(265 days)
The SD1 is a pocket Doppler device used for detecting the fetal heartbeat from the 10th week of gestation. It is intended to be used by medical professionals only.
SD1 Ultrasonic Pocket Doppler is a device prescribed by a licensed physician for use by professional healthcare providers. It is a hand-held, battery powered audio Doppler device integrated with 3 MHz probe and with optional use of Bluetooth/app, used for detecting fetal heart beats. The device is for prescription use and is intended for use at or after 10 weeks gestation.
The provided text describes the SD1 Ultrasonic Pocket Doppler, a device intended for detecting fetal heartbeats from the 10th week of gestation. While the document outlines performance data and its substantial equivalence to predicate devices, it does not detail specific acceptance criteria for performance metrics like sensitivity, specificity, or predictive values that would typically be associated with AI/ML diagnostic devices. The acceptance criteria mentioned primarily relate to regulatory compliance, electrical safety, electromagnetic compatibility, and general performance standards for ultrasonic equipment.
Therefore, I cannot provide an acceptance criteria table or information related to AI/ML specific aspects such as sample size for test sets/training sets, expert adjudication methods, MRMC studies, or standalone algorithm performance, as these details are not present in the provided document.
However, I can extract the information relevant to the performance evaluation that was conducted:
Here's a summary of the available information:
1. A table of acceptance criteria and the reported device performance
Based on the document, specific, quantitative clinical performance acceptance criteria (e.g., minimum sensitivity/specificity thresholds) and their corresponding reported values are not explicitly stated for the SD1 Ultrasonic Pocket Doppler in the context of fetal heart rate detection accuracy. The document focuses on demonstrating substantial equivalence to predicate devices by ensuring the SD1 performs comparably and meets relevant safety and performance standards.
The closest to "acceptance criteria" for clinical performance is the conclusion that:
"The results showed that it did not take more time to find the fetal heart rate in pregnant patients, from 10 weeks of gestation onward, using the SD1 Pocket Doppler in comparison to the predicate SD3 Ultrasonic Pocket Doppler." This implies an acceptance criterion related to the time taken to detect FHR, with the performance meeting this criterion by being comparable to the predicate.
General performance characteristics (like FHR Accuracy) are listed in the predicate comparison table, and the SD1 matches the predicate for these:
| Acceptance Criteria (for FHR Performance) | Reported Device Performance (SD1) |
|---|---|
| FHR Accuracy: ±2bpm (Same as predicate) | ±2bpm |
| FHR Measuring Range: 50bpm ~ 240bpm (Same as predicate SD3) | 50bpm ~ 240bpm |
Other acceptance criteria are regulatory and non-clinical in nature:
| Acceptance Criteria (Category) | Reported Device Performance |
|---|---|
| Electrical Safety (IEC 60601-1) | Met pre-defined acceptance criteria |
| Electromagnetic Compatibility (IEC 60601-1-2) | Met pre-defined acceptance criteria |
| Requirements for ultrasonic medical diagnostic and monitoring equipment (IEC 60601-2-37) | Met pre-defined acceptance criteria |
| Hand-Held probe Doppler fetal heartbeat detectors Performance requirements (IEC 61266) | Met pre-defined acceptance criteria |
| Acoustic output measurement standard (NEMA UD 2) | Met pre-defined acceptance criteria |
| Acoustic output testing (FDA guideline) | Met pre-defined acceptance criteria |
| Biocompatibility (ISO 10993-5, ISO 10993-10) | Met pre-defined acceptance criteria |
| Wireless technology testing (FDA guidance, FCC rules) | Met pre-defined acceptance criteria |
| Software Verification and Validation Testing (FDA guidance) | Met pre-defined acceptance criteria |
2. Sample sized used for the test set and the data provenance
- Sample Size for Test Set: Not explicitly stated. The document mentions "clinical testing was conducted at a Chinese hospital" with "pregnant patients, from 10 weeks of gestation onward." The exact number of patients or cases is not provided.
- Data Provenance: Prospective, from a "Chinese hospital."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The clinical study focused on comparing the time taken to detect fetal heart rate between the subject device (SD1) and a predicate device (SD3). The "ground truth" here would likely be the confirmed presence of a fetal heartbeat, assessed by medical professionals, but the number and qualifications of experts involved in this specific assessment are not detailed.
4. Adjudication method for the test set
Not applicable. The study design described does not involve a multi-reader adjudication process for establishing ground truth, as it's a comparative performance study of two Doppler devices in detecting FHR.
