(221 days)
No
The description focuses on mechanical and electrical components and their function, with no mention of AI or ML capabilities. The RFID tag is for identification and tracking, not intelligent processing.
No.
The device facilitates the placement of other treatment devices; it does not directly treat a condition.
No.
The SoundBite® Crossing System XS Peripheral is described as a "recanalization device" used to facilitate the placement of guidewires or treatment devices, indicating a therapeutic or interventional function, not a diagnostic one.
No
The device description clearly outlines hardware components including a console, foot switch, and active wire, indicating it is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "facilitate the intraluminal placement of conventional guidewires or treatment devices beyond peripheral artery chronic total occlusions." This describes a therapeutic or interventional procedure performed directly on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The device is a "recanalization device" that uses mechanical pulses to help cross blockages in arteries. This is a physical intervention, not a diagnostic test.
- Anatomical Site: The device is used in the "peripheral artery," which is an in-vivo application.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as analyzing biological samples (blood, urine, tissue), detecting biomarkers, or providing diagnostic information about a patient's condition based on laboratory analysis.
In summary, the SoundBite® Crossing System XS Peripheral is a medical device used for a therapeutic procedure within the body, not a diagnostic test performed on a sample outside the body.
N/A
Intended Use / Indications for Use
The SoundBite® Crossing System XS Peripheral is indicated to facilitate the intraluminal placement of conventional guidewires or treatment devices beyond peripheral artery chronic total occlusions.
The SoundBite® Crossing System XS Peripheral is not intended for use in the carotid arteries.
Product codes
PDU
Device Description
The SoundBite® Crossing System XS Peripheral, is a recanalization device designed to help physicians place a conventional guidewire or treatment device in the intraluminal space beyond peripheral chronic total occlusions (CTOs). It is intended for use in a professional healthcare facility, such as a catheterization laboratory, also known as a Cath Lab. The system consists of the AC-powered, reusable, mobile SoundBite® Console XS with a Foot Switch, and a single-use, sterile SoundBite® Active Wire XS 14P packaged together with two accessories, the SoundBite® Curving Tool 14 and the SoundBite® Torquer.
The AC-powered, reusable, mobile SoundBite® Console XS is an iteration of the predicate device, re-engineered for improved usability but with similar design, functional, safety, and performance specifications. It generates controlled, high-amplitude, short-duration mechanical pulses (i.e., shock waves) that are transmitted to the connected SoundBite® Active Wire XS 14P and cause the distal end of the wire to move back and forth (axially), acting like a micro-jackhammer.
The single-use SoundBite® Active Wire XS 14P is a 350 cm long metallic wire with an outer diameter of 0.36 mm (0.014") over its usable length. It is similar in construction to the Active Wire of the predicate and reference devices, but 50 cm longer. The proximal end of the SoundBite® Active Wire XS 14P includes a connector assembly that encapsulates a wire section reducer for easy connection to the SoundBite® Console XS, and a Radio Frequency ldentification (RFID) tag that allows the SoundBite® Console XS to detect and uniquely identify the wire and track its use. A thermoplastic elastomer sleeve was also added to proximal length of the wire during use.
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
professional healthcare facility, such as a catheterization laboratory, also known as a Cath Lab.
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)
Design verification and validation testing was conducted in compliable FDA-recognized consensus standards, FDA guidance, and current industry standards following systematic risk assessment in accordance with ISO 14971:2019.
The SoundBite® Console XS was assessed for substantial equivalence with the SoundBite® Active Wire XS 14P (i.e., electrical and mechanical safety, electromagnetic compatibility, functionality, and serviceability).
The medical device software system has been designed, and verified in compliance with IEC 62304.
Usability was assessed under anticipated use conditions in compliance with IEC 62366-1 and FDA guidance.
The sterility of the SoundBite® Active Wire XS 14P and its accessories to the point of care is assured by validated Ethylene Oxide sterilization processes, shelf-life testing, and sterity testing under foreseeable storage and transport conditions.
The biocompatibility of the SoundBite® Active Wire XS 14P was assessed in compliance with FDA-recognized standard ISO 10993-1 and FDA guidance for Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Acute Systemic Toxicity, Pyrogenicity, and Hemocompatibility.
The safety and performance of the SoundBite® Active Wire XS 14P were assessed, where appropriate using the supplied accessories, in the following areas:
-
Physical and dimensional specifications
-
Console connection and disconnection force
-
Proximal sleeve function
- Simulated use (crossing and durability) >
-
Wire coating integrity
- Particulates >
-
Corrosion resistance
- Lubricity in tortuous model >
-
Steerability
-
Kink resistance
-
Tensile strength on coil, proximal end assembly, and section reducer
-
Torque strength
-
Torqueability
-
Tip flexibility
-
Tip motion (maximum displacement)
-
Tip motion (vessel damage)
- Tip temperature >
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 28, 2023
Soundbite Medical Solutions, Inc. Diane Marceau Director, Ouality Assurance and Regulatory Affairs 2300 Alfred Nobel, Suite 230 Montreal, Quebec H4S 2A4 Canada
Re: K230159
Trade/Device Name: SoundBite® Crossing System XS Peripheral Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: PDU Dated: July 18, 2023 Received: July 18, 2023
Dear Diane Marceau:
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,
Digitally signed by Ariel Ariel G. Ashshakoor -S --- Date: 2
sn
G. Ash-shakoor -S Date: 2023.08.28 11:45:39
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) K230159
Device Name SoundBite® Crossing System XS Peripheral
Indications for Use (Describe)
The SoundBite® Crossing System XS Peripheral is indicated to facilitate the intraluminal placement of conventional guidewires or treatment devices beyond peripheral artery chronic total occlusions.
