SoundBite™ Crossing System - Peripheral is indicated to facilitate the intra-luminal placement of conventional guidewires or treatment devices beyond peripheral artery chronic total occlusions. The SoundBite™ Crossing System -Peripheral is not intended for use in the carotid arteries.

Device Description

The SoundBite™ Crossing System - Peripheral is a recanalization tool, designed to help physicians place conventional guidewires or treatment devices in the intraluminal space beyond chronic total occlusions in the peripheral vasculature. The SoundBite™ Crossing System - Peripheral consists of the reusable mobile SoundBite™ Console, the single-use sterile SoundBite™ Active Wire 18, and their accessories.

The SoundBite™ Console generates controlled mechanical pulses (i.e., shock waves) which are transmitted to the SoundBite™ Active Wire 18 and cause the distal tip of the wire to accelerate axially in a reciprocating motion, acting like a micro-jackhammer.

The SoundBite™ Active Wire 18 is similar in construction to other commercially available CTO crossing wires, with 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 0.46 mm (0.018") and it is 300 cm long, with a working length of 150 cm; the proximal end flares up to a larger diameter for connection to the console. The single-use SoundBite™ Active Wire 18 is supplied sterile with a shelf life of 24 months.

AI/ML Overview

Here's an analysis of the acceptance criteria and study findings for the SoundBite™ Crossing System - Peripheral, based on the provided document:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal acceptance criteria in a table format with pre-defined thresholds for performance metrics. However, it reports the primary and secondary endpoints observed in the clinical study, which implicitly serve as the performance measures. The primary endpoint was technical success of the device.

Based on the study summary, here's a representation of the reported performance:

Performance Metric	Acceptance Criteria (Implicit from Study Findings)	Reported Device Performance
Primary Endpoint:	Achieve technical success in a high percentage of cases.	92.3% technical success (48 of 52 study subjects)
Secondary Endpoints:	Demonstrate post-procedural patency.	88.5% (46/52) had post-procedural patency
	Cross a significant portion of the CTO.	≥0.5 cm of CTO crossed in 98.1% (51/52) of cases
		≥1.0 cm of CTO crossed in 98.1% (51/52) of cases
	Full CTO traversal without additional devices (where applicable).	59% (31/52) achieved full CTO traversal without additional guidewires or re-entry devices
Safety:	Low incidence of adverse events attributed to the device.	No adverse events attributed to the device (per independent physician adjudication)

Study Details

Sample size used for the test set and the data provenance:
- Test Set Sample Size: 52 patients.
- Data Provenance: The document states it was a "single-arm clinical study involving 52 patients with documented symptomatic infrainguinal chronic total occlusions (CTO)." It does not specify the country of origin, but given the submission is to the US FDA and the company is based in Canada, it's likely a multi-national or North American study. The study is prospective in nature as it involved actively evaluating the device in clinical conditions.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document mentions "independent physician adjudication" for adverse events but does not specify the number or qualifications of experts used to establish the ground truth (e.g., initial diagnosis of CTO or assessment of technical success) for the main efficacy endpoints. The "ground truth" for CTO diagnosis was "confirmed angiographically."
Adjudication method for the test set:
- The document explicitly mentions "independent physician adjudication" for adverse events. For the primary and secondary efficacy endpoints, the method details are not provided.
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, an MRMC comparative effectiveness study was not done. This device is a medical instrument (crossing system for CTOs), not an AI-powered diagnostic or assistive tool for human readers. Therefore, the concept of human readers improving with or without AI assistance is not applicable here.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is a physical medical instrument requiring human operation, not a standalone algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- CTO diagnosis: Confirmed angiographically.
- Technical Success: Defined as the ability to facilitate the treatment of target lesions by allowing additional crossing and/or treatment devices to cross the CTO. This would be based on procedural success documented by the operating physician and confirmed radiographically.
- Adverse Events: Based on clinical observation and "independent physician adjudication."
- Secondary Endpoints: Based on procedural and post-procedural clinical/radiographic observation.
The sample size for the training set:
- Not applicable. This is a physical medical device, not an AI model requiring a training set in the conventional sense. The "training" of the device's design and manufacturing processes comes from extensive bench, animal, and usability testing.
How the ground truth for the training set was established:
- Not applicable. As the device is not an AI model, a "training set" with ground truth as commonly understood for AI is not relevant. The device development involved design verification and validation testing, risk assessment, and comparison to reference devices through bench and animal testing. These processes validate technical specifications and safety rather than "train" an algorithm.

Summary

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January 17, 2020

SoundBite Medical Solution, Inc. Mr. Marc-Andre Cote Director. Regulatory Affairs 2300 Blvd Alfred Nobel Montreal, QC Canada H4S 2A4

Re: K192211

Trade/Device Name: SoundBite Crossing System - Peripheral Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: PDU Dated: December 13, 2019 Received: December 16, 2019

Dear Mr. Cote:

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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 (OS) 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,

For

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) K192211

Device Name

SoundBite Crossing System - Peripheral

Indications for Use (Describe)

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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K192211 p. 1 of 4

510(K) Summary

As required by 21 CFR 807.92

Date Prepared:	17 January 2020
Submitted by:	SoundBite Medical Solutions, Inc.2300 Alfred Nobel, Suite 230Montreal, QuebecCanada H4S 2A4
Contact:	Marc-André CôtéDirector, Regulatory AffairsTel: (514) 956-2525 x 3352Fax: (514) 956-2529E-mail : marc-andre.cote@soundbitemedical.com
Trade/Device Name:	SoundBite™ Crossing System ">– Peripheral
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:	The CROSSER® S6 System by FlowCardia, Inc. (K092175)
Reference Devices:	CROSSER® 14S RX Catheter – The CROSSER® System (K072776)TruePath™ CTO Device by Boston Scientific Corp. (K140288)V-18™ ControlWire™ Guidewire by Boston Scientific Corp. (K033742)

Device Description:

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Intended Use / Indications for Use:

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

The SoundBite™ Crossing System – Peripheral is not intended for use in the carotid arteries.

