(79 days)
Not Found
No
The summary describes a laser atherectomy catheter and its mechanism of action (photoablation). There is no mention of AI, ML, image processing, or any other technology that would suggest the use of AI/ML for decision-making, analysis, or control. The device appears to be a purely mechanical and optical system.
Yes
The device is indicated for laser atherectomy to treat lesions in arteries and in-stent restenosis, which is a therapeutic intervention to restore blood flow.
No
Explanation: The device is described as a laser atherectomy catheter used for the treatment of lesions in arteries (ablating lesions, photoablation, recanalizing diseased vessels). It is not designed to diagnose conditions or provide diagnostic information.
No
The device description explicitly details hardware components such as catheters, optical fibers, torque wire, and a motor drive unit (MDU). It is a physical medical device that utilizes laser energy.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The Turbo-Power Laser Atherectomy Catheter is a device that is inserted directly into the patient's arteries to physically ablate (remove) blockages using laser energy. It is an interventional device used in vivo (within the living body).
- Intended Use: The intended use is for laser atherectomy of lesions in arteries and treatment of in-stent restenosis. This is a therapeutic procedure performed directly on the patient, not a diagnostic test performed on a sample outside the body.
Therefore, the Turbo-Power Laser Atherectomy Catheter is a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Turbo-Power is indicated for laser atherectomy of de novo or restenotic lesions in native infrainguinal atteries and for the treatment of femoropopliteal artery in-stent restenosis (ISR) in bare nitinol stents, with adjunctive Percutaneous Transluminal Angioplasty (PTA).
Product codes
MCW
Device Description
The Turbo-Power (2.0mm, 2.3mm) Laser Atherectomy Catheter are laser atherectomy devices designed for use with the CVX-300™ Excimer Laser System and Philips Laser System. The Turbo-Power (2.0mm) and (2.3mm) Laser Atherectomy Catheters are sterile, single use, prescription only devices used for peripheral atherectomy. The Turbo-Power (2.0mm) and (2.3mm) are used to ablate lesions with reference vessel diameters of ≥3.0mm. Turbo-Power (2.0mm) and (2.3mm) Laser Atherectomy Catheters are comprised of 2 subassemblies:
-
- Catheter Subassembly
-
- Motor Drive Unit (MDU) Subassembly
The working length of the Turbo Power Laser Atherectomy Catheter is constructed of multiple optical fibers arranged eccentrically around a 0.018" (0.46 mm) quidewirecompatible lumen. The PTFE quidewire lumen tip is attached to a stainless steel torque wire which is connected to the MDU at the proximal end of the working length. The multifiber laser catheter transmits ultraviolet energy from the Spectranetics CVX-300 Excimer Laser System or Philips Laser System through the tip of the laser to an obstruction in the patient's artery. The outer surface of the laser catheter working length is hydrophilic-coated, and the distal tip of the catheter contains a radiopaque marker band for in situ visibility. The ultraviolet energy transmitted from the CVX-300 laser system or Philips Laser System is used to photoablate multiple morphology lesions which may be comprised of atheroma, fibrosis, calcium, and thrombus, thus recanalizing diseased vessels. Photoablation is the process by which energy photons cause molecular bond disruption at the cellular level without thermal damage to surrounding tissue.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
native infrainguinal arteries, femoropopliteal artery
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)
The following testing was conducted to verify that the subject device met all acceptance criteria as required by the risk analysis that was performed.
Design Verification and Validation Testing
- Functional Testing .
- . Software Testing
- Medical Electrical Safety Testing
No new pre-clinical or clinical data was required to demonstrate substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.4875 Intraluminal artery stripper.
(a)
Identification. An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.
December 8, 2022
Spectranetics Inc. Taylor Olen Regulatory Affairs Specialist 9965 Federal Drive Colorado Springs, Colorado 80921
Re: K222837
Trade/Device Name: Turbo-Power™ (2.0mm and 2.3mm) Laser Atherectomy Catheters Regulation Number: 21 CFR 870.4875 Regulation Name: Intraluminal Artery Stripper Regulatory Class: Class II Product Code: MCW Dated: November 15, 2022 Received: November 16, 2022
Dear Taylor Olen:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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 W. Digitally signed by Gregory W. O'connell -S O'connell -S Date: 2022.12.08
10:28:02 -05'00'28:02 -05'00'
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) K222837
Device Name
Turbo-Power (2.0mm and 2.3mm) Laser Atherectomy Catheters
Indications for Use (Describe)
Turbo-Power is indicated for laser atherectomy of de novo or restenotic lesions in native infrainguinal atteries and for the treatment of femoropopliteal artery in-stent restenosis (ISR) in bare nitinol stents, with adjunctive Percutaneous Transluminal Angioplasty (PTA).
