(105 days)
U-Lite is indicated for the visualization of structures and dynamic processes in the human body using ultrasound imaging and fluid flow analysis for diagnosis in the following clinical applications:
Abdominal
Small Parts
Vascular
Cardiac
Obstetrics
Gynecology
Fetal
Pediatrics
The U-Lite EXP are notebook-size, battery operated, general purpose track 3 diagnostic ultrasound system. It is used to acquire and display high-resolution, real-time ultrasound data and display the data as B Mode, Color Mode, Power Doppler Imaging, and Pulse Wave Doppler spectrum.
The handheld U-Lite EXP tablet's display is a high-resolution 7-inch color LED screen and the controls are intuitive and easy to use. Controls are touch-activated – there are no knobs or switches. The U-Lite EXP is equipped with a lithium-ion battery. When fully charged, the battery can give the system a total autonomy of up to 1h30 in the scanning mode.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Sonoscanner U-Lite EXP, structured to answer your questions:
Acceptance Criteria and Device Performance for Sonoscanner U-Lite EXP
The provided document, a 510(k) premarket notification, indicates that the Sonoscanner U-Lite EXP is an ultrasonic pulsed Doppler imaging system. For such medical devices, "acceptance criteria" are typically met through demonstrating substantial equivalence to a legally marketed predicate device, focusing on technological characteristics, intended use, and safety/performance standards. Performance data is primarily based on non-clinical testing and comparison to the predicate.
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) submission, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to the predicate device (U-Lite K143601) and compliance with relevant safety and performance standards. The table below summarizes the comparative performance and features, which serve as the basis for acceptance. The acceptance criterion is generally that the new device's performance is identical or equivalent to the predicate while adhering to safety standards.
| Acceptance Criteria (Implied by Predicate Comparison & Standards) | Reported Device Performance (U-Lite EXP) |
|---|---|
| Intended Use: Diagnostic ultrasound analysis and fluid flow analysis for specified clinical applications. | Identical to predicate. |
| Technological Characteristics: Similar operating principle, scanning modes (B, Color, Power Doppler, M, Pulse Wave Doppler). | Similar operating principle, Identical scanning modes to predicate. Offers advantage of exchangeable probes vs. fixed probes of predicate. |
| Physical Dimensions & Weight: (7.5 x 5.3 x 0.8 inches, 1.8 lbs) | Identical to predicate. |
| Battery Life: (1 hour 30 minutes) | Identical to predicate. |
| Display Size: (7 inches) | Identical to predicate. |
| Core Clinical Applications: Fetal, Abdominal, Pediatric, Small Organ, Trans-rectal, Trans-vaginal, Musculo-skeletal (Conventional & Superficial), Cardiac Adult, Cardiac Pediatric, Gynecological, Peripheral Vessel, Urology (including prostate). | Identical to predicate for these applications. |
| Added Clinical Applications (compared to predicate): Neonatal Cephalic. | Added Neonatal Cephalic indication. |
| Enhanced Features (compared to predicate): Mobile Cart, DICOM. | Added Mobile Cart and DICOM functionality. |
| Safety and Performance Standards Compliance: Acoustic output, biocompatibility, thermal, electrical, electromagnetic, and mechanical safety per listed EN/ISO/IEC standards. | Conforms to applicable medical device safety standards (EN ISO 13485, EN 60601 series, EN ISO 14971, EN 62304, EN 62366, EN ISO 10993 series). |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify a "test set" in the context of clinical images or patient data. The performance evaluation is based on non-clinical testing for compliance with harmonized standards. There is no mention of a dataset of patient images or specific patient studies used for testing the device's diagnostic performance. Therefore, also no information on country of origin or retrospective/prospective nature of such data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Since no clinical "test set" of patient data was used for evaluating diagnostic performance, there were no experts used to establish ground truth for such a set. The evaluation focuses on technical performance and safety compliance.
4. Adjudication Method for the Test Set
As no clinical "test set" was described, no adjudication method for a test set was mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical study was conducted." This type of study would typically be performed to assess the diagnostic accuracy or effectiveness of the device with human readers, potentially comparing performance with and without AI assistance if AI were a component of the diagnostic process.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone performance evaluation was not described in the document. The U-Lite EXP is a general-purpose diagnostic ultrasound system, not an AI-driven algorithm with standalone diagnostic capabilities. Its functionality is to acquire and display real-time ultrasound data for human interpretation.
7. The Type of Ground Truth Used
The ground truth used for this submission is based on regulatory standards and technical specifications for ultrasonic diagnostic equipment. Compliance with these standards (e.g., for acoustic output, electrical safety, biocompatibility) serves as the "ground truth" for the device's safety and fundamental performance characteristics. No clinical "ground truth" (e.g., pathology, expert consensus on images, outcomes data) for diagnostic accuracy was utilized as no clinical study was performed.
