternal Monitor is intended for non-invasive monitoring of fetus during antepartum examination, labor and delivery. It is intended to be used only by trained and qualified personnel in antepartum examination rooms, labor and delivery rooms.

F6/F9 Fetal & Maternal Monitor provides Non-Stress testing for pregnant women from the 28th week of gestation. It can externally monitor the FHRs using ultrasound and uterine activity via a TOCO transducer. Alternatively, it can internally monitor one of the FHRs with DECG and uterine activity with an IUPC.

F6 Express/F9 Express Fetal & Maternal Monitor is intended for monitoring physiological parameters of pregnant women during antepartum examination, labor and delivery. It is intended to be used only by trained and qualified personnel in antepartum examination rooms, labor and delivery rooms.

F6 Express/F9 Express Fetal & Maternal Monitor is intended for providing Non-Stress testing or fetal monitoring for pregnant women from the 28th week of gestation. In addition, it provides a solution for maternal vital signs monitoring.

F3/F2 Fetal Monitor is intended for non-invasive monitoring of fetus during antepartum examination, labor and delivery. It is intended to be used only by trained and qualified personnel in antepartum examination rooms, labor and delivery rooms.

The monitor provides non-stress testing for pregnant women from the 28th week of gestation. It can externally monitor the FHRs using ultrasound and uterine activity via a TOCO transducer. Alternatively, it can internally monitor one of the FHRs with DECG and uterine activity with an IUPC.

Device Description

The subject devices are bedside fetal and maternal monitors, which are used to monitor the physiological parameters of pregnant women including the fetus from 28 weeks gestation. The devices may be used antepartum as well as during labor and delivery. The submission seeks clearance for several devices and their accessories, which were modified since their last 510(k) clearance.

The subject devices of the present submission include the F2/F3 and F6/F9 fetal monitors as well as the F6/F9 Express, which provide both fetal and maternal monitoring capabilities.

The fetal and maternal physiological parameters that are supported by the EDAN bedside monitors are as follows:

Fetal heart rate (FHR)
Tocodynamometry (TOCO) for external monitoring of uterine contractions .
Fetal Movement (FM) ●
Automated Fetal Movement (AFM) ●
Direct ECG (DECG) for internal monitoring of fetal heart rate
. Intrauterine pressure catheter (IUP) for internal monitoring of uterine contractions
. Maternal ECG (MECG)
. Noninvasive blood pressure (NIBP) was added to F6/F9 Express in this submission
Maternal Sp02 (MSp02) for monitoring pulse rate (PR) .
. Temperature (TEMP) for monitoring maternal temperature

AI/ML Overview

This document describes the regulatory submission for Fetal & Maternal Monitors (Models F6, F6 Express, F9, F9 Express) and Fetal Monitors (Models F2, F3) by Edan Instruments, Inc. It is a 510(k) premarket notification, aiming to demonstrate substantial equivalence to previously marketed predicate devices.

The document does not contain information about a study that proves the device meets specific acceptance criteria in the context of an AI/algorithm-driven medical device. Instead, it focuses on demonstrating substantial equivalence to existing predicate devices based on technical specifications and regulatory safety/performance testing. The performance data provided are related to general device functionality, electrical safety, electromagnetic compatibility, and sensor evaluations, rather than demonstrating performance against an AI algorithm's specific performance targets (like sensitivity, specificity, or accuracy) on a clinical test set.

Therefore, many of the requested elements pertaining to an AI/algorithm study (such as ground truth establishment, sample sizes for training/test sets in an AI context, expert qualifications, or MRMC studies) are not present in this document.

However, I can extract information related to the device's technical specifications and the types of performance data submitted for its clearance, which could be interpreted as acceptance criteria for a traditional medical device, rather than an AI.

Here's a breakdown of the available information:

1. A table of acceptance criteria and the reported device performance:

The document doesn't provide a formal "acceptance criteria table" with specific numerical targets and results in the way an AI performance study would. However, it lists technical specifications for the new devices and compares them to predicate devices, indicating that "Same" values or minor acceptable "Different" values (with justification) serve as the "acceptance criteria" for substantial equivalence for these non-AI features.

