(264 days)
The Leltek Ultrasound Imaging System (Model: LU700 Series) is a software-based imaging system and accessories intended for use by qualified physicians and healthcare professionals who has the ability to conduct ultrasound scan process for evaluation by ultrasound imaging system or fluid flow analysis of the human body.
The clinical environments where the system can be used include physician offices, clinics, hospitals, and clinical point-of-care for diagnosis of patients
The modes of operation include B mode, PWD mode, Color Doppler (CD) mode, Power Doppler mode, and the combined mode (B+M, B+CD, B+PWD). Specific clinical applications and exam types including: LU700C General abdominal imaging, musculoskeletal (conventional), musculoskeletal (superficial), peripheral vessel and OB/Gyn. LU700L General abdominal imagine, small organ (breast, thyroid), musculoskeletal (superficial) and peripheral vessel. LU710C Fetal, abdominal, pediatric, small organ (thyroid, prostate, scrotum, breast), musculoskeletal (conventional), urology, gynecology, cardiac adult, cardiac pediatric and peripheral vessel. LU710M Fetal, abdominal, pediatric, small organ (thyroid, prostate, scrotum, breast), musculoskeletal (conventional), urology, gynecology, cardiac adult, cardiac pediatric and peripheral vessel. LU710PA Fetal, abdominal, pediatric, cardiac adult, cardiac pediatric. LU710E Fetal, abdominal, small organ (thyroid, prostate, scrotum, breast), trans-vaginal, urology, gynecology.
The Leltek Ultrasound Imaging System (Model: LU700 Series) is a portable, software controlled, handheld ultrasound system used to acquire and display hi-resolution, real-time ultrasound data through a commercial off-the-shelf (COTS) mobile device.
- l. The imaging system software runs as an app on a mobile device.
- II. The imaging system software can be download to a commercial off-the-shelf (COTS) mobile device and utilizes an icon touch-based user interface.
- III. The imaging system consists of a series of wireless transducers employing Wi-Fi-based technology to communicate with traditional tablet/smartphone devices via direct Wi-Fi. This allows the user to export ultrasound images and display them across a range portable personal device.
- IV. The imaging system houses a built-in battery, multichannel beamformer, prescan converter and Wi-Fi components
The device is intended for use in environments where healthcare is provided by trained healthcare professionals, but not intended for use in emergency medical service, ambulance, or aircraft.
Here's an analysis of the provided text regarding the acceptance criteria and study proving device performance:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document (K210432) is a 510(k) summary for premarket notification of a medical device (Leltek Ultrasound Imaging System). It focuses on establishing substantial equivalence to predicate devices rather than defining and meeting specific analytical or clinical performance acceptance criteria in the traditional sense of a clinical trial.
Therefore, the "acceptance criteria" here are compliance with recognized safety and performance standards and demonstrating similar performance characteristics to the predicate devices. The "reported device performance" is the system's demonstrated compliance with these standards and its functional equivalence.
