ULTRASONIC POCKET DOPPLER

K140579 · Edan Instruments, Inc. · KNG · Feb 6, 2015 · Obstetrics/Gynecology

Device Facts

• Record ID: K140579
• Device Name: ULTRASONIC POCKET DOPPLER
• Applicant: Edan Instruments, Inc.
• Product Code: KNG · Obstetrics/Gynecology
• Decision Date: Feb 6, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.2660
• Device Class: Class 2
• Attributes: Real-World Evidence

Real-World Evidence

Submission	Device	Sponsor	RWD Sources	RWE Use Summary	Key Tags
K140579 · Feb 6, 2015	ULTRASONIC POCKET DOPPLER	Edan Instruments, Inc.	Hospital clinical performance evaluation	The device's clinical performance (fetal heart rate detection) was evaluated across 6 hospitals to confirm effectiveness at specific gestational ages (9-10 weeks and 11-13 weeks) in a clinical setting.	Clinical performance; Fetal heart rate detection; Hospital-based evaluation

Clinical Evidence

Study Design	Population	Comparator	Key Endpoints
Clinical performance evaluation in hospital settings	Pregnant women (9-13 weeks gestation); Sample Size: 261 total tests (162 for 2 MHz probe; 99 for 3 MHz probe); Number of Sites: 6 hospitals	Not applicable for this study	Detection of fetal heart rate (pass/fail)

Indications for Use

The SD3 Series Ultrasonic Pocket Dopplers (hereinafter called "the Doppler") are 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. The 2 MHz and/or 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. The 3 MHz waterproof probe is used for more than 9-week gestation and the 2 MHz is used for 12-week gestation. They can also be used to verify fetal heart viability. 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.

Device Story

Hand-held ultrasonic pocket Doppler; uses 2/3 MHz probes for fetal heart rate (FHR) and 4/5/8 MHz probes for vascular blood flow. Ultrasound waves transmitted to body; reflected signals from moving objects (fetal heart/blood) received by probe; converted to electric signals. CPU performs digital processing; output displayed on OLED screen; audio signal routed to speaker. Used by clinicians (nurses, midwives, technicians) in hospitals/clinics. Provides real-time FHR or vascular flow data to assist clinical assessment of fetal well-being or peripheral vascular disease. Battery-powered; non-invasive.

Clinical Evidence

Clinical study conducted at 6 hospitals. 162 tests (11-13 weeks gestation) using 2 MHz probe; 157 passes (96.9%). 99 tests (9-10+ weeks gestation) using 3 MHz probe; 95 passes (96%). Pass rate >95% requirement met. Bench testing confirmed FHR accuracy ±2 BPM (50-240 BPM range) and repeatability.

Technological Characteristics

Hand-held ultrasonic Doppler; 2/3/4/5/8 MHz waterproof probes. OLED display. Internally powered (AA batteries or 18650 Lithium). Complies with IEC 60601-1, IEC 60601-2-37, IEC 60601-1-2, ISO 10993-1. IPX8 probe rating. Digital signal processing via CPU.

Indications for Use

Indicated for fetal heart rate detection (from early gestation to delivery) and fetal well-being assessment in pregnant women; also indicated for blood flow detection in veins and arteries to assist in peripheral vascular disease diagnosis. 3 MHz probe for >9-week gestation; 2 MHz probe for >12-week gestation.

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

• Sonotrax Series Ultrasonic Pocket Doppler (K101960)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure composed of three overlapping profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 9, 2015

Edan Instruments, Inc Queena Chen Certification Engineer 3/F - B, Nanshan Medical Equipments Park Nanhai Road 1019# Shekou. Nanshan Shenzhen 518067 P.R. China

Re: K140579 Trade/Device Name: SD3 Series Ultrasonic Pocket Doppler- SD3 LITE, SD3, SD3 PLUS, SD3 PRO, SD3 VASCULAR Regulation Number: 21 CFR 884.2660 Regulation Name: Fetal ultrasonic monitor and accessories Regulatory Class: II Product Code: KNG, DPW Dated: January 4, 2015 Received: January 7, 2015

Dear Queena Chen,

This letter corrects our substantially equivalent letter of February 6, 2015.

