(71 days)
Not Found
No
The document describes a standard ultrasonic A-scan system for ocular measurements and IOL power calculations using established formulas. There is no mention of AI, ML, or any related technologies in the device description, intended use, or performance studies. The software described is a standard Windows application for data management and system control.
No
The device is used for measurement and calculation of IOL power, not for direct treatment or therapy.
Yes
The device is used to measure ocular features (anterior chamber depth, lens thickness, and axial length) to calculate IOL powers, which are critical diagnostic measurements for ophthalmology.
No
The device description explicitly states that the system consists of hardware components including a solid A-probe, a base unit housing electronics, a foot pedal switch, and a USB cable, in addition to the software.
Based on the provided information, the Master-Vu A-Scan is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
- Master-Vu A-Scan Function: The Master-Vu A-Scan is an ultrasonic device that takes measurements directly within the eye (intraocular). It uses these measurements to help calculate IOL power. This is an in vivo (within the living body) measurement process, not an in vitro one.
Therefore, the Master-Vu A-Scan falls under the category of medical devices used for diagnostic or measurement purposes within the body, not for testing samples taken from the body.
N/A
Intended Use / Indications for Use
The Master-Vu A-Scan provides intraocular measurements of anterior chamber depth, lens thickness, and axial length which can be used with published industry-accepted refractive formulas to calculate associated IOL powers for implanted lenses.
Product codes
IYO
Device Description
The Master-Vu A-Scan is a portable ultrasonic A-scan system intended for use in ophthalmic applications. The system allows for the measurement of several key ocular features including axial length (AXL), anterior chamber depth, and lens thickness while also aiding in the calculation of associated IOL power for implanted lenses.
The Master-Vu A-Scan system consists of a solid A-probe, a base unit which houses the electronics, a foot pedal switch, and a USB cable which provides a means of interfacing the system with a host computer.
The standard Master-Vu software allows any Microsoft Windows compatible host computer (PC) to function as the control panel of the system. The host computer is not supplied by Sonomed as part of the Master-Vu A-Scan system and must be provided by the end user. Minimum requirements for compatible host computers are supplied in the documentation accompanying the system.
The Master-Vu software is compatible with the Microsoft Windows XP or Microsoft Windows Vista operating systems, and uses the features of the Windows graphical user interface to direct the operation of the system and maintain patient records. Patient data may be analyzed, saved, retrieved, and printed through the computer interface at the operator's discretion. The Microsoft Windows operating system provides an adequate and user-friendly interface for a wide variety of clinical environments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasonic
Anatomical Site
intraocular
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
Safety, EMC and Performance Data: Electrical, mechanical, environments safety and performance testing according to standard IEC 60601-1, IEC 60601-2-37, and EN/IEC 60601-1-2(2001) are currently pending.
Key Metrics
Not Found
Predicate Device(s)
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.
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APR - 9 2010
متر
Image /page/0/Picture/2 description: The image shows the logo for SONOMED INC. The logo is black and white. The word "SONOMED" is in large, bold letters, and the letters "INC." are in smaller letters to the right of the word "SONOMED".
510(K) Summary
Sonomed, Inc 1979 Marcus Avenue Lake Success, NY 11042, USA Tel 800-227-1285 / 516-354-0900 Fax 516-354-5902
1
510(K) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR Part 807.92
Date: January 22, 2010 -
-
- Company and Correspondent making the submission:
| Name: | Sonomed Inc. |
|---|---|
| Address: | 1979 Marcus Ave |
| Lake Success, NY, 11798 | |
| U.S.A. | |
| Telephone: | 516-354-0900 |
| Fax: | 516-354 |
| Website: | www.sonomed.com |
| Contact: | Mr. Charles C. O'Neal, Quality Manager |
| E-mail: | coneal@escalonmed.com |
-
- Device:
| Trade/proprietary name: | Master-Vu A-scan |
|---|---|
| Common Name: | Diagnostic ultrasound system |
| Classification Name: | System, imaging, pulsed echo, ultrasonic |
-
- Predicate Devices:
| Manufacturer: | Sonomed, Inc. |
|---|---|
| Device: | E-Z Scan 5500+ A-Scan / B-Scan System |
| 510(k) Number: | K040668 |
- Classification Names & Citations: 4.
Classification: Class 2 Classification Code: 21CFR 892.1560, 1570, IYO, ITX, system, imaging, pulsed echo, ultrasonic,
ട. Description:
The Master-Vu A-Scan is a portable ultrasonic A-scan system intended for use in ophthalmic applications. The system allows for the measurement of several key ocular features including axial length (AXL), anterior chamber depth, and lens thickness while also aiding in the calculation of associated IOL power for implanted lenses.
The Master-Vu A-Scan system consists of a solid A-probe, a base unit which houses the electronics, a foot pedal switch, and a USB cable which provides a means of interfacing the system with a host computer.
The standard Master-Vu software allows any Microsoft Windows compatible host computer (PC) to function as the control panel of the system. The host computer is not supplied by Sonomed as part of the Master-Vu A-Scan system and must be provided by the end user. Minimum requirements for compatible host computers are supplied in the documentation accompanying the system.
The Master-Vu software is compatible with the Microsoft Windows XP or Microsoft Windows Vista operating systems, and uses the features of the Windows graphical user
2
interface to direct the operation of the system and maintain patient records. Patient data may be analyzed, saved, retrieved, and printed through the computer interface at the operator's discretion. The Microsoft Windows operating system provides an adequate and user-friendly interface for a wide variety of clinical environments.
