(155 days)
Not Found
No
The description focuses on standard Doppler ultrasound technology and signal processing for fetal heart rate detection and display. There is no mention of AI, ML, or any advanced algorithms that would suggest their use.
No
The device is a diagnostic tool used to detect and display fetal heart rate, not to treat a condition.
Yes
The device detects fetal heartbeats and displays fetal heart rate, which are measurements taken to provide information about a medical condition (pregnancy).
No
The device description explicitly states it is a hand-held device with two major components: a main unit (containing hardware like a main board, power module, battery, speaker, and LCD screen) and a wired probe (containing ultrasonic crystals). This indicates it is a hardware device with embedded software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Fetal Doppler described here uses Doppler ultrasound to detect and display the fetal heart rate and play the heart sound. It is a non-invasive device that interacts directly with the body (applying the probe to the abdomen) rather than analyzing a sample taken from the body.
- Intended Use: The intended use clearly states it's for detecting fetal heart beats and displaying heart rate, not for analyzing biological samples.
Therefore, this device falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Fetal Doppler is intended to detect fetal heart beats, display fetal heart rate, and play the fetal heart sound from early gestation. The device should only be used by a trained medical professional in a clinical setting and is not intended for operated by the patient at home.
Product codes
KNG
Device Description
The subject device (model FD88) is a hand-held device for non-invasive measurement and display of the fetal heart rate (FHR) utilizing Dopler ultrasound. It includes two major components: main unit and probe. The main unit consists of the main board, power module, battery, speaker, and LCD screen. The main unit is supplied by a rechargeable 3.7V/500mAh Li-ion battery. The wired probe contains two angled semi-circle ultrasonic crystals, one for transmission and the other for reception. The ultrasonic signal is continuously transmitted (at a frequency of 2.5 MHz), received and presented to the user as numerical display. This device is intended to be used after 12 weeks gestation for singleton by a trained health professional in a clinical setting.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Doppler ultrasound
Anatomical Site
Not Found
Indicated Patient Age Range
from early gestation. ... intended to be used after 12 weeks gestation for singleton
Intended User / Care Setting
trained medical professional in a clinical setting
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
The following studies have been performed to support substantial equivalence to the predicate devices:
- Biocompatibility:
- Cytotoxicity Test per ISO 10995-5:2009
- Skin Irritation Test per ISO 10993-10:2010
- Guinea Pig Maximization Sensitization Test per ISO 10993-10:2010
- Cleaning and disinfection validation testing in accordance with FDA guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" issued March 17, 2015
- Software verification and validation testing in accordance with FDA guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued May 11, 2005
- Electrical safety testing per ANSI/AAMI ES60601-1:2005(R)2012 + A1:2012.
- Electromagnetic compatibility (EMC) testing per IEC 60601-1-2:2014
- Battery performance testing: In this test, battery life, operation time, recharging time and battery status indicator function were evaluated. The test showed that all design specifications were met.
- Ultrasound testing per IEC 60601-2-37:2015.
- Acoustic output testing per NEMA UD2 and FDA guidance "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers' issued September 9, 2008
- Use-life testing: In this study, the devices under simulated repeated use conditions were evaluated for appearance, deformation, malfunction, fetal heart rate measurement range and accuracy of fetal heart rate measurement. The results demonstrated that the subject device can be used for five years under normal use conditions.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the symbol of the Department of Health & Human Services on the left and the FDA acronym followed by the full name of the agency, "U.S. Food & Drug Administration," on the right. The FDA part of the logo is in blue, with the acronym in a solid blue square and the agency's name in a lighter blue font.
March 1. 2019
ShenzZhen Luckcome Technology Inc., Ltd. Linli He Regulatory Manager Floor 6A. 6th Building Tongfuyu Industrial Park Nanshan District Shenzhen, 518055 China
Re: K182710
Trade/Device Name: Fetal Doppler, Model FD88 Regulation Number: 21 CFR& 884.2660 Regulation Name: Fetal Ultrasonic Monitor and Accessories Regulatory Class: II Product Code: KNG Dated: January 28, 2019 Received: January 31, 2019
Dear Linli He:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Sharon M. Andrews -S
for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K182710
Device Name Fetal Doppler, Model FD88
Indications for Use (Describe)
The Fetal Doppler is intended to detect fetal heart beats, display fetal heart rate, and play the fetal heart sound from early gestation. The device should only be used by a trained medical professional in a clinical setting and is not intended for operated by the patient at home.
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."
3
510(k) Summary (K182710)
1. Submitter
| Name and Address | ShenZhen Luckcome Technology Inc., Ltd.
Floor 6A, 6th Building
Tongfuyu Industrial Park, Nanshan District
Shenzhen, 518055
P. R. China
Telephone: +86 755-26853526 |
|------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Linli He |
- Date Prepared: February 28, 2019
3. Device Information
| Trade Name: | Fetal Doppler, Model FD88 |
|---|---|
| Common Name: | Fetal Doppler |
| Regulation Name: | Fetal Ultrasonic Monitor and Accessories |
| Regulation Number: | 21 CFR 884.2660 |
| Product Code: | KNG (Monitor, Ultrasonic, Fetal) |
| Regulatory Class: | II |
4. Predicate Device
Ultrasonic Doppler (Model YM-2T8) (K180419) manufactured by Shenzhen IMDK Medical Technology Co., Ltd. This predicate device has not been subject to any design-related recalls.
5. Device Description
The subject device (model FD88) is a hand-held device for non-invasive measurement and display of the fetal heart rate (FHR) utilizing Dopler ultrasound. It includes two major components: main unit and probe. The main unit consists of the main board, power module, battery, speaker, and LCD screen. The main unit is supplied by a rechargeable 3.7V/500mAh Li-ion battery. The wired probe contains two angled semi-circle ultrasonic crystals, one for transmission and the other for reception. The ultrasonic signal is continuously transmitted (at a frequency of 2.5 MHz), received and presented to the user as numerical display. This device is intended to be used after 12 weeks gestation for singleton by a trained health professional in a clinical setting.
6. Indications for Use
The Fetal Doppler is intended to detect fetal heart beats, display fetal heart rate, and play the fetal heart sound from early gestation. The device should only be used by a trained medical professional in a clinical setting and is not intended for use by the patient at home.
4
7. Predicate Device Comparison
| Devices | Subject device (K182710) | Predicate device (K180419) |
|---|---|---|
| Indications for Use | The Fetal Doppler is intended to detect | |
| fetal heart beats, display fetal heart rate, | ||
| and play the fetal heart sound from early | ||
| gestation. The device should only be | ||
| used by a trained medical professional | ||
| in a clinical setting and is not intended | ||
| for use by the patient at home. | The Ultrasonic Doppler uses continuous- | |
| wave Doppler to detect fetal heart beats, | ||
| display fetal heart rate and play the fetal | ||
| heart sound from early gestation through | ||
| delivery for singleton pregnancies. The | ||
| Ultrasonic Doppler is intended for use by | ||
| trained healthcare professionals only in a | ||
| clinical setting. | ||
| Intended patients | Same as the predicate device | Women with pregnancy at 12 weeks or |
| onward | ||
| Design | Same as the predicate device | A main unit and a wired probe. The main |
| unit can display the FHR. | ||
| Mode of action | Same as the predicate device | Doppler ultrasound |
| Ultrasound frequency | 2.5 MHz | 2.0 MHz |
| Performance | Same as the predicate device | - FHR Measuring Range: 50-210 bpm |
- Resolution: 1 bpm
- Accuracy: $\pm$ 2 bpm |
| Acoustic output | Same as the predicate device | ISATA: