The VuMax High Resolution Ultrasound System is intended to be used for visualization by ultrasound of the eye and orbit by A-scan and B-scan. It is not intended to be used for determining the nower of timabaned ocular lenses, but it is capable of making intra-ocular measurements.

The VuMax 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 ultraseunded and to make measurements inside the eye.

The VuMax 35 MHz transducer is for use with the VuMax ultrasound system.

The VuMax 50 MHz transducer is for use with the Vumax ultrasound system.

Device Description

The system is PC-based, and can be used with a 35 MHz transducer (standard) or a 50 MHz transducer (optional). Because of the higher frequency of the transducers, it is expected that its greatest field of application will be in visualizing the anterior segment, because the focus area is about 11 mm form the transducer plane. The system will visualize other parts of the eye, but the resolution is not as high.

The VuMax is a conventional ophthalmic A and B-scan system using a motor-driven transducer and angle sensor for scanning. The A-scan is derived from the B-scan. There is a choice of transducer frequency of 35 MHz or 50 MHz. It uses a motor-driven 10 MHz transducer with an attached angle encoder. The system is PCbased, and the display is on the computer screen.

AI/ML Overview

The provided text is a 510(k) summary for the Sonomed Inc. VuMax Ophthalmic ultrasonic A and B scan system. It outlines the device description, intended use, technological characteristics, and a brief mention of performance data. However, it explicitly states that clinical tests were "Not required" and that the device's substantial equivalence to a predicate device (Sonomed EZ-Scan AB 5500+) was based on non-clinical tests (ultrasonic emissions and accuracy/validation tests).

Therefore, there is no information available in the provided document regarding acceptance criteria for device performance based on a study, nor any study details that would typically be associated with clinical evaluations of diagnostic accuracy.

Here's a breakdown based on your requested information, highlighting what is not available in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable/Not provided within the scope of clinical performance.
The document states "Both ultrasonic emissions tests and accuracy and validation tests have been done," but does not provide specific acceptance criteria or performance metrics for these non-clinical tests in the summary. It also does not list any clinical performance data as clinical tests were stated as "Not required."

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. No clinical test set data is provided as clinical tests were not required for this 510(k) clearance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

Not applicable. No clinical test data or ground truth establishment based on expert review is mentioned, as clinical tests were not required.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set data is provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The document explicitly states that "Clinical tests" were "Not required." Therefore, an MRMC comparative effectiveness study was not performed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is an ophthalmic ultrasound system, which inherently involves human operation and interpretation. The performance evaluation was against a predicate device based on non-clinical data, not a standalone algorithm without human involvement.

7. The Type of Ground Truth Used

Not applicable for clinical performance. For the non-clinical "accuracy and validation tests," the ground truth would likely be established through physical measurements, calibration standards, or simulated targets, rather than clinical ground truth (like pathology or outcomes data). However, the specific type of ground truth for these non-clinical tests is not detailed in the summary.

8. The Sample Size for the Training Set

Not applicable. This device's clearance did not involve AI/ML algorithms requiring a training set in the context of diagnostic performance as described in typical AI device submissions. The "PC-based" nature refers to its operating system, not necessarily an AI component requiring training data for diagnostic interpretation.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As no training set for AI/ML was reported, there's no information on how its ground truth would have been established.

Summary

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K060626

Sonomed Inc. Special 510(k) VuMax

APR 1 1 2006

510(k) Summary February 27, 2006

(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: February 25, 2004

. , Name of Device:

Trade Name: VuMax Common Name: Opththalmic ultrasonic A and B scan system Classification Name: System, Imaging, Ultrasonic, Ophthalmic, 9801YO

(3) Equivalent legally-marketed devices:

K040668 Sonomed EZ-Scan AB 5500+ ,

(4) Description

(5) Intended Use

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Page 5-2

. The VuMax High Resolution Ultrasound System is intended to be used for visualization by ultrasound of the 'e and orbit by A-scan and B-scan.
(6) Technological characteristics

(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 VuMax is equivalent in safety and efficacy to the legally marketed predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" surrounding the top half of the circle.

APR 1 1 2006

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

SonoMed, Inc. % Mr. George Myers President Medsys. Inc. 377 Route 17 S HASBROUCK HEIGHTS NJ 07604

Re: K060626

Trade Name: VuMax Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: IYO and ITX Dated: March 3, 2006 Received: March 17, 2006

Dear Mr. Myers:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

This determination of substantial equivalence applies to the following transducers intended for use with the VuMax, as described in your premarket notification:

Transducer Model Number

35 MHz transducer 50 MHz transducer

Image /page/2/Picture/12 description: The image shows a logo for the FDA Centennial, celebrating 1906-2006. The logo is circular with the text "FDA Centennial" in a stylized font. The letters "FDA" are large and bolded. The logo is surrounded by text that reads "Protecting and Promoting Your Health".

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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 (301) 443-6597 or at its Internet address http://www.fda.cov/cdrh/industry/support/index.html

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If you have any questions regarding the content of this letter, please contact Andrew Kang, M.D. at (301) 594-1212.

Sincerely yours,

Nancy Brogdon
Nancy C. Brogdon

Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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Page 4-1

Diagnostic Ultrasound Indications for Use Form

. age ______ of_3

510(k) Number (if known): K060626

Device Name: VuMax

Intended Use:

CLINICALAPPLICATION	A	B	OTHER(SPECIFY)
Ophthalmic	P	P	P (3D)
Fetal
Abdominal
Intra-operative(specify)
Intra-operativeNeurological
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
---------------------------------------	----------------------------	----	----------------------

Nancy Brogdon (Optional Format 1-2-96)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices

510(k) Number K160626

Mode of Operation

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Sonomed VuMax

Page 4-2

Diagnostic Ultrasound Indications for Use Form

ge 2 of 3

510(k) Number (if known): K060620

Device Name: VuMax 35 MHz transducer

Intended Use:

The VuMax 35 MHz transducer is for use with the VuMax ultrasound . Mode of Operation

CLINICALAPPLICATION	A	B	OTHER(SPECIFY)
Ophthalmic	P	P	P (3D)
Fetal
Abdominal
Intra-operative(specify)
Intra-operativeNeurological
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)

Over-the-Counter Use

(Optional Format 1-2-96)

Nancy Sharadon

(Division Sign-Off) Division of Reproductiv e. Ahdomi and Radiological Devices 510(k) Number

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Page 4-3

Diagnostic Ultrasound Indications for Use Form

Page 3 of 3

510(k) Number (if known): _ < 0 b 0 6 2

Device Name: VuMax 50 MHZ transducer

Intended Use:

The VuMax 50 MHz transducer is for use with the Vumax ultrasound system. Mode of Operation

CLINICALAPPLICATION	A	B	OTHER(SPECIFY)
Ophthalmic	P	P	P (3D)
Fetal
Abdominal
Intra-operative(specify)
Intra-operativeNeurological
Pediatric
Small Organ(Specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Trans-rectal
Trans-vaginal
Trans-urethral
Intra-luminal
PeripheralVascular
Laparoscopic
Musculo-Skeletal
Other (Specify)

N= new indication; P= previously cleared by FDA; E= added under Appendix E Additional Comments:

510(k) Number ___

(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)
	Nancyc hogdon(Division Sign-Off)Division of Reproductive, Abdominal,and Radiological Devices		K060626

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.