LIGHTMED Ultrasound System

K183173 · Lightmed USA, Inc. · IYO · Jul 1, 2019 · Radiology

Device Facts

• Record ID: K183173
• Device Name: LIGHTMED Ultrasound System
• Applicant: Lightmed USA, Inc.
• Product Code: IYO · Radiology
• Decision Date: Jul 1, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2

Intended 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.

Device Story

Portable ultrasound biometric ruler; used for ophthalmic applications. Inputs: ultrasonic echoes from ocular structures via A-scan, B-scan, or UBM probes. Operation: probe coupled to eye (direct contact or immersion); echoes converted to digital pulses; system calculates distances (AXL, ACD, lens, vitreous) using 9 tissue velocities; B-scan provides 2D images for pathology identification. Output: live traces, 2D images, and biometric measurements displayed on LCD; data exportable to PDF/JPEG/AVI. Used in clinical settings by eye care professionals. Benefits: facilitates ocular measurements and pathology visualization (e.g., cataracts) to support IOL power calculation and diagnostic decision-making.

Clinical Evidence

Bench testing only. Includes biocompatibility (ISO 10993-1, -5, -10, -11), electrical safety/EMC (AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-37), and software verification/validation. No clinical trial data presented.

Technological Characteristics

Portable ultrasound system; Windows 10 platform. Probes: A-scan (fixed single-element), B-scan (sealed, focused), UBM (water path, 35/50 MHz). Connectivity: DICOM, Windows-compatible printer. Power: 100-240 VAC medical-grade supply. Standards: AAMI/ANSI ES60601-1, IEC 60601-1-2:2014, IEC 60601-2-37:2007, ISO 14971:2007.

Indications for Use

Indicated for diagnostic ophthalmic ultrasound imaging and measurements of ocular structures, including orbital, anterior, and posterior segments, and axial length for IOL power determination.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• LIGHTMED USA, INC LIGHTSonic B UBM (K170761)

Reference Devices

• Sonomed Inc. Vupad (K140199)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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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.

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FORM FDA 3881 (7/17)

Page 1 of 1
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PSC Publishing Services [phone] 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}}\$

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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<br>(Track 1<br>Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | (A- mode)<br>N |
| Fetal<br>Imaging &<br>Other | Fetal<br>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<br>(Conventional) | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (Specify) | | | | | | | |

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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<br>(Track 1<br>Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) |
| Ophthalmic | Ophthalmic | P | | | | | | |
| Fetal<br>Imaging &<br>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<br>(Conventional) | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (Specify) | | | | | | | |

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

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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<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) |
| General<br>(Track 1<br>Only) | (Tracks 1 & 3) | | | | | | | |
| Ophthalmic | Ophthalmic | P | | | | | | |
| Imaging &<br>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<br>(Conventional) | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | |
| Cardiac | Intravascular | | | | | | | |
| | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (Specify) | | | | | | | |

N = new indication; P = previously cleared in K170761

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# Section 7 510(k) Summary

## I. SUBMITTER

K183173

LIGHTMED USA, INC. 1130 Calle Cordillera, San Clemente, CA 92673, U.S.A. T: [phone] F: [phone] 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<br>LIGHTSonic B UBM | K170761 | Decision<br>Date:04/13/2018 |
|--------------------------|-----------------------------------------|---------|-----------------------------|
| Reference Device | Sonomed Inc. Vupad | K140199 | Decision<br>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.

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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.

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System: _

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

| Clinical Application | | Mode of Operation | | | | | | | |
|---------------------------|------------------------------------|-------------------|---|-----|-----|------------------|-----------------------|---------------------|--|
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) | |
| Ophthalmic | Ophthalmic | P | | | | | | (A- mode)<br>N | |
| Fetal Imaging<br>& 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-<br>Card.) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (Specify) | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | | |
| | Other (Specify) | | | | | | | | |

N = new indication; P = previously cleared in K170761

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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<br>(Track 1<br>Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) | |
| Ophthalmic | Ophthalmic | | | | | | | (A- mode)<br>N | |
| Fetal<br>Imaging &<br>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<br>(Conventional) | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (Specify) | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | | |
| | Other (Specify) | | | | | | | | |

N = new indication; P = previously cleared in K170761

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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<br>(Track 1<br>Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) |
| Ophthalmic | Ophthalmic | P | | | | | | |
| Fetal<br>Imaging &<br>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<br>(Conventional) | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Cardiac | Cardiac Adult | | | | | | |
| | | Cardiac Pediatric | | | | | | |
| Intravascular (Cardiac) | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | |
| Intra-cardiac | | | | | | | | |
| Other (Specify) | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (Specify) | | | | | | | |
| Clinical Application | | Mode of Operation | | | | | | |
| General<br>(Track 1<br>Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) |
| Ophthalmic | Ophthalmic | P | | | | | | |
| Fetal<br>Imaging &<br>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<br>(Conventional) | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| | Peripheral vessel | | | | | | | |
| Peripheral<br>Vessel | Other (Specify) | | | | | | | |

N = new indication; P = previously cleared in K170761

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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

