(275 days)
Not Found
No
The document describes a standard ultrasound system with hardware and software for image acquisition and display. There is no mention of AI, ML, or related concepts like training or test sets for algorithmic performance.
No
The device is described as an "ultrasound imaging system" intended for "diagnostic information" and "real-time imaging," indicating its purpose is for diagnosis, not therapy.
Yes
The "Intended Use / Indications for Use" section states that the system is "possible to provide diagnostic information," and the "Device Description" section explicitly calls it "a basic diagnostic tool" and "diagnostic ultrasound system."
No
The device description explicitly states that the system is a "combination of proprietary hardware and software" and that it "only contains the hardware and firmware" with the software residing on a separate PC. This indicates the device includes significant hardware components beyond just software.
Based on the provided information, the SmartUs EXT-1M/3M ultrasound imaging system is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- SmartUs EXT-1M/3M Function: The SmartUs EXT-1M/3M is an ultrasound imaging system. It uses sound waves to create images of internal body structures. It does not involve the analysis of specimens taken from the body.
- Intended Use: The intended use clearly describes imaging applications for various anatomical sites and patient populations. This is consistent with the function of an ultrasound machine, not an IVD.
- Device Description: The description details the hardware and software for acquiring and displaying ultrasound images. This aligns with an imaging device.
- No Mention of Specimen Analysis: There is no mention of collecting, preparing, or analyzing biological specimens.
Therefore, the SmartUs EXT-1M/3M falls under the category of a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
SmartUs EXT-1M/3M ultrasound imaging system is intended to be used for applications in fetal, abdominal, pediatric, small organ (breast, thyroid, testicles), adult cefalic, musculo-skeletal (conventional), musculo-skeletal (superficial), cardiac adult, cardiac pediatric, peripheral vessel (B and M-mode, combined modes imaging, including imaging for needle guidance). It is possible to provide diagnostic information outside of an imaging lab, including at the bedside systems, for navigated medical application, in operating rooms/critical care units.
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX
Device Description
SmartUs EXT-1M/3M system is a combination of proprietary hardware and software that has been designed for real-time imaging and is intended to be a basic diagnostic tool. Its basic function is to acquire ultrasound echo data and to display the image in ultrasound B-Mode, M-Mode or combined modes. The system is designed for imaging with transducer ranges of 2 to 15 MHz. The devices referenced in this submission represent a transportable, software-controlled, diagnostic ultrasound system with accessories. This submission does not include technology or control feature changes nor deviations from indications for use different from those demonstrated in previously cleared devices operating in ultrasound B-Mode, M-Mode or combined modes, inclusive of the predicate devices so claimed.
SmartUs EXT-1M/3M only contains the hardware and firmware, everything else (e.g. ultrasound software, database) is located on a standard PC that is connected to the SmartUs EXT-1M/3M via USB 2.0/3.0. Minimum requirements are given for the PC. All echo-images (sonograms) are saved on the PC and can there be evaluated, printed and archived. The Echo Wave II software was especially designed for the TELEMED devices. Software able to reside in a Windows-based PC.
The device modifications are:
- SmartUs EXT-1M ultrasound system utilizing as hardware an ultrasound engine contained in a small standalone enclosure for connection to a host PC via a USB port with external power supply;
- SmartUs EXT-3M ultrasound system -modification with 3 probe ports.
The SmartUs EXT-1M/3M can be used together with the appropriate probes for the entire ultrasound diagnostic (2MHz to 15MHz probes).
- probe L15-7L40H-5, linear array, at a central ultrasonic frequency of approx. 12 MHz;
- probe C5-2R60HI-5, convex array at a central ultrasonic frequency of approx. 3.5 MHz;
- probe P5-1L15SI-6, phased array at a central ultrasonic frequency of approx. 4 MHz.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Fetal, abdominal, pediatric, small organ (breast, thyroid, testicles), adult cefalic, musculo-skeletal (conventional), musculo-skeletal (superficial), cardiac adult, cardiac pediatric, peripheral vessel.
Indicated Patient Age Range
Adult, Pediatric, Fetal, Neonatal Cephalic. No specific age ranges are provided.
