(64 days)
Not Found
No
The description focuses on standard ultrasound imaging and biometric measurements with calculation formulas, and explicitly states "Not Found" for mentions of AI, DNN, or ML.
No
The document describes the device as an "ultrasonic diagnostic system for ophthalmic application" intended to "visualize the interior of the eye by means of ultrasound and to make measurements inside the eye". It is for "diagnosis" and "measurement", not treatment.
Yes.
The device is described as an "ultrasonic diagnostic system for ophthalmic application" and is used to visualize the interior of the eye and measure key ocular features, which are diagnostic functions. It also states the device can aid in the calculation of IOL power and facilitate the identification and measurement of ocular pathologies.
No
The device description explicitly states that the system consists of a console, ultrasound probe(s) and transducer(s), and a foot pedal, which are hardware components.
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 taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The VuPad ultrasound system uses ultrasound technology to visualize and measure structures within the eye. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's for "ophthalmic application, intended to both visualize the interior of the eye by means of ultrasound and to make measurements inside the eye." This is an in-vivo (within the living body) diagnostic procedure.
Therefore, the VuPad ultrasound system falls under the category of medical devices used for in-vivo diagnostic imaging and measurement, not in-vitro diagnostics.
N/A
Intended Use / Indications for Use
The VuPad ultrasound system is a multi-purpose computer-based ultrasonic diagnostic system for ophthalmic application, 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
IYO, ITX
Device Description
The VuPad is a portable ultrasound biometric ruler 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 device is used by coupling the probe / transducer to the eye either through direct contact or immersion methods. Available modes are biometric A-scan, and UBM (high frequency B-scan).
The A-scan mode of the system features a live A-scan trace with storage for up to five scans. There are five (auto/ manual) examination modes that use three different tissue velocities to calculate individual intraocular distances within the eye (ACD, Lens, and Vitreous). Other features include: post examination review of scans & measurement; five IOL formulas (six refractive and three post refractive) for lens power calculations; an immersion scanning capability for zero corneal compression of the eye while scanning and storage for up to five different user profiles.
The B-Scan mode produces a live, two-dimensional image to facilitate the identification and measurement of ocular pathologies in the posterior-chamber of the eye, particularly when view of the chamber is obscured, such as is the case with cataracts.
The VuPad is a stand-alone system that runs on a Windows 8 platform and may be networked (by the user) for interface with electronic medical records systems, printing, and other purposes. The system consists of the VuPad console, ultrasound probe(s) and transducer(s), and foot pedal.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
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
Not Found
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.
0
K140199
Page 1 of 7
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: March 12, 2014
- Company and Correspondent making the submission: Sonomed Inc. Name: 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
2. Device:
| Trade/proprietary name: VuPad | |
|---|---|
| 510(k) Number: | K140199 |
| Common Name: | Diagnostic ultrasound system |
| Classification Name: | System, imaging, pulsed echo, ultrasonic |
3. Predicate Devices:
| Manufacturer: | Sonomed, Inc. |
|---|---|
| Device: | E-Z Scan 5500+ A-Scan / B-Scan System |
| 510(k) Number: | K040668 |
Manufacturer: Sonomed, Inc. Device: VuMax System 510(k) Number: K060626
- Classification Names & Citations: 4. Classification: Class 2 Classification Code: 21CFR 892.1560, 1570. IYO, ITX, system, imaging, pulsed echo, ultrasonic, .
5. Description:
The VuPad is a portable ultrasound biometric ruler 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 device is used by coupling the probe / transducer to the eye either through direct contact or immersion methods. Available modes are biometric A-scan, and UBM (high frequency B-scan).
The A-scan mode of the system features a live A-scan trace with storage for up to five scans. There are five (auto/ manual) examination modes that use three different tissue velocities to calculate individual intraocular distances within the eye (ACD, Lens, and Vitreous). Other features include: post examination review of scans & measurement; five IOL formulas (six refractive and three post refractive) for lens power calculations; an immersion scanning capability for zero corneal compression of the eye while scanning and storage for up to five different user profiles.
Sonomed. Inc 1979 Marcus Avenue Lake Success, NY 11042, USA Tel 800-227-1285 / 516-354-0900 Fax 516-354-5902
1
The B-Scan mode produces a live, two-dimensional image to facilitate the identification and measurement of ocular pathologies in the posterior-chamber of the eye, particularly when view of the chamber is obscured, such as is the case with cataracts.
