(15 days)
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
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.
The provided text describes the Eye Prime device, which is an ophthalmic ultrasound system. However, the document provided does not contain information about acceptance criteria, device performance metrics, sample sizes, expert adjudication, or clinical study results (MRMC or standalone) for the Eye Prime device itself.
The document primarily focuses on establishing "substantial equivalence" of the Eye Prime device to a predicate device (Eye Cubed Version 4) based on similar indications for use, technological characteristics, and safety testing. It explicitly states in Section IX: "Since the Eye Prime device uses the same technology and principles as the predicate device, clinical data is not required." This implies that no specific clinical study was conducted for the Eye Prime to prove its performance against acceptance criteria in the way a new, non-substantially equivalent device might.
Therefore, I cannot fulfill all parts of your request with the provided information. I can, however, extract details about the acceptance criteria assumed by demonstrating substantial equivalence, and other relevant information present in the document.
Here's a breakdown of what can and cannot be provided based on the input:
Acceptance Criteria and Device Performance
Since no specific performance metrics or acceptance criteria for the Eye Prime device itself are reported, we can infer that the acceptance criteria for this 510(k) submission were likely focused on demonstrating equivalence in safety and general performance characteristics to the predicate device, rather than specific diagnostic accuracy metrics.
Table of Performance (Based on "Substantial Equivalence" claim):
| Acceptance Criterion (Inferred from Substantial Equivalence) | Reported Device Performance (Eye Prime) |
|---|---|
| Safety: Device is as safe as the predicate device | Conformity to medical device safety standards (AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-1, NEMA UD2), biocompatibility. Acoustic output power below FDA limits (MI < 0.23, Ispta.3 < 17 mW/cm). |
| Effectiveness: Device is as effective as the predicate device | Principles of operation are the same (B-mode ultrasound scans, echo amplitude to pixel intensity). Equivalent in measurement accuracy to EyeCubed Version 4. |
| Indications for Use equivalence | Identical indications for use as the predicate device (Cataracts, Retinal Detachment, Orbital Lesions, Tumors, Foreign Bodies, Inflammation, Vascular Irregularities). |
| Technological Characteristics equivalence | Similar ultrasound frequencies (12-50 MHz vs 8-40 MHz for predicate), Windows OS, DICOM connectivity. |
| B-mode imaging capability | Retains B-mode (posterior and anterior) functionality. |
| Risk Profile equivalence | Risk analysis (ISO-14971) concluded the device was safe and posed no unacceptable risks. |
Study Details for Demonstrating Substantial Equivalence:
The "study" here is implicitly non-clinical testing and comparison to a predicate device rather than a traditional clinical trial proving diagnostic accuracy.
-
Sample sizes used for the test set and data provenance:
- Test Set (Non-clinical): Not applicable in the context of a clinical test set from patient data. The "test set" here refers to the extensive non-clinical and engineering tests performed (e.g., electrical safety, acoustic output, biocompatibility, software verification/validation).
- Data Provenance: Not specified for any patient data. The submission relies on adherence to standards and engineering tests. The information doesn't specify if any phantom or ex-vivo data was used for "measurement accuracy" validation, nor its origin.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not mentioned. No "ground truth" based on expert clinical assessment of images is established or used for performance evaluation in this 510(k) summary, as it explicitly states clinical data was not required. The "truth" in this context is adherence to engineering and safety standards.
-
Adjudication method for the test set:
- Not applicable/Not mentioned. There was no clinical test set requiring adjudication.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. The document explicitly states "Since the Eye Prime device uses the same technology and principles as the predicate device, clinical data is not required." This implies no MRMC study or any clinical study of human-in-the-loop performance was performed or submitted.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The Eye Prime is a diagnostic ultrasound system, not an AI algorithm. Its "performance" refers to its ability to generate images and measurements. The document claims "Measurement accuracy Eye Prime System has been verified and has been found to be equivalent in measurement accuracy to Eyecubed Version 4." This implies some form of standalone technical testing (e.g., using phantoms or calibrated measurements) was done to verify accuracy, but specific metrics, methods, or details are not provided beyond this statement.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical tests (e.g., electrical safety, acoustic output, biocompatibility), the "ground truth" is defined by the requirements of the relevant international and national safety and performance standards (e.g., IEC 60601 series, ISO 10993, NEMA UD2).