Intended User / Care Setting
It is possible to provide diagnostic information outside of an imaging lab, including at the bedside systems, for navigated medical application, in operating rooms/critical care units.
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)
No additional clinical testing is required, as the indications for use are not a novel indication as shown by the predicate devices in VOL_004 Predicate Device Comparison.
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.
LS128 K113184, SONOACE R7 K112646
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
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized representation of three human profiles facing right, arranged in a stacked formation. The profiles are black and have a flowing, abstract design. The seal is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 10, 2017
TELEMED % Yury Sokolov Engineering Manager Dariaus ir Gireno str. 42 Vilnius, LT-02189 LITHUANIA
Re: K163121
Trade/Device Name: SmartUs EXT-1M/3M Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: June 27, 2017 Received: July 12, 2017
Dear Yury Sokolov:
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 of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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,
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) K163121
Device Name SmartUs EXT-1M/3M
Indications for Use (Describe)
SmartUs EXT-1M/3M ultrasound imaging system is intended to be used for applications in fetal, abdominal, pediatric, small organ (breast, thyroid, testicles), adult cefalic, musculo-skeletal (conventional), musculo-skeletal (superficial), cardiac adult, cardiac pediatric, peripheral vessel (B and M-mode, combined modes imaging, including imaging for needle guidance). It is possible to provide diagnostic information outside of an imaging lab, including at thebedside systems, for navigatedmedical application, in operating rooms/critical care units.
| 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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3
Diagnostic Ultrasound Indications for Use Form
System: SmartUs EXT-1M/3M
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Table 1.3-1 | ||||||||
|---|---|---|---|---|---|---|---|---|
| Clinical Application | Mode of Operation | |||||||
| General | ||||||||
| (Track 1 Only) | Specific | |||||||
| (Track 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | Combined | |||||||
| (specify) | Other | |||||||
| (specify) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | N | N | N | N | N | Note 1 | Note 2,3,4 | |
| Abdominal | N | N | N | N | N | Note 1 | Note 2,3,4 | |
| Intraoperative (specify) | ||||||||
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | N | N | N | N | N | Note 1 | Note 2,3,4 | |
| Small Organ (specify) | N | N | N | N | N | Note 1 | Note 2,3,4 | |
| Neonatal Cephalic | ||||||||
| Fetal Imaging | Adult Cephalic | N | N | N | N | N | Note 1 | Note 4 |
| & Other | Trans-rectal | |||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (Non-Card) | ||||||||
| Musculo-skeletal | ||||||||
| (Conventional) | N | N | N | N | N | Note 1 | Note 2,3,4 | |
| Musculo-skeletal | ||||||||
| (Superficial) | N | N | N | N | N | Note 1 | Note 2,3,4 | |
| Intravascular | ||||||||
| Other (specify) | ||||||||
| Cardiac Adult | N | N | N | N | N | Note 1 | Note 2,3,4 | |
| Cardiac | Cardiac Pediatric | N | N | N | N | N | Note 1 | Note 4 |
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (specify) | ||||||||
| Peripheral | Peripheral vessel | N | N | N | N | N | Note 1 | Note 2,3,4 |
| Vessel | Other (specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Note 1 - Combined Modes: M(B+M), B(B+M), B+M, B(B+PW), B+PW, B(B+CFM/PD//DPDI), CFM/PDI/DPDI (B+CFM/PDI/DPDI), B+CFM/PDI/DPDI, B(B+CFM/PDI/DPDI+PW), CFM/PDI/DPDI (B+CFM/PDI/DPDI+PW), PW(B+CFM/PDI/DPDI+PW), B+CFM/PDI/DPDI+PW,
Note 2 - Includes Imaging for Needle Guidance
Note 3 - Small Organs (specifically Breast, Thyroid, Testicles)
