(425 days)
Fetal & Maternal Monitor (Model: F15A, F15A Air) is intended for providing Non-Stress testing or fetal monitoring for pregnant women from the 28th week of gestation. It is intended to be used only by trained and qualified personnel in antepartum examination rooms, labor and delivery rooms.
Fetal & Maternal Monitor (Model: F15A, F15A Air) is intended for real time monitoring of fetal and maternal physiological parameters, including non-invasive monitoring and invasive monitoring:
Non-invasive physiological parameters:
- Maternal heart rates (MHR)
- Maternal ECG (MECG)
- Maternal temperature (TEMP)
- Maternal oxygen saturation (SpO2) and pulse rates (PR)
- Fetal heart rates (FHR)
- Fetal movements (FM)
- FTS-3
Note: SpO2 and PR are not available in F15A Air.
Invasive physiological parameters:
- Uterine activity
- Direct ECG (DECG)
The F15A series fetal and maternal monitor can monitor multiple physiological parameters of the fetus/mother in real time. F15A series can display, store, and print patient information and parameters, provide alarms of fetal and maternal parameters, and transmit patient data and parameters to Central Monitoring System.
F15A series fetal and maternal monitors mainly provide following primary feature:
Non-invasive physiological parameters:
- Maternal heart rates (MHR)
- Maternal ECG (MECG)
- Maternal temperature (TEMP)
- Maternal oxygen saturation (SpO2) and pulse rates (PR)
- Fetal heart rates (FHR)
- Fetal movements (FM)
- FTS-3
Note: SpO2 and PR are not available in F15A Air.
Invasive physiological parameters:
- Uterine activity
- Direct ECG (DECG)
The provided FDA 510(k) clearance letter and summary for the Fetal & Maternal Monitor (F15A, F15A Air) do not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and the study that proves the device meets them.
The document focuses primarily on demonstrating substantial equivalence to a predicate device (Edan Instruments, Inc., F9 Express Fetal & Maternal Monitor, K173042) through comparison of intended use, technological characteristics, and conformance to various safety and performance standards. It mentions "functional and system level testing to validate the performance of the devices" and "results of the bench testing show that the subject device meets relevant consensus standards," but it does not specify quantitative acceptance criteria for each individual physiological parameter (e.g., FHR accuracy, SpO2 accuracy) nor the specific results of those tests beyond stating that they comply with standards.
Specifically, the document does not include information on:
- A table of acceptance criteria with specific quantitative targets for each parameter and the reported device performance values against those targets. It only states compliance with standards.
- Sample sizes used for a "test set" in the context of clinical performance evaluation (it mentions "bench testing," but this is typically laboratory-based and doesn't involve patient data in a "test set" sense for AI/algorithm performance validation).
- Data provenance for such a test set (e.g., country of origin, retrospective/prospective).
- Number or qualifications of experts used to establish ground truth.
- Adjudication methods.
- Multi-Reader Multi-Case (MRMC) studies or human reader improvement data with AI assistance.
- Standalone (algorithm-only) performance, as this is a monitoring device, not a diagnostic AI algorithm.
- Type of ground truth (beyond "bench testing" which implies engineered signals or controlled environments).
- Sample size for a training set or how ground truth for a training set was established. This device is a traditional medical device, not an AI/ML-driven diagnostic or interpretative algorithm in the way your request implies.
Therefore, based solely on the provided text, I can only address what is present or infer what is missing.
Here's a breakdown based on the available information:
Analysis of Acceptance Criteria and Performance Testing based on Provided Document
The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (F9 Express Fetal & Maternal Monitor, K173042) by showing that the new device (F15A, F15A Air) has the same intended use and fundamentally similar technological characteristics, with any differences not raising new safety or effectiveness concerns.
1. A table of acceptance criteria and the reported device performance
The document does not provide a specific table with quantitative acceptance criteria for each physiological parameter (e.g., FHR accuracy, SpO2 accuracy) and the corresponding reported performance values obtained in testing. Instead, it states that the device was assessed for conformity with relevant consensus standards. For example, it lists:
- IEC 60601-2-37:2015: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment (relevant for FHR).
- ISO 80601-2-61:2017+A1:2018: Particular requirements for basic safety and essential performance of pulse oximeter equipment (relevant for SpO2).
