(89 days)
No
The document describes a standard fetal and maternal monitor with basic physiological parameter monitoring and data transmission capabilities. There is no mention of AI, ML, or any advanced analytical features that would suggest the use of such technologies.
No
This device is intended for "non-invasive monitoring" and "providing Non-Stress testing or fetal monitoring," which are diagnostic or monitoring functions, not therapeutic interventions.
Yes
Explanation: The device is intended for "monitoring of fetus during antepartum examination, labor and delivery" and "provides Non-Stress testing," which are diagnostic procedures to assess fetal well-being and maternal physiological parameters. It collects and displays physiological data (FHR, TOCO, maternal vital signs) that aid in diagnosis and clinical decision-making.
No
The device description explicitly lists hardware components such as transducers (ultrasound, TOCO, DECG, IUPC), a lithium battery, and capabilities for maternal vital sign monitoring (ECG, SpO2, NIBP, temperature), indicating it is a hardware device with integrated software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The F6/F9 Fetal & Maternal Monitor directly monitors physiological parameters of the fetus and mother in vivo (within the living body). It uses ultrasound and transducers applied externally or internally to measure things like fetal heart rate, uterine activity, and maternal vital signs.
- Lack of Specimen Analysis: The device does not analyze any biological specimens taken from the patient.
Therefore, based on the provided information, the F6/F9 Fetal & Maternal Monitor is a medical device used for in vivo monitoring, not an in vitro diagnostic device.
N/A
Intended Use / 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/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 (hereinafter called F6 Express/F9 Express):
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.
Product codes (comma separated list FDA assigned to the subject device)
HGM
Device Description
F series Fetal & Maternal Monitor, including F6, F6 Express, F9, F9 Express which provides the following primary features that can be available for the multiple configurations:
• Basic parameters: FHR, TOCO, Event Mark, AFM
• Dual FHR monitoring
• Internal parameters: IUP/DECG
• FHR limit alarm
• Software for data transmission to PC, which means the subject device can be connected to Central Nursing System provided by EDAN, which has been cleared by K100358.
• Quick printing for stored waveform
• Lithium battery for continuous working
• Maternal ECG monitoring
• Maternal SpO2 monitoring
• Maternal NIBP
• Maternal temperature monitoring
• Used with FTS-3 Fetal Telemetry System (hereinafter called FTS-3)
The above is the maximum configuration for F series Fetal & Maternal Monitor, the user may select different measurement parameters in according with their requirements, which is also show in the following table.
| Model | F6 | F9 | F6
Express | F9
Express |
|-------------------------------------------------------|-----|-----|---------------|---------------|
| Measurement | | | | |
| Single-FHR | √ | √ | √ | √ |
| Dual-FHR | √ | √ | √ | √ |
| TOCO | √ | √ | √ | √ |
| FM | √ | √ | √ | √ |
| AFM | √ | √ | √ | √ |
| DECG/IUP | Opt | Opt | × | Opt |
| MECG | × | × | √ | √ |
| NIBP | × | × | √ | √ |
| MSpO2 | × | × | √ | √ |
| TEMP | × | × | √ | √ |
| NOTE: √ = Standard; Opt = Optional; × = Not Available | | | | |
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Not Found
Indicated Patient Age Range
pregnant women from the 28th week of gestation
Intended User / Care Setting
trained and qualified personnel in antepartum examination rooms, labor and delivery rooms.
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:
Biocompatibility testing: The biocompatibility evaluation for the F series Fetal & Maternal Monitor were conducted in accordance with the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The worst case of the whole system is considered tissue contacting for a duration of less than 24 hours. And the battery of testing included the following tests: Cytotoxicity, Skin Sensitization, Irritation or Intracutaneous Reactivity.
Electrical safety and electromagnetic compatibility (EMC): Electrical safety and EMC testing were conducted on the F series Fetal & Maternal Monitor device, consisting of all the modules and accessories in the system. The system complies with the IEC 60601-1:2005/A1: 2012 standards for safety and the IEC 60601-1-2: 2007 for EMC.
