(396 days)
Not Found
No
The description focuses on standard ultrasound technology and image processing, with no mention of AI or ML algorithms for analysis or interpretation.
No.
The device is described as a "non-invasion diagnostic ophthalmic ultrasound instrument" and is used for "measurements inside the ocular structures" and to "visualize other parts of the eye," indicating it is for diagnosis and not treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that "LIGHTSonic B | UBM is a non-invasion diagnostic ophthalmic ultrasound instrument". Additionally, the "Device Description" mentions that the B-Scan mode "produces a live, two-dimensional image to facilitate the identification and measurement of ocular pathologies".
No
The device description explicitly states that the system consists of a console, ultrasound probe(s) and transducer, and foot pedal, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The LIGHTSonic B | UBM is an ultrasound instrument that uses sound waves to create images and take measurements inside the eye. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's a "non-invasion diagnostic ophthalmic ultrasound instrument" for measurements and visualization within the ocular structures.
Therefore, this device falls under the category of a medical imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
LIGHTSonic B | UBM is a non-invasion diagnostic ophthalmic ultrasound instrument specifically designed for measurements inside the ocular structures including orbital, anterior and posterior segment of eye.
Product codes (comma separated list FDA assigned to the subject device)
IYO, ITX
Device Description
The LIGHTMED Ultrasound System is a portable ultrasound biometric ruler intended for use in ophthalmic applications. The system allows for the measurement of several key ocular features including axial length (AXL), anterior chamber depth. The device is used by coupling the probe / transducer to the eye either through direct contact or immersion methods. Available modes are biometric B-scan and UBM.
The B-Scan mode produces a live, two-dimensional image to facilitate the identification and measurement of ocular pathologies in the posterior-chamber of the eye, particularly when view of the chamber is obscured, such as is the case with cataracts.
The UBM mode can be used with a 35 MHz or a 50 MHz transducer. Because of the higher frequency of the transducer, it is expected that its greatest field of application will be in visualizing the anterior segment, because the focus area is about 11 mm from the transducer plane. The system will visualize other parts of the eye, but the resolution is not as high.
LIGHTMED Ultrasound System is a stand-alone system that runs on a Windows 10 platform and may be networked (by the user) for interface with electronic medical records systems, printing, and other purposes. The system consists of the LIGHTSonic B|UBM console, ultrasound probe(s) and transducer, and foot pedal.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
ocular structures including orbital, anterior and posterior segment of eye.
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 following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing:
The patient contact components for B-scan and UBM probes along with LIGHTMED Ultrasound System conducted cytotoxicity, sensitization, and irritation testing in accordance with FDA guidance- Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process." The patient contact materials for B-scan and UBM probes fall into surface device and the contact is mucosal membrane. Contact duration is A-limited. The results showed patient contact materials conform to ISO 10993-1, 10993-5 and ISO 10993-10.
Electrical safety and electromagnetic compatibility (EMC):
Electrical safety and EMC testing were conducted on LIGHTMED Ultrasound System. It complies with the following applicable federal and international safety and performance standards:
- AAMI / ANSI ES60601-1:2005/(R)2012 And A1:2012, C1:2009/(R)2012 And A2:2010/(R)2012 (Consolidated Text)
- IEC 60601-1-2:2007
- IEC 60601-1-6:2013
- IEC 60601-2-37:2007
- ISO 14971:2007
- IEC 62366:2014
Software verification and validation testing:
Software verification and validation testing were performed, and documents are established as recommended by FDA "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". The software for this device was considered as a Moderate Level of Concern, since failures or latent flaws in the software could directly result in non-serious injury to the patient, operator, and/or bystander.
Measurement accuracy:
LIGHTMED Ultrasound System has been validated and is safe and effective for the functions described in the indications for use.
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
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
April 13, 2018
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA acronym with the full name of the agency on the right. The Department of Health and Human Services logo is a stylized depiction of a human figure embracing a sphere. The FDA acronym is in a blue square, and the full name of the agency, "U.S. Food & Drug Administration," is in blue text to the right of the square.
