Leltek Ultrasound Imaging System (Model: LU700 Series)

K222365 · Leltek, Inc. · IYN · Oct 25, 2022 · Radiology

Device Facts

• Record ID: K222365
• Device Name: Leltek Ultrasound Imaging System (Model: LU700 Series)
• Applicant: Leltek, Inc.
• Product Code: IYN · Radiology
• Decision Date: Oct 25, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended 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.

Device Story

Portable, software-controlled, handheld ultrasound system; acquires/displays high-resolution, real-time ultrasound data. System consists of wireless transducers (Linear, Convex, MicroConvex, Phased, Endocavity) communicating via Wi-Fi to COTS mobile devices (iOS, Android, Windows). Transducers contain built-in battery, multichannel beamformer, prescan converter, and Wi-Fi components. Operated by physicians/healthcare professionals in clinics, offices, and point-of-care settings. User interacts via touch-based mobile app to view images, perform measurements, and conduct fluid flow analysis. Output aids clinical decision-making for diagnosis and interventional guidance. Benefits include portability and wireless imaging capability.

Clinical Evidence

No clinical data. Substantial equivalence established via bench testing only, including acoustic output, biocompatibility, cleaning/disinfection effectiveness, and electromagnetic/mechanical safety testing.

Technological Characteristics

Handheld wireless transducers; Wi-Fi (IEEE 802.11 a/b/g/n) connectivity; Li-ion battery; multichannel beamformer. Software-based imaging (mobile app). Standards: AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-1/5/10, ISO 14971, ISO 13485. Sterilization: Cleaning/disinfection per manual.

Indications for Use

Indicated for qualified physicians and healthcare professionals to perform ultrasound scans for diagnostic evaluation or fluid flow analysis. Clinical applications include: Ophthalmic, Fetal, General abdominal, Pediatric, Small organ (thyroid, prostate, scrotum, breast), Neonatal cephalic, Trans-rectal, Trans-vaginal, Urology, OB/Gyn, Cardiac (adult/pediatric), Musculoskeletal (conventional/superficial), Peripheral vessel, Carotid, Pulmonary, and interventional guidance (free hand needle/catheter).

Regulatory Classification

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.

Predicate Devices

• Leltek Ultrasound Imaging System (K210432)

Reference Devices

• Vscan Air (K202035)

Submission Summary (Full Text)

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October 25, 2022

Image /page/0/Picture/1 description: The image contains 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 the FDA logo, which 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. % Paul Chang Manager 6F .- 3, No. 293, Sec. 1, Beixin Rd., Xindian Dist., New Taipei City, Taiwan 23147 REPUBLIC OF CHINA

#### Re: K222365

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: August 4, 2022 Received: August 4, 2022

#### Dear Paul 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

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801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Yanna Kang, Ph.D. Assistant Director Mammography and Ultrasound Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K222365

#### 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 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:

- LU700L
General abdominal imaging, Pediatric, Small organ (thyroid, prostate, scrotum, breast), Neonatal cephalic, Musculoskeletal (conventional),Musculosketal (superficial),Peripheral vessel ,Other (Carotid),Pulmonary,interventional guidance (free hand needle/ catheter)

LU710L

Ophthalmic, General abdominal imaging, Pediatric, Small organ (thyroid, prostate, scrotum, breast), Neonatal cephalic.Musculoskeletal (conventional),Musculoskeletal (superficial),Peripheral vessel ,Other

(Carotid),Pulmonary,interventional guidance (free hand needle/ catheter)

LU710LH

Ophthalmic, General abdominal imaging, Pediatric, Small organ (thyroid, prostate, scrotum, breast), Neonatal cephalic,Musculoskeletal (conventional),Musculoskeletal (superficial),Peripheral vessel ,Other

(Carotid),Pulmonary,interventional guidance (free hand needle/ catheter)

LU700C

General abdominal imaging,Musculoskeletal (conventional),Musculoskeletal (superficial),OB/Gyn,Peripheral vessel ,interventional guidance (free hand needle/ catheter)

LU710C

Fetal.General abdominal imaging.Small organ (thyroid, prostate, scrotum, breast).Urology.Musculoskeletal (conventional),OB/Gyn,Cardiac (pediatric),Peripheral vessel ,interventional guidance (free hand needle/ catheter)

LU710M

Fetal,General abdominal imaging,Pediatric,Small organ (thyroid, prostate, scrotum, breast),Neonatal cephalic. Urology. Musculoskeletal (conventional), OB/Gyn. Cardiac (pediatric), Peripheral vessel ,interventional guidance (free hand needle/ catheter)

LU710PA

Fetal, General abdominal imaging, Pediatric, Cardiac (adult), Cardiac (pediatric), Pulmonary LU710E

Fetal, General abdominal imaging, Pediatric, Small organ (thyroid, prostate, scrotum, breast), Transvaginal,Urology,OB/Gyn,interventional guidance (free hand needle/ catheter)

The clinical environments where the system can be used include physician offices, clinics, and clinical point-ofcare for diagnosis of patients.