-
- Indications for Use:
The Master-Vu A-Scan provides intraccular measurements of anterior chamber depth. lens thickness, and axial length which can be used with published industry-accepted refractive formulas to calculate associated IOL powers for implanted lenses.
- Indications for Use:
-
- Comparison with predicate device:
Sonomed, Inc. believes that the technologies incorporated into the Master-Vu A-scan are substantially equivalent to those of the E-Z Scan 5500+ A-scan / B-scan system.
- Comparison with predicate device:
-
- Safety, EMC and Performance Data: Electrical, mechanical, environments safety and performance testing according to standard IEC 60601-1, IEC 60601-2-37, and EN/IEC 60601-1-2(2001) are currently pending.
-
- Conclusions:
In accordance with the Federal Food, Drug and Cosmetic Act 21 CFR Part 807 and based on the information provided in this premarket notification Sonomed. Inc. concluded that the Master-Vu A-scan is safe and effective and substantially equivalent to predicate devices as described herein.
-
- Sonomed Inc. will update and include in this summary any other information deemed reasonably necessary by the FDA.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
APR - 9 2010
Charles C. O'Neal Quality Manager Sonomed, Inc. 1979 Marcus Avenue, Suite C150 LAKE SUCCESS NY 11042
Re: K100252
Trade/Device Name: Master-Vu A-Scan, Model MV4500 Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO Dated: March 24, 2010 Received: March 25, 2010
Dear Mr. O'Neal:
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 A-Scan, Model MV4500 as described in your premarket notification:
Transducer Model Number
Model DCT-10 A-Scan Transducer
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 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. O'Neal
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
If you have any questions regarding the content of this letter, please contact Shahram Vaezy at (301) 796-6242.
Sincerely yours,
Donald J. St.Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure(s)
5
Indications for Use
510(k) Number (if known): K100252
Device Name: Master-Vu A-Scan
Indications for Use: The Master-Vu A-Scan provides intraocular measurements of anterior chamber depth, lens thickness, and axial length which can be used with published industryaccepted refractive formulas to calculate associated IOL powers for implanted lenses.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
D
(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) Number K100252
Page 1 of_3
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Diagnostic Ultrasound Indications For Use Form
510(k) Number System Transducer
K100252 Model MV4500 Master-Vu A-Scan - Not Applicable -
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | |||||||||
| (Track 1 Only) | Specific | ||||||||
| (Tracks 1 & 3) | A | B | M | PWD | CWD | Color | |||
| Doppler | Combined | ||||||||
| (Specify) | Other | ||||||||
| (Specify) | |||||||||
| Ophthalmic | Ophthalmic | N | |||||||
| Fetal Imaging | |||||||||
| & Other | Fetal | ||||||||
| Abdominal | |||||||||
| Intraoperative (Specify) | |||||||||
| Intraoperative (Neurological) | |||||||||
| Pediatric | |||||||||
| Small Organ (Specify) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-Rectal | |||||||||
| Trans-Vaginal | |||||||||
| Trans-Urethral | |||||||||
| Trans-Esophageal (Non- | |||||||||
| Cardiac) | |||||||||
| Musculo-Skeletal | |||||||||
| (Conventional) | |||||||||
| Musculo-Skeletal (Superficial) | |||||||||
| Intravascular | |||||||||
| Other (Specify) | |||||||||
| Cardiac | Cardiac Adult | ||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-Esophageal (Cardiac) | |||||||||
| Intra-Cardiac | |||||||||
| Other (Specify) | |||||||||
| Peripheral | |||||||||
| Vessel | Peripheral Vessel | ||||||||
| Other (Specify) |
N = New Indication | P = Previously Cleared by FDA | E = Added Under This Appendix
510K
signature
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Devices
Office of In Vitro Diagnostic Devices Evaluation and Safety
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Diagnostic Ultrasound Indications For Use Form
510(k) Number System Transducer
K100252 . . - Not Applicable -Model DCT-10 A-Scan Transducer
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | |||||||||
| (Track 1 Only) | Specific | ||||||||
| (Tracks 1 & 3) | A | B | M | PWD | CWD | Color | |||
| Doppler | Combined | ||||||||
| (Specify) | Other | ||||||||
| (Specify) | |||||||||
| Ophthalmic | Ophthalmic | P | |||||||
| Fetal Imaging | |||||||||
| & Other | Fetal | ||||||||
| Abdominal | |||||||||
| Intraoperative (Specify) | |||||||||
| Intraoperative (Neurological) | |||||||||
| Pediatric | |||||||||
| Small Organ (Specify) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-Rectal | |||||||||
| Trans-Vaginal | |||||||||
| Trans-Urethral | |||||||||
| Trans-Esophageal (Non- | |||||||||
| Cardiac) | |||||||||
| Musculo-Skeletal | |||||||||
| (Conventional) | |||||||||
| Musculo-Skeletal (Superficial) | |||||||||
| Intravascular | |||||||||
| Other (Specify) | |||||||||
| Cardiac | Cardiac Adult | ||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-Esophageal (Cardiac) | |||||||||
| Intra-Cardiac | |||||||||
| Other (Specify) | |||||||||
| Peripheral | |||||||||
| Vessel | Peripheral Vessel | ||||||||
| Other (Specify) |
N = New Indication | P = Previously Cleared by FDA | E = Added Under This Appendix
D.H.H
(Division Sign-Off)
(Division Sign-Off) Division of Radiological Devices Division of Hadlological Device Evaluation and Safety
510K K100252
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