(118 days)
Not Found
No
The document describes a mechanical device (balloon catheter with lithotripsy emitters) and a generator. 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 clinical outcomes and device mechanics, not algorithmic performance.
Yes
The device is described as a "Lithoplasty System" intended for "lithotripsy-enhanced balloon dilatation of lesions" in the peripheral vasculature to facilitate the passage of blood and treat stenotic lesions, which directly addresses a medical condition.
No
Explanation: The device is described as a Lithoplasty System intended for lithotripsy-enhanced balloon dilatation, which is a treatment procedure, not a diagnostic one.
No
The device description clearly states that the system has three hardware components: a balloon catheter, a generator, and a connector cable. It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The Shockwave Medical Lithoplasty System is a therapeutic device used within the body to treat calcified lesions in blood vessels. It physically interacts with the patient's anatomy to break up calcium and dilate the vessel.
- Lack of Specimen Analysis: The description does not mention the device analyzing any biological specimens. Its function is entirely focused on mechanical intervention within the vascular system.
Therefore, the Shockwave Medical Lithoplasty System is a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Shockwave Medical Lithoplasty System is intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the illiac. femoral, ilio-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 Lithoplasty System has three components: a proprietary balloon catheter, a generator, and a connector cable. The balloon catheter has integrated lithotripsv 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 Lithoplasty 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 Shockwave Medical Lithoplasty Generator delivers energy through the Connector Cable to the pulse emitters located inside the balloon in the Lithoplasty Catheter. The Lithoplasty Catheter is a single-use device supplied sterile to the customer. The Generator and 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
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)
A chronic GLP study was conducted in a porcine in vivo model to determine the safety of delivering pulsatile mechanical energy to peripheral arteries with the Lithoplasty System. The histopathology evaluation revealed no trends between the treatment and control groups in injurv, inflammation, fibrin, endothelialization or neointimal smooth muscle cells scores. The results demonstrated that the Shockwaye Medical Lithoplasty System treatment was overall as safe as the control device in a chronic healthy porcine model.
To evaluate the safety and performance of the Lithoplasty System, Shockwave Medical, Inc. conducted a two-phased, non-randomized, multi-center study for the treatment of peripheral stenotic lesions (PAD I and PAD II, combined referred to as the DISRUPT PAD Program). Thirty-four (34) investigators participated at seven (7) sites in Austria, New Zealand, and Germany. A total of 95 subjects were enrolled. This clinical study summary presents outcomes from all 95 subjects at 30 days and at 6 months.
A total of 95 subjects were enrolled in the study. Baseline characteristics were consistent with a complex, calcified patient population. Calcium burden was significant with severe calcification involving both sides of the arterial wall observed by the Core Lab in 54.7% of the subjects, and an average length of calcium of 93.4 mm. Ninety-four (94) of the 95 subjects received treatment with the Lithoplasty System. The procedures were completed with a low use of adjunctive therapies including pre and post-dilatation balloons and embolic protection filters, along with a low use of stents in this difficult to treat population.
The study met its primary safety endpoint. The lower bound of the 95% confidence interval for freedom from Major Adverse Events (MAE) at 30 days of 97.0% was above the performance goal of 91.3%. The freedom from MAE at 30 days was 100%.
The study also met its primary effectiveness endpoint. The lower bound of the 95% confidence interval for procedural success of 97.0% was above the performance goal of 89.3%. Procedural success was defined as
§ 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized caduceus, which is a symbol often associated with healthcare and medicine.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 14, 2016
Shockwave Medical, Inc. Nora Hadding Vice President, Regulatory Affairs and Quality Assurance 48501 Warm Springs Blvd., Suite 108 Fremont, California 94539
Re: K161384
Trade/Device Name: Shockwave Medical Lithoplasty System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: PPN Dated: August 3, 2016 Received: August 4, 2016
Dear Nora Hadding:
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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Brian D. Pullin -S
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K161384
Device Name
Shockwave Medical Lithoplasty® System
Indications for Use (Describe)
The Shockwave Medical Lithoplasty 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) | |
|---|---|
| ------------------------------------------------- | -- |
|X 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
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, Phone, and Fax Number of Applicant
Shockwave Medical, Inc. 48501 Warm Springs Blvd., Suite 108 Fremont, CA 94539 Phone: (510) 279-3068 Fax: (510) 279-5934
Contact Person
Nora Hadding
Date Prepared
May 17, 2016
Device Name and Classification
| Trade Name: | Shockwave Medical Lithoplasty® 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 Shockwave Medical Lithoplasty System is the Spectranetics, Inc. AngioSculpt PTA Scoring Balloon Catheter (K142983). Additional predicates in terms of intended use and technologic characteristics are the Bard Peripheral Vascular VascuTrak PTA Dilatation Catheter (K103459) and the EKOS Corporation EKOS Lysus Micro-Infusion System (K060422).
Indications for Use / Intended Use
The Shockwave Medical Lithoplasty System is intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the illiac. femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. Not for use in the coronary or cerebral vasculature.
Device Description
The Shockwave Medical Lithoplasty System has three components: a proprietary balloon catheter, a generator, and a connector cable. The balloon catheter has integrated lithotripsv 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
4
vascular deposit (stenosis) prior to low-pressure balloon dilation of the stenosis and facilitates the passage of blood.
The Lithoplasty 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 Shockwave Medical Lithoplasty Generator delivers energy through the Connector Cable to the pulse emitters located inside the balloon in the Lithoplasty Catheter. The Lithoplasty Catheter is a single-use device supplied sterile to the customer. The Generator and Connector Cable are non-sterile reusable devices.
Technological Comparison
The Shockwave Medical Lithoplasty System incorporates substantially equivalent design, dimensional, and performance specifications when compared to the 510(k) cleared AngioSculpt and VascuTrak devices. The Lithoplasty Catheter fundamental scientific technology is the same as the AngioSculpt and VascuTrak devices: sheath and guidewire compatibility, usable catheter length, balloon diameters and lengths, nominal pressure, and rated burst pressure are consistent with the identified predicate devices. The Lithoplasty System also has a similar intended use and indications for use, same target population, and same operating principles as the identified predicate devices.
The Lithoplasty System also has similarities in design and construction as well as principles of operation to the identified predicate EKOS Lysus Micro-Infusion System. Both use catheters that deliver electro-mechanical energy to a blood vessel via a catheter which is connected via a cable to a generator.
Summary of Performance Data
Objective evidence demonstrating that the Lithoplasty 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 and all applicable FDA guidance documents and relevant international standards. The following tests were conducted for the Lithoplasty 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 ●
5
- Fluoroscopic visibility ●
- Particulate evaluation
- Pulsing cycles and output ●
The following tests were conducted for the Lithoplasty Generator and Connector Cable:
- Hardware design verification ●
- Electrical performance .
- . Electromagnetic compatibility
- Software verification and validation
- . Life expectancy
Results demonstrate that the performance of the Shockwave Medical Lithoplasty Balloon 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 Lithoplasty Generator or Connector Cable because they are non-patient contacting. The Lithoplasty Catheter is categorized as "Externally communicating, Circulating Blood, (A) Limited exposure (