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.

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.

AI/ML Overview

The provided text describes the Sonomed VuPad (K140199) as a multi-purpose computer-based ultrasonic diagnostic system for ophthalmic applications, used for visualizing the interior of the eye and making measurements, including axial length for IOL power determination. The submission compares the device to two predicate devices: the E-Z Scan 5500+ A-Scan / B-Scan System (K040668) and the VuMax System (K060626).

However, the provided documentation primarily focuses on establishing substantial equivalence to predicate devices based on similarities in intended use, technology, method of operation, and various functional parameters. It does not contain a dedicated study section with acceptance criteria and a detailed report of device performance against those criteria in a clinical or analytical study context.

The only direct performance metric mentioned for the device itself is "A-Scan Measurement Accuracy: ±0.1 mm (clinical) ±0.02 mm (theoretical)." This is listed in the comparison tables as a similarity to the EZScan AB5500+. The document states that "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," implying that detailed performance studies to explicitly "prove the device meets the acceptance criteria" were not yet fully completed or included in the summary at the time of submission.

Therefore, many of the requested details about a study evaluating the device against acceptance criteria cannot be extracted from this document, as such a study is not explicitly described.

Here's the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the "Similarities" table, the clinical measurement accuracy from the predicate device is implicitly adopted as an expected performance level for the VuPad's A-Scan.

Acceptance Criteria (Implied from Predicate - EZScan AB5500+)	Reported Device Performance (VuPad)
A-Scan Measurement Clinical Accuracy: ±0.1 mm	A-Scan Measurement Clinical Accuracy: ±0.1 mm
A-Scan Measurement Theoretical Accuracy: ±0.023 mm	A-Scan Measurement Theoretical Accuracy: ±0.02 mm
A-Scan Measurement Range: 18 - 40 mm	A-Scan Measurement Range: 18 - 40 mm
A-Scan Transducer Frequency: 10 MHz	A-Scan Transducer Frequency: 10 MHz
B-Scan Lines per Scan: 128 or 256 (VuMax: 256)	B-Scan Lines per Scan: 256
B-Scan Axial Accuracy (Theoretical): 10 MHz: 0.2088 mm (EZScan)	B-Scan Axial Accuracy (Theoretical): 12.5 MHz: 0.2034 mm; 35 or 50 MHz: 0.0146mm
Acoustic Output: ISPTA.3 < 50 mW/cm2; MI < 0.23	Acoustic Output: ISPTA.3 < 50 mW/cm2; MI < 0.23

Study Information (Based on available text):

2. Sample size used for the test set and the data provenance:

Not explicitly provided. The document relies on substantial equivalence to predicate devices rather than reporting new clinical trial data for the VuPad itself. The A-scan accuracy is stated as a specification, not a study outcome.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable/provided. No clinical study with a test set requiring expert ground truth establishment is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable/provided.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable/provided. This device is an ultrasound system making direct measurements, not an AI-assisted diagnostic tool that aids human readers in interpretation.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

The device performs measurements (e.g., axial length, depths), which would be considered a form of "standalone" performance in its context. However, no specific details of a standalone performance study are provided beyond the stated accuracy specifications. The device's operation involves a human operator coupling the probe to the eye.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not explicitly provided. For the A-scan measurement accuracy, the "theoretical" accuracy suggests a technical specification based on the system's design and physical principles, while "clinical" accuracy implies historical performance from the predicate device in clinical use, but the specific method of establishing this clinical ground truth (e.g., comparison to optical biometry, surgical measurements) for either device is not detailed.

8. The sample size for the training set:

Not applicable/provided. This device is an ultrasound system, not explicitly an AI/machine learning device that would require a "training set" in that sense. It performs measurements based on ultrasound signal processing.

9. How the ground truth for the training set was established:

Not applicable/provided.

Summary of what is known:

The submission for the VuPad (K140199) primarily establishes substantial equivalence to existing predicate devices (E-Z Scan 5500+ and VuMax) by demonstrating similar intended use, technology, and performance specifications. Key performance criteria like A-Scan measurement accuracy and range are presented as specifications that are identical or very similar to the predicate devices. The document does not describe a separate, dedicated clinical or analytical study performed on the VuPad itself to generate new performance data against pre-defined acceptance criteria, beyond the implicit acceptance of the predicate's established performance. The "pending" safety and performance testing suggests that detailed compliance verification was ongoing or would be addressed later, but not part of this 510(k) summary submission as a reported study.

Summary

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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 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

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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:

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.

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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 ultrasoundsystem is a multi-purpose computer-based ultrasonicdiagnostic system forophthalmic application,intended to bothvisualize the interior ofthe eye by means ofultrasound and to makemeasurements insidethe eye, including themeasurement of axiallength for determinationof IOL Power.	The EZ Scan ultrasoundsystem is a multi-purposecomputer based ultrasonicdiagnostic system forophthalmic applications,intended to both visualizethe interior of the eye bymeans of ultrasound and tomake measurements insidethe eye, including themeasurement of axiallength for determination ofIOL Power.	The VuMAXultrasound syst5emis a multi-purposecomputer -basedultrasonic diagnosticsystem forophthalmicapplications,intended to bothvisualize the interiorof the eye by meansof ultrasound and tomake measurementsinside the eye.
Ultrasound Modes	Ophthalmic A and BScans	Ophthalmic A and B Scans	Ophthalmic A and BScans
Technology	Visualization byUltrasound	Visualization by Ultrasound	Visualization byUltrasound
General Method ofOperation	Echoes converted toimages on a screen.Measurement made bytime delays	Echoes converted toimages on a screen.Measurement made bytime delays	Echoes converted toimages on a screen.Measurement madeby time delays
Digital System	Echoes converted intodigital pulses, alloperation carried outdigitally	Echoes converted intodigital pulses, all operationcarried out digitally	Echoes convertedinto digital pulses, alloperation carried outdigitally
Ability To MakeMeasurements	Can makemeasurements using A-scan technology	Can make measurementsusing A-scan technology	Can makemeasurements usingA-scan technology
Eye-transducer Interface	Sealed probes withscanning transducerbehind ultrasoundtransparent membrane(10, 12.5, 20 MHz); andStand-off or "nose-scone" separatesexposed transducerfrom patient (35, 50MHz)	Sealed probes withscanning transducer behindultrasound transparentmembrane (10 MHz)	Stand-off or "nose-scone" separatesexposed transducerfrom patient (35, 50MHz)
IOL Power Calculation	Various formulasavailable	Various formulas available	Not available
Method of generating A-Scans	Separate A-Scantransducer, A-scanmeasuring system	Separate A-Scantransducer, A-scanmeasuring system	Line traced on B-Scan, A-scan shown,caliper formeasurement
Focus feature	Improves resolution byreducing transducerringing by software	Not available.	Improves resolutionby reducingtransducer ringing bysoftware
A-Scan Probe Design	Closed Fixed Single-Element with InternalFixation Light	Closed Fixed Single-Element with InternalFixation Light	N/A
Parameter	VuPad(K140199)	EZScan AB5500+(K040668)	VuMax(K060626)
Similarities (cont.)
A-Scan TransducerFrequency	10 MHz	10 MHz	N/A
A-Scan Available ProbeConfigurations	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 ChamberDepthLens ThicknessAxial LengthManual Measurements	Anterior Chamber DepthLens ThicknessAxial LengthManual Measurements	N/A
A-Scan MeasurementAccuracy	±0.1 mm (clinical)±0.02 mm (theoretical)	±0.1 mm (clinical)±0.023 mm (theoretical)	N/A
A-Scan MeasurementRange	18 - 40 mm	18 - 40 mm	N/A
A-Scan MeasurementModes	Automatic - CataractAutomatic - DenseCataractAutomatic - AphakicAutomatic -PseduophakicManual	Automatic - CataractAutomatic - DenseCataractAutomatic - AphakicAutomatic - PseduophakicManual	N/A
A-Scan IOL Formulas	ManualHolladayRegression-IITheoretic-TBinkhorstHoffer-QHaigisLatkany Mypoic Post-RefractiveLatkany HyperopticPost-RefractiveAramberri Double-KPost-Refractive	HolladayRegression-IITheoretic-TBinkhorstHoffer-QHaigisLatkany Mypoic Post-RefractiveLatkany Hyperoptic Post-RefractiveAramberri Double-K Post-Refractive	N/A
A-Scan Tissue VelocityConstants	Anterior ChamberLensVitreous	Anterior ChamberLensVitreous	N/A
A-Scan User Constants	Personalized A-ConstantsSurgeon Factors	Personalized A-ConstantsSurgeon Factors	N/A
A-Scan Acoustic OutputGlobal Maximum	ISPTA.3 < 50 mW/cm2MI < 0.23	ISPTA.3 < 50 mW/cm2MI < 0.23	N/A
B-Scan Probe Design	Sealed Pivoting Single-Element, and OpenPivoting Single-Element	Sealed Pivoting Single-Element Only	Open PivotingSingle-Element Only
B-Scan Lines per Scan	256	128 or 256	256
Selectable A-Scan Vectorwhile in B-Scan mode	Yes	Yes	Yes
Parameter	VuPad (K140199)	EZScan AB5500+ (K040668)	VuMax (K060626)
Similarities (cont.)
B-Scan Scan Display Controls	Fully adjustable time-varied gain (TVG),baseline, log gain, andexponential gain	Fully adjustable time-varied gain (TVG), log gain, andexponential gain	Fully adjustable time-varied gain (TVG),baseline, log gain, andexponential gain
B-Scan Video Clips	Capture and store 50-frame video clips	N/A	Capture and store50-frame video clips

Sonomed, Inc
1979 Marcus Avenue Lake Success, NY 11042, USA Tel 800-227-1285 / 516-354-0900 Fax 516-354-5902

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and which and the

Sonomed, Inc 1979 Marcus Avenue Lake Success, NY 11042, USA Tel 800-227-1285 / 516-354-0900 Fax 516-354-5902

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A summary listing of VuPad design characteristics that differ from established predicate devices is provided below:

Parameter	VuPad	EZScan AB5500+K040668	VuMax
Differences
HardwareConfiguration andComponents	System consists ofunit with integratedLCD touch screen, A-probe, sealed B-probe, opentransducer water pathB-probe, calibrationcylinder, probe holder,and foot pedal	System consists of unitwith integrated LCDtouch screen, A-probe,sealed B-probe,calibration cylinder,probe holder, and footpedal	Systems consists of tower PC withintegrated ultrasound electronics,PC monitor, open transducer waterpath B-probe, keyboard, mouse,and foot pedal
Control Interface	Operator uses tabletPC with LCD touchscreen and foot pedalswitch to collect examdata.	Operator uses LCDtouch screen and footpedal switch to collectexam data.	Operator uses desktop computercontrol interface to collect examdata. Hardware includes monitor,keyboard, mouse, and foot pedalswitch.
System Dimensions	13.3" x 8.0" x 2.0"	9.4" x 8.9" x 2.8"	Dimensions vary for multiplecomponents
Display Screen	Integrated LCD Panel(10.1" diagonal wide-screen, 1920 x 1080pixel resolution)	Integrated LCD Panel(5.25" x 3.4", 640x480)	PC Monitor(17" Diagonal, 1280 x 1024 pixelresolution)
Data StorageLocation	Storage withinsoftware databasewith ability to recallpatient exam records	Internal storage of asingle patient exam(previous exam dataoverwritten when newexam initiated)Capability to export examrecord to PC via serialconnector for long-termstorage	Storage within software databasewith ability to recall patient examrecords
Printer	Any Windows-compatible printer(separate)	Sony UP-897MD videoprinter (separate)	Any Windows-compatible printer(separate)
A-ScanMeasurementAccuracy	$\pm$ 0.1 mm (clinical)$\pm$ 0.02 mm theoretical)	$\pm$ 0.1 mm (clinical)$\pm$ 0.023 mm (theoretical)	N/A
B-Scan TransducerFrequencies	12.5 MHz, 20 MHz, 35MHz, 50MHz	10MHz	35 MHz, 50MHz
B-Scan Transducerdrive and receiver	Circuitry suitable for12.5-50MHz	Circuitry suitable for10MHz	Circuitry suitable for 10-50 MHz
B-Scan AxialAccuracy(Theoretical)	12.5 MHz: 0.2034 mm35 or 50 MHz:0.0146mm	10 MHz: 0.2088 mm	35 or 50 MHz: 0.0146mm

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K140199
Page 7 of 7

8. Conclusions:

The goal in designing the VuPad system was to combine the primary features of two previously marketed predicate devices into a single self-contained package along with enhancements in ergonomics and utility that embody the current state of the industry.

The core technologies incorporated into the VuPad are primarily based on two predicate devices that are currently legally marketed by Sonomed. Inc: the E-Z Scan 5500+ A-Scan / B-Scan system (K040668) and the VuMax System (K060626). The similarities in intended usage, method of application, and system capability between the VuPad and predicate devices are evidenced in the comparison tables provided herein.

Both the E-Z Scan 5500+ A/B system and the VuPad system provide Operators with a combination of B-scan and A-scan ultrasound. The A-scan technology incorporated into the VuPad system is fundamentally identical to that currently in use by the E-Z Scan 5500+ A/B system.

Similarly, the Ultrasound Biomicroscopy (UBM) capabilities of the VuPad System are fundamentally identical to that of the VuMAX. The VuPad utilizes the exact same models of 35Mhz and 50Mhz transducers as the VuMAX system to collect live B-scan images of the anterior segment of the eye. The intended usage and method of application for these transducers are the same for both systems.

The VuPad also provides users with the additional option of using 12.5 MHz or 20 MHz Bscan transducers for enhanced B-Scan imaging of the posterior segment of the eve. The intended use and application of these transducers are exactly the same as the 10 MHz Bscan transducer provided for use with the previously cleared E-Z Scan AB5500+. The dual transducer frequencies made available with the VuPad system (12.5 MHz and 20 MHz) provide users with superior image resolution and greater exam flexibility while maintaining a comparable scanning depth when compared to the use of a single 10 MHz transducer.

The differences in Hardware Configuration, Control Interface, System Dimensions, Display Screen. Data Storage Location, and Printing Capability evident in the VuPad system do not render the device substantially different from the predicate devices because they do not establish a new intended usage, nor do they significantly alter the core A-scan and B-scan scan technologies employed by the system. These variances in form factor and data presentation have been evaluated by Sonomed's Risk Management Team and shall be addressed and fully detailed within the Operator's Instruction Manual that shall accompany the system.

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. has concluded that the VuPad is safe and effective and substantially equivalent to predicate devices as described herein.

1. 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.
1. Sonomed Inc. will update and include in this summary any other information deemed reasonably necessary by the FDA.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA", which is arranged in a circular fashion around the eagle.

Food and Drug Administration

Public Health Service

10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 1, 2014

Sonomed. Inc. % Mr. Charles O'Neal Quality Manager 1979 Marcus Avenue, Suite 105C LAKE SUCCESS NY 11042

Re: K140199

Trade/Device Name: VuPad Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO, ITX Dated: March 12, 2014 Received: March 20, 2014

Dear Mr. O'Neal:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA), 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

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Page 2-Mr. O'Neal

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industrv/default.htm. 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/dcfault.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

for

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Orug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Stalement below

510(k) Number (if known) K140109

Device Name

VirPad

Indications for Use (Describe)

The VePad ultrasound system is a multi-purpose computer-based ultrasonic system for ophitaline application, intended to both visualize the interior of the eye by neans of ultrasound and to make neasurements inside the eve. including the measurement of axial length for determination of IOL Power.

System: VuPad Transducer_10 Mhz

Clinical Application			Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other*(Specify)
Ophthalmic	Ophthalmic							A-Mode (NEW)

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)

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)

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 time to review instructions, search existing data sources, gather and maintain the dala 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 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

K140179

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	ColorDoppler	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	ColorDoppler	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	ColorDoppler	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)

Regulation Number and Section

§ 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.