Here's an attempt to structure relevant technical specifications from the comparison tables (pages 7 and 12-15), which imply the "acceptance criteria" through their "Comparison" column:

Metric (Implied Acceptance Criteria)	Device Performance (F6/F6 Express/F9/F9 Express)	Predicate Performance (K150901 F9 Express)	Comparison
Manufacturer	Edan Instruments, Inc.	Edan Instruments, Inc.	Same
K#	K174042	K150901	Different
Intended use	Same as predicate	Described in doc	Same
Anti-electric-shock degree	FHR1, FHR2, TOCO, FM, IUP: BF; SpO2, NIBP: BF (Defibrillator-proof); DECG:CF; ECG, TEMP: CF (Defibrillator-proof); FTS-3: FHR1, FHR2, TOCO: BF (Defibrillator-proof).	Same as subject device	Same
Safety (flammable gas)	Equipment not suitable for use in presence of flammable gases	Same as subject device	Same
Protection against Water Ingress	Main Unit: IPX1; US/TOCO Transducers: IPX8; FTS-3: Base station: IPX1, Transducers: IPX8	Same as subject device	Same
Working mode	Continuous running equipment	Same as subject device	Same
FHR Technique	Pulse Doppler with autocorrelation processing	Same as subject device	Same
FHR Pulse Repetition Frequency	2 KHz	Same as subject device	Same
FHR Effective Radiating Area	F9/F9 Express/FTS-3: 942 mm² ± 15% (12 ultrasound crystals); F6/F6 Express: 628 mm² ± 15% (8 ultrasound crystals); F6/F6 Express /FTS-3: 549.5 mm²± 15% (7 ultrasound crystals)	F9/F9 Express /FTS-3: 942 mm² ± 15% (12 ultrasound crystals); F6/F6 Express: 628 mm² ± 15% (8 ultrasound crystals)	Different
TOCO Range	0-100	Same as subject device	Same
TOCO Resolution	1	Same as subject device	Same
DECG Technique	Peak-peak detection technique	Same as subject device	Same
DECG Heart Rate Counting Range	30 bpm ~ 240 bpm	Same as subject device	Same
IUP Pressure Range	0 ~ 100mmHg (0.0~13.3 kPa)	Same as subject device	Same
IUP Sensitivity	5uV/V/mmHg	Same as subject device	Same
IUP Resolution	1mmHg (0.1 kPa)	Same as subject device	Same
IUP Zero Mode	Automatic/Manual	Same as subject device	Same
MECG Heart Rate Range	30-240BPM	Same as subject device	Same
MECG Defibrillator Protection	YES	Same as subject device	Same
MECG HR averaging method	Heart rate is computed by averaging the 12 most recent RR intervals.	Same as subject device	Same
SpO2 Measuring Range	50% ~ 100%	Same as subject device	Same
SpO2 Resolution	1%	Same as subject device	Same
SpO2 Pulse Rate Measurement Range	30-240BPM	Same as subject device	Same
SpO2 Pulse Rate Measuring Accuracy	±3BPM	Same as subject device	Same
SpO2 Emitted light energy	< 15 mW	Same as subject device	Same
NIBP Blood Pressure Range	Systolic Pressure: 40 mmHg ~ 270 mmHg (5.3 kPa~~36.0 kPa); Diastolic Pressure: 10 mmHg ~ 215 mmHg (1.3 kPa~~28.7 kPa)	Systolic pressure:40mmHg ~ 270mmHg; Diastolic pressure:10mmHg ~ 215mmHg	Different
NIBP Measuring Accuracy	Max. average deviation ≤ ±5mmHg (≤ ±0.8 kPa); Max. standard deviation ≤ 8mmHg (≤ 1.2 kPa)	Max. average deviation ≤ ±5mmHg; Max. standard deviation ≤ 8mmHg	Different
NIBP Cuff Pressure measuring range	0 mmHg ~ 300 mmHg (0.0 kPa~40.0 kPa)	0 mmHg ~ 300 mmHg	Different
TEMP Measurement Range	0 °C ~ +50 °C	Same as subject device	Same
TEMP Accuracy	±0.3 °C (Transducer error excluded: ±0.1 °C, Transducer: ≤ ±0.2 °C)	0°C ~ +25°C: ± 0.2°C; +25°C ~ +45°C: ± 0.1°C; +45°C ~ +50°C: ± 0.2°C	Different
Printer Paper width	152mm (GE), 150mm (PHILIPS)	Same as subject device	Same
Printer Standard Speed	1 cm/min, 2 cm/min, 3 cm/min	Same as subject device	Same
Screen Type	LCD	Same as subject device	Same
Screen Diagonal	F9 Express / F9: 12.1"; F6 Express / F6: 10.1"	Same as subject device	Same
Power Supply	AC or battery	Same as subject device	Same
Operating Voltage	a.c.100 V-240 V	Same as subject device	Same
Line Frequency	50/60 Hz	Same as subject device	Same
Pmax	1.0A-0.5A	Same as subject device	Same
Battery	Rechargeable Lithium-ion Battery	Same as subject device	Same
Dimensions	347mm × 330mm × 126mm	Same as subject device	Same
Weight	F6: Approx. 5.3 kg; F6 Express: Approx. 6.1 kg; F9: Approx. 5.5 kg; F9 Express: Approx. 6.3 kg	Same as subject device	Same
Operating Temperature	+5 °C ~ + 40 °C (+41 °F ~ +104 °F)	Same as subject device	Same
Transport/Storage Temperature	-20 °C ~ +55 °C (-4°F ~ +131 °F)	Same as subject device	Same
Operating Humidity	15% ~ 93% (non-condensing)	Same as subject device	Same
Transport/Storage Humidity	15% ~ 93% (non-condensing)	Same as subject device	Same
Operating atmospheric pressure	86 kPa ~ 106 kPa	860 hPa ~1060 hPa	Different
Transport/Storage atmospheric pressure	70 kPa ~ 106 kPa	700 hPa ~1060 hPa	Different
FTS-3 compatible transducers	Wireless US Transducer, Wireless TOCO Transducer	Same as subject device	Same

