AVISO OPHTHALMIC ULTRASOUND SYSTEM

K051851 · Quantel Medical · IYO · Aug 3, 2005 · Radiology

Device Facts

• Record ID: K051851
• Device Name: AVISO OPHTHALMIC ULTRASOUND SYSTEM
• Applicant: Quantel Medical
• Product Code: IYO · Radiology
• Decision Date: Aug 3, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1560
• Device Class: Class 2

Intended Use

Axial Length measurement of the eye by ultrasonic means Implanted IOL power calculation, using the Axial Length measurement. Visualization of the interior of the eye and the orbit by A and B scans.

Device Story

Aviso is a combined ophthalmic A and B scan ultrasound system; utilizes ultrasonic transducers (10 MHz B-scan, 8 MHz A-scan, 20 MHz B-HF B-scan) to capture images of eye/orbit and perform biometric measurements; processes ultrasonic echoes to generate visual representations and calculate IOL power; operated by clinicians in ophthalmic settings; output displayed for physician review to assist in diagnostic imaging and surgical planning; benefits include non-invasive visualization and precise biometric data for cataract surgery and ocular assessment.

Clinical Evidence

No clinical data; bench testing only. Device relies on established technology equivalent to predicate.

Technological Characteristics

Ophthalmic ultrasound system; transducers: 10 MHz B-scan, 8 MHz A-scan, 20 MHz B-HF B-scan; pulsed echo imaging; electrical safety per IEC 601-1; electromagnetic compatibility per IEC 601-1-2; software-based processing for biometry and imaging.

Indications for Use

Indicated for diagnostic imaging of the eye and orbit, axial length measurement, and IOL power calculation in patients requiring ophthalmic ultrasound assessment.

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

• Quantel Cinescan S (K021683)

Submission Summary (Full Text)

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K05185/

#### Quantel Medical Inc. Special 510(k) Submission Aviso Ophthalmic A and B Scan Ultrasound System

510(k) Summary

June 28, 2005

# (1) Submitter information Name : Quantel Medical S.A. Address: 21 rue Newton - Zone du BREZET Clermont-Ferrand 63039 France -Telephone: [phone] Contact person: Dr. George MYERS (Official Correspondent). Medsys Inc. 377 Route 17 South Hasbrouck Heights, New Jersey 07064 Tel : [phone] Fax: [phone] June 23, 2005 Date prepared:

# (2) Name of Device

| Trade Name: | "Aviso" Ophthalmic Ultrasound System |
|----------------------|-------------------------------------------------|
| Common Name: | Ophthalmic A and B scan ultrasound system |
| Classification name: | System, Imaging, Ultrasonic, Ophthalmic, 980IYC |

# (3) Legally-marketed predicate device

The predicate device is Quantel Cinescan S, K021683.

# (4) Description

The Aviso is a combined ophthalmic A and B scan system that can also be used for biometric measurements of the eye and for IOL calculations.

# (5) Intended Use

The Quantel Medical Aviso is intended to be used for:

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- Axial Length measurement of the eye by ultrasonic means
- Implanted IOL power calculation, using the Axial Length measurement.
- Visualization of the interior of the eye and the orbit by A and B scans.

#### (6) Performance Data

(a) Non-Clinical tests

- for Electrical Security . IEC 601-1
- 트 IEC 601-1-2 for Electromagnetic Compatibility
- FDA transducer emissions tests ■
- 트 Software validation tests

#### (b) Clinical tests

Since the Aviso uses the same technology as existing devices, clinical tests are not required.

# (7) Conclusion

The Aviso is equivalent in safety and efficacy to the legally-marketed predicate devices.

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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 graphic of three wavy lines that resemble a human figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 3 - 2005

Quantel Medical S.A. % Mr. George H. Myers, Sc.D. Official Correspondent Medsys, Inc. 377 Route 17 South HASBROUCK HEIGHTS NJ 07604

Re: K051851

Trade Name: Aviso Ophthalmic Ultrasonic System 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: June 24, 2005 Received: July 21, 2005

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 Aviso Ophthalmic Ultrasonic System, as described in your premarket notification:

Transducer Model Number

B-Scan, 10 MHz "STD-A" A-Scan, 8 MHz B-Scan B-HF, 20 MHZ

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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 (OS) 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 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

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

Sincerely yours,

Nancy C. 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 1 1 of of 4

510(k) Number (if known):

Device Name: Aviso

Intended Use: The intended use of the Aviso is for diagnostic imaging of the eye by A and B scans and for biometric measurements of the eye.

#### CLINICAL A B M PWD CWD COLOR POWER COLOR COMBINED OTHER APPLICATION DOPPLER (AMPLITUDE) VELOCITY (SPECIFY) (SPECIFY) DOPPLER IMAGING 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-lumina! Peripheral Vascular Laparoscopic Musculo-Skeletal Other (Specify)*

# Mode of Operation

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)

Nancyc Gordon
(Division Sign-Off)

Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K051851

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Page _ 2 of __ 4_

510(k) Number (if known):

# Device Name: Aviso B-scan Transducer , 10 MHz

Intended Use: The intended use of the Aviso 10 MHz B-scan transducer is for diagnostic imaging of the eye by B 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) |
|---------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|--------------------|
| Ophthamic | | 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<br>Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-Skeletal | | | | | | | | | | |
| Other (Specify)* | | | | | | | | | | |

#### Mode of Operation

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

510(k) Number __

Additional Comments

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

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

(Per 21 CFR 810.109) Prescription Use 17

Nancy C. Brogdon

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

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of of 4 Page 3

510(k) Number (if known):

Device Name: Quantel Medical S.A. "STD-A" A-scan 8 MHz transducer for "Aviso"

Intended Use: The Quantel Medical Aviso 8 Mhz A-scan transducer is intended to be used with the Quantel Aviso A-scans of the eye and for biometric measurements.

| 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<br>Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-Skeletal | | | | | | | | | | |
| Other (Specify)* | | | | | | | | | | |

#### Mode of Operation

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)

ano Radiological Devices 511-tkj Normber ______________________________________________________________________________________________________________________________________________________________

Nancy Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,

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Page 4

510(k) Number (if known):

Device Name: Aviso B-scan\transducer B-HF 20 MHz

Intended Use: The intended use of the Aviso B-HF B-scan transducer is for diagnostic imaging of the eye by B scans and for biometric measurements of the eye.

| CLINICAL APPLICATION | A | B | M | PWD | CWD | COLOR DOPPLER | POWER (AMPLITUDE) DOPPLER | COLOR VELOCITY IMAGING | COMBINED (SPECIFY) | OTHER (SPECIFY) |
|---------------------------------|---|---|---|-----|-----|---------------|---------------------------|------------------------|--------------------|-----------------|
| Ophthamic | | 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)* | | | | | | | | | | |

#### Mode of Operation

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

V

(Per 21 CFR 810.109)

Nancy Beaudon

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