Who is the manufacturer of SD1 Ultrasonic Pocket Doppler?

Edan Instruments, Inc. filed the 510(k) submission for SD1 Ultrasonic Pocket Doppler (K172780).

What is the FDA product code for SD1 Ultrasonic Pocket Doppler?

KNG. It is classified under 21 CFR 884.2660 as a Class 2 device in the Obstetrics/Gynecology panel.

What is the regulatory pathway for SD1 Ultrasonic Pocket Doppler?

510(k) clearance (submission type: Traditional).

What are the predicate devices for SD1 Ultrasonic Pocket Doppler?

FETAL ULTRASONIC MONITOR AND ACCESSORIES /JPD-100B, Shenzhen Jumper Medical Equipment Co. (K131457); SD3 ULTRASONIC POCKET DOPPLER, Edan Instruments, Inc. (K140579).

Who can help prepare an FDA 510(k) submission like SD1 Ultrasonic Pocket Doppler?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

SD1 Ultrasonic Pocket Doppler

K172780 · Edan Instruments, Inc. · KNG · Jun 6, 2018 · Obstetrics/Gynecology

Device Facts

Record ID	K172780
Device Name	SD1 Ultrasonic Pocket Doppler
Applicant	Edan Instruments, Inc.
Product Code	KNG · Obstetrics/Gynecology
Decision Date	Jun 6, 2018
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 884.2660
Device Class	Class 2

Intended Use

The SD1 is a pocket Doppler device used for detecting the 10th week of gestation. It is intended to be used by medical professionals only.

Device Story

Hand-held, battery-powered ultrasonic Doppler device; utilizes 3 MHz probe to detect fetal heartbeats via pulsed-wave ultrasound. Operates by transmitting ultrasound to maternal abdomen; reflected signals from fetal heart converted to electrical signals; processed for display and audio output. Used by medical professionals in clinical settings. Optional Bluetooth connectivity allows data transmission to mobile application. Provides real-time fetal heart rate (FHR) monitoring; assists clinicians in confirming fetal viability; enables non-invasive assessment of fetal well-being.

Clinical Evidence

Clinical study conducted at a Chinese hospital compared SD1 (pulsed-wave) to SD3 (continuous-wave) predicate. Study evaluated time required to detect fetal heart rate in pregnant patients from 10 weeks gestation. Results showed no significant difference in detection time, indicating no increased ultrasound radiation exposure for the fetus. Bench testing confirmed compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 61266, and NEMA UD 2 standards. Biocompatibility testing (ISO 10993-5, ISO 10993-10) and wireless technology testing (FCC Part 15) were also performed.

Technological Characteristics

Hand-held ultrasonic Doppler; 3 MHz probe; pulsed-wave operation; battery-powered (2x LR6 AA). Connectivity: Bluetooth/App (optional). Biocompatibility per ISO 10993-5/10. Electrical safety per IEC 60601-1; EMC per IEC 60601-1-2; acoustic output per NEMA UD 2. Dimensions: 48mm x 39mm x 147mm; weight <180g. Display: LCD. Ingress protection: IP22.

Indications for Use

Indicated for detection of fetal heartbeat in pregnant women from 10 weeks gestation. Intended for use by medical professionals only.

Regulatory Classification

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.

Predicate Devices

FETAL ULTRASONIC MONITOR AND ACCESSORIES /JPD-100B, Shenzhen Jumper Medical Equipment Co. (K131457)
SD3 ULTRASONIC POCKET DOPPLER, Edan Instruments, Inc. (K140579)

Related Devices

K100626 — DOPPLER FETAL HEART RATE DETECTOR, MODEL FM-200 · Shenzhen Biocare Electronics Co., Ltd. · May 21, 2010
K252669 — Fetal Doppler U8-25, U9-25 · Zhongshan Xiaolan Town Senlan Electronic Factory · Jan 8, 2026
K182526 — Fetal Doppler (Models: FD-231B, FD-231D, FD-640B, FD-640D, FD-200B, FD-200D, FD-591B, and FD-591D) · Vcomin Technology Limited · May 29, 2019
K110630 — F10 · Mediana Co., Ltd. · Jun 24, 2011
K131457 — FETAL ULTRASONIC MONITOR AND ACCESSORIES · Shenzhen Jumper Medical Equipment Co., Ltd. · Jan 24, 2014