Note: Differences are highlighted. The document states that "The differences in technological characteristics do not raise different questions for safety or effectiveness."

For Fetal Monitors F2 & F3 vs. Predicate F3:

Metric (Implied Acceptance Criteria)	Device Performance (F2&F3)	Predicate Performance (K102140 F3)	Comparison
Manufacturer	Edan Instruments, Inc.	Edan Instruments, Inc.	Same
K#	K174042	K102140	Different
Intended use	Same as predicate	Described in doc	Same
Anti-electric-shock degree	FHR1, FHR2, TOCO, FM, IUP: BF; DECG:CF;	FHR1, FHR2, TOCO, FM: B; IUP: BF; DECG: CF;	Different
Safety (flammable gas)	Equipment not suitable for use in presence of flammable gases	Same as subject device	Same
Protection against Water Ingress	US/TOCO Transducers: IPX8	Same as subject device	Same
Working mode	Continuous running equipment	Same as subject device	Same
FHR Technique	Pulse Doppler with autocorrelation processing	Same as subject device	Same
FHR Pulse Repetition Frequency	2 KHz	Same as subject device	Same
FHR Effective Radiating Area	628 mm² ± 15% (8 ultrasound crystals), 549.5 mm²± 15% (7 ultrasound crystals)	628 mm² ± 15% (8 ultrasound crystals)	Different
TOCO Range	0-100	Same as subject device	Same
TOCO Resolution	1	Same as subject device	Same
DECG Technique	Peak-peak detection technique	Same as subject device	Same
DECG Heart Rate Counting Range	30 bpm ~ 240 bpm	Same as subject device	Same
IUP Pressure Range	0 ~ 100mmHg (0.0 kPa~13.3 kPa)	0 ~ 100mmHg	Different
IUP Sensitivity	5uV/V/mmHg	Same as subject device	Same
IUP Resolution	1mmHg (0.1 kPa)	Same as subject device	Same
Screen Type	LCD	Same as subject device	Same
Screen Diagonal	5.6"	Same as subject device	Same
Power Supply	AC or battery	Same as subject device	Same
Operating Voltage	a.c.100 V-240 V	Same as subject device	Same
Line Frequency	50/60 Hz	Same as subject device	Same
Pmax	70VA	Same as subject device	Same
Battery	Rechargeable Lithium-ion Battery	Same as subject device	Same
Dimensions	350mm x 300mm x 104mm	Same as subject device	Same
Weight	Approx. 3.5kg	Same as subject device	Same
Operating Temperature	+5 ℃~ + 40 ℃ (+41 ºF ~ +104 °F)	5 °C ~ 40 °C	Different
Transport/ Storage Temperature	-20 °C ~ +55 °C (-4°F ~ +131 °F)	-20 °C ~ 55 °C	Different
Operating Humidity	15% ~ 93% (non-condensing)	25%~80% (non-condensing)	Different
Transport/ Storage Humidity	15% ~ 93% (non-condensing)	25%~93% (non-condensing)	Different
Operating atmospheric pressure	86 kPa ~ 106 kPa	860 hPa ~ 1060 hPa	Different
Transport/Storage atmospheric pressure	70 kPa ~ 106 kPa	700 hPa ~ 1060 hPa	Different

Note: Differences are highlighted. The document states that "The differences in technological characteristics do not raise different questions for safety or effectiveness."

