E-Z SCAN AB5500+

K040668 · Sonomed, Inc. · IYO · Apr 13, 2004 · Radiology

Device Facts

• Record ID: K040668
• Device Name: E-Z SCAN AB5500+
• Applicant: Sonomed, Inc.
• Product Code: IYO · Radiology
• Decision Date: Apr 13, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1560
• Device Class: Class 2

Intended Use

The E-Z scan AB 5500+ ultrasound system is a multi-purpose computer-based ultrasonic diagnostic system ophthalmic applications, intended to both visualize the interior of the eye by means of ultrasound and to mak measurements inside the eye, including the measurement of axial length for determination of IOL power.

Device Story

The E-Z Scan AB5500+ is a portable, computer-controlled ophthalmic ultrasound system. It utilizes two separate 10 MHz transducers: a motor-driven transducer with an angle encoder for B-scan imaging of the eye and orbit, and a contact transducer for A-scan biometry. The system is operated by clinicians in a clinical setting. Inputs consist of ultrasonic echoes from ocular structures; these are processed by an internal microprocessor to generate visual images and biometric measurements displayed on a video touch screen. The touch screen serves as the primary interface for system control. By providing real-time visualization and precise axial length measurements, the device assists physicians in diagnosing ophthalmic disorders and calculating IOL power for surgical planning, ultimately supporting improved patient outcomes in cataract and ocular surgery.

Clinical Evidence

No clinical data required. Substantial equivalence is supported by non-clinical bench testing, including ultrasonic emissions tests and accuracy/validation tests.

Technological Characteristics

Portable ophthalmic ultrasound system; 10 MHz transducers (A-mode and B-mode); motor-driven B-scan transducer with angle encoder; internal microprocessor control; video touch screen interface; standalone device; non-ionizing ultrasonic energy.

Indications for Use

Indicated for ophthalmic applications including visualization of the eye and orbit, localization of ophthalmic disorders, and measurement of ocular distances (including axial length for IOL power determination).

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 Ophthalmic B-scan B-3000 (K844031)
• Sonomed A-scan A-2000 (K843696)

Submission Summary (Full Text)

{0}------------------------------------------------

APR 1 3 2004

Sonomed Inc. Special 510(k) E-Z Scan AB5500*

510(k) Summary February 25, 2004

(1) Submitter Information

Name: Sonomed Inc..

Address: 3000 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

(2) Name of Device;

Trade Name: Sonome F-Z Scan AB5500+ Common Name: Portable ophthalmic A and B scan system Classification Name: System, Imaging, Ultrasonic, Ophthalmic, 9801YO

(3) Equivalent legally-marketed devices:

1. Sonomed Ophthalmic B-scan B-3000. K844031

- 2. Sonomed A-scan A-2000, K843696
(4) Description

The E-Z Scan AB5500* combines a contact B-scanner used for the visualization by ultrasound of the eye and orbit and an A-scan used for intraocular measurements. The intended use of this system includes the localization and visualization of ophthalmic disorders and measurement of the eye and orbit.

(5) Intended Use

. The intended use of this system includes the localization and visualization of ophthalmic disorders and measurement of ocular distances.

(6) Technological characteristics

K040668
Page 1 of 3

{1}------------------------------------------------

Koy 0668
Page 2 of 2

The E-Z Scan AB5500+ is a conventional ophthalmic B-scan system using a motordriven transducer and angle sensor for scanning and a conventional contact A-scan system. The transducer frequency is 10 MHz. It uses a motor-driven 10 MHz transducer with an attached angle encoder. The display is on a video touch screen, also used for controlling the system. The entire device is computer-controlled by an internal microprocessor. The A-scan uses a separate 10 MIIz transducer and its own pulserreceiver.

(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 E-Z scan AB5500+ is equivalent in safety and efficacy to the legally marketed predicate device.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of an eagle with three wavy lines representing the agency's mission to protect the health of all Americans and provide essential human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 3 2004

Mr. Barry Durante Executive Vice President SONOMED, Inc. 3000 Marcus Avenue LAKE SUCCESS NY 11042

Re: K040668

Trade Name: Sonomed E-Z Scan AB 5500+ 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: Class II Product Code: 90 IYO and ITX Dated: March 1, 2004 Received: March 17, 2004

Dear Mr. Durante:

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 Sonomed E-Z Scan AB 5500+, as described in your premarket notification:

Transducer Model Number

## A-Mode, 10 MHz B-Mode, 10 MHz

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

{3}------------------------------------------------

Page 2 - Mr. Durante

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]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or at [phone] or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

{4}------------------------------------------------

Page 3 - Mr. Durante

If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at [phone].

Sincerely yours,

Daniel Webster Lyman

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

Enclosure

{5}------------------------------------------------

Sonomod E-7. Scan

Page 9 Diagnostic Ultrasound Indications for Use Form

Page 1 of 1

510(k) Number (if known): K040668

Device Name: E-Z Scan AB 5500+

### Intended Use:

The E-Z scan AB 5500+ ultrasound system is a multi-purpose computer-based ultrasonic diagnostic system ophthalmic applications, intended to both visualize the interior of the eye by means of ultrasound and to mak measurements inside the eye, including the measurement of axial length for determination of IOL power. 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 | P | | | | | | | | |
| 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 CDRII, Office of Device Evaluation (ODE)

| Prescription Use (Per 21 CFR 810.109) | |
|---------------------------------------|--|
|---------------------------------------|--|

OR

| Over-the-Counter Use | |
|----------------------|--------------------------|
| | (Optional Format 1-2-96) |

(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices

| 510(k) Number | K040608 |
|---------------|---------|
|---------------|---------|

{6}------------------------------------------------

## Diagnostic Ultrasound Indications for Use Form

Page _________________________________________________________________________________________________________________________________________________________________________ 510(k) Number (if known):

Device Name: A-Mode Probe E-Z Scan AB 5500+

### Intended Use:

The Intended Use of the A_Mode probe for the E-Z scan AB 5500+ ultrasound system is to make measurements inside the eye, including the measurement of axial length for determination of IOL power, and to visualize the eye by means of A-scans .

| 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 | | | | | | | | | | |
| 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) | | | | | | | | | | |

Mode of Operation

N= new indication; P= previously cleared by FDA; L= added under Appendix D 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) | |
|-----------------------------------------------|--|
|-----------------------------------------------|--|

| (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices | |
|-----------------------------------------------------------------------------------|---------|
| 510(k) Number | K040668 |

nter Use

{7}------------------------------------------------

## Diagnostic Ultrasound Indications for Use Form

Page _________________________________________________________________________________________________________________________________________________________________________ 510(k) Number (if known):

Device Name: B-Mode Probe, E-Z Scan AB 5500+

#### Intended Use:

The intended use of the B-Mode for the E-Z scan AB 5500 is to visualize the interior of the eye by means of ultrasound and to make measurements inside the eye by B-scan ultrasound.

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

OR

| Over-the-Counter Use (Optional Format 1-2-96) | <div></div> |
|-----------------------------------------------|-------------|
|-----------------------------------------------|-------------|

| (Division Sign-Off)<br>Division of Reproductive, Abdominal,<br>and Radiological Devices | <div></div> |
|-----------------------------------------------------------------------------------------|-------------|
| 510(k) Number | K640668 |

Mode of Operation