(265 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on standard Doppler technology.
No.
The device is used for detecting, not treating, a condition.
Yes.
Explanation: The device is described as detecting the fetal heartbeat and measuring the fetal heart rate, which falls under the definition of providing information for diagnosis, even if it is only a preliminary step or an accessory to a more comprehensive diagnostic process. Additionally, the non-clinical performance data references "IEC 60601-2-37 Requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment," explicitly using the term "diagnostic."
No
The device description explicitly states it is a "hand-held, battery powered audio Doppler device integrated with 3 MHz probe," indicating it includes hardware components beyond just software.
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 SD1 Ultrasonic Pocket Doppler uses ultrasound to detect the fetal heartbeat externally on the abdomen surface of a pregnant woman. It does not analyze samples taken from the body.
- Intended Use: The intended use is to detect the fetal heartbeat, not to diagnose a disease or condition based on analysis of a biological sample.
Therefore, the SD1 Ultrasonic Pocket Doppler falls under the category of a medical device, specifically an ultrasonic diagnostic and monitoring equipment, rather than an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
KNG
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasonic Doppler
Anatomical Site
Abdomen surface
Indicated Patient Age Range
Pregnant woman, from 10 weeks of gestation onward.
Intended User / Care Setting
medical professionals, 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)
Clinical Performance Data: Clinical testing was conducted at a Chinese hospital to demonstrate that the SD1 Ultrasonic Pocket Doppler, which uses the pulse-wave mode of Doppler ultrasound, is as safe and effective for finding and measuring the fetal heart rate as the SD3 Ultrasonic Pocket Doppler, which uses the continuous-wave mode of Doppler ultrasound. The results showed that it did not take more time to find the fetal heart rate in pregnant patients, from 10 weeks of gestation onward, using the SD1 Pocket Doppler in comparison to the predicate SD3 Ultrasonic Pocket Doppler. Therefore, the fetus would not be exposed to a longer duration of ultrasound radiation during the course of an exam with the SD1 Ultrasonic Pocket Doppler.
Non-clinical Performance Data: Bench testing was conducted per the following standards, and all the results met pre-defined acceptance criteria as applicable and were acceptable.
- (1) IEC 60601-1 Electrical Safety
(2) IEC 60601-1-2 Electromagnetic Compatibility
(3) IEC 60601-2-37 Requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
(4) IEC 61266 ULTRASONICS Hand-Held probe Doppler fetal heartbeat detectors Performance requirements and methods of measurement and reporting
(5) NEMA UD 2 Standard for Acoustic output measurement standard for diagnostic ultrasound equipment.
(6) Acoustic output testing as per the guideline "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" dated September 9, 2008.
(7) Biocompatibility, ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation and sensitization) (8) Wireless technology testing per the FDA guidance, "Radio Frequency Wireless Technology in Medical Devices" dated August 14, 2013 and Part 15 of the FCC rules.
Software Verification and Validation Testing: Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered to have a "moderate" level of concern, since a failure or latent flaw in the software will not directly result in serious injury or death to the patient or operator, and the software device is an accessory to a medical device that has a Moderate Level of Concern.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
0
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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)
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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:
- 2 MHz for fetal
heart rate. - 3 MHz for fetal
heart rate - 4 MHz for
detections of arterial
and venous blood
flow velocity. - 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) |