(260 days)
Not Found
No
The device description and performance studies focus on standard Doppler ultrasound technology and its accuracy in measuring fetal heart rate. There is no mention of AI, ML, or any related concepts in the provided text.
No
The device is used for detection and measurement of the fetal heart rate, which is a diagnostic function, not a therapeutic one. It does not treat or alleviate any condition.
Yes
The device is used to "detect the fetal heart rate" and perform "non-invasive measurement and display of the fetal heart rate (FHR)". This collection of physiological data for health assessment is characteristic of a diagnostic device.
No
The device description explicitly states that the device consists of hardware components including a main unit (main board, power module, battery, speaker, LED screen) and a probe (ultrasonic transducers). 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 description clearly states the device uses Doppler ultrasound to non-invasively measure the fetal heart rate. This is a physical measurement taken directly from the body, not a test performed on a sample outside the body.
- Intended Use: The intended use is to detect fetal heart rate, which is a physiological measurement.
- Device Description: The components and operation described (ultrasonic transducers, receiving reflected signals, detecting Doppler shift) are consistent with an ultrasound device, not an IVD.
Therefore, this device falls under the category of a medical device, specifically an ultrasound device for fetal heart rate detection, rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The device is used to detect the fetal heart rate. The device should be used by health care professionals including nurses, midwives, and specialized technicians in hospital, clinic, community and home.
Product codes
KNG
Device Description
The 510(k) covers four series of Fetal Doppler devices, including FD-200, FD-231, FD-591, and FD-640. Each series contains two models, and four series consists of a total of eight individual models (FD-231B, FD-231D, FD-640B, FD-640D, FD-200B, FD-200D, FD-591B, and FD-591D).
The subject devices are used for non-invasive measurement and display of the fetal heart rate (FHR) utilizing Doppler ultrasound. All models have two hand-held components, a main unit and a probe. The main unit consists of the main board, power module, battery, speaker, and LED screen. The probe consists of the ultrasonic transducers for transmission and one for signal reception. The ultrasonic signal is continuously transmitted at a frequency of 2.0. 2.5, or 3.0 MHz, depending on the probe selected. The reflected continuous signal is received, and detected Doppler shift is presented to the user. These devices are intended for use at or after 12 weeks' gestation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Doppler ultrasound, continuous wave
Anatomical Site
Not Found
Indicated Patient Age Range
The device is intended for use at or after 12 weeks' gestation.
Intended User / Care Setting
The device should be used by health care professionals including nurses, midwives, and specialized technicians in hospital, clinic, community and home.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 and IEC 60601-1-11:2015
- Electromagnetic compatibility (EMC) testing per IEC 60601-1-2:2014
- Ultrasound testing per IEC 60601-2-37:2015
- Battery testing per EN 62133:2013
- Acoustic output testing 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 pressing-key performance and FHR measurement accuracy. The results demonstrated that the subject device can be used for three years under normal use conditions.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- FHR Measuring Range: 50-210 bpm
- Resolution: 1 bpm
- Accuracy: ±2 bpm
Acoustic output (statistical maximum limit) - 2.0MHz - ISATA: 17.24 mW/cm²
- 2.5MHz - ISATA: 18.57 mW/cm²
- 3.0MHz - ISATA: 11.496 mW/cm²
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). On the left, there is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
May 29, 2019
Vcomin Technology Limited % Lucy Yan Consult Shenzhen Joyantech Consulting Co., Ltd. 1122#, International Mayor Communication Center 55 Shizhou Zhong Road, Nanshan District Shenzhen, Guangdong 518100 China
Re: K182526
Trade/Device Name: Fetal Doppler ((Models: FD-231D, FD-640B, FD-640D, FD-200B, FD-200D, FD-591B,and FD-591D) Regulation Number: 21 CFR§ 884.2660 Regulation Name: Fetal Ultrasonic Monitor and Accessories Regulatory Class: II Product Code: KNG Dated: April 15, 2019 Received: April 29, 2019
Dear Lucy Yan:
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.htm); 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 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 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,
Sharon M. Andrews -S
Sharon M. Andrews Assistant Division 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
2
Indications for Use
510(k) Number (if known) K182526
Device Name
Fetal Doppler (Models: FD-231B, FD-231D, FD-640D, FD-200B, FD-200D, FD-591B,and FD-591D)
Indications for Use (Describe)
The device is used to detect the fetal heart rate. The device should be used by health care professionals including nurses, midwives, and specialized technicians in hospital, clinic, community and home.