Substantial Equivalence Comparison:

The SoundBite™ Crossing System - Peripheral is substantially equivalent to the predicate device - The CROSSER® S6 System (K092175) - in intended use and indications for use, fundamental technologies, principles of operation, and labeling. Non-clinical bench testing data, and performance data from animal and clinical studies have been submitted to demonstrate that the differences in technological characteristics do not raise different questions of safety and effectiveness. A side-by-side comparison of key device characteristics is presented in the following table:

DeviceCharacteristic	The CROSSER® S6 System(K092175)	SoundBite™ Crossing System – Peripheral
Systemcomponents	- AC-powered, mobile CROSSER®Generator with footswitch;- High-frequency transducer;- Single-use CROSSER® S6 Catheter;- FLOWMATE® Injector (optional)	- AC-powered, mobile SoundBite™ Consolegenerator and footswitch;- Single-use SoundBite™ Active Wire 18
CatheterIrrigation	Irrigation port and lumen on catheter.Requires refrigerated saline to controlheat generation.	Not required
Mechanism ofaction	High-frequency mechanical vibrationsare propagated through a Nitinol corewire to the Stainless Steel tip of theCROSSER® S6 Catheter.	Mechanical pulses sent along the length of theTitanium alloy SoundBite™ Active Wire 18cause the distal tip to accelerate axially in areciprocating (back-and-forth) motion, actinglike a micro-jackhammer.
GuidewireCompatibility	No guidewire required	No guidewire required
Catheter/WireConnection	Connection hub on catheter withtransducer coupling and irrigation port	Titanium alloy section reducer for connectionto the SoundBite™ Console
WorkingLength	154 cm or 106 cm	150 cm
RadiopaqueMarker	Stainless Steel catheter tip	10 mm radiopaque coil starting at 1.5 mmfrom the distal tip
Wire/CatheterShaft Diameter	1.3 mm (0.051")	0.46 mm (0.018")

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DeviceCharacteristic	The CROSSER® S6 System(K092175)	SoundBiteTM Crossing System - Peripheral
Wire/CatheterTip Diameter	0.6 mm (0.025")	0.29 mm (0.0115")
Wire/CatheterMaterial	Core: NitinolMain body: PebaxTip: Stainless Steel	Titanium alloy
Wire/CatheterCoating	Main body and catheter tip:Hydrophilic coating(material not known)	PTFE coating on main body of the wire only;no coating on distal end
Wire/CatheterSold Sterile	Yes	Yes
SterilizationMethod	Gamma Irradiation	Ethylene Oxide
Shelf Life	Not known	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.

Basic safety and performance 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) have been verified and/or validated in accordance with current FDArecognized consensus standards and regulatory requirements. The medical device software system has been designed, developed and verified in compliance with the FDA-recognized consensus standard IEC 62304.

For device characteristics where objective performance standards and acceptance criteria have not been established, and where direct comparison with the predicate device was not possible, the SoundBite™ Crossing System – Peripheral was compared to commercially available reference devices having substantially similar technological, physiological and anatomical site of use characteristics. The overall acute and chronic safety profile of the proposed system were compared to a reference device in an animal study.

SoundBite™ Crossing System - Peripheral was assessed in the following areas:

. Visual and dimensional inspection
Simulated use
Coating integrity
. Tip pull
Flexibility resistance ●
Fracture resistance
. Torque strength
Tensile strength ●
Corrosion resistance ●
. Torqueability
Distal temperature

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Tip flexibility ●
Catheter qualification ●
Lubricity assessment ●
Particulate testing
Shelf life testing ●

SoundBite™ Console was assessed in the following areas:

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: 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 rigors.

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

The results from bench and animal testing indicate that the performance characteristics of the SoundBite™ Crossing System - Peripheral are comparable to the reference devices and do not raise different questions of safety and effectiveness.

Summary of Clinical Testing:

The performance of the SoundBite™ Crossing System – Peripheral was also evaluated under actual clinical conditions in a single-arm clinical study involving 52 patients with documented symptomatic infrainguinal chronic total occlusions (CTO). All CTOs were confirmed angiographically to be 100% occluded.

The SoundBite™ Crossing System - Peripheral has met the primary performance endpoint of technical success in 92.3% of cases (48 of 52 study subjects). Technical success was defined as the abilitate treatment of the target lesions by allowing additional crossing and/or treatment devices to cross the CTO.

In assessing the secondary endpoints, 88.5% (46/52) of subjects had post-procedural patency following successful crossing of the CTO. In 98.1% (51/52) of cases, ≥0.5 cm of any segment of the CTO was crossed. Similarly, in 98.1% (51/52) of cases, ≥1.0 cm of any segment of the CTO was crossed. Furthermore, in 59% (31/52) of cases, the system fully traversed the CTO with entry into the distal lumen without the need for additional guidewires or re-entry devices.

There were no adverse events attributed to the device, as per independent physician adjudication. The study results demonstrate the favorable clinical safety and performance profile of the proposed device.

Conclusion

The data submitted with this 510(k) premarket notification demonstrate that the SoundBite™ Crossing System - Peripheral 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).