(18 days)
Not Found
No
The provided text describes a diagnostic ultrasound device for ophthalmic imaging and does not mention AI, ML, or related concepts.
No.
The provided text indicates that the device is for "ophthalmic imaging" and "diagnostic ultrasound imaging or fluid flow analysis," and it is used to identify various conditions. This describes a diagnostic device, not a therapeutic one.
Yes
The text explicitly states "Diagnostic ultrasound imaging" and lists specific transducers for "Diagnostic A-scan imaging of the eye," indicating its use for diagnosing medical conditions.
No
The device description is not provided, but the intended use clearly describes the use of various ophthalmic ultrasound transducers (hardware) for imaging. This indicates it is a hardware device with associated software, not a software-only device.
Based on the provided information, the Eye Cubed V4 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens, such as blood, urine, or tissue, that are taken from the human body. They are used to diagnose diseases or other conditions, including a state of health, in order to cure, mitigate, treat, or prevent disease.
- Eye Cubed V4 Function: The Eye Cubed V4 is described as a diagnostic ultrasound imaging device used for ophthalmic imaging. It directly images the human eye using ultrasound technology.
- Lack of Specimen Analysis: The description does not mention the analysis of any biological specimens taken from the patient. The device operates by sending and receiving ultrasound waves through the eye itself.
Therefore, the Eye Cubed V4 falls under the category of in vivo diagnostic imaging devices, not in vitro diagnostic devices.
N/A
Intended Use / Indications for Use
The Eye Cubed V4 is indicated for use in 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
- Tumors
- Foreign bodies
- Inflammation
- Vascular Irregularities
Transducer: Ophthalmic 40 MHz Anterior Segment B-scan transducer
Intended Use: Anterior 40 MHz B-scan imaging of the eye. Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Ophthalmic B-mode. Indicated use for - B-scan anterior segment imaging.
Transducer: Ophthalmic 10 MHz Posterior Segment B-scan transducer
Intended Use: Posterior 10 MHz B-scan imaging of the eye. Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Ophthalmic B-mode.
Transducer: Ophthalmic 10 MHz Biometric A-scan transducer
Intended Use: 10 MHz Biometric A-scan imaging of the eye. Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Ophthalmic A-mode. Indicated use for - Biometric A-scan.
Transducer: Ophthalmic 8 MHz Diagnostic A-scan transducer
Intended Use: 8 MHz Diagnostic A-scan imaging of the eye. Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Ophthalmic A-mode. Indicated use for - Diagnostic A-scan.
Transducer: Ophthalmic 20 MHz Anterior Segment B-scan transducer
Intended Use: Anterior 20 MHz B-scan imaging of the eye. Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Ophthalmic B-mode. Indicated use for - B-scan anterior segment imaging.
Product codes (comma separated list FDA assigned to the subject device)
IYO, ITX
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Ophthalmic / Eye / Human body
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)
Not Found
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.
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
§ 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the circumference. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Mr. Jonathan Strawn Business Manager Ellex Innovative Imaging 9940 Business Park Drive, Suite 165 SACRAMENTO CA 95827
DEC. 2 7 2010
Re: K103608
Trade/Device Name: · Eye Cubed Version 4 Diagnostic Ultrasound Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO and ITX Dated: December 7, 2010 Received: December 9, 2010
Dear Mr. Strawn:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
This determination of substantial equivalence applies to the following transducers intended for use with the Eye Cubed Version 4 Diagnostic Ultrasound, as described in your premarket notification:
Transducer Model Number
40 MHz Anterior Segment B-Scan 10 MHz Posterior Segment B-Scan 10 MHz Biometric A-Scan 8 MHz Diagnostic A-Scan 20 MHz Anterior Segment B-Scan
1
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
If you have any questions regarding the content of this letter, please contact Andrew Kang at (301) 796-6544.
Sincerely yours,
David G. Brown, Ph.D. Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure(s)
2
Indications for Use
510(k) Number (if known): K103508 Device Name: Eye Cubed Version 4 Diagnostic Ultrasound
DEC 2 7 2010
Indications for Use:
The Eye Cubed V4 is indicated for use in 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 11
- Tumors । ਸਿ
- Foreign bodies 11
- Inflammation î î
- Vascular Irregularities îî
Refer to the Attachments for the Diagnostic Ultrasound Indications for Use Forms
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
(Division Sign-Off)
Page 1 of __1
(Division S
リ
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K K103608
3
Image /page/3/Picture/0 description: The image shows a black circle with the word "ellex" written in white letters inside. The word is written in a lowercase sans-serif font. There is a small dot to the right of the word. The black circle has a slightly rough or textured appearance.
