(280 days)
No
The document describes a standard ultrasound imaging system with software running on a mobile device and wireless transducers. There is no mention of AI, ML, or advanced image processing techniques that would typically indicate the use of such technologies. The focus is on the hardware and basic imaging modes.
No.
The device is described as an "Ultrasound Imaging System" intended for evaluation by ultrasound imaging, not for treatment or therapy.
Yes
The device is an "Ultrasound Imaging System" used by "qualified physicians and healthcare professionals" for "evaluation by ultrasound imaging system or fluid flow analysis of the human body." It performs "General abdominal imaging, musculoskeletal (conventional), musculoskeletal (superficial), peripheral vessel and OB/ Gyn," which are all diagnostic applications.
No
The device description explicitly states that the imaging system consists of wireless transducers with built-in batteries, beamformers, prescan converters, and Wi-Fi components, which are hardware components. While the software runs on a mobile device, the overall system includes hardware beyond the COTS device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Leltek Ultrasound Imaging System is an imaging system that uses ultrasound technology to visualize internal structures of the human body. It does not perform tests on biological samples.
- Intended Use: The intended use clearly states it's for "evaluation by ultrasound imaging system or fluid flow analysis of the human body," which is a diagnostic imaging function, not an in vitro diagnostic function.
Therefore, the Leltek Ultrasound Imaging System falls under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Leltek Ultrasound Imaging System (Model: LU700) 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 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.
Specific clinical applications and exam types including:
For LU700C:
General abdominal imaging, musculoskeletal (conventional), musculoskeletal (superficial), peripheral vessel and OB/ Gyn. The modes of operation include B mode. M mode. PWD mode, Color Doppler (CD) mode. Power Doppler mode. and the combined mode(B+M, B+CD, B+PWD).
For LU700L:
General abdominal imaging, small organ (breast, thyroid), musculoskeletal (conventional), musculoskeletal (superficial) and peripheral vessel. The modes of operation includes B mode, M mode, Color Doppler (CD) mode, Power Doppler mode, and the combined mode(B+M, B+CD, B+PWD).
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO and ITX
Device Description
The Leltek Ultrasound Imaging System 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) Android 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) Android mobile device and utilizes an icon touch-based user interface.
lll. 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
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).
Indicated Patient Age Range
The intended population is adults.
Intended User / Care Setting
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 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.
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 did not require clinical testing to establish substantial equivalence. Verification and validation testing has been conducted on the Leltek Ultrasound Imaging System and ascertain that it is safe for use by physicians. This device is similar to an existing licensed device using technologies that exist on the market today. This premarket notification submission demonstrates that the Leltek Ultrasound Imaging System is substantially equivalent 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
February 12, 2020
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
LELTEK Inc % Kiefe Chang Director 6F-3., No. 293, Sec. 1, Beixin Rd., Xindian Dist., New Taipei City, 23147 TAIWAN R.O.C.
Re: K191235
Trade/Device Name: Leltek Ultrasound Imaging System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO and ITX Dated: December 31, 2019 Received: January 6, 2020
Dear Kiefe Chang:
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 mediation-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) K191235
Device Name Leltek Ultrasound Imaging System
Indications for Use (Describe)
The Leltek Ultrasound Imaging System (Model: LU700) 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 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.
Specific clinical applications and exam types including:
For LU700C:
General abdominal imaging, musculoskeletal (conventional), musculoskeletal (superficial), peripheral vessel and OB/ Gyn. The modes of operation include B mode. M mode. PWD mode, Color Doppler (CD) mode. Power Doppler mode. and the combined mode(B+M, B+CD, B+PWD).
For LU700L:
General abdominal imaging, small organ (breast, thyroid), musculoskeletal (conventional), musculoskeletal (superficial) and peripheral vessel. The modes of operation includes B mode, M mode, Color Doppler (CD) mode, Power Doppler mode, and the combined mode(B+M, B+CD, B+PWD).
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
System: Leltek Ultrasound Imaging System (Model: LU700)
Ultrasound Pulsed Echo System
Ultrasound Pulsed Doppler Imaging System
Scanner LU700C with Transducer: C2-5 Convex 3.6MHz Curved Linear Array Diagnostic Ultrasound Transducer.