Type of Use (Select one or both, as applicable) Over-The-Counter Use (21 CFR 801 Subpart C) X Prescription Use (Part 21 CFR 801 Subpart D)

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# 510(k) Summary: K222365

## 1. Submitter's Information

| Manufacturer: | LELTEK Inc. |
|-----------------|--------------------------------------------------------------------------------------------|
| Address: | 6F-3., No.293, Sec. 1, Beixin Rd., Xindian Dist.,<br>New Taipei City 23147, Taiwan, R.O.C. |
| Tel: | [phone] |
| Fax: | [phone] |
| Website: | www.leltek.com |
| Contact: | Paul Chang/Manager |
| E-mail: | [e-mail] |
| 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<br>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 | K210432 |
| Reference Device | |
| Device Name | 510(k) Number |
| "GE" Vscan Air | K202035 |

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#### 4. Reason for Submission

Following changes have been made compared to the cleared device (Predicate Device #1)

- Wi-Fi module changed to support both 2.4 GHz & 5GHz connectivity
- New transducer added to the LU700 series: The LU710L, LU710LH with new transducer which can apply to the same main board of the 700 series.
- New clinical application added: Ophthalmic, Neonatal cephalic, Pulmonary and interventional guidance (free hand needle/ catheter)
- Software (Mobile application) Changes: Windows 10 support.
- Label Changes: Device label, Box label, User Manual

## 5. 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 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). Specific clinical applications and exam types including:

LU700L

General abdominal imaging,Pediatric,Small organ (thyroid, prostate, scrotum, breast),Neonatal cephalic,Musculoskeletal (conventional),Musculoskeletal (superficial),Peripheral vessel ,Other (Carotid),Pulmonary,interventional guidance (free hand needle/ catheter)

LU710L

Ophthalmic,General abdominal imaging,Pediatric,Small organ (thyroid, prostate, scrotum, breast),Neonatal cephalic,Musculoskeletal (conventional),Musculoskeletal (superficial),Peripheral vessel ,Other (Carotid),Pulmonary,interventional guidance (free hand needle/ catheter)

LU710LH

Ophthalmic,General abdominal imaging,Pediatric,Small organ (thyroid, prostate, scrotum, breast),Neonatal cephalic,Musculoskeletal (conventional),Musculoskeletal (superficial),Peripheral vessel ,Other (Carotid),Pulmonary,interventional guidance (free hand needle/ catheter)

LU700C

General abdominal imaging,Musculoskeletal (conventional),Musculoskeletal (superficial),OB/Gyn,Peripheral vessel ,interventional guidance (free hand needle/ catheter)

LU710C

Fetal,General abdominal imaging,Pediatric,Small organ (thyroid, prostate, scrotum, breast),Urology,Musculoskeletal (conventional),OB/Gyn,Cardiac (adult),Cardiac (pediatric),Peripheral vessel ,interventional guidance (free hand needle/ catheter) LU710M

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Fetal,General abdominal imaging,Pediatric,Small organ (thyroid, prostate, scrotum, breast),Neonatal cephalic,Urology,Musculoskeletal (conventional),OB/Gyn,Cardiac (adult),Cardiac (pediatric),Peripheral vessel ,interventional guidance (free hand needle/ catheter) LU710PA Fetal,General abdominal imaging,Pediatric,Cardiac (adult),Cardiac (pediatric),Pulmonary LU710E Fetal,General abdominal imaging,Pediatric,Small organ (thyroid, prostate, scrotum, breast),Trans-rectal,Trans-vaginal,Urology,OB/Gyn,interventional guidance (free hand needle/ catheter)

The clinical environments where the system can be used include physician offices, clinics, hospitals, and clinical point-of-care for diagnosis of patients.

#### 6. 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.

- I. 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.

Image /page/6/Figure/10 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. There are Wi-Fi symbols between the two devices, indicating that they are communicating wirelessly. The text labels identify the different components of the diagram.

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.