Lightmed USA, Inc. % Ms. Angel Hsieh Regulatory Affairs Administrator 1130 Calle Cordillera SAN CLEMENTE CA 92673
Re: K170761
Trade/Device Name: LIGHTSonic B | UBM Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO, ITX Dated: March 1, 2018 Received: April 2, 2018
Dear Ms. Hsieh:
We have reviewed vour 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 of medical device-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.
1
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice
(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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)
Device Name
LIGHTSonic B | UBM
Indications for Use (Describe)
LIGHTSonic B | UBM is a non-invasion diagnostic ophthalmic ultrasound instrument specifically designed for measurements inside the ocular structures including orbital, anterior and posterior segment of eye.
| 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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3
Section 5 510(k) Summary
I. SUBMITTER
LIGHTMED USA, INC. 1130 Calle Cordillera, San Clemente, CA 92673, U.S.A. T: +1-949-218-9555 F: +1-949-218-9556 Contact Person: Katrina Hsu/Regulatory Affairs Administrator Date Prepared: June 30, 2017
II. DEVICE
Trade name: LIGHTMED Ultrasound System Model name: LIGHTSonic B | UBM Classification name: System, Imaging, Pulsed Echo, Ultrasonic Classification Panel: Radiology Regulation number: 892.1560, 892.1570 Product code: IYO, ITX
III. PREDICATE DEVICE
Substantial equivalence to the following predicate device is as follows:
IV. DEVICE DESCRIPTION
The LIGHTMED Ultrasound System is a portable ultrasound biometric ruler intended for use in ophthalmic applications. The system allows for the measurement of several key ocular features including axial length (AXL), anterior chamber depth. The device is used by coupling the probe / transducer to the eye either through direct contact or immersion methods. Available modes are biometric B-scan and UBM.
4
The B-Scan mode produces a live, two-dimensional image to facilitate the identification and measurement of ocular pathologies in the posterior-chamber of the eye, particularly when view of the chamber is obscured, such as is the case with cataracts.
The UBM mode can be used with a 35 MHz or a 50 MHz transducer. Because of the higher frequency of the transducer, it is expected that its greatest field of application will be in visualizing the anterior segment, because the focus area is about 11 mm from the transducer plane. The system will visualize other parts of the eye, but the resolution is not as high.
LIGHTMED Ultrasound System is a stand-alone system that runs on a Windows 10 platform and may be networked (by the user) for interface with electronic medical records systems, printing, and other purposes. The system consists of the LIGHTSonic B|UBM console, ultrasound probe(s) and transducer, and foot pedal.
V. INDICATIONS FOR USE
The LIGHTMED Ultrasound System is a non-invasion diagnostic ophthalmic ultrasound instrument specifically designed for measurements inside the ocular structures including orbital, anterior and posterior segment of eye.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
A summary listing of the LIGHTMED Ultrasound System design characteristics that are identical as the predicate is provided below:
| product name | LIGHTMED Ultrasound System | Vupad System |
|---|---|---|
| model name | LIGHTSonic B UBM | Vupad |
5
| manufacturer | LIGHTMED USA, INC. | Sonomed Inc. |
|---|---|---|
| 510(k) number | K170761 | K140199 |
| intended use | * make measurements inside | |
| the ocular structures including |
- orbital structure
- anterior segment of eye
- posterior segment of eye | *visualize the interior of the eye
*make measurement inside the
eye such as - axial length
- anterior chamber depth
- lens thickness |
| hard drive | 128 GB C-fast card | 128 GB SSD solid-state drive |
| operating
voltage | 100 - 240 VAC, 50/60 Hz
auto-switching medical-grade
power supply | 100 - 240 VAC, 50/60 Hz
auto-switching medical-grade
power supply |
| control
interface | Operator uses LCD
multi-touch control panel and
foot pedal switch to collect
exam data. | Operator uses LCD multi-touch
control panel and foot pedal
switch to collect exam data. |
| EMR
connectivity | DICOM | DICOM |
| general method
of operation | * Echoes converted to images
on a screen
- Measurement made by