Bench Testing: Bench testings were conducted on the F series Fetal & Maternal Monitor device, consisting of all the modules and accessories in the system complies with the IEC 60601-1-8: 2006, IEC 60601-2-27: 2011, IEC 60601-2-37: 2007, IEC 60601-2-49: 2011, IEC 80601-2-30: 2009, ISO 80601-2-56: 2009, ISO 80601-2-61: 2011, ISO 81060-2: 2013 and IEC 62366: 2007 standards.
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 "moderate" level of concern, since a failure or latent flaw in the software will not directly result in serious injury or death to the patient or operator, and the software device is an accessory to a medical device that has a Moderate Level of Concern.
Acoustic testing: All measurements were conducted in accordance with the measurement procedures of the NEMA Standard Publications UD-2 and IEC 62359 and following the calibration procedures given in Section 4 of UD-2, and the reporting requirements of the September 9, 2008 FDA Guide for Track 1.
Clinical data: Not applicable.
Summary: Based on the non-clinical and clinical performance as documented in the system development, the subject devices were found to have a safety and effectiveness profile that is similar to the predicate device. The non-clinical data support the safety of the device and the hardware and software verification and validation demonstrate that the F series Fetal & Maternal Monitor device should perform as intended in the specified use conditions, and all the data demonstrate that the subject devices perform comparably to the predicate device that is currently marketed for the same intended use.
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.
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
§ 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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border 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
July 1, 2015
Edan Instruments, Inc. % Doug Worth Sr. Dir. Us RA/QA Edan Medical 1200 Crossman Ave, Suite 200 Sunnyvale, California 94089
Re: K150901
Trade/Device Name: Fetal & Maternal Monitor, models F6, F6 Express Regulation Number: 21 CFR 884.2740 Regulation Name: Perinatal monitoring system and accessories Regulatory Class: Class II Product Code: HGM Dated: March 27, 2015 Received: April 3, 2015
Dear Mr. 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.
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 device
1
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 contact the Division of Industry and Consumer Education 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 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 yours,
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) K150901
Device Name
Fetal & Maternal Monitor, models F6, F6 Express, F9, F9 Express
Indications for Use (Describe)
F6/F9 Fetal & Maternal Monitor (hereinafter called F6/F9):
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. Alternally monitor one of the FHRs with DECG and uterine activity with an IUPC.
F6 Express/F9 Express Fetal & Maternal Monitor (hereinafter called F6 Express/F9 Express):
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.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CER 801 Subpart D) | Over-The-Counter Use (21 CER 801 Subpart C) |
|---|---|
| ---------------------------------------------- | --------------------------------------------- |
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3
510(K) Summary
Prepared in accordance with the content and format regulatory requirements of 21 CFR Part 807.92
| 1. Submitter: | Edan Instruments, Inc
3/F - B, Nanshan Medical
Equipments Park, Nanhai Rd 1019#,
Shekou, Nanshan Shenzhen,
518067 P.R. China
Tel: +86(0755) 26858736
Fax: +1 (408) 418-4059 |
|-----------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person:
Preparing date: | Queena Chen
June 29, 2015 |
| 2. Device name and
classification: | Device Name: Fetal & Maternal Monitor, models F6, F6 Express,
F9, F9 Express (hereinafter called F series)
Classification Name/ Product code:
884.2740 Perinatal monitoring system and accessories/ HGM
Regulatory Class: Class II |
| 3.Premarket
Notification Class III
Certification and
Summary | Not applicable, the subject device is Class II. |
| 4. Predicate Device(s): | 1) Edan Instruments, Inc., Fetal & Maternal Monitor/F9 Express
/K100797.
