The SoundBite® Crossing System - Peripheral (14P) is indicated to facilitate the intraluminal placement of conventional guidewires or treatment devices beyond peripheral artery chronic total occlusions.

The SoundBite® Crossing System - Peripheral (14P) is not intended for use in the carotid arteries.

Device Description

The SoundBite® Crossing System - Peripheral (14P) is a recanalization tool, designed to help physician's placement of conventional guidewires or treatment devices in the intraluminal space beyond chronic total occlusions in the peripheral vasculature. The SoundBite® Crossing System - Peripheral (14P) consists of the reusable mobile SoundBite® Console, a single-use sterile SoundBite® Active Wire 14P, and their respective accessories.

The SoundBite® Console generates controlled mechanical pulses (i.e., shock waves) which are transmitted to the SoundBite® Active Wire 14P and cause the distal tip of the wire to accelerate axially in a reciprocating motion, acting like a micro-jackhammer.

The SoundBite® Active Wire 14P is similar in construction to the 0.018" CTO crossing wire provided with the predicate device, with a friction reducing PTFE coating (except for the distal tip), a radiopaque marker near the tip, and enhanced flexibility at the distal end. It has an outer diameter of 0.36 mm (0.014") and it is 300 cm long, with a working length of 145 cm. At the proximal end of the SoundBite® Active Wire 14P, a section reducer allows the wire to be connected to the SoundBite® Console. The single-use SoundBite® Active Wire 14P is supplied sterile with a shelf life of 24 months.

AI/ML Overview

This document is a 510(k) summary for the SoundBite® Crossing System - Peripheral (14P), a medical device. It focuses on demonstrating substantial equivalence to a predicate device, not on proving clinical efficacy through a specific study with acceptance criteria for device performance as would be the case for an AI/ML-driven device.

Therefore, the requested information elements related to acceptance criteria, device performance, sample sizes for test sets, expert-driven ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable to this document. This submission relies on non-clinical testing and comparison to a predicate device.

However, I can provide the available information from the document as it relates to the device and its testing:

1. A table of acceptance criteria and the reported device performance

This document does not specify quantitative acceptance criteria or reported device performance in the manner typically seen for AI/ML device evaluations (e.g., sensitivity, specificity, accuracy thresholds). Instead, it states that "The results from bench testing indicate that the performance characteristics of the SoundBite® Crossing System - Peripheral (14P) are substantially equivalent to the predicate device and do not raise new questions of safety or performance." The performance is evaluated through various non-clinical tests to show substantial equivalence.

Non-Clinical Testing Areas:

Visual and dimensional inspection
Simulated use
Coating integrity
Tip pull
Flexibility resistance
Fracture resistance
Torque strength
Tensile strength
Corrosion resistance
Torqueability
Distal temperature
Tip flexibility
Catheter qualification
Lubricity assessment
Particulate testing
Shelf-life testing
Console Output Stability
Life-Cycle Testing
Console and Shipping Container Labels Verification
Electronics and Software Verification
ANSI AAMI ES60601-1:2005/(R) 2012 and A1:2012
IEC 60601-1-2 Edition 4.0 2014-02
Biocompatibility (full panel performed under GLP)
Usability (summative evaluation)

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. The submission is based on non-clinical bench testing, animal studies, and usability evaluations, not clinical data sets from human subjects with specified sample sizes for testing or training AI/ML alongside provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. The ground truth for the non-clinical tests would be established by standard engineering and testing procedures, not by human experts interpreting clinical data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This concept pertains to expert review of clinical data, which is not the basis of this submission.

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

Not applicable. This device is a physical medical device (a catheter system), not an AI/ML-driven diagnostic or assistive tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithm-only device. It is a physical medical device used by a physician.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" for this device's evaluation comes from established engineering standards, material science, biocompatibility testing protocols, and usability guidelines to ensure safety and performance equivalence to the predicate device. For example, "biocompatibility" is assessed against established biological response criteria, and "tensile strength" against material specifications.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/ML device that requires a training set.

