(29 days)
Not Found
No
The summary describes a mechanical device (lithotripsy system) and its components. There is no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies. The performance studies focus on mechanical and physical properties of the device.
Yes
The 'Intended Use / Indications for Use' section clearly states that the system is "intended for lithotripsy-enhanced balloon dilatation of lesions...in the peripheral vasculature", which describes a medical treatment. The 'Device Description' further elaborates on how it "enhances percutaneous transluminal angioplasty by enabling delivery of the calcium disrupting capability of lithotripsy" and "facilitates the passage of blood," all indicative of a therapeutic function.
No
The device is intended for lithotripsy-enhanced balloon dilatation, which is a treatment procedure, not a diagnostic one. Its function is to modify calcified lesions to facilitate blood flow, rather than to identify or characterize diseases.
No
The device description explicitly states it has three hardware components: an IVL Catheter, an IVL Generator, and an IVL Connector Cable. The performance studies also detail hardware testing.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use 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 system with a catheter, generator, and cable used to deliver mechanical energy (lithotripsy) and inflate a balloon within blood vessels. This is an interventional device used for treatment.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (blood, tissue, etc.) or provide diagnostic information about a patient's condition. IVD devices are used to diagnose diseases or other conditions, including a state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae.
In summary, the Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System is a therapeutic device used for treating calcified lesions in blood vessels, not for performing in vitro diagnostic tests.
N/A
Intended Use / Indications for Use
The Shockwave Medical Peripheral 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, infra-popliteal, and renal arteries. Not for use in the coronary or cerebral vasculature.
Product codes (comma separated list FDA assigned to the subject device)
PPN
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 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 arterv 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 non-sterile reusable devices.
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, infra-popliteal, and renal arteries.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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, all applicable FDA guidance documents and relevant international standards. Testing included:
- . IVL Catheter design verification and validation testing:
- Sheath compatibility o
- Nominal balloon diameter 0
- Balloon compliance (at 10 ATM) 0
- Nominal balloon working length (at 6 ATM) 0
- Inflation (to 6 ATM) / Deflation times (from 10 ATM) 0
- Crossing profile 0
- Distal tip profile and Tip durability 0
- Marker band alignment 0
- Distal & Proximal bond strength 0
- Catheter torsional strength 0
- Emitters and marker band bond strength integrity 0
- Pressure leakage during lithotripsy treatment 0
- Minimum RBP o
- System burst o
- Balloon fatigue (multiple inflations) 0
- Emitter spacing & emitter to marker band spacing 0
- Maximum total pulsing cycles 0
- Catheter compatibility with OTW peripheral balloon angioplasty accessories 0
- Catheter compatibility with specific lithotripsy generator and its accessories designed o by Shockwave Medical
- Catheter must enable smooth delivery through tortuous anatomy via femoral approach 0 & cross lesions without undue difficulty
- Catheter must maintain structural integrity prior to and during delivery, treatment, 0 and retraction
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): 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.
Not Found
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
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August 7, 2019
Shockwave Medical, Inc. Ms. Cindy Morrow Manager, Regulatory Affairs 5403 Betsy Ross Drive Santa Clara, California 95054
Re: K191840
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: July 8, 2019 Received: July 9, 2019
Dear Ms. Morrow:
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) K191840
Device Name
Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System
Indications for Use (Describe)
The Shockwave Medical Peripheral 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, 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 word "SHOCKWAVE" is written in a bold, sans-serif font, with a series of concentric circles emanating from the "O" in "SHOCKWAVE". Below the word "SHOCKWAVE" is the text "MEDICAL INC" in a smaller, sans-serif font.
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.
510(k) Owner
Shockwave Medical, Inc. 5403 Betsy Ross Drive Santa Clara, CA 95054 Phone: (510) 279-4262 Fax: (510) 279-5934
Contact Person
Cindy Morrow
Date Prepared
August 7, 2019
Device Name and Classification
| Trade Name: | Shockwave S⁴ Intravascular Lithotripsy (IVL) Catheter,
Shockwave Medical Peripheral Intravascular Lithotripsy 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 Peripheral Intravascular Lithotripsy System, K180454, cleared by FDA on June 27, 2018.
Indications for Use / Intended Use
The Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System is intended for lithotripsy-enhanced balloon dilatation of lesions. including calcified lesions, in the peripheral vasculature, including the iliac, femoral, ilio-femoral, 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 the structure of an occlusive vascular deposit (stenosis) prior to low-pressure balloon dilation of the stenosis and facilitates the passage of blood.
4
Image /page/4/Picture/0 description: The image shows the logo for Shockwave Medical Inc. The word "SHOCKWAVE" is written in a bold, sans-serif font, with a series of concentric circles emanating from the "O". Below "SHOCKWAVE", the words "MEDICAL INC" are written in a smaller, lighter font.
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 arterv 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 non-sterile reusable devices.
Technological Comparison
This Special 510(k) Premarket Notification is being submitted for minor modifications to the Peripheral IVL Catheter sizes (2.5mm, 3.0mm, 3.5mm, and 4.0mm in diameter and 40mm length) for use with the IVL Generator and Connector Cable. The minor modifications include small dimensional changes to the balloon and emitter components, and new tooling for improved manufacturability.
The IVL System has the same intended use, principles of operation and has substantially equivalent technological characteristics, including the same fundamental scientific technology, design, energy source, shelf life, and sterilization method as the already 510(k) cleared IVL System. The IVL Catheters are the same design as the predicate; the IVL Catheters with integrated lithotripsy emitters enable the localized delivery of pulsatile mechanical energy to disrupt calcified lesions.
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, all applicable FDA guidance documents and relevant international standards. Testing included:
- . IVL Catheter design verification and validation testing:
- Sheath compatibility o
- Nominal balloon diameter 0
- Balloon compliance (at 10 ATM) 0
- Nominal balloon working length (at 6 ATM) 0
- Inflation (to 6 ATM) / Deflation times (from 10 ATM) 0
- Crossing profile 0
- Distal tip profile and Tip durability 0
- Marker band alignment 0
- Distal & Proximal bond strength 0
- Catheter torsional strength 0
- Emitters and marker band bond strength integrity 0
- Pressure leakage during lithotripsy treatment 0
- Minimum RBP o
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Image /page/5/Picture/0 description: The image shows the logo for Shockwave Medical Inc. The logo is in gray and blue. The word "SHOCKWAVE" is in large, bold letters, with a blue circle and wave design around the "O". Below "SHOCKWAVE" is the text "MEDICAL INC" in smaller, lighter gray letters.
510(k) Summary for K191840
- System burst o
- Balloon fatigue (multiple inflations) 0
- Emitter spacing & emitter to marker band spacing 0
- Maximum total pulsing cycles 0
- Catheter compatibility with OTW peripheral balloon angioplasty accessories 0
- Catheter compatibility with specific lithotripsy generator and its accessories designed o by Shockwave Medical
- Catheter must enable smooth delivery through tortuous anatomy via femoral approach 0 & cross lesions without undue difficulty
- Catheter must maintain structural integrity prior to and during delivery, treatment, 0 and retraction
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 System with the minor modifications to the Peripheral IVL Catheter 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. The IVL System with the minor modifications to the Peripheral IVL Catheter is therefore substantially equivalent to the predicate device.