| Acceptance Criteria (Implied by Substantial Equivalence and Standards Compliance) | Reported Device Performance |
|---|---|
| Similar Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body. | Same as predicate and reference devices. The LU700 Series is a software-based imaging system and accessories intended for use by qualified physicians and healthcare professionals for evaluation by ultrasound imaging system or fluid flow analysis of the human body. (K210432, page 6, 9) |
| Functional Equivalence in Operating Modes: B Mode, M mode, PWD, Color Doppler, Power Doppler, and combined modes. | Same as predicate and reference devices. (K210432, page 6) |
| Wireless Communication: Communication via Wi-Fi. | Same as predicate. The device communicates wirelessly via Wi-Fi. (K210432, page 6) |
| Portability: Portable ultrasound system. | Same as predicate and reference devices. The Leltek Ultrasound Imaging System (Model: LU700 Series) is a portable, software-controlled, handheld ultrasound system. (K210432, page 5, 6) |
| Power Source: Rechargeable battery (Li-ion). | Same as predicate and reference devices. (K210432, page 6) |
| Display: iOS or Android mobile device. | Same as predicate and reference devices. The imaging system software runs as an app on a mobile device and utilizes an icon touch-based user interface, displaying images across a range of portable personal devices. (K210432, page 5, 6) |
| Compliance with Safety Standards: AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-37, IEC 62133, IEC 62304, IEC 62366-1, ISO 10993 (1, 5, 10), ISO 13485, ISO 14971, ISO 15223-1. | The device has been designed, manufactured, tested, and certified to comply with all listed international standards. Acoustic output, biocompatibility, cleaning and disinfection effectiveness, wireless, thermal, electromagnetic, and mechanical safety have been evaluated and found to conform. The maximum acoustic output level is under the FDA recommended limit. (K210432, page 9, 10) |
| Biosafety Equivalence: (Implied biological compatibility as per ISO 10993 series) | Biosafety equivalence is asserted, and the device conforms to applicable electromedical device safety standards. Biocompatibility testing has been conducted for the new transducers. (K210432, page 8, 10) |
| No Pragmatic Detriments: Differences from predicate devices (e.g., expanded Indications for Use, additional transducer types) do not negatively impact safety or effectiveness. | The differences specified have no pragmatic detriments. All safety and performance tests of the essential requirements are met. The new models (LU710C, LU710PA, LU710E) were tested and determined to be in full compliance with acoustic output, biocompatibility, cleaning, and disinfection effectiveness, and have no pragmatic detriments. (K210432, page 8, 10) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide details on specific sample sizes for a "test set" in the context of clinical performance or image-based evaluation.
Instead, the submission relies on:
- Compliance with recognized performance and safety standards: This implicitly means testing against defined criteria within those standards.
- Bench testing and engineering verification: "Acoustic output, biocompatibility, cleaning, and disinfection effectiveness as well as wireless, thermal, electromagnetic and mechanical safety" were evaluated by tests, but specific sample sizes for these tests are not mentioned.
- Substantial equivalence argument: The core of the 510(k) relies on demonstrating that the new device performs as safely and effectively as a legally marketed predicate device (K191235) and a reference device (K192107).
The data provenance is related to the testing performed to ensure compliance with the listed standards. This would typically be internal testing by the manufacturer (LELTEK, Inc. in Taiwan) as part of their design, manufacturing, and quality control processes. The document does not indicate the use of external or clinical data for the performance evaluation in the way a clinical trial would. It states, "The Leltek Ultrasound Imaging System did not require clinical testing to establish substantial equivalence." (K210432, page 10).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Since the document explicitly states that clinical testing was not required, there was no "test set" in the clinical sense that would require expert-established ground truth for diagnostic accuracy. The evaluation focused on engineering, safety, and performance characteristics against established standards.
4. Adjudication Method for the Test Set
Not applicable, as a clinical "test set" requiring adjudication for diagnostic accuracy as described in the prompt was not part of this 510(k) submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The document states, "The Leltek Ultrasound Imaging System did not require clinical testing to establish substantial equivalence." (K210432, page 10). The submission is based on demonstrating technical and safety equivalence to predicate devices, not on a clinical comparison of diagnostic efficacy with human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not directly applicable in the context of this device. The Leltek Ultrasound Imaging System is an ultrasound imaging device, not an AI algorithm intended for automated diagnosis or interpretation. The "software" aspect refers to the app running on a mobile device and controlling the ultrasound hardware, not a standalone diagnostic algorithm. Therefore, "standalone" performance for an algorithm is not a relevant concept for this type of device based on the provided information.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
Given that clinical testing for diagnostic performance was not required, there was no "ground truth" of the type typically used for evaluating diagnostic accuracy (e.g., pathology, surgical findings, long-term outcomes, expert consensus on images). The ground truth for this submission was based on:
- Engineering specifications and measurements: To ensure parameters like acoustic output, image quality (implied by functional equivalence), and electrical safety met defined standards.
- Biocompatibility testing results: Against ISO 10993 standards.
