(16 days)
OTI i-scan, K960622
Not Found
No
The summary does not mention AI, ML, or related terms, and the description focuses on standard ultrasound principles and measurements.
No
The device is described as a diagnostic system for visualizing the interior of the eye and making measurements. It does not mention any therapeutic function.
Yes
The "Intended Use / Indications for Use" states that the system is a "multi-purpose personal-computer-based ultrasonic diagnosis system for ophthalmic applications," which directly indicates its diagnostic purpose. It further elaborates on visualizing the interior of the eye and making measurements.
No
The device description explicitly states it is a "compact Ultrasonic ophthalmic A-scan system and B-scan system" and uses "pulsed ultrasound," indicating it includes hardware components for generating and receiving ultrasound signals.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "ophthalmic applications, intended to both visualize the interior of the eye by means of ultrasound and to make measurements inside the eye, including the measurement of axial length for determination of IOL power." This describes a diagnostic imaging and measurement device used directly on the patient's eye.
- Device Description: The description reinforces this by stating it "uses the principles of sonar (pulsed ultrasound) to measure the axial length of the eyes and to visualize the interior of the eye." This is a description of an in-vivo (within the living body) diagnostic tool.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices that are used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. This device does not operate on samples taken from the body.
Therefore, the OTI-scan ultrasound system is an in-vivo diagnostic device, not an in-vitro diagnostic device.
N/A
Intended Use / Indications for Use
The OTI-scan ultrasound system is a multi-purpose personal-computer-based ultrasonic diagnosis system for ophthalmic applications, intended to both visualize the interior of the eye by means of ultrasound and to make measurements inside the eye, including the measurement of axial length for determination of IOL power.
Product codes
90 IYO, ITX
Device Description
The OTI-scan is a compact Ultrasonic ophthalmic A-scan system and B-scan system that uses the principles of sonar (pulsed ultrasound) to measure the axial length of the eyes and to visualize the interior of the eye.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Ophthalmic (eye)
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
(a) Non-clinical tests
The A-B scan has had accuracy tests, ultrasonic emissions tests, electrical safety tests, and software validation tests.
(b) Clinical tests
Not required.
(c) Conclusions
The A-B scan is equivalent in safety and efficacy to the legally-marketed predicate device.
Key Metrics
Not Found
Predicate Device(s)
OTI i-scan, K960622
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
Page A 2
Ophthalmic Technologies Inc. Special 510(k) Submission OTI-scan Ophthalmic Ultrasonic System A-B scab
510(k) Summary February 26, 2003
(1) Submitter Information
Name: Ophthalmic Technologies Inc.
Address:
Ophthalmic Technologies Inc. 37 Kodiak Crescent, Unit 16 Downsview, Ontario, Canada M3J 3E5
Telephone number:
416-631-9123 • 1-800-517-4444
Contact Person: Dr. George Myers (Official Correspondent) Medsys Inc. 377 Route 17 S Hasbrouck Heights, NJ 07604 Telephone 201-727-1703 Fax 201-727-1708
Date Prepared: December 10, 2002
(2) Name of Device
Trade Name: OTI-scan Common Name: Ophthalmic A-scan and B-scan Classification name: System, Imaging, Ultrasonic, Ophthalmic, 9801YO Diagnostic Ultrasound Transducer, 90-ITX
(3) Equivalent legally-marketed devices.
OTI i-scan, K960622
(4) Description
MAR 2 7 2003
1
The OTI-scan is a compact Ultrasonic ophthalmic A-scan system and B-scan system that uses the principles of sonar (pulsed ultrasound) to measure the axial length of the eyes and to visualize the interior of the eye.
(5) Intended Use
The ()T-scan ultrasound system is a multi-purpose personal-computer-based ultrasonic diagnosis system for ophthalmic applications, intended to both visualize the interior of the eye by means of ultrasound and to make measurements inside the eve. including the measurement of axial length for determination of IOL power.