2. Sample sized used for the test set and the data provenance:

Test Set Sample Size: Not specified for any AI/algorithm performance testing as none was conducted in this context. The performance data listed (software validation, electrical safety, EMC, NIBP sensor evaluation, ultrasound transducer evaluation) are typical for medical device regulatory clearance, which usually involves a defined set of tests on the device itself, rather than a clinical dataset for AI performance.
Data Provenance: Not applicable for an AI test set. The nature of these tests is laboratory or bench testing on the device prototypes. No mention of country of origin of data or retrospective/prospective studies in the context of clinical data for performance evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. No AI/algorithm performance study requiring expert adjudication was conducted or reported.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. No AI/algorithm performance study requiring adjudication was conducted or reported.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No MRMC study was done or reported. This device is a monitoring system and not an AI-assisted diagnostic tool for which such a study would be relevant.

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

Not applicable. This is a monitoring device, not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Not applicable. The performance data provided relate to device function and safety parameters (e.g., electrical safety, NIBP accuracy against reference measurements, etc.). "Ground truth" in this context would be defined by standard test methodologies and calibrated reference equipment.

8. The sample size for the training set:

Not applicable. This document is not describing an AI/machine learning device.

9. How the ground truth for the training set was established:

Not applicable. This document is not describing an AI/machine learning device.

Summary

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 5, 2018

Edan Instruments, Inc % Alice Yang Regulatory Engineer Edan Medical 1200 Crossman Ave, Suite 200 Sunnyvale, California 94089

Re: K173042

Trade/Device Name: Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models F2, F3 Regulation Number: 21 CFR 884.2740 Regulation Name: Perinatal monitoring system and accessories Regulatory Class: Class II Product Code: HGM, HGL, DSI, DRT, DXN, FLL, DQA, DPS Dated: September 20, 2017 Received: September 28, 2017

Dear Alice Yang:

This letter corrects our substantially equivalent letter of August 30, 2018.

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 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for 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

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Indications for Use

510(k) Number (if known) K173042

Device Name Fetal & Maternal Monitor Model: F6, F6 Express, F9, F9 Express

Indications for Use (Describe)

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:

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Indications for Use

510(k) Number (if known) K173042

Device Name Fetal Monitor Model: F2, F3 Fetal Monitor

Indications for Use (Describe)

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)

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.

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."

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Prepared in accordance with the requirements of 21 CFR Part 807.92

Submitter:	Edan Instruments, Inc#15 Jinhui Road,Jinsha Community,Kengzi Sub-District, Pingshan District,Shenzhen, 518122 P.R.China.Tel.: (0755) 28340011Fax: +1 (408) 418-4059
Contact Person:	Alice Yang
Date Prepared:	August 30, 2018
Device Name andClassification:	Device Name: Fetal & Maternal MonitorModel: F6, F6 Express, F9, F9 ExpressCommon Name: Fetal & Maternal MonitorClassification Name:884.2740 Perinatal monitoring system and accessoriesProduct Codes:HGM (system, monitoring, perinatal)DSI (detector and alarm, arrhythmia)DRT (monitor, cardiac (incl. cardiotachometer & rate alarm))DXN (system, measurement, blood-pressure, non-invasive)FLL (thermometer, electronic, clinical)DQA (oximeter)DPS (electrocardiograph)
	Device Name: Fetal MonitorModel: F2, F3Common Name: Fetal MonitorClassification Name884.2740 Perinatal monitoring system and accessoriesProduct codes:HGM (system, monitoring, perinatal)HGL (transducer, ultrasonic, obstetric)Regulatory Class: Class II
Predicate Device(s):	1. Fetal & Maternal Monitor, F9 Express, Edan Instruments, Inc.,K150901 (Primary for F6, F6 Express, F9, F9 Express)2. Fetal Monitor, F3, Edan Instruments, Inc., K102140 (Primary for F2 and F3)3. Patient Monitor, iM20, Edan Instruments, Inc., K152552(Secondary)
	The predicate devices have not been subject to a design relatedrecall.

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Device Description:

The subject devices of the present submission include the F2/F3 and F6/F9 fetal monitors as well as the F6/F9 Express, which provide both fetal and maternal monitoring capabilities.

The fetal and maternal physiological parameters that are supported by the EDAN bedside monitors are as follows:

Fetal heart rate (FHR)
Tocodynamometry (TOCO) for external monitoring of uterine contractions .
Fetal Movement (FM) ●
Automated Fetal Movement (AFM) ●
Direct ECG (DECG) for internal monitoring of fetal heart rate
. Intrauterine pressure catheter (IUP) for internal monitoring of uterine contractions
. Maternal ECG (MECG)
. Noninvasive blood pressure (NIBP) was added to F6/F9 Express in this submission
Maternal Sp02 (MSp02) for monitoring pulse rate (PR) .
. Temperature (TEMP) for monitoring maternal temperature

The following table summarizes the fetal and maternal physiological parameters measured by each fetal monitor.