- Compliance with cleaning/disinfection protocols.
8. The Sample Size for the Training Set
Not applicable. This device is an ultrasound imaging system, and the submission does not describe it as an AI/ML-based diagnostic algorithm that would require a "training set" of data in the sense used for machine learning. The "software" is for image acquisition, processing, and display, not for learning to diagnose from a dataset.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no mention of a "training set" for an AI/ML algorithm in this 510(k) submission.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
LELTEK, Inc. % Jessie Wang Chief of Marketing 6F-3., No. 293, Sec. 1, Beixin Rd., Xindian Dist., New Taipei City, 23147 TAIWAN. R.O.C
November 3, 2021
Re: K210432
Trade/Device Name: Leltek Ultrasound Imaging System (Model: LU700 Series) Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: September 29, 2021 Received: Otober 4, 2021
Dear Jessie Wang:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name
Leltek Ultrasound Imaging System (Model: LU700 Series)
Indications for Use (Describe)
The Leltek Ultrasound Imaging System (Model: LU700 Series) is a software-based imaging system and accessories intended for use by qualified physicians and healthcare professionals who has the ability to conduct ultrasound scan process for evaluation by ultrasound imaging system or fluid flow analysis of the human body.
The clinical environments where the system can be used include physician offices, clinics, hospitals, and clinical point-ofcare for diagnosis of patients
The modes of operation include B mode, PWD mode, Color Doppler (CD) mode, Power Doppler mode, and the combined mode (B+M, B+CD, B+PWD). Specific clinical applications and exam types including: LU700C
General abdominal imaging, musculoskeletal (conventional), musculoskeletal (superficial), peripheral vessel and OB/Gyn. LU700L
General abdominal imagine, small organ (breast, thyroid), musculoskeletal (superficial) and peripheral vessel.
LU710C
Fetal, abdominal, pediatric, small organ (thyroid, prostate, scrotum, breast), musculoskeletal (conventional), urology, gynecology, cardiac adult, cardiac pediatric and peripheral vessel.
LU710M
Fetal, abdominal, pediatric, small organ (thyroid, prostate, scrotum, breast), musculoskeletal (conventional), urology, gynecology, cardiac adult, cardiac pediatric and peripheral vessel.
LU710PA
Fetal, abdominal, pediatric, cardiac adult, cardiac pediatric.
LU710E
Fetal, abdominal, small organ (thyroid, prostate, scrotum, breast), trans-vaginal, urology, gynecology.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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K210432
510(k) Summary
1. Submitter's Information
| Manufacturer: | LELTEK Inc. |
|---|---|
| Address: | 6F-3., No.293, Sec. 1, Beixin Rd., Xindian Dist.,New Taipei City 23147, Taiwan, R.O.C. |
| Tel: | +886-2-2913-7577 |
| Fax: | +886-2-2913-7599 |
| Website: | www.leltek.com |
| Contact: | Jessie wang / Chief of Marketing |
| E-mail: | jessie.wang@leltek.com |
| Name of Device: | Leltek Ultrasound Imaging System (Model: LU700 Series) |
2. Class and Predicate Information
| Device Name: | Leltek Ultrasound Imaging System | |
|---|---|---|
| Model: | LU700 series | |
| Common Name: | Diagnostic Ultrasound System and Accessories | |
| Classification: | Class II | |
| Classification Name: | ||
| 21 CRF Section | Classification Name | Product Code |
| 892.1550 | Ultrasonic Pulsed Doppler Imaging System | 90 IYN |
| 892.1560 | Ultrasonic Pulsed Echo Imaging System | 90 IYO |
3. Substantially Equivalent Devices
| Device Name | 510(k) Number |
|---|---|
| Leltek Ultrasound Imaging System | K191235 |
| Reference DeviceDevice Name | 510(k) Number |
| Clarius Ultrasound System | K192107 |
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4. Indications for Use
The Leltek Ultrasound Imaging System (Model: LU700 Series) is a software-based imaging system and accessories intended for use by qualified physicians and healthcare professionals who has the ability to conduct ultrasound scan process for evaluation by ultrasound imaging system or fluid flow analysis of the human body.