time delays | * Echoes converted to
images on a screen - Measurement made by
time delays |
| digital system | Echoes converted into digital
pulses, all operation carried out
digitally. | Echoes converted into digital
pulses, all operation carried out
digitally. |
| probe design | * B-scan: sealed probes
with focused transducer - UBM: water path probe with
interchangeable focused
transducer | * B-scan: sealed probes
with focused transducer - UBM: water path probe with
interchangeable focused
transducer |
| pulse repetition
frequency | B-scan & UBM: 2560 Hz | B-scan & UBM: 2560 Hz |
| export image | PDF ; JPEG; AVI | PDF ; JPEG; AVI |
| printer | Any Windows-compatible
printer (separate) | Any Windows-compatible printer
(separate) |
6
A summary listing of the LIGHTMED Ultrasound System design characteristics
| product name | LIGHTMED Ultrasound System | Vupad System |
|---|---|---|
| model name | LIGHTSonic B UBM | Vupad |
| manufacturer | LIGHTMED USA, INC. | Sonomed Inc. |
| 510(k) number | K170761 | K140199 |
| unit | 12.75" w x 3" d x 8" h | |
| (32.3 x 7.6 x 20.3 cm) | 13.3" w x 8.0" d x 2" h | |
| device system | The LIGHTSonic B UBM is | Vupad is an innovative |
| an advanced | ultrasonic system, composed of | |
| microprocessor-controlled | the following sub-systems: | |
| ultrasonic system, composed of | * LCD touch screen | |
| the following sub-systems: | * sealed A-probe | |
| * LCD control panel | * B-probes |
differ from the predicate is provided below:
7
| | * B-scan probes
- UBM probes
- footswitch | * UBM probes
- foot pedal |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| operating
system | Microsoft Windows 10 | Microsoft Windows 8 |
| annotation | image annotation with six tools:
orientation, angle, distance,
pointer, area, text | automatic annotation of images
and video clips |
| scan controls | fully adjustable time gain
control (TGC) | fully adjustable time-varied gain
(TVG), baseline, log gain, and
exponential gain (e-gain) |
| compliance
standard | * US Federal Performance
Standards 21 CFR 892.1560 for
Class II Ultrasonic products
- AAMI/ANSI
ES60601-1:2005/(R)2012 And
A1:2012, C1:2009/(R)2012
And A2:2010/(R)2012 - IEC 60601-1-2: 2007
- IEC 60601-1-6:2013
- IEC 60601-2-37:2007
- ISO 14971:2007
- IEC 62366:2014 | * US Federal Performance
Standards 21 CFR 892.1560 and
1570 for Class II Ultrasonic
products - IEC 60601-1
- EN/IEC 60601-1-2 (2001)
- IEC 60601-2-37 |
VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
8
The patient contact components for B-scan and UBM probes along with LIGHTMED Ultrasound System conducted cytotoxicity, sensitization, and irritation testing in accordance with FDA guidance- Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process." The patient contact materials for B-scan and UBM probes fall into surface device and the contact is mucosal membrane. Contact duration is A-limited. The results showed patient contact materials conform to ISO 10993-1, 10993-5 and ISO 10993-10.
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on LIGHTMED Ultrasound System. It complies with the following applicable federal and international safety and performance standards.
-
- AAMI / ANSI ES60601-1:2005/(R)2012 And A1:2012, C1:2009/(R)2012 And A2:2010/(R)2012 (Consolidated Text)
-
- IEC 60601-1-2:2007
-
- IEC 60601-1-6:2013
-
- IEC 60601-2-37:2007
-
- ISO 14971:2007
-
- IEC 62366:2014
Software verification and validation testing
Software verification and validation testing were performed, and documents are established as recommended by FDA "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". The software for this device was considered as a Moderate Level of Concern, since failures or latent flaws in the software could directly result in non-serious injury to the patient, operator, and/or bystander.
9
Measurement accuracy
LIGHTMED Ultrasound System has been validated and is safe and effective for the functions described in the indications for use.
VIII. CONCLUSIONS
The LIGHTMED Ultrasound System is substantially equivalent to the predicate devices in technical characteristics, design features, operating principles, functional and performance characteristics, and for the intended uses in the stated medical specialties. The LIGHTMED Ultrasound System is designed to comply with applicable federal and international safety and performance standards. There are no new safety and effectiveness issues being raised.