ModelMeasurement	F3	F2	F6	F9	F6 Express	F9 Express
Single-FHR	√	√	√	√	√	√
Dual-FHR	√	√	√	√	√	√
TOCO	√	√	√	√	√	√
FM	√	√	√	√	√	√
AFM	√	√	√	√	√	√
DECG/IUP	Opt	Opt	Opt	Opt	×	Opt
MECG	×	×	×	×	√	√
NIBP	×	×	×	×	√	√
MSpO2	×	×	×	×	√	√
TEMP	×	×	×	×	√	√
NOTE: √ = Standard; Opt = Optional; × = Not Available

The following features are available for the F6/F9 and F6/F9 Express bedside fetal and maternal monitors:

Basic parameters: FHR, TOCO, Event Mark, AFM
. Dual FHR monitoring
Internal parameters: IUP/DECG ●
FHR limit alarm
Software for data transmission to PC
Quick printing for stored waveform ●
Lithium battery for continuous operation ●
Maternal ECG, Sp02, NIBP, and temperature monitoring ●
Used with FTS-3 Fetal Telemetry System (hereinafter called FTS-3) ●

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The following features are available for the F2/F3 bedside fetal monitors:

Basic parameters: FHR, TOCO, Event Mark, AFM ●
Dual FHR monitoring
Internal parameters: IUP/DECG
FHR limit alarm
Software for data transmission to PC
Quick printing for stored waveform ●
Lithium battery for continuous working ●

Indications for Use:

F6/F9 Fetal & Maternal Monitor (hereinafter called F6/F9):

F6/F9 Fetal & Maternal Monitor is intended for non-invasive and invasive monitoring of fetus during antepartum examination, labor and delivery. It is intended to be used only by trained and qualified personnel in antepartum examination rooms, labor and delivery rooms.

F6 Express/F9 Express Fetal & Maternal Monitor (hereinafter called F6 Express/F9 Express):

F3/F2 Fetal Monitor is intended for non-invasive and invasive monitoring of fetus during antepartum examination, labor and delivery. It is intended to be used only by trained and qualified personnel in antepartum examination rooms, labor and delivery rooms.

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Comparison between the subject F9 series and the previously cleared F9 Express