- ISO 80601-2-56:2017+A1:2018: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement (relevant for TEMP).
- IEC 60601-2-27:2011: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment (relevant for MECG/DECG).
Acceptance Criteria (Inferred from standards compliance): The acceptance criteria are implicitly the performance requirements specified within these listed consensus standards. These standards set limits for accuracy, precision, response time, and other performance metrics for each type of measurement.
Reported Device Performance: The document states: "The results of the bench testing show that the subject device meets relevant consensus standards." This implies that the measured performance statistics (e.g., accuracy, bias, precision) for each parameter fell within the acceptable limits defined by the respective standards. However, the specific measured values are not provided in this summary.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "Bench Testing" which implies laboratory-based testing using simulators, controlled signals, or phantoms, rather than a "test set" involving patient data. There is no information provided regarding:
- Sample size (e.g., number of recordings, duration of recordings, number of simulated cases) for the bench tests for each parameter.
- Data provenance (e.g., country of origin, retrospective or prospective) as this is not a study involving patient data collection for performance validation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable and not provided. For a traditional physiological monitor, ground truth for bench testing is typically established using:
- Calibrated reference equipment/simulators: e.g., ECG simulators to generate known heart rates, SpO2 simulators to generate known oxygen saturation levels.
- Physical standards/phantoms: e.g., temperature baths at known temperatures.
- Known physical properties: e.g., precise weights for pressure transducers.
Clinical experts are not involved in establishing ground truth for bench performance of these types of physiological measurements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable and not provided. Adjudication methods are relevant for human expert review of complex clinical data (e.g., medical images for AI validation) to establish a consensus ground truth. For bench testing of physiological monitors, ground truth is objectively determined by calibrated instruments or defined physical parameters.
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
This is not applicable and not provided. An MRMC study is typically performed to evaluate the diagnostic accuracy of AI-assisted human interpretations versus unassisted human interpretations for AI-driven diagnostic devices. The Fetal & Maternal Monitor is a physiological monitoring device, not an AI-assisted diagnostic imaging or interpretation system. It measures and displays physiological parameters; it does not provide AI-driven assistance for human "readers" to interpret complex clinical information.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is a monitor that directly measures physiological parameters. It is not an "algorithm only" device in the sense of an AI model providing a diagnostic output. Its performance (e.g., FHR accuracy) is its standalone performance, as it directly measures these parameters. The document states "functional and system level testing to validate the performance of the devices," which would represent this type of standalone performance for the measurement functionalities. However, specific quantitative results are not given, only compliance with standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
As explained in point 3, the ground truth for bench testing of physiological monitors is established using calibrated reference equipment/simulators and physical standards.
8. The sample size for the training set
This is not applicable and not provided. This device is a traditional physiological monitor, not a machine learning model that requires a "training set." Its algorithms for parameter measurement are based on established physiological principles and signal processing techniques, not on statistical learning from large datasets.
9. How the ground truth for the training set was established
This is not applicable and not provided for the same reasons as point 8.
FDA 510(k) Clearance Letter - Fetal & Maternal Monitor
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.08.00
August 27, 2025
Edan Instruments, Inc.
Yue Tracy
Official Correspondent
15 Jinhui Road, Jinsha Community, Kengzi Sub-district,
Pingshan District
Shenzhen, 518122
China
Re: K241882
Trade/Device Name: Fetal & Maternal Monitor (F15A, F15A Air)
Regulation Number: 21 CFR§ 884.2740
Regulation Name: Perinatal Monitoring System and Accessories
Regulatory Class: II
Product Code: HGM
Dated: June 28, 2024
Received: February 25, 2025
Dear Yue Tracy:
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 (the 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 available 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.
Page 2
K241882 - Yue Tracy
Page 2
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
Page 3
K241882 - Yue Tracy
Page 3
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Monica D. Garcia -S
Monica D. Garcia, Ph.D.
Assistant Director
DHT3B: Division of Reproductive,
Gynecology and Urology Devices
OHT3: Office of GastroRenal, ObGyn,
General Hospital and Urology Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.
510(k) Number (if known)
K241882
Device Name
Fetal & Maternal Monitor (F15A, F15A Air)
Indications for Use (Describe)
Fetal & Maternal Monitor (Model: F15A, F15A Air) is intended for providing Non-Stress testing or fetal monitoring for pregnant women from the 28th week of gestation. It is intended to be used only by trained and qualified personnel in antepartum examination rooms, labor and delivery rooms.
