(176 days)
KDEN: K110124
Not Found
No
The device description details a standard ultrasonic Doppler technology for detecting fetal heart rate and converting it to an audible signal. There is no mention of AI, ML, or any computational processing beyond basic signal demodulation and frequency analysis to determine heart rate. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is indicated for monitoring fetal heart rate as a general indication of fetal well-being, not for therapeutic purposes. It primarily functions for detection and listening of the fetal heartbeat.
Yes
The device is a diagnostic device because its intended use is to monitor fetal heart rate as a "general indication of fetal well-being," which is a diagnostic purpose. It "detects the Fetal Heart Rate (FHR)" and converts ultrasonic wave echoes into voltage to detect and demodulate the Doppler signal, providing information about the fetal heart's rhythm. The "Key Metrics" section also lists an accuracy for FHR, which implies it's providing a measurement used for diagnosis.
No
The device description explicitly states it is a "hand-held ultrasonic fetal heart beat detector" with "piezoelectric ceramic" components and a "built-in speaker," powered by a "9V alkaline battery." These are all hardware components, indicating it is not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices that are used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the body (in vitro).
- Device Function: The iCareNewlife Fetal Doppler uses ultrasound to detect and amplify the fetal heartbeat within the pregnant woman's body. It does not analyze samples taken from the body.
- Intended Use: The intended use is for monitoring fetal heart rate as a general indication of fetal well-being, which is a direct measurement of a physiological function within the body.
Therefore, based on the provided information, the iCareNewlife Fetal Doppler is a medical device used for in vivo (within the body) monitoring, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The iCareNewlife Fetal Doppler is indicated for monitoring fetal heart rate during the antepartum period as a general indication of fetal well-being. The device is for heart sounds through the speaker only. The device is intended to be used by health care professionals including registered nurses, midwives, ultrasound technicians, and physician assistants, by prescription from licensed physicians in hospitals, clinics and private offices.
Product codes
HEK
Device Description
The device is a hand-held ultrasonic fetal heart beat detector, which can detect the Fetal Heart Rate (FHR). The built-in speaker of the device allows for listening of the fetal heartbeat. The device is generally applied to above 16 weeks gestation.
Ultrasonic wave is transmitted from one piezoelectric ceramic at the front of the uterus of the pregnant women. Echo is received by the other piezoelectric ceramic at the front of the probe when ultrasonic wave reaches the fetal heart. Then it is converted into voltage. This Doppler signal is detected and demodulated from the received signal. And the Doppler frequency is consistent with the rhythm of the fetal systole and diastole. Once cardiac valves vibrate and a Doppler frequency excursion is formed. lt is transmitted an output signal of cardiac valves vibrating, and it is sent to the loudspeaker for getting a rhythmical sound with the fetal heartbeat.
The device is powered by a 9V alkaline battery.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound (Doppler)
Anatomical Site
Fetal heart
Indicated Patient Age Range
The device is generally applied to above 16 weeks gestation.
Intended User / Care Setting
The device is intended to be used by health care professionals including registered nurses, practical nurses, midwives, ultrasound technicians, and physician assistants, by prescription from licensed physicians in hospitals, clinics and private offices.
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)
Bench testing: The device was evaluated for levels of acoustic output.
Biocompatibility testing: The biocompatibility evaluation for the iCare Newlife Fetal Doppler was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The battery of testing included the following tests: Cytotoxicity, Sensitization, Irritation.
Electrical safety and electromagnetic compatibility (EMC): testing were conducted on the iCare Newlife Fetal Doppler. The device complies with the IEC 60601-1, IEC 60601-2-37 standards for safety and the IEC 60601-1-2 standard for EMC.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: 16 weeks gestation
FHR measuring range: 50~210 bpm
FHR resolution: 1 bpm
Accuracy: ± 2 bpm
Predicate Device(s)
Fetal Doppler JPD-100S, K110124.