2) Philips Medical Systems, Inc./Avalon CTS cordless Fetal
Transducer System/K023931 |
| 5. Reason for
Submission | Modification for previous cleared product Fetal & Maternal
Monitor, models F6, F6 Express, F9, F9 Express. |
| 6. Pre-Submission,
IDE | Not applicable, there is no prior submission. |
| 7. Device Description: | F series Fetal & Maternal Monitor, including F6, F6 Express,
F9, F9 Express which provides the following primary features
that can be available for the multiple configurations:
• Basic parameters: FHR, TOCO, Event Mark, AFM
• Dual FHR monitoring
• Internal parameters: IUP/DECG
• FHR limit alarm |
4
• Software for data transmission to PC, which means the subject device can be connected to Central Nursing System provided by EDAN, which has been cleared by K100358.
- Quick printing for stored waveform
- Lithium battery for continuous working
- · Maternal ECG monitoring
- · Maternal SpO2 monitoring
- · Maternal NIBP
- · Maternal temperature monitoring
- Used with FTS-3 Fetal Telemetry System (hereinafter called FTS-3)
The above is the maximum configuration for F series Fetal & Maternal Monitor, the user may select different measurement parameters in according with their requirements, which is also show in the following table.
| Model | F6 | F9 | F6
Express | F9
Express |
|-------------------------------------------------------|-----|-----|---------------|---------------|
| Measurement | | | | |
| Single-FHR | √ | √ | √ | √ |
| Dual-FHR | √ | √ | √ | √ |
| TOCO | √ | √ | √ | √ |
| FM | √ | √ | √ | √ |
| AFM | √ | √ | √ | √ |
| DECG/IUP | Opt | Opt | × | Opt |
| MECG | × | × | √ | √ |
| NIBP | × | × | √ | √ |
| MSpO2 | × | × | √ | √ |
| TEMP | × | × | √ | √ |
| NOTE: √ = Standard; Opt = Optional; × = Not Available | | | | |
8. 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/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.
5
F6 Express/F9 Express Fetal & Maternal Monitor (hereinafter called F6 Express/F9 Express):
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.
9. Predicate Device Comparison
The subject devices share the same characteristics in all items with the predicate device, concluding from using the same technology and principle. All the technological differences existed between the subject and predicate devices are only some performance parameters items, detailed comparison information can be found in the following tables.
| Item | F6 / F6 Express/ F9 / F9 Express | F9 Express | Substantial Equivalence (SE) |
|---|---|---|---|
| Manufacturer | Edan Instruments, Inc. | Edan Instruments, Inc. | / |
| K# | N/A | K100797 | / |
| Intended use | The 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. It is not intended for use in intensive care units, operating rooms or for home use. F9 Express fetal & maternal monitor is intended for providing | The 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. It is not intended for use in intensive care units, operating rooms or for home use. F9 Express fetal & maternal monitor is intended for providing | Same |
| Non-Stress testing or fetal | |||
| monitoring for pregnant | |||
| women .In addition, it | |||
| provides a solution for | |||
| maternal vital signs | |||
| monitoring. | Non-Stress testing or fetal | ||
| monitoring for pregnant | |||
| women. In addition, it | |||
| provides a solution for | |||
| maternal vital signs | |||
| monitoring. | |||
| Electrical Safety | |||
| 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). | FHR1, FHR2, TOCO, FM, | ||
| IUP: BF; | |||
| SpO2, NIBP: BF | |||
| (Defibrillator-proof); | |||
| DECG: CF; | |||
| ECG, TEMP: CF | |||
| (Defibrillator-proof). | Different | ||
| Degree of safety of | |||
| application in the | |||
