(17 days)
The Shockwave Medical IVL System is intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, popliteal, infra-popliteal, and renal arteries. Not for use in the coronary or cerebral vasculature.
The Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System has three components: a proprietary IVL Catheter, an IVL Generator, and an IVL Connector Cable. The IVL Catheter has integrated lithotripsy emitters and is designed to enhance percutaneous transluminal angioplasty by enabling delivery of the calcium disrupting capability of lithotripsy prior to full balloon dilatation at low pressures. The application of lithotripsy mechanical pulse waves alters the structure of an occlusive vascular deposit (stenosis) prior to low-pressure balloon dilation of the stenosis and facilitates the passage of blood.
The IVL Catheter is delivered through the peripheral arterial system of the lower extremities to the site of an otherwise difficult to treat lesion. The balloon is partially inflated and the lithotripsy emitters are energized thereby generating pulsatile mechanical energy within the balloon at the target treatment site and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. The IVL Generator delivers energy through the IVL Connector Cable to the pulse emitters located inside the balloon in the IVL Catheter. The IVL Catheter is a single-use device supplied sterile to the customer. The IVL Generator and IVL Connector Cable are nonsterile reusable devices.
This document describes the regulatory submission for the Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System, specifically for a Special 510(k) Premarket Notification. The submission focuses on modifications to an already cleared predicate device (Shockwave Medical Intravascular Lithotripsy System, K203365). Therefore, the "study that proves the device meets the acceptance criteria" refers to the verification and validation testing performed on these modifications, rather than a full de novo clinical trial.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a specific table with numerical acceptance criteria values and corresponding reported performance metrics. Instead, it broadly states that "objective evidence demonstrating that the IVL System design output meets the product design input requirements as well as that device performance characteristics conform to user needs and intended uses as defined in the product specification was provided."
The types of testing performed, which would be designed against underlying acceptance criteria, are listed as:
| Acceptance Criteria Category | Reported Device Performance Summary (Implicit) |
|---|---|
| Electronic Hardware Design Verification | "Results demonstrated that the performance of the IVL System meets its design specifications for its intended use" for: - User interface - Battery system (charging, management) - System power supplies - Internal system verification - Control system - Catheter management system - Pulse delivery system |
| Software Verification and Validation | "Results demonstrated that the performance of the IVL System meets its design specifications for its intended use" for: - Unit Test - Integration Test - System Test - Regression Test |
| Extended Life Testing | "Results demonstrated that the performance of the IVL System meets its design specifications for its intended use" |
| 60601-1 Type Testing (Safety and EMC) | "Results demonstrated that the performance of the IVL System meets its design specifications for its intended use" |
| Transit Testing | "Results demonstrated that the performance of the IVL System meets its design specifications for its intended use" |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify sample sizes for any of the testing performed (e.g., number of units tested, number of software test cases). Given that this is a Special 510(k) for modifications to an existing device, the testing would likely involve design verification and validation on a limited sample of physical devices and extensive software testing.
The data provenance is implied to be from internal Shockwave Medical, Inc. testing facilities, as it states "Testing was conducted in accordance with Shockwave Medical's Risk Analysis procedures". It does not specify country of origin for the data or whether the data was retrospective or prospective in detail, but given it's device verification, it would be prospective testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information (experts, qualifications, ground truth establishment) is typically associated with clinical studies involving human interpretation or pathology. Since this submission relies on engineering and software verification and validation, such expert involvement for "ground truth" as it's typically understood in clinical AI/MRMC studies is not applicable or described. The "ground truth" for this device's performance is established by its design specifications and validated through engineering tests.
4. Adjudication Method for the Test Set
Not applicable, as this is primarily engineering and software verification and validation, not a multi-reader clinical study requiring adjudication.
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
No MRMC study was done or described. The device is a physical medical device (catheter, generator) for lithotripsy, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This refers to the performance of the physical device itself and its modified hardware and software functionalities. The performance testing done (hardware, software, life testing, safety, EMC, transit) represents the "standalone" performance of the modified device components satisfying their design requirements.
7. The Type of Ground Truth Used
The "ground truth" for this submission is based on design specifications and engineering requirements. The performed tests (hardware, software, electrical safety, etc.) verify that the device's output and performance characteristics meet these predefined specifications, which are themselves derived from user needs and intended uses. It is not based on expert consensus, pathology, or outcomes data in the clinical sense, as this is a modification submission for an already cleared device where clinical data was previously provided or deemed unnecessary for the original clearance.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/Machine Learning device that requires a "training set". The "training" here refers to the manufacturing and design processes that lead to the device.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no "training set" in the context of an AI algorithm.
