(50 days)
No
The summary describes a mechanical device that uses pulsatile energy to disrupt calcium. There is no mention of AI/ML in the device description, intended use, or performance studies.
Yes
The device is described as an Intravascular Lithotripsy (IVL) System intended for "lithotripsy-enhanced balloon dilatation of lesions...in the peripheral vasculature" and is designed to disrupt calcium and allow subsequent dilation of stenoses. This clearly indicates a direct treatment of a medical condition.
No
The device is described as a treatment device, delivering pulsatile mechanical energy to disrupt calcium and allow for balloon dilation of stenotic arteries, rather than identifying or characterizing a medical condition.
No
The device description explicitly details hardware components including a catheter, connector cable, and generator, and the performance studies focus on the physical characteristics and performance of these hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "lithotripsy-enhanced balloon dilatation of lesions... in the peripheral vasculature." This describes a therapeutic procedure performed directly on the patient's body to treat a physical condition (calcified lesions).
- Device Description: The description details a catheter with a balloon and lithotripsy emitters designed to be inserted into the peripheral arterial system to physically disrupt calcium. This is an interventional device.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (like blood, urine, or tissue) or to provide diagnostic information about a patient's condition. IVDs are used to diagnose diseases or conditions.
The device is a therapeutic medical device used for treating vascular lesions, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Shockwave Medical Intravascular Lithotripsy (IVL) System is intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the ilia-femoral, popliteal, infrapopliteal, and renal arteries. Not for use in the coronary or cerebral vasculature.
Product codes
PPN
Device Description
The IVL Catheter is a proprietary lithotripsy device delivered through the peripheral arterial system of the lower extremities to the site of an otherwise difficult to treat calcified stenosis. Energizing the lithotripsy device will generate pulsatile mechanical energy within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. The IVL Catheter is comprised of an integrated balloon with an array of integrated lithotripsy emitters for the localized delivery of pulsatile mechanical energy. The system consists of an IVL Catheter, an IVL Connector Cable and an IVL Generator.
The Shockwave L Peripheral IVL Catheter shaft contains an inflation lumen, a guidewire lumen. and the lithotripsy emitters. The emitters are positioned along the length of the balloon working length for delivery of pulsatile mechanical energy. The balloon is located near the distal tip of the catheter. Two radiopaque marker bands within the balloon denote the length of the balloon to aid in positioning of the balloon during treatment. The balloon is designed to provide an expandable segment of known length and diameter at a specific pressure.
The IVL Generator and Connector Cable are used with a Shockwave Medical IVL Catheter to deliver localized, lithotripsy-enhanced, balloon dilatation of calcified, stenotic arteries. The IVL Generator, IVL Connector Cable and IVL Catheters are designed to exchange data during patient treatment.
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, iliofemoral, popliteal, infra-popliteal, and renal arteries. Not for use in the coronary or cerebral vasculature.
Indicated Patient Age Range
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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:
- IVL Catheter design verification and validation testing: ●
- o Guidewire compatibility
- o Introducer sheath compatibility
- Nominal balloon diameter O
- Balloon diameter at Rated Burst Pressure (RBP) о
- Balloon length O
- Balloon inflation time O
- Balloon deflation time O
- Useable catheter length O
- Balloon crossing profile O
- Catheter distal tip O
- Distal tip durability O
- Catheter bonds tensile strength O
- O Catheter torsional strength
- Emitter and marker band integrity O
- System leakage O
- O Minimum balloon RBP
- Balloon fatigue (multiple inflations) O
- Sonic output O
- Catheter pulse count and pulse rate O
- Temperature rise O
- Catheter particle count O
- Catheter connector length O
- Catheter connection O
- Catheter identification O
- Catheter sterility (visual inspection) O
- Cable sleeve packaging O
- Catheter compatibility with materials and accessories commonly used in Over-the- O Wire (OTW) peripheral balloon angioplasty procedures
- о Simulated use testing
- Confirmatory chronic GLP animal testing ●
Results demonstrated that the performance of the IVL System meets its design specifications and demonstrates substantial equivalence for its intended use; therefore, additional clinical data were not required.
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).
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August 16, 2022
Shockwave Medical, Inc. Danica Van Principal Regulatory Affairs Specialist 5403 Betsy Ross Dr Santa Clara, California 95054
Re: K221852
Trade/Device Name: Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: PPN Dated: June 24, 2022 Received: June 27, 2022
Dear Danica Van:
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
1
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,
for
Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K221852
Device Name
Shockwave Intravascular Lithotripsy System with the Shockwave L6 Peripheral IVL Catheter
Indications for Use (Describe)
The Shockwave Medical Intravascular Lithotripsy (IVL) System is intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the ilia-femoral, popliteal, infrapopliteal, and renal arteries. Not for use in the coronary or cerebral vasculature.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X 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 consists of the word "SHOCKWAVE" in a sans-serif font, with three concentric circles to the left of the word. Below the word "SHOCKWAVE" is the phrase "MEDICAL INC" in a smaller font. The logo is simple and modern, and the use of the concentric circles suggests the idea of waves or vibrations.
