Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes standard image processing and does not mention AI, ML, or related terms, nor does it describe training or test sets typically associated with AI/ML development.

Therapeutic

No.
The device is described as a "diagnostic ophthalmic ultrasound" and its intended use is for "ophthalmic imaging" to identify various conditions, not to treat them.

Diagnostic

Yes
The "Device Description" explicitly states, "The Eye Prime is a new, diagnostic ophthalmic ultrasound Track 1 device." Additionally, the "Intended User / Care Setting" section mentions "Diagnostic ophthalmic ultrasound."

SaMD (Software as a Medical Device)

No

The device description explicitly states that the system consists of a console supporting ultrasound probes and a laptop for image processing and user interface. This indicates the presence of hardware components beyond just software.

IVD (In Vitro Diagnostic)

Based on the provided information, the Eye Prime device is not an In Vitro Diagnostic (IVD).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
Eye Prime's Function: The Eye Prime is an ophthalmic ultrasound device. It uses ultrasound waves to create images of the eye and surrounding structures within the living body. It does not analyze specimens taken from the body.
Intended Use: The intended use describes imaging the eye for various conditions, which is a diagnostic process performed directly on the patient.

Therefore, the Eye Prime falls under the category of an in vivo diagnostic imaging device, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Eye Prime is intended for ophthalmic imaging when the following conditions are present or suspected:
·Cataracts
·Retinal Detachment (separation of the retina from the middle coat of the eyeball)
·Orbital Lesions
·Tumors
·Foreign Bodies
•Inflammation
· Vascular Irregularities

Diagnostic ultrasound imaging of the human body as follows:
Clinical Application: Ophthalmic, Mode of Operation: B

Ophthalmic Anterior Segment B-scan (UBM) probe: Imaging anterior segment of the eye. The probe may operate at a nominal frequency of 50 MHz or 35 MHz, depending on the transducer selected.
Clinical Application: Ophthalmic, Mode of Operation: B

Ophthalmic 12 MHz Posterior Segment B-scan transducer: Imaging posterior segment of the eye.
Clinical Application: Ophthalmic, Mode of Operation: B

Ophthalmic 18 MHz Posterior Segment B-scan transducer: Imaging posterior segment of the eye.
Clinical Application: Ophthalmic, Mode of Operation: B

Product codes (comma separated list FDA assigned to the subject device)

IYO, ITX

Device Description

The Eye Prime is a new, diagnostic ophthalmic ultrasound Track 1 device. Its function is to perform B-mode ultrasound scans. The system consists of 1) A console which supports 12 and 18MHz Posterior B scan probes and Anterior B- Scan. Ultrasound Bio-microscopy (UBM) probes with either 35 or 50MHz transducers. 2) A laptop which performs the image processing requirements of the system; provides the user interface for operating the device and viewing the resultant images. The laptop also provides data storage, export, archiving and networking for the device and includes the connection for footswitch.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Eye (ophthalmic, anterior segment of the eye, posterior segment of the eye)

Indicated Patient Age Range

Adult male and female

Intended User / Care Setting

Clinics/Hospitals by ophthalmologists, sonographers or trained echographers.

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)

Non-Clinical Tests:
Acoustic output, biocompatibility, as well as thermal, electrical, electromagnetic and mechanical safety were evaluated.
Measurement accuracy: Eye Prime System has been verified and has been found to be equivalent in measurement accuracy to Eyecubed Version 4.
Risk Analysis Method Used: Ellex Medical Pty Ltd applied ISO-14971 to the design and development of the Eye Prime system. The conclusion from the risk analysis was the device was safe for its intended use and does not pose any unacceptable risks.

Clinical Tests:
Since the Eye Prime device uses the same technology and principles as the predicate device, clinical data is not required.

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.