Note 4 - Tissue harmonic Imaging (THI)
Note 5 - Intraoperative applications: Include Needle Guidance
Note 4 - Tissue harmonic Imaging (THI)
4
Pg. 1.3-3
Diagnostic Ultrasound Indications for Use Form
SmartUs EXT-1M/3M System:
Transducer: Convex array C5-2R60HI-5
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Table 1.3-2
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track 1 Only) | Specific | |||||||
| (Track 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | Combined | |||||||
| (specify) | Other | |||||||
| (specify) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | N | N | N | N | Note 1 | Note 2,3,4 | ||
| Abdominal | N | N | N | N | Note 1 | Note 2,3,4 | ||
| Intraoperative (specify) | ||||||||
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (specify)1 | ||||||||
| Neonatal Cephalic | ||||||||
| Fetal Imaging | Adult Cephalic | |||||||
| & Other | Trans-rectal | |||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (Non-Card) | ||||||||
| Musculo-skeletal | ||||||||
| (Conventional) | ||||||||
| Musculo-skeletal | ||||||||
| (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (specify) | ||||||||
| Cardiac Adult | N | N | N | N | Note 1 | Note 2,3,4 | ||
| Cardiac Pediatric | ||||||||
| Cardiac | Intravascular (Cardiac) | |||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (specify) | ||||||||
| Peripheral | Peripheral vessel | |||||||
| Vessel | Other (specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Note 1 - Combined Modes: M(B+M), B(B+M), B+M, B(B+PW), B+PW, B(B+CFM/PD//DPD), CFM/PDI/DPDI (B+CFM/PDI/DPDI), B+CFM/PDI/DPDI, B(B+CFM/PDI/DPDI+PW), CFM/PDI/DPDI (B+CFM/PDI/DPDI+PW), PW(B+CFM/PDI/DPDI+PW), B+CFM/PDI/DPDI+PW,
Note 2 - Includes Imaging for Needle Guidance
Note 3 - Small Organs (specifically Breast, Thyroid, Testicles)
Note 4 - Tissue harmonic Imaging (THI)
Note 5 - Intraoperative applications: Include Needle Guidance
Note 4 - Tissue harmonic Imaging (THI)
5
Pg. 1.3-4
Diagnostic Ultrasound Indications for Use Form
System: SmartUs EXT-1M/3M Transducer:
Linear array L15-7L40HI-5
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Table 1.3-3 | ||||||||
|---|---|---|---|---|---|---|---|---|
| Clinical Application | Mode of Operation | |||||||
| General | ||||||||
| (Track 1 Only) | Specific | |||||||
| (Track 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | Combined | |||||||
| (specify) | Other | |||||||
| (specify) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | ||||||||
| Intraoperative (specify) | ||||||||
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | N | N | N | N | Note 1 | Note 2,3,4 | ||
| Small Organ (specify) | N | N | N | N | Note 1 | Note 2,3,4 | ||
| Neonatal Cephalic | ||||||||
| Fetal Imaging | Adult Cephalic | |||||||
| & Other | Trans-rectal | |||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (Non-Card) | ||||||||
| Musculo-skeletal | ||||||||
| (Conventional) | N | N | N | N | Note 1 | Note 2,3,4 | ||
| Musculo-skeletal | ||||||||
| (Superficial) | N | N | N | N | Note 1 | Note 2,3,4 | ||
| Intravascular | ||||||||
| Other (specify) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Cardiac | Intravascular (Cardiac) | |||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | N | N | N | N | Note 1 | Note 2,3,4 | |
| Other (specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Note 1 - Combined Modes: M(B+M), B(B+M), B+M, B(B+PW), B+PW, B(B+CFM/PD//DPDI), CFM/PDI/DPDI (B+CFM/PDI/DPDI), B+CFM/PDI/DPDI, B(B+CFM/PDI/DPDI+PW), CFM/PDI/DPDI (B+CFM/PDI/DPDI+PW), PW(B+CFM/PDI/DPDI+PW), B+CFM/PDI/DPDI+PW,
Note 2 - Includes Imaging for Needle Guidance
Note 3 - Small Organs (specifically Breast, Thyroid, Testicles)
Note 4 - Tissue harmonic Imaging (THI)
Note 5 - Intraoperative applications: Include Needle Guidance
Note 4 - Tissue harmonic Imaging (THI)
6
Pg. 1.3-5
Diagnostic Ultrasound Indications for Use Form
System: SmartUs EXT-1M/3M Transducer: Phased array P5-1L15SI-6
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Table 1.3-4 | ||||||||
