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 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), Trans-rectal, Trans-vaginal, Urology, OB/Gyn, interventional guidance (free hand needle/ catheter)

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-the-shelf (COTS) mobile device and utilizes an icon touch-based user interface.
III. The imaging system consists of a series of wireless transducers employing Wi-Fi-based technology to communicate with traditional tablet/smartphone devices via direct Wi-Fi. This allows the user to export ultrasound images and display them across a range portable personal device.
IV. The imaging system houses a built-in battery, multichannel beamformer, prescan converter and Wi-Fi components

AI/ML Overview

This document is a 510(k) Premarket Notification from Leltek Inc. to the FDA for their Ultrasound Imaging System (LK128L; LK128LH; LK128C; LK128M; LK128PA; LK128E; LU700C; LU700L; LU710L; LU710LH; LU710C; LU710M; LU710PA; LU710E).

The information provided does not contain details about acceptance criteria or a study proving the device meets those criteria, specifically in the context of AI/algorithm performance. The document focuses on demonstrating substantial equivalence to a predicate device (Leltek Ultrasound Imaging System, K222365) and a reference device (Aco Apache Ultrasound System, K231509) for an ultrasound imaging system, which is a hardware and software system for acquiring and displaying ultrasound data, not an AI or algorithm for diagnostic interpretation that would typically require the detailed performance metrics you're asking for.

The submission is primarily focused on:

Adding new specific clinical applications (FAST/EFAST, Nerve)
Adding new transducers for the LK128 series.

The "Performance standards" section (Section 8) lists compliance with various electrical and medical device safety and performance standards (e.g., IEC 60601-1, ISO 10993). It mentions "acoustic output" and "cleaning, and disinfection effectiveness" tests, but these are general safety and performance aspects of an ultrasound machine, not a study to evaluate an AI's diagnostic accuracy.

Therefore, I cannot provide the requested information regarding acceptance criteria and an AI performance study from this document because it is not relevant to the scope of this 510(k) submission. The device described is a diagnostic ultrasound imaging system, not an AI/algorithm-based diagnostic aid that would involve the kind of performance study you're asking for (e.g., sensitivity, specificity, MRMC studies, ground truth establishment methodologies, and sample sizes for AI training/testing).

Summary

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September 11, 2024

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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

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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.

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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

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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)

rectal, Trans-vaginal, Urology, OB/Gyn, interventional guidance (free hand needle/ catheter) LU700L

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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)

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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

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3. Substantially Equivalent Devices

Primary Predicate DeviceDevice Name"Leltek" Ultrasound Imaging System	510(k) NumberK222365
Reference DeviceDevice NameAco Apache Ultrasound System	510(k) NumberK231509

4. Reason for Submission

Add new specific clinical applications: FAST/EFAST, Nerve ●
Add new transducer: LK128C, LK128L, LK128LH, LK128M, LK128PA, LK128E. ●

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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

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(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

LU710M

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.

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6. Device description

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

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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- Fetal- Abdominal- Pediatric- Small organ- Neonatal cephalic- Trans-rectal- Trans-vaginal- Musculoskeletal(conventional)- Musculoskeletal (superficial)- Urology- OB/Gyn- Cardiac adult- Cardiac pediatric- Peripheral vessel- Carotid- Pulmonary interventional guidance (includes free hand needle/ catheter)- FAST/EFAST,- Nerve,	- Ophthalmic- Fetal- Abdominal- Pediatric- Small organ- Neonatal cephalic- Trans-rectal- Trans-vaginal- Musculoskeletal(conventional)- Musculoskeletal (superficial)- Urology- OB/Gyn- Cardiac adult- Cardiac pediatric- Peripheral vessel- Carotid- Pulmonary interventional guidance (includes free hand needle/ catheter)	- Ocular- Fetal / Fetal Echo- Abdominal,- Pediatric,- Small Organ (including breast, scrotum, thyroid),- Musculo-skeletal (conventional- Musculo-skeletal (superficial)- Urology,- Obstetric/ Gynecological,- Cephalic (adult),- Peripheral Vessel,- Carotid,- Lung,- Needle Guidance- FAST/EFAST,- 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:128 series)	Ultrasound Imaging System (Model: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,B+PWD)	Combined mode (B+M, B+CF, B+PWD)	Combined mode (B+M, B+CD, B+PWD)
Connect	Wireless communication via IEEE802.11 a/b/g/n	Wireless communication via IEEE802.11 a/b/g/n	Wireless communication via IEEE802.11g/n	Same
TransducerTypes	Linear (LK128L, LK128LHLU700L, LU710L, LU710LH)Convex array (LK128C,LU700C, LU710C)MicroConvex array (LK128M, LU710MPhased array (LK128PA, LU710PA)Endocavity array (LK128E, LU710E)	Linear (LU700L,LU710L,LU710LH)Convex array (LU700C,LU710C)MicroConvex array (LU710M)Phased array (LU710PA)Endocavity array (LU710E)	Linear arrayConvex array	Moretransducersare added tothe 128series.
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 orOTC	iOS, Android mobile device orWindows	iOS, Android mobile device or Windows	iOS or Android mobile device	Same
510(k) Track	Track 3	Track 3	Track 3	Same
ComplianceStandards	- AAMI/ANSI ES60601-1 (2012)- IEC 60601-1-2 (2014)	- AAMI/ANSI ES60601-1 (2012)- IEC 60601-1-2 (2014)	- ANSI/AAMI ES60601-1:2005/(R)2012and A1:2012- 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- IEC60601-1-12 Edition 1.1 2020-07- IEC 60601-2-37 (2015)- AIUM/NEMA UD 2- 2004 R2009- AIUM/NEMA UD 3- 2004 R2009- IEC 62133-2:2017+ AMD1:2021 IEC 62366 (2014)- ISO 10993-1:2018- ISO 10993-5(2009)- ISO 10993-10:2021- ISO 10993-23(2021)- IEC 62304:2006+ AMD1:2015- ISO 15223-1 Fourth edition 2021-07- ISO 14971 (2019)- ISO 13485 (2016)	- IEC 60601-1-6 (2013)- IEC 60601-2-37 (2015)- AIUM/NEMA UD 2- 2004 R2009- AIUM/NEMA UD 3- 2004 R2009- IEC 62133 (2012)- IEC 62366 (2014)- ISO 10993-1:2018- ISO 10993-5(2009)- ISO 10993-10(2010)- IEC 62304 (2006)- ISO 15223-1 (2016)- ISO 14971 (2012)- ISO 13485 (2016)	- IEC 60601-1-6:2010+AMD1:2013+AMD2:2020- IEC 60601-2-37:2007+ AMD1:2015- AIUM/NEMA UD 2- 2004 R2009- ISO 10993-1:2018- ISO 62304- ISO 15223-1- 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.

