(89 days)
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 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.
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)
This document is a 510(k) Pre-market Notification for the Edan Instruments Fetal & Maternal Monitor (models F6, F6 Express, F9, F9 Express), seeking to demonstrate substantial equivalence to previously cleared predicate devices. The submission focuses on non-clinical performance data.
Here's an analysis of the provided information concerning acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a dedicated "acceptance criteria" table in the format of pass/fail metrics. Instead, it provides a "Predicate Device Comparison" table that lists performance specifications for the subject devices and the predicate device. The implied acceptance criterion for each parameter is that the subject device's performance is "Same" or "Different" but without raising new questions of safety or effectiveness.
Below is a summarized table consolidating various performance parameters and their comparison to the predicate device, indicating the reported performance:
| Item | Implied Acceptance Criterion | Subject Device Performance (F6/F6 Express/F9/F9 Express) | Predicate Device Performance (K100797, F9 Express & K023931, Avalon CTS) | Meets Acceptance Criterion? |
|---|---|---|---|---|
| FHR | Maintain/Match Predicate | |||
| Technique | Pulse Doppler w/ autocorrelation | Pulse Doppler with autocorrelation processing | Pulse Doppler with autocorrelation processing | Yes (Same) |
| Pulse Repetition Freq. | 2 KHz | 2 KHz | 2 KHz | Yes (Same) |
| Pulse Duration | 92 μs | 92 μs | 92 μs | Yes (Same) |
| Ultrasound Frequency | 1.0MHz±10% | 1.0MHz±10% | 1.0MHz±10% | Yes (Same) |
| Spatial-Peak Temporal Avg. Intensity | Ispta < 100 mW/cm2 | Ispta < 100 mW/cm2 | Ispta < 100 mW/cm2 | Yes (Same) |
| FHR Range | 50 bpm-240 bpm | 50 bpm-240 bpm | 50 bpm-240 bpm | Yes (Same) |
| Resolution | 1 bpm | 1 bpm | 1 bpm | Yes (Same) |
| Accuracy | ±1 bpm (F9), ±2 bpm (F6) | ±1 bpm (F9), ±2 bpm (F6, FTS-3) | ±1 bpm (F9), ±2 bpm (F6) | Yes (Same - FTS-3 specified for subject, not predicate) |
| TOCO | Maintain/Match Predicate | |||
| TOCO Range | 0%-100% | 0%-100% | 0%-100% | Yes (Same) |
| Resolution | 1% | 1% | 1% | Yes (Same) |
| ECG | Maintain/Match Predicate | |||
| Technique | Peak-peak detection | Peak-peak detection technique | Peak-peak detection technique | Yes (Same) |
| Heart Rate Counting Range | 30 bpm ~ 240 bpm | 30 bpm ~ 240 bpm | 30 bpm ~ 240 bpm | Yes (Same) |
| Heart Rate Resolution | ±1 BPM | ±1 BPM | ±1 BPM | Yes (Same) |
| SpO2 | Maintain/Match Predicate | |||
| Measuring Range | 50% ~ 100% | 50% ~ 100% | 50%~100% | Yes (Same) |
| Resolution | 1% | 1% | 1% | Yes (Same) |
| Measuring Accuracy (EDAN) | $90-100% \pm 2%, 70-90% \pm 4%$ | $90% \sim 100% \pm 2%$, $70% \sim 90% \pm 4%$, $< 70%$ unspecified | $90% \sim 100% \pm 2%$, $70% \sim 90% \pm 4%$, $< 70%$ unspecified | Yes (Same) |
| Measuring Accuracy (Nellcor) | $70-100% \pm 2%$ | $70% \sim 100% \pm 2%$, $< 70%$ unspecified | $70%~100% \pm 2%$, $< 70%$ unspecified | Yes (Same) |
| NIBP | Maintain/Match Predicate | |||
| Measuring Accuracy | $\le 8mmHg$ | $\le 8mmHg$ | $\le 8mmHg$ | Yes (Same) |
| TEMP | Maintain/Match Predicate | |||
| Accuracy | Varied based on range | 0°C ~ +25°C: ±0.2°C; +25°C ~ +45°C: ±0.1°C; +45°C ~ +50°C: ±0.2°C | 0°C ~ +25°C: ±0.2°C; +25°C ~ +45°C: ±0.1°C; +45°C ~ +50°C: ±0.2°C | Yes (Same) |
| Other Differences | Justified as not affecting safety/effectiveness | Electrical Safety degree for FTS-3, Operating Humidity, Transport/Storage Humidity, Complied Standards, FTS-3 Transmission Power, FTS-3 Transmission Range, FTS-3 Transmission Rate (all noted as different, but deemed not to affect substantial equivalence) | The predicate F9 Express has slightly different electrical safety classifications for certain connections and different humidity ranges. The FTS-3 (a component of the subject device) has different transmission power, range, and rate compared to the Avalon CTS predicate. The predicate uses older versions of some standards (e.g., MDD93/42/EEC, older IEC versions). | Yes (Differences were justified as not raising new questions of safety or effectiveness) |
2. Sample Size for the Test Set and Data Provenance
The submission primarily relies on non-clinical testing to demonstrate substantial equivalence. No specific "test set" in the context of clinical data (e.g., patient cases for a diagnostic AI) is mentioned, as clinical data was deemed "Not applicable."
