Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes standard ultrasound technology and image processing without mentioning AI or ML algorithms for analysis, interpretation, or calculation.

Therapeutic

Question: Is this device a therapeutic device?

No.
The device is described as a "non-invasion diagnostic ophthalmic ultrasound instrument" specifically designed for "measurements inside the ocular structures" and "Diagnostic ultrasound imaging or fluid flow analysis." Its functions, such as A-scan, B-scan, and UBM modes, are used for imaging, measurement, and identification of ocular pathologies, not for treatment.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that the device is a "non-invasion diagnostic ophthalmic ultrasound instrument." Additionally, the "Device Description" details various modes (A-scan, B-scan, UBM) used for measurements and to produce images to "facilitate the identification and measurement of ocular pathologies," which are all diagnostic functions.

SaMD (Software as a Medical Device)

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.

IVD (In Vitro Diagnostic)

Based on the provided text, the LIGHTMED Ultrasound System is not an In Vitro Diagnostic (IVD) device.

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
Device Function: The LIGHTMED Ultrasound System is a non-invasive diagnostic ophthalmic ultrasound instrument. It uses ultrasound waves to create images and take measurements inside the ocular structures of the eye. It does not analyze samples taken from the body.
Intended Use: The intended use clearly states it's for measurements inside the ocular structures and diagnostic ultrasound imaging of the human body. This is an in-vivo (within the living body) diagnostic method, not in-vitro (in glass/outside the body).

Therefore, the LIGHTMED Ultrasound System falls under the category of an in-vivo diagnostic imaging device, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

LIGHTMED Ultrasound System is a non-invasion diagnostic ophthalmic ultrasound instrument specifically designed for measurements inside the ocular structures including orbital, anterior, posterior segment of eye and axial length for determination of IOL Power.

Product codes

IYO, ITX

Device Description

The LIGHTMED Ultrasound System (model name: LIGHTSonic Ultrasound) 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 A scan, biometric B-scan and UBM.

The A-scan mode of the system features a live A scan trace with storage for up to four scans. There are four (auto/manual) examination modes that use 9 different tissue velocities to calculate individual intraocular distances within the eye (AXL, ACD, Lens, and Vitreous). Other features include: post examination review of scans & measurement; four IOL formulas for lens power calculations; an immersion scanning capability for zero corneal compression of the eye while scanning and storage for up to five different user files.

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 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 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, 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 to support substantial equivalence determination.

Biocompatibility testing

The patient contact components for A-scan, B-scan and UBM probes along with LIGHTMED Ultrasound System were subjected to 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 A-scan and UBM probes are surface contact device with mucosal membrane. Contact duration is limited to less than 30 minutes. (which is shorten than 24 hours mentioned in ISO 10993 A-limited.) The Biocompatibility testing results showed patient contact materials of LIGHTMED Ultrasound System conform to ISO 10993-1, 10993-5, ISO 10993-10, and ISO 10993-11.

Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on LIGHTMED Ultrasound System, according to 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 60601-1-2:2014
- IEC 60601-1-6:2013
- IEC 60601-2-37:2007
- ISO 14971:2007
- IEC 62366:2014

The testing results demonstrate that LIGHTMED Ultrasound System comply with all the required standards.

Software verification and validation testing

The software for LIGHTMED Ultrasound System 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. Software verification and validation were performed, keep as recommended by FDA "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".

Measurement accuracy

LIGHTMED Ultrasound System has been validated and is safe and effective for the intended use described in the indications for use.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K170761

Reference Device(s)

K140199

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

0

July 1, 2019

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

Lightmed USA, Inc. % Hedy Chiang Regulatory Affairs Administrator 1130 Calle Cordillera SAN CLEMENTE CA 92673

Re: K183173

Trade/Device Name: LIGHTMED Ultrasound System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: Class II Product Code: IYO, ITX Dated: June 4, 2019 Received: June 5, 2019

Dear Hedy Chiang:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

1

https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

2

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K183173

Device Name LIGHTMED Ultrasound System

Indications for Use (Describe)

LIGHTMED Ultrasound System is a non-invasion diagnostic ophthalmic ultrasound instrument specifically designed for measurements inside the ocular structures including orbital, anterior, posterior segment of eye and axial length for determination of IOL Power.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (7/17)

Page 1 of 1
6-1

PSC Publishing Services (301) 443-6740 EF

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LIGHTMED Ultrasound System System:_______________________________________________________________________________________________________________________________________________________________________

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
General	Specific	B	M	PWD	CWD	Color	Combined	Other*
(Track 1 Only)	(Tracks 1 & 3)					Doppler	(Specify)	(Specify)
Ophthalmic	Ophthalmic	P						(A- mode)
								N
Fetal Imaging	Fetal
& Other	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-
	Card.)
	Musculo-skeletal
	(Conventional)
	Musculo-skeletal
	(Superficial)
	Intravascular
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral	Peripheral vessel
Vessel	Other (Specify)

