(57 days)
Shockwave Medical Intravascular Lithoplasty System (K203365)
No
The summary does not mention AI, ML, deep learning, or any related terms. The device description focuses on mechanical and electrical components, and the performance studies describe traditional engineering and clinical evaluations.
Yes
The device is intended for lithotripsy-enhanced balloon dilatation of lesions in the peripheral vasculature to treat calcified lesions, which directly addresses a medical condition.
No
The device is intended for treatment (lithotripsy-enhanced balloon dilatation), not for diagnosing conditions.
No
The device description clearly outlines both a hardware component (console) and a disposable hardware component (catheter), in addition to the software.
Based on the provided information, the Bolt Intravascular Lithotripsy (IVL) System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for "lithotripsy-enhanced balloon dilatation of lesions... in the peripheral vasculature". This describes a therapeutic procedure performed within the patient's body to treat a medical condition.
- Device Description: The description details a "balloon catheter and console designed to enhance percutaneous transluminal angioplasty by delivering calcium disrupting lithotripsy prior to balloon dilatation". This is a medical device used for intervention and treatment, not for examining specimens outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, tissue, urine, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on samples taken from the body. The Bolt IVL System is an interventional medical device used directly on the patient's vasculature.
N/A
Intended Use / Indications for Use
The Bolt Intravascular Lithotripsy (IVL) System is intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, popliteal, and infra-popliteal arteries. Not for use in the coronary, carotid, or cerebral vasculature.
Product codes
PPN
Device Description
The Bolt Intravascular Lithotripsy (Bolt IVL) System is a proprietary balloon catheter and console designed to enhance percutaneous transluminal angioplasty by delivering calcium disrupting lithotripsy prior to balloon dilatation at low pressures. The application of lithotripsy mechanical pulse waves alters the structure of an occlusive vascular deposit (stenosis) allowing low-pressure balloon dilatation of the stenosis.
The Bolt IVL catheter is delivered through the peripheral arterial system of the lower extremities to the lesion site. The balloon is partially inflated and the lithotripsy emitters generate pulsatile mechanical energy within the balloon at the target treatment site allowing subsequent dilatation of a peripheral artery stenosis using low balloon pressure. The Bolt IVL Catheter is a single-use device supplied sterile to the customer.
The Bolt IVL console delivers energy through the integrated catheter cabling to the emitters located inside the catheter balloon. The Bolt IVL Console is a non-sterile, reusable device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Peripheral vasculature, including the iliac, femoral, popliteal, and infra-popliteal arteries.
Indicated Patient Age Range
Adult subjects (implied by clinical study data for peripheral arterial disease)
Intended User / Care Setting
Not Found
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
RESTORE ATK:
Study Type: prospective, non-randomized, multicenter, single arm study
Sample Size: 95 adult subjects
Key Results:
Primary safety endpoint: The lower bound of the 95% confidence interval for freedom from Major Adverse Events (MAE) at 30 days (96.8%) was above the performance goal (91.3%). Freedom from MAE ranged from 100% to 97.9%, with a lower 95% confidence interval of 96.9% to 93.5%. This interval was still within the performance goal of 91.3%.
Primary effectiveness endpoint: The lower bound of the 95% confidence interval for procedural success (96.9%) was above the performance goal (89.3%). Procedural success, defined as residual stenosis
§ 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).
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Bolt Medical, Inc. Stephanie Onstot Regulatory Affairs Manager 2131 Faraday Ave Carlsbad, California 92008
Re: K250225
Trade/Device Name: Bolt Intravascular Lithotripsy (IVL) System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: PPN Dated: January 24, 2025 Received: January 27, 2025
Dear Stephanie Onstot:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
2
Sincerely,
ARIEL G. ASH-SHAKOOR -S
Digitally signed by ARIEL G. ASH-SHAKOOR -S Date: 2025.03.25 08:41:46
-04'00'
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) K250225
Device Name Bolt Intravascular Lithotripsy (IVL) System
Indications for Use (Describe)
The Bolt Intravascular Lithotripsy (IVL) System is intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, popliteal, and infra-popliteal arteries. Not for use in the coronary, carotid, or cerebral vasculature.