- For "measurement accuracy," the "ground truth" would likely be based on calibrated measurements using known physical standards or phantoms, rather than clinical ground truth (pathology, expert consensus). The details are not provided.
-
The sample size for the training set:
- Not applicable. The Eye Prime is a hardware ultrasound system with associated software for image processing and user interface. This is not an AI/ML device that requires a training set in that sense. Its design and verification are based on engineering principles and established medical device development processes.
-
How the ground truth for the training set was established:
- Not applicable, as there is no "training set" in the context of an AI/ML algorithm.
{0}------------------------------------------------
Indications for Use
510(k) Number (if known)
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)
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."
{1}------------------------------------------------
| DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM | |
|---|---|
| Device Name | Eye Prime SystemProbes : Posterior B-Scan Probe (12 MHz), Posterior B-Scan Probe (18 MHz), AnteriorB-Scan (UBM) Probe ( 35 or 50 MHz) |
| Intended Use | The Eye Prime is intended for ophthalmic imaging when the following conditions arepresent 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 | PWDoppler | CWDoppler | ColorDoppler | PowerDoppler | CombinedModes |
| 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-scantransducer |
|---|---|
| Intended Use | Imaging posterior segment of the eye |
| Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWDoppler | CWDoppler | ColorDoppler | PowerDoppler | CombinedModes |
| 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 | PWDoppler | CWDoppler | ColorDoppler | PowerDoppler | CombinedModes |
| 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
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 ImagingSystem | 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 | Eye Prime(proposed device) | Eye Cubed Version 4(predicate device) |
|---|---|---|
| 510(K) number | N/A | K(103608) |
| Clinical application | Diagnostic ophthalmic ultrasoundfor use in Clinics/Hospitals byophthalmologists, sonographers ortrained echographers. | Diagnostic ophthalmic ultrasoundfor use in Clinics/Hospitals byophthalmologists, sonographers ortrained echographers. |
| Sterility | Non Sterile | Non Sterile |
| Patient population | Adult male and female | Adult male and female |
| Intended Use | Ophthalmic imaging when thefollowing conditions are present orsuspected:•cataracts•retinal detachments (a separationof the retina from the middle coatof the eyeball)•orbital lesions•tumours•foreign bodies•inflammation•vascular irregularities. | Ophthalmic imaging when thefollowing conditions are present orsuspected:•cataracts•retinal detachments (a separationof the retina from the middle coatof the eyeball)•orbital lesions•tumours•foreign bodies•inflammation•vascular irregularities. |
| Modes of Operation | B-Mode (Posterior and Anterior) | A-Mode (Biometry and Diagnostic)B-Mode (Posterior and Anterior) |
| Probe /Transducer type | Mechanical Sector (1 element)Annular Array (6 elements) | Mechanical Sector (1 element) |
| N/AN/A | N/AStatic Biometry A-ScanStatic Diagnostic A-Scan | |
| Transducer Frequency Range(MHz) | 12-50 | 8-40 |
| Image Acquisition Rate | 10 FPS | 12.5 - 50 FPS |
| Operating System | Windows 10 | Windows XP |
| Internal Storage | 512GB | 160 GB |
| Image processing unit andUser Interface | Laptop | A desktop computer with anexternal monitor is used toprocess image data and as the userinterface |
| Electronic Medical Record(EMR) connectivity | DICOM(Digital Imaging andCommunications in Medicine) | DICOM(Digital Imaging andCommunications in Medicine) |
| Model | Eye Prime (proposed device) | Eye Cubed V4 |
| Dimensions (inches) | 3.4 x 6.9x8.9 | 6.5x15.3x16.9 |
| Power requirements | 100-240VAC, 50/60HZ, 50VA(console only) | 100-240VAC, 50/60HZ,220VA |
| Acoustic output powerMI < 0.23Ispta.3 < 17 mW/cm | Track 1 | Track 1 |
| Compliance standards | * US Federal Performance *Standards 21 CFR 892.1560 and21CFR 892.1570 for Class IIUltrasonic products-AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012,-IEC 60601-1-2:2014-IEC 60601 1-6:2010 + AMD1: 2013-IEC 60601-2-37:2007 +AMD1:2015-IEC 62366:2007+AMD1:2014-ISO 10993-1-NEMA UD2-2:2004 | * US Federal Performance *Standards 21 CFR 892.1560 and21CFR 892.1570 for Class IIUltrasonic products-IEC 60601-1-IEC 60601-1-2-IEC 60601-2-37-ISO 10993-1-NEMA UD2-2-2004 |
VII.Comparison of Intended use and Technological Characteristics with Predicate Device
{10}------------------------------------------------
Summary of Non-Clinical Tests VIII.