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/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized eagle or bird in flight, composed of three interconnected human profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 20, 2015
iCare Newlife Technologies, Inc. % Mike Gu Regulatory Affairs Manager Guangzhou Osmunda Medical Device Consulting Co., Ltd 7th Floor, Jingui Business Building, No. 982 Congyun Rd. Baiyun District, Guangdong 510240 China
Re: K142769
Trade/Device Name: Fetal Doppler Regulation Number: 21 CFR 884.2660 Regulation Name: Fetal ultrasonic monitor and accessories Regulatory Class: II Product Code: HEK Dated: February 17, 2015 Received: February 18, 2015
Dear Mike Gu.
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. 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 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
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Joyce M. Whang -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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known) K142769
Device Name Fetal Doppler
Indications for Use (Describe)
The iCareNewlife Fetal Doppler is indicated for monitoring fetal heart rate during the antepartum period as a general indication of fetal well-being. The device is for heart sounds through the speaker only. The device is intended to be used by health care professionals including registered nurses, midwives, ultrasound technicians, and physician assistants, by prescription from licensed physicians in hospitals, clinics and private offices.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Diagnostic Ultrasound Indications for Use
Fetal Doppler (K142769)
Intended Use: Detect fetal heart rate as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track 1 Only) | Specific | |||||||
| (Tracks 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | Combined | |||||||
| (Specify) | Other* | |||||||
| (Specify) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Imaging | ||||||||
| & Other | Fetal | N | ||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Specify) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skeletal | ||||||||
| (Conventional) | ||||||||
| Musculo-skeletal | ||||||||
| (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix
*Examples of other modes of operation may include: A-mode, Amplitude Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler, and Color Velocity Imaging
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In accordance with 21 CFR 807.92 the following summary of information is provided:
| I. SUBMITTER | iCare Newlife Technologies, Inc. |
|---|---|
| Wangjing Science Pioneer Park, Suite E-510A, Chaoyang, Beijing, P.R.C. 100102 | |
| Phone: | +86-10-8414-8058 |
| Fax: | +86-10-8414-8058 |
| Primary Contact Person: | Mike Gu |
| Regulatory Affairs Manager | |
| OSMUNDA Medical Device Consulting Co., Ltd | |
| Tel: (+86) 20-6232 1333 | |
| Fax: (+86) 20-8633 0253 | |
| Secondary Contact Person: | Mr. Bo Xiao |
| Vice President | |
| iCare Newlife Technologies, Inc. | |
| Date Prepared: | 17 March, 2015 |
| II. DEVICE | |
| Name of Device: | iCareNewlife Fetal Doppler |
| Common/Usual Name: | Fetal Monitor |
| Classification Names: | Fetal ultrasonic monitor and accessories (21 CFR 884.2660) |
| Regulation Class: | II |
| Product Code: | HEK |
| III. PREDICATE DEVICE |
Fetal Doppler JPD-100S, K110124.
This predicate has not been subject to a design-related recall.
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Image /page/6/Picture/0 description: The image shows the logo for Newlife iCare. The logo is white text on a pink background. The word "Newlife" is on the top right of the logo, and the word "iCare" is in a larger, cursive font on the bottom left.
IV. INDICATION FOR USE
The iCareNewlife Fetal Doppler is indicated for monitoring fetal heart rate during the antepartum period as a general indication of fetal well-being. The device is for hearing fetal heart sounds through the speaker only. The device is intended to be used by health care professionals including registered nurses, practical nurses, midwives, ultrasound technicians, and physician ssistants, by prescription from licensed physicians in hospitals, clinics and private offices.
The Indications for Use statement for the iCareNewlife Fetal Doppler is not identical to the predicate device; however, the differences do not alter the intended diagnostic use of the device nor do they affect the safety and effectiveness of the device relative to the predicate. Both the subject and predicate devices have the same intended use for the detecting of fetal heart beat.
V. DEVICE DESCRIPTION
The device is a hand-held ultrasonic fetal heart beat detector, which can detect the Fetal Heart Rate (FHR). The built-in speaker of the device allows for listening of the fetal heartbeat. The device is generally applied to above 16 weeks gestation.
