(198 days)
Not Found
No
The description focuses on standard Doppler ultrasound technology and signal processing for heart rate detection, with no mention of AI or ML algorithms.
No.
The device is used for detection and monitoring of the fetal heart rate, which is a diagnostic function, not a therapeutic one.
No
The device is used to detect the fetal heart rate, which is a measurement. It is not described as being used to diagnose a medical condition based on that measurement.
No
The device description clearly states it is a hand-held, battery powered audio Doppler device with physical components including a main unit and a probe containing transducers, a speaker, and an LCD screen. This indicates it is a hardware device, not software-only.
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 uses Doppler ultrasound to detect the fetal heart rate non-invasively by applying the device to the mother's abdomen. It does not analyze samples taken from the body.
- Intended Use: The intended use is to "detect the fetal heart rate," which is a direct measurement of a physiological function, not an analysis of a biological sample.
Therefore, the Fetal Doppler falls under the category of a medical device that uses physical principles (ultrasound) to obtain information about the patient, rather than an in vitro diagnostic device that analyzes biological samples.
N/A
Intended Use / Indications for Use
The Fetal Doppler is used to detect the feal heart rate. The device should be used by health care professionals including nurses, midwives, and specialized technicians in hospital, clinic, community and home. The device is intended for use at or after 16 weeks gestation.
Product codes
KNG
Device Description
The Fetal Doppler, model TK-T802CR, is a hand-held, battery powered audio Doppler device used for detecting fetal heart beats and sounds. The Fetal Doppler is used for non-invasive detection and display of the fetal heart rate (FHR) utilizing Doppler ultrasound. It has two hand-held components, a main unit and a probe. The main unit consists of the main board, power module, battery, speaker, and LCD screen. The probe consists of the ultrasonic transducers for transmission and 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 settings selected.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Doppler ultrasound
Anatomical Site
Fetal heart
Indicated Patient Age Range
at or after 16 weeks gestation
Intended User / Care Setting
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
The following performance data were provided in support of the substantial equivalence determination:
- Biocompatibility: Biocompatibility testing on the patient-contacting components of the subject device in accordance with the FDA guidance "Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" dated September 4, 2020. Testing included the following assessments:
- Cytotoxicity per ISO 10993-5:2009
- Sensitization per ISO 10993-10:2010
- Irritation per ISO 10993-10:2010
The patient-contacting materials were shown to be non-cytotoxic, non-irritating, and nonsensitizing.
- Electrical Safety, Electromagnetic Compatibility, and Wireless Technology:
- IEC 60601-1:2005+CORR.1:2006+CORR.2:2007+A1:2012, Medical electrical equipment - Part 1: General requirements for basic safety, and essential performance with US deviations per AAMI/ANSI ES 60601-1:2005/(R)2012 and A1:2012.
- IEC 60601-1-11:2015, Medical electrical equipment - Part 1-11: General requirements for basic safety, and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
- IEC 60601-1-2:2014, Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic Compatibility
- IEC 62133:2012 - Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications
- Software Verification: Software verification and validation was conducted and software documentation was provided in accordance with the FDA Guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" dated May 11, 2005 for a moderate software level of concern.
- Performance Testing: The following testing was provided to support the safety and effectiveness of the subject device:
- Use-Life Testing
- Fetal Heart Rate Accuracy Testing
- Testing per IEC 60601-2-37 Edition 2.1 2015 Medical electrical equipment Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
- Acoustic output testing per NEMA UD 2-2004(R2009) Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment and the acoustic output measurement methodology as recommended in FDA guidance document "Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" dated June 27, 2019 was followed for Track 1 devices.
Key Metrics
FHR Measuring Range: 50-210 bpm
Accuracy: ±2 bpm
Resolution: 1 bpm
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).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a smaller font.
January 7, 2022
Shenzhen Taikang Medical Equipment Co., Ltd. Shigui Du General Manager 3F East, Building 4, Lanzhu East Road 8, Grand Industrial Park, Pingshan District Shenzhen, Guangdong 518015 CHINA
Re: K211940
Trade/Device Name: Fetal Doppler Regulation Number: 21 CFR 884.2660 Regulation Name: Fetal Ultrasonic Monitor And Accessories Regulatory Class: II Product Code: KNG Dated: December 6, 2021 Received: December 6, 2021
Dear Shigui Du:
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.
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
1
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/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-device-advice-comprehensive-regulatoryassistance/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, 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
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Indications for Use
510(k) Number (if known) K211940
Device Name Fetal Doppler
Indications for Use (Describe)
The Fetal Doppler is used to detect the feal heart rate. The device should be used by health care professionals including nurses, midwives, and specialized technicians in hospital, clinic, community and home. The device is intended for use at or after 16 weeks gestation.
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)
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510(k) Summary K211940
Prepared in accordance with the requirements of SMDA and 21 CFR §807.92
1.0 Information of Submitter and Correspondent
Submitter's information:
Company Name: Shenzhen Taikang Medical Equipment Co., Ltd.
