(105 days)
Not Found
No
The document describes standard ultrasound imaging modes and post-processing techniques, but there is no mention of AI, ML, or related terms.
No.
The device is described as a "diagnostic ultrasound system" and is indicated for "visualization of structures and dynamic processes... for diagnosis," not for treatment.
Yes
The device description explicitly states, "The U-Lite EXP are notebook-size, battery operated, general purpose track 3 diagnostic ultrasound system."
No
The device description explicitly states it is a "notebook-size, battery operated, general purpose track 3 diagnostic ultrasound system" with a physical display and controls, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for the "visualization of structures and dynamic processes in the human body using ultrasound imaging and fluid flow analysis for diagnosis". This describes an in vivo diagnostic process (examining the body directly), not an in vitro diagnostic process (examining samples outside the body).
- Device Description: The description details a general purpose diagnostic ultrasound system used to acquire and display real-time ultrasound data. This is consistent with an in vivo imaging device.
- Input Imaging Modality: The input modality is Ultrasound, which is an in vivo imaging technique.
- Anatomical Site: The listed anatomical sites are all locations within the human body that are examined directly using ultrasound.
IVD devices are used to examine specimens such as blood, urine, or tissue samples outside of the body to provide information for diagnosis. This device operates by sending and receiving ultrasound waves within the body.
N/A
Intended Use / 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
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound imaging
Anatomical Site
Human body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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:
- 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)
No clinical study was conducted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
2
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.
3
Probe: PR50: Convex probe for U-Lite EXP
Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
| Clinical
| Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | Color | |||||
| Doppler | Power | ||||||||
| Doppler | Tissue | ||||||||
| Harmonic | |||||||||
| Imaging | Combined* | ||||||||
| (B+Color | |||||||||
| Doppler) | 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 | Color | |||||
| Doppler | Power | ||||||||
| Doppler | Tissue | ||||||||
| Harmonic | |||||||||
| Imaging | Combined* | ||||||||
| (B+Color | |||||||||
| Doppler) | 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 | Color | |||||
| Doppler | Power | ||||||||
| Doppler | Tissue | ||||||||
| Harmonic | |||||||||
| Imaging | Combined* | ||||||||
| (B+Color | |||||||||
| Doppler) | 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 | Color | |||||
| Doppler | Power | ||||||||
| Doppler | Tissue | ||||||||
| Harmonic | |||||||||
| Imaging | 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 | Color | |||||
| Doppler | Power | ||||||||
| Doppler | Tissue | ||||||||
| Harmonic | |||||||||
| Imaging | Combined* | ||||||||
| (B+Color | |||||||||
| Doppler) | 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 | Color | |||||
| Doppler | Power | ||||||||
| Doppler | Tissue | ||||||||
| Harmonic | |||||||||
| Imaging | Combined* | ||||||||
| (B+Color | |||||||||
| Doppler) | 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 |
4
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:
7
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 Voguet |
| Ivry Sur Seine, France 94200 | |
| Telephone Number: | +33 954-971-557 |
| Email Address: | richard@sonoscanner.com |
| Contact Person: | Bruno Richard |
| Scientific 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 diagnostic | ||
| ultrasound analysis | |||
| and fluid flow analysis | Intended for diagnostic | ||
| ultrasound analysis and | |||
| fluid flow analysis | Identical | ||
| Track | Track 3 | Track 3 | Identical |
| Dimensions | 7.5 x 5.3 x 0.8 | ||
| inches | 7.5 x 5.3 x 0.8 | ||
| inches | 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
12
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.