MASTER-VU

K073196 · Sonomed, Inc. · IYO · Dec 19, 2007 · Radiology

Device Facts

• Record ID: K073196
• Device Name: MASTER-VU
• Applicant: Sonomed, Inc.
• Product Code: IYO · Radiology
• Decision Date: Dec 19, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1560
• Device Class: Class 2

Intended Use

The Master-Vu High Resolution Ultrasound System is intended to be used for visualization by ultrasound of the eye and orbit by B-scan.

Device Story

Master-Vu is a PC-based ophthalmic ultrasound system; utilizes motor-driven 12 MHz transducer and angle sensor for B-scan imaging of eye and orbit. System requires user-supplied standard PC; displays images on computer screen. Device performs visualization and measurements. Operated by clinicians in clinical settings. Output provides visual diagnostic information to assist healthcare providers in assessing ocular and orbital structures; aids in clinical decision-making regarding eye health and pathology.

Clinical Evidence

Bench testing only. Ultrasonic emissions tests and accuracy/validation tests performed. No clinical data required.

Technological Characteristics

Conventional ophthalmic B-scan system; motor-driven 12 MHz transducer; angle sensor for scanning; PC-based architecture; display via computer screen.

Indications for Use

Indicated for ophthalmic B-scan ultrasound visualization of the eye and orbit. Prescription use only.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Sonomed EZ-Scan AB 5500+

Submission Summary (Full Text)

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K073196
page 1 of 2

Sonomed Inc. Special 510(k) Master-Vu Ophthalmic Ultrasound System

> 510(k) Summary October 24, 2007

#### (1) Submitter Information

Name: Sonomed Inc..

Address: 1979 Marcus Avenue Lake Success, NY 11042

Telephone Number: 516-354-0900

Contact Person: Dr. George Myers Medsys Inc. 377 Rt. 17 S Hasbrouck Heights, NJ 07604 201-727-1703

Date Prepared: October 23, 2007

#### (2) Name of Device:

Trade Name: Master-Vu Common Name: Opththalmic ultrasonic B scan system Classification Name: System, Imaging, Ultrasonic, Ophthalmic, 90IYO

- (3) Equivalent legally-marketed devices:
Sonomed EZ-Scan AB 5500+

(4) Description

The Master-Vu High Resolution Ultrasound System is intended to be used for visualization by ultrasound of the eye and orbit by B-scan.

The system is PC-based, and is used with a 12 MHz transducer . The computer is a standard pc, and is usersupplied. Computer requirements are supplied in the instructions. The scanner is motor-driven. The system can also make measurements.

(5) Intended Use

The Master-Vu High Resolution Ultrasound System is intended to be used for visualization by

DEC 1 9 2007

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Sonomed Master-Vu

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ultrasound of the eye and orbit by B-scan.

(6) Technological characteristics

The Master-Vu is a conventional ophthalmic B-scan system using a motor-driven transducer and angle sensor for scanning. It uses a motor-driven 12 MHz transducer. The system is PC-based, and the display is on the computer screen.

(b) Performance data

(1) Non-clinical tests

Both ultrasonic emissions tests and accuracy and validation tests have been done.

(2) Clinical tests

Not required

(3) Conclusions

The Sonomed Master-Vu is equivalent in safety and efficacy to the legally marketed predicate device.

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Public Health Service

MAR 1 1 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Sonomed, Incorporated % Dr. George Myers President Medsys, Incorporated 377 Route 17 S HASBROUCK HEIGHTS NJ 07604

Re: K073196

Trade/Device Name: Master-Vu Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO and ITX Dated: October 30, 2007 Received: November 13, 2007

Dear Dr. Myers:

This letter corrects our substantially equivalent letter of December 19, 2007.

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

This determination of substantial equivalence applies to the following transducers intended for use with the Master-Vu Ultrasound System, as described in your premarket notification:

Transducer Model Number

12 MHz Transducer

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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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

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Page 3 – Dr. George Myers

If you have any questions regarding the content of this letter, please contact Ms. Lauren Hefner at [phone].

Sincerely yours,

Hebert Semen for

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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# Diagnostic Ultrasound Indications for Use Form

Page

K073/96

510(k) Number (if known):

# Device Name: Master-Vu

#### Intended Use:

The Master-Vu High Resolution Ultrasound System is intended to be used for visualization by ultrasound of the eye and orbit by B-scan.

| CLINICAL<br>APPLICATION | A | B | M | PWD | CWD | COLOR<br>DOPPLER | POWER<br>(AMPLITUDE)<br>DOPPLER | COLOR<br>VELOCITY<br>IMAGING | COMBINED<br>(SPECIFY) | OTHER<br>(SPECIFY) |
|------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|--------------------|
| Ophthalmic | | P | | | | | | | | P (3D) |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-operative<br>(specify) | | | | | | | | | | |
| Intra-operative | | | | | | | | | | |
| Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ<br>(Specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | |
| Intra-luminal | | | | | | | | | | |
| Peripheral | | | | | | | | | | |
| Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-Skeletal | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | |

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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

| Concurrence of CDRH, Office of Device Evaluation (ODE) | | |
|--------------------------------------------------------|----|--------------------------|
| Prescription Use | OR | Over-the-Counter Use |
| (Per 21 CFR 810.109) | | (Optional Format 1-2-96) |

(Division Sign-Off)

Division of Reproductive, Abdominal,

and Radiological Devices

| 510(k) Number | K073196 |
|---------------|---------|
|---------------|---------|

### Mode of Operation

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Sonomed Master-Vu

## Diagnostic Ultrasound Indications for Use Form

| Page | 1 of |
|---------------------------|---------|
| 510(k) Number (if known): | K073196 |

# Device Name: Master-Vu 12 MHz transducer

## Intended Use:

The Master-Vu 12 MHz transducer is for use with the Master-Vu ultrasound system Mode of Operation

| CLINICAL<br>APPLICATION | A | B | M | PWD | CWD | COLOR<br>DOPPLER | POWER<br>(AMPLITUDE)<br>DOPPLER | COLOR<br>VELOCITY<br>IMAGING | COMBINED<br>(SPECIFY) | OTHER<br>(SPECIFY) |
|---------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|--------------------|
| Ophthalmic | | P | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-operative<br>(specify) | | | | | | | | | | |
| Intra-operative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ<br>(Specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | |
| Intra-luminal | | | | | | | | | | |
| Peripheral | | | | | | | | | | |
| Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-Skeletal | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | |

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

# (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

### Concurrence of CDRH, Office of Device Evaluation (ODE)

**Prescription Use**
(Per 21 CFR 810.109)

**OR**

Over-the-Counter Use

(Optional Format 1-2-96)

Hubert Hunn

(Division Sign-Off) Division of Reproductive, Abdominal. and Radiological Devices 510(k) Number.