Ultrasound Imaging System (LK128L); Ultrasound Imaging System (LK128LH); Ultrasound Imaging System (LK128C); Ultrasound Imaging System (LK128M); Ultrasound Imaging System (LK128PA); Ultrasound Imaging System (LK128E); Ultrasound Imaging System (LU700C); Ultrasound Imaging System (LU700L); Ultrasound Imaging System (LU710L); Ultrasound Imaging System (LU710LH); Ultrasound Imaging System (LU710C); Ultrasound Imaging System (LU710M); Ultrasound Imaging System (LU710PA); Ultrasound Imaging

{0}------------------------------------------------ September 11, 2024 Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" surrounding a graphic. To the right of the seal, there is a blue square with the letters "FDA" in white. Next to the blue square, the text "U.S. FOOD & DRUG ADMINISTRATION" is written in blue. Leltek Inc. Paul Chang Manager 6F .- 3, No.293, Sec 1, Beixin Rd., Xindian Dist., New Taipei City, 23147 TAIWAN #### Re: K241161 Trade/Device Name: Ultrasound Imaging System (LK128L); Ultrasound Imaging System (LK128LH); Ultrasound Imaging System (LK128C); Ultrasound Imaging System (LK128M); Ultrasound Imaging System (LK128PA); Ultrasound Imaging System (LK128E); Ultrasound Imaging System (LU700C); Ultrasound Imaging System (LU700L); Ultrasound Imaging System (LU710L); Ultrasound Imaging System (LU710LH); Ultrasound Imaging System (LU710C); Ultrasound Imaging System (LU710M); Ultrasound Imaging System (LU710PA); Ultrasound Imaging System (LU710E) Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: August 12, 2024 Received: August 12, 2024 #### 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 (the 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 available 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 {1}------------------------------------------------ Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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. {2}------------------------------------------------ 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, ## Yanna S. Kang -S 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 {3}------------------------------------------------ ## Indications for Use Submission Number (if known) | K241161 | |--------------------------------------| | Device Name | | Ultrasound Imaging System (LK128L); | | Ultrasound Imaging System (LK128LH) | | Ultrasound Imaging System (LK128C); | | Ultrasound Imaging System (LK128M); | | Ultrasound Imaging System (LK128PA); | | Ultrasound Imaging System (LK128E); | | Ultrasound Imaging System (LU700C); | | Ultrasound Imaging System (LU700L); | | Ultrasound Imaging System (LU710L); | | Ultrasound Imaging System (LU710LH); | | Ultrasound Imaging System (LU710C); | | Ultrasound Imaging System (LU710M); | | Ultrasound Imaging System (LU710PA); | | Ultrasound Imaging System (LU710E) | | Indications for Use (Describe) | The Ultrasound Imaging System (Model: 128 Series) and (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: LK128C Fetal, General abdominal imaging, Pediatric, Small organ (thyroid, prostate, scrotum, breast), Urology, Musculoskeletal (conventional), OB/Gyn, Cardiac (adult), Cardiac (pediatric).Peripheral vessel .interventional quidance (free hand needle/ catheter).FAST/ EFAST,Nerve LK128L 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), Nerve LK128LH 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), Nerve LK128M 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) LK128PA Fetal, General abdominal imaging, Pediatric, Cardiac (adult), Cardiac (pediatric), Pulmonary, FAST/ EFAST,Nerve LK128E Fetal, General abdominal imaging, Pediatric, Small organ (thyroid, prostate, scrotum, breast), Trans- rectal, Trans-vaginal, Urology, OB/Gyn, interventional guidance (free hand needle/ catheter) LU700L {4}------------------------------------------------ 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),Nerve 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), Nerve LU710LH Ophthalmic, General abdominal imaging, Pediatric, Small organ (thyroid, prostate, scrotum, breast),Neonatal cephalic,Musculoskeletal (conventional),Musculoskeletal (superficial),Peripheral vessel . Other (Carotid),Pulmonary.interventional quidance (free hand needle/ catheter),Nerve LU700C General abdominal imaging, Musculoskeletal (conventional), Musculoskeletal (superficial), OB/ Gyn, Peripheral vessel .interventional guidance (free hand needlel catheter),FAST/EFAST,Nerve 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),FAST/ EFAST,Nerve LU710M Fetal General abdominal imaging, Pediatric, Small organ (thyroid, prostate, scrotum, breast), Neonatal cephalic.Urology.Musculoskeletal (conventional).OB/Gvn.Cardiac (adult).Cardiac (pediatric),Peripheral vessel ,interventional guidance (free hand needle/ catheter) LU710PA Fetal,General abdominal imaging,Pediatric,Cardiac (adult),Cardiac (pediatric),Pulmonary,FAST/ EFAST.Nerve LU710E Fetal, General abdominal imaging, Pediatric, Small organ (thyroid, prostate, scrotum, breast), Transrectal, Trans-vaginal, Urology, OB/Gyn, interventional guidance (free hand needle/ catheter) 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. 