(113 days)
Not Found
No
The summary describes a laser atherectomy catheter and its mechanism of action (photoablation). There is no mention of AI or ML in the device description, intended use, or performance studies. The device appears to be a purely mechanical and optical system.
Yes
The device is used for laser atherectomy to treat de novo and restenotic lesions in arteries, which directly benefits a patient's health by removing obstructions.
No
This device is a therapeutic laser atherectomy device designed to ablate lesions in arteries, not to diagnose conditions. Its intended use is for treatment, specifically "laser atherectomy of de novo and restenotic lesions."
No
The device description clearly outlines physical components like a catheter subassembly, motor drive unit, optical fibers, guidewire lumen, torque wire, and a radiopaque marker band. It is a hardware device that utilizes laser energy.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for laser atherectomy of lesions in arteries within the human body. This is a therapeutic procedure performed in vivo (within a living organism).
- Device Description: The device is a catheter designed to be inserted into a patient's arteries to ablate tissue. This is a medical device used for treatment, not for testing samples outside the body.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens, including blood, tissue, and urine, from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform such testing on specimens.
The device is clearly a therapeutic medical device used for a surgical procedure.
N/A
Intended Use / Indications for Use
The Turbo-Power is indicated for laser atherectomy of de novo and restenotic lesions in native infrainguinal arteries and for the treatment of femoropopliteal artery in-stent restenosis (ISR) in bare nitinol stents, with adjunctive Pecutaneous Transluminal Angioplasty (PTA).
Product codes (comma separated list FDA assigned to the subject device)
MCW
Device Description
The Turbo-Power (2.0mm) Laser Atherectomy Catheter is a laser atherectomy device designed for use with the CVX-300™ Excimer Laser System. The Turbo-Power (2.0mm) Laser Atherectomy Catheter is a sterile, single use, prescription only device used for peripheral atherectomy.
The Turbo-Power (2.0mm) is used to ablate lesions with reference vessel diameters of ≥3.0mm. Turbo-Power (2.0mm) Laser Atherectomy Catheter is 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) guidewirecompatible 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 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 is used to photoablate multiple morphology lesions which mav 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)
Design Verification and Validation Testing
- Simulated Use Testing
- Functional Testing
- Physical Testing
- Laser Testing
Sterilization
- Product adoption equivalency per AAMI TIR:28-2009
Biocompatibility
- Cytotoxicity
- Sensitization
- Intracutaneous Reactivity
- Acute Systemic Toxicity
- Direct Hemolysis
- Indirect Hemolysis
- In Vivo Thrombogenicity-Ovine Model
- Genotoxicity - Ames Test
- Material Mediated Pyrogenicity
Pre-clinical and Clinical Data:
- a pre-clinical GLP study was conducted to compare the usability and procedural safety of the Turbo-Power (2.0mm) and the Turbo-Power (2.3) laser catheters, and support this premarket notification. New clinical data was not required to demonstrate substantial equivalence.
Key results: 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) Laser Atherectomy Catheter for the proposed indication does not raise new questions related to safety and effectiveness compared with the predicate. Therefore Turbo-Power (2.0mm) is substantially equivalent to Turbo-Power (2.3mm).
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
§ 870.4875 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/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the largest and the bottom profile being the smallest.
January 5, 2017
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Spectranetics, Inc. Ms. Priscila Tapia Regulatory Specialist 9965 Federal Drive Colorado Springs, Colorado 80921
Re: K162561
Trade/Device Name: Turbo-Power (2.0mm) Laser Atherectomy Catheter Regulation Number: 21 CFR 870.4875 Regulation Name: Intraluminal Artery Stripper Regulatory Class: Class II Product Code: MCW Dated: September 12, 2016 Received: September 14, 2016
Dear Ms. Tapia:
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 the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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 vours.
Mada Jellm
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) K162561
Device Name
Turbo-Power (2.0mm) Laser Atherectomy Catheters
Indications for Use (Describe)
The Turbo-Power is indicated for laser atherectomy of de novo and restenotic lesions in native infrainguinal arteries and for the treatment of femoropopliteal artery in-stent restenosis (ISR) in bare nitinol stents, with adjunctive Pecutaneous 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 C) |
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3
Image /page/3/Picture/1 description: The image shows the Spectranetics logo. The logo consists of a blue diamond shape on the left, followed by the word "Spectranetics" in blue, bold font. Below the word "Spectranetics" is the phrase "Always Reaching Farther" in a smaller, black font. At the top right of the image, the text "Page 1 of 3" is visible.
510(k) Summary
This 510(k) summary was prepared in accordance with 21 CFR 807.92(c) Prepared on September 12, 2016
| 510(k) Submitter / Holder: | The Spectranetics Corporation
9965 Federal Drive
Colorado Springs, CO 80921.3617
Establishment Registration No: 3007284006 |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Ms. Priscila Tapia
Senior Regulatory Affairs Specialist
Office: 719.447.2587
Mobile: 719.393.5354
Fax: 719.447.2070
Email: Priscila.Tapia@spnc.com |
Subject Device
| Device Trade Name: | Turbo-Power TM (2.0mm) Laser Atherectomy
Catheters |
|----------------------------|-------------------------------------------------------|
| Device Common Name: | Laser Atherectomy Catheter |
| Device Class: | II |
| Classification Regulation: | 21 CFR 870.4875, Intraluminal Artery Stripper |
| Regulation Description: | Cardiovascular |
| Product Code: | MCW |
| 510(k) Type: | Traditional |
| Model Numbers: | 420-050 |
Predicate Device
The Turbo-Power (2.0mm) Laser Atherectomy Catheter is being compared to the following legally marketed predicate device:
| 510(k) Number: | K152181 |
|---|---|
| Manufacturer: | The Spectranetics Corporation |
| Trade Name: | Turbo-Power™ Laser Atherectomy Catheter |
| Device Common Name: | Laser Atherectomy Catheter |
| Model Number: | 423-050 |
Intended and Indications for Use
Turbo-Power™ (2.0mm) Laser Atherectomy Catheter 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
Image /page/4/Picture/1 description: The image shows the Spectranetics logo. The logo consists of a blue diamond shape with a white circle in the center, followed by the word "Spectranetics" in blue. Below the word "Spectranetics" is the phrase "Always Reaching Farther" in a smaller font. The image also contains the text "Page 2 of 3" in the upper right corner.
Device Description
The Turbo-Power (2.0mm) Laser Atherectomy Catheter is a laser atherectomy device designed for use with the CVX-300™ Excimer Laser System. The Turbo-Power (2.0mm) Laser Atherectomy Catheter is a sterile, single use, prescription only device used for peripheral atherectomy.
The Turbo-Power (2.0mm) is used to ablate lesions with reference vessel diameters of ≥3.0mm. Turbo-Power (2.0mm) Laser Atherectomy Catheter is 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) guidewirecompatible 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 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 is used to photoablate multiple morphology lesions which mav 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
The Turbo-Power (2.0mm) introduces a smaller size catheter that can reach smaller vessels (≥3.0mm), however, it does not affect the fundamental scientific technology used in the Turbo-Power family of devices. The mechanism of action, principle of operation, and intended use, remain unchanged from the predicate Turbo-Power (2.3mm).
5
Image /page/5/Picture/1 description: The image shows the Spectranetics logo with the tagline "Always Reaching Farther." The logo features a blue diamond shape with a white circle inside, followed by the company name in a bold, blue font. Above the logo, the text "Page 3 of 3" is visible, indicating that this is the last page of a document.
Performance Data"
The following testing was conducted to validate and verify that the subject device met all acceptance criteria as required by the risk analysis that was performed:
Design Verification and Validation Testing
- Simulated Use Testing ●
- . Functional Testing
- Physical Testing ●
- . Laser Testing
Sterilization
- Product adoption equivalency per AAMI TIR:28-2009* ●
Biocompatibility
- Cytotoxicity
- Sensitization*
- Intracutaneous Reactivity* ●
- Acute Systemic Toxicity*
- Direct Hemolysis*
- Indirect Hemolysis* ●
- . In Vivo Thrombogenicity-Ovine Model*
- Genotoxicity - Ames Test*
- Material Mediated Pyrogenicity* ●
Pre-clinical and Clinical Data:
In addition to the design verification and validation tests, a pre-clinical GLP study was conducted to compare the usability and procedural safety of the Turbo-Power (2.0mm) and the Turbo-Power (2.3) laser catheters, and support this premarket notification. New clinical data was not 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) Laser Atherectomy Catheter for the proposed indication does not raise new questions related to safety and effectiveness compared with the predicate. Therefore Turbo-Power (2.0mm) is substantially equivalent to Turbo-Power (2.3mm).