N = new indication; P = previously cleared in K170761

$\frac{}{\text{Signature}}$

6-2

4

System:_______________________________________________________________________________________________________________________________________________________________________

Transducer:

Transducer:___________________________________________________________________________________________________________________________________________________________________

Probe

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
General
(Track 1
Only)	Specific
(Tracks 1 & 3)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other*
(Specify)
Ophthalmic	Ophthalmic					(A- mode)
N
Fetal
Imaging &
Other	Fetal
Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)

Peripheral
Vessel	Peripheral vessel
	Other (Specify)

6-3

5

N = new indication; P = previously cleared in K170761

System: _ ____________________________________________________________________________________________________________________________________________________________________ Transducer:_______12MHz, 20MHz B-scan Probe

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
General
(Track 1
Only)	Specific
(Tracks 1 & 3)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other*
(Specify)
Ophthalmic	Ophthalmic	P
Fetal
Imaging &
Other	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vessel
	Other (Specify)

$\frac{1}{6-4}$

6

N = new indication; P = previously cleared in K170761

System: LIGHTMED Ultrasound System

Transducer:_35MHz, 50MHz UBM Probe

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
	Specific	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other*
(Specify)
General
(Track 1
Only)	(Tracks 1 & 3)
Ophthalmic	Ophthalmic	P
Imaging &
Other	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
Cardiac	Intravascular
	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vessel
	Other (Specify)

N = new indication; P = previously cleared in K170761

5-6
6-5

7

Section 7 510(k) Summary

I. SUBMITTER

K183173

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: Hedy Chiang/Regulatory Affairs Coordinator Date Prepared: Oct 26, 2018

II. DEVICE

Trade name: LIGHTMED Ultrasound System Model name: LIGHTSonic Ultrasound 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:

| Primary Predicate Device | LIGHTMED USA, INC
LIGHTSonic B UBM | K170761 | Decision
Date:04/13/2018 |
|--------------------------|-----------------------------------------|---------|-----------------------------|
| Reference Device | Sonomed Inc. Vupad | K140199 | Decision
Date:04/01/2014 |

IV. DEVICE DESCRIPTION

The LIGHTMED Ultrasound System (model name: LIGHTSonic Ultrasound) 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 A scan, biometric B-scan and UBM.

8

The A-scan mode of the system features a live A scan trace with storage for up to four scans. There are four (auto/manual) examination modes that use 9 different tissue velocities to calculate individual intraocular distances within the eye (AXL, ACD, Lens, and Vitreous). Other features include: post examination review of scans & measurement; four IOL formulas for lens power calculations; an immersion scanning capability for zero corneal compression of the eye while scanning and storage for up to five different user files.

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 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 console, ultrasound probe(s) and transducer, and foot pedal.

V. INDICATIONS FOR USE

LIGHTMED Ultrasound System is a non-invasion diagnostic ophthalmic ultrasound instrument specifically designed for measurements inside the ocular structures including orbital, anterior, posterior segment of eye and axial length for determination of IOL Power.

9

System: _

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
General
(Track 1 Only)	Specific
(Tracks 1 & 3)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other*
(Specify)
Ophthalmic	Ophthalmic	P				(A- mode)
N
Fetal Imaging
& Other	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-
Card.)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vessel
	Other (Specify)

N = new indication; P = previously cleared in K170761

10

LIGHTMED Ultrasound System Transducer:_____10MHz A-scan Probe System:

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
General
(Track 1
Only)	Specific
(Tracks 1 & 3)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other*
(Specify)
Ophthalmic	Ophthalmic					(A- mode)
N
Fetal
Imaging &
Other	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vessel
	Other (Specify)

N = new indication; P = previously cleared in K170761

11

System:LIGHTMED Ultrasound System_________________________________________________________________________________________________________________________

Transducer:_____12MHz, 20MHz B-scan

Probe_____

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
General
(Track 1
Only)	Specific
(Tracks 1 & 3)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other*
(Specify)
Ophthalmic	Ophthalmic	P
Fetal
Imaging &
Other	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
	Cardiac	Cardiac Adult
		Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral
Vessel	Peripheral vessel
	Other (Specify)
Clinical Application		Mode of Operation
General
(Track 1
Only)	Specific
(Tracks 1 & 3)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other*
(Specify)
Ophthalmic	Ophthalmic	P
Fetal
Imaging &
Other	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
	Peripheral vessel
Peripheral
Vessel	Other (Specify)

N = new indication; P = previously cleared in K170761

12

LIGHTMED Ultrasound System Transducer: 35MHz, 50MHz UBM Probe System:

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

N = new indication; P = previously cleared in K170761

13

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

A summary of the LIGHTMED Ultrasound System design characteristics that are identical as the predicate is provided below:

| Product name | LIGHTMED Ultrasound
System | LIGHTMED Ultrasound
System | VuPad |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Model name | LIGHTSonic Ultrasound | LIGHTSonic B UBM | VuPad |
| Manufacturer | LIGHTMED USA, INC. | LIGHTMED USA, INC. | Sonomed Inc. |
| 510(k) number | | K170761 | K140199 |
| Intended use | * visualize the interior of
the eye

make measurement
inside the eye such as

axial length
anterior chamber depth
lens thickness | * 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 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 | 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. | Operator uses LCD
multi-touch control panel
and foot pedal switch to
collect exam data. |
| EMR | DICOM | 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 | * 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. | Echoes converted into
digital pulses, all
operation carried out
digitally. |
| Probe design | * A-scan: closed fixed
single-element with
internal fixation light
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 | * A-scan: closed fixed
single-element with
internal fixation light
B-scan: sealed probes
with focused
transducer
UBM: water path probe
with interchangeable
focused transducer |
| Pulse repetition
frequency | A-scan: 5880 Hz
B-scan & UBM: 2560
Hz | B-scan & UBM: 2560 Hz | A-scan: 5880 Hz
B-scan & UBM: 2560 Hz |
| Export image | PDF ; JPEG; AVI | PDF ; JPEG; AVI | PDF ; JPEG; AVI |
| Printer | Any Windows-
compatible
printer (separate) | Any Windows-compatible
printer (separate) | Any Windows-
compatible printer
(separate) |

14

A summary of the LIGHTMED Ultrasound System design characteristics differ from the predicate is provided below:

| Product name | LIGHTMED Ultrasound
System | LIGHTMED Ultrasound
System | VuPad |
|--------------|-------------------------------|-------------------------------|-------|
| Model name | LIGHTSonic Ultrasound | LIGHTSonic B UBM | VuPad |

15

Manufacturer	LIGHTMED USA, INC.	LIGHTMED USA, INC.	Sonomed Inc.
510(k) number	new	K170761	K140199
Unit	12.75" w x 3" d x 8" h
(32.3 x 7.6 x 20.3 cm)	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
Ultrasound is an advanced
microprocessor-controlled
ultrasonic system,
composed of the following
sub-systems:

LCD control panel
*A mode probe
B-scan probes
UBM probes
foot pedal switch | The LIGHTSonic
Ultrasound is an advanced
microprocessor-controlled
ultrasonic system,
composed of the following
sub-systems:
LCD control panel
B-scan probes
UBM probes
foot pedal switch | Vupad is an innovative
ultrasonic system,
composed of the following
sub-systems:
LCD touch screen
sealed A-probe
B-probes
UBM probes
foot pedal |
| Operating
system | Microsoft Windows 10 | Microsoft Windows 10 | Microsoft Windows 8 |
| Annotation | image annotation with six
tools: orientation, angle,
distance, pointer, area, text | 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 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 | * 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 | * 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 |
| | | | |
| A2:2010/(R)2012 | A2:2010/(R)2012 | | |
| - IEC 60601-1-2: 2014 | - IEC 60601-1-2: 2007 | | |
| - IEC 60601-1-6:2013 | - IEC 60601-1-6:2013 | | |
| - IEC 60601-2-37:2007 | - IEC 60601-2-37:2007 | | |
| - ISO 14971:2007 | - ISO 14971:2007 | | |
| - IEC 62366:2014 | - IEC 62366:2014 | | |

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VII. PERFORMANCE DATA

The following performance data were provided to support substantial equivalence determination.

Biocompatibility testing

The patient contact components for A-scan, B-scan and UBM probes along with LIGHTMED Ultrasound System were subjected to 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 A-scan and UBM probes are surface contact device with mucosal membrane. Contact duration is limited to less than 30 minutes. (which is shorten than 24 hours mentioned in ISO 10993 A-limited.) The Biocompatibility testing results showed patient contact materials of LIGHTMED Ultrasound System conform to ISO 10993-1, 10993-5, ISO 10993-10, and ISO 10993-11.

Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on LIGHTMED Ultrasound System, according to 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 60601-1-2:2014
- IEC 60601-1-6:2013
- IEC 60601-2-37:2007
- ISO 14971:2007
- IEC 62366:2014

The testing results demonstrate that LIGHTMED Ultrasound System comply with all the

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required standards.

Software verification and validation testing

The software for LIGHTMED Ultrasound System 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. Software verification and validation were performed, keep as recommended by FDA "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".

Measurement accuracy

LIGHTMED Ultrasound System has been validated and is safe and effective for the intended use described in the indications for use.

VII. 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.