| Street Address: | 3F East, Building 4, Lanzhu East Road 8, Grand Industrial Park,
Pingshan District |
|------------------|--------------------------------------------------------------------------------------|
| City: | Shenzhen |
| State/ Province: | Guangdong |
| Country: | China |
| Telephone: | +86(755)-89664986 |
| Fax: | +86(755)-89664986 |
| Contact Person: | Shigui Du |
| Contact Title: | General Manager |
| Contact Email: | dushigui@taikang-medical.com |
Submission correspondent's information:
| Name: | Shenzhen Reanny Medical Devices Management Consulting Co., Ltd |
|---|---|
| Address: | Room 2012#, Gebu Commercial Building, Hongxing Community |
| Songgang Street, Baoan District, Shenzhen 518000, China | |
| Contact Person: | Reanny Wang |
| E-mail: | reanny@reanny.com |
Date Summary Prepared: January 5, 2022
2.0 Device Information
| Trade/Device Name | Fetal Doppler |
|---|---|
| Model: | TK-T802CR |
| Regulation Name: | Fetal ultrasonic monitor and accessories |
| Requlation Number: | 21 CFR 884.2660 |
| Common Name: | Fetal Doppler |
| Product Code: | KNG (monitor, ultrasonic, fetal) |
| Regulatory Class: | Class II |
| Review Panel: | Obstetrics/Gynecology |
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3.0 Predicate Device Information
| Sponsor: | Vcomin Technology Limited Company |
|---|---|
| Device: | Fetal Doppler, Model: FD-200D |
| 510(K) Number: | K182526 |
| The predicate device has not been subject to a design-related recall. |
4.0 Device Description
The Fetal Doppler, model TK-T802CR, is a hand-held, battery powered audio Doppler device used for detecting fetal heart beats and sounds. The Fetal Doppler is used for non-invasive detection and display of the fetal heart rate (FHR) utilizing Doppler ultrasound. It has two hand-held components, a main unit and a probe. The main unit consists of the main board, power module, battery, speaker, and LCD screen. The probe consists of the ultrasonic transducers for transmission and 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 settings selected.
5.0 Indications for Use
The Fetal Doppler 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 device is intended for use at or after 16 weeks gestation.
6.0 Comparison to the Predicate Device
The following table compares the subject device to the predicate device with respect to the intended use and technological characteristics:
| Device & Predicate
| Device(s): | Subject Device | Predicate Device | Comparison |
|---|---|---|---|
| K211940 | K182526 | ||
| Fetal Doppler | |||
| Model: TK-T802CR | Fetal Doppler | ||
| Model: FD-200D | |||
| Indications for Use | The Fetal Doppler 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 device is intended for | |||
| use at or after 16 weeks | |||
| gestation. | 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. | Same | ||
| Design | A main unit and a probe. The | ||
| main unit displays FHR | A main unit and a probe. The | ||
| main unit displays FHR | Same | ||
| Mode of action | Doppler ultrasound, continuous | ||
| wave | Doppler ultrasound, continuous | ||
| wave | Same | ||
| Ultrasound | |||
| frequency | 2.0 MHz, 2.5 MHz, and 3.0 MHz | 2.0 MHz, 2.5 MHz, and 3.0 MHz | Same |
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| FHR Specifications | FHR Measuring Range: 50-210 bpm | FHR Measuring Range: 50-210 bpm | Same | |
|---|---|---|---|---|
| Accuracy: ±2 bpm | Accuracy: ±2 bpm | |||
| Resolution: 1 bpm | Resolution: 1 bpm | |||
| Acoustic output | 2.0MHz - ISATA: 6.01mW/cm² | 2.0MHz - ISATA: 17.24 mW/cm² | Different | |
| 2.5MHz - ISATA: 6.67mW/cm² | 2.5MHz - ISATA: 18.57 mW/cm² | |||
| 3.0MHz - ISATA: 6.87mW/cm² | 3.0MHz - ISATA: 11.496 mW/cm² | |||
| Material - Patient | ||||
| Contacting | ||||
| Components | ABS | ABS, Silicone, Colorants | Same |
The subject and predicate device have the same intended use (i.e., to detect the fetal heartbeat). The subject and predicate device have different technological characteristics, including different acoustic output specifications, physical dimensions, and weight. The differences in technological characteristics do not raise new questions of safety and effectiveness.
7.0 Performance Summary
The following performance data were provided in support of the substantial equivalence determination:
-
a. Biocompatibility
Biocompatibility testing on the patient-contacting components of the subject device in accordance with the FDA guidance "Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" dated September 4, 2020. Testing included the following assessments: -
Cytotoxicity per ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: ● Tests for in vitro cytotoxicity
-
. Sensitization per ISO 10993-10:2010 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization
-
Irritation per ISO 10993-10:2010 Biological evaluation of medical devices -- Part 10: ● Tests for irritation and skin sensitization
The patient-contacting materials were shown to be non-cytotoxic, non-irritating, and nonsensitizing.
- b. Electrical Safety, Electromagnetic Compatibility, and Wireless Technology
- IEC 60601-1:2005+CORR.1:2006+CORR.2:2007+A1:2012, Medical electrical . equipment - Part 1: General requirements for basic safety, and essential performance with US deviations per AAMI/ANSI ES 60601-1:2005/(R)2012 and A1:2012.
- . IEC 60601-1-11:2015, Medical electrical equipment - Part 1-11: General requirements for basic safety, and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
- IEC 60601-1-2:2014, Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic Compatibility
- IEC 62133:2012 - Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications
- c. Software Verification
6
Software verification and validation was conducted and software documentation was provided in accordance with the FDA Guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" dated May 11, 2005 for a moderate software level of concern.
-
d. Performance Testing
The following testing was provided to support the safety and effectiveness of the subject device: -
i. Use-Life Testing
-
ii. Fetal Heart Rate Accuracy Testing
-
Testing per IEC 60601-2-37 Edition 2.1 2015 Medical electrical equipment Part iii. 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
-
iv. Acoustic output testing per NEMA UD 2-2004(R2009) Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment and the acoustic output measurement methodology as recommended in FDA guidance document "Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" dated June 27, 2019 was followed for Track 1 devices.
9. Conclusion
The non-clinical performance data described above demonstrate that the Fetal Doppler is as safe and effective as the predicate device and supports a determination of substantial equivalence.