The device has been evaluated for acoustic output, biocompatibility, as well as thermal, electrical, electromagnetic and mechanical safety, and has been found to conform to the applicable medical device safety standards as below:
Safety and Product Specific testing: ●
- AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012, Medical Electrical Equipment Part . 1: General Requirements for Basic Safety and Essential Performance
- IEC 60601-1-2:2014, Medical Electrical Equipment Part 1-2: General Requirements for . Safety - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests
{11}------------------------------------------------
- IEC 60601 1-6:2010 + AMD1: 2013, Medical Electrical Equipment Part 1-6: General 트 Requirements for Safety - Collateral Standard: Usability
- . IEC 60601-2-37:2007 + AMD1:2015, Medical Electrical Equipment – Part 2-37: Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment
- IEC 62366:2007+AMD1:2014, Medical devices Application of usability engineering to I medical devices
- ISO 10993-5:2009, Biological Evaluation of Medical Devices Part 5: Tests For In Vitro . Cytotoxicity
- ISO 10993-10:2010, Biological evaluation of Medical Devices- -Part 10: Tests for irritation . and skin sensitization
- NEMA UD2-2:2004, Acoustic Output Measurement Standard for Diagnostic Ultrasound . Equipment
Biocompatibility Testing .
The Eye Prime has two patient-contacting elements: the Posterior B-Scan Probes, the single use ClearScan transducer cover / Scleral Shells for the Anterior UBM probe transducers. In all cases, the patient-contacting materials were found to be biocompatible.
Software Verification and Validation Testing .
Verification and Validation activities were designed and performed to demonstrate that the Eye Prime met pre-determined performance specifications.
. Measurement accuracy
Eye Prime System has been verified and has been found to be equivalent in measurement accuracy to Eyecubed Version 4.
{12}------------------------------------------------
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.
IX. Summary of Clinical Tests
Since the Eye Prime device uses the same technology and principles as the predicate device, clinical data is not required.
X. Substantial Equivalence Discussion
The Indications for Use for Eye Prime are exactly the same as predicate Eye Cubed Version 4 Diagnostic Ultrasound.
Technological characteristics of the Eye Prime are substantially equivalent with respect to the basic design and function of the predicate device. Both the subject and predicate device are based on the same ultrasound imaging and measurement principles. The major technological aspects they have in common are the following:
- · Ophthalmic B-mode scanning for imaging and measurement.
- · Ultrasound frequencies ranging from 8MHz to 50MHz.
- Windows PC or laptop for operator controls and display of measurements and images. Database for storage of measurements and images.
- The systems are manufactured with materials which have been evaluated and found to be safe for the intended use of the device.
- The systems have acoustic power levels which are below the applicable FDA limits.
- · The systems have been designed in compliance with approved electrical and physical safety standards.
{13}------------------------------------------------
There are differences in the probes in the proposed device and there is neither the Biometry A-Scan nor the Diagnostic A-scan available for Eye Prime. However the modifications do not raise concerns for safety and effectiveness of the device based on the device safety and performance testing.
XI. Conclusion
Based on the indications for use, technological characteristics, and safety and performance testing, the subject Eye Prime met the minimum requirements that are considered adequate for its intended use and is substantially equivalent in design, principles of operation and indications for use to the predicate device(s).
§ 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.