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.

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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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 [phone] or [phone] 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 [phone] or [phone] 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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## Indications for Use Statement

510(k) Number (if known): K140579

Device Name: SD3 Series Ultrasonic Pocket Doppler SD3 LITE, SD3, SD3 PLUS, SD3 PRO, SD3 VASCULAR

#### Intended Use:

The SD3 Series Ultrasonic Pocket Dopplers (hereinafter called "the Doppler") are 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.

The 2 MHz and/or 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. The 3 MHz waterproof probe is used for more than 9-week gestation and the 2 MHz is used for 12-week gestation. They can also be used to verify fetal heart viability.

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.

n Prescription Use Or Over the Counter Use

(21 CFR Part 801 Subpart D)

Over the Counter Use **_**

(21 CFR Part 801 Subpart C)

#### IPI FASE DO NOT WRITE RFI OW THIS I INF-C.ONTINUIF ON ANOTHER PAGE IFNFFDFD)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

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## 510(k) Summary

### Prepared in accordance with the requirements of 21 CFR Part 807.92

| 1. Submitter: | Edan Instruments, Inc. |
|--------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 3/F-B, Nanshan Medical Equipments Park, Nanhai Rd 1019#, Shekou, Nanshan Shenzhen, 518067 P.R. China |
| | Tel.: [phone] |
| | Fax: [phone] |
| Contact Person: | Queena Chen |
| Prepare date: | 2015-02-04 |
| 2. Device name and classification: | Device Name: SD3 series Ultrasonic Pocket Doppler |
| | Model: SD3 LITE, SD3, SD3 PLUS, SD3 PRO, SD3 VASCULAR, hereinafter called SD3 series |
| Classification Name: | |
| | 21 CFR 884.2660 Fetal ultrasonic monitor and accessories |
| | 21 CFR 870.2100 Cardiovascular blood flowmeter |
| | Product code: KNG, DPW |
| | Regulatory Class: Class II |
| 3.Premarket Notification Class III Certification and Summary | Not applicable, the subject device is Class II. |
| 4. Predicate Device(s): | Sonotrax Series Ultrasonic Pocket Doppler / K101960 / Edan Instruments, Inc. |
| 5. Device Description: | 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 |

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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. 5. 8 MHz for detections of arterial and venous blood flow velocity. The subject device is not a sterilized product, so there is no detailed information about its sterilization status and the shelf life included in the submission. FHR Performance: Sensitivity: 9 weeks gestation (3 MHz) FHR Measuring Range: 50 bpm ~ 240 bpm Resolution: 1 bpm ±2 bpm Accuracy: The SD3 Series Ultrasonic Pocket Dopplers (hereinafter called "the 6. Indications for Doppler") are intended to be used by health care professionals including Use: 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/or 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. The 3 MHz waterproof probe is used for more than 9-week gestation and the 2 MHz is used for 12-week gestation. They can also be used to verify fetal heart viability.

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.

#### 7. Predicate Device Comparison

Comparison to the predicate devices, the subject device has same intended use, similar product design, same performance effectiveness, performance safety as the predicate device.

The differences between the subject device and predicate device include physical specifications, display type. Please refer to following table. All above differences do not affect the basic design principle, usage, effectiveness and safety of the subject device. And no question is raised regarding to effectiveness and safety.

