(58 days)
No
The device description details standard Doppler ultrasound technology and signal processing without mentioning AI or ML. The performance studies and key metrics are also typical for this type of device and do not suggest the use of AI/ML.
No.
The device is used for detection and measurement of fetal heart rate and is not intended to treat any medical condition.
Yes
Explanation: The device is indicated for "detection of fetal heart rate... and as a general indication of fetal well being. They can also be used to verify fetal heart viability." This information is used for diagnosis of fetal condition.
No
The device description explicitly states it is a "hand-held device" that utilizes "ultrasound is transmitted from the probe to patient body" and "reflected ultrasound is received by the probe and is converted into electric signals." This indicates the presence of physical hardware components (probe, main unit, speaker, batteries) that are integral to the device's function, not just software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The description clearly states that the device uses ultrasound transmitted from a probe to the patient's body (maternal abdominal wall) to detect fetal heart rate. It does not analyze blood, urine, tissue, or any other bodily fluid or substance in vitro (outside the body).
- The device is a diagnostic ultrasound device. The description explicitly mentions "Diagnostic ultrasound imaging or fluid flow analysis" as the input imaging modality and describes the use of Doppler shift of ultrasound to measure fetal heart rate. This falls under the category of medical imaging devices, not IVDs.
Therefore, the SD5 and SD6 Ultrasonic TableTop Dopplers are diagnostic ultrasound devices used for monitoring fetal heart rate in vivo, not IVDs.
N/A
Intended Use / Indications for Use
The SD5 Ultrasonic TableTop Doppler (hereinafter called "SD5") and SD6 Ultrasonic TableTop Doppler (hereinafter called "SD6") are intended to be used by health care professionals including registered nurses, midwives, ultrasound technicians, and physician assistants, by prescription 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.
Product codes (comma separated list FDA assigned to the subject device)
KNG
Device Description
The SD5&SD6 Ultrasonic Tabletop Doppler is a hand-held device for non-invasive measurement and display of fetal heart rate 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 LED Display, operation keys. The audio signal is taken off for the routing to the speaker to generate the analogue signals before digital processing. The system is compatible with 2 MHz or 3 MHz for fetal heart rate. The signal acquired can be transferred to SD5 by wired method, and by Bluetooth to SD6.
The main unit can be powered by main supply (100 V-240 V~) or Ni-MH Battery (7.2 V/2000 mAh). And transducers are powered by 3.7 V/800 mAh Lithium Battery only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Fetal heart (via maternal abdominal wall)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care professionals including registered nurses, midwives, ultrasound technicians, and physician assistants, by prescription 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)
Non-clinical test:
- Biocompatibility testing: The biocompatibility evaluation for the SD5&SD6 Ultrasonic Tabletop Doppler was conducted in accordance with the International Standard ISO 10993-1. The worst case of the whole system is considered tissue contacting for duration of less than 24 hours. The battery of testing included Cytotoxicity, Skin Sensitization, and Irritation or Intracutaneous Reactivity. No new biocompatibility data provided as shell of probe and jacket of wire are identified to that of F9 Fetal & Maternal Monitor (K150901) in formulation, processing, and sterilization, and no other chemicals have been added.
- Electrical safety and electromagnetic compatibility (EMC): Testing was conducted on the F series Fetal & Maternal Monitor device, consisting of all modules and accessories. The system complies with IEC 60601-1:2005/A1: 2012 for safety and IEC 60601-1-2: 2007 for EMC.
- Bench Testing: Bench testing was conducted on the SD5&SD6 Ultrasonic Tabletop Doppler, consisting of all modules and accessories. The system complies with IEC 60601-2-37: 2007.
- Software Verification and Validation Testing: Testing was conducted and documentation 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 was considered a "moderate" level of concern.
- Acoustic testing: All measurements were conducted in accordance with the measurement procedures of the NEMA Standard Publications UD-2 and following the calibration procedures given in Section 4 of UD-2, and the reporting requirements of the September 9, 2008 FDA Guide for Track 1.
Clinical test:
Not applicable.
Conclusion:
Verification and validation testing was conducted on the SD5&SD6 Ultrasonic Tabletop Doppler and all testing passed pre-specified criteria. This premarket notification demonstrates that the Diagnostic Ultrasonic System is substantially equivalent to the predicate devices.
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.