K103608

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

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

Indications for Use

510(k) Number (if known)

K190786

Device Name Eye Prime

Indications for Use (Describe)

The Eye Prime is intended for ophthalmic imaging when the following conditions are present or suspected:

·Cataracts

·Retinal Detachment (separation of the retina from the middle coat of the eyeball)
·Orbital Lesions

·Tumors

·Foreign Bodies

•Inflammation

· Vascular Irregularities

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)

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1

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM
Device Name	Eye Prime System
Probes : Posterior B-Scan Probe (12 MHz), Posterior B-Scan Probe (18 MHz), Anterior
B-Scan (UBM) Probe ( 35 or 50 MHz)
Intended Use	The Eye Prime is intended for ophthalmic imaging when the following conditions are
present or suspected:
•Cataracts
•Retinal Detachment (separation of the retina from the middle coat of the eyeball)
•Orbital Lesions
•Tumors
•Foreign Bodies
•Inflammation
•Vascular Irregularities

Intended Use: Diagnostic ultrasound imaging of the human body as follows:

Intended Use: Diagnostic ultrasound imaging of the human body as follows:
Mode of Operation
Clinical Application	A	B	M	PW Doppler	CW Doppler	Color Doppler	Power Doppler	Combined Modes
Ophthalmic		N
Fetal
Abdominal
Intraoperative
Intraoperative Neurological
Pediatric
Small Organ
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Transcranial
Peripheral Vascular
Laparoscopic
MSK Conventional
MSK Superficial
Vascular Access
Nerve Block
Other

2

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

Probe	Ophthalmic Anterior Segment B-scan (UBM) probe
Intended Use	Imaging anterior segment of the eye. The probe may operate at a nominal frequency of 50 MHz or 35 MHz, depending on the transducer selected.

	Mode of Operation
Clinical Application	A	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Power
Doppler	Combined
Modes
Ophthalmic		N
Fetal
Abdominal
Intraoperative
Intraoperative Neurological
Pediatric
Small Organ
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Transcranial
Peripheral Vascular
Laparoscopic
MSK Conventional
MSK Superficial
Vascular Access
Nerve Block
Other

Intended Use: Diagnostic ultrasound imaging of the human body as follows:

3

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

| Probe | Ophthalmic 12 MHz Posterior Segment B-scan
transducer |
|--------------|----------------------------------------------------------|
| Intended Use | Imaging posterior segment of the eye |

	Mode of Operation
Clinical Application	A	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Power
Doppler	Combined
Modes
Ophthalmic		N
Fetal
Abdominal
Intraoperative
Intraoperative Neurological
Pediatric
Small Organ
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Transcranial
Peripheral Vascular
Laparoscopic
MSK Conventional
MSK Superficial
Vascular Access
Nerve Block
Other

Intended Use: Diagnostic ultrasound imaging of the human body as follows:

4

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

Probe	Ophthalmic 18 MHz Posterior Segment B-scan
	transducer
Intended Use	Imaging posterior segment of the eye

Mode of Operation
Clinical Application	A	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Power
Doppler	Combined
Modes
Ophthalmic		N
Fetal
Abdominal
Intraoperative
Intraoperative Neurological
Pediatric
Small Organ
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Transcranial
Peripheral Vascular
Laparoscopic
MSK Conventional
MSK Superficial
Vascular Access
Nerve Block
Other

Intended Use: Diagnostic ultrasound imaging of the human body as follows:

5

Image /page/5/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Ellex Medical Pty Ltd. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, NW BUFFALO MN 55313

April 11, 2019

Re: K190786

Trade/Device Name: Eye Prime Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: Class II Product Code: IYO, ITX Dated: March 25, 2019 Received: March 27, 2019

Dear Mr. Job:

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/cfpmn/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

6

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 https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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,

For

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

Enclosure

7

510(k) Summary 21 CFR 807.92

K190786

I. Submitter

Ellex Medical Pty Ltd.

