(264 days)
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on standard ultrasound technology and software running on a mobile device.
No
The device is an imaging system designed for diagnosis and evaluation, not for treating any medical condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is "intended for use by qualified physicians and healthcare professionals who has the ability to conduct ultrasound scan process for evaluation by ultrasound imaging system or fluid flow analysis of the human body." and "The clinical environments where the system can be used include physician offices, clinics, hospitals, and clinical point-of-care for diagnosis of patients". The mention of "diagnosis of patients" clearly indicates a diagnostic purpose.
No
The device description explicitly states that the system consists of "a series of wireless transducers" and "houses a built-in battery, multichannel beamformer, prescan converter and Wi-Fi components," which are hardware components. While the software runs on a COTS mobile device, the core ultrasound imaging system includes dedicated hardware.
Based on the provided information, the Leltek Ultrasound Imaging System (Model: LU700 Series) is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis. The description of the Leltek Ultrasound Imaging System clearly states it is an "ultrasound imaging system" that acquires and displays "real-time ultrasound data" of the "human body." It uses ultrasound waves to create images of internal structures.
- The intended use and device description focus on imaging the human body directly. There is no mention of analyzing biological samples or performing tests on specimens outside of the body.
- The modes of operation (B mode, PWD mode, Color Doppler, Power Doppler) are standard ultrasound imaging modes. These modes are used to visualize tissues, blood flow, and other anatomical features within the body.
- The clinical applications listed are all related to imaging internal organs and structures.
In summary, the Leltek Ultrasound Imaging System is an in vivo diagnostic imaging device, not an in vitro diagnostic device. It is used to diagnose conditions by visualizing the inside of the living body using ultrasound technology.
N/A
Intended Use / Indications for Use
The Leltek Ultrasound Imaging System (Model: LU700 Series) is a software-based imaging system and accessories intended for use by qualified physicians and healthcare professionals who has the ability to conduct ultrasound scan process for evaluation by ultrasound imaging system or fluid flow analysis of the human body.
The clinical environments where the system can be used include physician offices, clinics, hospitals, and clinical point-of-care for diagnosis of patients
The modes of operation include B mode, PWD mode, Color Doppler (CD) mode, Power Doppler mode, and the combined mode (B+M, B+CD, B+PWD). Specific clinical applications and exam types including:
LU700C
General abdominal imaging, musculoskeletal (conventional), musculoskeletal (superficial), peripheral vessel and OB/Gyn.
LU700L
General abdominal imagine, small organ (breast, thyroid), musculoskeletal (superficial) and peripheral vessel.
LU710C
Fetal, abdominal, pediatric, small organ (thyroid, prostate, scrotum, breast), musculoskeletal (conventional), urology, gynecology, cardiac adult, cardiac pediatric and peripheral vessel.
LU710M
Fetal, abdominal, pediatric, small organ (thyroid, prostate, scrotum, breast), musculoskeletal (conventional), urology, gynecology, cardiac adult, cardiac pediatric and peripheral vessel.
LU710PA
Fetal, abdominal, pediatric, cardiac adult, cardiac pediatric.
LU710E
Fetal, abdominal, small organ (thyroid, prostate, scrotum, breast), trans-vaginal, urology, gynecology.
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX
Device Description
The Leltek Ultrasound Imaging System (Model: LU700 Series) is a portable, software controlled, handheld ultrasound system used to acquire and display hi-resolution, real-time ultrasound data through a commercial off-the-shelf (COTS) mobile device.
- l. The imaging system software runs as an app on a mobile device.
- II. The imaging system software can be download to a commercial off-the-shelf (COTS) mobile device and utilizes an icon touch-based user interface.
- III. The imaging system consists of a series of wireless transducers employing Wi-Fi-based technology to communicate with traditional tablet/smartphone devices via direct Wi-Fi. This allows the user to export ultrasound images and display them across a range portable personal device.
- IV. The imaging system houses a built-in battery, multichannel beamformer, prescan converter and Wi-Fi components
The device is intended for use in environments where healthcare is provided by trained healthcare professionals, but not intended for use in emergency medical service, ambulance, or aircraft.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
General abdominal, musculoskeletal (conventional), musculoskeletal (superficial), peripheral vessel, OB/Gyn, small organ (breast, thyroid, prostate, scrotum), fetus, pediatric, urology, gynecology, cardiac adult, cardiac pediatric, trans-rectal, trans-vaginal.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified physicians and healthcare professionals; physician offices, clinics, hospitals, and clinical point-of-care environments. Not intended for use in emergency medical service, ambulance, or aircraft.
