SONICEYE ULTRASOUND TRANSDUCER

K113832 · Blacktoe Medical Iii, Inc. · ITX · Mar 6, 2012 · Radiology

Device Facts

• Record ID: K113832
• Device Name: SONICEYE ULTRASOUND TRANSDUCER
• Applicant: Blacktoe Medical Iii, Inc.
• Product Code: ITX · Radiology
• Decision Date: Mar 6, 2012
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 892.1570
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The SonicEye® ultrasound transducer is a general-purpose transducer intended for use by a qualified clinician for diagnostic ultrasound imaging or fluid flow analysis of the human body in the following applications: Pediatric, Small Organ (breast, thyroid, testicles, prostate), Musculo-skeletal (conventional and superficial), and Peripheral Vessel.

Device Story

SonicEye is a finger-mounted linear ultrasound transducer designed for attachment to the SonoSite MicroMaxx ultrasound system. It replaces standard hand-held probes to enable simultaneous palpation and imaging. The device features a 5-12 MHz linear array (128 elements, 200-micron pitch) housed in a ring structure worn on the clinician's finger. It supports 2D, M-Mode, Pulsed Wave (PW) Doppler, and Color Power Doppler. The clinician operates the device by wearing it on the finger, allowing one-handed imaging while using the same hand to stabilize the patient or perform needle-guided procedures. The system processes acoustic signals to generate images on the MicroMaxx display. The ergonomic form factor improves dexterity and spatial orientation, facilitating clinical workflows for ultrasound-guided interventions.

Clinical Evidence

Bench testing only. The device was evaluated for safety and effectiveness through comparison testing with the predicate probe. Testing confirmed that the SonicEye conforms to IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, NEMA UD-2, NEMA UD-3, and ISO 10993 standards. No clinical data was required or presented.

Technological Characteristics

Linear array transducer; 5-12 MHz frequency range; 128 elements; 200-micron pitch; 25.6 mm azimuthal aperture; 4 mm elevational aperture; 3 cm average scan depth (6 cm max). Ergonomic finger-ring form factor. Connects to standard SonoSite MicroMaxx transducer port. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, NEMA UD-2, NEMA UD-3, and ISO 10993.

Indications for Use

Indicated for diagnostic ultrasound imaging and fluid flow analysis in pediatric patients and adults for small organ (breast, thyroid, testicles, prostate), musculoskeletal (conventional and superficial), and peripheral vessel applications.

Regulatory Classification

Identification

A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.

Predicate Devices

• SonoSite SLA/13-6 Transducer for MicroMaxx high-resolution ultrasound system (K053069)

Submission Summary (Full Text)

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K113832

Image /page/0/Picture/1 description: The image shows the logo for Blacktoe Medical. The word "Blacktoe" is in large, bold, black letters, with a horizontal line underneath. Below that, the word "MEDICAL" is in a smaller, thinner font. The tagline "Pioneering ultrasound in a new direction" is at the bottom of the logo in a very small font.

MAR - 6 2012

### 510(k) Summary of Safety and Effectiveness

As required by 21 CFR, part 807.92

- Submitted By: Blacktoe Medical III, Inc. 8305 SW Creekside Place, Suite C Beaverton, OR. 97008 Phone [phone] Fax [phone]
- Contact: Kendra Rathkey Manager, Quality and Regulatory
- Date Prepared: December 22, 2011

Proprietary SonicEye® Ultrasound Transducer Name:

- Common / Diagnostic Ultrasound Transducer Usual Name:
## Product

892.1570, ITX, class II, Diagnostic Ultrasound Transducer Classification:

Device The SonicEye® is a finger-mounted ultrasound transducer Description: designed to attach to the SonoSite MicroMaxx® ultrasound system, in place of the SonoSite SLA/13-6 transducer, to acquire ultrasound images for display on the system. The SonicEye® transducer connects to the MicroMaxx® system's standard transducer port. Upon connection, the visual display on the MicroMaxx® system denotes that a type "SLA" transducer is in operation.

> The SonicEye® acoustic array is located in a small ring structure worn on the user's finger. The array is a linear type, with a 5-12 MHz frequency range, average scan depth of 3 cm and maximum scan depth of 6 cm. The array contains 128 elements spaced at 200 micron pitch, forming an azimuthal total aperture size of 25.6 mm. The elevational aperture height is 4 mm. The array supports acquisition of ultrasound images in 2D, M-Mode, Pulsed Wave (PW) Doppler, and Color Power Doppler, or in a combination of these modes.

#### Intended Use: The SonicEye® ultrasound transducer is a general-purpose transducer intended for use by a qualified clinician for diagnostic

Blacktoe Medical III, Inc. 8305 SW Creekside Place, Suite C Beaverton, OR 96778 t: 503-636-6999 w: www.blacktoemedical.com

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Image /page/1/Picture/0 description: The image shows the logo for Blacktoe Medical. The word "Blacktoe" is in a bold, sans-serif font, with a thick line underneath it. Below the line, the word "MEDICAL" is in a thinner, sans-serif font. The words "Pointing ultrasound in a new direction" are below the word "MEDICAL" in a smaller font.

ultrasound imaging or fluid flow analysis of the human body in the following applications: Pediatric, Small Organ (breast, thyroid, testicles, prostate), Musculo-skeletal (conventional and superficial), and Peripheral Vessel. The SonicEye® was designed to make a conventional hand held Technological probe wearable on the finger. This ergonomic form factor, Characteristics: enables imaging while freeing the operator to use the hand to assist in other elements of the examination. Elements of the probe related to image generation and safety, for example array design, housing, cabling and insulation are similar to conventional probes and differ only in form factor. Safety testing of the SonicEye® and comparison testing with the predicate probe show no differences in safety or image quality that would impact the effectiveness of the device. The SonicEve® transducer is substantially equivalent to the Substantial cleared Sonosite SLA/13-6 Transducer for MicroMaxx® high-Equivalence: resolution ultrasound system (K053069) with regard to safety and effectiveness.