8. The Sample Size for the Training Set
Not applicable. The U-Lite EXP is a hardware-based ultrasonic imaging system. There is no mention of an algorithm or AI component that would require a "training set" of data in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no described training set for an AI/algorithm component.
In summary: The submission for the Sonoscanner U-Lite EXP primarily focuses on demonstrating substantial equivalence to a predicate device and compliance with established safety and performance standards through non-clinical testing. It explicitly states that "No clinical study was conducted." Therefore, information related to clinical test sets, training sets, ground truth based on medical diagnoses, or expert evaluations of diagnostic performance is not present in this document.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 3, 2017
Sonoscanner % E. J. Smith Consultant Smith Associates 1468 Harwell Avenue CROFTON MD 21114
Re: K171164
Trade/Device Name: U-Lite EXP Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: June 31, 2017 Received: August 1, 2017
Dear E. J. Smith:
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. 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 (reporting of medical device
{1}------------------------------------------------
related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Michael D. O'Hara For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K171164
Device Name U-Lite EXP
Indications for Use (Describe)
U-Lite is indicated for the visualization of structures and dynamic processes in the human body using and fluid flow analysis for diagnosis in the following clinical applications:
Abdominal Small Parts Vascular Cardiac Obstetrics Gynecology Fetal Pediatrics
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
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Probe: PR50: Convex probe for U-Lite EXP
Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
| ClinicalApplication | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | ColorDoppler | PowerDoppler | TissueHarmonicImaging | Combined*(B+ColorDoppler) | Other**(Specify) | |
| Ophthalmic | |||||||||
| Fetal | N | N | N | N | N | N | N | ||
| Abdominal | N | N | N | N | N | N | N | ||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | N | N | N | N | N | N | |||
| Small Organ(breast, testes, thyroid) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card) | |||||||||
| Musculo-skeletal(Conventional) | N | N | N | N | N | N | |||
| Musculo-skeletal(Superficial) | |||||||||
| Intravascular | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (Gynecological) | N | N | N | N | N | ||||
| Peripheral Vessel | |||||||||
| Urology(including prostate) | N | N | N | N | N | ||||
| Clinical Application | Mode of Operation | ||||||||
| B | M | PWD | CWD | ColorDoppler | PowerDoppler | TissueHarmonicImaging | Combined*(B+ColorDoppler) | Other**(Specify) | |
| Ophthalmic | |||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | N | N | N | N | N | N | N | ||
| Small Organ(breast, testes, thyroid) | N | N | N | N | N | N | N | ||
| Neonatal Cephalic | N | N | N | N | N | N | N | ||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card) | |||||||||
| Musculo-skeletal(Conventional) | N | N | N | N | N | N | N | ||
| Musculo-skeletal(Superficial) | N | N | N | N | N | N | N | ||
| Intravascular | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (Specify) | |||||||||
| Peripheral Vessel | N | N | N | N | N | N | N | ||
| Urology(including prostate) | |||||||||
| Clinical Application | Mode of Operation | ||||||||
| B | M | PWD | CWD | ColorDoppler | PowerDoppler | TissueHarmonicImaging | Combined*(B+ColorDoppler) | Other**(Specify) | |
| Ophthalmic | |||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | N | N | N | N | N | N | N | ||
| Small Organ(breast, testes, thyroid) | N | N | N | N | N | N | N | ||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card) | |||||||||
| Musculo-skeletal(Conventional) | N | N | N | N | N | N | N | ||
| Musculo-skeletal(Superficial) | N | N | N | N | N | N | N | ||
| Intravascular | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (Specify) | |||||||||
| Peripheral Vessel | N | N | N | N | N | N | N | ||
| Urology(including prostate) | |||||||||
| Clinical Application | Mode of Operation | ||||||||
| B | M | PWD | CWD | ColorDoppler | PowerDoppler | TissueHarmonicImaging | Combined*(Specify) | Other**(Specify) | |
| Ophthalmic | |||||||||
| Fetal | N | N | N | N | N | N | N | ||
