(156 days)
No
The description focuses on the mechanical action of the device (generating controlled mechanical pulses) and does not mention any AI/ML components or functions.
Yes
The device is described as a "recanalization tool" and its intended use is to "facilitate the intra-luminal placement of conventional guidewires or treatment devices beyond peripheral artery chronic total occlusions," which is a direct therapeutic intervention. The clinical study also evaluates "post-procedural patency following successful crossing of the CTO," indicating a therapeutic outcome.
No
This device is a recanalization tool designed to facilitate the placement of guidewires or treatment devices beyond chronic total occlusions, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states that the system consists of a reusable mobile console and a single-use sterile active wire, both of which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The SoundBite™ Crossing System - Peripheral is a mechanical device used within the body (intraluminal) to facilitate the placement of guidewires or treatment devices through chronic total occlusions in peripheral arteries. It physically interacts with the blockage.
- Intended Use: The intended use clearly describes a procedure performed in vivo (within a living organism), not a test performed in vitro (in a lab setting).
- Device Description: The description details a console that generates mechanical pulses and an active wire that acts like a "micro-jackhammer" to cross blockages. This is a therapeutic/interventional device, not a diagnostic one.
The device's purpose is to enable a medical procedure, not to analyze a sample for diagnostic information.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
PDU
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral artery
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physicians
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The performance of the SoundBite™ Crossing System – Peripheral was 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Technical success in 92.3% of cases (48 of 52 study subjects).
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.
In 98.1% (51/52) of cases, ≥1.0 cm of any segment of the CTO was crossed.
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.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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
2
Indications for Use
510(k) Number (if known) K192211
Device Name
SoundBite Crossing System - Peripheral
Indications for Use (Describe)
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.
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 230 | ||
| Montreal, Quebec | ||
| Canada H4S 2A4 | ||
| Contact: | Marc-André Côté | |
| Director, Regulatory Affairs | ||
| Tel: (514) 956-2525 x 3352 | ||
| Fax: (514) 956-2529 | ||
| E-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:
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.
4
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:
| Device
Characteristic | The CROSSER® S6 System
(K092175) | SoundBite™ Crossing System – Peripheral |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| System
components | - AC-powered, mobile CROSSER®
Generator with footswitch;
- High-frequency transducer;
- Single-use CROSSER® S6 Catheter;
- FLOWMATE® Injector (optional) | - AC-powered, mobile SoundBite™ Console
generator and footswitch; - Single-use SoundBite™ Active Wire 18 |
| Catheter
Irrigation | Irrigation port and lumen on catheter.
Requires refrigerated saline to control
heat generation. | Not required |
| Mechanism of
action | High-frequency mechanical vibrations
are propagated through a Nitinol core
wire to the Stainless Steel tip of the
CROSSER® S6 Catheter. | Mechanical pulses sent along the length of the
Titanium alloy SoundBite™ Active Wire 18
cause the distal tip to accelerate axially in a
reciprocating (back-and-forth) motion, acting
like a micro-jackhammer. |
| Guidewire
Compatibility | No guidewire required | No guidewire required |
| Catheter/Wire
Connection | Connection hub on catheter with
transducer coupling and irrigation port | Titanium alloy section reducer for connection
to the SoundBite™ Console |
| Working
Length | 154 cm or 106 cm | 150 cm |
| Radiopaque
Marker | Stainless Steel catheter tip | 10 mm radiopaque coil starting at 1.5 mm
from the distal tip |
| Wire/Catheter
Shaft Diameter | 1.3 mm (0.051") | 0.46 mm (0.018") |
5
| Device
Characteristic | The CROSSER® S6 System
(K092175) | SoundBiteTM Crossing System - Peripheral |
|-------------------------------|----------------------------------------------------------------------------|-------------------------------------------------------------------------|
| Wire/Catheter
Tip Diameter | 0.6 mm (0.025") | 0.29 mm (0.0115") |
| Wire/Catheter
Material | Core: Nitinol
Main body: Pebax
Tip: Stainless Steel | Titanium alloy |
| Wire/Catheter
Coating | 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/Catheter
Sold Sterile | Yes | Yes |
| Sterilization
Method | 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
6
- 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.