Item	F6 / F6 Express/ F9 / F9 Express	F9 Express	Comparison
Manufacturer	Edan Instruments, Inc.	Edan Instruments, Inc.
K#	K174042	K150901
Intended use	F6/F9 Fetal & MaternalMonitor is intended fornon-invasive and invasivemonitoring of fetus duringantepartum examination,labor and delivery. It isintended to be used only bytrained and qualifiedpersonnel in antepartumexamination rooms, laborand delivery rooms.F6/F9 Fetal & MaternalMonitor provides Non-Stress testing for pregnantwomen from the 28th weekof gestation. It canexternally monitor theFHRs using ultrasound anduterine activity via aTOCO transducer.Alternatively, it caninternally monitor one ofthe FHRs with DECG anduterine activity with anIUPC.F6 Express/F9 ExpressFetal & Maternal Monitoris intended for monitoringphysiological parametersof pregnant women during	F6/F9 Fetal & MaternalMonitor is intended fornon-invasive and invasivemonitoring of fetus duringantepartum examination,labor and delivery. It isintended to be used only bytrained and qualifiedpersonnel in antepartumexamination rooms, laborand delivery rooms.F6/F9 Fetal & MaternalMonitor providesNon-Stress testing forpregnant women from the28th week of gestation. Itcan externally monitor theFHRs using ultrasound anduterine activity via aTOCO transducer.Alternatively, it caninternally monitor one ofthe FHRs with DECG anduterine activity with anIUPC.F6 Express/F9 ExpressFetal & Maternal Monitor(hereinafter called F6Express/F9 Express):F6 Express/F9 ExpressFetal & Maternal Monitoris intended for monitoringphysiological parametersof pregnant women during	Same
	antepartumexamination,labor and delivery. It isintended to be used only bytrained and qualifiedpersonnel in antepartumexamination rooms, laborand delivery rooms.F6 Express/F9 ExpressFetal & Maternal Monitoris intended for providingNon-Stress testing or fetalmonitoring for pregnantwomen from the 28th weekof gestation. In addition, itprovides a solution formaternal vital signsmonitoring.	antepartum examination,labor and delivery. It isintended to be used only bytrained and qualifiedpersonnel in antepartumexamination rooms, laborand delivery rooms.F6 Express/F9 ExpressFetal & Maternal Monitoris intended for providingNon-Stress testing or fetalmonitoring for pregnantwomen from the 28th weekof gestation. In addition, itprovides a solution formaternal vital signsmonitoring.
Electrical Safety
Anti-electric-shockdegree:	FHR1, FHR2, TOCO, FM,IUP: BF;SpO2, NIBP: BF(Defibrillator-proof);DECG:CF;ECG, TEMP: CF(Defibrillator-proof);FTS-3: FHR1, FHR2,TOCO: BF(Defibrillator-proof).	FHR1, FHR2, TOCO, FM,IUP: BF;SpO2, NIBP: BF(Defibrillator-proof);DECG: CF;ECG, TEMP: CF(Defibrillator-proof).FTS-3: FHR1,FHR2,TOCO: BF(Defibrillator-proof).	Same
Degree of safety ofapplication in thepresence offlammable gas:	Equipment not suitable foruse in presence offlammable gases	Equipment not suitable foruse in presence offlammable gases	Same
Degree of Protectionagainst HarmfulIngress of Water	Main Unit:IPX1, protected againstvertically falling waterdrops (provided recorderdrawer is shut and themonitor is not mounted onthe wall vertically)	Main Unit:IPX1, protected againstvertically falling waterdrops (provided recorderdrawer is shut and themonitor is not mounted onthe wall vertically)	Same
	US/TOCO Transducers:IPX8, protected against theeffects of continuousemersion in waterFTS-3:Base station: IPX1(protected againstvertically falling waterdrops)Transducers: IPX8(Protected against theeffects of continuousimmersion in water 1.1mdeep for 24 hours)	US/TOCO Transducers:IPX8, protected against theeffects of continuousemersion in waterFTS-3:Base station: IPX1(protected againstvertically falling waterdrops)Transducers: IPX8(Protected against theeffects of continuousimmersion in water 1.1mdeep for 24 hours)
Working mode:	Continuous runningequipment	Continuous runningequipment	Same
FHR (F6 / F6 Express/ F9 / F9 Express)
Technique:	Pulse Doppler withautocorrelation processing	Pulse Doppler withautocorrelation processing	Same
Pulse RepetitionFrequency:	2 KHz	2 KHz	Same
Effective RadiatingArea:	942 mm² ± 15%( F9/F9Express/ FTS-3, 12ultrasound crystals)628 mm² ± 15%( F6/F6Express, 8 ultrasoundcrystals)549.5 mm²± 15%( F6/F6Express /FTS-3, 7ultrasound crystals)	942 mm² ± 15%( F9/F9Express /FTS-3, 12ultrasound crystals)628 mm² ± 15%( F6/F6Express, 8 ultrasoundcrystals)	Different
TOCO (F6 / F6 Express/ F9 / F9 Express)
TOCO Range:	0-100	0-100	Same
Resolution:	1	1	Same
DECG (F6 / F9 / F9 Express)
Technique:	Peak-peak detectiontechnique	Peak-peak detectiontechnique	Same
Heart Rate CountingRange:	30 bpm ~ 240 bpm	30 bpm ~ 240 bpm	Same
IUP (F6 / F9 / F9 Express)