Scanner LU700L with Transducer: L10-5 7.1MH Linear Array Diagnostic Ultrasound Transducer. Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| Specific | B | M | PWD | CWD | Color | |||
| Doppler | Combined | |||||||
| (Specify) | Other | |||||||
| General | ||||||||
| (Track 1) | (Track 1 & 3) | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging & | ||||||||
| Other | Fetal | |||||||
| Abdominal | N | N | N | N | B+M, B+CD | |||
| Intra-operative(Specify) | ||||||||
| Intra-operative(Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small organ (Breast, | ||||||||
| Thyroid) | N | N | N | N | B+M, B+CD | |||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculoskeletal | ||||||||
| (conventional) | N | N | N | N | B+M, B+CD | |||
| Musculoskeletal | ||||||||
| (superficial) | N | N | N | N | B+M, B+CD | |||
| Intravascular | ||||||||
| Other (OB/Gyn.) | N | N | N | N | B+M, B+CD | |||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular(Cardiac) | ||||||||
| Trans-esoph.(Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Fetal Echo) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral Vessel | N | N | N | N | B+M, B+CD | ||
| Other(Carotid) |
N = new indication P = previously cleared by FDA E = added under this appendix *The intended population is adults.
4
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: | Kiefe Chang /Director |
| E-mail: | kiefe.chang@leltek.com |
| Name of Device: | Leltek Ultrasound Imaging System |
2. Class and Predicate Information
| Device Name: | Leltek Ultrasound Imaging System | |
|---|---|---|
| Model: | LU700 | |
| 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 |
3. Substantially Equivalent Device
| Device Name | 510(k) Number |
|---|---|
| Clarius Ultrasound System | K172385 |
| Reference Device | |
| Device Name | 510(k) Number |
Device Name 510(k) Number Clarius Ultrasound System K163138
4. Indications for Use
The Leltek Ultrasound Imaging System (Model: LU700) 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
5
by ultrasound imaging system or fluid flow analysis of the human body. 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.
Specific clinical applications and exam types including:
For LU700C:
General abdominal imaging, musculoskeletal (conventional), musculoskeletal (superficial), peripheral vessel and OB/Gyn. The modes of operation include B mode, M mode, PWD mode, Color Doppler (CD) mode, Power Doppler mode, and the combined mode(B+M, B+CD, B+PWD).
For LU700L:
General abdominal imaging, small organ (breast, thyroid), musculoskeletal (conventional), musculoskeletal (superficial) and peripheral vessel. The modes of operation includes B mode, M mode, PWD mode, Color Doppler (CD) mode, Power Doppler mode, and the combined mode(B+M, B+CD, B+PWD).
5. Device description
The Leltek Ultrasound Imaging System 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) Android 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) Android mobile device and utilizes an icon touch-based user interface.
lll. 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
System drawing:
6
Image /page/6/Figure/0 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 diagram, and the ultrasound imaging system is at the bottom. The Wi-Fi communication is represented by a dashed line and a Wi-Fi symbol. The ultrasound imaging system has a button with a clock symbol on it.
7
6. Determination of Substantial Equivalence
| Item | Application device | Predicate device | Reference device | Comparison |
|---|---|---|---|---|
| Device name | Leltek Ultrasound Imaging System | |||
| (Model: LU700) | Clarius Ultrasound Scanner | Clarius Ultrasound Scanner | - | |
| 510(k) Number | K191235 | K172385 | K163138 | - |
| Intended Use | Diagnostic ultrasound imaging or | |||
| fluid flow analysis of the human | ||||
| body | Diagnostic ultrasound imaging or | |||
| fluid flow analysis of the human Diagnostic ultrasound imaging | ||||
| or fluid flow analysis of the | ||||
| human body Same | ||||
| Indications for | ||||
| Use | - Abdominal |
- Small organ (Breast, Thyroid)
- Musculoskeletal (conventional)
- Musculoskeletal (superficial)
- OB/Gyn
- Peripheral Vessel | - Abdominal
- Small organ
- Musculoskeletal (conventional)
- Musculoskeletal (superficial)
- OB/Gyn
- Peripheral vessel
- Ophthalmic
- Fetal
- Intra-operative
(nonneurological) - Pediatric
- Adult Cephalic
- Cardiac Adult
- Cardiac Pediatric
- Carotid
- Procedural guidance of needles
into the body. | - Abdominal - Small organ (Thyroid, scrotum,
prostate, breast) - Musculoskeletal (conventional)
- Musculoskeletal (superficial)
- Urology, Gynecology
- Peripheral Vessel
- Fetal
- Pediatric
- Cardiac Adult
- Cardiac Pediatric
- Carotid | Different.