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)
The Leltek Ultrasound Imaging System has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as wireless, thermal, electromagnetic and mechanical safety and has been found to conform with applicable medical device safety standards. The Leltek Ultrasound Imaging System did not require clinical testing to establish substantial equivalence.
This device is the addition of new transducer models to the Leltek Ultrasound Imaging System, using technologies existing on the market as of this submission. The Leltek Ultrasound Imaging System (Model: LU700 series) meets FDA requirements for Track 3 devices, have biosafety equivalence, and conform to applicable electromedical devices safety standards.
The new models comprise LU710C, LU710PA, LU710E, which are tested and determined to be in full compliance with acoustic output, biocompatibility, cleaning, and disinfection effectiveness, and have no pragmatic detriments. No additional clinical testing is required. The maximum acoustic output level is under the FDA recommended limit, and the power level is displayed all the safety and performance tests of the device meet the essential requirements. Therefore, the system is substantially equivalent to predicate devices.
Verification and validation testing have been conducted on the Leltek Ultrasound Imaging System and ascertain that it is safe for use by physicians. The 510(k) submission is the modification of the existing licensed device using technologies that exist on the market today and demonstrating the new transducers of the Leltek Ultrasound Imaging System are substantially equivalent in safety and effectiveness to the predicate device.
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
§ 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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
LELTEK, Inc. % Jessie Wang Chief of Marketing 6F-3., No. 293, Sec. 1, Beixin Rd., Xindian Dist., New Taipei City, 23147 TAIWAN. R.O.C
November 3, 2021
Re: K210432
Trade/Device Name: Leltek Ultrasound Imaging System (Model: LU700 Series) Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: September 29, 2021 Received: Otober 4, 2021
Dear Jessie Wang:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
Leltek Ultrasound Imaging System (Model: LU700 Series)
Indications for Use (Describe)
The Leltek Ultrasound Imaging System (Model: LU700 Series) is a software-based imaging system and accessories intended for use by qualified physicians and healthcare professionals who has the ability to conduct ultrasound scan process for evaluation by ultrasound imaging system or fluid flow analysis of the human body.
The clinical environments where the system can be used include physician offices, clinics, hospitals, and clinical point-ofcare for diagnosis of patients
The modes of operation include B mode, PWD mode, Color Doppler (CD) mode, Power Doppler mode, and the combined mode (B+M, B+CD, B+PWD). Specific clinical applications and exam types including: LU700C
General abdominal imaging, musculoskeletal (conventional), musculoskeletal (superficial), peripheral vessel and OB/Gyn. LU700L
General abdominal imagine, small organ (breast, thyroid), musculoskeletal (superficial) and peripheral vessel.
LU710C
Fetal, abdominal, pediatric, small organ (thyroid, prostate, scrotum, breast), musculoskeletal (conventional), urology, gynecology, cardiac adult, cardiac pediatric and peripheral vessel.
LU710M
Fetal, abdominal, pediatric, small organ (thyroid, prostate, scrotum, breast), musculoskeletal (conventional), urology, gynecology, cardiac adult, cardiac pediatric and peripheral vessel.
LU710PA
Fetal, abdominal, pediatric, cardiac adult, cardiac pediatric.
LU710E
Fetal, abdominal, small organ (thyroid, prostate, scrotum, breast), trans-vaginal, urology, gynecology.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
K210432
510(k) Summary
1. Submitter's Information
| Manufacturer: | LELTEK Inc. |
|---|---|
| Address: | 6F-3., No.293, Sec. 1, Beixin Rd., Xindian Dist., |
| New Taipei City 23147, Taiwan, R.O.C. | |
| Tel: | +886-2-2913-7577 |
| Fax: | +886-2-2913-7599 |
| Website: | www.leltek.com |
| Contact: | Jessie wang / Chief of Marketing |
| E-mail: | jessie.wang@leltek.com |
| Name of Device: | Leltek Ultrasound Imaging System (Model: LU700 Series) |
2. Class and Predicate Information
| Device Name: | Leltek Ultrasound Imaging System | |
|---|---|---|
| Model: | LU700 series | |
| Common Name: | Diagnostic Ultrasound System and Accessories | |
| Classification: | Class II | |
| Classification Name: | ||
| 21 CRF Section | Classification Name | Product Code |
| 892.1550 | Ultrasonic Pulsed Doppler Imaging System | 90 IYN |
| 892.1560 | Ultrasonic Pulsed Echo Imaging System | 90 IYO |
3. Substantially Equivalent Devices
| Device Name | 510(k) Number |
|---|---|
| Leltek Ultrasound Imaging System | K191235 |
| Reference Device | |
| Device Name | 510(k) Number |
| Clarius Ultrasound System | K192107 |
4
4. Indications for Use
The Leltek Ultrasound Imaging System (Model: LU700 Series) is a software-based imaging system and accessories intended for use by qualified physicians and healthcare professionals who has the ability to conduct ultrasound scan process for evaluation by ultrasound imaging system or fluid flow analysis of the human body.