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# 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<br>System | LIGHTMED Ultrasound<br>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<br>the eye<br>* make measurement<br>inside the eye such as<br>- axial length<br>- anterior chamber depth<br>- lens thickness | * make measurements<br>inside the ocular structures<br>including<br>- orbital structure<br>- anterior segment of eye<br>- posterior segment of eye | * visualize the interior of<br>the eye<br>* make measurement<br>inside the eye such as<br>- axial length<br>- anterior chamber depth<br>- lens thickness |
| Hard drive | 128 GB C-fast card | 128 GB C-fast card | 128 GB SSD solid-state<br>drive |
| Operating<br>voltage | 100 - 240 VAC, 50/60<br>Hz auto-switching<br>medical-grade power<br>supply | 100 - 240 VAC, 50/60 Hz<br>auto-switching medical-<br>grade power supply | 100 - 240 VAC, 50/60<br>Hz auto-switching<br>medical-grade power<br>supply |
| Control<br>interface | Operator uses LCD<br>multi-touch control panel<br>and foot pedal switch to<br>collect exam data. | Operator uses LCD multi-<br>touch control panel and<br>foot pedal switch to collect<br>exam data. | Operator uses LCD<br>multi-touch control panel<br>and foot pedal switch to<br>collect exam data. |
| EMR | DICOM | DICOM | DICOM |
| General<br>method of<br>operation | * Echoes converted to<br>images on a screen<br>* Measurement made by<br>time delays | * Echoes converted to<br>images on a screen<br>* Measurement made by<br>time delays | * Echoes converted to<br>images on a screen<br>* Measurement made by<br>time delays |
| Digital system | Echoes converted into<br>digital pulses, all<br>operation carried out<br>digitally. | Echoes converted into<br>digital pulses, all operation<br>carried out digitally. | Echoes converted into<br>digital pulses, all<br>operation carried out<br>digitally. |
| Probe design | * A-scan: closed fixed<br>single-element with<br>internal fixation light<br>* B-scan: sealed probes<br>with focused<br>transducer<br>* UBM: water path<br>probe with<br>interchangeable<br>focused transducer | B-scan: sealed probes<br>with focused transducer<br>* UBM: water path probe<br>with interchangeable<br>focused transducer | * A-scan: closed fixed<br>single-element with<br>internal fixation light<br>* B-scan: sealed probes<br>with focused<br>transducer<br>* UBM: water path probe<br>with interchangeable<br>focused transducer |
| Pulse repetition<br>frequency | A-scan: 5880 Hz<br>B-scan & UBM: 2560<br>Hz | B-scan & UBM: 2560 Hz | A-scan: 5880 Hz<br>B-scan & UBM: 2560 Hz |
| Export image | PDF ; JPEG; AVI | PDF ; JPEG; AVI | PDF ; JPEG; AVI |
| Printer | Any Windows-<br>compatible<br>printer (separate) | Any Windows-compatible<br>printer (separate) | Any Windows-<br>compatible printer<br>(separate) |

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

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

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| 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<br>(32.3 x 7.6 x 20.3 cm) | 12.75" w x 3" d x 8" h<br>(32.3 x 7.6 x 20.3 cm) | 13.3" w x 8.0" d x 2" h |
| Device system | The LIGHTSonic<br>Ultrasound is an advanced<br>microprocessor-controlled<br>ultrasonic system,<br>composed of the following<br>sub-systems:<br>* LCD control panel<br>*A mode probe<br>* B-scan probes<br>* UBM probes<br>* foot pedal switch | The LIGHTSonic<br>Ultrasound is an advanced<br>microprocessor-controlled<br>ultrasonic system,<br>composed of the following<br>sub-systems:<br>* LCD control panel<br>* B-scan probes<br>* UBM probes<br>* foot pedal switch | Vupad is an innovative<br>ultrasonic system,<br>composed of the following<br>sub-systems:<br>* LCD touch screen<br>* sealed A-probe<br>* B-probes<br>* UBM probes<br>* foot pedal |
| Operating<br>system | Microsoft Windows 10 | Microsoft Windows 10 | Microsoft Windows 8 |
| Annotation | image annotation with six<br>tools: orientation, angle,<br>distance, pointer, area, text | image annotation with six<br>tools: orientation, angle,<br>distance, pointer, area, text | automatic annotation of<br>images and video clips |
| Scan controls | fully adjustable time gain<br>control (TGC) | fully adjustable time gain<br>control (TGC) | fully adjustable time-varied<br>gain (TVG), baseline, log<br>gain, and exponential gain<br>(e-gain) |
| Compliance<br>standard | * US Federal Performance<br>Standards 21 CFR<br>892.1560 for Class II<br>Ultrasonic products<br>- AAMI/ANSI ES60601-<br>1:2005/(R)2012 and<br>A1:2012,<br>C1:2009/(R)2012 and | * US Federal Performance<br>Standards 21 CFR<br>892.1560 for Class II<br>Ultrasonic products<br>- AAMI/ANSI ES60601-<br>1:2005/(R)2012 and<br>A1:2012,<br>C1:2009/(R)2012 and | * US Federal Performance<br>Standards 21 CFR<br>892.1560 and 1570 for<br>Class II Ultrasonic<br>products<br>- IEC 60601-1<br>- EN/IEC 60601-1-2 (2001)<br>- 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.