(49 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on traditional ultrasonic principles.
No.
The device is used to visualize and measure the interior of the eye, which is a diagnostic function, not a therapeutic one.
Yes
Explanation: The device is described as an "ultrasonic ophthalmic B-scan system that uses the principles of sonar (pulsed ultrasound) to visualize and measure the interior of the eye," which is a diagnostic function.
No
The device description explicitly states it is an "ultrasonic ophthalmic B-scan system" that "uses the principles of sonar (pulsed ultrasound) to visualize and measure the interior of the eye with high-frequency transducers." This indicates the device includes hardware components (transducers, ultrasound system) in addition to any software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- Device description: The description clearly states that the device is an "ultrasonic ophthalmic B-scan system" that uses "pulsed ultrasound to visualize and measure the interior of the eye." This is an imaging technique performed on the body, not a test performed on a sample taken from the body.
- Intended Use/Indications for Use: The intended use is for "B-scans with OTI-Scan HF Module Mode of Operation Ophthalmic," which further confirms it's an imaging device for the eye.
Therefore, this device falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The OTI-scan HF module is an option for the OTI-scan (K030770), a multi-purpose personal-computer-based ultrasonic B-scan diagnostic system for ophthalmic applications.
Transducer for B-scans with OTI-Scan HF Module
Product codes (comma separated list FDA assigned to the subject device)
90 IYO, ITX
Device Description
The OTI-scan HF module is an ultrasonic ophthalmic B-scan system that uses the principles of sonar (pulsed ultrasound) to visualize and measure the interior of the eye with high-frequency transducers to obtain better accuracy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasonic B-scan
Anatomical Site
Ophthalmic
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: The HF Module has had accuracy tests, ultrasonic emissions tests, electrical safety tests, and software validation tests.
Clinical tests: Not required.
Conclusions: The HF Module is equivalent in safety and efficacy to the legally-marketed predicate device.
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.
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Page A 2
JUN 2 0 2003
Ophthalmic Technologies Inc. Special 510(k) Submission OTI-Scan HF Module April 24, 2003 510(k) Summary
(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: April 24, 2003
(2) Name of Device
Trade Name: OTI-scan HF Module Common Name: Ophthalmic B-scan system Classification name: System, Imaging, Ultrasonic, Ophthalmic, 9801YO
(3) Equivalent legally-marketed devices.
OTI-scan K030770
- (4) Description
The OTI-scan HF module is an ultrasonic ophthalmic B-scan system that uses the principles of sonar (pulsed ultrasound) to visualize and measure the interior of the eye with high-frequency transducers to obtain better accuracy.
・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ . Far and Children
1
(5) Intended Use
The OTI-scan HF module is an option for the OTI-scan (K030770), a multi-purpose personal-computer-based ultrasonic B-scan diagnostic system for ophthalmic applications.
(6) Performance Data
-
(a) Non-clinical tests
The HF Module has had accuracy tests, ultrasonic emissions tests, electrical safety tests, and software validation tests. -
(b) Clinical tests
Not required.
(c) Conclusions
The HF Module is equivalent in safety and efficacy to the legally-marketed predicate device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the circumference of the circle.
Public Health Service
JUN 2 0 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ophthalmic Technologies, Inc. % George H. Myers, Sc.D. Official Correspondent Medsys. Inc. 377 Route 17 South HASBROUCK HEIGHTS NJ 07604
Re: K031391
Trade Name: OTI-scan HF-Module 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: 90 IYO and ITX Dated: April 29, 2003 Received: June 3, 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 HF-Module System, as described in your premarket notification:
Transducer Model Number
35 MHz B-Scan 50 MHz B-Scan
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
3
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.
The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:
Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850
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,
David A. Bergman
for
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
OTI-Scan
Diagnostic Ultrasound Indications for Use Form
Page 1
510(k) Number (if known): K031391
Device Name: OTI-scan 35 mHz B-scan transducer
Intended Use: Transducer for B-scans with OTI-Scan HF Module Mode of Operation
| CLINICAL | A | B | M | PWD | CWD | COLOR
DOPPLER | POWER
(AMPLITUDE)
DOPPLER | COLOR
VELOCITY
IMAGING | COMBINED
(SPECIFY) | OTHER
(SPECIFY) |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|--------------------|
| APPLICATION | | | | | | | | | | |
| 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 | ✓ |
|---|---|
| Counter Use | |
| (Per 21 CFR 810.109) |
Over-the-
OR
David A. Soper
(Optional Format 1-2-96)
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
5
Diagnostic Ultrasound Indications for Use Form
। Page
510(k) Number (if known): `K031391
Device Name:OTI-Scan 50 Mhz B-scan transducer
Intended Use: Transducer for B-scans with OTI-Scan HF Module Ophthalmic system
Mode of Operation
COLOR COMBINED OTHER COLOR POWER PWD CWD CLINICAL B м | A VELOCITY (AMPLITUDE) (SPECIFY) (SPECIFY DOPPLER APPLICATION DOPPLER IMAGING Ophthalmic × Fetal Abdominal Intraoperative (specify) Intraoperative Neurological Pediatric Small Organ (Specify) Neonatal Cephalic Adult Cephalic Cardiac Transesophageal Trans-rectal Transvaginal Transurethral Intraluminal Peripheral Vascular Laparoscopic Musculo-Skeletal Other (Specify) N= new indication; P= previously cleared by FDA; E= added under Appendix E
N= new Indication; P= previously created by FDA; L= added un
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) | |||
| David R. Symm (Division Sign-Off) |
Division of Reproductive, Abdominal, 1122241 and Radiological Devices