The clinical environments where the system can be used include physician offices, clinics, hospitals, and clinical point-of-care for diagnosis of patients
The modes of operation include B mode, M mode, Color Doppler (CD) mode, Power Doppler mode, and the combined mode (B+M, B+CD, B+PWD). Specific clinical applications and exam types including:
LU700C
General abdominal imaging, musculoskeletal (conventional), musculoskeletal (superficial), peripheral vessel and OB/Gyn.
LU700L
General abdominal imaging, small organ (breast, thyroid), musculoskeletal (conventional), musculoskeletal (superficial) and peripheral vessel.
LU710C
Fetal, abdominal, pediatric, small organ (thyroid, prostate, scrotum, breast), musculoskeletal (conventional), urology, gynecology, cardiac adult, cardiac pediatric and peripheral vessel.
LU710M
Fetal, abdominal, pediatric, small organ (thyroid, prostate, scrotum, breast), musculoskeletal (conventional), urology, gynecology, cardiac adult, cardiac pediatric and peripheral vessel.
LU710PA
Fetal, abdominal, pediatric, cardiac adult, cardiac pediatric.
LU710E
Fetal, abdominal, small organ (thyroid, prostate, scrotum, breast), trans-rectal, trans-vaginal, urology, gynecology.
5
USFDA_510(k)
5. Device description
The Leltek Ultrasound Imaging System (Model: LU700 Series) is a portable, software controlled, handheld ultrasound system used to acquire and display hi-resolution, real-time ultrasound data through a commercial off-the-shelf (COTS) mobile device.
- l. The imaging system software runs as an app on a mobile device.
- II. The imaging system software can be download to a commercial off-the-shelf (COTS) mobile device and utilizes an icon touch-based user interface.
- III. The imaging system consists of a series of wireless transducers employing Wi-Fi-based technology to communicate with traditional tablet/smartphone devices via direct Wi-Fi. This allows the user to export ultrasound images and display them across a range portable personal device.
- IV. The imaging system houses a built-in battery, multichannel beamformer, prescan converter and Wi-Fi components
The device is intended for use in environments where healthcare is provided by trained healthcare professionals, but not intended for use in emergency medical service, ambulance, or aircraft.
System drawing:
Image /page/5/Picture/11 description: The image shows a diagram of a mobile device UI App communicating with a Leltek Ultrasound Imaging System via Wi-Fi. The mobile device is at the top of the image, and the ultrasound imaging system is at the bottom. The Wi-Fi communication is represented by a dashed line and a Wi-Fi symbol in the middle of the image. The text labels the different components of the diagram.
6
6. Determination of Substantial Equivalence
| Item | Application device | Predicate device | Reference device | Comparison |
|---|---|---|---|---|
| Device name | Leltek Ultrasound Imaging System | |||
| (Model: LU700 series) | Leltek Ultrasound Imaging System | |||
| (Model: LU700) | Clarius Ultrasound Scanner | |||
| 510(k) Number | Current Submission | K191235 | K192107 | |
| Intended Use | Diagnostic ultrasound imaging or | |||
| fluid flow analysis of the human | ||||
| body | Diagnostic ultrasound imaging or | |||
| fluid flow analysis of the human | ||||
| body | Diagnostic ultrasound imaging | |||
| or fluid flow analysis of the | ||||
| human body | Same | |||
| Indications for | ||||
| Use | - Fetal |
- Abdominal
- Pediatric
- Small organ
- Trans-rectal
- Trans-vaginal
- Musculoskeletal(conventional)
- Musculoskeletal (superficial)
- Urology
- OB/Gyn
- Cardiac adult
- Cardiac pediatric
- Peripheral vessel
- Carotid | - Abdominal
- Small organ
- Musculoskeletal(conventional)
- Musculoskeletal (superficial)
- OB/Gyn
- Peripheral vessel | - Ophthalmic
- Fetal
- Abdominal
- Intraoperative (Ab/Vasc)
- Pediatric
- Small organ
- Adult cephalic
- Trans-rectal
- Trans-vaginal
- Musculo-skel. (Conv.)