- Wearing the transducer on the finger potentially provides several Summary of benefits over a hand-held probe including: Benefits:
- The finger form factor allows the clinician to . simultaneously palpate or elicit symptoms through touch with the finger and hand using the probe, thus correlating symptoms with diagnostic image generation.
- The probe leverages innate hand/finger/eye . coordination and innate spatial orientation of the finger probe to improve imaging dexterity. It is especially suitable for performing needle-guided ultrasound procedures.
- The probe can be used with conventional gloves or . commercially available transducer sheaths, facilitating clinical workflow for ultrasound-guided procedures.
- The hand performing the exam can be used to � stabilize the region being scanned.

Blacktoe Medical III, Inc. 8305 SW Creekside Place, Suite C Beaverton, OR 96778 t: 503-636-6999 w: www.blacktoemedical.com

Submittal Page 50

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Image /page/2/Picture/0 description: The image shows the logo for Blacktoe Medical. The word "Blacktoe" is in large, bold letters, with a line underneath it. Below that, the word "MEDICAL" is in smaller, all-caps letters. Underneath that is a line of text that is too small to read.

| & Conclusion: following product safety standards: | |
|---------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Reference Number | Title |
| IEC 60601-1:1990<br>plus A1:1993 and<br>A2:1995 | Medical electrical equipment - Part 1:<br>General requirements for basic safety<br>and essential performance |
| IEC 60601-1-2:2008 | Medical Electrical Equipment - Part 1-<br>2: General Requirements for Safety -<br>Collateral Standard: Electromagnetic<br>Compatibility - Requirements and<br>Tests |
| IEC 60601-2-<br>37:2007 | Medical electrical equipment - Part 2-<br>37: Particular requirements for the<br>basic safety and essential<br>performance of ultrasonic medical<br>diagnostic and monitoring equipment |
| NEMA UD-2:2004 | Acoustic Output Measurement<br>Standard for Diagnostic Ultrasound<br>Equipment |
| NEMA UD-3:2004 | Standard for Real Time Display of<br>Thermal and Mechanical Acoustic<br>Output Indices on Diagnostic<br>Ultrasound Equipment |
| ISO 10993:2009 | Biological evaluation of medical<br>devices - Part 1: Evaluation and<br>Testing |

Test Summary The SonicEye transducer has been designed to conform with the

Blacktoe Medical III, Inc. 8305 SW Creekside Place, Suite C Beaverton, OR 96778 t: 503-636-6999 w: www.blacktoemedical.com

י

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around it. Inside the circle is a stylized symbol that resembles a human figure or a stylized eagle.

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

Ms. Kendra Rathkey Manager, Ouality & Regulatory Blacktoe Medical III, Inc. 8305 Creekside Place, Suite C BEAVERTON OR 97008

Re: K113832

Trade/Device Name: SonicEye Transducer for use with SonoSite MicroMaxx® Ultrasound System

Regulation Number: 21 CFR 892.1570 Regulation Name: Diagonstic ultrasonic transducer Regulatory Class: II Product Code: ITX Dated: December 22, 2011 Received: December 27, 2011

Dear Ms. Rathkey:

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 SonoSite MicroMaxx® Ultrasound System, as described in your premarket notification:

#### Transducer Model Number

SonicEye Transducer for use with SonoSite MicroMaxx® Ultrasound System

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.

MAR = 6 2012

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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 (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 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,

Mary S. Patel for

Janine M. Morris Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

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# Diagnostic Ultrasound Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: SonicEye Transducer for use with SonoSite MicroMax® Ultrasound System

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| | Mode of Operation | | | | | | |
|-------------------------------------------------------|-------------------|---|-----|-----|------------------|--------------------|--------------------|
| Clinical Application<br> | B | M | PWD | CWD | Color<br>Doppler | Combined (Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | |
| Fetal | | | | | | | |
| Abdominal | | | | | | | |
| Intra-operative (Specify) | | | | | | | |
| Intra-operative (Neuro) | | | | | | | |
| Laparoscopic | | | | | | | |
| Pediatric | N | N | N | | N | B+M, B+CD, B+PWD | |
| Small Organ (breast, thyroid,<br>testicles, prostate) | N | N | N | | N | B+M, B+CD, B+PWD | |
| Neonatai Cephalic | | | | | | | |
| Adult Cephalic | | | | | | | |
| Trans-rectal | | | | | | | |
| Trans-vaginal | | | | | | | |
| Trans-urethral | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | |
| Musculo-skeletal (Conventional) | N | N | N | | N | B+M, B+CD, B+PWD | |
| Musculo-skeletal (Superficial) | N | N | N | | N | B+M, B+CD, B+PWD | |
| Intravascular | | | | | | | |
| Other (Specify) | | | | | | | |
| Cardiac Adult | | | | | | | |
| Cardiac Pediatric | | | | | | | |
| Intravascular (Cardiac) | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | |
| Intra-cardiac | | | | | | | |
| Other (Specify) | | | | | | | |
| Peripheral vessel | N | N | N | | N | B+M, B+CD, B+PWD | |
| Other (Specify) | | | | | | | |

Stree (Open))
N = new indication; P = previously cleared by FDA; E = added under this appendix

#### Additional Comments:

Prescription Use (per 21 CFR 801.109)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Mary S Patel
(Division Sign-Off)

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

510K 5113832

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Submittal Page 47