| 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 G) |
Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
This 510(k) summary was prepared in accordance with 21 CFR 807.92(c) Prepared on November 22, 2022
| 510(k) Submitter / Holder: | The Spectranetics Corporation
9965 Federal Drive
Colorado Springs, CO 80921.3617
Establishment Registration No: 3007284006 |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Ms. Taylor Olen
Regulatory Affairs Specialist
Mobile: 719-437-4129
Fax: 719.447.2070
Email: taylor.olen@philips.com |
Subiect Device
Device Trade Name:
Device Common Name: Device Class: Classification Requlation: Regulation Description: Product Code: 510(k) Number: 510(k) Type: Model Numbers:
Turbo-Power™ (2.0mm, 2.3mm) Laser Atherectomy Catheters Laser Atherectomy Catheter . 21 CFR 870.4875, Intraluminal Artery Stripper Cardiovascular MCW K222837 Special 420-050, 423-050
Predicate Device
The Turbo-Power™ (2.0mm and 2.3mm) Laser Atherectomy Catheters are being compared to the following legally marketed predicate device:
510(k) Number: Manufacturer: Trade Name: Device Common Name: Model Number:
K180694 (cleared April 5,2018) The Spectranetics Corporation Turbo-Power Laser Atherectomy Catheter Laser Atherectomy Catheter 420-050, 423-050
Intended and Indications for Use
Turbo-Power is indicated for laser atherectomy of de novo or restenotic lesions in native infrainguinal arteries and for the treatment of femoropopliteal artery in-stent restenosis (ISR) in bare nitinol stents, with adjunctive Percutaneous Transluminal Angioplasty (PTA).
4
Device Description
The Turbo-Power (2.0mm, 2.3mm) Laser Atherectomy Catheter are laser atherectomy devices designed for use with the CVX-300™ Excimer Laser System and Philips Laser System. The Turbo-Power (2.0mm) and (2.3mm) Laser Atherectomy Catheters are sterile, single use, prescription only devices used for peripheral atherectomy. The Turbo-Power (2.0mm) and (2.3mm) are used to ablate lesions with reference vessel diameters of ≥3.0mm. Turbo-Power (2.0mm) and (2.3mm) Laser Atherectomy Catheters are comprised of 2 subassemblies:
-
- Catheter Subassembly
-
- Motor Drive Unit (MDU) Subassembly
The working length of the Turbo Power Laser Atherectomy Catheter is constructed of multiple optical fibers arranged eccentrically around a 0.018" (0.46 mm) quidewirecompatible lumen. The PTFE quidewire lumen tip is attached to a stainless steel torque wire which is connected to the MDU at the proximal end of the working length. The multifiber laser catheter transmits ultraviolet energy from the Spectranetics CVX-300 Excimer Laser System or Philips Laser System through the tip of the laser to an obstruction in the patient's artery. The outer surface of the laser catheter working length is hydrophilic-coated, and the distal tip of the catheter contains a radiopaque marker band for in situ visibility. The ultraviolet energy transmitted from the CVX-300 laser system or Philips Laser System is used to photoablate multiple morphology lesions which may be comprised of atheroma, fibrosis, calcium, and thrombus, thus recanalizing diseased vessels. Photoablation is the process by which energy photons cause molecular bond disruption at the cellular level without thermal damage to surrounding tissue.
Technological Characteristics
This submission introduces a new Printed Circuit Board Assembly (PCBA) and firmware; however, it does not affect the fundamental scientific technology used in the Turbo-Power family of devices. The mechanism of action, and intended use, remain unchanged from the predicate Turbo- Power (2.0mm, 2.3mm). Functional testing was performed to confirm the devices with the new PCBA meet the relevant product requirements. Additionally, Software testing and Medical Electrical Safety Testing was performed on devices with the new PCBA.
Performance Data
The following testing was conducted to verify that the subject device met all acceptance criteria as required by the risk analysis that was performed.
Design Verification and Validation Testing
- Functional Testing .
- . Software Testing
- Medical Electrical Safety Testing ●
Sterilization
An assessment was conducted and concluded that additional sterilization testing was not required for the subject device to demonstrate substantial equivalence.
5
K222837
Pre-clinical and Clinical Data
No new pre-clinical or clinical data was required to demonstrate substantial equivalence.
Substantial Equivalence
Based on the similarities in design between the subject and predicate devices currently in use, and the performance and pre-clinical data, the use of the Turbo-Power (2.0mm and 2.3mm) Laser Atherectomy Catheter for the new PCBA and firmware does not raise new questions related to safety and effectiveness compared with the predicate. Therefore Turbo-Power (2.0mm and 2.3mm) are substantially equivalent to Turbo-Power (2.3mm) and Turbo-Power (2.0mm) (K180694).