Fetal & Maternal Monitor (Model: F15A, F15A Air) is intended for real time monitoring of fetal and maternal physiological parameters, including non-invasive monitoring and invasive monitoring:
Non-invasive physiological parameters:
- Maternal heart rates (MHR)
- Maternal ECG (MECG)
- Maternal temperature (TEMP)
- Maternal oxygen saturation (SpO2) and pulse rates (PR)
- Fetal heart rates (FHR)
- Fetal movements (FM)
- FTS-3
Note: SpO2 and PR are not available in F15A Air.
Invasive physiological parameters:
- Uterine activity
- Direct ECG (DECG)
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.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (6/20)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
Page 5
510(k) Summary
Prepared in accordance with the requirements of 21 CFR Part 807.92
K241882
Page 1 of 7
1. Submitter:
Edan Instruments, Inc.
#15 Jinhui Road, Jinsha Community, Kengzi Sub-District, Pingshan District,
Shenzhen, 518122 P.R.China.
Tel: +86(0755) 84513592
Fax: +86(0755) 26882223
2. Contact person:
Tracy Yue
Preparing date: August 27, 2025
3. Device name and classification:
Trade name: Fetal & Maternal Monitor (F15A, F15A Air)
Common name: Perinatal monitoring system
Regulation Number/Classification Name/Product Code:
- 21 CFR 884.2740 Perinatal monitoring system and accessories, HGM
- 21 CFR 884.2960 Obstetric ultrasonic transducer and accessories, HGL
- 21 CFR 870.2300 Cardiac monitor (including cardiotachometer and rate alarm), DRT
- 21 CFR 880.2910 Clinical electronic thermometer, FLL
- 21 CFR 870.2700 Oximeter, DQA
- 21 CFR 870.2340 Electrocardiograph, DPS
- 21 CFR 870.2700 Intrauterine pressure monitor and accessories, HFN
- 21 CFR 884.2720 External uterine contraction monitor and accessories, HFM
Regulatory Class: Class II
4. Predicate Device:
- Edan Instruments, Inc., F9 Express Fetal & Maternal Monitor, cleared under K173042 (Predicate device)
The predicate device has not been subject to a design related recall.
5. Device Description:
The F15A series fetal and maternal monitor can monitor multiple physiological parameters of the fetus/mother in real time. F15A series can display, store, and print patient information and parameters, provide alarms of fetal and maternal parameters, and transmit patient data and parameters to Central Monitoring System.
F15A series fetal and maternal monitors mainly provide following primary feature:
Page 6
Traditional 510(k) of F15A Series Fetal & Maternal Monitor
26.0_510(k)_Summary 2 / 7
Non-invasive physiological parameters:
- Maternal heart rates (MHR)
- Maternal ECG (MECG)
- Maternal temperature (TEMP)
- Maternal oxygen saturation (SpO2) and pulse rates (PR)
- Fetal heart rates (FHR)
- Fetal movements (FM)
- FTS-3
Note: SpO2 and PR are not available in F15A Air.
Invasive physiological parameters:
- Uterine activity
- Direct ECG (DECG)
6. Indication for Use
Fetal & Maternal Monitor (Model: F15A, F15A Air) is intended for providing Non-Stress testing or fetal monitoring for pregnant women from the 28th week of gestation. It is intended to be used only by trained and qualified personnel in antepartum examination rooms, labor and delivery rooms.
Fetal & Maternal Monitor (Model: F15A, F15A Air) is intended for real time monitoring of fetal and maternal physiological parameters, including non-invasive monitoring and invasive monitoring:
Non-invasive physiological parameters:
- Maternal heart rates (MHR)
- Maternal ECG (MECG)
- Maternal temperature (TEMP)
- Maternal oxygen saturation (SpO2) and pulse rates (PR)
- Fetal heart rates (FHR)
- Fetal movements (FM)
- FTS-3
Note: SpO2 and PR are not available in F15A Air.