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April 25, 2022
Shockwave Medical, Inc. Soraya Hori Principal Regulatory Affairs Specialist 5403 Betsy Ross Drive Santa Clara, California 95054
Re: K221041
Trade/Device Name: Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: PPN Dated: April 4, 2022 Received: April 8, 2022
Dear Soraya Hori:
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
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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 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 medical devices and radiation-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) K221041
Device Name
Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System
Indications for Use (Describe)
The Shockwave Medical IVL System is intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, popliteal, infra-popliteal, and renal arteries. Not for use in the coronary 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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Image /page/3/Picture/0 description: The image shows the logo for Shockwave Medical Inc. The logo has the word "SHOCKWAVE" in gray, with three blue curved lines emanating from the "O" in Shockwave. Below the word "SHOCKWAVE" is the text "MEDICAL INC" in a smaller, gray font.
510(k) Summary - K221041
Name, Address, and Phone Number of Applicant
Shockwave Medical, Inc. 5403 Betsy Ross Drive Santa Clara, CA 95054 Phone: 1-510-279-4262
Contact Person
Soraya L. Hori
Date Prepared
April 20, 2022
Device Name and Classification
| Trade Name: | Shockwave Medical Peripheral Intravascular Lithotripsy(IVL) System |
|---|---|
| Common Name: | Catheter, lithotripsy, peripheral, transluminal |
| CFR Classification: | 21 CFR 870.1250 |
| Classification Name: | Percutaneous catheter |
| Product Code: | PPN |
Predicate Device
The predicate device is the Shockwave Medical Intravascular Lithotripsy System, K203365, cleared by FDA on April 22, 2021.
Indications for Use / Intended Use
The Shockwave Medical IVL System is intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, iliofemoral, popliteal, infra-popliteal, and renal arteries. Not for use in the coronary or cerebral vasculature.
Device Description
The Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System has three components: a proprietary IVL Catheter, an IVL Generator, and an IVL Connector Cable. The IVL Catheter has integrated lithotripsy emitters and is designed to enhance percutaneous transluminal angioplasty by enabling delivery of the calcium disrupting capability of lithotripsy prior to full balloon dilatation at low pressures. The application of lithotripsy mechanical pulse waves alters
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Image /page/4/Picture/1 description: The image shows the logo for Shockwave Medical Inc. The word "SHOCKWAVE" is in large, gray, sans-serif font, with blue concentric circles emanating from the "O". Below "SHOCKWAVE" is the phrase "MEDICAL INC" in a smaller, gray, sans-serif font.
the structure of an occlusive vascular deposit (stenosis) prior to low-pressure balloon dilation of the stenosis and facilitates the passage of blood.
The IVL Catheter is delivered through the peripheral arterial system of the lower extremities to the site of an otherwise difficult to treat lesion. The balloon is partially inflated and the lithotripsy emitters are energized thereby generating pulsatile mechanical energy within the balloon at the target treatment site and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. The IVL Generator delivers energy through the IVL Connector Cable to the pulse emitters located inside the balloon in the IVL Catheter. The IVL Catheter is a single-use device supplied sterile to the customer. The IVL Generator and IVL Connector Cable are nonsterile reusable devices.
Technological Comparison
This Special 510(k) Premarket Notification describes the addition of an alternate energy storage component, software updates consisting of both customer facing features and updates for manufacturability and servicing, and the inclusion of additional data for storage of system event records and the means for non-invasive retrieval of system event records to facilitate enhanced diagnostics and troubleshooting.
The Generator labeling was updated to reference the catalog model number of the modified device, Shockwave 825Dx Generator.
The IVL System has the same intended use, principles of operation and has substantially equivalent technological characteristics including same fundamental scientific technology, design, energy source, shelf life, and sterilization as the 510(k) cleared IVL System.
Summarv of Performance Data
Objective evidence demonstrating that the IVL System design output meets the product design input requirements as well as that device performance characteristics conform to user needs and intended uses as defined in the product specification was provided. Testing was conducted in accordance with Shockwave Medical's Risk Analysis procedures, applicable FDA guidance documents, and relevant international standards. Testing included:
- Electronic Hardware Design Verification Testing: ●
- User interface O
- Battery system O
- Battery charging system
- I Battery management system
- System power supplies o
- Internal system verification O
- Control system O
- Catheter management system O
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Image /page/5/Picture/1 description: The image shows the logo for Shockwave Medical Inc. The word "SHOCKWAVE" is in large, gray, sans-serif font. To the left of the "O" in "SHOCKWAVE" are three curved blue lines, resembling sound waves. Below the word "SHOCKWAVE" is the text "MEDICAL INC" in a smaller, gray, sans-serif font.
- o Pulse delivery system
- Software Verification and Validation Testing: ●
- Unit Test о
- Integration Test O
- System Test o
- Regression Test O
- Extended Life Testing .
- 60601-1 Type Testing for Safety and Electromagnetic Compatibility
- . Transit Testing
Results demonstrated that the performance of the IVL System meets its design specifications for its intended use; therefore, additional clinical data were not required.
Basis for Substantial Equivalence
The IVL System with modified hardware and software shares the same intended use, principles of operation, overall technical and functional capabilities, and similar design and materials as the identified predicate device. Any differences between the IVL Systems were evaluated through design verification and validation testing which demonstrated device performance and confirmed that there are no new questions of safety or effectiveness. The IVL System with modified hardware and software is therefore substantially equivalent to the predicate device.
§ 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).