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 K182526
1. Submitter Information
| Manufacturer information | Company Name: Vcomin Technology Limited
Company address:
2&3 Fl., No.1, Kangzheng Rd., Buji Town, Shenzhen,
Guangdong 518110, P. R. China
Contact person: Han JieLin
Phone: +86-755-33826016
Fax: +86-755-61658248
E-mail: info@vcomin.com |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submission Correspondent | Shenzhen Joyantech Consulting Co., Ltd.
Address: Room 1122, International Mayors
Communication Centre, 55 Shizhou Zhong Rd.,
Nanshan District, Shenzhen, Guangdong 518000, P. R. China
Contact person: Ms. Lucy Yan; Mr. Field Fu
E-Mail: lucy@cefda.com; field@cefda.com |
2. Date Prepared: May 29, 2019
3. Device Identification
Trade Name | Fetal Doppler (Models: FD-231B, FD-231D, FD-640B, FD-640D, FD-200B, FD-200D, FD-591B, and FD-591D) |
---|---|
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
Fetal Doppler (K131457) manufactured by Shenzhen Jumper Medical Equipment Co., Ltd. This predicate has not been subject to any design related recalls.
5. Device Description
The 510(k) covers four series of Fetal Doppler devices, including FD-200, FD-231, FD-591, and FD-640. Each series contains two models, and four series consists of a total of eight individual models (FD-231B, FD-231D, FD-640B, FD-640D, FD-200B, FD-200D, FD-591B, and FD-591D).
4
The subject devices are used for non-invasive measurement and display of the fetal heart rate (FHR) utilizing Doppler ultrasound. All models have two hand-held components, a main unit and a probe. The main unit consists of the main board, power module, battery, speaker, and LED screen. The probe consists of the ultrasonic transducers for transmission and one for signal reception. The ultrasonic signal is continuously transmitted at a frequency of 2.0. 2.5, or 3.0 MHz, depending on the probe selected. The reflected continuous signal is received, and detected Doppler shift is presented to the user. These devices are intended for use at or after 12 weeks' gestation.
6. Indications for Use
The device is used to detect the fetal heart rate. The device should be used by health care professionals including nurses, midwives, and specialized technicians in hospital, clinic, community and home.
Devices | Subject devices (K182526) | Predicate device (K131457) |
---|---|---|
Indications for Use | The device is used to detect the fetal | |
heart rate. The device should be used | ||
by health care professionals including | ||
nurses, midwives, and specialized | ||
technicians in hospital, clinic, | ||
community and home. | The fetal doppler JPD-100B is a hand- | |
held, battery powered audio doppler | ||
device used for detecting fetal heart beats. | ||
Intended population | Same as the predicate device | Women with pregnancy at or after 12 |
weeks | ||
Design | Same as the predicate device | A main unit and a probe. The main unit |
can display FHR | ||
Mode of action | Same as the predicate device | Doppler ultrasound, continuous wave |
Ultrasound frequency | 2.0 MHz, 2.5 MHz, and 3.0 MHz | 2.5 MHz |
Performance | - FHR Measuring Range: 50-210 bpm |
- Resolution: 1 bpm
- Accuracy: ±2 bpm | - FHR Measuring Range: 50-230 bpm
- Resolution: 1 bpm
- Accuracy: ±2 bpm |
| Acoustic output (statistical
maximum limit) | - 2.0MHz - ISATA: 17.24 mW/cm² - 2.5MHz - ISATA: 18.57 mW/cm²
- 3.0MHz - ISATA: 11.496 mW/cm² | ISATA: