(36 days)
Sonomed EZ-Scan AB 5500+
Not Found
No
The description focuses on conventional ultrasound technology, a motor-driven transducer, and standard PC-based display and measurement capabilities. There is no mention of AI, ML, or advanced image processing techniques that would suggest the use of such technologies.
No.
The device description and intended use focus solely on visualization and measurement for diagnostic purposes (e.g., B-scan of the eye and orbit), with no mention of treating or alleviating any condition.
Yes
The device is intended for visualization by ultrasound and can make measurements. The indication for use, "visualization by ultrasound of the eye and orbit by B-scan," implies gathering information about a medical condition, which is a diagnostic purpose.
No
The device description explicitly mentions hardware components such as a 12 MHz transducer, a motor-driven scanner, and a PC-based system, indicating it is not solely software.
Based on the provided information, the Master-Vu High Resolution Ultrasound System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "visualization by ultrasound of the eye and orbit by B-scan." This describes a medical imaging device used to visualize internal structures of the body.
- Device Description: The description details an ultrasound system with a transducer, scanner, and PC-based display. This is consistent with a medical imaging device.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a physiological state, health, or disease. The Master-Vu system directly images the body in vivo.
Therefore, the Master-Vu High Resolution Ultrasound System is a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Master-Vu High Resolution Ultrasound System is intended to be used for visualization by ultrasound of the eye and orbit by B-scan.
Product codes
IYO, ITX
Device Description
The Master-Vu High Resolution Ultrasound System is intended to be used for visualization by ultrasound of the eye and orbit by B-scan. The system is PC-based, and is used with a 12 MHz transducer. The computer is a standard pc, and is user-supplied. Computer requirements are supplied in the instructions. The scanner is motor-driven. The system can also make measurements.
The Master-Vu is a conventional ophthalmic B-scan system using a motor-driven transducer and angle sensor for scanning. It uses a motor-driven 12 MHz transducer. The system is PC-based, and the display is on the computer screen.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
eye and 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)
(1) Non-clinical tests: Both ultrasonic emissions tests and accuracy and validation tests have been done.
(2) Clinical tests: Not required
(3) Conclusions: The Sonomed Master-Vu is equivalent in safety and efficacy to the legally marketed predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Sonomed EZ-Scan AB 5500+
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
K073196
page 1 of 2
Sonomed Inc. Special 510(k) Master-Vu Ophthalmic Ultrasound System
510(k) Summary October 24, 2007
(1) Submitter Information
Name: Sonomed Inc..
Address: 1979 Marcus Avenue Lake Success, NY 11042
Telephone Number: 516-354-0900
Contact Person: Dr. George Myers Medsys Inc. 377 Rt. 17 S Hasbrouck Heights, NJ 07604 201-727-1703
Date Prepared: October 23, 2007
(2) Name of Device:
Trade Name: Master-Vu Common Name: Opththalmic ultrasonic B scan system Classification Name: System, Imaging, Ultrasonic, Ophthalmic, 90IYO
- (3) Equivalent legally-marketed devices:
Sonomed EZ-Scan AB 5500+
(4) Description
The Master-Vu High Resolution Ultrasound System is intended to be used for visualization by ultrasound of the eye and orbit by B-scan.
The system is PC-based, and is used with a 12 MHz transducer . The computer is a standard pc, and is usersupplied. Computer requirements are supplied in the instructions. The scanner is motor-driven. The system can also make measurements.
(5) Intended Use
The Master-Vu High Resolution Ultrasound System is intended to be used for visualization by
DEC 1 9 2007
1
Sonomed Master-Vu
Image /page/1/Picture/2 description: The image shows the text "KO 73196 Page 2 of 2". The text appears to be handwritten. The text is black against a white background.
ultrasound of the eye and orbit by B-scan.
(6) Technological characteristics
The Master-Vu is a conventional ophthalmic B-scan system using a motor-driven transducer and angle sensor for scanning. It uses a motor-driven 12 MHz transducer. The system is PC-based, and the display is on the computer screen.
(b) Performance data
(1) Non-clinical tests
Both ultrasonic emissions tests and accuracy and validation tests have been done.
(2) Clinical tests
Not required
(3) Conclusions
The Sonomed Master-Vu is equivalent in safety and efficacy to the legally marketed predicate device.
2
Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the seal is a stylized image of three human profiles facing to the right, with flowing lines beneath them.
Public Health Service
MAR 1 1 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Sonomed, Incorporated % Dr. George Myers President Medsys, Incorporated 377 Route 17 S HASBROUCK HEIGHTS NJ 07604
Re: K073196
Trade/Device Name: Master-Vu Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO and ITX Dated: October 30, 2007 Received: November 13, 2007
Dear Dr. Myers:
This letter corrects our substantially equivalent letter of December 19, 2007.
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 Master-Vu Ultrasound System, as described in your premarket notification:
Transducer Model Number
12 MHz Transducer
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 determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.
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 (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
4
Page 3 – Dr. George Myers
If you have any questions regarding the content of this letter, please contact Ms. Lauren Hefner at (240) 276-3666.
Sincerely yours,
Hebert Semen for
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
5
Diagnostic Ultrasound Indications for Use Form
Page
K073/96
510(k) Number (if known):
Device Name: Master-Vu
Intended Use:
The Master-Vu High Resolution Ultrasound System is intended to be used for visualization by ultrasound of the eye and orbit by B-scan.
| CLINICAL
APPLICATION | A | B | M | PWD | CWD | COLOR
DOPPLER | POWER
(AMPLITUDE)
DOPPLER | COLOR
VELOCITY
IMAGING | COMBINED
(SPECIFY) | OTHER
(SPECIFY) |
|------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|--------------------|
| Ophthalmic | | 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 | K073196 |
|---|---|
| --------------- | --------- |
Mode of Operation
6
Sonomed Master-Vu
Diagnostic Ultrasound Indications for Use Form
| Page | 1 of |
|---|---|
| 510(k) Number (if known): | K073196 |
Device Name: Master-Vu 12 MHz transducer
Intended Use:
The Master-Vu 12 MHz transducer is for use with the Master-Vu ultrasound system Mode of Operation
| 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) | | | | | | | | | | |
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)
OR
Over-the-Counter Use
(Optional Format 1-2-96)
Hubert Hunn
(Division Sign-Off) Division of Reproductive, Abdominal. and Radiological Devices 510(k) Number.