| 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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510(k) Summary
Name, Address, Phone Number of Applicant
Bolt Medical, Inc. 2131 Faraday Ave Carlsbad, CA 92008 Phone: 760-979-1890
Contact Person
Stephanie Onstot
Date Prepared
March 19, 2025
Device Name and Classification
| Trade Name: | Bolt IVL™ Lithotripsy System |
|---|---|
| Common Name: | Catheter, angioplasty, peripheral, transluminal |
| CFR Classification: | 21 CFR 870.1250 |
| Classification Name: | Percutaneous catheter |
| Product Code: | PPN |
Predicate Device
The primary predicate for the Bolt IVL Lithotripsy System is the Shockwave Medical Lithoplasty System (K161384) cleared by FDA on September 14, 2016.
Reference Device
The reference device for the Bolt IVL Lithotripsy System is the Shockwave Medical Intravascular Lithoplasty System (K203365) cleared by FDA on April 22, 2021.
Indications for Use / Intended Use
The Bolt Intravascular Lithotripsy (IVL) System is intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, popliteal, and infra-popliteal arteries. Not for use in the coronary, carotid, or cerebral vasculature.
Device Description
The Bolt Intravascular Lithotripsy (Bolt IVL) System is a proprietary balloon catheter and console designed to enhance percutaneous transluminal angioplasty by delivering calcium disrupting lithotripsy prior to balloon dilatation at low pressures. The application of lithotripsy mechanical pulse waves alters the structure of an occlusive vascular deposit (stenosis) allowing low-pressure balloon dilatation of the stenosis.
The Bolt IVL catheter is delivered through the peripheral arterial system of the lower extremities to the lesion site. The balloon is partially inflated and the lithotripsy emitters generate pulsatile mechanical energy within the balloon at the target treatment site allowing subsequent dilatation of a peripheral artery stenosis using low balloon pressure. The Bolt IVL Catheter is a single-use device supplied sterile to the customer.
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Bolt Medical, Inc. Premarket Notification, Traditional 510(k) Bolt IVL™ System
The Bolt IVL console delivers energy through the integrated catheter cabling to the emitters located inside the catheter balloon. The Bolt IVL Console is a non-sterile, reusable device.
Technological Comparison
The Bolt IVL System incorporates substantially equivalent design, dimensional, and performance specifications when compared to the predicate device. The Bolt IVL Catheter's fundamental scientific technology is the same as the predicate device: sheath and guidewire compatibility, usable catheter length, balloon diameters and lengths, as well as treatment and nominal pressure are consistent with the predicate device. The Bolt IVL System also has the same intended use, target population, and operating principles as the predicate device. The indications for use are nearly identical. Both systems use catheters that deliver acoustic energy to a blood vessel via a catheter which is connected via a cable to a console.
Summary of Performance Data
Objective evidence demonstrating the Bolt IVL System design output meets the product design input requirements as well as device performance characteristics conform to user needs and intended uses as defined in the product specification was provided. Testing was conducted in accordance with Bolt Medical's risk analysis and all applicable FDA guidance documents and relevant international standards. The following tests were conducted for the Bolt IVL Catheter:
- Catheter diameter and balloon profile ●
- Tensile strength
- Kink resistance / flexibility
- Catheter torsional strength
- Balloon Inflation / deflation time
- Minimum Burst Strength (RBP)
- Balloon compliance
- Fatigue (multiple inflations)
- Pushability and trackability
- Fluoroscopic visibility
- Particulate evaluation
- Pulsing cycles and output
The following tests were conducted for the Bolt IVL Console:
- Hardware design verification
- Electrical performance
- Electromagnetic compatibility
- Software verification and validation ●
- Life expectancy
Results demonstrate that the performance of the Bolt IVL System meets its design specifications and is safe and effective for its intended use.
Summary of Biocompatibility Testing
Biocompatibility testing was not required for the Bolt IVL Console as it is non-patient contacting. The Bolt IVL Catheter is categorized as "Externally communicating Blood, (A) Limited exposure (