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 is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized human figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 8, 2016
Edan Instruments, Inc. % Ms. Queena Chen Regulatory Engineer 3/F - B, Nanshan Medical Equipments Park Nanhai Road 1019# Shenzhen, Guangdong 518067 CHINA
Re: K153475
Trade/Device Name: SD5 & SD6 Ultrasonic Tabletop Doppler Regulation Number: 21 CFR 884.2660 Regulation Name: Fetal ultrasonic monitor and accessories Regulatory Class: II Product Code: KNG Dated: November 30, 2015 Received: December 2, 2015
Dear Ms. Chen:
This letter corrects our substantially equivalent letter of January 29, 2016. 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 Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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/Resourcesfor You/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,
Michael D. O'Hara
For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
SD5&SD6 Ultrasonic Tabletop Doppler
Indications for Use (Describe)
The SD5 Ultrasonic TableTop Doppler (hereinafter called "SDS") and SD6 Ultrasonic TableTop Doppler (hereinafter called "SD6") are intended to be used by health care professionals including registered nurses, midwives, ultrasound technicians, and physician assistants, by prescription 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.
Type of Use (Select one or both, as applicable)
| ☑ 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
Diagnostic Ultrasound Indications for Use Ultrasonic Tabletop Doppler SD5
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | Specific | B | M | PWD | CWD | Colour Doppler | Combined (Specify) | Other* (Specify) |
| Ophthalm | Ophthalmic | |||||||
| Fetal | P | |||||||
| Abdominal | ||||||||
| Intra-operative | ||||||||
| (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Fetal | Small Organ (Specify) | |||||||
| Imaging | ||||||||
| & Other | Neonatal Cephalic | |||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. | ||||||||
| (Non-Card.) | ||||||||
| Musculo-skel | ||||||||
| (conventional) | ||||||||
| Musculo-skel | ||||||||
| (superficial) | ||||||||
| Intra-luminal | ||||||||
| Other (Specify) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-Esoph. (Cardiac) | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (Specify) |
N = new indication; P=previously licensed Additional Comments:
4
System: Ultrasonic Tabletop Doppler SD5
Transducer: 2 MHz CW fetal probe
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation | | | | | | Other*
(Specify) |
|----------------------|--------------------------------|-------------------|---|-----|-----|-------------------|-----------------------|---------------------|
| General | Specific | B | M | PWD | CWD | Colour
Doppler | Combined
(Specify) | |
| Ophthalm
ic | Ophthalmic | | | | | | | |
| | Fetal | | | | P | | | |
| | Abdominal | | | | | | | |
| | Intra-operative
(Specify) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| Fetal | Small Organ (Specify) | | | | | | | |
| Imaging
& Other | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph.
(Non-Card.) | | | | | | | |
| | Musculo-skel
(conventional) | | | | | | | |
| | Musculo-skel
(superficial) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (Specify) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-Esoph. (Cardiac) | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral
Vessel | Peripheral vessel | | | | | | | |
| | Other (Specify) | | | | | | | |
N = new indication; P=previously licensed
5
System: Ultrasonic Tabletop Doppler SD5
Transducer: 3 MHz CW fetal probe
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | Specific | B | M | PWD | CWD | Colour | ||
| Doppler | Combined | |||||||
| (Specify) | Other* | |||||||
| (Specify) | ||||||||
| Ophthalm | ||||||||
| ic | Ophthalmic | |||||||
| Fetal | P | |||||||
| Abdominal | ||||||||
| Intra-operative | ||||||||
| (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Fetal | ||||||||
| Imaging | ||||||||
| & Other | Small Organ (Specify) | |||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. | ||||||||
| (Non-Card.) | ||||||||
| Musculo-skel | ||||||||
| (conventional) | ||||||||
| Musculo-skel | ||||||||
| (superficial) | ||||||||
| Intra-luminal | ||||||||
| Other (Specify) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-Esoph. (Cardiac) | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (Specify) |
N = new indication; P=previously licensed
6
Diagnostic Ultrasound Indications for Use Ultrasonic Tabletop Doppler SD6
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | Specific | B | M | PWD | CWD | Colour | ||
| Doppler | Combined | |||||||
| (Specify) | Other* | |||||||
| (Specify) | ||||||||
| Ophthalm | ||||||||
| ic | Ophthalmic | |||||||
| Fetal | P | |||||||
| Abdominal | ||||||||
| Intra-operative | ||||||||
| (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Fetal | Small Organ (Specify) | |||||||
| Imaging | ||||||||