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
Not applicable. This device is a fetal Doppler, not an AI-assisted diagnostic tool for image interpretation. Therefore, an MRMC study comparing human readers with and without AI assistance was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a hardware-based fetal Doppler, not an AI algorithm. Its performance inherently involves a human operator to locate the fetal heartbeat.
7. The type of ground truth used
The clinical study compared the SD1 to a legally marketed predicate device (SD3 Ultrasonic Pocket Doppler). The "ground truth" for the clinical performance aspect would be the successful detection of the fetal heart rate by a medical professional during the clinical test, effectively using the predicate device as a reference for comparison of detection time. There is no mention of pathology or other advanced outcomes data for ground truth in this context.
8. The sample size for the training set
Not applicable. This device is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This device is not an AI/ML device that requires a training set.
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June 6, 2018
Edan Instruments, Inc. Alice Yang Regulatory Engineer #15 Jinhui Road, Jinsha Community Kengzi Sub-District, Pingshan District Shenzhen. Guangdong 518067 China
Re: K172780
Trade/Device Name: SD1 Ultrasonic Pocket Doppler Regulation Number: 21 CFR§ 884.2660 Regulation Name: Fetal Ultrasonic Monitor and Accessories Regulatory Class: II Product Code: KNG Dated: May 3, 2018 Received: May 7, 2018
Dear Alice Yang:
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. Iisting 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.
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You must comply with all the Act's requirements. including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Joyce M. Whang -S
Benjamin R. Fisher, Ph.D. for 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) K172780
Device Name SD1 Ultrasonic Pocket Doppler
Indications for Use (Describe)
The SD1 is a pocket Doppler device used for detecting the 10th week of gestation. It is intended to be used by medical professionals only.
| Type of Use (Select one or both, as applicable) | |
|---|---|
X | Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
Prepared in accordance with the requirements of 21 CFR Part 807.92
| 1. Submitter: | Edan Instruments, Inc.#15 Jinhui Road, Jinsha Community, Kengzi Sub-District, Pingshan District,Shenzhen, 518122 P.R.China.Tel.: (0755) 26856469 Fax: +1 (408) 418-4059 |
|---|---|
| Contact Person: | Alice Yang |
| Date Prepared: | 2018-5-30 |
| 2. Device nameand classification: | Device Name:SD1 Ultrasonic Pocket DopplerModel:SD1(with or without Bluetooth/APP)Common Name: Fetal DopplerClassification Number and Name:21 CFR 884.2660 Fetal ultrasonic monitor and accessoriesProduct code: KNG (monitor, ultrasonic, fetal)Regulatory Class: Class II |
| 3. PredicateDevice(s): | 1. K131457, FETAL ULTRASONIC MONITOR AND ACCESSORIES /JPD-100B, Shenzhen Jumper Medical Equipment Co. (Primary)2. K140579, SD3 ULTRASONIC POCKET DOPPLER, Edan Instruments, Inc.(Secondary)The predicate devices were not subjected to design-related recalls. |
| 4. DeviceDescription: | SD1 Ultrasonic Pocket Doppler is a device prescribed by a licensed physicianfor use by professional healthcare providers. It is a hand-held, battery poweredaudio Doppler device integrated with 3 MHz probe and with optional use ofBluetooth/app, used for detecting fetal heart beats. The device is for prescriptionuse and is intended for use at or after 10 weeks gestation. |
| 5. Indications forUse: | The SD1 is a pocket Doppler device used for detecting the fetal heartbeat fromthe 10th week of gestation. It is intended to be used by medical professionalsonly. |
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6. Predicate Device Comparison
The subject device shares the same characteristics with the predicate device except as shown in the table below. The following differences in technological characteristics do not raise different questions of safety and effectiveness.