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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.

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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 &A1:2012 C1:2009/(R)2012& A2:2010/(R)2012 (Cons.Text) [Incl. AMD2:2021]	Medical electrical equipment - Part 1:General requirements for basic safety andessential performance (IEC 60601-1:2005MOD) [Including Amendment 2 (2021)]
12/21/2020	19-36	ANSI AAMI IEC	60601-1-2:2014 [IncludingAMD 1:2021]	Medical electrical equipment - Part 1-2:General requirements for basic safety andessential performance - Collateral Standard:Electromagnetic disturbances - Requirementsand tests [Including Amendment 1 (2021)]
12/21/2020	5-132	IEC	60601-1-6 Edition 3.2 2020-07 CONSOLIDATEDVERSION	Medical electrical equipment - Part 1-6:General requirements for basic safety andessential performance - Collateral standard:Usability
12/21/2020	19-38	IEC	60601-1-11 Edition 2.12020-07 CONSOLIDATEDVERSION	Medical electrical equipment - Part 1-11:General requirements for basic safety andessential performance - Collateral Standard:Requirements for medical electricalequipment and medical electrical systemsused in the home healthcare environment
06/27/2016	12-293	IEC	60601-2-37 Edition 2.12015	Medical electrical equipment - Part 2-37:Particular requirements for the basic safetyand essential performance of ultrasonicmedical diagnostic and monitoringequipment
12/23/2019	19-33	IEC	62133-2 Edition1.0 2017-02	Secondary cells and batteries containingalkaline or other non-acid electrolytes -Safety requirements for portable sealedsecondary cells and for batteries made fromthem for use in portable applications - Part 2Lithium systems
01/14/2019	13-79	ANSI AAMI IEC	62304:2006/A1:2016	Medical device software - Software life cycleprocesses [Including Amendment 1 (2016)]
07/06/2020	5-129	ANSI AAMI IEC	62366-1:2015+AMD1:2020(Consolidated Text)	Medical devices Part 1: Application ofusability engineering to medical devicesincluding Amendment 1
01/14/2019	2-258	ISO	10993-1 Fifth edition 2018-08	Biological evaluation of medical devices -Part 1: Evaluation and testing within a riskmanagement process
12/23/2016	2-245	ISO	10993-5 Third edition2009-06-01	Biological evaluation of medical devices -Part 5: Tests for in vitro cytotoxicity
12/19/2022	2-296	ISO	10993-10 Fourth edition2021-11	Biological evaluation of medical devices -Part 10: Tests for skin sensitization
06/07/2021	2-291	ISO	10993-23 First edition2021-01	Biological evaluation of medical devices -Part 23: Tests for irritation
12/20/2021	5-134	ISO	15223-1 Fourth edition2021-07	Medical devices - Symbols to be used withinformation to be supplied by themanufacturer - Part 1: General requirements
12/23/2019	5-125	ISO	14971 Third Edition 2019-12	Medical devices - Application of riskmanagement to medical devices

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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

Regulation Number and Section

§ 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.