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.

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.

AI/ML Overview

This document is a 510(k) summary for the LIGHTMED Ultrasound System (LIGHTSonic B | UBM). It focuses on establishing substantial equivalence to a predicate device and does not contain information about the performance criteria or a study proving the device meets acceptance criteria related to a specific clinical task or AI algorithm.

Therefore, I cannot provide the requested information, which typically pertains to the evaluation of an AI/ML-driven medical device. The document primarily details hardware specifications, software validation for general device function (not AI-specific), and safety/EMC standards compliance.

Based on the provided text, here's what I can determine regarding the device validation:

Acceptance Criteria and Reported Device Performance: This information is not present in the document. The document primarily focuses on establishing substantial equivalence to a predicate device based on technical characteristics, rather than reporting on specific performance metrics against defined acceptance criteria for a clinical task.
Sample size and data provenance for test set: Not applicable and not provided. The document does not describe a clinical performance study using a test set of patient data to evaluate a measurement or diagnostic outcome.
Number of experts used to establish ground truth and qualifications: Not applicable and not provided. There is no mention of a ground truth established by experts for a clinical evaluation.
Adjudication method: Not applicable and not provided.
Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable and not provided. The document does not describe a study involving human readers or AI assistance.
Standalone (algorithm-only) performance: Not applicable and not provided. The document describes an ultrasound system, not an AI algorithm evaluated in standalone mode.
Type of ground truth used: Not applicable and not provided.
Sample size for the training set: Not applicable and not provided. The document does not describe the development or training of an AI algorithm.
How the ground truth for the training set was established: Not applicable and not provided.

Summary of what the document does provide regarding validation:

The document focuses on the following types of performance data and compliance:

Biocompatibility testing: Conducted on patient contact components (B-scan and UBM probes) for cytotoxicity, sensitization, and irritation, in accordance with ISO 10993-1, 10993-5, and 10993-10 regulations. The contact duration is "A-limited."
Electrical safety and electromagnetic compatibility (EMC) testing: The device complies with AAMI / ANSI ES60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-37, ISO 14971, and IEC 62366.
Software verification and validation testing: Performed according to FDA guidance, with the device software considered a "Moderate Level of Concern."
Measurement accuracy: The document states that "LIGHTMED Ultrasound System has been validated and is safe and effective for the functions described in the indications for use," but no specific metrics or studies for measurement accuracy are provided in this section. This statement is a general conclusion rather than detailed performance data.

In conclusion, the provided text describes regulatory compliance and safety testing for a medical device (an ultrasound system), but it does not detail the acceptance criteria or a clinical study proving the device meets specific performance criteria related to a diagnostic or measurement outcome in the way an AI/ML device submission would.

Summary

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April 13, 2018

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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.

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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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K170761

Device Name

LIGHTSonic B | UBM

Indications for Use (Describe)

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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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

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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

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manufacturer	LIGHTMED USA, INC.	Sonomed Inc.
510(k) number	K170761	K140199
intended use	* make measurements insidethe ocular structures including- orbital structure- anterior segment of eye- posterior segment of eye	visualize the interior of the eyemake measurement inside theeye such as- axial length- anterior chamber depth- lens thickness
hard drive	128 GB C-fast card	128 GB SSD solid-state drive
operatingvoltage	100 - 240 VAC, 50/60 Hzauto-switching medical-gradepower supply	100 - 240 VAC, 50/60 Hzauto-switching medical-gradepower supply
controlinterface	Operator uses LCDmulti-touch control panel andfoot pedal switch to collectexam data.	Operator uses LCD multi-touchcontrol panel and foot pedalswitch to collect exam data.
EMRconnectivity	DICOM	DICOM
general methodof operation	* Echoes converted to imageson a screen* Measurement made bytime delays	* Echoes converted toimages on a screen* Measurement made bytime delays
digital system	Echoes converted into digitalpulses, all operation carried outdigitally.	Echoes converted into digitalpulses, all operation carried outdigitally.
probe design	* B-scan: sealed probeswith focused transducer* UBM: water path probe withinterchangeable focusedtransducer	* B-scan: sealed probeswith focused transducer* UBM: water path probe withinterchangeable focusedtransducer
pulse repetitionfrequency	B-scan & UBM: 2560 Hz	B-scan & UBM: 2560 Hz
export image	PDF ; JPEG; AVI	PDF ; JPEG; AVI
printer	Any Windows-compatibleprinter (separate)	Any Windows-compatible printer(separate)

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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:

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	* B-scan probes* UBM probes* footswitch	* UBM probes* foot pedal
operatingsystem	Microsoft Windows 10	Microsoft Windows 8
annotation	image annotation with six tools:orientation, angle, distance,pointer, area, text	automatic annotation of imagesand video clips
scan controls	fully adjustable time gaincontrol (TGC)	fully adjustable time-varied gain(TVG), baseline, log gain, andexponential gain (e-gain)
compliancestandard	* US Federal PerformanceStandards 21 CFR 892.1560 forClass II Ultrasonic products- AAMI/ANSIES60601-1:2005/(R)2012 AndA1:2012, C1:2009/(R)2012And 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 PerformanceStandards 21 CFR 892.1560 and1570 for Class II Ultrasonicproducts- 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

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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.

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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.

Regulation Number and Section

§ 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.