(337 days)
Not Found
No
The device description and performance studies focus on standard Doppler technology and signal processing, with no mention of AI or ML algorithms for interpretation or analysis.
No.
The device is strictly for diagnostic purposes (detection of fetal heart rate and blood flow) and does not provide any therapeutic intervention.
Yes
The device is intended for the detection of fetal heart rate and blood flow in veins and arteries to assist in the detection of peripheral vascular disease, which are diagnostic purposes.
No
The device description explicitly states it is a "hand-held device" that includes probes, a CPU, OLED display, operation keys, and a speaker, indicating it is a hardware device with integrated software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended to be used in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to monitor therapeutic measures.
- Device Function: The SD3 Series Ultrasonic Pocket Dopplers use ultrasound to detect fetal heart rate and blood flow velocity directly within the body (in vivo). They do not analyze specimens taken from the body.
- Intended Use: The intended use is to detect fetal heart rate and blood flow, which are physiological measurements taken directly from the patient.
Therefore, while it is a medical device, it falls under the category of devices used for in vivo measurements rather than in vitro analysis of specimens.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
KNG, DPW
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Fetal heart, veins, arteries (for blood flow detection)
Indicated Patient Age Range
Not Found (Gestational age specified for fetal heart rate detection: more than 9-week gestation for 3 MHz probe, 12-week gestation for 2 MHz probe)
Intended User / Care Setting
Health care professionals including registered 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
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical test:
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy: ±2 bpm
FHR Performance: Sensitivity: 9 weeks gestation (3 MHz)
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
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.
1
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 (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
2
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)
3
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.: (0755) 26856469 | |
| Fax: (0755) 26882223 | |
| 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 | |
| Doppler are intended for use by health care | ||
| professionals including registered nurses, | ||
| practical nurses, midwives, ultrasound | ||
| technicians, and physicians assistants, by | ||
| prescription from licensed physicians in | The SD3 Series Ultrasonic Pocket | |
| Dopplers (hereinafter called “the | ||
| Doppler”) are intended to be used by | ||
| health care professionals including | ||
| registered nurses, practical nurses, | ||
| 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 | ||
| probes are indicated for the detection of fetal | ||
| heart rate from early gestation thru delivery | ||
| and as a general indication of fetal well | ||
| being. They can also be used to verify fetal | ||
| heart viability following patient trauma. | 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 vascular | ||
| probes are indicated for the detection of | ||
| blood flow in veins and arteries for assisting | ||
| in the detection of peripheral vascular | ||
| disease. | 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. | ||
| Installation | ||
| and | ||
| 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 |