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#### USFDA_510(k)

LELTEK_LU700

# 7. Determination of Substantial Equivalence

| Item | Application device | Primary Predicate device #1 | Reference Device #2 | Comparison |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| Device name | Leltek Ultrasound Imaging System<br>(Model: LU700 series) | Leltek Ultrasound Imaging System<br>(Model: LU700 series) | Vscan Air | - |
| 510(k) Number | Current Submission | K210432 | K202035 | - |
| 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<br>Use | Ophthalmic<br>Fetal<br>Abdominal<br>Pediatric<br>Small organ<br>Neonatal cephalic<br>Trans-rectal<br>Trans-vaginal<br>Musculoskeletal(conventional)<br>Musculoskeletal (superficial)<br>Urology<br>OB/Gyn<br>Cardiac adult<br>Cardiac pediatric<br>Peripheral vessel<br>Carotid<br>Pulmonary<br>interventional guidance (includes<br>free hand needle/ catheter) | Fetal<br>Abdominal<br>Pediatric<br>Small organ<br>Trans-rectal<br>Trans-vaginal<br>Musculoskeletal(conventional)<br>Musculoskeletal (superficial)<br>Urology<br>OB/Gyn<br>Cardiac adult<br>Cardiac pediatric<br>Peripheral vessel<br>Carotid | With the curved array transducer of the<br>dual headed probe solution, the specific<br>clinical applications and exam types<br>include:<br>abdominal, fetal/obstetrics,<br>gynecological, urology, thoracic/<br>lung,<br>cardiac (adult and pediatric, 40 kg<br>and above), vascular/peripheral<br>vascular, musculoskeletal<br>(conventional), pediatrics,<br>interventional guidance (includes<br>free hand needle/ catheter<br>placement, fluid drainage, nerve<br>block and biopsy).<br>With the linear array transducer of the<br>dual headed probe solution, the<br>specific clinical applications and exam<br>types include:<br>vascular/peripheral vascular,<br>musculoskeletal (conventional and<br>superficial), small organs,<br>thoracic/lung, ophthalmic,<br>pediatrics, neonatal cephalic,<br>interventional guidance (includes<br>free hand<br>needle/catheter placement, fluid<br>drainage, nerve block, vascular<br>access and biopsy). | More intended<br>purpose than the<br>Primary Predicate<br>device which<br>referred to the<br>reference device |
| Mode of<br>Operations | B Mode (Ophthalmic and others)<br>M mode<br>Pulsed wave Doppler (PWD) | B Mode<br>M mode<br>PWD | B mode | Same. |
| USFDA_510(k) | | LELTEK_LU700 | 5_510(k) Summary | |
| Item | Application device | Primary Predicate device #1 | Reference Device #2 | Comparison |
| Device name | Leltek Ultrasound Imaging System<br>(Model: LU700 series) | Leltek Ultrasound Imaging System<br>(Model: LU700 series) | Vscan Air | |
| | - Color Doppler(CF)<br>- Power Doppler(PD)<br>- Combined mode (B+M, B+CF, B+PWD) | - Color Doppler<br>- Power Doppler<br>- Combined mode (B+M, B+CF, B+PWD) | - Color Doppler<br>- Combined mode (B+CF) | |
| Connect | Communicates wirelessly via Wi-Fi | Communicates wirelessly via Wi-Fi | Communicates wirelessly via Wi-Fi and Bluetooth | Same |
| Transducer Types | - Linear (LU700L, LU710L)<br>- Linear HD (LU710H)<br>- Convex HD array (LU700C,LU710C)<br>- MicroConvex array (LU710M)<br>- Phased array (LU710PA)<br>- Endocavity array (LU710E) | - Linear (LU700L)<br>- Convex HD array (LU700C,LU710C)<br>- MicroConvex array (LU710M)<br>- Phased array (LU710PA)<br>- Endocavity array (LU710E) | - Convex array<br>- Linear array | More transducers<br>are added to the<br>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<br>and Windows | iOS or Android mobile device | iOS or Android mobile device | Windows App<br>added |
| Wireless<br>Networking | IEEE 802.11<br>a/b/g/n | IEEE 802.11<br>b/g/n | -- | 5G WiFi added |
| 510(k) Track | Track 3 | Track 3 | Track 3 | Same |
| Compliance<br>Standards | - AAMI/ANSI ES60601-1 (2012)<br>- IEC 60601-1-2 (2014)<br>- IEC 60601-1-6 (2013)<br>- IEC 60601-2-37 (2015) | - AAMI/ANSI ES60601-1 (2012)<br>- IEC 60601-1-2 (2014)<br>- IEC 60601-1-6 (2013)<br>- IEC 60601-2-37 (2008) | - IEC60601-1<br>- IEC 60601-1-2<br>- IEC 60601-1-6 (2013)<br>- IEC 60601-1-11<br>- IEC 60601-1-12 (2014)<br>- IEC 60601-2-37 (2015) | Same.<br>As compared to<br>the predicate, the<br>LU700 series |
| USFDA_510(k)<br>LELTEK_LU700 | | 5_510(k) Summary | | |
| Item | Application device | Primary Predicate device #1 | Reference Device #2 | Comparison |
| Device name | Leltek Ultrasound Imaging System<br>(Model: LU700 series) | Leltek Ultrasound Imaging System<br>(Model: LU700 series) | Vscan Air | - |
| | - AIUM/NEMA UD 2- 2004 R2009<br>- AIUM/NEMA UD 3- 2004 R2009<br>- IEC 62133 (2012)<br>- IEC 62366 (2014)<br>- ISO 10993-1(2009)<br>- ISO 10993-5(2009)<br>- ISO 10993-10(2010)<br>- IEC 62304 (2006)<br>- ISO 15223-1 (2016)<br>- ISO 14971 (2019)<br>- ISO 13485 (2016) | - AIUM/NEMA UD 2- 2004 R2009<br>- AIUM/NEMA UD 3- 2004 R2009<br>- IEC 62133 (2012)<br>- IEC 62366 (2014)<br>- ISO 10993-1(2009)<br>- ISO 10993-5(2009)<br>- ISO 10993-10(2010)<br>- IEC 62304 (2006)<br>- ISO 15223-1 (2016)<br>- ISO 14971 (2012)<br>- ISO 13485 (2016) | - ISO 10993-1<br>- ISO 62304<br>- ISO 15223-1<br>- ISO 14971 | comply with the<br>safety and<br>performance<br>tests, which<br>meets all the<br>essential<br>requirement for<br>its intended use. |