Pressure Range:	$0 ~ 100mmHg(0.0~13.3 kPa)$	$0 ~ 100mmHg(0.0~13.3 kPa)$	Same
Sensitivity:	$5uV/V/mmHg$	$5uV/V/mmHg$	Same
Resolution:	$1mmHg (0.1 kPa)$	$1mmHg (0.1 kPa)$	Same
Zero Mode:	Automatic (TOCO value becomes zero or below lasting for 30 seconds) / Manual	Automatic (TOCO value becomes zero or below lasting for 30 seconds)/ Manual	Same
MECG (F6 Express / F9 Express)
Heart Rate Range	30-240BPM	30-240BPM	Same
Defibrillator Protection	YES	YES	Same
HR averaging method	Heart rate is computed by averaging the 12 most recent RR intervals.	Heart rate is computed by averaging the 12 most recent RR intervals.	Same
SpO2 (F6 Express/ F9 Express)
Measuring Range:	50% ~ 100%	50% ~ 100%	Same
Resolution:	1%	1%	Same
Pulse Rate Measurement Range:	30-240BPM	30-240BPM	Same
Pulse Rate Measuring Accuracy:	$\pm 3BPM$	$\pm 3BPM$	Same
Emitted light energy	< 15 mW	< 15 mW	Same
NIBP (F6 Express/ F9 Express)
Blood Pressure Range	Systolic Pressure: 40 mmHg ~ 270 mmHg (5.3 kPa~~36.0 kPa)Diastolic Pressure: 10 mmHg ~ 215 mmHg (1.3 kPa~~28.7 kPa)	Systolic pressure:40mmHg ~ 270mmHg Diastolic pressure:10mmHg ~ 215mmHg	Different
Measuring Accuracy:	Max. average deviation $\le \pm 5mmHg$ ( $\le \pm 0.8 kPa$ )Max. standard deviation $\le 8mmHg$ ( $\le 1.2 kPa$ )	Max. average deviation $\le \pm 5mmHg$Max. standard deviation $\le 8mmHg$	Different
Cuff Pressure measuring range	0 mmHg ~ 300 mmHg (0.0 kPa~40.0 kPa)	0 mmHg ~ 300 mmHg	Different
Channel:	1	1	Same
MeasurementRange:	0 °C ~ +50 °C	0 °C ~ +50 °C	Same
Accuracy:	±0.3 °C(Transducer error excluded:±0.1 °C) (Transducer: ≤±0.2 °C)	0°C ~ +25°C (+32°F ~+77°F): ± 0.2°C(±0.36°F)+25°C ~ +45°C (+77°F ~+113°F): ± 0.1°C(±0.18°F)+45°C ~ +50°C (+113°F ~+122°F): ± 0.2°C(±0.36°F)	Different
Printer (F6 / F6 Express/ F9 / F9 Express)
Paper width:	152mm (GE), 150mm(PHILIPS)	152mm (GE), 150mm(PHILIPS)	Same
Standard Speed(Real-Time Traces ):	1 cm/min, 2 cm/min, 3cm/min	1 cm/min, 2 cm/min, 3cm/min	Same
Physical Specification (F6 / F6 Express/ F9 / F9 Express)
Screen	LCD	LCD	Same
Screen Diagonal:	F9 Express / F9:12.1"F6 Express / F6:10.1"	F9 Express / F9:12.1"F6 Express / F6:10.1"	Same
Power Supply:	AC or battery	AC or battery	Same
Operating Voltage:	a.c.100 V-240 V	a.c.100 V-240 V	Same
Line Frequency:	50/60 Hz	50/60 Hz	Same
Pmax:	1.0A-0.5A	1.0A-0.5A	Same
Battery:	Rechargeable Lithium-ionBattery	Rechargeable Lithium-ionBattery	Same
Dimensions:	347mm × 330mm ×126mm	347mm × 330mm ×126mm	Same
Weight:	F6: Approx. 5.3 kgF6 Express: Approx. 6.1 kgF9: Approx. 5.5 kgF9 Express: Approx. 6.3 kg	F6: Approx. 5.3 kgF6 Express: Approx. 6.1 kgF9: Approx. 5.5 kgF9 Express: Approx. 6.3 kg	Same
OperatingTemperature:	+5 °C ~ + 40 °C (+41 °F ~+104 °F)	+5 °C ~ + 40 °C (+41 °F ~+104 °F)	Same
Transport/ StorageTemperature:	-20 °C ~ +55 °C (-4°F ~+131 °F)	-20 °C ~ +55 °C (-4 °F ~+131 °F)	Same
Operating Humidity:	15% ~ 93%(non-condensing)	15% ~ 93%(non-condensing)	Same
Transport/ StorageHumidity:	15% ~ 93%(non-condensing)	15% ~ 93%(non-condensing)	Same
Operatingatmosphericpressure:	86 kPa ~ 106 kPa	860 hPa ~1060 hPa	Different
Transport/Storageatmosphericpressure:	70 kPa ~ 106 kPa	700 hPa ~1060 hPa	Different
FTS-3 compatibletransducers	Wireless US TransducerWireless TOCO Transducer	Wireless US TransducerWireless TOCO Transducer	Same

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Comparison between the subject F9 series and iM20

Item	F6 Express/ F9 Express	iM20	Comparison
Manufacturer	Edan Instruments, Inc.	Edan Instruments, Inc.
K#	K174042	K152552
Pulse Rate (PR)by NIBPmodule	Measurement Range: 40bpm~ 240bpmMeasuring Accuracy: ±3bpm or 3.5%, take themaximum value	Measurement Range: 40bpm~ 240bpmMeasuring Accuracy: ±3bpm or 3.5%, take themaximum value	Same