Invasive physiological parameters:
- Uterine activity
- Direct ECG (DECG)
7. Predicate Device Comparison
The subject device is technologically equivalent to predicate devices. Any differences are explained to demonstrate in this submission that these differences do not raise any new questions of safety and effectiveness. The table below compares the intended use and technological characteristics of the subject and primary predicate device:
| Item | < Subject Device > EDAN Instrument Inc. | < Predicate Device > EDAN Instrument Inc. | Comparison Result |
Page 7
K241882
Page 2 of 7
| Item | F15A series Fetal & Maternal Monitor | F9 Express Fetal & Maternal Monitor | Comparison Result |
|---|---|---|---|
| K# | K241882 | K173042 | —— |
| Intended Use/Indications for Use | Fetal & Maternal Monitor (Model: F15A, F15A Air) is intended for providing Non-Stress testing or fetal monitoring for pregnant women from the 28th week of gestation. It is intended to be used only by trained and qualified personnel in antepartum examination rooms, labor and delivery rooms.Fetal & Maternal Monitor (Model: F15A, F15A Air) is intended for real time monitoring of fetal and maternal physiological parameters, including non-invasive monitoring and invasive monitoring:Non-invasive physiological parameters:• Maternal heart rates (MHR)• Maternal ECG (MECG)• Maternal temperature (TEMP)• Maternal oxygen saturation (SpO2) and pulse rates (PR)• Fetal heart rates (FHR)• Fetal movements (FM)• FTS-3Note: SpO2 and PR are not available in F15A Air.Invasive physiological parameters:• Uterine activity• Direct ECG (DECG) | 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.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. | Similar |
Physical Specification
| Parameter | F15A series | F9 Express | Comparison |
|---|---|---|---|
| Power Supply: | AC or battery | AC or battery | Same |
| Operating Voltage: | a.c.100 V-240 V | a.c.100 V-240 V | Same |
| Operating Frequency: | 50/60 Hz | 50/60 Hz | Same |
| Power Supply Input Power: | 1.2A-0.5A | 1.0A-0.5A | Different |
| Battery: | Rechargeable Lithium-ion | Rechargeable Lithium-ion | Same |
Page 8
K241882
Page 3 of 7
| Parameter | F15A series Fetal & Maternal Monitor | F9 Express Fetal & Maternal Monitor | Comparison |
|---|---|---|---|
| Dimensions: | 389mm×296mm×82.5mm, ±5mm | 347mm x 330mm x 126mm | Different |
| Weight: | ≤ 8kg | Approx. 6.3 kg | Different |
Electrical Safety
| Parameter | F15A series | F9 Express | Comparison |
|---|---|---|---|
| Anti-electric-shock degree: | CF: FHR1, FHR2, AFM/MFM, DECG, IUPCF(defibrillation-proof): MECG, SpO2, TEMP | BF:FHR1, FHR2, TOCO, AFM/MFM,IUPBF (defibrillation-proof): NIBP, SpO2CF :DECGCF (defibrillation-proof): MECG, TEMP | 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 Operation equipment | Continuous Operation equipment | Same |
FHR
| Parameter | F15A series | F9 Express | Comparison |
|---|---|---|---|
| Technique: | Pulse Doppler with autocorrelation processing | Pulse Doppler with autocorrelation processing | Same |
| Ultrasound Frequency: | (1.0±10%) MHz | (1.0±10%) MHz | Same |
| Spatial-Peak Temporal Average Intensity: | Ispta < 100 mW/cm2 | Ispta < 100 mW/cm2 | Same |
| Effective Radiating Area: | 942 mm2 ± 15%( 12 ultrasound crystals)550 mm2 ± 15%( 7 ultrasound crystals)942 mm2 ± 15%( 12 ultrasound crystals) | Different |
DECG
| Parameter | F15A series | F9 Express | Comparison |
|---|---|---|---|
| Heart Rate Counting Range: | 30 bpm ~ 240 bpm | 30 bpm ~ 240 bpm | Same |
IUP
| Parameter | F15A series | F9 Express | Comparison |
|---|---|---|---|
| Pressure Range: | 0 ~ 100mmHg | 0 ~ 100mmHg | Same |
| Resolution: | 1mmHg | 1mmHg | Same |
FM
| Parameter | F15A series | F9 Express | Comparison |
|---|---|---|---|
| FM Mode | Automatic(AFM)/Manual(MFM) | Automatic(AFM)/Manual(MFM) | Same |
MECG
| Parameter | F15A series | F9 Express | Comparison |
|---|---|---|---|
| MHR | 30bpm ~ 240bpm | 30bpm ~ 240bpm | Same |
Page 9
K241882
Page 4 of 7
| Parameter | F15A series | F9 Express | Comparison |
|---|---|---|---|
| Number of electrodes | Three leads | Three leads | Same |
SpO2 (Nellcor, F15A only)