(6) Performance Data
(a) Non-clinical tests
The A-B scan has had accuracy tests, ultrasonic emissions tests, electrical safety tests, and software validation tests.
(b) Clinical tests
Not required.
(c) Conclusions
The A-B scan is equivalent in safety and efficacy to the legally-marketed predicate device.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 7 2003
Ophthalmic Technologies. Inc. % George H. Myers, Sc.D. Official Correspondent Medsys, Inc. 377 Route 17 South HASBROUCK HEIGHTS NJ 07604
Re: K030770
Trade Name: OTI-scan Ophthalmic Ultrasound System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging sytem Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: Class II Product Code: 90 IYO and ITX Dated: February 26, 2003 Received: March 11, 2003
Dear Dr. 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 OTI-scan Ophthalmic Ultrasound System, as described in your premarket notification:
Transducer Model Number
13 MHz (Biometric A-scan) 12 MHz (B-scan)
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 (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 (301) 594-4591. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.
Sincerely yours,
Daniel A. Lyman
fr
Nancy C. Brogdor Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
4
Diagnostic Ultrasound Indications for Use Form
of of of _____________________________________________________________________________________________________________________________________________________________________ Page 1
510(k) Number (if known): K030770
Device Name: OTI-scan
Intended Use:
The OTI-scan ultrasound system is a multi-purpose personal-computer-based ultrasonic diagnosis system for ophthalmic applications, intended to both visualize the interior of the eye by means of ultrasound and to mak measurements inside the eye, including the measurement of axial length for determination of IOL power. Mode of Operation
| CLINICAL
APPLICATION | A | B | M | PWD | CWD | COLOR
DOPPLER | POWER
(AMPLITUDE)
DOPPLER | COLOR
VELOCITY
IMAGING | COMBINED
(SPECIFY) | OTHER
(SPECIFY) |
|---------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|--------------------|
| Ophthalmic | P | P | | | | | | | | P (3D) |
| 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) | | | | | | | | | | |
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 | OR | Over-the-Counter Use | ||
|---|---|---|---|---|
| (Per 21 CFR 810.109) | (Optional Format 1-2-96) |
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
| 510(k) Number | 2030770 |
|---|---|
| --------------- | --------- |
5
Diagnostic Ultrasound Indications for Use Form
Page
510(k) Number (if known): K030770
Device Name: OTI-scan B-scan transducer
Intended Use: Transducer for B-scans with OTI-Scan Ophthalmic system Mode of Operation
| CLINICAL
APPLICATION | A | E | M | PWD | CWD | COLOR
DOPPLER | POWER
(AMPLITUDE)
DOPPLER | COLOR
VELOCITY
IMAGING | COMBINED
(SPECIFY) | OTHER
(SPECIFY) |
|-------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|--------------------|
| Ophthalmic | | x | | | | | | | | |
| 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) | | | | | | | | | | |
usly 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 | ✓ | OR Over-the- |
| Counter Use | ||
| (Per 21 CFR 810.109) | (Optional Format 1-2-96) |
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
| 510(k) Number | K030770 |
|---|---|
| --------------- | --------- |
6
Diagnostic Ultrasound Indications for Use Form
Page 1 of
510(k) Number (if known): K030770
Device Name:OTI-Scan A-scan transducer
Intended Use: Biometric and diagnostic A-scans with OTI-scan ophthalmic system
Mode of Operation
| CLINICAL
APPLICATION | A | B | M | PWD | CWD | COLOR
DOPPLER | POWER
(AMPLITUDE)
DOPPLER | COLOR
VELOCITY
IMAGING | COMBINED
(SPECIFY) | OTHER
(SPECIFY) |
|----------------------------------------------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|--------------------|
| Ophthalmic | X | | | | | | | | | |
| 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) | | | | | | | | | | |
| 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 | ✓ | OR | Over-the- |
|---|---|---|---|
| Counter Use | |||
| (Per 21 CFR 810.109) | (Division Sign-Off) |
of Reproductive ological Devi