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.

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.

AI/ML Overview

Here's an analysis of the provided text regarding the iCareNewlife Fetal Doppler, focusing on the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Fetal Doppler JPD-100S, K110124) rather than explicit acceptance criteria defined by the manufacturer for this specific device. However, by comparing the subject device to the predicate, we can infer some performance benchmarks that were considered acceptable for market clearance.

Descriptor	Acceptance Criteria (Inferred from Predicate)	Reported Device Performance (iCareNewlife Fetal Doppler)
Intended Use	Detect Fetal Heart Rate (FHR)	Detect FHR
Sensitivity	From 12 weeks gestation	From 16 weeks gestation
Mode of Operation	Continuous wave	Continuous wave
Ultrasound Frequency	3.0 MHz	2.5 MHz
Ultrasonic Power	13.3 mW	≤ 22 mW
Area Corresponding to Entrance Beam Dimensions	2.65 cm²	1.57 cm²
Acoustic Output	5.02 mW/cm²	14.01 mW/cm² (actual max value measured)
Acoustic Output Safety Limit	≤ 20 mW/cm² (for unfocused CW FHR devices)	14.01 mW/cm² (below limit)
FHR Measuring Range	50-210 bpm	50-210 bpm
FHR Resolution	1 bpm	1 bpm
Accuracy	± 2 bpm	± 2 bpm
FHR Readout	Speaker sound	Speaker sound
Power Supply	9V alkaline battery	9V alkaline battery
Transducer Housing Material	ABS plastic	ABS plastic
Biocompatibility	Meet ISO 10993 standards	Passed Cytotoxicity, Sensitization, Irritation tests
Electrical Safety	Comply with IEC 60601-1, IEC 60601-2-37	Complies with IEC 60601-1, IEC 60601-2-37
Electromagnetic Compatibility (EMC)	Comply with IEC 60601-1-2	Complies with IEC 60601-1-2

2. Sample Size Used for the Test Set and the Data Provenance

The document does not provide details on a specific clinical test set sample size or its provenance (country of origin, retrospective/prospective). The "Performance Data" section primarily describes bench testing, biocompatibility testing, electrical safety, and EMC testing. The comparison to the predicate device is a theoretical assessment based on specifications.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This information is not provided in the document. Since there is no described clinical test set, there's no mention of experts establishing ground truth for such a set.

4. Adjudication Method for the Test Set

This information is not provided in the document, as a clinical test set with an adjudication method is not described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

This document describes a Fetal Doppler, which is a device for detecting fetal heart rate through sound. It is not an AI-assisted diagnostic imaging system that would involve human readers. Therefore, an MRMC comparative effectiveness study involving AI assistance is not applicable and was not done.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The iCareNewlife Fetal Doppler is a standalone device in the sense that it directly outputs fetal heart sounds via a speaker, and heart rate measurements (if displayed). It doesn't appear to be an "algorithm only" device that relies on a separate human interpretive step for its primary function of detecting the FHR. The "Performance Data" section details the device's technical specifications and compliance with safety and performance standards for its direct operation.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the technical performance characteristics (e.g., FHR measuring range, accuracy, acoustic output), the "ground truth" would have been established through calibrated measurement instruments and standardized testing procedures during bench testing. For biocompatibility, electrical safety, and EMC, compliance was determined against recognized international standards (ISO 10993, IEC 60601 series). There is no mention of clinical ground truth (e.g., expert consensus on observed fetal heart rates, pathology, or outcomes data) for a clinical performance study.

8. The Sample Size for the Training Set

This information is not provided in the document. The device does not appear to involve machine learning or AI algorithms that would require a "training set" in the conventional sense. The "Performance Data" describes traditional engineering and safety testing.

9. How the Ground Truth for the Training Set Was Established

Since there is no "training set" for an AI algorithm mentioned, information on how its ground truth was established is not applicable and therefore not provided.

Summary

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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

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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)

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	ColorDoppler	Combined(Specify)	Other*(Specify)
Ophthalmic	Ophthalmic
FetalImaging& 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)
PeripheralVessel	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 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
Ultrasoundfrequency	2.5 MHz	3.0 MHz
Ultrasonic power	$\leq$ 22 mW	13.3 mW
Area correspondingto entrance beamdimensions	1.57 cm²	2.65 cm²
Acoustic output	14.01 mW/cm² (actual maxvalue measured)	5.02 mW/cm²
FHR measuringrange	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 housingmaterial	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.

Regulation Number and Section

§ 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).