| & Other | Neonatal Cephalic | |||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. | ||||||||
| (Non-Card.) | ||||||||
| Musculo-skel | ||||||||
| (conventional) | ||||||||
| Musculo-skel | ||||||||
| (superficial) | ||||||||
| Intra-luminal | ||||||||
| Other (Specify) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-Esoph. (Cardiac) | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (Specify) |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P=previously licensed
7
System: Ultrasonic Tabletop Doppler SD6
Transducer: 2 MHz CW fetal probe
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | Specific | B | M | PWD | CWD | Colour | ||
| Doppler | Combined | |||||||
| (Specify) | Other* | |||||||
| (Specify) | ||||||||
| Ophthalm | ||||||||
| ic | Ophthalmic | |||||||
| Fetal | P | |||||||
| Abdominal | ||||||||
| Intra-operative | ||||||||
| (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Fetal | Small Organ (Specify) | |||||||
| Imaging | ||||||||
| & Other | Neonatal Cephalic | |||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. | ||||||||
| (Non-Card.) | ||||||||
| Musculo-skel | ||||||||
| (conventional) | ||||||||
| Musculo-skel | ||||||||
| (superficial) | ||||||||
| Intra-luminal | ||||||||
| Other (Specify) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-Esoph. (Cardiac) | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (Specify) |
N = new indication; P=previously licensed
8
System: Ultrasonic Tabletop Doppler SD6
Transducer: 3 MHz CW fetal probe
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | Specific | B | M | PWD | CWD | Colour | ||
| Doppler | Combined | |||||||
| (Specify) | Other* | |||||||
| (Specify) | ||||||||
| Ophthalm | ||||||||
| ic | Ophthalmic | |||||||
| Fetal | P | |||||||
| Abdominal | ||||||||
| Intra-operative | ||||||||
| (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Fetal | ||||||||
| Imaging | ||||||||
| & Other | Small Organ (Specify) | |||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. | ||||||||
| (Non-Card.) | ||||||||
| Musculo-skel | ||||||||
| (conventional) | ||||||||
| Musculo-skel | ||||||||
| (superficial) | ||||||||
| Intra-luminal | ||||||||
| Other (Specify) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-Esoph. (Cardiac) | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (Specify) |
N = new indication; P=previously licensed
9
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) 26858736 | |
| Fax: (0755) 26882223 | |
| Contact Person: | Queena Chen |
| Prepare date: | 2015-11-30 |
| 2. Device name | |
| and classification: | Device Name: Ultrasonic Tabletop Doppler |
| Model: SD5, SD6 | |
| Classification Name: | |
| 21 CFR 884.2660 Fetal ultrasonic monitor and accessories | |
| Product code: KNG | |
| Regulatory Class: Class II | |
| 3. Reason for | |
| Submission | Technology Change. |
| 4. Predicate | |
| Device(s): | SD5&SD6 Ultrasonic Tabletop Doppler / K102138 / Edan Instruments, Inc. |
| 5. Device | |
| Description: | The SD5&SD6 Ultrasonic Tabletop Doppler is a hand-held device for non-invasive measurement and display of fetal heart rate 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 LED Display, operation keys. The audio signal is taken off for the routing to the speaker to generate the analogue signals before digital processing. The system is compatible with 2 MHz or 3 MHz for fetal heart rate. The signal acquired can be transferred to SD5 by wired method, and by Bluetooth to SD6. |
| The main unit can be powered by main supply (100 V-240 V~) or Ni-MH Battery (7.2 V/2000 mAh). And transducers are powered by 3.7 V/800 mAh Lithium Battery only. |
10
The SD5 Ultrasonic TableTop Doppler (hereinafter called "SD5") and SD6 6. Indications for Ultrasonic TableTop Doppler (hereinafter called "SD6") are intended to be Use: 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/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.
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.
Please refer to following table to find differences between the subject device and predicate device. All the 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 | SD5/SD6 | SD5/SD6 | Comparison
Result |
|-------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| Manufacturer/K# | EDAN Instruments/
K102138 | Current Submission | --- |
| Intended Use/Indications for Use | | | |
| Intended
Use/Indications for
Use | The SD5 Ultrasonic
TableTop Doppler
(hereinafter called “SD5”)
and SD6 Ultrasonic
TableTop Doppler
(hereinafter called “SD6”)
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/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 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 SD5 Ultrasonic TableTop
Doppler (hereinafter called
“SD5”) and SD6 Ultrasonic
TableTop Doppler (hereinafter
called “SD6”) 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/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. | Different |
| Operation characteristic | | | |
| Mode of operation | Continuous operation | Continuous operation | Same |
| Physical Specifications | | | |
