(243 days)
Not Found
No
The description details standard Doppler ultrasound technology and signal processing, with no mention of AI, ML, or related concepts.
No
The device is used for detection and display of fetal heart rate, which is a diagnostic function, not a therapeutic one.
No
The device is used to detect and display fetal heart rate, which is a measurement, not a diagnosis.
No
The device description explicitly states it is a "hand-held FHR detection device" with "two hand-held components, a main unit and a probe," and contains hardware components like an "ultrasonic signal transmitter and receiver." This indicates it is a physical 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 Pocket Fetal Doppler uses Doppler ultrasound to detect the fetal heart rate externally on the pregnant person's abdomen. It does not analyze samples taken from the body.
- Intended Use: The intended use is to detect fetal heart rate, which is a physiological measurement, not a diagnostic test performed on a biological sample.
Therefore, the device falls under the category of a medical device used for monitoring, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL) is used to detect the fetal heart rate. The device should be used by health care professionals including nurses, midwives, and specialized technicians in the hospital, clinic, community and home. The device is intended for use at or after 12 weeks gestation.
Product codes (comma separated list FDA assigned to the subject device)
KNG
Device Description
The Pocket Fetal Doppler is a hand-held FHR detection device, it is used for non-invasive measurement and display of the fetal heart rate (FHR) utilizing Doppler ultrasound. The Pocket Fetal Doppler consists of two models (CONTEC10C, CONTEC10CL). Both models have two hand-held components, a main unit and a probe. The device contains components of ultrasonic signal transmitter and receiver, analog signals processing unit, FHR calculating unit, and LCD display control unit.
The CONTEC10C is powered by three AA batteries, and the ultrasonic signal is continuously transmitted at a frequency of 2.0MHz.
The CONTEC10CL is powered by a 3.7V lithium battery, and the ultrasonic signal is continuously transmitted at a frequency of 3.0MHz.
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
health care professionals including nurses, midwives, and specialized technicians in the 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)
Non-clinical tests were conducted to verify that the subject device met all design specifications and to support device safety and effectiveness. The test results demonstrated that the subject device complies with the following standards:
- Recommended biocompatibility endpoints per the 2020 FDA guidance Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"
- ISO 10993-5: 2009 Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity
- ISO 10993-10: 2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
- IEC 60601-1:2012, Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-11 Edition 2.0 2015-01 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-Requirements And Tests
- Acoustic output testing per the 2019 FDA guidance Marketing Clearance of Diagnostic Ultrasound Systems and Transducers
- 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;
- IEC 62133-2 Edition1.0 2017-02 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 - Part 2: Lithium systems
In addition, the following performance testing was performed on the subject device: - Use Life Testing
- Battery Life Testing
- Battery Indicator Testing
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- FHR Measuring Range: 50 BPM ~ 240 BPM
- Resolution: 1 BPM
- Accuracy: ±2 BPM
- Acoustic output (statistical maximum limit): ISATA
§ 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 is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 28, 2022
Contec Medical Systems Co., Ltd. % Ray Wang General Manager Beijing Believe-Med Technology Service Co., Ltd. Rm. 912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District Beijing, Beijing 102401 China
Re: K220245
Trade/Device Name: Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL) Regulation Number: 21 CFR$ 884,2660 Regulation Name: Fetal Ultrasonic Monitor and Accessories Regulatory Class: II Product Code: KNG Dated: August 24, 2022 Received: August 24, 2022
Dear Ray Wang:
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/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); 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 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
2
Indications for Use
510(k) Number (if known) K220245
Device Name
Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL)
Indications for Use (Describe)
The Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL) is used to detect the fetal heart rate. The device should be used by health care professionals including nurses, midwives, and specialized technicians in the hospital, clinic, community and home. The device is intended for use at or after 12 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) |
X Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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The assigned 510(k) Number: K220245
Tab #4 510(k) Summary
This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.
-
- Date of Preparation: September 27, 2022
-
- 510(k) Owner
Contec Medical Systems Co., Ltd.
No.112 Qinhuang West Street, Economic & Technical Development Zone, Qinhuangdao, Hebei Province, PEOPLE'S REPUBLIC OF CHINA.