The clinical environments where the system can be used include physician offices, clinics, hospitals, and clinical point-of-care for diagnosis of patients
The modes of operation include B mode, M mode, Color Doppler (CD) mode, Power Doppler mode, and the combined mode (B+M, B+CD, B+PWD). Specific clinical applications and exam types including:
LU700C
General abdominal imaging, musculoskeletal (conventional), musculoskeletal (superficial), peripheral vessel and OB/Gyn.
LU700L
General abdominal imaging, small organ (breast, thyroid), musculoskeletal (conventional), musculoskeletal (superficial) and peripheral vessel.
LU710C
Fetal, abdominal, pediatric, small organ (thyroid, prostate, scrotum, breast), musculoskeletal (conventional), urology, gynecology, cardiac adult, cardiac pediatric and peripheral vessel.
LU710M
Fetal, abdominal, pediatric, small organ (thyroid, prostate, scrotum, breast), musculoskeletal (conventional), urology, gynecology, cardiac adult, cardiac pediatric and peripheral vessel.
LU710PA
Fetal, abdominal, pediatric, cardiac adult, cardiac pediatric.
LU710E
Fetal, abdominal, small organ (thyroid, prostate, scrotum, breast), trans-rectal, trans-vaginal, urology, gynecology.
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USFDA_510(k)
5. Device description
The Leltek Ultrasound Imaging System (Model: LU700 Series) is a portable, software controlled, handheld ultrasound system used to acquire and display hi-resolution, real-time ultrasound data through a commercial off-the-shelf (COTS) mobile device.
- l. The imaging system software runs as an app on a mobile device.
- II. The imaging system software can be download to a commercial off-the-shelf (COTS) mobile device and utilizes an icon touch-based user interface.
- III. The imaging system consists of a series of wireless transducers employing Wi-Fi-based technology to communicate with traditional tablet/smartphone devices via direct Wi-Fi. This allows the user to export ultrasound images and display them across a range portable personal device.
- IV. The imaging system houses a built-in battery, multichannel beamformer, prescan converter and Wi-Fi components
The device is intended for use in environments where healthcare is provided by trained healthcare professionals, but not intended for use in emergency medical service, ambulance, or aircraft.
System drawing:
Image /page/5/Picture/11 description: The image shows a diagram of a mobile device UI App communicating with a Leltek Ultrasound Imaging System via Wi-Fi. The mobile device is at the top of the image, and the ultrasound imaging system is at the bottom. The Wi-Fi communication is represented by a dashed line and a Wi-Fi symbol in the middle of the image. The text labels the different components of the diagram.
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6. Determination of Substantial Equivalence
| Item | Application device | Predicate device | Reference device | Comparison |
|---|---|---|---|---|
| Device name | Leltek Ultrasound Imaging System(Model: LU700 series) | Leltek Ultrasound Imaging System(Model: LU700) | Clarius Ultrasound Scanner | |
| 510(k) Number | Current Submission | K191235 | K192107 | |
| Intended Use | Diagnostic ultrasound imaging orfluid flow analysis of the humanbody | Diagnostic ultrasound imaging orfluid flow analysis of the humanbody | Diagnostic ultrasound imagingor fluid flow analysis of thehuman body | Same |