|---|---|---|---|---|---|---|---|---|
| Clinical Application | Mode of Operation | |||||||
| General | ||||||||
| (Track 1 Only) | Specific | |||||||
| (Track 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | Combined | |||||||
| (specify) | Other | |||||||
| (specify) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | N | N | N | N | Note 1 | Note 4 | ||
| Intraoperative (specify) | ||||||||
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (specify) | ||||||||
| Neonatal Cephalic | ||||||||
| Fetal Imaging | ||||||||
| & Other | Adult Cephalic | N | N | N | N | Note 1 | Note 4 | |
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (Non-Card) | ||||||||
| Musculo-skeletal | ||||||||
| (Conventional) | ||||||||
| Musculo-skeletal | ||||||||
| (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (specify) | ||||||||
| Cardiac | Cardiac Adult | N | N | N | N | Note 1 | Note 4 | |
| Cardiac Pediatric | N | N | N | N | Note 1 | Note 4 | ||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Note 1 - Combined Modes: M(B+M), B(B+M), B+M, B(B+PW), B+PW, B(B+CFM/PD//DPD), CFM/PDI/DPDI (B+CFM/PDI/DPDI), B+CFM/PDI/DPDI, B(B+CFM/PDI/DPDI+PW), CFM/PDI/DPDI
(B+CFM/PDI/DPDI+PW), PW(B+CFM/PDI/DPDI+PW), B+CFM/PDI/DPDI+PW,
Note 2 - Includes Imaging for Needle Guidance
Note 3 - Small Organs (specifically Breast, Thyroid, Testicles)
Note 4 - Tissue harmonic Imaging (THI)
7
Pg. 1.2-3
510k Summary
1. Identifying information
| Manufacturer | TELEMED |
|---|---|
| Address | Dariaus ir Gireno str. 42 Vilnius LT-02189 Lithuania |
| Telephone | +370-5 2106272 +370-5 2106273 |
| Fax | +370-5 2306733 |
| Web | http://www.pcultrasound.com/ www.telemed.lt |
| info@telemed.lt yury@telemed.lt | |
| Contact | Yury Sokolov / Engineering Manager |
| Name of Device | SmartUs EXT-1M/3M |
2. Class and Predicate Information
| Classification Name | FR Number | Product Code |
|---|---|---|
| Ultrasonic Pulsed Doppler Imaging System | 892.1550 | IYN |
| Ultrasonic Pulsed Echo Imaging System | 892.1560 | IYO |
| Diagnostic Ultrasonic Transducer | 892.1570 | ITX |
| Common Name | Ultrasound imaging system | |
| Propietary Name | SmartUs EXT-1M/3M | |
| Class | Regulatory Class II | |
| Predicate Device | TELEMED | LS128 K113184 |
| SAMSUNG MEDISON | SONOACE R7 K112646 |
3. Performance Standards
The SmartUs SmartUs EXT-1M/3M has been designed to meet the following:
Safety and EMC Requirements for Medical Equipment:
IEC 60601-1: 2005, Part 1: General requirements for basic safety and essential performance. IEC 60601-1-2: 2007, Part 1: General requirements for basic safety and essential performance,
2.Collateral standard: Electromagnetic compatibility - Requirements and tests
IEC 60601-2-37:2007 Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
ISO 14971:2012 Medical devices -- Application of risk management to medical devices ISO-10993-1:2009, Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing within a risk management process.
IEC 62304: 2006 Medical device software -- Software life cycle processes
NEMA UD 2-2004: 2003, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment
NEMA UD 3-2004: 2004, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
AIUM MUS: 2002, Medical Ultrasound Safety
Essential Requirements of Council Directive 93/42/EEC (Medical Device Directive)
The system's acoustic output is in accordance with ALARA principle (as low as reasonably achievable)
8
4. Indication for Use
SmartUs EXT-1M/3M ultrasound imaging system is intended to be used for applications in fetal, abdominal, pediatric, small organ (breast, thyroid, testicles), musculo-skeletal (conventional), musculo-skeletal (superficial), cardiac pediatric, adult cephalic, peripheral vessel (B- and M-mode, combined modes imaging, including imaging for needle guidance). It is possible to provide diagnostic information outside of an imaging lab, including at the bedside systems, for navigated
medical application, in operating rooms/critical care units.
