AXIS NANO OPTHALMIC BIOMETER ULTRASOUND SYSTEM

K102027 · Quantel Medical S.A. · IYO · Dec 22, 2010 · Radiology

Device Facts

• Record ID: K102027
• Device Name: AXIS NANO OPTHALMIC BIOMETER ULTRASOUND SYSTEM
• Applicant: Quantel Medical S.A.
• Product Code: IYO · Radiology
• Decision Date: Dec 22, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2

Intended Use

The QUANTEL MEDICAL AXIS NANO Ophthalmic Ultrasound System and the probes that are used with it are indicated for the biometric measurement of the eye including: - Axial Length measurement of the eye by ultrasonic means. - Implanted IOL power calculation, using the Axial Length measurement. .

Device Story

AXIS NANO is an ophthalmic ultrasound system consisting of a laptop computer connected to an acquisition module and an A-scan probe (TP-01-b or TP-02-las). Device operates at 11 MHz to perform A-scan biometric measurements of the eye. Used in clinical settings by healthcare professionals to obtain axial length measurements; data is used to calculate implanted IOL power. System provides a subset of functionality compared to the predicate Compact TOUCH, focusing exclusively on biometry. Benefits include accurate ocular measurements for surgical planning.

Clinical Evidence

Bench testing only. No clinical data required. Testing followed FDA guidance 'Information for manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound systems and Transducers' (Sept 9, 2008) to verify design specifications and equivalence to predicate.

Technological Characteristics

Ophthalmic ultrasound system; A-scan probe (TP-01-b/TP-02-las) operating at 11 MHz with 5 mm effective diameter. System architecture: laptop computer connected to an acquisition module. Connectivity: wired probe-to-module interface. Sterilization: not specified.

Indications for Use

Indicated for biometric eye measurement, specifically axial length measurement and implanted 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 Medical Compact TOUCH Ophthalmic Ultrasound System (K094038)

Submission Summary (Full Text)

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# Section 5

8102027 DEC 2 2 2010

## 510(k) Summary

This 510(k) Summary is submitted in accordance with the requirements of 21 CFR 807.87 and 807.92. Summary preparation date 06-04-10 [21 CFR 807.92(a)(1)].

Applicant Name and Address [21 CFR 807.92(a)(1)] A.

Quantel Medical S.A.

21 rue Newton

ZI Le Brezet

63039 Clermont Ferrand Cedex 2

FRANCE

Tel: [phone]

Fax: [phone]

#### B. Contact Information

Quantel USA

601 Haggerty Lane

Bozeman, MT 59715

Tel: [phone]

Fax: [phone]

Contact person: Michael Johnson M.D.

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### Device Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)] C.

Trade Name: AXIS NANO Ophthalmic Biometer Ultrasound System

Device Common Name: Ophthalmic Ultrasound System

Classification Name: System, Imaging, Ultrasonic, Ophthalmic (per 21 CFR 892.1560)

Product Code: IYO

Panel: Ophthalmology

Device Classification: Class II

#### Predicate Devices [21 CFR 807.92(a)(3)] D.

The AXIS NANO uses similar technology and physical output characteristics as the following predicate devices:

K094038 Quantel Medical Compact TOUCH Ophthalmic Ultrasound System

Device Description [21 CFR 807.92(a)(4)] E.

> The AXIS NANO is an ultrasonic system designed for ophthalmic use. It uses A type scaris for biometric measurements of the eye. The system is composed of a laptop computer connected an acquisition module. The A-scan probe (either TP-01-b or TP-02-las) connects to the acquisition module.

#### Device Specifications [21 CFR 807.92(a)(6)] F.

The AXIS NANO system includes an A-scan ultrasonic probe. The A-scan probe (TP-01 / TP-02-las) operates at 11 MHz and has an effective diameter of 5 mm. This probe is identical to that used by the predicate, Compact TOUCH cleared under k094038.

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G.

## Indications for Use [21 CFR 807.92(a)(5)]

The QUANTEL MEDICAL AXIS NANO Ophthalmic Ultrasound System and the probes that are used with it are indicated for the biometric measurement of the eye including:

- Axial Length measurement of the eye by ultrasonic means.
- Implanted IOL power calculation, using the Axial Length measurement. .

#### H. Performance Data [21 CFR 807.92(b)(2)]

Laboratory testing following the guidance "Information for manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound systems and Transducers" (Sept 9, 2008) was conducted to verify that the AXIS NANO met design specifications and was substantially equivalent to the predicate devices. No Clinical testing is required.

#### I. Conclusion [21 CFR 807.92(b)(3)]

Technologically, the AXIS NANO was found to be substantially equivalent to the currently cleared k094038 Quantel Medical Compact TOUCH Ophthalmic Ultrasound System. The AXIS NANO has only a subset of functionality that the Compact TOUCH has, specifically it only connects to the A-scan transducer and only does biometric measurements. It lacks the B-scan and Pachymetry functions of the Compact TOUCH. The indications for use are similar to the previously cleared device. The risks and benefits for the AXIS NANO are argued to be comparable to the predicate devices. We believe that there are no new questions of safety or efficacy raised by the introduction of the AXIS NANO.

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Image /page/3/Picture/14 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with flowing lines, representing movement or progress. The text "DEPARTMENT OF HEALTH" is vertically oriented and positioned to the left of the emblem.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Quantel Medical S.A. % Michael Johnson, M.D. Medical Product Manager Quantel USA 601 Haggerty Lane BOZEMAN MT 59715

DEC 2 2 2010

Re: K102027

Trade/Device Name: AXIS NANO with Quantel Medical Transducer for Biometery Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO and ITX Dated: November 2, 2010 Received: November 5, 2010

Dear Dr. Johnson:

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 AXIS NANO with Quantel Medical Transducer for Biometery, as described in your premarket notification:

## Transducer Model Number

## TP-01-b / TP-02-las

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 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

If you have any questions regarding the content of this letter, please contact Shahram Vaezy at [phone].

Sincerely yours,

Dneth Kffl

David G. Brown, Ph.D. Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure(s)

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# Section 4

# Indications for Use

510(k) Number (if known): NA

DEC 2 2 2010

Device Name:

Indications for Use:

The QUANTEL MEDICAL AXIS NANO Ophthalmic Ultrasound System and the probes that are used with it are indicated for the biometric measurement of the eye including:

- Axial Length measurement of the eye by ultrasonic means.
- Implanted IOL power calculation, using the Axial Length measurement. .

4-1

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

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

Prescription Use (Per 21 CFR 810.109)

Division Sign Off

Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

510K K102027

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# Diagnostic Ultrasound Indications for Use Form

#### 2 of Page

# 510(k) Number (if known): NA

Device Name: AXIS NANO with Quantel Medical Transducer for Biometry (Ref: TP-01-b / TP-02-las).

## Intended Use:

The QUANTEL MEDICAL AXIS NANO Ophthalmic Ultrasound System and the probes that are used with it are indicated for the biometric measurement of the eye including:

- Axial Length measurement of the eye by ultrasonic means. -
- Implanted IOL power calculation, using the Axial Length measurement. .

| 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)* | | | | | | | | | | |

## Mode of Operation

| Other (Specify)"
N= new indication; P= previously cleared by FDA; E=added under Appendix E N= new nutcation, F= proviously cleared by PP-01-b / TP-02-las were previously cleared in K094038.

4-2 (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)

Signature

(Division Sign-Of Division of Radiological De Vitro Diagnostic Device Evalua Office of In

510K K10227