| Indications forUse | - Fetal- Abdominal- Pediatric- Small organ- Trans-rectal- Trans-vaginal- Musculoskeletal(conventional)- Musculoskeletal (superficial)- Urology- OB/Gyn- Cardiac adult- Cardiac pediatric- Peripheral vessel- Carotid | - Abdominal- Small organ- Musculoskeletal(conventional)- Musculoskeletal (superficial)- OB/Gyn- Peripheral vessel | - Ophthalmic- Fetal- Abdominal- Intraoperative (Ab/Vasc)- Pediatric- Small organ- Adult cephalic- Trans-rectal- Trans-vaginal- Musculo-skel. (Conv.)- Musculo-skel. (Superfic.)- Urology- Gynecology- Cardiac adult- Cardiac pediatric- Peripheral vessel- Carotid- Needle guidance | Different.LU700 series addmore itemsincluding invasivesubjects. |
| Mode ofOperations | B ModeM modePWDColor DopplerPower Doppler | B ModeM modePWDColor DopplerPower Doppler | B ModeM modePWDColor DopplerPower Doppler | Same. |
| Item | Application device | Predicate device | Reference device | Comparison |
| Device name | Leltek Ultrasound Imaging System(Model: LU700 series) | Leltek Ultrasound Imaging System(Model: LU700) | Clarius Ultrasound Scanner | |
| - Combined mode (B+M, B+CD, B+PWD) | - Combined mode (B+M, B+CD, B+PWD) | - Combined mode (B+M, B+CD, B+PD, B+PWD) | ||
| Connect | Communicates wirelessly via Wi-Fi | Communicates wirelessly via Wi-Fi | Communicates wirelessly viaWi-Fi and Bluetooth | Same |
| Transducer Types | Convex HD array (LU710C)MicroConvex array (LU710M)Phased array (LU710PA)Endocavity array (LU710E) | Linear array (LU700L)Convex array (LU700C) | Convex array Linear arrayPhased array Intracavity | More transducers areadded to the LU700series. |
| Portability | Portable ultrasound system | Portable ultrasound system | Portable ultrasound system | Same |
| Power Source | Rechargeable battery (Li-ion) | Rechargeable battery (Li-ion) | Rechargeable battery (Li-ion) | Same |
| Display | iOS or Android mobile device | iOS or Android mobile device | iOS or Android mobile device | Same |
| 510(k) Track | Track 3 | Track 3 | Track 3 | Same |
| ComplianceStandards | - AAMI/ANSI ES60601-1 (2012)- IEC 60601-1-2 (2014)- IEC 60601-1-6 (2013)- IEC 60601-2-37 (2008)- AIUM/NEMA UD 2- 2004R2009- AIUM/NEMA UD 3- 2004R2009- IEC 62133 (2012) | - AAMI/ANSI ES60601-1 (2012)- IEC 60601-1-2 (2014)- IEC 60601-1-6 (2013)- IEC 60601-2-37 (2008)- AIUM/NEMA UD 2- 2004R2009- AIUM/NEMA UD 3- 2004R2009- IEC 62133 (2012) | - AAMI/ANSI ES60601-1 (2012)- IEC 60601-1-2 (2014)- IEC 60601-1-6 (2013)- IEC 60601-1-12 (2014)- IEC 60601-2-37 (2015)- UD 2- 2004 (R2009)- IEC 62133 (2012) | Same.As compared to thepredicate, theLU700 seriescomply with thesafety and |
| Item | Application device | Predicate device | Reference device | Comparison |
| Device name | Leltek Ultrasound Imaging System(Model: LU700 series) | Leltek Ultrasound Imaging System(Model: LU700) | Clarius Ultrasound Scanner | - |
| - IEC 62366 (2014) | - IEC 62366 (2014) | - IEC 62366 (2014) | performance testswhich meets all the | |
| - ISO 10993-1(2009) | - ISO 10993-1(2009) | - ISO 10993-1 (2009) | essential | |
| - ISO 10993-5(2009) | - ISO 10993-5(2009) | - ISO 10993-5 (2009) | requirement for its | |
| - ISO 10993-10(2010) | - ISO 10993-10(2010) | - ISO 10993-10 (2010) | intended use. | |
| - | - | - ISO 10993-11 (2017) | ||
| - IEC 62304 (2006) | - IEC 62304 (2006) | - IEC 62304 (2006) | ||
| - ISO 15223-1 (2016) | - ISO 15223-1 (2016) | - ISO 15223-1 (2012) | ||
| - ISO 14971 (2012) | - ISO 14971 (2012) | - ISO 14971 (2007) | ||
| - ISO 13485 (2016) | - ISO 13485 (2016) | - |
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This device is a modification of an existing licensed device (K191235) using technologies that exist of the date of this submission. The Leltek Ultrasound Imaging System (Model: LU700 series) meets FDA requirements for Track 3 devices, have biosafety equivalence, and conform to applicable electromedical devices safety standards. The differences specified above have no pragmatic detriments. All the safety and performance tests of the essential requirements. Therefore, the system is substantially equivalent to predicate devices.