| Dimensions | Main Unit: 265 mm x 155
mm x 180 mm | Main Unit: 265 mm x 155 mm x
180 mm | Same |
| Weight | Main Unit: 1.7 kg (with
battery and probe) | Main Unit: 1.7 kg (with battery
and probe) | Same |
| Display: | Effective display area: 62.0
mm (W) x 44.0mm(H)
Number of characters:
12864 Dots
Dot size: 0.39 mm (W) x
0.55 mm (H)
Dot pitch: 0.44 mm (W) x
0.60 mm (H) | Effective display area: 62.0 mm
(W) x 44.0mm(H)
Number of characters: 12864
Dots
Dot size: 0.39 mm (W) x 0.55
mm (H)
Dot pitch: 0.44 mm (W) x 0.60
mm (H) | Same |
| Environmental Specifications | | | |
| Working | Temperature: + 5 °C ~ + 40°C
( +41°F ~ +104°F)
Relative Humidity: 25% RH
~ 80% RH (non-condensing)
Atmospheric Pressure: 86
kPa106 kPa | Temperature:0°C ~ + 40°C106 kPa | Temperature: -20°C ~ +55°C (-4°F
(+32°F ~ +104°F)
Relative Humidity: 15% RH ~
95% RH (non-condensing)
Atmospheric Pressure: 86 kPa ~
106 kPa | Different |
| Transport and
Storage | Temperature: -20°C ~ +55°C
(-4°F ~ +131°F)
Relative Humidity: 25% RH
~ 93% RH (non-condensing)
Atmospheric Pressure: 70
kPa
~ +131°F)
Relative Humidity: 15% RH ~
95% RH (non-condensing)
Atmospheric Pressure: 70 kPa ~
106 kPa | Same |
| Safety Classifications | | | |
| Anti-electric Shock
Type | Class I equipment with
internal power supply | Class I equipment with internal
power supply | Same |
| Anti-electric Shock
Degree | Type B applied parts | Type BF applied parts | Different |
| Degree of Protection
against Harmful
Ingress of Water | Main Unit: Ordinary
equipment (Sealed equipment
without liquid proof)
Probe: IPX4 | Main Unit: Ordinary equipment
(Sealed equipment without liquid
proof)
Probe: IPX4 | Same |
| Degree of Safety 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 |
| The degree of RF | CISPR 11 Group1 Class A | CISPR 11 Group1 Class A | Same |
| The electrical,
mechanical and
thermal safety
Evaluation | Complies with the standard:
IEC 60601-1
IEC 60601-2-37 | Complies with the standard:
IEC 60601-1
IEC 60601-2-37 | Same |
| EMC Evaluation | Complies with the standard:
IEC 60601-1-2 | Complies with the standard:
IEC 60601-1-2 | Same |
| Software life cycle
processes | Complies with the standard:
IEC 62304 | Complies with the standard:
IEC 62304 | Same |
| Acoustic output
Evaluation | Complies with the standard:
IEC 60601-2-37
NEMA UD 2-2004 | Complies with the standard:
IEC 60601-2-37
NEMA UD 2-2004 | Same |
| Biocompatibility
Evaluation | Complies with the standard:
ISO 10993-1 | Complies with the standard:
ISO 10993-1 | Same |
| | ISO 10993-5
ISO 10993-10 | ISO 10993-5
ISO 10993-10 | |
| Wireless connection mode(SD6) | | | |
| Wireless connection
mode(SD6) | Infrared | Bluetooth | Different |
| FHR Specifications | FHR Measuring Range:
50bpm ~ 210bpm
Accuracy: ±3bpm
Resolution:1 bpm | FHR Measuring Range: 50bpm ~
240bpm
Accuracy: ±2bpm
Resolution:1 bpm | Different |
11
12
8. Performance Testing:
Non-clinical test:
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
The biocompatibility evaluation for the SD5&SD6 Ultrasonic Tabletop Doppler was conducted in accordance with the 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 worst case of the whole system is considered tissue contacting for duration of less than 24 hours. And the battery of testing included the following tests:
- Cytotoxicity ●
- Skin Sensitization
- Irritation or Intracutaneous Reactivity ●
Since The shell of probe and Jacket of wire are identified to that of the F9 Fetal & Maternal Monitor as it was approved in K150901 [06/01/2015] in formulation, processing, and sterilization, and no other chemicals have been added (e.g., plasticizers, fillers, color additives, cleaning agents, mold release agents, etc., no new biocompatibility data is provided in this submission.
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the F series Fetal & Maternal Monitor device, consisting of all the modules and accessories in the system. The system complies with the IEC 60601-1:2005/A1: 2012 standards for safety and the IEC 60601-1-2: 2007 for EMC. No changes happened during the testing in order to conform the international standards.
Bench Testing
Bench testing was conducted on the SD5&SD6 Ultrasonic Tabletop Doppler, consisting of all the modules and accessories in the system. The system complies with the IEC 60601-2-37: 2007.
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 as 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.
Acoustic testing
All measurements were conducted in accordance with the measurement procedures of the NEMA Standard Publications UD-2 and following the calibration procedures given in Section 4 of UD-2, and
13
the reporting requirements of the September 9, 2008 FDA Guide for Track 1.
Clinical test:
Not applicable.
9. Conclusion:
Verification and validation testing was conducted on the SD5&SD6 Ultrasonic Tabletop Doppler and all testing passed pre-specified criteria. This premarket notification demonstrates that the Diagnostic Ultrasonic System is substantially equivalent to the predicate devices.