(87 days)
Not Found
Not Found
No
The provided 510(k) summary does not contain any mention of AI, ML, deep learning, or related concepts, nor does it describe features or performance metrics typically associated with AI/ML-driven devices.
No
The device is described as performing "Diagnostic ultrasound imaging or fluid flow analysis," indicating its purpose is to diagnose conditions rather than to treat them.
Yes
The "Intended Use / Indications for Use" section explicitly states "Diagnostic ultrasound imaging or fluid flow analysis of the human body".
No
The intended use describes diagnostic ultrasound imaging, which inherently requires hardware (an ultrasound transducer and processing unit) to acquire the images. The summary does not mention the device being software that processes images from a separate hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "Diagnostic ultrasound imaging or fluid flow analysis of the human body". This describes a device that interacts directly with the patient's body to acquire images or data, which is characteristic of an in vivo diagnostic device.
- Anatomical Site: The anatomical site is the "Eye", which is a part of the living human body.
- Input Imaging Modality: The input modality is "Ultrasound", which is a method used to image structures within the body.
IVD devices, on the other hand, are used to examine specimens derived from the human body (like blood, urine, tissue samples) in vitro (outside the body) to provide diagnostic information.
The information provided aligns with the description of an in vivo diagnostic ultrasound device for ophthalmology.
N/A
Intended Use / Indications for Use
Posterior 10MHz B-scan Imaging of the Eye
10MHz Biometric A-scan Imaging of the Eye
8MHz Diagnostic A-scan Imaging of the Eye
Anterior 20MHz B-scan Imaging of the Eye
Product codes
IYO, ITX
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasonic pulsed echo imaging system
Anatomical Site
Eye
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is positioned to the right of a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Tom Davis General Manager Ellex Innovative Imaging
JAN - 9 2009
Ellex Innovative Imaging
9940 Business Park Drive, Suite 165 SACRAMENTO CA 95827
-
Re: K083061
Trade/Device Name: 13 SYSTEM-ABD Ver.4.0 (Eye Cubed V4) Regulation Number: 21 CFR 892.1560 -
Regulation Name: Ultrasonic pulsed echo imaging system
Regulatory Class: II
Product Code: IYO and ITX Dated: December 4, 2008
Received: December 8, 2008
Dear Mr. Davis:
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 I SYSTEM-ABD Ver.4.0 (Eye Cubed V4), as described in your premarket notification:
Transducer Model Number
10MHz Posterior Segment B-scan 10MHz Biometric A-scan 8MHz Diagnostic A-scan 20MHz Anterior 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 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); 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 contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
If you have any questions regarding the content of this letter, please contact Andrew Kang, M.D. at (240) 276-3666.
Sincerely yours,
Hubert Leuen
Janine M. Morris
Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
2
Image /page/2/Picture/0 description: The image shows a logo for a company called "ellex". The logo consists of the word "ellex" in lowercase letters, with a rounded sans-serif font. The word is white and is set against a circular background. The background is textured with a pattern of small dots, giving it a slightly grainy appearance.
3.1.1. Attachment: Diagnostic Ultrasound Indications for Use Form
:
Fill out one form for each ultrasound system
| Transducer Name | Ophthalmic 10MHz Posterior Segment B-scan Transducer | |
|---|---|---|
| Intended Use | Posterior 10MHz B-scan Imaging of the Eye | |
| 510(K) Number | K083061 |
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) | " System-ABD Special 510(K) |
| Division of Reproductive, Abdominal and Radiological Devices | |
| 510(k) Number | K083061 |
3
Attachment: Diagnostic Ultrasound Indications for Use Form 3.1.2.
Fill out one form for each ultrasound system
| Transducer Name | Ophthalmic 10MHz Biometric A- scan Transducer |
|---|---|
| Intended Use | 10MHz Biometric A-scan Imaging of the Eye |
| 510(K) Number | K083061 |
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 Reproductive, Abdominal and
Radiological Devices: K083061
510(k) Number
2
4
Image /page/4/Picture/14 description: The image shows a logo for "ellex" inside of a circle. The text is in a sans-serif font and is white. The circle is filled with a black and white pattern. The logo is simple and modern.
3.1.3. Attachment: Diagnostic Ultrasound Indications for Use Form
Fill out one form for each ultrasound system
| Transducer Name | Ophthalmic 8MHz Diagnostic A- scan Transducer |
|---|---|
| Intended Use | 8MHz Diagnostic A-scan Imaging of the Eye |
| 510(K) Number | K083061 |
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 | 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:
(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)
Herbs Teemer
(Division Sigh-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K083061
് System-ABD Special 510(K)
5
3.1.4. Attachment: Diagnostic Ultrasound Indications for Use Form Fill out one form for each ultrasound system
| Transducer Name | Ophthalmic 20MHz Anterior Segment B-scan Transducer |
|---|---|
| Intended Use | Anterior 20MHz B-scan Imaging of the Eye |
| 510(K) Number | K083061 |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| 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:
ﻨــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ
(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 Reproductive, Abdominal and
Radiological Devices
510(k) Number K083061