| presence of | |||
| flammable gas: | Equipment not suitable | ||
| for use in presence of | |||
| flammable gases | Equipment not suitable for | ||
| use in presence of | |||
| flammable gases | Same | ||
| Working mode: | Continuous running | ||
| equipment | Continuous running | ||
| equipment | Same | ||
| FHR | |||
| Technique: | Pulse Doppler with | ||
| autocorrelation processing | Pulse Doppler with | ||
| autocorrelation processing | Same | ||
| Pulse Repetition | |||
| Frequency: | 2 KHz | 2 KHz | Same |
| Pulse Duration: | 92 μs | 92 μs | Same |
| Ultrasound | |||
| Frequency: | 1.0MHz±10% | 1.0MHz±10% | Same |
| Spatial-Peak | |||
| Temporal Average | |||
| Intensity: | Ispta 10ΜΩ (Differential,) |
20ΜΩ (Common Mode) | >10ΜΩ (Differential,)
20ΜΩ (Common Mode) | Same |
| Countable Input
Signal Range: | 20uV-3mV peak-to-peak | 20uV-3mV peak-to-peak | Same |
| Pressure Range: | 0100mmHg | 0100mmHg | Same |
| Sensitivity: | 5uV/V/mmHg | 5uV/V/mmHg | Same |
| Resolution: | 1% | 1% | Same |
| Zero Mode: | Automatic / Manual | Automatic / Manual | Same |
| Heart Rate Range | 30-240BPM | 30-240BPM | Same |
| Heart Rate
Resolution | ±1 BPM | ±1 BPM | Same |
| Input Signal Range | ±8 mV PP | ±8 mV PP | Same |
| Defibrillator
Protection | YES | YES | Same |
| Tall T-wave
Rejection | 1.2mV(12mm) | 1.2mV(12mm) | 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 |
| Accuracy and
Response to
Irregular Rhythm | Ventricular bigeminy:
80bpm±1bpm
Slow alternating
ventricular bigeminy:
60bpm±1bpm
Rapid alternating
ventricular bigeminy:
120bpm±1bpm
Bidirectional systoles:
91bpm±1bpm | Ventricular bigeminy:
80bpm±1bpm
Slow alternating
ventricular bigeminy:
60bpm±1bpm
Rapid alternating
ventricular bigeminy:
120bpm±1bpm
Bidirectional systoles:
91bpm±1bpm | Same |
| Response time to
Change in HR | HR range: 80bpm ~
120bpm
Range: 7s ~ 8s (average:
7.5s)
HR range: 80bpm ~
40bpm
Range : 7s ~ 8s (average:
7.5s) | HR range: 80bpm ~
120bpm
Range: 7s ~ 8s (average:
7.5s)
HR range: 80bpm ~ 40bpm
Range : 7s ~ 8s (average:
7.5s) | Same |
| SpO2 | | | |
| Measuring Range: | 50% ~ 100% | 50%~100% | Same |
| Resolution: | 1% | 1% | Same |
| | | | |
| Measuring
Accuracy
(EDAN): | $90% \sim 100% \pm 2%$
$70% \sim 90% \pm 4%$
$Physical Specification | | | |
| 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-ion
Battery | Rechargeable Lithium-ion
Battery | Same |
| Dimensions: | 347mm × 330mm ×
126mm | 347mm × 330mm ×
126mm | Same |
| Weight: | F6: Approx. 5.3 kg
F6 Express: Approx. 6.1
kg
F9: Approx. 5.5 kg
F9 Express: Approx. 6.3
kg
FTS-3:
1.8 kg | F6: Approx. 5.3 kg
F6 Express: Approx. 6.1
kg
F9: Approx. 5.5 kg
F9 Express: Approx. 6.3
kg | Same |
| Operating
Temperature: | 5 °C ~ 40 °C | 5 °C ~ 40 °C | Same |
10
| Transport/ Storage
| Temperature: | -20 °C ~ 55 °C | -20 °C ~ 55 °C | |
|---|---|---|---|
| Operating | |||
| Humidity: | 15%~93% | ||
| (non-condensing) | 25%~80% | ||
| (non-condensing) | Different | ||
| Transport/Storage | |||
| Humidity: | 15%~93% | ||
| (non-condensing) | 25%~93% | ||
| (non-condensing) | |||
| Operating | |||
| atmospheric | |||
| pressure: | 860 hPa ~1060 hPa | 860 hPa ~1060 hPa | Same |
| Transport/Storage | |||
| atmospheric | |||
| pressure: | 700 hPa ~1060 hPa | 700 hPa ~1060 hPa | Same |
| Complied Standards | |||
| Detail | IEC 60601-1:2005, EN | ||
| 60601-1:2006/AC:2010, | |||
| IEC 60601-1-2:2007, EN | |||
| 60601-1-2:2007/AC:2010, | |||
| IEC/EN 60601-2-27, | |||
| IEC/EN 60601-2-37, | |||
| IEC/EN 60601-2-49, | |||
| IEC 80601-2-30, | |||
| ISO 80601-2-61, | |||
| ISO 80601-2-56, | |||
| EN 12470-4 AAMI/ANSI | |||
| EC13 | |||
| UD 2 | |||
| FCC 47 CFR Part 15 | |||
| FCC 47 CFR Part 95 | MDD93/42/EEC, | ||
| EN60601-1:1990+A1:1993 |