5. Device Description
SmartUs EXT-1M/3M system is intended for the multipurpose ultrasound examinations, based on electronic linear and convex scanning.
SmartUs EXT-1M/3M system is a combination of proprietary hardware and software that has been designed for real-time imaging and is intended to be a basic diagnostic tool. Its basic function is to acquire ultrasound echo data and to display the image in ultrasound B-Mode, M-Mode or combined modes. The system is designed for imaging with transducer ranges of 2 to 15 MHz. The devices referenced in this submission represent a transportable, software-controlled, diagnostic ultrasound system with accessories. This submission does not include technology or control feature changes nor deviations from indications for use different from those demonstrated in previously cleared devices operating in ultrasound B-Mode, M-Mode or combined modes, inclusive of the predicate devices so claimed.
SmartUs EXT-1M/3M only contains the hardware and firmware, everything else (e.g. ultrasound software, database) is located on a standard PC that is connected to the SmartUs EXT-1M/3M via USB 2.0/3.0. Minimum requirements are given for the PC. All echo-images (sonograms) are saved on the PC and can there be evaluated, printed and archived.
The Echo Wave II software was especially designed for the TELEMED devices. Software able to reside in a Windows-based PC
The device modifications are:
- SmartUs EXT-1M ultrasound system utilizing as hardware an ultrasound ● engine contained in a small standalone enclosure for connection to a host PC via a USB port with external power supply;
- SmartUs EXT-3M ultrasound system -modification with 3 probe ports ●
The SmartUs EXT-1M/3M can be used together with the appropriate probes for the entire ultrasound diagnostic (2MHz to 15MHz probes).
- . probe L15-7L40H-5, linear array, at a central ultrasonic frequency of approx. 12 MHz;
- probe C5-2R60HI-5, convex array at a central ultrasonic frequency of approx. 3.5 MHz; ●
- probe P5-1L15SI-6, phased array at a central ultrasonic frequency of approx. 4 MHz. ●
9
6. General Safety and Effectiveness
The SmartUs EXT-1M/3M color Doppler ultrasound system is similar to currently distributed ultrasonic pulsed echo imaging systems.
There are no technological characteristics or features or indications for use in this Submission that are not previously evaluated and approved in the predicate devices, nor are there such technologies, features and indications for use not commonly used in the practice of diagnostic ultrasound.
The ultrasound system and its accessories are designed for compliance to all applicable medical devices safety standards, as referenced in VOL_001 008_Declaration of Conformity.
Prior release for manufacturing, all such devices, so designed, are tested and determined to be in full compliance with acoustic output, biocompatibility, cleaning and disinfection effectiveness. No additional clinical testing is required, as the indications for use are not a novel indication as shown by the predicate devices in VOL_004 Predicate Device Comparison.
Maximum acoustic output level is under by the FDA recommended limit and power level is displayed all the time.
7. Patient Contact Materials
The materials/parts of probe, coming in contact with patient are:
- . Acoustic Lens Cover, Housing, Handle & Nosepiece
- Silicone Elastomer
- . ABS
Standards for the biological evaluation:
ISO-10993-1:2009, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process
ISO-10993-5:2009, Biological Evaluation of Medical Devices Part 5: Tests for in vitro cytotoxicity ISO-10993-10:2010, Biological Evaluation of Medical Devices Part 10: Tests for irritation and skin sensitization
8. Software
The SmartUs EXT-1M/3M system contains the hardware and software which collect and pro-processes 'rough'' data and send it via USB 2.0/3.0 connection to a Windows® based PC. The main application software is Echo Wave II software running on the PC, it is receiving data, SmartUs EXT-1M/3Mprocessing and showing image/data on the screen. The main user interface shows an ultrasound image, controls and drop-out menus. The ultrasound images and calculated/measured data can be stored in memory.
9. Conclusion
In accordance with the FDA and based on the information provided in this Premarket notification, TELEMED concludes that the SmartUs EXT-1M/3M is safe and effective and substantially equivalent to predicate devices described herein.