Ultrasonic wave is transmitted from one piezoelectric ceramic at the front of the uterus of the pregnant women. Echo is received by the other piezoelectric ceramic at the front of the probe when ultrasonic wave reaches the fetal heart. Then it is converted into voltage. This Doppler signal is detected and demodulated from the received signal. And the Doppler frequency is consistent with the rhythm of the fetal systole and diastole. Once cardiac valves vibrate and a Doppler frequency excursion is formed. lt is transmitted an output signal of cardiac valves vibrating, and it is sent to the loudspeaker for getting a rhythmical sound with the fetal heartbeat.
The device is powered by a 9V alkaline battery.
VI. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Bench testing
The device was evaluated for levels of acoustic output.
Biocompatibility testing:
The biocompatibility evaluation for the iCare Newlife Fetal Doppler was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological
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Image /page/7/Picture/0 description: The image is a logo for Newlife iCare. The logo is white text on a pink background. The word "Newlife" is above the word "iCare".
Traditional 510(k) Submission Fetal Doppler
Evaluation of Medical Devices Part 1: Evaluation and Testing,"" May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The battery of testing included the following tests:
- . Cytotoxicity
- Sensitization
- . Irritation
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the iCare Newlife Fetal Doppler. The device complies with the IEC 60601-1, IEC 60601-2-37 standards for safety and the IEC 60601-1-2 standard for EMC.
| Descriptor | Subject device | Fetal Doppler JPD-100S (K110124) |
|---|---|---|
| Intended use | detect FHR | detect FHR |
| Sensitivity | 16 weeks gestation | 12 weeks gestation |
| Mode of operation | Continuous wave | Continuous wave |
| Ultrasound | ||
| frequency | 2.5 MHz | 3.0 MHz |
| Ultrasonic power | $\leq$ 22 mW | 13.3 mW |
| Area corresponding | ||
| to entrance beam | ||
| dimensions | 1.57 cm² | 2.65 cm² |
| Acoustic output | 14.01 mW/cm² (actual max | |
| value measured) | 5.02 mW/cm² | |
| FHR measuring | ||
| range | 50~210 bpm | 50~210 bpm |
| FHR resolution | 1 bpm | 1 bpm |
| Accuracy | $\pm$ 2 bpm | $\pm$ 2 bpm |
| FHR readout | Speaker sound | Speaker sound |
| Power supply | 9V alkaline battery | 9V alkaline battery |
| Transducer housing | ||
| material | ABS plastic | ABS plastic |
VII. Predicate Device Comparison
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Image /page/8/Picture/0 description: The image shows the logo for Newlife iCare. The logo is white text on a pink background. The word "Newlife" is on the top right of the logo, and the word "iCare" is in a larger font on the bottom left.
Substantial Equivalence Discussion
- Intended use The subject and predicate devices have the same intended use to detect the ● FHR. The predicate device can detect the FHR from 12 weeks gestation whereas the subject device can detect the FHR from 16 weeks gestation. The difference does not raise any effectiveness concerns, because the subject device is labeled for detecting the FHR during the antepartum period.
- Technological characteristics - Similarity in design
The subject and predicate devices have the same fundamental design. They have the following same or comparable technological characteristics:
- ★ Mode of operation
-
- Ultrasound frequency
-
- FHR measuring range
-
- FHR resolution
-
- Accuracy
- ★ FHR readout
-
- Power supply
- Technological characteristics Difference in design ●
The subject device has higher ultrasonic power and smaller area corresponding to entrance beam dimensions, resulting in higher acoustic output. The differences do not raise safety concerns, because the statistical maximum acoustic output of the subject device meets the requirement (≤20 mW/cm² for unfocused CW FHR devices) in the FDA guidance document, "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" (issued on September 09, 2008).
- . Material – The subject and predicate device use the same type of material – ABS plastic. To ensure safety, the subject device has been evaluated for biocompatibility, and the results demonstrated the subject device is safe.
In conclusion, the subject device is substantial equivalent to the predicate device in terms of safety and effectiveness.