(270 days)
Kng
Not Found
No
The device description details standard signal processing and calculation units, and there is no mention of AI, ML, or related concepts in the document.
No.
The device is used to detect and display fetal heart rate, which is a diagnostic function, not a therapeutic one.
Yes
This device is used to detect and display the fetal heart rate, which is a measurement used for diagnostic purposes (monitoring fetal well-being). The "Intended Use" explicitly states it's for detecting fetal heart rate, and the "Device Description" details its function for "non-invasive measurement and numerical display." Furthermore, the performance testing section references "Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment," directly linking it to diagnostic use.
No
The device description explicitly states it includes hardware components such as an upper shell, display, probe, ultrasonic signal transmitter and receiver, analog signals processing unit, FHR calculating unit, and LCD display control unit. It also mentions being powered by batteries. While software verification and validation are mentioned, the device is clearly a physical device with integrated software, not a software-only device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The description clearly states the Pocket Fetal Doppler uses non-invasive measurement utilizing pulsed-wave Doppler ultrasound to detect the fetal heart rate. It does not involve collecting or analyzing biological samples like blood, urine, or tissue.
- The intended use is direct measurement of a physiological parameter. The device directly measures the fetal heart rate in vivo (within the body) using ultrasound technology. This is characteristic of a diagnostic device, but not an in vitro diagnostic device.
Therefore, while it is a medical device used for diagnostic purposes (detecting fetal heart rate), it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Pocket Fetal Doppler (Models CONTEC 10D, CONTEC 10E and CONTEC10F) 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
KNG
Device Description
The Pocket Fetal Doppler is a hand-held fetal Doppler used for non-invasive measurement and numerical display of the fetal heart rate (FHR) utilizing pulsed-wave Doppler ultrasound. The Pocket Fetal Doppler includes three models: CONTEC10E and CONTEC10E and CONTEC10F. All models have four components: upper shell, display and probe. The material for probe cap and shell is ABS. The device contains an ultrasonic signal transmitter and receiver, analog signals processing unit, FHR calculating unit, and LCD display control unit. 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. This device can detect a fetal heart rate value at or after twelve weeks gestation.
The CONTEC10D is powered by a 3.7V lithium battery, the ultrasonic signal is continuously transmitted at a frequency of 2.5MHz.
The CONTEC10E and CONTEC10F is powered by two 1.5V batteries (AA LR6), the ultrasonic signal is continuously transmitted at a frequency of 2.5MHz.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Doppler ultrasound, pulsed 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 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
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:
- AAMI/ANSI/ES 60601-1: 2012 Medical electrical equipment Part 1: General requirements A for basic safety and essential performance
- A 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 disturbances -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 A 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
- This device meets the recommendations of Attachment G of the FDA Guidance document "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" (issued September 2023). Therefore, this device is considered biocompatible.
- IEC 62359: 2017 Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields
- A Software verification and validation documentation consistent with a Basic level of documentation per the 2023 FDA guidance Content of Premarket Submissions for Device Software Functions (fda.gov)
In addition, the following performance testing was performed on the subject device:
- Use Life testing
- Battery life testing
- Battery indicator testing
Key results: The non-clinical performance testing described above demonstrates that the device is as safe and effective as the predicate device (K220245) and supports a determination of substantial equivalence.
Key Metrics
FHR Measuring Range: 50 BPM ~ 240 BPM
Resolution: 1 BPM
Accuracy: ±2 BPM
Acoustic output (statistical maximum limit): CONTEC 10D: 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 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" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".
June 14, 2024
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: K232893
Trade/Device Name: Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal Doppler (CONTEC 10F) Regulation Number: 21 CFR 884.2660 Regulation Name: Fetal Ultrasonic Monitor And Accessories Regulatory Class: II Product Code: KNG Dated: May 11, 2024 Received: May 13, 2024
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 (the 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 available 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
1
Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devicereporting-mdr-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/medical-device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the
2
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-comprehensiveregulatory-assistance/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 -S
Monica D. Garcia, PhD 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
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
Pocket Fetal Doppler (CONTEC 10D); Pocket Fetal Doppler (CONTEC 10E); Pocket Fetal Doppler (CONTEC 10F)
Indications for Use (Describe)
The Pocket Fetal Doppler (Models CONTEC 10D, CONTEC 10E and CONTEC10F) 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)
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."