Fill out one form for each ultrasound system
| Transducer Name | Ophthalmic 40 MHz Anterior Segment B-scan transducer |
|---|---|
| Intended Use | Anterior 40 MHz B-scan imaging of the eye |
| 510(k) Number | K103508 |
2 7 2010
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Colour | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Colour | |||||||||
| Velocity | ||||||||||
| Imaging | Combine | |||||||||
| d | ||||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Ophthalmic | N | |||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative(specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other(specify) |
N= new indication; P=previously cleared by FDA; E=added under Appendix E
Additional Comments:
Indicated use for - B-scan anterior segment imaging
Prescription Use (Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K. K103608
13 System-ABD Special 510(k)
4
Image /page/4/Picture/0 description: The image shows a black circle with the word "ellex" written in white letters inside. The word is written in a lowercase, sans-serif font. The circle has a slightly rough or textured edge, and there are some small white spots or imperfections within the black area, giving it a slightly distressed appearance. The overall impression is of a logo or emblem.
Fill out one form for each ultrasound system
| Transducer Name | Ophthalmic 10 MHz Posterior Segment B-scan transducer |
|---|---|
| Intended Use | Posterior 10 MHz B-scan imaging of the eye |
| 510(k) Number | K083061 , K103508 |
DEC, 2 7 2010
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Colour | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Colour | |||||||||
| Velocity | ||||||||||
| Imaging | Combine | |||||||||
| d | ||||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Ophthalmic | P | |||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative(specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other(specify) |
N= new indication; P=previously cleared by FDA; E=added under Appendix E.
Additional Comments:
(PLEASE DO NOT WRITE BELOW THIS LINE—CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K. K103608
I³ System-ABD Special 510(k)
.
5
Image /page/5/Picture/0 description: The image shows a black circle with the word "ellex" written in white inside. The word is written in a sans-serif font, and there is a small dot after the "x". The circle is slightly distorted, and the edges are not perfectly smooth.
Fill out one form for each ultrasound system
| Transducer Name | Ophthalmic 10 MHz Biometric A-scan transducer |
|---|---|
| Intended Use | 10 MHz Biometric A-scan imaging of the eye |
| 510(k) Number | K083061, K103508 |
DEC 2 7 2010
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Colour | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Colour | |||||||||
| Velocity | ||||||||||
| Imaging | Combine | |||||||||
| ರ | ||||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Ophthalmic | P | |||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative(specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other(specify) | ||||||||||
| ( |
N= new indication; P=previously cleared by FDA; E=added under Appendix E
_Additional Comments:
Indicated use for - Biometric A-scan
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| Prescription Use (Per 21 CFR 801.109) |
| (Division Sign-Off) | |
|---|---|
| Division of Radiological Devices | |
| Office of In Vitro Diagnostic Device Evaluation and Safety | 1 System-ABD Special 510(k) |
| 510K | K103608 |
|---|---|
| ------ | --------- |
6
Image /page/6/Picture/0 description: The image shows a black circle with the word "ellex" written in white letters inside. The word is written in a sans-serif font, and the letters are lowercase. The black circle provides a contrasting background, making the word stand out. The logo appears simple and modern.
Fill out one form for each ultrasound system
| Transducer Name | Ophthalmic 8 MHz Diagnostic A-scan transducer |
|---|---|
| Intended Use | 8 MHz Diagnostic A-scan imaging of the eye |
| 510(k) Number | K083061, K103508 |
DEC 2 7 2010
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | в | M | PWD | CWD | Colour | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Colour | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Ophthalmic | P | |||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative(specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other(specify) |
N= new indication; P=previously cleared by FDA; E=added under Appendix E
Additional Comments:
Indicated use for - Diagnostic A-scan
(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED) of CDRA, Office of Device Evatuation (ODE) Concurrence Prescription Use (Per 21 CFR 801.109) (Division Sign-Off) on of Radiological Devices Divis tion and Safety Office of In Vitro 510K
13 System-ABD Special 510(k)
7
Image /page/7/Picture/0 description: The image shows a black circle with the word "ellex" written in white letters inside. The word is written in a sans-serif font, and the letters are all lowercase. The circle has a slightly rough or textured appearance, as if it were stamped or printed. The background is plain white.
Fill out one form for each ultrasound system
| Transducer Name | Ophthalmic 20 MHz Anterior Segment B-scan transducer |
|---|---|
| Intended Use | Anterior 20 MHz B-scan imaging of the eye |
| 510(k) Number | K083061, K103508 |
DEC 2 7 2010
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Colour | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Colour | |||||||||
| Velocity | ||||||||||
| Imaging | Combine | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Ophthalmic | P | |||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative(specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other(specify) |
N= new indication; P=previously cleared by FDA; E=added under Appendix E
Additional Comments:
. .......
Indicated use for – B-scan anterior segment imaging
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use (Per 21 CFR 801.109) | (Division Sign-Off) |
|---|---|
| Division of Radiological Devices | |
| Office of In Vitro Diagnostic Device Evaluation and Safety |
| 510K. | K103608 |
|---|---|
| 23 | |
| 3 System-ABD Special 510(k) |