Less items and
without invasive
subjects. |
| Mode of
Operations | - B Mode - M mode
- PWD
- Color Doppler | - B Mode
- M mode
- Color Doppler | - B mode | Different. The device
has Pulse Wave Doppler
(PWD) mode as
compared to the |
| Item | Application device | Predicate device | Reference device | Comparison |
| Device name | Leltek Ultrasound Imaging System
(Model: LU700) | Clarius Ultrasound Scanner | Clarius Ultrasound Scanner | - |
| | - Power Doppler | - Power Doppler | - | predicate. The PWD
mode is common in
many ultrasound
machines . The essentia
requirements are
identical, and the
proposed device has
passed the tests. |
| | - Combined mode (B+M, B+CD,
B+PWD) | - Combined mode (B+M, B+CD,
B+PD) | | |
| Connect | Communicates wirelessly via Wi-
Fi | Communicates wirelessly via Wi-
Fi and Bluetooth | Communicates wirelessly via Wi-
Fi and Bluetooth | Different.
Both are wirelessly
connected devices,
whereas the application
device uses only Wi-Fi
as compared to the
predicate. |
| Transducer
Types | Linear array (LU700L)
Convex array (LU700C) | Convex Array
Linear Array
Phased Array | Convex Array
Linear Array | Different.
Less transducers are
provided with the
application device. |
| 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 | Android mobile device | iOS or Android mobile device | iOS or Android mobile device | Different. Less for the
application device . |
| 510(k) Track | Track 3 | Track 3 | Track 3 | Same |
| | - AAMI/ANSI ES60601-1 (2012) | - AAMI/ANSI ES60601-1 (2012) | - IEC 60601-1 (2012) | Different. |
| Item | Application device | Predicate device | Reference device | Comparison |
| Device name | Leltek Ultrasound Imaging System
(Model: LU700) | Clarius Ultrasound Scanner | Clarius Ultrasound Scanner | - |
| Compliance
Standards | - IEC 60601-1-2 (2014) - IEC 60601-1-6 (2013)
- IEC 60601-2-37 (2008)
- AIUM/NEMA UD 2- 2004 R2009
- AIUM/NEMA UD 3- 2004 R2009
- IEC 62133 (2012)
- IEC 62366 (2014)
- ISO 10993-1(2009)
- ISO 10993-5(2009)
- ISO 10993-10(2010)
- IEC 62304 (2006)
- ISO 15223-1 (2016)
- ISO 14971 (2012)
- ISO 13485 (2016) | - IEC 60601-1-2 (2014)
- IEC 60601-1-6 (2013)
- IEC 60601-1-12 (2014)
- IEC 60601-2-37 (2004)
- NEMA UD2 (2009)
- IEC 62133 (2012)
- IEC 62366 (2014)
- ISO 10993-1 (2009)
- ISO 10993-5 (2014)
- ISO 10993-10(2014)
- ISO 10993-12 (2014)
- ISO 62304 (2006)
- ISO 15223-1(2012)
- ISO 14971 (2007) | - IEC 60601-1-2 (2014)
- IEC 60601-2-37 (2004)
- NEMA UD2 (2009)
- ISO 10993-1 (2009)
- ISO 14971 (2007) | The application device
does not claim its
compliance with
IEC60606-1-12 and ISO
10993-12 as compared
to the predicate but
can be compared to
the reference device,
which also excludes
the emergency use.
All the safety and
performance tests
meet the essential
requirement to its
intended use. |
8
9
Based on the abovementioned SE table, the proposed device, Leltek Ultrasound Imaging system (Model: LU700), has the same intended use as the predicate devices. Nevertheless, the indications for use of the proposed device does not the same as the predicate device. The proposed device has less items, excludes the emergency use, and without invasive subjects. Thus, as all the safety and performance tests of the device meet the essential requirement, it does not affectiveness of the proposed device.
10
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 |
11
Evaluation per standard AAMI/ANSI/ES60601-1 and IEC 60601-1-2 were performed for use of the transducers with a specific computer model (Panel PC Xiaomi/M1806D9W) and adaptor (FranMar, Model FRM06-S05) to charge the medical device. Use of alternate compatible computer 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, electrical, 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
The differences between the proposed device, Leltek Ultrasound Imaging system and the predicate devices do not raise new questions of safety or effectiveness. Both of them meet FDA requirements for Track 3 devices, have biosafety equivalence, and conform to applicable electromedical devices safety standards. The intended use of both devices is the same whereas the differences all comply with the Food and Drug Administration's guidance. The Leltek Ultrasound Imaging System is designed for compliance to all applicable medical devices safety standards. 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. Maximum acoustic output level is under by the FDA recommended limit and power level is displayed all the time. The proposed device, Leltek Ultrasound Imaging system can be considered substantially equivalent to the listed predicate devices.
9. Conclusion
Verification and validation testing has been conducted on the Leltek Ultrasound Imaging System and ascertain that it is safe for use by physicians. This device is similar to an existing licensed device using technologies that exist on the market today. This premarket notification submission demonstrates that the Leltek Ultrasound Imaging System is substantially equivalent to the predicate device.