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.

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.

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.

Device 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.

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.

AI/ML Overview

The provided text describes a 510(k) submission for the Sonomed E-Z Scan AB5500+, an ophthalmic A and B scan system. Here's an analysis of the acceptance criteria and the study information based on the given document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Reported Device Performance	Comments
Safety	Determined equivalent to legally marketed predicate device.	Non-clinical tests included ultrasonic emissions tests. Clinical tests were "Not required."
Efficacy	Determined equivalent to legally marketed predicate device.	Non-clinical tests included accuracy and validation tests. Clinical tests were "Not required."
Intended Use	The device is intended for localization and visualization of ophthalmic disorders and measurement of ocular distances, including axial length for IOL power determination.	This matches the intended use of the predicate devices.
Technological Characteristics	The E-Z Scan AB5500+ is a conventional ophthalmic B-scan system using a motor-driven transducer and angle sensor (10 MHz) and a conventional contact A-scan system with a separate 10 MHz transducer. Displays on a video touch screen and is computer-controlled.	This information describes the device's technical specifications and is considered acceptable for demonstrating substantial equivalence to the predicate.

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

The document explicitly states "Clinical tests: Not required" for both safety and efficacy. This indicates that no clinical test set was used for this 510(k) submission. The substantial equivalence was based on non-clinical tests (ultrasonic emissions, accuracy, and validation) and comparison to existing predicate devices.

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

Since no clinical test set was used, there is no information on experts establishing ground truth for a test set. Ground truth was not established via expert review of clinical data for this submission.

4. Adjudication Method for the Test Set

As no clinical test set was used, there was no adjudication method for a test set.

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

No MRMC comparative effectiveness study was mentioned or performed, as clinical tests were "Not required."

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

The device is an ultrasound system directly operated by a human, not an algorithm. Therefore, a standalone algorithm performance study is not applicable and was not done.

7. The Type of Ground Truth Used

For the safety and efficacy assessment, the ground truth was based on the performance and established safety/efficacy of the legally marketed predicate devices (Sonomed Ophthalmic B-scan B-3000 and Sonomed A-scan A-2000), as well as non-clinical test results (ultrasonic emissions, accuracy, and validation).

8. The Sample Size for the Training Set

There is no mention of a training set in the document. This is common for predicate-based 510(k) submissions for conventional medical devices that do not involve AI/ML algorithms.

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

As no training set was used, ground truth for a training set was not established.

Summary

{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:

Sonomed Ophthalmic B-scan B-3000. K844031

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

(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

(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 (301) 594-4591. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or at (301) 443-6597 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 (301) 594-1212.

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:

CLINICALAPPLICATION	A	B
Ophthalmic	P	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-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)
---------------------------------------	--

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:

CLINICALAPPLICATION	A	B	M	PWD	CWD	COLORDOPPLER	POWER(AMPLITUDE)DOPPLER	COLORVELOCITYIMAGING	COMBINED(SPECIFY)	OTHER(SPECIFY)
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-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)
---------------------------------------	--

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

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)
---------------------------------------	-------------

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

(Division Sign-Off)Division of Reproductive, Abdominal,and Radiological Devices
510(k) Number	K640668

Mode of Operation

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.