Summary of the Study (as described in the document):

The submission for the SoundBite® Crossing System - Peripheral (14P) is a 510(k) premarket notification seeking to demonstrate substantial equivalence to an existing predicate device (SoundBite® Crossing System - Peripheral, K192211). The study primarily consists of non-clinical bench testing, animal studies, and usability evaluations.

Objective: To demonstrate that the SoundBite® Crossing System - Peripheral (14P) is substantially equivalent to its predicate device in intended use, indications for use, fundamental technologies, principles of operation, and labeling.
Methodology:
- Non-clinical bench testing: A wide range of physical and mechanical tests were performed on the device components and the system (as listed in point 1 above) to assess its design, performance characteristics, and compliance with recognized standards (e.g., ISO 14971, IEC 62304, ANSI AAMI ES60601-1, IEC 60601-1-2).
- Biocompatibility testing: A full panel of tests was performed under GLP to ensure materials met biocompatibility requirements.
- Usability evaluation: Representative users were included in a summative evaluation to confirm safe and effective use.
- Animal studies: Performance data from animal studies were submitted to support the substantial equivalence claim, particularly concerning the differences in device characteristics (e.g., smaller diameter wire, different pulse repetition rate).
Conclusion: "The data submitted with this Special 510(k) premarket notification demonstrate that the SoundBite® Crossing System - Peripheral (14P) is substantially equivalent to the predicate device." The differences between the new device and the predicate device (e.g., wire diameter, working length, radiopaque marker position, console setting for pulse repetition rate) were addressed by the non-clinical and animal testing to show they do not raise new questions of safety or performance.

Summary

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April 20, 2021

Soundbite Medical Solutions, Inc. Dominique Abecassis Director, Compliance 2300 Boulevard Alfred-Nobel Montreal, Quebec H4S 2A4 Canada

Re: K210839

Trade/Device Name: SoundBite Crossing System - Peripheral (14P) Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: PDU Dated: March 18, 2021 Received: March 22, 2021

Dear Dominique Abecassis:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K210839

Device Name SoundBite® Crossing System - Peripheral (14P)

Indications for Use (Describe)

SoundBite® Crossing System - Peripheral (14P) is indicated to facilitate the intraluminal placement of conventional guidewires or treatment devices beyond peripheral artery chronic total occlusions.

SoundBite® Crossing System - Peripheral (14P) is not intended for use in the carotid arteries.

Type of Use (Select one or both, as applicable)

☒ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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K210839

Page 1 of 4

510(K) Summary

As required by 21 CFR 807.92

Date Prepared:	15 March 2021
Submitted by:	Soundbite Medical Solutions, Inc.
	2300 Boulevard Alfred-Nobel,Montreal, Quebec, CanadaH4S 2A4
Contact:	Dominique AbecassisDirector, ComplianceTel: (514) 956-2525 x 3352Fax: (514) 956-2529E-mail: dominique.abecassis@soundbitemedical.com
Trade/Device Name:	SoundBite® Crossing System – Peripheral (14P)
Common Name:	System for Crossing Total Occlusions
Regulation:	21 CFR 870.1250, Percutaneous Catheter
Device Class:	Class II
Product Code:	PDU (Catheter for Crossing Total Occlusions)
Predicate Device:	SoundBite® Crossing System – Peripheral by Soundbite MedicalSolutions Inc. (K192211)

Device Description:

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diameter of 0.36 mm (0.014") and it is 300 cm long, with a working length of 145 cm. At the proximal end of the SoundBite® Active Wire 14P, a section reducer allows the wire to be connected to the SoundBite® Console. The single-use SoundBite® Active Wire 14P is supplied sterile with a shelf life of 24 months.

Intended Use / Indications for Use:

The SoundBite® Crossing System - Peripheral (14P) is not intended for use in the carotid arteries.