The SoundBite® Crossing System XS 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
SOUNCBITE 510(k) Summary
Image /page/3/Picture/2 description: The image shows the text 'K230159' in a bold, sans-serif font. The text is black against a white background. The characters are evenly spaced and easily readable.
| As required by 21 CFR 807.92 | |
|---|---|
| Date Prepared: | August 25, 2023 |
| Trade/Device name: | SoundBite® Crossing System XS Peripheral |
| Common Name: | System for Crossing Total Occlusions |
| Classification Name: | Catheter for Crossing Total Occlusions |
| Classification Product Code: | PDU |
| Regulation: | 21 CFR 870.1250, Percutaneous Catheter |
| Regulatory Class: | Class II |
| Manufacturer: | Soundbite Medical Solutions, Inc. |
| 2300 Alfred Nobel, Suite 230 | |
| Montreal, QC H4S 2A4, Canada | |
| Establishment Registration No.: | 3013290687 |
| Regulatory Contact: | Diane Marceau |
| Director, Quality Assurance and Regulatory Affairs | |
| Tel: (514) 956-2525 x 3352 | |
| Email: diane.marceau@soundbitemedical.com | |
| Predicate Device: | SoundBite® Crossing System – Peripheral (14P) [K210839] |
| Reference Device: | SoundBite® Crossing System - Peripheral [K192211] |
Device Description:
The SoundBite® Crossing System XS Peripheral, is a recanalization device designed to help physicians place a conventional guidewire or treatment device in the intraluminal space beyond peripheral chronic total occlusions (CTOs). It is intended for use in a professional healthcare facility, such as a catheterization laboratory, also known as a Cath Lab. The system consists of the AC-powered, reusable, mobile SoundBite® Console XS with a Foot Switch, and a single-use, sterile SoundBite® Active Wire XS 14P packaged together with two accessories, the SoundBite® Curving Tool 14 and the SoundBite® Torquer.
The AC-powered, reusable, mobile SoundBite® Console XS is an iteration of the predicate device, re-engineered for improved usability but with similar design, functional, safety, and performance specifications. It generates controlled, high-amplitude, short-duration mechanical pulses (i.e., shock waves) that are transmitted to the connected SoundBite® Active Wire XS 14P and cause the distal end of the wire to move back and forth (axially), acting like a micro-jackhammer.
The single-use SoundBite® Active Wire XS 14P is a 350 cm long metallic wire with an outer diameter of 0.36 mm (0.014") over its usable length. It is similar in construction to the Active Wire of the predicate and reference devices, but 50 cm longer. The proximal end of the SoundBite® Active Wire XS 14P includes a connector assembly that encapsulates a wire section reducer for easy connection to the SoundBite® Console XS, and a Radio Frequency ldentification (RFID) tag that allows the SoundBite® Console XS to detect and uniquely identify the wire and track its use. A thermoplastic elastomer sleeve was also added to proximal length of the wire during use.
Intended Use / Indications for Use:
The SoundBite® Crossing System XS Peripheral is indicated to facilitate the intraluminal placement of conventional guidewires or treatment devices beyond peripheral artery chronic total occlusions.
The SoundBite® Crossing System XS Peripheral is not intended for use in the carotid arteries.
4
SOUNCBITE 510(k) Summary
Substantial Equivalence Comparison:
The SoundBite® Crossing System XS Peripheral has the same intended use and indications for use, the same fundamental technology and principles of operation, and substantially equivalent technological characteristics as the predicate device, the SoundBite® Crossing System – Peripheral (14P) (K210839). A side-by-side comparison of key device characteristics is presented in the following table:
| Device Characteristic | SoundBite® Crossing System - Peripheral
(14P) / K210839 | SoundBite® Crossing System XS Peripheral |
|----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Mechanism of Action | Mechanical pulses sent along the length of the
SoundBite® Active Wire cause the distal tip to
accelerate axially in a reciprocating (back-and-
forth) motion, acting like a micro-jackhammer. | Mechanical pulses sent along the length of the
SoundBite® Active Wire cause the distal tip to
accelerate axially in a reciprocating (back-and-
forth) motion, acting like a micro-jackhammer. |
| Mobile Console | SoundBite® Console | SoundBite® Console XS |
| Energy Source | AC mains-powered | AC mains-powered |
| Software System | Firmware only | Firmware and Linux-based Software |
| User Interface | 20-character monochrome screen,
4 physical knobs, 4 lights | 10-inch color, touchscreen on the operator
side; 3-inch color, LCD on the physician side |
| Wire Identification | No | Radiofrequency identification (RFID) |
| Wire Tracking | No | Defect logging and usage time tracking |
| Wire Monitoring | No | Connection quality and tip activity monitoring |
| Wire Activation Means | Foot Switch | Foot Switch |
| Dimensions | 130 cm x 59 cm x 49 cm | 106 cm x 55 cm x 30 cm |
| Weight | 160 kg | 64 kg |
| Sound Level when Active | 70 dB | Physical and dimensional specifications
-
Console connection and disconnection force
-
Proximal sleeve function
- Simulated use (crossing and durability) >
-
Wire coating integrity
- Particulates >
-
Corrosion resistance
- Lubricity in tortuous model >
-
Steerability
-
Kink resistance
-
Tensile strength on coil, proximal end assembly, and section reducer
-
Torque strength
-
Torqueability
-
Tip flexibility
-
Tip motion (maximum displacement)
-
Tip motion (vessel damage)
- Tip temperature >
Conclusion:
The results from risk assessment and non-clinical testing of the SoundBite® Crossing System XS Peripheral do not raise new questions of safety or effectiveness. The data submitted with this 510(k) premarket notification demonstrate that the SoundBite® Crossing System XS Peripheral is substantially equivalent to the predicate device.