Comparison between the subject F2&F3 and the previously cleared F3

Item	F2&F3	F3	Comparison
Manufacturer	Edan Instruments, Inc.	Edan Instruments, Inc.
K#	K174042	K102140
Intended use	F3/F2 Fetal Monitor isintended for non-invasiveand invasive monitoring offetus during antepartumexamination, labor anddelivery. It is intended to beused only by trained and	The F3 & F2 FetalMonitors are intended fornon-invasive and invasivemonitoring of fetus duringantepartum examination,labor and delivery. Theyare intended to be used	Same
	qualified personnel inantepartum examinationrooms, labor and deliveryrooms.The monitor providesnon-stress testing forpregnant women from the28th week of gestation. Itcan externally monitor theFHRs using ultrasound anduterine activity via a TOCOtransducer. Alternatively, itcan internally monitor oneof the FHRs with DECG anduterine activity with anIUPC.	only by trained andqualified personnel inantepartum examinationrooms, labor and deliveryrooms.They provide non-stresstesting for pregnantwomen from the 28thweek of gestation. Theycan externally monitor theFHRs using ultrasoundand uterine activity via aTOCO transducer.Alternatively, they caninternally monitor one ofthe FHRs with DECG anduterine activity with anIUPC.
Electrical Safety
Anti-electric-shockdegree:	FHR1, FHR2, TOCO, FM,IUP: BF;DECG:CF;	FHR1, FHR2, TOCO,FM: B;IUP: BF;DECG: CF;	Different
Degree of safety ofapplication in thepresence offlammable gas:	Equipment not suitable foruse in presence offlammable gases	Equipment not suitablefor use in presence offlammable gases	Same
Degree of Protectionagainst HarmfulIngress of Water	US/TOCO Transducers:IPX8, protected against theeffects of continuousemersion in water	US/TOCO Transducers:IPX8, protected againstthe effects of continuousemersion in water	Same
Working mode:	Continuous runningequipment	Continuous runningequipment	Same
FHR

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Technique:	Pulse Doppler withautocorrelation processing	Pulse Doppler withautocorrelation processing	Same
Pulse RepetitionFrequency:	2 KHz	2 KHz	Same
Effective RadiatingArea:	628 mm² ± 15%( 8ultrasound crystals)549.5 mm2± 15%( 7ultrasound crystals)	628 mm² ± 15%( 8ultrasound crystals)	Different
TOCO
TOCO Range:	0-100	0-100	Same
Resolution:	l	l	Same
DECG
Technique:	Peak-peak detectiontechnique	Peak-peak detectiontechnique	Same
Heart Rate CountingRange:	30 bpm ~ 240 bpm	30 bpm ~ 240 bpm	Same
IUP
Pressure Range:	0 ~ 100mmHg(0.0 kPa~13.3kPa)	0 ~ 100mmHg	Different
Sensitivity:	5uV/V/mmHg	5uV/V/mmHg	Same
Resolution:	1mmHg (0.1 kPa)	1mmHg (0.1 kPa)	Same
Physical Specification
Screen	LCD	LCD	Same
Screen Diagonal:	5.6"	5.6"	Same
Power Supply:	AC or battery	AC or battery	Same
Operating Voltage:	a.c.100 V-240 V	a.c.100 V-240 V	Same
Line Frequency:	50/60 Hz	50/60 Hz	Same
Pmax:	70VA	70VA	Same
Battery:	Rechargeable Lithium-ionBattery	Rechargeable Lithium-ionBattery	Same
Dimensions:	350mm x 300mm x 104mm	350mm x 300mm x104mm	Same
Weight:	Approx. 3.5kg	Approx. 3.5kg	Same
OperatingTemperature:	+5 ℃~ + 40 ℃ (+41 ºF ~+104 °F)	5 °C ~ 40 °C
Transport/ StorageTemperature:	-20 °C ~ +55 °C (-4°F ~+131 °F)	-20 °C ~ 55 °C	Different
Operating Humidity:	15% ~ 93%	25%~80%
	(non-condensing)	(non-condensing)	Different
Transport/ Storage	15% ~ 93%	25%~93%

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Humidity:	(non-condensing)	(non-condensing)
Operatingatmosphericpressure:	86 kPa ~ 106 kPa	860 hPa ~ 1060 hPa	Different
Transport/Storageatmosphericpressure:	70 kPa ~ 106 kPa	700 hPa ~ 1060 hPa

The subject devices and their respective primary predicate device have the same intended use. The subject devices and their respective primary predicate devices have different technological characteristics as evidenced by the preceding table. The differences in technological characteristics do not raise different questions for safety or effectiveness.

Performance Data:

The following performance data were provided in support of the substantial equivalence determination:

Software validation per the FDA's Guidance for Industry and FDA Staff, "Guidance for . the Content of Premarket Submissions for Software Contained in Medical Devices."
. Electrical safety testing per IEC 60601-1
. Electromagnetic compatibility testing per IEC 60601-2
Evaluation of NIBP sensor ●
Evaluation of ultrasound transducer ●

The remaining performance tests were leveraged from the predicate device.

The results of all completed performance testing were acceptable.

Conclusion:

The subject devices are substantially equivalent to their respective primary predicate devices.

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).