4
The assigned 510(k) Number: _ K232893
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: June 14, 2024
-
- 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
-
- Identification of Subject Device
Trade Name: Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal Doppler (CONTEC 10F) Common Name: Fetal Doppler
- Identification of Subject Device
Regulatory Information Regulation Name: Fetal ultrasonic monitor and accessories Regulation Number: 21 CFR 884.2660
5
Regulatory Class: II Product Code: KNG (Monitor, Ultrasonic, Fetal) Review Panel: Obstetrics/Gynecology
-
- Predicate Device
Predicate Device:
510(k) Number: K220245 Product Name: Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL) Manufacturer: Contec Medical Systems Co., Ltd.
The predicate device has not been subject to a design-related recall.
- Device Description: 6.
The Pocket Fetal Doppler is a hand-held fetal Doppler used for non-invasive measurement and numerical display of the fetal heart rate (FHR) utilizing pulsed-wave Doppler ultrasound. The Pocket Fetal Doppler includes three models: CONTEC10E and CONTEC10E and CONTEC10F. All models have four components: upper shell, display and probe. The material for probe cap and shell is ABS. The device contains an ultrasonic signal transmitter and receiver, analog signals processing unit, FHR calculating unit, and LCD display control unit. 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. This device can detect a fetal heart rate value at or after twelve weeks gestation.
The CONTEC10D is powered by a 3.7V lithium battery, the ultrasonic signal is continuously transmitted at a frequency of 2.5MHz.
The CONTEC10E and CONTEC10F is powered by two 1.5V batteries (AA LR6), the ultrasonic signal is continuously transmitted at a frequency of 2.5MHz.
-
- Indications for use Statement:
The Pocket Fetal Doppler (Models CONTEC 10D, CONTEC 10E and CONTEC10F) 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.
- Indications for use Statement:
-
- Substantial Equivalence Discussion The following table compares the intended use and technological characteristics of the subject and predicate device.
| Item | Subject Device | Predicate Device | Remark |
|---|---|---|---|
| K232893 | K220245 |
Table 1 General Comparison
6
| Device name | Pocket Fetal Doppler
(CONTEC 10D), Pocket
Fetal Doppler (CONTEC
10E), Pocket Fetal Doppler
(CONTEC 10F | Pocket Fetal Doppler | / |
|---------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Model | CONTEC 10D; CONTEC
10E; CONTEC 10F | CONTEC10C and
CONTEC10CL | / |
| Classification
Regulation | 21 CFR 884.2660 | 21 CFR 884.2660 | Same |
| Classification | II | II | Same |
| Product Code | KNG | KNG | Same |
| Regulation
Name | Fetal ultrasonic monitor and
accessories. | Fetal ultrasonic monitor and
accessories. | Same |
| Indications
for use | The Pocket Fetal Doppler
(Models CONTEC 10D,
CONTEC 10E and
CONTEC10F) 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 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. | Same |
| Intended
population | Women with pregnancy at
or after 12 weeks | Women with pregnancy at or
after 12 weeks | Same |
| Design | A main unit and a probe.
The main unit can display a
numerical FHR value | A main unit and a probe.
The main unit can display a
numerical FHR value | Same |
| Mode of
action | Doppler ultrasound, pulsed
wave | Doppler ultrasound,
continuous wave | Different |
| Ultrasound
frequency | 2.5MHz
Pulse repetition frequency:
5556Hz (CONTEC 10D)
5560Hz (CONTEC 10E/F) | 2.0 MHz, 3.0 MHz | Different |
| Performance | -FHR Measuring Range:
50 BPM ~ 240 BPM
-Resolution: 1 BPM
Accuracy: ±2 BPM | -FHR Measuring Range:
50 BPM ~ 240 BPM
-Resolution: 1 BPM
Accuracy: ±2 BPM | Same |
| Acoustic
output
(statistical
maximum
limit) | CONTEC 10D: ISATA IEC 60601-1-2: 2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -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 A 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
-
This device meets the recommendations of Attachment G of the FDA Guidance document "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" (issued September 2023). Therefore, this device is considered biocompatible.
-
IEC 62359: 2017 Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields
- A Software verification and validation documentation consistent with a Basic level of documentation per the 2023 FDA guidance Content of Premarket Submissions for Device Software Functions (fda.gov)
In addition, the following performance testing was performed on the subject device:
9
- Use Life testing >
- Battery life testing >
- ア Battery indicator testing
-
- Conclusion
The non-clinical performance testing described above demonstrates that the device is as safe and effective as the predicate device (K220245) and supports a determination of substantial equivalence.