| Item | JPD-100B | SD3 | SD1 | ComparisonResult |
|---|---|---|---|---|
| Manufacturer/K# | SHENZHENJUMPERMEDICALEQUIPMENT CO.,LTD / K131457 | EDANINSTRUMENTS,INC./K | EDANINSTRUMENTS,INC./currentsubmission | |
| Indications for use | The device isultrasonic fetalheart detector,which can detectthe Fetal HeartRate. The built-inspeaker of thedevice allows forlistening of the fetalheartbeat. It candisplay values offetal heart rate.The Fetal DopplerJPD-100B is ahand-held, batterypowered audioDoppler deviceused for detectingfetal heart beats. | The SD3 SeriesUltrasonic PocketDopplers areintended to be usedby health careprofessionalsincluding registerednurses, practicalnurses, midwives,ultrasoundtechnicians, andphysician assistants,by prescription fromlicensed physicians inhospitals, clinics andprivate offices.The 2 MHz and 3MHz waterproofprobes are indicatedfor the detection offetal heart rate fromearly gestation thrudelivery and as ageneral indication offetal well being.Specifically, the 3MHz probe is usedfor more than 9-weekgestation and the 2MHz is used for 12-week gestation.The 4 MHz, 5 MHzand/or 8 MHzwaterproof vascularprobes are indicatedfor the detection ofblood flow in veinsand arteries forassisting in thedetection ofperipheral vasculardisease. | The SD1 is a pocketDoppler device usedfor detecting the fetalheartbeat from the10th week ofgestation. It isintended to be usedby medicalprofessionals only. | Different,but thesubject andpredicatedevices havethe sameintended use |
| DeviceDescription | JPD-100B FetalDoppler is deviceprescribed by alicensed physicianfor use in hospitalsand the homecareenvironment. It is ahand-held, batterypowered audioDoppler deviceintegrated with 2.5MHz probe, usedfor detecting fetalheart beats. And thedevice is forprescription use andis intended for useat or after 12 weeksgestation. | The SD3 seriesUltrasonic PocketDoppler is a hand-held device for non-invasivemeasurement anddisplay of fetal heartrate and blood flowvelocity utilizing theprinciple of Dopplershift of an ultrasound.The ultrasound istransmitted from theprobe to patient body(maternal abdominalwall), and movesthrough biophysicalobjects. The acousticultrasound isreflected by bloodand moving objectssuch as the fetalheart. The reflectedultrasound is receivedby the probe and isconverted intoelectric signals. Thewaveform data areapplied to the CPUfor all the digitalprocessing on OLEDDisplay, operationkeys. The audiosignal is taken off forthe routing to thespeaker to generatethe analogue signalsbefore digitalprocessing. Thefollowing probes aresupplied with theSD3 series UltrasonicPocket Doppler:1. 2 MHz for fetalheart rate.2. 3 MHz for fetalheart rate3. 4 MHz fordetections of arterialand venous bloodflow velocity.4. 5 MHz fordetections of arterialand venous bloodflow velocity. | SD1 UltrasonicPocket Doppler is adevice prescribed bya licensed physicianfor use byprofessionalhealthcare providers.It is a hand-held,battery poweredaudio Dopplerdevice integratedwith 3 MHz probeand with optionaluse ofBluetooth/app, usedfor detecting fetalheart beats. Thedevice is forprescription use andis intended for use ator after 10 weeksgestation. | Different,minordifferencesin the devicedescription,but theintended useis the same. |
| Intended patientpopulation | 5. 8 MHz fordetections of arterialand venous bloodflow velocity.FHR Performance:Sensitivity: 9 weeksgestation (3 MHz) | Pregnant woman | Pregnant woman | Same |
| Application site | Indoor | Indoor | Indoor | Same |
| Contactinglocation | Abdomen surface | Abdomen surface | Abdomen surface | Same |
| Operational characteristics | ||||
| Operationprinciple | UltrasonicDoppler/ContinuousWave | UltrasonicDoppler/ContinuousWave | UltrasonicDoppler/Pulsed Wave | Different,clinical testsshow thattheperformanceissubstantiallyequivalent. |
| Installation anduse | hand-held | hand-held | hand-held | Same |
| Mode of operation | Continuousoperation | Continuous operation | Continuous operation | Same |
| Specifications | ||||
| UltrasoundWorkingFrequency | 2MHz, 2.5MHz,3MHz | 2MHz, 3MHz, 4MHz,5MHz, 8MHz | 3MHzPulse repetitionfrequency: 5kHz | Different,but benchand clinicalperformancetestsdemonstratesubstantialequivalence. |
| Size | 128 mm× 91.5 mm×37.5 mm | 168 mm x 31 mm x 67mm | 48mm× 39 mm× 147mm | Different,but thesubjectdeviceconforms to |
| Weight | 530g | about 350 g(including thebattery) | < 180g | deviceconforms to |
| Battery Supply | NI-MH 300mAh9.6v | 3*LR6 AA18650 Lithiumbattery | 2*LR6AA | IEC 60601-1. |
| Display | LCD display | LCD display | LCD display | Same |
| Resolution | 1 bpm | 1 bpm | 1 bpm | Same |