Substantial Equivalence Comparison:

The SoundBite® Crossing System - Peripheral (14P) is substantially equivalent to the predicate device, the SoundBite® Crossing System - Peripheral (K192211), in intended use and indications for use, fundamental technologies, principles of operation, and labeling. Non-clinical bench testing data, and performance data from animal studies have been submitted to demonstrate that the differences in device characteristics do not raise questions related to safety or performance. A side-by-side comparison of key device characteristics is presented in the following table:

DeviceCharacteristic	Predicate Device 510(k) K192211SoundBite® Crossing System – Peripheral	SoundBite® Crossing System –Peripheral (14P)
SystemComponents	■ AC-powered, mobile SoundBite®Console generator and footswitch.■ Single-use SoundBite® Active Wire 18	■ AC-powered, mobile SoundBite®Console generator and footswitch.■ Single-use SoundBite® Active Wire 14P
Mechanism ofAction	Mechanical pulses sent along the length ofthe Titanium alloy SoundBite® Active Wirecause the distal tip to accelerate axially in areciprocating (back-and-forth) motion,acting like a micro-jackhammer.	Mechanical pulses sent along the length ofthe Titanium alloy SoundBite® Active Wirecause the distal tip to accelerate axially in areciprocating (back-and-forth) motion, actinglike a micro-jackhammer.
Console Setting:Pulse RepetitionRate (PRR)	10 Hz	20 Hz
Wire Connection	Titanium alloy section reducer forconnection to the SoundBite® Console	Titanium alloy section reducer forconnection to the SoundBite® Console
MaximumActive WireDiameterover UsableLength	0.46 mm (0.018")	0.36 mm (0.014")
WorkingLength	150 cm	145 cm
Radiopaque Marker	10 mm radiopaque coil starting at 1.5 mmfrom the distal tip	10 mm radiopaque coil starting at 0.75 mmfrom the distal tip

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DeviceCharacteristic	Predicate Device 510(k) K192211SoundBite® Crossing System – Peripheral	SoundBite® Crossing System –Peripheral (14P)
Wire Shaft Diameter	0.46 mm (0.018")	0.36 mm (0.014")
Wire Tip Diameter	0.29 mm (0.0115")	0.27 mm (0.0105")
Wire Material	Titanium alloy	Titanium alloy
Wire Coating	PTFE coating on main body of the wire only;no coating on distal end	PTFE coating on main body of the wire only;no coating on distal end
Wire Sold Sterile	Yes	Yes
Sterilization Method	Ethylene Oxide	Ethylene Oxide
Shelf Life	24 months	24 months

Summary of Non-Clinical Testing:

Design verification and validation testing was conducted following systematic risk assessment in accordance with the FDA-recognized consensus standard ISO 14971 and FDA guidance.

Substantial equivalence of the device, both at the system and component levels (i.e., sterility assurance to the point of care, packaging integrity and shelf-life, biocompatibility, electrical/mechanical safety, and electromagnetic compatibility) has been verified and/or validated in accordance with current FDA-recognized consensus standards and regulatory requirements. The medical device software system has been designed, and verified in compliance with the FDA-recognized consensus standard IEC 62304.

SoundBite® Crossing System - Peripheral (14P) was assessed in the following areas:

. Visual and dimensional inspection
트 Simulated use
Coating integrity l
Tip pull l
l Flexibility resistance
Fracture resistance l
l Torque strength
Tensile strength 트
Corrosion resistance I
l Torqueability
Distal temperature i
Tip flexibility .
Catheter qualification l
Lubricity assessment 트
Particulate testing I

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트 Shelf-life testing
SoundBite® Console was assessed in the following areas:
트 Console Output Stability
Life-Cycle Testing 트
Console and Shipping Container Labels Verification
트 Electronics and Software Verification
트 ANSI AAMI ES60601-1:2005/(R) 2012 and A1:2012
IEC 60601-1-2 Edition 4.0 2014-02

Biocompatibility: A full panel of biocompatibility tests was successfully performed in accordance with product classification, under GLP, demonstrating that all utilized materials and methods of construction/processing passed biocompatibility requirements.

Usability: Representative users were included in a summative evaluation. The study confirms that the SoundBite® Crossing System - Peripheral (14P) can be used without serious use errors or problems, for the intended uses under the expected use conditions.

The results from bench testing indicate that the performance characteristics of the SoundBite® Crossing System - Peripheral (14P) are substantially equivalent to the predicate device and do not raise new questions of safety or performance.

Conclusion:

The data submitted with this Special 510(k) premarket notification demonstrate that the SoundBite® Crossing System - Peripheral (14P) is substantially equivalent to the predicate device.

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).