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) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {5}------------------------------------------------ # 510(k) Summary K241161 #### 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 #205 Fax: 886-2-2913-7599 Website: info@Leltek.com Contact: Paul Chang/Manager E-mail: Paul.Chang@leltek.com Name of Device: Ultrasound Imaging System (LK128L); Ultrasound Imaging System (LK128LH) Ultrasound Imaging System (LK128C); Ultrasound Imaging System (LK128M); Ultrasound Imaging System (LK128PA); Ultrasound Imaging System (LK128E); Ultrasound Imaging System (LU700C); Ultrasound Imaging System (LU700L); Ultrasound Imaging System (LU710L); Ultrasound Imaging System (LU710LH); Ultrasound Imaging System (LU710C); Ultrasound Imaging System (LU710M); Ultrasound Imaging System (LU710PA); Ultrasound Imaging System (LU710E) #### 2. Class Information | Date: | 2024/09/10 | | |----------------------|----------------------------------------------|--------------| | Device Name: | Ultrasound Imaging System | | | Proprietary Name: | LU700 Series, 128 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 $ Ι $ YN | | 892.1560 | Ultrasonic Pulsed Echo Imaging System | 90 IYO | | 892.1570 | Diagnostic Ultrasound Transducer | 90 ITX | {6}------------------------------------------------ #### 3. Substantially Equivalent Devices | Primary Predicate Device<br>Device Name<br>"Leltek" Ultrasound Imaging System | 510(k) Number<br>K222365 | |-------------------------------------------------------------------------------|--------------------------| | Reference Device<br>Device Name<br>Aco Apache Ultrasound System | 510(k) Number<br>K231509 | #### 4. Reason for Submission - Add new specific clinical applications: FAST/EFAST, Nerve ● - Add new transducer: LK128C, LK128L, LK128LH, LK128M, LK128PA, LK128E. ● {7}------------------------------------------------ #### 5. Indications for Use The Ultrasound Imaging System 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: LK128C 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),FAST/EFAST,Nerve LK128L 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),Nerve LK128LH 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),Nerve LK128M 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) LK128PA Fetal,General abdominal imaging,Pediatric,Cardiac (adult),Cardiac (pediatric), Pulmonary, FAST/EFAST, Nerve LK128E Fetal,General abdominal imaging,Pediatric,Small organ (thyroid, prostate, scrotum, breast),Trans-rectal,Trans-vaginal,Urology,OB/Gyn,interventional guidance (free hand needle/ catheter) 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),Nerve LU710L Ophthalmic,General abdominal imaging,Pediatric,Small organ (thyroid, prostate, scrotum, breast),Neonatal cephalic,Musculoskeletal (conventional),Musculoskeletal {8}------------------------------------------------ (superficial),Peripheral vessel ,Other (Carotid),Pulmonary,interventional guidance (free hand needle/ catheter),Nerve 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),Nerve LU700C General abdominal imaging,Musculoskeletal (conventional),Musculoskeletal (superficial),OB/Gyn,Peripheral vessel ,interventional guidance (free hand needle/ catheter),FAST/EFAST,Nerve 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),FAST/EFAST,Nerve LU710M 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,FAST/EFAST,Nerve 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 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. {9}------------------------------------------------ #### 6. Device description The 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) 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/9/Picture/8 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 identify the different components of the diagram. - IV. The imaging system houses a built-in battery, multichannel beamformer, prescan converter and Wi-Fi components {10}------------------------------------------------ #### 7. Determination of Substantial Equivalence | Item | Application device | Primary Predicate | Reference Device | Comparison | |-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device name | Ultrasound Imaging System (Model: 128 series) | Ultrasound Imaging System (Model: LU700 series) | Aco Apache Ultrasound System | | | 