(58 days)
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 heart well being. They can also be used to verify fetal heart viability.
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.
The provided document is a 510(k) Premarket Notification from the FDA for the Edan Instruments, Inc. SD5 & SD6 Ultrasonic Tabletop Doppler. This document describes the device, its intended use, and compares it to a predicate device. It also briefly mentions performance testing.
However, the document does not contain the specific acceptance criteria or the detailed study results that prove the device meets these criteria in a quantitative manner, which is typical for a clinical performance study. The primary focus of this document is to demonstrate substantial equivalence to a previously cleared device (K102138, also an SD5/SD6 Ultrasonic Tabletop Doppler from Edan Instruments).
Based on the information available in the document, here's what can be extracted and inferred, along with the information that is not present:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from Predicate Comparison) | Reported Device Performance (Current Submission) |
|---|---|
| FHR Measuring Range: 50bpm ~ 210bpm | FHR Measuring Range: 50bpm ~ 240bpm |
| Accuracy: ±3bpm | Accuracy: ±2bpm |
| Resolution: 1 bpm | Resolution: 1 bpm |
Note: The above table is derived directly from the "FHR Specifications" comparison with the predicate device (K102138). The current device (SD5/SD6) actually specifies a better performance for FHR measuring range and accuracy than its predicate, which supports its substantial equivalence claim. However, these are technical specifications and not necessarily acceptance criteria from a specific clinical performance study. The document states that "all testing passed pre-specified criteria," but does not explicitly list these criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. The document states "Clinical test: Not applicable." This indicates that no new clinical study (with a test set of patients) was conducted for this 510(k) submission to assess the device's performance in a clinical setting. The substantial equivalence is based on technical comparisons, safety, and performance bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. As no clinical test data is provided, there is no mention of experts or ground truth establishment for a patient test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical test data is provided.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. The device is a fetal ultrasonic monitor (Doppler) for detecting fetal heart rate. It is a standalone measurement device, not an AI-powered image analysis tool that assists human readers. Therefore, an MRMC study and AI assistance effect size are not relevant to this device type.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Yes, effectively. The performance data related to FHR measuring range, accuracy, and resolution (as shown in the table above) represent the standalone technical performance of the device. This performance is assessed through bench testing and compliance with standards (e.g., IEC 60601-2-37). The device, by its nature, provides a direct measurement (fetal heart rate) rather than involving an "algorithm only" in the sense of image interpretation, but its core function is performed independently to provide the output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the technical specifications (FHR measuring range, accuracy, resolution), the ground truth would typically be established by reference measurement techniques using calibrated equipment and simulated fetal heart rate signals during bench testing. The document states "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." This standard specifies requirements for the safety and essential performance of ultrasonic diagnostic and monitoring equipment, including accuracy of measurements.
8. The sample size for the training set
- Not applicable. This device is a hardware-based fetal Doppler. It does not appear to employ machine learning or AI algorithms that would require a "training set" of data in the conventional sense. Its functionality relies on established Doppler physics and signal processing techniques.
9. How the ground truth for the training set was established
- Not applicable. (See point 8).
Summary of what the document focuses on for acceptance:
The primary method for demonstrating acceptance and substantial equivalence in this 510(k) submission relies on:
- Predicate Device Comparison: Showing that the new device has the same intended use, similar product design, and comparable performance and safety characteristics to a legally marketed predicate device.
- Compliance with Recognized Standards: Mentioning compliance with standards such as IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), IEC 60601-2-37 (ultrasonic equipment safety/performance), IEC 62304 (software life cycle), ISO 10993-1, -5, -10 (biocompatibility), and NEMA UD-2 (acoustic output). Passing these tests implicitly means meeting the criteria outlined within those standards.
- Bench Testing: Conducted to ensure the system meets specified technical performance.
- Software Verification and Validation: Performed for the "moderate" level of concern software.
The absence of clinical study data is explicitly noted as "Not applicable," suggesting that the FDA deemed the technical and bench testing sufficient to establish substantial equivalence for this type of device based on its intended use and comparison to the predicate.