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7. Performance standards
The Leltek Ultrasound Imaging System has been designed, manufactured, tested, and certified to comply with the following internationally recognized standards:
| Reference No. | Year | Title |
|---|---|---|
| AAMI/ANSI/ES60601-1:2005/(R)2012 andA1:2012 andC1:2009/(R)2012 andA2:2010/(R)2012 | 2009 &2012 | Medical electrical equipment - Part 1: General requirements for basicsafety and essential performance |
| IEC 60601-1-2 | 2014 | Medical electrical equipment - Part 1-2: General requirements for basicsafety and essential performance - Collateral Standard: Electromagneticdisturbances - Requirements and tests |
| IEC 60601-1-6 | 2013 | Medical electrical equipment Part 1-6 General requirements for basicsafety and essential performance Collateral standard Usability |
| IEC 60601-2-37/AMD1 | 2008 &2015 | Medical electrical equipment - Part 2-37: Particular requirements for thebasic safety and essential performance of ultrasonic medical diagnosticand monitoring equipment |
| IEC 62133 | 2012 | Safety requirements for portable sealed secondary cells, and for batteriesmade from them, for use in portable applications |
| IEC 62304 | 2014 | Medical device software - Software life-cycle processes |
| EC 62366-1 | 2015 | Medical devices -- Part 1: Application of usability engineering to medicaldevices |
| ISO 10993-1 | 2009 | Biological evaluation of medical devices Part 1: Evaluation and testingwithin a risk management process |
| ISO 10993-5 | 2009 | Biological evaluation of medical devices Part 5: Tests for in vitrocytotoxicity |
| ISO 10993-10 | 2010 | Biological evaluation of medical devices Part 10: Tests for irritation andskin sensitization |
| ISO 13485 | 2016 | Medical devices - Quality management systems - Requirements forregulatory purposes |
| ISO 14971 | 2012 | Medical devices - Application of risk management to medical devices |
| ISO 15223-1 | 2016 | Medical devices -- Symbols to be used with medical device labels, labellingand information to be 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 adaptor (Apple Model A1385) to charge the medical device. Use of alternate compatible mobile hardware requires verification by the end user. Further information is provided in the user manual.
The Leltek Ultrasound Imaging System has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as wireless, thermal, electromagnetic and mechanical safety and has been found to conform with applicable medical device safety standards. The Leltek Ultrasound Imaging System did not require clinical testing to establish substantial equivalence.
8. General Safety and Effectiveness
This device is the addition of new transducer models to the Leltek Ultrasound Imaging System, using technologies existing on the market as of this submission. The Leltek Ultrasound Imaging System (Model: LU700 series) meets FDA requirements for Track 3 devices, have biosafety equivalence, and conform to applicable electromedical devices safety standards.
The new models comprise LU710C, LU710PA, LU710E, which are tested and determined to be in full compliance with acoustic output, biocompatibility, cleaning, and disinfection effectiveness, and have no pragmatic detriments. No additional clinical testing is required. The maximum acoustic output level is under the FDA recommended limit, and the power level is displayed all the safety and performance tests of the device meet the essential requirements. Therefore, the system is substantially equivalent to predicate devices.
9. Conclusion
Verification and validation testing have been conducted on the Leltek Ultrasound Imaging System and ascertain that it is safe for use by physicians. The 510(k) submission is the modification of the existing licensed device using technologies that exist on the market today and demonstrating the new transducers of the Leltek Ultrasound Imaging System are substantially equivalent in safety and effectiveness to the predicate device.
§ 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.