Contact Person: Jie Xiao Position: Deputy Manager Tel: +86-335-8015490 Fax: +86-335-8015490 Email: pms.qms(@contecmed.com
-
- Designated Submission Correspondent
Mr. Ray Wang
- Designated Submission Correspondent
Beijing Believe-Med Technology Service Co., Ltd.
Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, Beijing, 102401, China
Tel: +86-18910677558 Fax: +86-10-56335780 Email: information(@believe-med.com
4
4. Identification of Subject Device
Trade Name: Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL) Common Name: Fetal Doppler
Regulatory Information Regulation Name: Fetal ultrasonic monitor and accessories Regulation Number: 21 CFR 884.2660 Regulatory Class: II Product Code: KNG Review Panel: Obstetrics/Gynecology
- Predicate Device 5.
510(k) Number: K182526 Product Name: Fetal Doppler Manufacturer: Vcomin Technology Limited
The predicate device has not been subject to a design related recall.
Device Description:
The Pocket Fetal Doppler is a hand-held FHR detection device, it is used for non-invasive measurement and display of the fetal heart rate (FHR) utilizing Doppler ultrasound. The Pocket Fetal Doppler consists of two models (CONTEC10C, CONTEC10CL). Both models have two hand-held components, a main unit and a probe. The device contains components of ultrasonic signal transmitter and receiver, analog signals processing unit, FHR calculating unit, and LCD display control unit.
The CONTEC10C is powered by three AA batteries, and the ultrasonic signal is continuously transmitted at a frequency of 2.0MHz.
The CONTEC10CL is powered by a 3.7V lithium battery, and the ultrasonic signal is continuously transmitted at a frequency of 3.0MHz.
Indications for use Statement:
The Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL) is used to detect the fetal heart rate. The device should be used by health care professionals including nurses, midwives, and specialized technicians in the hospital, clinic, community and home. The device is intended for use at or after 12 weeks gestation.
-
- Substantial Equivalence Discussion
The table below compares the intended use and technological characteristics of the subject and predicate device.
- Substantial Equivalence Discussion
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Item | Subject Device | Predicate Device |
---|---|---|
K182526 | ||
Device name | Pocket Fetal Doppler | Fetal Doppler |
Classification | ||
Regulation | 21 CFR 884.2660 | 21 CFR 884.2660 |
Classification | II | II |
Product Code | KNG | KNG |
Regulation | ||
Name | Fetal ultrasonic monitor and | |
accessories. | Fetal ultrasonic monitor and | |
accessories. | ||
Indications | ||
for use | The Pocket Fetal Doppler (Models | |
CONTEC10C and CONTEC10CL) is | ||
used to detect the fetal heart rate. The | ||
device should be used by health care | ||
professionals including nurses, | ||
midwives, and specialized | ||
technicians in the hospital, clinic, | ||
community and home. The device is | ||
intended for use at or after 12 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. | ||
Intended | ||
population | Women with pregnancy at or after 12 weeks | Women with pregnancy at or after 12 weeks |
Design | A main unit and a probe. The main | |
unit can display FHR | A main unit and a probe. The main | |
unit can display FHR | ||
Mode of action | Doppler ultrasound, continuous wave | Doppler ultrasound, continuous wave |
Ultrasound | ||
frequency | 2.0 MHz, 3.0 MHz | 2.0 MHz, 2.5 MHz, and 3.0 MHz |
-FHR Measuring Range: | ||
50 BPM ~ 240 BPM | -FHR Measuring Range: | |
50-210 bpm | ||
Performance | -Resolution: 1 BPM | |
Accuracy: ±2 BPM | -Resolution: 1 bpm | |
-Accuracy: ±2 bpm | ||
Acoustic output | ||
(statistical | ||
maximum limit) | ISATA IEC 60601-1-2:2014, Medical Electrical Equipment-Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility-Requirements And Tests |
-
Acoustic output testing per the 2019 FDA guidance Marketing Clearance of Diagnostic Ultrasound Systems and Transducers
- 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;
7
-
IEC 62133-2 Edition1.0 2017-02 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 - Part 2: Lithium systems
In addition, the following performance testing was performed on the subject device: -
Use Life Testing
-
Battery Life Testing
-
Battery Indicator Testing
8
8. Conclusion
The non-clinical performance testing described above demonstrates that the subject device is as safe and effective as the predicate device and supports a determination of substantial equivalence.