For the non-clinical tests:
- Biocompatibility testing: The "worst case of the whole system is considered tissue contacting for a duration of less than 24 hours." This doesn't specify a sample size for the tests themselves (e.g., number of test specimens), but rather the basis for the test choice.
- Electrical safety and electromagnetic compatibility (EMC): Performed on "the F series Fetal & Maternal Monitor device, consisting of all the modules and accessories in the system." This likely refers to a single device or a small number of units for engineering testing.
- Bench Testing: Performed on "the F series Fetal & Maternal Monitor device, consisting of all the modules and accessories in the system." Similar to EMC, this implies engineering testing on a limited number of devices.
- Software Verification and Validation Testing: Documented according to FDA guidance. No specific "sample size" of software test cases is provided, but it would involve comprehensive testing scenarios.
- Acoustic testing: Conducted using standard measurement procedures (NEMA Standard Publications UD-2 and IEC 62359).
Data Provenance: All data appears to be from retrospective internal testing conducted by the manufacturer, Edan Instruments, Inc., likely at their facilities in P.R. China or through contracted testing laboratories. There is no mention of data from specific countries of origin related to patient studies, as no clinical data was submitted.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the submission relies on non-clinical testing and states "Clinical data: Not applicable." For non-clinical tests (e.g., electrical safety, performance measurements), the "ground truth" is established by calibrated reference instruments, defined test procedures, and adherence to international standards. Experts involved would be engineers and technicians qualified in performing such tests, not clinical experts establishing diagnostic ground truth.
4. Adjudication Method for the Test Set
This information is not applicable as there was no clinical test set requiring expert adjudication of ground truth.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission explicitly states "Clinical data: Not applicable" and focuses on demonstrating substantial equivalence through non-clinical performance data and comparison of specifications with predicate devices. Therefore, there is no effect size of human readers improving with or without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not directly applicable to this device in the context of AI/algorithm performance. The Fetal & Maternal Monitor is a hardware device with embedded software for monitoring physiological parameters (FHR, TOCO, ECG, SpO2, NIBP, TEMP). Its performance is evaluated as a whole system, not as a standalone AI algorithm. The software verification and validation are part of the overall system performance.
7. The Type of Ground Truth Used
For the non-clinical performance data, the "ground truth" is based on:
- International Standards: Adherence to standards like IEC 60601-1, IEC 60601-1-2, IEC 60601-2-27, ISO 80601-2-61, etc.
- Reference Measurements: Use of calibrated equipment and defined test methodologies to measure parameters (e.g., FHR accuracy, SpO2 accuracy, NIBP accuracy) against expected or known values.
- Biocompatibility Standards: Results of standard biological tests (Cytotoxicity, Skin Sensitization, Irritation) against defined pass/fail criteria from ISO 10993-1.
There is no mention of expert consensus, pathology, or outcomes data as these are typically associated with clinical studies for diagnostic accuracy, which were not performed.
8. The Sample Size for the Training Set
This information is not applicable as the device is not described as an AI/ML device that requires a "training set" in the conventional sense for algorithm development. It's a monitoring device with specified performance characteristics.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8; no training set in the AI/ML context is mentioned or implied. If the device uses any internal algorithms (e.g., for signal processing or heart rate detection), their "truth" would be established by engineering validation against known input signals or simulated physiological data, but this is handled under the general "Software Verification and Validation Testing" section.
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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
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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
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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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510(K) Summary
Prepared in accordance with the content and format regulatory requirements of 21 CFR Part 807.92
| 1. Submitter: | Edan Instruments, Inc3/F - B, Nanshan MedicalEquipments Park, Nanhai Rd 1019#,Shekou, Nanshan Shenzhen,518067 P.R. ChinaTel: +86(0755) 26858736Fax: +1 (408) 418-4059 |
|---|---|
| Contact person:Preparing date: | Queena ChenJune 29, 2015 |
| 2. Device name andclassification: | 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/ HGMRegulatory Class: Class II |
| 3.PremarketNotification Class IIICertification andSummary | 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 FetalTransducer System/K023931 |
| 5. Reason forSubmission | Modification for previous cleared product Fetal & MaternalMonitor, 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 featuresthat can be available for the multiple configurations:• Basic parameters: FHR, TOCO, Event Mark, AFM• Dual FHR monitoring• Internal parameters: IUP/DECG• FHR limit alarm |
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• 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 | F6Express | F9Express |
|---|---|---|---|---|
| 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.