510(k) Number | Current Submission | K222365 | K231509 | | | 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 | Same | | Indications for 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 interventional guidance (includes free hand needle/ catheter)<br>- FAST/EFAST,<br>- Nerve, | - 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 interventional guidance (includes free hand needle/ catheter) | - Ocular<br>- Fetal / Fetal Echo<br>- Abdominal,<br>- Pediatric,<br>- Small Organ (including breast, scrotum, thyroid),<br>- Musculo-skeletal (conventional<br>- Musculo-skeletal (superficial)<br>- Urology,<br>- Obstetric/ Gynecological,<br>- Cephalic (adult),<br>- Peripheral Vessel,<br>- Carotid,<br>- Lung,<br>- Needle Guidance<br>- FAST/EFAST,<br>- Nerve, | Different. 128 series adds more clinical applications. | | Mode of Operations | - B Mode (Ophthalmic and others) | - B Mode (Ophthalmic and others) | B Mode | Same. | | | - M mode | - M mode | M mode | | | | - Pulsed wave Doppler (PWD) | - Pulsed wave Doppler (PWD) | Pulsed wave Doppler (PWD) | | | USFDA_510(k) | | LELTEK_LU700 &128 Series | 050_510(k) Summary | | | Item | Application device | Primary Predicate | Reference Device | Comparison | | Device name | Ultrasound Imaging System (Model:<br>128 series) | Ultrasound Imaging System (Model:<br>LU700 series) | Aco Apache Ultrasound System | - | | | - Color flow Doppler(CF / CD) | - Color flow Doppler(CF / CD) | Color Doppler(CD) | | | | - Power Doppler(PD) | - Power Doppler(PD) | Power Doppler(PD) | | | | - Combined mode (B+M, B+CF,<br>B+PWD) | Combined mode (B+M, B+CF, B+PWD) | Combined mode (B+M, B+CD, B+PWD) | | | Connect | Wireless communication via IEEE<br>802.11 a/b/g/n | Wireless communication via IEEE<br>802.11 a/b/g/n | Wireless communication via IEEE<br>802.11g/n | Same | | Transducer<br>Types | Linear (LK128L, LK128LH<br>LU700L, LU710L, LU710LH)<br>Convex array (LK128C,<br>LU700C, LU710C)<br>MicroConvex array (LK128M, LU710M<br>Phased array (LK128PA, LU710PA)<br>Endocavity array (LK128E, LU710E) | Linear (LU700L,LU710L,LU710LH)<br>Convex array (LU700C,LU710C)<br>MicroConvex array (LU710M)<br>Phased array (LU710PA)<br>Endocavity array (LU710E) | Linear array<br>Convex array | More<br>transducers<br>are added to<br>the 128<br>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 or<br>OTC | iOS, Android mobile device or<br>Windows | iOS, Android mobile device or Windows | iOS or Android mobile device | Same | | 510(k) Track | Track 3 | Track 3 | Track 3 | Same | | Compliance<br>Standards | - AAMI/ANSI ES60601-1 (2012)<br>- IEC 60601-1-2 (2014) | - AAMI/ANSI ES60601-1 (2012)<br>- IEC 60601-1-2 (2014) | - ANSI/AAMI ES60601-1:2005/(R)2012<br>and A1:2012<br>- ANSI/AAMI IEC 60601-1-2:2014 | Same. | | USFDA_510(k) | LELTEK_LU700 &128 Series | | | 050_510(k) Summary | | Item | Application device | Primary Predicate | Reference Device | Comparison | | Device name | Ultrasound Imaging System (Model: 128 series) | Ultrasound Imaging System (Model: LU700 series) | Aco Apache Ultrasound System | - | | | - IEC 60601-1-6:2010+AMD1:2013+AMD2:2020<br>- IEC60601-1-12 Edition 1.1 2020-07<br>- IEC 60601-2-37 (2015)<br>- AIUM/NEMA UD 2- 2004 R2009<br>- AIUM/NEMA UD 3- 2004 R2009<br>- IEC 62133-2:2017+ AMD1:2021 IEC 62366 (2014)<br>- ISO 10993-1:2018<br>- ISO 10993-5(2009)<br>- ISO 10993-10:2021<br>- ISO 10993-23(2021)<br>- IEC 62304:2006+ AMD1:2015<br>- ISO 15223-1 Fourth edition 2021-07<br>- ISO 14971 (2019)<br>- ISO 13485 (2016) | - IEC 60601-1-6 (2013)<br>- IEC 60601-2-37 (2015)<br>- AIUM/NEMA UD 2- 2004 R2009<br>- AIUM/NEMA UD 3- 2004 R2009<br>- IEC 62133 (2012)<br>- IEC 62366 (2014)<br>- ISO 10993-1:2018<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) | - IEC 60601-1-6:2010+AMD1:2013+AMD2:2020<br>- IEC 60601-2-37:2007+ AMD1:2015<br>- AIUM/NEMA UD 2- 2004 R2009<br>- ISO 10993-1:2018<br>- ISO 62304<br>- ISO 15223-1<br>- ISO 14971 | As compared to the predicate, the 128 series comply with the safety and performance tests, which meets all the essential requirement for its intended use. | {11}------------------------------------------------ {12}------------------------------------------------ This device is a modification of an existing cleared device (K22365) using technologies that exist on the date of this submission. The Lettek Ultrasound Imaging System (Model: 128 series) meets 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 device meet the essential requirements. Therefore, the system is substantially equivalent to the primary predicate device. {13}------------------------------------------------ #### 8. Performance standards The Ultrasound Imaging System has been designed, manufactured, tested, and certified to comply with the following internationally recognized standards: | Date of Entry | Recognition Number | Standard Developing Organization | Standard Designation Number/Date | Title of Standard | |---------------|--------------------|----------------------------------|------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 05/30/2022 | 19-46 | ANSI AAMI | ES60601-1:2005/(R)2012 &<br>A1:2012 C1:2009/(R)2012<br>& A2:2010/(R)2012 (Cons.