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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 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) |
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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) | ||||||||
| PeripheralVessel | 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 | ColourDoppler | Combined(Specify) | |
| Ophthalmic | 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) | ||||||||
| PeripheralVessel | 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 | ColourDoppler | Combined(Specify) | Other*(Specify) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal | P | |||||||
| Abdominal | ||||||||
| Intra-operative(Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| FetalImaging& 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) | ||||||||
| PeripheralVessel | 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 | ColourDoppler | Combined(Specify) | Other*(Specify) |
| Ophthalmic | 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) | ||||||||
| PeripheralVessel | 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 | ColourDoppler | Combined(Specify) | Other*(Specify) |
| Ophthalmic | 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) | ||||||||
| PeripheralVessel | 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 | ColourDoppler | Combined(Specify) | Other*(Specify) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal | P | |||||||
| Abdominal | ||||||||
| Intra-operative(Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| FetalImaging& 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) | ||||||||
| PeripheralVessel | 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 nameand classification: | Device Name: Ultrasonic Tabletop Doppler |
| Model: SD5, SD6 | |
| Classification Name:21 CFR 884.2660 Fetal ultrasonic monitor and accessories | |
| Product code: KNGRegulatory Class: Class II | |
| 3. Reason forSubmission | Technology Change. |
| 4. PredicateDevice(s): | SD5&SD6 Ultrasonic Tabletop Doppler / K102138 / Edan Instruments, Inc. |
| 5. DeviceDescription: | 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 | ComparisonResult |
|---|---|---|---|
| Manufacturer/K# | EDAN Instruments/K102138 | Current Submission | --- |
| Intended Use/Indications for Use | |||
| IntendedUse/Indications forUse | The SD5 UltrasonicTableTop Doppler(hereinafter called “SD5”)and SD6 UltrasonicTableTop Doppler(hereinafter called “SD6”)are intended to be used byhealth care professionalsincluding registered nurses,practical nurses, midwives,ultrasound technicians, andphysician assistants, byprescription from licensedphysicians in hospitals,clinics and private offices.The 2 MHz and/or 3 MHzobstetrical probes areindicated for the detection offetal heart rate from earlygestation thru delivery and asa general indication of fetalwell being. They can also beused to verify fetal heartviability following patienttrauma.The 4 MHz, 5 MHz and/or 8MHz vascular probes areindicated for the detection ofblood flow in veins andarteries for assisting in thedetection of peripheralvascular disease. | The SD5 Ultrasonic TableTopDoppler (hereinafter called“SD5”) and SD6 UltrasonicTableTop Doppler (hereinaftercalled “SD6”) are intended to beused by health care professionalsincluding registered nurses,practical nurses, midwives,ultrasound technicians, andphysician assistants, byprescription from licensedphysicians in hospitals, clinicsand private offices.The 2 MHz and/or 3 MHzobstetrical probes are indicatedfor the detection of fetal heart ratefrom early gestation thru deliveryand as a general indication of fetalwell being. They can also be usedto verify fetal heart viability. | Different |
| Operation characteristic | |||
| Mode of operation | Continuous operation | Continuous operation | Same |
| Physical Specifications | |||
| Dimensions | Main Unit: 265 mm x 155mm x 180 mm | Main Unit: 265 mm x 155 mm x180 mm | Same |
| Weight | Main Unit: 1.7 kg (withbattery and probe) | Main Unit: 1.7 kg (with batteryand probe) | Same |
| Display: | Effective display area: 62.0mm (W) x 44.0mm(H)Number of characters:128*64 DotsDot size: 0.39 mm (W) x0.55 mm (H)Dot pitch: 0.44 mm (W) x0.60 mm (H) | Effective display area: 62.0 mm(W) x 44.0mm(H)Number of characters: 128*64DotsDot size: 0.39 mm (W) x 0.55mm (H)Dot pitch: 0.44 mm (W) x 0.60mm (H) | Same |
| Environmental Specifications | |||
| Working | Temperature: + 5 °C ~ + 40°C( +41°F ~ +104°F)Relative Humidity: 25% RH~ 80% RH (non-condensing)Atmospheric Pressure: 86kPa~106 kPa | Temperature:0°C ~ + 40°C(+32°F ~ +104°F)Relative Humidity: 15% RH ~95% RH (non-condensing)Atmospheric Pressure: 86 kPa ~106 kPa | Different |
| Transport andStorage | Temperature: -20°C ~ +55°C(-4°F ~ +131°F)Relative Humidity: 25% RH~ 93% RH (non-condensing)Atmospheric Pressure: 70kPa~106 kPa | Temperature: -20°C ~ +55°C (-4°F~ +131°F)Relative Humidity: 15% RH ~95% RH (non-condensing)Atmospheric Pressure: 70 kPa ~106 kPa | Same |
| Safety Classifications | |||
| Anti-electric ShockType | Class I equipment withinternal power supply | Class I equipment with internalpower supply | Same |
| Anti-electric ShockDegree | Type B applied parts | Type BF applied parts | Different |
| Degree of Protectionagainst HarmfulIngress of Water | Main Unit: Ordinaryequipment (Sealed equipmentwithout liquid proof)Probe: IPX4 | Main Unit: Ordinary equipment(Sealed equipment without liquidproof)Probe: IPX4 | Same |
| Degree of Safety inPresence ofFlammable Gases | Equipment not suitable foruse in presence of flammablegases | Equipment not suitable for use inpresence of flammable gases | Same |
| The degree of RF | CISPR 11 Group1 Class A | CISPR 11 Group1 Class A | Same |
| The electrical,mechanical andthermal safetyEvaluation | Complies with the standard:IEC 60601-1IEC 60601-2-37 | Complies with the standard:IEC 60601-1IEC 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 cycleprocesses | Complies with the standard:IEC 62304 | Complies with the standard:IEC 62304 | Same |
| Acoustic outputEvaluation | Complies with the standard:IEC 60601-2-37NEMA UD 2-2004 | Complies with the standard:IEC 60601-2-37NEMA UD 2-2004 | Same |
| BiocompatibilityEvaluation | Complies with the standard:ISO 10993-1 | Complies with the standard:ISO 10993-1 | Same |
| ISO 10993-5ISO 10993-10 | ISO 10993-5ISO 10993-10 | ||
| Wireless connection mode(SD6) | |||
| Wireless connectionmode(SD6) | Infrared | Bluetooth | Different |
| FHR Specifications | FHR Measuring Range:50bpm ~ 210bpmAccuracy: ±3bpmResolution:1 bpm | FHR Measuring Range: 50bpm ~240bpmAccuracy: ±2bpmResolution: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
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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.
§ 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).