(26 days)
Not Found
No
The summary describes a standard ultrasonic imaging and biometric measurement device and does not mention any AI or ML capabilities.
No
The device is described as being used for diagnostic imaging and biometric measurements, not for treating any conditions or diseases.
Yes
The "Intended Use / Indications for Use" section explicitly states that "The intended use of the Aviso is for diagnostic imaging of the eye by A and B scans and for biometric measurements of the eye." It also mentions "diagnostic imaging of the eye by B scans" in relation to specific transducers.
No
The device description explicitly states it is a "combined ophthalmic A and B scan system," which implies the inclusion of hardware components (transducers) for ultrasonic imaging and measurement. The performance studies also mention "FDA transducer emissions tests," further confirming the presence of hardware.
Based on the provided information, the Quantel Medical Aviso is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, in order to provide information for diagnostic, monitoring or compatibility purposes.
- Aviso's Function: The Aviso is an ultrasound system that performs imaging and biometric measurements directly on the patient's eye and orbit. It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states "diagnostic imaging of the eye by A and B scans and for biometric measurements of the eye," which are in-vivo procedures.
Therefore, the Aviso falls under the category of an in-vivo diagnostic imaging device, not an in-vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Quantel Medical Aviso is intended to be used for:
- Axial Length measurement of the eye by ultrasonic means
- Implanted IOL power calculation, using the Axial Length measurement.
- Visualization of the interior of the eye and the orbit by A and B scans.
The intended use of the Aviso is for diagnostic imaging of the eye by A and B scans and for biometric measurements of the eye.
The intended use of the Aviso 10 MHz B-scan transducer is for diagnostic imaging of the eye by B scans.
The Quantel Medical Aviso 8 Mhz A-scan transducer is intended to be used with the Quantel Aviso A-scans of the eye and for biometric measurements.
The intended use of the Aviso B-HF B-scan transducer is for diagnostic imaging of the eye by B scans and for biometric measurements of the eye.
Product codes (comma separated list FDA assigned to the subject device)
IYO, ITX
Device Description
The Aviso is a combined ophthalmic A and B scan system that can also be used for biometric measurements of the eye and for IOL calculations.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasonic
Anatomical Site
Eye, orbit
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)
Non-Clinical tests
- for Electrical Security . IEC 601-1
- IEC 601-1-2 for Electromagnetic Compatibility
- FDA transducer emissions tests
- Software validation tests
Clinical tests
Since the Aviso uses the same technology as existing devices, clinical tests are 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.
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
K05185/
Quantel Medical Inc. Special 510(k) Submission Aviso Ophthalmic A and B Scan Ultrasound System
510(k) Summary
June 28, 2005
(1) Submitter information Name : Quantel Medical S.A. Address: 21 rue Newton - Zone du BREZET Clermont-Ferrand 63039 France -Telephone: 33-473-745 745 Contact person: Dr. George MYERS (Official Correspondent). Medsys Inc. 377 Route 17 South Hasbrouck Heights, New Jersey 07064 Tel : 201-727-1703 Fax: 201-727-1708 June 23, 2005 Date prepared:
(2) Name of Device
| Trade Name: | "Aviso" Ophthalmic Ultrasound System |
|---|---|
| Common Name: | Ophthalmic A and B scan ultrasound system |
| Classification name: | System, Imaging, Ultrasonic, Ophthalmic, 980IYC |
(3) Legally-marketed predicate device
The predicate device is Quantel Cinescan S, K021683.
(4) Description
The Aviso is a combined ophthalmic A and B scan system that can also be used for biometric measurements of the eye and for IOL calculations.
(5) Intended Use
The Quantel Medical Aviso is intended to be used for:
1
- Axial Length measurement of the eye by ultrasonic means
- Implanted IOL power calculation, using the Axial Length measurement.
- Visualization of the interior of the eye and the orbit by A and B scans.
(6) Performance Data
(a) Non-Clinical tests
- for Electrical Security . IEC 601-1
- 트 IEC 601-1-2 for Electromagnetic Compatibility
- FDA transducer emissions tests ■
- 트 Software validation tests
(b) Clinical tests
Since the Aviso uses the same technology as existing devices, clinical tests are not required.