<br>Text) [Incl. AMD2:2021] | Medical electrical equipment - Part 1:<br>General requirements for basic safety and<br>essential performance (IEC 60601-1:2005<br>MOD) [Including Amendment 2 (2021)] | | 12/21/2020 | 19-36 | ANSI AAMI IEC | 60601-1-2:2014 [Including<br>AMD 1:2021] | Medical electrical equipment - Part 1-2:<br>General requirements for basic safety and<br>essential performance - Collateral Standard:<br>Electromagnetic disturbances - Requirements<br>and tests [Including Amendment 1 (2021)] | | 12/21/2020 | 5-132 | IEC | 60601-1-6 Edition 3.2 2020-<br>07 CONSOLIDATED<br>VERSION | Medical electrical equipment - Part 1-6:<br>General requirements for basic safety and<br>essential performance - Collateral standard:<br>Usability | | 12/21/2020 | 19-38 | IEC | 60601-1-11 Edition 2.1<br>2020-07 CONSOLIDATED<br>VERSION | Medical electrical equipment - Part 1-11:<br>General requirements for basic safety and<br>essential performance - Collateral Standard:<br>Requirements for medical electrical<br>equipment and medical electrical systems<br>used in the home healthcare environment | | 06/27/2016 | 12-293 | IEC | 60601-2-37 Edition 2.1<br>2015 | Medical electrical equipment - Part 2-37:<br>Particular requirements for the basic safety<br>and essential performance of ultrasonic<br>medical diagnostic and monitoring<br>equipment | | 12/23/2019 | 19-33 | IEC | 62133-2 Edition1.0 2017-02 | Secondary cells and batteries containing<br>alkaline or other non-acid electrolytes -<br>Safety requirements for portable sealed<br>secondary cells and for batteries made from<br>them for use in portable applications - Part 2<br>Lithium systems | | 01/14/2019 | 13-79 | ANSI AAMI IEC | 62304:2006/A1:2016 | Medical device software - Software life cycle<br>processes [Including Amendment 1 (2016)] | | 07/06/2020 | 5-129 | ANSI AAMI IEC | 62366-1:2015+AMD1:2020<br>(Consolidated Text) | Medical devices Part 1: Application of<br>usability engineering to medical devices<br>including Amendment 1 | | 01/14/2019 | 2-258 | ISO | 10993-1 Fifth edition 2018-<br>08 | Biological evaluation of medical devices -<br>Part 1: Evaluation and testing within a risk<br>management process | | 12/23/2016 | 2-245 | ISO | 10993-5 Third edition<br>2009-06-01 | Biological evaluation of medical devices -<br>Part 5: Tests for in vitro cytotoxicity | | 12/19/2022 | 2-296 | ISO | 10993-10 Fourth edition<br>2021-11 | Biological evaluation of medical devices -<br>Part 10: Tests for skin sensitization | | 06/07/2021 | 2-291 | ISO | 10993-23 First edition<br>2021-01 | Biological evaluation of medical devices -<br>Part 23: Tests for irritation | | 12/20/2021 | 5-134 | ISO | 15223-1 Fourth edition<br>2021-07 | Medical devices - Symbols to be used with<br>information to be supplied by the<br>manufacturer - Part 1: General requirements | | 12/23/2019 | 5-125 | ISO | 14971 Third Edition 2019-<br>12 | Medical devices - Application of risk<br>management to medical devices | {14}------------------------------------------------ #### 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: 128 Series) and (Model: LU700 Series) meets FDA requirements for Track 3 devices, have biosafety equivalence, and conform to applicable electromedical devices safety standards. The new models 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 the primary predicate device. #### 10. Conclusion With increased clinical experience and imaging, additional clinical applications such as FAST/EFAST and Nerve diagnosis have been identified by clinics, which can be added to the existing legally marketed LU700 series device (K222365). Furthermore, the Leltek Ultrasound Imaging System (Model: 128 series) utilizes the same software and hardware architecture and transducer specifications as the LU700 series but replaces the cover material with plastic and features a smaller PCBA with same block diagram. Pre-clinical test outcomes provide evidence that both the LU700 series and 128 series models meet FDA requirements for Track 3 devices, exhibit biosafety equivalence, and conform to applicable electromedical device safety standards. The specified differences have no pragmatic detriments. All safety and performance tests of the device meet essential requirements. Therefore, the system is considered substantially equivalent to the primary predicate device