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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 fetalmonitoring for pregnantwomen .In addition, itprovides a solution formaternal vital signsmonitoring. | Non-Stress testing or fetalmonitoring for pregnantwomen. 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). | Different |
| Degree of safety ofapplication in thepresence offlammable gas: | Equipment not suitablefor use in presence offlammable gases | Equipment not suitable foruse in presence offlammable gases | Same |
| Working mode: | Continuous runningequipment | Continuous runningequipment | Same |
| FHR | |||
| Technique: | Pulse Doppler withautocorrelation processing | Pulse Doppler withautocorrelation processing | Same |
| Pulse RepetitionFrequency: | 2 KHz | 2 KHz | Same |
| Pulse Duration: | 92 μs | 92 μs | Same |
| UltrasoundFrequency: | 1.0MHz±10% | 1.0MHz±10% | Same |
| Spatial-PeakTemporal AverageIntensity: | Ispta < 100 mW/cm2 | Ispta < 100 mW/cm2 | Same |
| FHR Range: | 50 bpm-240 bpm | 50 bpm-240 bpm | Same |
| Resolution: | 1 bpm | 1 bpm | Same |
| Accuracy: | ±1 bpm(F9)±2 bpm(F6,FTS-3) | ±1 bpm(F9)±2 bpm(F6) | Same |
| TOCO | |||
| TOCO Range: | 0%-100% | 0%-100% | Same |
| Resolution: | 1%/ | 1%/ | Same |
| ECG | |||
| Technique: | Peak-peak detectiontechnique | Peak-peak detectiontechnique | Same |
| Heart RateCounting Range: | 30 bpm ~ 240 bpm | 30 bpm ~ 240 bpm | Same |
| Heart RateResolution: | ±1 BPM | ±1 BPM | Same |
| Input Impedance: | >10ΜΩ (Differential,)>20ΜΩ (Common Mode) | >10ΜΩ (Differential,)>20ΜΩ (Common Mode) | Same |
| Countable InputSignal Range: | 20uV-3mV peak-to-peak | 20uV-3mV peak-to-peak | Same |
| Pressure Range: | 0~100mmHg | 0~100mmHg | 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 RateResolution | ±1 BPM | ±1 BPM | Same |
| Input Signal Range | ±8 mV PP | ±8 mV PP | Same |
| DefibrillatorProtection | YES | YES | Same |
| Tall T-waveRejection | 1.2mV(12mm) | 1.2mV(12mm) | Same |
| HR averagingmethod | Heart rate is computed byaveraging the 12 mostrecent RR intervals. | Heart rate is computed byaveraging the 12 mostrecent RR intervals. | Same |
| Accuracy andResponse toIrregular Rhythm | Ventricular bigeminy:80bpm±1bpmSlow alternatingventricular bigeminy:60bpm±1bpmRapid alternatingventricular bigeminy:120bpm±1bpmBidirectional systoles:91bpm±1bpm | Ventricular bigeminy:80bpm±1bpmSlow alternatingventricular bigeminy:60bpm±1bpmRapid alternatingventricular bigeminy:120bpm±1bpmBidirectional systoles:91bpm±1bpm | Same |
| Response time toChange in HR | HR range: 80bpm ~120bpmRange: 7s ~ 8s (average:7.5s)HR range: 80bpm ~40bpmRange : 7s ~ 8s (average:7.5s) | HR range: 80bpm ~120bpmRange: 7s ~ 8s (average:7.5s)HR range: 80bpm ~ 40bpmRange : 7s ~ 8s (average:7.5s) | Same |
| SpO2 | |||
| Measuring Range: | 50% ~ 100% | 50%~100% | Same |
| Resolution: | 1% | 1% | Same |
| MeasuringAccuracy(EDAN): | $90% \sim 100% \pm 2%$$70% \sim 90% \pm 4%$$< 70%$unspecified | $90% \sim 100% \pm 2%$$70% \sim 90% \pm 4%$$< 70%$unspecified | Same |
| MeasuringAccuracy(Nellcor): | $70% \sim 100% \pm 2%$$< 70%$unspecified | $70%~100% \pm 2%$$< 70%$unspecified | Same |
| Pulse RateMeasurementRange: | 30-240BPM | 30-240BPM | Same |
| Pulse RateMeasuringAccuracy: | $\pm$ ulse | $\pm$ ulse | Same |
| Emitted lightenergy | < 15 mW | < 15 mW | Same |
| NIBP | |||
| Blood PressureRange | Systolicpressure:40mmHg ~270mmHg Diastolicpressure:10mmHg ~215mmHg | Systolic pressure:40mmHg~ 270mmHg Diastolicpressure:10mmHg ~215mmHg | Same |
