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 Description

The SonicEye® is a finger-mounted ultrasound transducer 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.

AI/ML Overview

This document describes a 510(k) premarket notification for the "SonicEye® Ultrasound Transducer" by Blacktoe Medical III, Inc. The core of this submission is to demonstrate substantial equivalence to a legally marketed predicate device, the SonoSite SLA/13-6 Transducer for MicroMaxx® high-resolution ultrasound system (K053069).

The acceptance criteria and study information provided in this document are focused on demonstrating that the SonicEye® transducer is safe and effective when compared to the predicate device, primarily through safety testing and comparison testing with the predicate probe, rather than a clinical study measuring diagnostic accuracy against a specific ground truth.

Here's an breakdown based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of a 510(k) for an ultrasound transducer, the "acceptance criteria" are related to safety and "performance" refers to image quality and functionality being equivalent to the predicate. The document doesn't explicitly list numerical acceptance criteria in terms of diagnostic metrics (e.g., sensitivity, specificity) for a particular disease. Instead, it asserts equivalence in general safety and image quality.

Acceptance Criterion (Implicit)	Reported Device Performance
Conformance to Product Safety Standards	The SonicEye® transducer has been designed to conform with the following product safety standards: IEC 60601-1:1990 plus A1:1993 and A2:1995, IEC 60601-1-2:2008, IEC 60601-2-37:2007, NEMA UD-2:2004, NEMA UD-3:2004, ISO 10993:2009.
Image Quality and Safety Equivalent to Predicate Device	"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." (Page 1, "Technological Characteristics")
Functionality (Modes of Operation)	Supports acquisition of ultrasound images in 2D, M-Mode, Pulsed Wave (PW) Doppler, and Color Power Doppler, or in a combination of these modes. (Page 0, "Device Description"). This implies these modes are also available and functionally equivalent to what the predicate device can provide.
Intended Use Applications Match Predicate Device or are Equivalent	Intended for use in Pediatric, Small Organ (breast, thyroid, testicles, prostate), Musculo-skeletal (conventional and superficial), and Peripheral Vessel applications, consistent with "N = new indication" marking for these applications in the Indications for Use table, implying these are covered by the equivalence.

Study Proving Acceptance Criteria:

The document explicitly states: "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." This is the core 'study' described for demonstrating equivalence for safety and image quality. It is a direct comparison between the subject device and the predicate device.

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

The document does not specify a sample size for a test set in the context of diagnostic performance (e.g., number of patients, images). The "comparison testing" mentioned for image quality and safety is likely an engineering/benchtop comparison rather than a clinical study involving human subjects or a dataset of images with established ground truth diagnoses.

Data Provenance: Not applicable as it's not a clinical diagnostic study with patient data. The comparison testing would likely involve physical measurements and potentially phantom imaging.

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

This information is not provided and is likely not relevant to this type of submission. As it's an ultrasound transducer, the "ground truth" for its performance typically refers to physical specifications, image quality metrics (e.g., resolution, penetration, contrast), and safety parameters, which are assessed through engineering tests and comparison to a predicate, not by expert diagnostic consensus on patient cases.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of an adjudication process as there is no clinical diagnostic test set requiring human interpretation.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not conducted. This device is an ultrasound transducer, a hardware component, not an AI software algorithm. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.

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

No, a standalone performance study in the context of an algorithm's diagnostic accuracy was not done. This is a hardware device.

7. The Type of Ground Truth Used

For the "comparison testing" regarding image quality and safety, the ground truth would be established by:

Physical measurements and engineering specifications: For safety (acoustic output, electrical safety, biological compatibility per referenced standards) and fundamental image quality parameters (e.g., spatial resolution, contrast resolution, penetration, sensitivity), often assessed using phantoms.
Direct comparison to the predicate device: The predicate device itself, having already been cleared by the FDA, serves as the de facto "ground truth" for acceptable performance. The aim is to demonstrate that the SonicEye® performs "no different" from the predicate.

8. The Sample Size for the Training Set

Not applicable. This submission is for a hardware device, an ultrasound transducer. There is no mention of an algorithm or a training set for machine learning.

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

Not applicable. As there is no training set for an algorithm, the method for establishing its ground truth is irrelevant.

Summary

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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 503-636-6999 Fax 503-715-0597
- 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 60601-1:1990plus A1:1993 andA2:1995	Medical electrical equipment - Part 1:General requirements for basic safetyand essential performance
IEC 60601-1-2:2008	Medical Electrical Equipment - Part 1-2: General Requirements for Safety -Collateral Standard: ElectromagneticCompatibility - Requirements andTests
IEC 60601-2-37:2007	Medical electrical equipment - Part 2-37: Particular requirements for thebasic safety and essentialperformance of ultrasonic medicaldiagnostic and monitoring equipment
NEMA UD-2:2004	Acoustic Output MeasurementStandard for Diagnostic UltrasoundEquipment
NEMA UD-3:2004	Standard for Real Time Display ofThermal and Mechanical AcousticOutput Indices on DiagnosticUltrasound Equipment
ISO 10993:2009	Biological evaluation of medicaldevices - Part 1: Evaluation andTesting

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

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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 (301) 796-6242.

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	B	M	PWD	CWD	ColorDoppler	Combined (Specify)	Other(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,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

Page 1 of 1

Submittal Page 47

Regulation Number and Section

§ 892.1570 Diagnostic ultrasonic transducer.

(a)
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.(b)
Classification. Class II.