| Abdominal | |||||||||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ(breast, testes, thyroid) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | N | N | N | N | N | N | |||
| Trans-vaginal | N | N | N | N | N | N | N | ||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card) | |||||||||
| Musculo-skeletal(Conventional) | |||||||||
| Musculo-skeletal(Superficial) | |||||||||
| Intravascular | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (Gynecological) | N | N | N | N | N | N | |||
| Peripheral Vessel | |||||||||
| Urology(including prostate) | N | N | N | N | N | N | |||
| Clinical Application | Mode of Operation | ||||||||
| B | M | PWD | CWD | ColorDoppler | PowerDoppler | TissueHarmonicImaging | Combined*(B+ColorDoppler) | Other**(Specify) | |
| Ophthalmic | |||||||||
| Fetal | N | N | N | N | N | N | N | ||
| Abdominal | N | N | N | N | N | N | |||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | N | N | N | N | N | N | |||
| Small Organ(breast, testes, thyroid) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card) | |||||||||
| Musculo-skeletal(Conventional) | N | N | N | N | N | N | |||
| Musculo-skeletal(Superficial) | |||||||||
| Intravascular | |||||||||
| Cardiac Adult | N | N | N | N | N | N | |||
| Cardiac Pediatric | N | N | N | N | N | N | |||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (Gynecological) | N | N | N | N | N | ||||
| Peripheral Vessel | |||||||||
| Urology(including prostate) | N | N | N | N | N | ||||
| Clinical Application | Mode of Operation | ||||||||
| B | M | PWD | CWD | ColorDoppler | PowerDoppler | TissueHarmonicImaging | Combined*(B+ColorDoppler) | Other**(Specify) | |
| Ophthalmic | |||||||||
| Fetal | N | N | N | N | N | N | N | N | |
| Abdominal | N | N | N | N | N | N | N | N | |
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | N | N | N | N | N | N | N | N | |
| Small Organ(breast, testes, thyroid) | N | N | N | N | N | N | N | N | |
| Neonatal Cephalic | N | N | N | N | N | N | N | N | |
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card) | |||||||||
| Musculo-skeletal(Conventional) | N | N | N | N | N | N | N | N | |
| Musculo-skeletal(Superficial) | N | N | N | N | N | N | N | N | |
| Intravascular | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (Specify) | |||||||||
| Peripheral Vessel | N | N | N | N | N | N | N | N | |
| Urology(including prostate) | N | N | N | N | N | N | N | N |
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Probe: PR51: Linear probe 40mm for U-Lite EXP
Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
{5}------------------------------------------------
Probe: PR52: Linear probe 50mm for U-Lite EXP
Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
{6}------------------------------------------------
Probe: PR53: Endocavitary probe for U-Lite EXP
Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
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Probe: PR54: Phased Array probe for U-Lite EXP
Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
{8}------------------------------------------------
Probe: PR55: MicroConvex probe for U-Lite EXP
Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
{9}------------------------------------------------
510(k) Summary
| Sponsor: | Sonoscanner |
|---|---|
| Address: | 6 rue Andre VoguetIvry Sur Seine, France 94200 |
| Telephone Number: | +33 954-971-557 |
| Email Address: | richard@sonoscanner.com |
| Contact Person: | Bruno RichardScientific Director, Quality Manager |
Summary Preparation Date: July 31, 2017
DEVICE NAME:
| Trade Name: | U-Lite EXP |
|---|---|
| Common/Usual Name: | Ultrasonic Pulsed Doppler Imaging System |
| Classification Name: | Ultrasonic Pulsed Doppler Imaging System |
| Regulation Number: | 21 CFR 892.1550, 21 CFR 892.1560 and 21 CFR 892.1570 |
| Product Code: | IYN, IYO and ITX |
| Device Class: | Class II |
| Panel: | Radiology |
DEVICE DESCRIPTION:
The U-Lite EXP are notebook-size, battery operated, general purpose track 3 diagnostic ultrasound system. It is used to acquire and display high-resolution, real-time ultrasound data and display the data as B Mode, Color Mode, Power Doppler Imaging, and Pulse Wave Doppler spectrum.
The handheld U-Lite EXP tablet's display is a high-resolution 7-inch color LED screen and the controls are intuitive and easy to use. Controls are touch-activated – there are no knobs or switches. The U-Lite EXP is equipped with a lithium-ion battery. When fully charged, the battery can give the system a total autonomy of up to 1h30 in the scanning mode.