3-4 Second Avenue, Mawson Lakes,

South Australia 5095, AUSTRALIA

Contact Person: Andrew Pfeiffer

Telephone: 61 8 70748104

Email: apfeiffer@ellex.com

Date of preparation: 20/02/2019

II. Proposed Device

Trade Name: Eye Prime

Manufacturer: Ellex Medical Pty Ltd

Common or Usual Name: Diagnostic ophthalmic ultrasound system

Classification:

Name	21 CFR Number	Product Code
Ultrasonic Pulsed Echo Imaging
System	892.1560	90-IYO
Diagnostic Ultrasound Transducer	892.1570	90-ITX

III. Legally marketed Device /Predicate Device

Device name: Eye Cubed Version 4 Diagnostic Ultrasound

Premarket Notification: K103608

Manufacturer: Ellex Innovative Imaging

8

IV. Device Technological characteristics

The Eye Prime is a new, diagnostic ophthalmic ultrasound Track 1 device. Its function is to perform B-mode ultrasound scans. The system consists of 1) A console which supports 12 and 18MHz Posterior B scan probes and Anterior B- Scan. Ultrasound Bio-microscopy (UBM) probes with either 35 or 50MHz transducers. 2) A laptop which performs the image processing requirements of the system; provides the user interface for operating the device and viewing the resultant images. The laptop also provides data storage, export, archiving and networking for the device and includes the connection for footswitch.

V. Principle of Operation

In ophthalmic ultrasound imaging, a transducer emits a short acoustic pulse in response to a voltage transient generated by a pulser. Echoes are generated as the pulse propagates through eye tissue and encounters ophthalmic structures differing in acoustic impedance from their surroundings. When these echoes are received by the transducer they are converted back into voltages and amplified. The range of each echo is proportional to the time delay between pulse emission and echo return. Each pulse/echo provides information along a line of sight. By mechanically sweeping the transducer across an arc, information from a series of lines-of-sight is obtained. Converting the echo amplitude into pixel intensity allows a 2D cross-sectional B-Scan image to be displayed. This is the basis for B-Scan imaging.

VI. Indications for Use

Eye Prime is used for ophthalmic imaging when the following conditions are present or suspected:

. cataracts
retinal detachments (a separation of the retina from the middle coat of the eyeball) .
. orbital lesions
. tumours
foreign bodies
. inflammation
vascular irregularities. .

9

| Model (proposed device) (predicate device) |----------------------- | 510(K) number | Clinical application for use in Clinics/Hospitals by
ophthalmologists, sonographers or
trained echographers. for use in Clinics/Hospitals by
ophthalmologists, sonographers or
trained echographers. | Sterility | Patient population | Intended Use following conditions suspected:
•cataracts
•retinal detachments (a separation
of the retina from the middle coat
of the eyeball)
•orbital lesions
•tumours
•foreign bodies
•inflammation
•vascular irregularities. following conditions suspected:
•cataracts
•retinal detachments (a separation
of the retina from the middle coat
of the eyeball)
•orbital lesions
•tumours
•foreign bodies
•inflammation
•vascular irregularities. |
| Modes of Operation B-Mode (Posterior and Anterior) | Probe /Transducer type Annular Array (6 elements) | N/A Static Biometry A-Scan
Static Diagnostic A-Scan | Transducer Frequency Range
(MHz) | Image Acquisition Rate | Operating System | Internal Storage | Image processing unit and
User Interface external monitor is used to
process image data and as the user
interface | Electronic Medical Record
(EMR) connectivity Communications in Medicine) Communications in Medicine) | Model | Dimensions (inches) | Power requirements (console only) | Acoustic output power
MI | Eye Prime
| Eye Cubed Version 4
|
-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| N/A | K(103608) |
| Diagnostic ophthalmic ultrasound
| Diagnostic ophthalmic ultrasound
|
| Non Sterile | Non Sterile |
| Adult male and female | Adult male and female |
| Ophthalmic imaging when the
are present or
| Ophthalmic imaging when the
are present or
| B-Mode (Posterior and Anterior) | A-Mode (Biometry and Diagnostic)
|
| Mechanical Sector (1 element)
| Mechanical Sector (1 element) |
| N/A
| N/A
|
| 12-50 | 8-40 |
| 10 FPS | 12.5 - 50 FPS |
| Windows 10 | Windows XP |
| 512GB | 160 GB |
| Laptop | A desktop computer with an
|
| DICOM(Digital Imaging and
| DICOM(Digital Imaging and
|
| Eye Prime (proposed device) | Eye Cubed V4 |
| 3.4 x 6.9x8.9 | 6.5x15.3x16.9 |
| 100-240VAC, 50/60HZ, 50VA
| 100-240VAC, 50/60HZ,220VA |