- Musculo-skel. (Superfic.)
- Urology
- Gynecology
- Cardiac adult
- Cardiac pediatric
- Peripheral vessel
- Carotid
- Needle guidance | Different.
LU700 series add
more items
including invasive
subjects. |
| Mode of
Operations | B Mode
M mode
PWD
Color Doppler
Power Doppler | B Mode
M mode
PWD
Color Doppler
Power Doppler | B Mode
M mode
PWD
Color Doppler
Power Doppler | Same. |
| Item | Application device | Predicate device | Reference device | Comparison |
| Device name | Leltek Ultrasound Imaging System
(Model: LU700 series) | Leltek Ultrasound Imaging System
(Model: LU700) | Clarius Ultrasound Scanner | |
| | - Combined mode (B+M, B+CD, B+PWD) | - Combined mode (B+M, B+CD, B+PWD) | - Combined mode (B+M, B+CD, B+PD, B+PWD) | |
| Connect | Communicates wirelessly via Wi-Fi | Communicates wirelessly via Wi-Fi | Communicates wirelessly via
Wi-Fi and Bluetooth | Same |
| Transducer Types | Convex HD array (LU710C)
MicroConvex array (LU710M)
Phased array (LU710PA)
Endocavity array (LU710E) | Linear array (LU700L)
Convex array (LU700C) | Convex array Linear array
Phased array Intracavity | More transducers are
added to the LU700
series. |
| Portability | Portable ultrasound system | Portable ultrasound system | Portable ultrasound system | Same |
| Power Source | Rechargeable battery (Li-ion) | Rechargeable battery (Li-ion) | Rechargeable battery (Li-ion) | Same |
| Display | iOS or Android mobile device | iOS or Android mobile device | iOS or Android mobile device | Same |
| 510(k) Track | Track 3 | Track 3 | Track 3 | Same |
| Compliance
Standards | - AAMI/ANSI ES60601-1 (2012) - IEC 60601-1-2 (2014)
- IEC 60601-1-6 (2013)
- IEC 60601-2-37 (2008)
- AIUM/NEMA UD 2- 2004R2009
- AIUM/NEMA UD 3- 2004R2009
- IEC 62133 (2012) | - AAMI/ANSI ES60601-1 (2012)
- IEC 60601-1-2 (2014)
- IEC 60601-1-6 (2013)
- IEC 60601-2-37 (2008)
- AIUM/NEMA UD 2- 2004R2009
- AIUM/NEMA UD 3- 2004R2009
- IEC 62133 (2012) | - AAMI/ANSI ES60601-1 (2012)
- IEC 60601-1-2 (2014)
- IEC 60601-1-6 (2013)
- IEC 60601-1-12 (2014)
- IEC 60601-2-37 (2015)
- UD 2- 2004 (R2009)
- IEC 62133 (2012) | Same.
As compared to the
predicate, the
LU700 series
comply with the
safety and |
| Item | Application device | Predicate device | Reference device | Comparison |
| Device name | Leltek Ultrasound Imaging System
(Model: LU700 series) | Leltek Ultrasound Imaging System
(Model: LU700) | Clarius Ultrasound Scanner | - |
| | - IEC 62366 (2014) | - IEC 62366 (2014) | - IEC 62366 (2014) | performance tests
which meets all the |
| | - ISO 10993-1(2009) | - ISO 10993-1(2009) | - ISO 10993-1 (2009) | essential |
| | - ISO 10993-5(2009) | - ISO 10993-5(2009) | - ISO 10993-5 (2009) | requirement for its |
| | - ISO 10993-10(2010) | - ISO 10993-10(2010) | - ISO 10993-10 (2010) | intended use. |
| | - | - | - ISO 10993-11 (2017) | |
| | - IEC 62304 (2006) | - IEC 62304 (2006) | - IEC 62304 (2006) | |
| | - ISO 15223-1 (2016) | - ISO 15223-1 (2016) | - ISO 15223-1 (2012) | |
| | - ISO 14971 (2012) | - ISO 14971 (2012) | - ISO 14971 (2007) | |
| | - ISO 13485 (2016) | - ISO 13485 (2016) | - | |
7
8
This device is a modification of an existing licensed device (K191235) using technologies that exist of the date of this submission. The Leltek Ultrasound Imaging System (Model: LU700 series) meets FDA requirements for Track 3 devices, have biosafety equivalence, and conform to applicable electromedical devices safety standards. The differences specified above have no pragmatic detriments. All the safety and performance tests of the essential requirements. Therefore, the system is substantially equivalent to predicate devices.