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. June 6, 2018 Edan Instruments, Inc. Alice Yang Regulatory Engineer #15 Jinhui Road, Jinsha Community Kengzi Sub-District, Pingshan District Shenzhen. Guangdong 518067 China Re: K172780 Trade/Device Name: SD1 Ultrasonic Pocket Doppler Regulation Number: 21 CFR§ 884.2660 Regulation Name: Fetal Ultrasonic Monitor and Accessories Regulatory Class: II Product Code: KNG Dated: May 3, 2018 Received: May 7, 2018 Dear Alice Yang: 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. Iisting 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. {1}------------------------------------------------ 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); 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. 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # Joyce M. Whang -S Benjamin R. Fisher, Ph.D. for Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K172780 Device Name SD1 Ultrasonic Pocket Doppler Indications for Use (Describe) The SD1 is a pocket Doppler device used for detecting the 10th week of gestation. It is intended to be used by medical professionals only. | 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) #### 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." {3}------------------------------------------------ # 510(k) Summary # Prepared in accordance with the requirements of 21 CFR Part 807.92 | 1. Submitter: | Edan Instruments, Inc. #15 Jinhui Road, Jinsha Community, Kengzi Sub-District, Pingshan District, Shenzhen, 518122 P.R.China. Tel.: (0755) 26856469 Fax: +1 (408) 418-4059 | |---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Alice Yang | | Date Prepared: | 2018-5-30 | | 2. Device name and classification: | Device Name:SD1 Ultrasonic Pocket Doppler Model:SD1(with or without Bluetooth/APP) Common Name: Fetal Doppler Classification Number and Name: 21 CFR 884.2660 Fetal ultrasonic monitor and accessories Product code: KNG (monitor, ultrasonic, fetal) Regulatory Class: Class II | | 3. Predicate Device(s): | 1. K131457, FETAL ULTRASONIC MONITOR AND ACCESSORIES /JPD- 100B, Shenzhen Jumper Medical Equipment Co. (Primary) 2. K140579, SD3 ULTRASONIC POCKET DOPPLER, Edan Instruments, Inc. (Secondary) The predicate devices were not subjected to design-related recalls. | | 4. Device Description: | SD1 Ultrasonic Pocket Doppler is a device prescribed by a licensed physician for use by professional healthcare providers. It is a hand-held, battery powered audio Doppler device integrated with 3 MHz probe and with optional use of Bluetooth/app, used for detecting fetal heart beats. The device is for prescription use and is intended for use at or after 10 weeks gestation. | | 5. Indications for Use: | The SD1 is a pocket Doppler device used for detecting the fetal heartbeat from the 10th week of gestation. It is intended to be used by medical professionals only. | {4}------------------------------------------------ # 6. Predicate Device Comparison The subject device shares the same characteristics with the predicate device except as shown in the table below. The following differences in technological characteristics do not raise different questions of safety and effectiveness. | Item | JPD-100B | SD3 | SD1 | Comparison Result | |------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer/K# | SHENZHEN JUMPER MEDICAL EQUIPMENT CO., LTD / K131457 | EDAN INSTRUMENTS, INC./K | EDAN INSTRUMENTS, INC./current submission | | | Indications for use | The device is ultrasonic fetal heart detector, which can detect the Fetal Heart Rate. The built-in speaker of the device allows for listening of the fetal heartbeat. It can display values of fetal heart rate. The Fetal Doppler JPD-100B is a hand-held, battery powered audio Doppler device used for detecting fetal heart beats. | The SD3 Series Ultrasonic Pocket Dopplers are 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. The 2 MHz and 3 MHz waterproof probes are indicated for the detection of fetal heart rate from early gestation thru delivery and as a general indication of fetal well being. Specifically, the 3 MHz probe is used for more than 9-week gestation and the 2 MHz is used for 12- week gestation. The 4 MHz, 5 MHz and/or 8 MHz waterproof vascular probes are indicated for the detection of blood flow in veins and arteries for assisting in the detection of peripheral vascular disease. | The SD1 is a pocket Doppler device used for detecting the fetal heartbeat from the 10th week of gestation. It is intended to be used by medical professionals only. | Different, but the subject and predicate devices have the same intended