- A2:1995,
EN 60601-2-37:2001,
EN 60601-1-1:2001,
EN 60601-1-2:2001,
EN 61157:1995
EN ISO 9919,
EN 12470-4
UD 2
FCC 47 CFR Part 15
FCC 47 CFR Part 95 | Different |
Comparison between FTS-3 and Avalon CTS
| Items | FTS-3 | Avalon CTS cordless
Fetal Transducer System | Substantial
Equivalenc
e (SE) |
|-------------------------------------------|-----------------------|------------------------------------------------|-------------------------------------|
| Transmission
Power: | 110 m | >100 m | Different |
| Modem
Mode: | FSK | FSK | Same |
| Transmission
Rate: | About 25kbps | 200 bits/s | Different |
11
As seen in the comparison tables, the subject and predicate devices have similar design features and performance specifications. The main technological differences between the subject and predicate devices are related to the wireless transmission characteristics. These minor differences, however, do not raise different questions of safety or effectiveness. As demonstrated in the non-clinical testing, the different technological characteristics do not affect the safety and effectiveness of the Edan Fetal & Maternal Monitors.
10. Performance Data:
Non-clinical data:
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
The biocompatibility evaluation for the F series Fetal & Maternal Monitor were conducted in accordance with the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The worst case of the whole system is considered tissue contacting for a duration of less than 24 hours. And the battery of testing included the following tests:
- Cytotoxicity
- Skin Sensitization
- Irritation or Intracutaneous Reactivity .
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the F series Fetal & Maternal Monitor device, consisting of all the modules and accessories in the system. The system complies with the IEC 60601-1:2005/A1: 2012 standards for safety and the IEC 60601-1-2: 2007 for EMC.
Bench Testing
Bench testings were conducted on the F series Fetal & Maternal Monitor device, consisting of all the modules and accessories in the system complies with the IEC 60601-1-8: 2006, IEC 60601-2-27: 2011, IEC 60601-2-37: 2007, IEC 60601-2-49: 2011, IEC 80601-2-30: 2009, ISO 80601-2-56: 2009, ISO 80601-2-61: 2011, ISO 81060-2: 2013 and IEC 62366: 2007 standards.
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 "moderate" level of concern, since a failure or latent flaw in the software will not directly result in serious injury or death to the patient or operator, and the software device is an accessory to a medical device that has a Moderate Level of Concern.
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Acoustic testing
All measurements were conducted in accordance with the measurement procedures of the NEMA Standard Publications UD-2 and IEC 62359 and following the calibration procedures given in Section 4 of UD-2, and the reporting requirements of the September 9, 2008 FDA Guide for Track 1.
Clinical data: Not applicable.
Summary
Based on the non-clinical and clinical performance as documented in the system development, the subject devices were found to have a safety and effectiveness profile that is similar to the predicate device.
11. Conclusion
The non-clinical data support the safety of the device and the hardware and software verification and validation demonstrate that the F series Fetal & Maternal Monitor device should perform as intended in the specified use conditions, and all the data demonstrate that the subject devices perform comparably to the predicate device that is currently marketed for the same intended use. In other words, the subject F series Fetal & Maternal Monitor devices are substantially equivalent to the predicate devices.