9
7. Performance standards
The Leltek Ultrasound Imaging System has been designed, manufactured, tested, and certified to comply with the following internationally recognized standards:
| Reference No. | Year | Title |
|---|---|---|
| AAMI/ANSI/ES60601- | ||
| 1:2005/(R)2012 and | ||
| A1:2012 and | ||
| C1:2009/(R)2012 and | ||
| A2:2010/(R)2012 | 2009 & | |
| 2012 | Medical electrical equipment - Part 1: General requirements for basic | |
| safety and essential performance | ||
| IEC 60601-1-2 | 2014 | Medical electrical equipment - Part 1-2: General requirements for basic |
| safety and essential performance - Collateral Standard: Electromagnetic | ||
| disturbances - Requirements and tests | ||
| IEC 60601-1-6 | 2013 | Medical electrical equipment Part 1-6 General requirements for basic |
| safety and essential performance Collateral standard Usability | ||
| IEC 60601-2- | ||
| 37/AMD1 | 2008 & | |
| 2015 | Medical electrical equipment - Part 2-37: Particular requirements for the | |
| basic safety and essential performance of ultrasonic medical diagnostic | ||
| and monitoring equipment | ||
| IEC 62133 | 2012 | Safety requirements for portable sealed secondary cells, and for batteries |
| made from them, for use in portable applications | ||
| IEC 62304 | 2014 | Medical device software - Software life-cycle processes |
| EC 62366-1 | 2015 | Medical devices -- Part 1: Application of usability engineering to medical |
| devices | ||
| 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 | ||
| ISO 13485 | 2016 | Medical devices - Quality management systems - Requirements for |
| regulatory purposes | ||
| ISO 14971 | 2012 | Medical devices - Application of risk management to medical devices |
| ISO 15223-1 | 2016 | Medical devices -- Symbols to be used with medical device labels, labelling |
| and information to be supplied -- Part 1: General requirements |
10
Evaluation per standard AAMI/ANSI/ES60601-1 and IEC 60601-1-2 were performed for use of the transducers with a specific adaptor (Apple Model A1385) to charge the medical device. Use of alternate compatible mobile hardware requires verification by the end user. Further information is provided in the user manual.
The Leltek Ultrasound Imaging System has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as wireless, thermal, electromagnetic and mechanical safety and has been found to conform with applicable medical device safety standards. The Leltek Ultrasound Imaging System did not require clinical testing to establish substantial equivalence.
8. General Safety and Effectiveness
This device is the addition of new transducer models to the Leltek Ultrasound Imaging System, using technologies existing on the market as of this submission. The Leltek Ultrasound Imaging System (Model: LU700 series) meets FDA requirements for Track 3 devices, have biosafety equivalence, and conform to applicable electromedical devices safety standards.
The new models comprise LU710C, LU710PA, LU710E, which are tested and determined to be in full compliance with acoustic output, biocompatibility, cleaning, and disinfection effectiveness, and have no pragmatic detriments. No additional clinical testing is required. The maximum acoustic output level is under the FDA recommended limit, and the power level is displayed all the safety and performance tests of the device meet the essential requirements. Therefore, the system is substantially equivalent to predicate devices.
9. Conclusion
Verification and validation testing have been conducted on the Leltek Ultrasound Imaging System and ascertain that it is safe for use by physicians. The 510(k) submission is the modification of the existing licensed device using technologies that exist on the market today and demonstrating the new transducers of the Leltek Ultrasound Imaging System are substantially equivalent in safety and effectiveness to the predicate device.