use | | | | | | | | Device Description | JPD-100B Fetal Doppler is device prescribed by a licensed physician for use in hospitals and the homecare environment. It is a hand-held, battery powered audio Doppler device integrated with 2.5 MHz probe, used for detecting fetal heart beats. And the device is for prescription use and is intended for use at or after 12 weeks gestation. | The SD3 series Ultrasonic Pocket Doppler is a hand- held device for non- invasive measurement and display of fetal heart rate and blood flow velocity utilizing the principle of Doppler shift of an ultrasound. The ultrasound is transmitted from the probe to patient body (maternal abdominal wall), and moves through biophysical objects. The acoustic ultrasound is reflected by blood and moving objects such as the fetal heart. The reflected ultrasound is received by the probe and is converted into electric signals. The waveform data are applied to the CPU for all the digital processing on OLED Display, operation keys. The audio signal is taken off for the routing to the speaker to generate the analogue signals before digital processing. The following probes are supplied with the SD3 series Ultrasonic Pocket Doppler: 1. 2 MHz for fetal heart rate. 2. 3 MHz for fetal heart rate 3. 4 MHz for detections of arterial and venous blood flow velocity. 4. 5 MHz for detections of arterial and venous blood flow velocity. | SD1 Ultrasonic Pocket Doppler is a device prescribed by a licensed physician for use by professional healthcare providers. It is a hand-held, battery powered audio Doppler device integrated with 3 MHz probe and with optional use of Bluetooth/app, used for detecting fetal heart beats. The device is for prescription use and is intended for use at or after 10 weeks gestation. | Different, minor differences in the device description, but the intended use is the same. | | Intended patient population | 5. 8 MHz for detections of arterial and venous blood flow velocity. FHR Performance: Sensitivity: 9 weeks gestation (3 MHz) | Pregnant woman | Pregnant woman | Same | | Application site | Indoor | Indoor | Indoor | Same | | Contacting location | Abdomen surface | Abdomen surface | Abdomen surface | Same | | Operational characteristics | | | | | | Operation principle | Ultrasonic Doppler/Continuous Wave | Ultrasonic Doppler/Continuous Wave | Ultrasonic Doppler/Pulsed Wave | Different, clinical tests show that the performance is substantially equivalent. | | Installation and use | hand-held | hand-held | hand-held | Same | | Mode of operation | Continuous operation | Continuous operation | Continuous operation | Same | | Specifications | | | | | | Ultrasound Working Frequency | 2MHz, 2.5MHz, 3MHz | 2MHz, 3MHz, 4MHz, 5MHz, 8MHz | 3MHz Pulse repetition frequency: 5kHz | Different, but bench and clinical performance tests demonstrate substantial equivalence. | | Size | 128 mm× 91.5 mm× 37.5 mm | 168 mm x 31 mm x 67 mm | 48mm× 39 mm× 147 mm | Different, but the subject device conforms to | | Weight | 530g | about 350 g (including the battery) | < 180g | device conforms to | | Battery Supply | NI-MH 300mAh 9.6v | 3*LR6 AA 18650 Lithium battery | 2*LR6AA | IEC 60601- 1. | | Display | LCD display | LCD display | LCD display | Same | | Resolution | 1 bpm | 1 bpm | 1 bpm | Same | | Accuracy | ±2bpm | ±2bpm | ±2bpm | Same | | FHR Measuring Range | 50bpm ~ 210bpm | 50bpm ~ 240bpm | 50bpm ~ 240bpm | Different, but measuring range is the same as the SD3 predicate. | | Acoustic output (3MHz) | <20mW/cm2 | <20mW/cm2 | <10mW/cm2 | Different, but the | | | | | | | | | | | | subject device has lower acoustic output and performance comparable to predicates. Different, Wireless technology testing per | | Wireless function | Not support | Not support | Bluetooth/APP function (optional). | the FDA guidance, "Radio Frequency Wireless Technology in Medical Devices" dated August 14, 2013 and Part 15 of the FCC rules. | | | | Safety Classifications | | | | Anti-electric Shock Type | Internally powered equipment | Internally powered equipment | Internally powered equipment | Same | | Anti-electric Shock Degree | Type BF equipment | Type B equipment | Type BF equipment | Same | | Degree of Protection against Harmful Ingress of Water: | Probes: IPX4 | Probes: IPX8 | IP22 | Different, but the subject device conforms to IEC 60529:2001. | | The degree of safety of application in the presence of a flammable gas | Equipment not suitable for use in presence of flammable gases | Equipment not suitable for use in presence of flammable gases | Equipment not suitable for use in presence of flammable gases | Same…