| Parameter | F15A series | F9 Express | Comparison |
|---|---|---|---|
| Resolution | 1 % | 1 % | Same |
| Measurement Range | 50% ~ 100% | 50% ~ 100% | Same |
| PR Measurement | Range: 30~240bpmResolution: 1 bpmAccuracy:±3bpm | Range: 30~240bpmResolution: 1 bpmAccuracy: ±3 bpm | Same |
TEMP(Only applicable for F15A)
| Parameter | F15A series | F9 Express | Comparison |
|---|---|---|---|
| Measurement Range | 0°C ~ +50°C | 0°C ~ +50°C | Same |
| Resolution | 0.1°C | 0.1°C | Same |
Printer
| Parameter | F15A series | F9 Express | Comparison |
|---|---|---|---|
| Paper width: | 152mm (GE), 150mm (PHILIPS) | 152mm (GE), 150mm (PHILIPS) | Same |
| Standard Speed (Real-Time Traces): | 1 cm/min, 2 cm/min, 3 cm/min | 1 cm/min, 2 cm/min, 3 cm/min | Same |
FTS-3
| Parameter | F15A series | F9 Express | Comparison |
|---|---|---|---|
| Operating Voltage | 100V-240V~ | 100V-240V~ | Same |
| Battery | 14.8VDC/5000mAh | 14.8VDC/5000mAh | Same |
FHR
| Parameter | F15A series | F9 Express | Comparison |
|---|---|---|---|
| Measurement Range | 50 bpm ～ 240 bpm | 50 bpm ～ 240 bpm | Same |
| FHR Resolution | 1 bpm | 1 bpm | Same |
| Ultrasound Frequency | (1+10%) MHz | (1+10%) MHz | Same |
TOCO
| Parameter | F15A series | F9 Express | Comparison |
|---|---|---|---|
| Range | 0~ 100 | 0~ 100 | Same |
The subject device and predicate device have the same intended use – monitoring of fetal and maternal physiological parameters. The subject device and predicate device have different technological characteristics, including differences in power supply input power, physical dimensions, weight, electrical safety classification, and effective radiating area. However, the differences in technological characteristics do not raise different questions for safety or effectiveness.
8. Performance Data:
Page 10
K241882
Page 5 of 7
Non-clinical test:
Electrical safety and electromagnetic compatibility (EMC)
F15A Series Fetal & Maternal Monitor was assessed for conformity with the relevant requirements of the following standards and found to comply:
- IEC 60601-1:2005/AMD2:2020 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
- IEC 60601-1-2:2014+A1:2020 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: electromagnetic disturbances – Requirements and tests.
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." issued June 14, 2023.
Cybersecurity Testing
Cybersecurity testing was conducted, and documentation was provided as recommended by FDA's "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions" issued September 27, 2023.
Bench Testing:
Edan has conducted functional and system level testing to validate the performance of the devices. The results of the bench testing show that the subject device meets relevant consensus standards.
- IEC 60601-1-8:2006, AMD1:2012, AMD2:2020 Medical electrical equipment - part 1-8: general requirements for basic safety and essential performance - collateral standard: general requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
- IEC 60601-2-27:2011 Medical electrical equipment--Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
- IEC 60601-2-37:2015 Medical electrical equipment – Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
- IEC 80601-2-49:2018 Medical electrical equipment — Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment
- ISO 80601-2-56:2017+A1:2018 Medical electrical equipment - part 2-56: particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
- ISO 80601-2-61 Second edition 2017-12 (Corrected version 2018-02): Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
- ANSI IEEE USEMCSC C63.27-2021 American National Standard for Evaluation of Wireless Coexistence
- IEC 62359:2017 Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields
- ANSI AAMI EC53:2013/(R)2020 ECG trunk cables and patient leadwires
9. Conclusion
Page 11
K241882
Page 6 of 7
The results of the performance testing described above demonstrate that the Fetal & Maternal Monitor (F15A, F15A Air) is as safe and effective as the predicate device and supports a determination of substantial equivalence.
§ 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).