| Item | SONOTRAX | SD3 |
|-------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer/K# | EDAN Instruments/ K101960 | EDAN Instruments/ K140579 |
| Intended Use | The Sonotrax series of Ultrasonic Pocket<br>Doppler are intended for use by health care<br>professionals including registered nurses,<br>practical nurses, midwives, ultrasound<br>technicians, and physicians assistants, by<br>prescription from licensed physicians in | The SD3 Series Ultrasonic Pocket<br>Dopplers (hereinafter called “the<br>Doppler”) are intended to be used by<br>health care professionals including<br>registered nurses, practical nurses,<br>midwives, ultrasound technicians, and |
| | hospitals, clinics and private offices. | physician assistants, by prescription from |
| | | licensed physicians in hospitals, clinics and |
| | | private offices. |
| | The 2 MHz and/ or 3 MHz obstetrical<br>probes are indicated for the detection of fetal<br>heart rate from early gestation thru delivery<br>and as a general indication of fetal well<br>being. They can also be used to verify fetal<br>heart viability following patient trauma. | The 2 MHz and/or 3 MHz waterproof<br>probes are indicated for the detection of<br>fetal heart rate from early gestation thru<br>delivery and as a general indication of fetal<br>well being. The 3 MHz waterproof probe is<br>used for more than 9-week gestation and<br>the 2 MHz is used for 12-week gestation.<br>They can also be used to verify fetal heart<br>viability. |
| | The 4 MHz, 5 MHz and/or 8 MHz vascular<br>probes are indicated for the detection of<br>blood flow in veins and arteries for assisting<br>in the detection of peripheral vascular<br>disease. | The 4 MHz, 5 MHz and/or 8 MHz<br>waterproof vascular probes are indicated<br>for the detection of blood flow in veins and<br>arteries for assisting in the detection of<br>peripheral vascular disease. |
| Installation<br>and<br>use | hand-held | hand-held |
| Mode of operation | Continuous operation | Continuous operation |
| Dimensions | 138mm (W) × 85 mm (L) × 32 mm (H) | 168mm (W)×67 mm (L) × 31 mm (H) |
| Weight | 290g | <350 g (including the battery) |
| Operating: | 5°C ~40°C | 5°C ~40°C |
| Transport/<br>Storage: | -20°C~55°C | -20~55°C |
| | 25%~85% RH | 25% ~ 80%RH |
| Operating: | (no condensation) | (no condensation) |
| Transport/ | 25%~93% RH | 25% ~ 93%RH |
| Storage: | (no condensation) | (no condensation) |
| Operating: | 860hPa~1060hPa | 860hPa ~1060hPa |
| Transport/<br>Storage: | 700hPa~1060hPa | 700hPa ~1060hPa |
| Type of protection<br>against<br>electric<br>shock | Internally powered equipment | Internally powered equipment |
| The<br>degree<br>of<br>protection against<br>electric shock | Type B | Type B |
| The<br>degree<br>of | The main unit : IPX0, | The main unit : IPX0, |
| protection against<br>harmful ingress of | probes : IPX8 | probes : IPX8 |
| liquid<br>The<br>degree<br>of | | |
| safety<br>of<br>application in<br>the<br>presence<br>of<br>a<br>flammable gas | Equipment not suitable for use in presence<br>of flammable gases | Equipment not suitable for use in presence<br>of flammable gases |
| The degree of RF | Group 1, Class B | Group 1, Class B |
| The<br>electrical, | Complies with the standard: | Complies with the standard: |
| mechanical<br>and | IEC 60601-1:2005 | IEC 60601-1:2005 |
| thermal<br>safety | | |
| Evaluation | IEC 60601-2-37:2007 | IEC 60601-2-37:2007 |
| EMC Evaluation | Complies with the standard:<br>IEC<br>60601-1-2:2007 | Complies with the standard:<br>IEC<br>60601-1-2:2007 |
| Software<br>life | Complies with the standard:<br>IEC | Complies with the standard:<br>IEC |
| cycle processes | 62304:2006 | 62304:2006 |
| Acoustic output<br>Evaluation | Complies with the standard: | Complies with the standard: |
| | IEC 61157:2007 | IEC 61157:2007 |
| | IEC 60601-2-37:2007 | IEC 60601-2-37:2007 |
| | NEMA UD 2-2004 | NEMA UD 2-2004 |
| Biocompatibility<br>Evaluation | Complies with the standard: ISO 109931-1. | Complies with the standard: ISO<br>109931-1. |
| | | |
| | Clean the equipment case, probe, etc. as<br>above, and then wipe the probe with an | Clean the equipment case, probe, etc. as<br>above, and then wipe the probe with an |
| Disinfection | alcohol | alcohol |
| | impregnated wipe (ethanol 75%,<br>isopropanol alcohol ≤ 70% or<br>glutaraldehyde ≤3.6%). | impregnated wipe (ethanol 75%,<br>isopropanol alcohol ≤ 70% or<br>glutaraldehyde ≤3.6%). |
| | Wipe the probe with a clean, dry cloth to<br>remove any remaining moisture. | Wipe the probe with a clean, dry cloth to<br>remove any remaining moisture. |
| Display | 45mm*25mm LCD display | 0.96'' OELD double color screen |
| Battery Supply | 2*LR6AA | 3*LR6AA |
| | | 18650 Lithium Battery |
| Auto Shut down | 1 minute after no signal or operation, auto<br>shut down | 1 minute after no signal or operation, auto<br>shut down |
| | | Probe replacement, auto shut down |
| | | |
| Resolution | 1 bpm | 1 bpm |
| Accuracy | ±3bpm | ±2bpm |
| Sensitivity | 10 weeks gestation (3MHz)/<br>105.4dB in 200mm distance | 9 weeks gestation (3MHz)/<br>130dB in 200mm distance |
| | | |
| FHR Measuring<br>Range | 50bpm ~ 240bpm | 50bpm ~ 240bpm |
| | | |
| Recording Length | 240s | 240s |