{10}------------------------------------------------
INDICATIONS FOR USE:
U-Lite is indicated for the visualization of structures and dynamic processes in the human body using ultrasound imaging and fluid flow analysis for diagnosis in the following clinical applications:
Abdominal
Small Parts
Vascular
Cardiac
Obstetrics
Gynecology
Fetal
Pediatrics
PREDICATE PRODUCT COMPARISON:
Predicate Product Comparison Table
| DEVICE COMPARISON TABLE | |||
|---|---|---|---|
| Parameters | U-Lite K143601 | U-Lite EXP | Comment |
| Intended Use | Intended for diagnosticultrasound analysisand fluid flow analysis | Intended for diagnosticultrasound analysis andfluid flow analysis | Identical |
| Track | Track 3 | Track 3 | Identical |
| Dimensions | 7.5 x 5.3 x 0.8inches | 7.5 x 5.3 x 0.8inches | Identical |
| Weight | 1.8 lbs | 1.8 lbs | Identical |
| Configuration/Design | Notebook,handheld | Notebook,handheld | Identical |
| Battery Life | 1hr 30mins | 1hr 30mins | Identical |
| Display Size | 7in | 7in | Identical |
| Table Top Docking | Yes | Yes | Identical |
| Mobile Cart | No | Yes | Added |
| Scanning Modes | |||
| B Mode | Y | Y | Identical |
| Color Mode | Y | Y | Identical |
| Power Doppler | Y | Y | Identical |
| M Mode | Y | Y | Identical |
| Pulse Wave Doppler | Y | Y | Identical |
| Indications | |||
| Ophthalmic | N | N | Identical |
| Fetal | Y | Y | Identical |
| Abdominal | Y | Y | Identical |
| Intra-operative (Specify) | N | N | Identical |
| Intra-operative (Neuro) | N | N | Identical |
| Laparoscopic | N | N | Identical |
| Pediatric | Y | Y | Identical |
| Small Organ | Y | Y | Identical |
| Neonatal Cephalic | N | Y | No |
| Adult Cephalic | N | N | Identical |
| Trans-rectal | Y | Y | Identical |
| Trans-vaginal | Y | Y | Identical |
| Trans-urethral | N | N | Identical |
| Trans-esoph. (Non-Card.) | N | N | Identical |
| Musculo-skeletal(Conventional) | Y | Y | Identical |
| Musculo-skeletal(Superficial) | Y | Y | Identical |
| Intravascular | N | N | Identical |
| Cardiac Adult | Y | Y | Identical |
| Cardiac Pediatric | Y | Y | Identical |
| Intravascular (Cardiac) | N | N | Identical |
| Trans-esoph. (Cardiac) | N | N | Identical |
| Intra-cardiac | N | N | Identical |
| Gynecological | Y | Y | Identical |
| Peripheral Vessel | Y | Y | Identical |
| Urology (Including prostate) | Y | Y | Identical |
| Integrated Speaker | Y | Y | Identical |
| DICOM | N | Y | Identical |
{11}------------------------------------------------
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Summary of the Technological Characteristics of the Device Compared to the Predicate Device
The U-Lite EXP is comparable to the U-Lite (K143601) in technological characteristics and operating principle. The U-Lite EXP offers the advantage of exchangeable probes versus fixed probes of the predicate. Both devices transmit ultrasonic energy into patients, then perform post processing of received echoes to generate on-screen display of anatomic structures and fluid flow within the body, and have similar intended use and basic operating modes. Both systems allow for specialized measurements of structures and flow and calculations.
Performance Data:
The device has been evaluated for acoustic output, biocompatibility, as well as for thermal, electrical, electromagnetic and mechanical safety, and has been found to conform to applicable medical device safety standards. The U-Lite complies with the voluntary standards:
{13}------------------------------------------------
- . EN ISO 13485:2012, EN ISO 13485:2012/AC:2012 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)
- . EN 60601-1:2006 + A1:2013 Medical electrical equipment - Part 1: General requirements for safety (IEC 60601-1:2005, IEC 60601-1:2005/A1:2012)
- . EN 60601-1-1:2001 + A1:2006 Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems (IEC 60601-1-1:2000)
- . EN 60601-1-2:2007 + AC:2010 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests (IEC 60601-1-2:2007 (Modified))
- EN 60601-1-6:2010Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability (IEC 60601-1-6:2010)
- . EN 60601-2-37:2008 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment (IEC 60601-2-37:2007)
- . EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007)
- . EN 62304:2006 Medical device software - Software life-cycle processes (IEC 62304:2006)
- . EN 62366:2008 Medical devices - Application of usability engineering to medical devices (IEC 62366:2007)
- EN ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process(ISO 10993-1:2009)
- . EN ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)
- . EN ISO 10993-10: 2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10: 2010)
- EN ISO 10993-11:2009 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2006)
{14}------------------------------------------------
Clinical Study:
No clinical study was conducted.
Conclusion:
Based upon the testing and comparison to the predicate device, the Sonoscanner U-Lite EXP Diagnostic Ultrasound Device has similar intended use, identical technological characteristics and operating principle. The U-Lite EXP is substantially equivalent to the predicate U-Lite and does not raise any new safety and effectiveness issues.
§ 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.