| MeasuringAccuracy: | $\le 8mmHg$ | $\le 8mmHg$ | Same |
| Cuff PressureProtection | 300mmHg | 300mmHg | Same |
| TEMP | |||
| Channel: | 1 | 1 | Same |
| MeasurementRange: | 0 °C ~ 50 °C | 0 °C ~ 50 °C | Same |
| Accuracy: | 0°C ~ +25°C (+32°F ~+77°F): $\pm$ 0.2°C( $\pm$ 0.36°F)+25°C ~ +45°C (+77°F ~+113°F): $\pm$ 0.1°C( $\pm$ 0.18°F)+45°C ~ +50°C (+113°F ~+122°F): $\pm$ 0.2°C( $\pm$ 0.36°F) | 0°C ~ +25°C (+32°F ~+77°F): $\pm$ 0.2°C( $\pm$ 0.36°F)+25°C ~ +45°C (+77°F ~+113°F): $\pm$ 0.1°C( $\pm$ 0.18°F)+45°C ~ +50°C (+113°F ~+122°F): $\pm$ 0.2°C( $\pm$ 0.36°F) | Same |
| Printer | |||
| Paper width: | 152mm (GE), 150mm(PHILIPS) | 152mm (GE), 150mm(PHILIPS) | Same |
| Effective printingwidth: | 110mm (AmericanStandard)120mm (International | 110mm (AmericanStandard)120mm (International | Same |
Comparison between the subject F9 series and the previous cleared F9 Express
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| Standard) | Standard) | ||
|---|---|---|---|
| FHR printoutwidth: | 70mm (AmericanStandard)80mm (InternationalStandard) | 70mm (AmericanStandard)80mm (InternationalStandard) | Same |
| FHR scaling: | 30bpm/cm (AmericanStandard)20bpm/cm (InternationalStandard) | 30bpm/cm (AmericanStandard)20bpm/cm (InternationalStandard) | Same |
| TOCO printoutwidth: | 40mm | 40mm | Same |
| TOCO scaling: | 25%/cm | 25%/cm | Same |
| Standard Speed(Real-TimeTraces ): | 1 cm/min, 2 cm/min, 3cm/min | 1 cm/min, 2 cm/min, 3cm/min | Same |
| Paper: | Z-fold, thermosensitive(compatible with GE andPHILIPS record papers) | Z-fold, thermosensitive(compatible with GE andPHILIPS record papers) | Same |
| 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-ionBattery | Rechargeable Lithium-ionBattery | Same |
| Dimensions: | 347mm × 330mm ×126mm | 347mm × 330mm ×126mm | Same |
| Weight: | F6: Approx. 5.3 kgF6 Express: Approx. 6.1kgF9: Approx. 5.5 kgF9 Express: Approx. 6.3kgFTS-3:1.8 kg | F6: Approx. 5.3 kgF6 Express: Approx. 6.1kgF9: Approx. 5.5 kgF9 Express: Approx. 6.3kg | Same |
| OperatingTemperature: | 5 °C ~ 40 °C | 5 °C ~ 40 °C | Same |
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| Transport/ StorageTemperature: | -20 °C ~ 55 °C | -20 °C ~ 55 °C | |
|---|---|---|---|
| OperatingHumidity: | 15%~93%(non-condensing) | 25%~80%(non-condensing) | Different |
| Transport/StorageHumidity: | 15%~93%(non-condensing) | 25%~93%(non-condensing) | |
| Operatingatmosphericpressure: | 860 hPa ~1060 hPa | 860 hPa ~1060 hPa | Same |
| Transport/Storageatmosphericpressure: | 700 hPa ~1060 hPa | 700 hPa ~1060 hPa | Same |
| Complied StandardsDetail | IEC 60601-1:2005, EN60601-1:2006/AC:2010,IEC 60601-1-2:2007, EN60601-1-2:2007/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/ANSIEC13UD 2FCC 47 CFR Part 15FCC 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 61157:1995EN ISO 9919,EN 12470-4UD 2FCC 47 CFR Part 15FCC 47 CFR Part 95 | Different |
Comparison between FTS-3 and Avalon CTS
| Items | FTS-3 | Avalon CTS cordlessFetal Transducer System | SubstantialEquivalence (SE) |
|---|---|---|---|
| TransmissionPower: | < 10 mW ERP | 0.1mW ERP (ClassicValue) | Different |
| FrequencyRange: | 608.00 MHz~614.00 MHz | 608.0125 MHz to613.9875 MHz | Same |
| TransmissionRange (lineof sight): | >110 m | >100 m | Different |
| ModemMode: | FSK | FSK | Same |
| TransmissionRate: | About 25kbps | 200 bits/s | Different |
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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.
§ 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).