(7) Conclusion
The Aviso is equivalent in safety and efficacy to the legally-marketed predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized graphic of three wavy lines that resemble a human figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 3 - 2005
Quantel Medical S.A. % Mr. George H. Myers, Sc.D. Official Correspondent Medsys, Inc. 377 Route 17 South HASBROUCK HEIGHTS NJ 07604
Re: K051851
Trade Name: Aviso Ophthalmic Ultrasonic System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: IYO and ITX Dated: June 24, 2005 Received: July 21, 2005
Dear Mr. Myers:
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 Aviso Ophthalmic Ultrasonic System, as described in your premarket notification:
Transducer Model Number
B-Scan, 10 MHz "STD-A" A-Scan, 8 MHz B-Scan B-HF, 20 MHZ
3
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 (OS) 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 (301) 443-6597 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 Rodrigo C. Perez at (301) 594-1212.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
4
Page 1 1 of of 4
510(k) Number (if known):
Device Name: Aviso
Intended Use: The intended use of the Aviso is for diagnostic imaging of the eye by A and B scans and for biometric measurements of the eye.
CLINICAL A B M PWD CWD COLOR POWER COLOR COMBINED OTHER APPLICATION DOPPLER (AMPLITUDE) VELOCITY (SPECIFY) (SPECIFY) DOPPLER IMAGING Ophthalmic P P Fetal Abdominal Intra-operative (specify) Intra-operative Neurological Pediatric Small Organ (Specify) Neonatal Cephalic Adult Cephalic Cardiac Trans-esophageal Trans-rectal Trans-vaginal Trans-urethral Intra-lumina! Peripheral Vascular Laparoscopic Musculo-Skeletal Other (Specify)*
Mode of Operation
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 810.109)
Nancyc Gordon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K051851
5
Page _ 2 of __ 4_
510(k) Number (if known):
Device Name: Aviso B-scan Transducer , 10 MHz
Intended Use: The intended use of the Aviso 10 MHz B-scan transducer is for diagnostic imaging of the eye by B scans ..
| CLINICAL
APPLICATION | A | B | M | PWD | CWD | COLOR
DOPPLER | POWER
(AMPLITUDE)
DOPPLER | COLOR
VELOCITY
IMAGING | COMBINED
(SPECIFY) | OTHER
(SPECIFY) |
|---------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|--------------------|
| Ophthamic | | P | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-operative
(specify) | | | | | | | | | | |
| Intra-operative
Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ
(Specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | |
| Intra-luminal | | | | | | | | | | |
| Peripheral
Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-Skeletal | | | | | | | | | | |
| Other (Specify)* | | | | | | | | | | |
Mode of Operation
N= new indication; P= previously cleared by FDA; E= added under Appendix E
510(k) Number __
Additional Comments
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Per 21 CFR 810.109) Prescription Use 17
Nancy C. Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510
6
of of 4 Page 3
510(k) Number (if known):
Device Name: Quantel Medical S.A. "STD-A" A-scan 8 MHz transducer for "Aviso"
Intended Use: The Quantel Medical Aviso 8 Mhz A-scan transducer is intended to be used with the Quantel Aviso A-scans of the eye and for biometric measurements.
| CLINICAL
APPLICATION | A | B | M | PWD | CWD | COLOR
DOPPLER | POWER
(AMPLITUDE)
DOPPLER | COLOR
VELOCITY
IMAGING | COMBINED
(SPECIFY) | OTHER
(SPECIFY) |
|---------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|--------------------|
| Ophthalmic | P | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-operative
(specify) | | | | | | | | | | |
| Intra-operative
Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ
(Specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | |
| Intra-luminal | | | | | | | | | | |
| Peripheral
Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-Skeletal | | | | | | | | | | |
| Other (Specify)* | | | | | | | | | | |
Mode of Operation
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 810.109)
ano Radiological Devices 511-tkj Normber ______________________________________________________________________________________________________________________________________________________________
Nancy Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
7
Page 4
510(k) Number (if known):
Device Name: Aviso B-scan\transducer B-HF 20 MHz
Intended Use: The intended use of the Aviso B-HF B-scan transducer is for diagnostic imaging of the eye by B scans and for biometric measurements of the eye.
| CLINICAL APPLICATION | A | B | M | PWD | CWD | COLOR DOPPLER | POWER (AMPLITUDE) DOPPLER | COLOR VELOCITY IMAGING | COMBINED (SPECIFY) | OTHER (SPECIFY) |
|---|---|---|---|---|---|---|---|---|---|---|
| Ophthamic | P | |||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intra-operative | ||||||||||
| (specify) | ||||||||||
| Intra-operative | ||||||||||
| Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ | ||||||||||
| (Specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Trans-esophageal | ||||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Intra-luminal | ||||||||||
| Peripheral | ||||||||||
| Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-Skeletal | ||||||||||
| Other (Specify)* |
Mode of Operation
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
V
(Per 21 CFR 810.109)
Nancy Beaudon
(Division Sign-Off) Division of Reproductive. A and Radiological Devices 510(k) Number .