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This device is a modification of an existing (K210432) using technologies that exist on the market as of this submission. The Lettek Ultrasound Imaging System (Model: LU700 series) meets FDA requirements for Track 3 devices, and conform to applicable electromedical devices safety standards. The differences specified above have no pragmatic detriments. All the safety and performance tests of the device meet the essential requirements. Therefore, the system is substantially equivalent to predicate devices.

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#### 8. 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-<br>1:2005/(R)2012 and<br>A1:2012 and<br>C1:2009/(R)2012 and<br>A2:2010/(R)2012 | 2009<br>&<br>2012 | Medical electrical equipment - Part 1: General<br>requirements for basic safety and essential<br>performance |
| IEC 60601-1-2 | 2014 | Medical electrical equipment - Part 1-2: General<br>requirements for basic safety and essential<br>performance - Collateral Standard: Electromagnetic<br>disturbances - Requirements and tests |
| IEC 60601-1-6 | 2013 | Medical electrical equipment Part 1-6 General<br>requirements for basic safety and essential<br>performance Collateral standard Usability |
| IEC 60601-2-<br>37/AMD1 | 2008<br>&<br>2015 | Medical electrical equipment - Part 2-37: Particular<br>requirements for the basic safety and essential<br>performance of ultrasonic medical diagnostic and<br>monitoring equipment |
| IEC 62133 | 2012 | Safety requirements for portable sealed secondary<br>cells, and for batteries made from them, for use in<br>portable applications |
| IEC 62304 | 2014 | Medical device software - Software life-cycle<br>processes |
| IEC 62366-1 | 2015 | Medical devices -- Part 1: Application of usability<br>engineering to medical devices |
| ISO 10993-1 | 2009<br>&<br>2018 | Biological evaluation of medical devices Part 1:<br>Evaluation and testing within a risk management<br>process |
| ISO 10993-5 | 2009 | Biological evaluation of medical devices Part 5:<br>Tests for in vitro cytotoxicity |
| ISO 10993-10 | 2010 | Biological evaluation of medical devices Part 10:<br>Tests for irritation and skin sensitization |
| ISO 13485 | 2016 | Medical devices - Quality management systems -<br>Requirements for regulatory purposes |
| ISO 14971 | 2019 | Medical devices - Application of risk management<br>to medical devices |
| ISO 15223-1 | 2016 | Medical devices -- Symbols to be used with medical<br>device labels, labelling and information to be<br>supplied -- Part 1: General requirements |

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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 (Model A1385) 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.

#### 9. 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 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 new models comprise LU710L, LU710LH, 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 time. All the safety and performance tests of the device meet the essential requirements. Therefore, the system is substantially equivalent to predicate devices.

#### 10. 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.