| Accuracy | ±2bpm | ±2bpm | ±2bpm | Same |
| FHR MeasuringRange | 50bpm ~ 210bpm | 50bpm ~ 240bpm | 50bpm ~ 240bpm | Different,butmeasuringrange is thesame as theSD3predicate. |
| Acoustic output(3MHz) | <20mW/cm2 | <20mW/cm2 | <10mW/cm2 | Different,but the |
| subjectdevice hasloweracousticoutput andperformancecomparabletopredicates.Different,Wirelesstechnologytesting per | ||||
| Wireless function | Not support | Not support | Bluetooth/APPfunction (optional). | the FDAguidance,"RadioFrequencyWirelessTechnologyin MedicalDevices"datedAugust 14,2013 andPart 15 ofthe FCCrules. |
| Safety Classifications | ||||
| Anti-electricShock Type | Internally poweredequipment | Internally poweredequipment | Internally poweredequipment | Same |
| Anti-electricShock Degree | Type BF equipment | Type B equipment | Type BF equipment | Same |
| Degree ofProtection againstHarmful Ingress ofWater: | Probes: IPX4 | Probes: IPX8 | IP22 | Different,but thesubjectdeviceconforms toIEC60529:2001. |
| The degree ofsafety ofapplication in thepresence of aflammable gas | Equipment notsuitable for use inpresence offlammable gases | Equipment notsuitable for use inpresence offlammable gases | Equipment notsuitable for use inpresence offlammable gases | Same |
| EMC | CISPR 11 Group 1Class R | CISPR 11 Group 1Class R | CISPR 11 Group 1Class R | Same |
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7. Summary of Performance Data:
Clinical Performance Data:
Clinical testing was conducted at a Chinese hospital to demonstrate that the SD1 Ultrasonic Pocket Doppler, which uses the pulse-wave mode of Doppler ultrasound, is as safe and effective for finding and measuring the fetal heart rate as the SD3 Ultrasonic Pocket Doppler, which uses the continuous-wave
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mode of Doppler ultrasound. The results showed that it did not take more time to find the fetal heart rate in pregnant patients, from 10 weeks of gestation onward, using the SD1 Pocket Doppler in comparison to the predicate SD3 Ultrasonic Pocket Doppler. Therefore, the fetus would not be exposed to a longer duration of ultrasound radiation during the course of an exam with the SD1 Ultrasonic Pocket Doppler.
Non-clinical Performance Data:
Bench testing was conducted per the following standards, and all the results met pre-defined acceptance criteria as applicable and were acceptable.
- (1) IEC 60601-1 Electrical Safety
(2) IEC 60601-1-2 Electromagnetic Compatibility
(3) IEC 60601-2-37 Requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
(4) IEC 61266 ULTRASONICS Hand-Held probe Doppler fetal heartbeat detectors Performance requirements and methods of measurement and reporting
(5) NEMA UD 2 Standard for Acoustic output measurement standard for diagnostic ultrasound equipment.
(6) Acoustic output testing as per the guideline "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" dated September 9, 2008.
(7) Biocompatibility, ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation and sensitization) (8) Wireless technology testing per the FDA guidance, "Radio Frequency Wireless Technology in Medical Devices" dated August 14, 2013 and Part 15 of the FCC rules.
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 to have 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.
8. Conclusion:
Verification and validation testing was conducted on the SD1 Ultrasonic Pocket Doppler with optional use of Bluetooth/app and all testing passed pre-specified criteria. This premarket notification submission demonstrates that the SD1Ultrasonic Pocket Doppler is substantially equivalent to the predicate devices.
§ 884.2660 Fetal ultrasonic monitor and accessories.
(a)
Identification. A fetal ultrasonic monitor is a device designed to transmit and receive ultrasonic energy into and from the pregnant woman, usually by means of continuous wave (doppler) echoscopy. The device is used to represent some physiological condition or characteristic in a measured value over a period of time (e.g., perinatal monitoring during labor) or in an immediately perceptible form (e.g., use of the ultrasonic stethoscope). This generic type of device may include the following accessories: signal analysis and display equipment, electronic interfaces for other equipment, patient and equipment supports, and component parts. This generic type of device does not include devices used to image some relatively unchanging physiological structure or interpret a physiological condition, but does include devices which may be set to alarm automatically at a predetermined threshold value.(b)
Classification. Class II (performance standards).