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#### 8. Performance Testing:

#### Non-clinical test:

The following safety standards are conducted on the subject device:

(1) IEC 60601-1:2005 Safety requirements for medical electrical systems

(2) IEC 60601-1-2:2007 Electromagnetic compatibility requirements and tests

(3) AIUM/NEMA UD 2-2004 Acoustic output measurement standard for diagnostic ultrasound equipment

(4) IEC 60601-2-37:2007 Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment

(5) ISO 10993-1:2009, ISO 10993-5:2009 and ISO 10993-10:2010 Biological evaluation of medical devices

(6) Y Y0449:2009 Ultrasonic Doppler fetal monitor (a Chinese standard)-Performance requirements and methods of measurement and reporting

(7) IEC61266:1994 Ultrasonics Hand-held probe Doppler fetal heartbeat

detectors-Performance requirements and methods of measurement and reporting

Accuracy of FHR for the SD3 devices was tested with the 2 MHz and 3 MHz probes using an FHR simulator for FHR between 50 and 240 BPM. Testing showed the accuracy met the pre-specified criteria of ±2 BPM.

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Repeatability of FHR measurements for the SD3 devices was shown by taking multiple measurements and comparing with set values on the FHR simulator. A students T test analysis showed that measurements were repeatable to a 95% confidence.

#### Clinical test:

Physicians at 6 hospitals used the 2 MHz or the 3 MHz probe depending on the gestational age. There were 162 tests for 11-week to 13-week pregnant women and 99 tests for 9-week to 10(+)-week pregnant women. The test was considered a "pass" if the FHR could be detected and a "fail" if no FHR was detected. A pass rate of 95% was required to support use at a particular gestational age.

Of the 162 cases for the 2 MHz probe from 11-week to 13-week , 157 were considered a "pass." This met the requirements of the test.

Of the 99 cases for the 3 MHz probe for 9-week to 10(+)-week pregnant women, 95 were considered a "pass." This met the requirements of the test.

The subject device passed all testing. The tests were selected to show substantial equivalence between the subject device and the predicate, and since the testing passed, substantial equivalence is shown.

#### 9. Conclusion:

Verification and validation testing was conducted on the SD3 series Ultrasonic Pocket Doppler SD3 series and all testing passed prespectied criteria. This premarket notification submission demonstrates that the Diagnostic Ultrasonic System is substantially equivalent to the predicate devices.