The VuPad is a stand-alone system that runs on a Windows 8 platform and may be networked (by the user) for interface with electronic medical records systems, printing, and other purposes. The system consists of the VuPad console, ultrasound probe(s) and transducer(s), and foot pedal.
ි. Indications for Use:
The VuPad ultrasound system is a multi-purpose computer-based ultrasonic diagnostic system for ophthalmic application, 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.
7. Comparison with predicate device:
Sonomed. Inc. believes that the technologies incorporated into the VuPad are substantially equivalent to those of the E-Z Scan 5500+ A-scan / B-scan system and the VuMax System.
A summary listing of design characteristics that are shared between the VuPad and the established predicate devices is provided on the following pages.
A summary listing of design characteristics that differ between the VuPad and the established predicate devices is also provided on the following pages.
2
A summary listing of VuPad design characteristics that are the same as established predicate devices is provided below:
| Parameter. | VuPad
(K140199 ) | EZScan AB5500+
(K040668) | VuMax
(K060626) |
|--------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | | |
| Intended Use | The VuPad ultrasound
system is a multi-
purpose computer-
based ultrasonic
diagnostic system for
ophthalmic application,
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. | The EZ Scan ultrasound
system is a multi-purpose
computer based ultrasonic
diagnostic 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. | The VuMAX
ultrasound syst5em
is a multi-purpose
computer -based
ultrasonic diagnostic
system for
ophthalmic
applications,
intended to both
visualize the interior
of the eye by means
of ultrasound and to
make measurements
inside the eye. |
| Ultrasound Modes | Ophthalmic A and B
Scans | Ophthalmic A and B Scans | Ophthalmic A and B
Scans |
| Technology | Visualization by
Ultrasound | Visualization by Ultrasound | Visualization by
Ultrasound |
| General Method of
Operation | Echoes converted to
images on a screen.
Measurement made by
time delays | Echoes converted to
images on a screen.
Measurement made by
time delays | Echoes converted to
images on a screen.
Measurement made
by time delays |
| Digital System | Echoes converted into
digital pulses, all
operation carried out
digitally | Echoes converted into
digital pulses, all operation
carried out digitally | Echoes converted
into digital pulses, all
operation carried out
digitally |
| Ability To Make
Measurements | Can make
measurements using A-
scan technology | Can make measurements
using A-scan technology | Can make
measurements using
A-scan technology |
| Eye-transducer Interface | Sealed probes with
scanning transducer
behind ultrasound
transparent membrane
(10, 12.5, 20 MHz); and
Stand-off or "nose-
scone" separates
exposed transducer
from patient (35, 50
MHz) | Sealed probes with
scanning transducer behind
ultrasound transparent
membrane (10 MHz) | Stand-off or "nose-
scone" separates
exposed transducer
from patient (35, 50
MHz) |
| IOL Power Calculation | Various formulas
available | Various formulas available | Not available |
| Method of generating A-
Scans | Separate A-Scan
transducer, A-scan
measuring system | Separate A-Scan
transducer, A-scan
measuring system | Line traced on B-
Scan, A-scan shown,
caliper for
measurement |
| Focus feature | Improves resolution by
reducing transducer
ringing by software | Not available. | Improves resolution
by reducing
transducer ringing by
software |
| A-Scan Probe Design | Closed Fixed Single-
Element with Internal
Fixation Light | Closed Fixed Single-
Element with Internal
Fixation Light | N/A |
| Parameter | VuPad
(K140199) | EZScan AB5500+
(K040668) | VuMax
(K060626) |
| Similarities (cont.) | | | |
| A-Scan Transducer
Frequency | 10 MHz | 10 MHz | N/A |
| A-Scan Available Probe
Configurations | Solid Tip
(for immersion scan)
Soft-Touch
(for direct contact scan) | Solid Tip
(for immersion scan)
Soft-Touch
(for direct contact scan) | N/A |
| A-Scan Measurements | Anterior Chamber
Depth
Lens Thickness
Axial Length
Manual Measurements | Anterior Chamber Depth
Lens Thickness
Axial Length
Manual Measurements | N/A |
| A-Scan Measurement
Accuracy | ±0.1 mm (clinical)
±0.02 mm (theoretical) | ±0.1 mm (clinical)
±0.023 mm (theoretical) | N/A |
| A-Scan Measurement
Range | 18 - 40 mm | 18 - 40 mm | N/A |
| A-Scan Measurement
Modes | Automatic - Cataract
Automatic - Dense
Cataract
Automatic - Aphakic
Automatic -
Pseduophakic
Manual | Automatic - Cataract
Automatic - Dense
Cataract
Automatic - Aphakic
Automatic - Pseduophakic
Manual | N/A |
| A-Scan IOL Formulas | Manual
Holladay
Regression-II
Theoretic-T
Binkhorst
Hoffer-Q
Haigis
Latkany Mypoic Post-
Refractive
Latkany Hyperoptic
Post-Refractive
Aramberri Double-K
Post-Refractive | Holladay
Regression-II
Theoretic-T
Binkhorst
Hoffer-Q
Haigis
Latkany Mypoic Post-
Refractive
Latkany Hyperoptic Post-
Refractive
Aramberri Double-K Post-
Refractive | N/A |
| A-Scan Tissue Velocity
Constants | Anterior Chamber
Lens
Vitreous | Anterior Chamber
Lens
Vitreous | N/A |
| A-Scan User Constants | Personalized A-
Constants
Surgeon Factors | Personalized A-Constants
Surgeon Factors | N/A |
| A-Scan Acoustic Output
Global Maximum | ISPTA.3 Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@tda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (1/14)
10
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved. OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K140199
Device Name
VuPad
Indicalions for Use (Describe)
The Vullad ultrasound system is a multi-purpose computer-based ultrasonic system for ophitalian. 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.
System: VuPad Transducer 12,5 Mhz
| Clinical Application | Specific
(Tracks 1 & 3) | Mode of Operation | | | | | | |
|---------------------------|----------------------------|-------------------|---|-----|-----|------------------|-----------------------|---------------------|
| General
(Track 1 Only) | | B | M | PWD | CWD | Color
Doppler | Combined
(Specify) | Other*
(Specify) |
| Ophthalmic | Ophthalmic | ✓ | | | | | | |
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subparl D)
Over . The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Sm.h.7).
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources. gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimale or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Acl (PRA) Staff PRAStaff@lda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to. a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (1/14)
11
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) ייצולון א
Device Name Val¹ad
Indications for Use (Describe)
The Vullad ultrasound system is a multi-purpose computer-based ultrasmic system for ophication. 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.
System: VuPad Transducer_20 Mhz
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General (Track 1 Only) | Specific (Tracks 1 & 3) | B | M | PWD | CWD | Color Doppler | Combined (Specify) | Other* (Specify) |
| Ophthalmic | Ophthalmic | ✓ |
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
ﺎ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Smh.7)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
•DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.'
The burden lime for this collection of information is estimated to average 79 hours per response, including the lime to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection.of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, lo:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
12
DEPARTMENT OF HEAL.TH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K140199
Devico Name VuPad
Indications for Use (Describe)
The VuPad ultrisound system is a multi-purpose computer-based ultrasonic system for ophitalinic application. intended to both visualize the interior of the eye by newns of ultrassund and to make measurements inside the eye. including the measurement of axial length for determination of IOI. Power.
System: VuPad Transducer_ 35 Mhz
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track 1 Only) | Specific | |||||||
| (Tracks 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | Combined | |||||||
| (Specify) | Other* | |||||||
| (Specify) | ||||||||
| Ophthalmic | Ophthalmic | ✓ |
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Smh.7)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing dala sources, gather and mainlain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection. including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStall@ida.hhs.gov
"An agency may not conduct or sponsor. and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
13
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statumont below.
510(k) Number (if known) ド140199
Device Name VuPad
Indications for Use (Describe)
The Vullad ultrasound system is a multi-purpose computer-based ultrasonic system for ophitalinic application, 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.
System: VuPad Transducer_50 Mhz
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track 1 Only) | Specific | |||||||
| (Tracks 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | Combined | |||||||
| (Specify) | Other | |||||||
| (Specify) | ||||||||
| Ophthalmic | Ophthalmic |
Type of Use (Select one or both, as applicable)
الط Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signalure)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
'DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.'
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, galher and maintain the data needed and complete line to review the collection. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (1/14)