510(k) Summary
This 510(k) Summary is submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92.
Name, Address, and Phone Number of Applicant
Shockwave Medical, Inc. 5403 Betsy Ross Drive Santa Clara, CA 95054 Phone: (510) 279-4262
Contact Person
Danica Van
Date Prepared
June 23, 2022
| Trade Name: | Shockwave Intravascular Lithotripsy (IVL) System with the
Shockwave L6 Peripheral IVL Catheter |
|----------------------|---------------------------------------------------------------------------------------------------|
| Common Name: | Catheter, lithotripsy, peripheral, transluminal |
| CFR Classification: | 21 CFR 870.1250 |
| Classification Name: | Percutaneous catheter |
| Product Code: | PPN |
Device Name and Classification
Predicate Device
The predicate device is the Shockwave Medical Intravascular Lithotripsy System, K180958, cleared by FDA on July 26, 2018.
Reference Device
The reference device is the Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ Peripheral IVL Catheter, 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 IVL Catheter is a proprietary lithotripsy device delivered through the peripheral arterial system of the lower extremities to the site of an otherwise difficult to treat calcified stenosis. Energizing
4
Image /page/4/Picture/0 description: The image shows the logo for Shockwave Medical Inc. The word "SHOCKWAVE" is written in a gray sans-serif font, with three blue concentric circles to the left of the "O" in "SHOCKWAVE". Below the word "SHOCKWAVE" is the text "MEDICAL INC" in a smaller, gray sans-serif font.
the lithotripsy device will generate pulsatile mechanical energy within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. The IVL Catheter is comprised of an integrated balloon with an array of integrated lithotripsy emitters for the localized delivery of pulsatile mechanical energy. The system consists of an IVL Catheter, an IVL Connector Cable and an IVL Generator.
The Shockwave L Peripheral IVL Catheter shaft contains an inflation lumen, a guidewire lumen. and the lithotripsy emitters. The emitters are positioned along the length of the balloon working length for delivery of pulsatile mechanical energy. The balloon is located near the distal tip of the catheter. Two radiopaque marker bands within the balloon denote the length of the balloon to aid in positioning of the balloon during treatment. The balloon is designed to provide an expandable segment of known length and diameter at a specific pressure.
The IVL Generator and Connector Cable are used with a Shockwave Medical IVL Catheter to deliver localized, lithotripsy-enhanced, balloon dilatation of calcified, stenotic arteries. The IVL Generator, IVL Connector Cable and IVL Catheters are designed to exchange data during patient treatment.
Technological Comparison
This Traditional 510(k) Premarket Notification describes dimensional modifications to the Shockwave Mr IVL Catheter, including increased sheath and guidewire compatibility, larger balloon diameters and a shorter balloon length.
The catheter labeling was updated to reference the name of the modified device, Shockwave L Peripheral IVL Catheter. Additionally, the Shockwave L 1abeling includes a sterile cable sleeve in the packaging to form a convenience kit.
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.
Summary 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:
- IVL Catheter design verification and validation testing: ●
- o Guidewire compatibility
- o Introducer sheath compatibility
- Nominal balloon diameter O
- Balloon diameter at Rated Burst Pressure (RBP) о
- Balloon length O
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Image /page/5/Picture/0 description: The image shows the logo for Shockwave Medical Inc. The word "SHOCKWAVE" is written in a gray sans-serif font, with three blue curved lines emanating from the "O" in "SHOCKWAVE". Below "SHOCKWAVE" is the text "MEDICAL INC" in a smaller, gray sans-serif font.
- Balloon inflation time O
- Balloon deflation time O
- Useable catheter length O
- Balloon crossing profile O
- Catheter distal tip O
- Distal tip durability O
- Catheter bonds tensile strength O
- O Catheter torsional strength
- Emitter and marker band integrity O
- System leakage O
- O Minimum balloon RBP
- Balloon fatigue (multiple inflations) O
- Sonic output O
- Catheter pulse count and pulse rate O
- Temperature rise O
- Catheter particle count O
- Catheter connector length O
- Catheter connection O
- Catheter identification O
- Catheter sterility (visual inspection) O
- Cable sleeve packaging O
- Catheter compatibility with materials and accessories commonly used in Over-the- O Wire (OTW) peripheral balloon angioplasty procedures
- о Simulated use testing
- Confirmatory chronic GLP animal testing ●
Results demonstrated that the performance of the IVL System meets its design specifications and demonstrates substantial equivalence for its intended use; therefore, additional clinical data were not required.
Basis for Substantial Equivalence
The IVL Catheter with dimensional modifications 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 modified IVL Catheter is therefore substantially equivalent to the predicate device.