(10 days)
For use in the endovascular treatment of symptomatic infrainguinal lower extremity vascular disease where total obstructions can not be crossed with standard guide wires.
Spectranetics' CLiRpath excimer laser atherectorny catheters, including CLiRpath Turbo models, consist of a bundle of optical fibers, encased within medical grade tubing. The optical fibers conduct ultraviolet laser light (excimer laser light at 308 nm) from a source to the tip of the catheter. The catheter is inserted into a patient's vasculature along the length of a previously inserted medical guidewire, allowing the attending physician to deliver laser energy targeted to a lesion (blockage) in the blood vessel. CLiRpath laser catheters are provided in models designed for both "over-the-wire" and rapid exchange interventional techniques. Laser energy impinged on a blockage ablates, or debulks, the lesion material re-establishing blood flow within the vessel, and permitting placement of devices used in vascular interventions.
Spectranetics brand CLiRpath Turbo laser catheters will be supplied in addlional tip diameters between 0.9 and 2.3 mm, appropriate for interventional use in the peripheral vasculature of the leg.
This is a 510(k) summary for a medical device (CLiRpath Turbo Excimer Laser Catheter), not an AI/ML device. Therefore, the requested information regarding acceptance criteria, study details, expert involvement, and training/test set specifics for demonstrating AI performance is not applicable to this document.
The document discusses the substantial equivalence of the CLiRpath Turbo Excimer Laser Catheter to previously cleared predicate devices based on:
- Device Description: The CLiRpath Turbo models are variations of existing laser catheters, featuring a bundle of optical fibers to deliver UV laser light (308 nm) from a source to a catheter tip, intended for ablating vascular lesions. The new "Turbo" feature allows for continuous laser delivery without mandatory 5-second pauses, unlike prior models (except the 2.5mm Turbo predicate).
- Intended Use: For endovascular treatment of symptomatic infrainguinal lower extremity vascular disease where total obstructions cannot be crossed with standard guide wires.
- Comparison to Predicate Devices: The document explicitly states that the CLiRpath Turbo catheters are "substantially equivalent in form, fit, and function" to other Spectranetics CLiRpath laser catheters, including the 2.5 mm Turbo catheter (K043465) and other peripheral CLiRpath catheters (K040067). The main difference is the "Continuous-On" capability for a wider range of tip diameters (0.9 mm to 2.3 mm).
- Biocompatibility, Sterilization, Packaging, and Bench Testing: The new devices use the same components and materials as previously marketed Spectranetics products, and their biocompatibility has been confirmed according to ISO 10993. Sterilization processes are in accordance with ISO 11135, and packaging integrity is validated. Device integrity and functionality were qualified/validated to meet Spectranetics' in-house requirements and ISO 10555-1.
Key takeaway for your request: This document is about conventional medical device clearance, not an AI/ML device that would have acceptance criteria for algorithm performance. There are no models, test sets, ground truths, or expert adjudications as would be found in an AI/ML device submission.
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510(k) SUMMARY
SEP 0 2 2005
SUBMITTER INFORMATION
- A. Company Name: Spectranetics Corporation, Inc.
- B. Company Address: 96 Talamine Court Colorado Springs, Colorado 80907
- C. Company Phone: 719-633-8333 / 1-800-633-0960
- D. Company Facsimile: 719 442 2248
- E. Contact Person: Adrian Elfe Vice President Quality Assurance & Regulatory Affairs Compliance
DEVICE IDENTIFICATION
- A. Device Trade Name: CLiRpath Turbo Excimer Laser Catheter
- B. Device Common Name: Laser Catheter
- C. Classification Name: Catheter, Peripheral, Atherectomy
- D. Device Class: Class II (per 21 CFR 870.4875)
- E. Device Code: MCW
IDENTIFICATION OF PREDICATE DEVICES
Spectranetics CLiRpath excimer laser catheters for peripheral use, cleared to market under 510(k) K040067, serve as predicate to the line of CLiRpath excimer laser catheters with Continuous-On capability. The 2.5 mm CLiRpath Turbo excimer laser catheter, cleared under 510(k) K043465, likewise serves as a predicate. _
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DEVICE DESCRIPTION
Spectranetics' CLiRpath excimer laser atherectorny catheters, including CLiRpath Turbo models, consist of a bundle of optical fibers, encased within medical grade tubing. The optical fibers conduct ultraviolet laser light (excimer laser light at 308 nm) from a source to the tip of the catheter. The catheter is inserted into a patient's vasculature along the length of a previously inserted medical guidewire, allowing the attending physician to deliver laser energy targeted to a lesion (blockage) in the blood vessel. CLiRpath laser catheters are provided in models designed for both "over-the-wire" and rapid exchange interventional techniques. Laser energy impinged on a blockage ablates, or debulks, the lesion material re-establishing blood flow within the vessel, and permitting placement of devices used in vascular interventions.
Spectranetics brand CLiRpath Turbo laser catheters will be supplied in addlional tip diameters between 0.9 and 2.3 mm, appropriate for interventional use in the peripheral vasculature of the leg.
INTENDED USE
For use in the endovascular treatment of symptomatic infrainguinal lower extremity vascular disease where total obstructions can not be crossed with standard guide wires.
COMPARISON TO PREDICATE DEVICES
CLiRpath Turbo catheters for peripheral use are substantially equivalent in form, fit, and function to other Spectranetics CLiRpath laser catheters, including the 2.5 mm Turbo catheter, which have received market clearance under section 510(k) rules. CLiRpath Turbo catheters form an addition to the CLiRpath product line, providing the medical community with more control over the duration of treatment. Prior models of CLiRpath catheters, excluding the 2.5 mm Turbo model, delivered ablating laser energy for up to 10 seconds, when the activating footswitch was depressed, before electronic controls stopped the system for at least 5 seconds. Only the 2.5 mm Turbo predicate was provided with CLiRpath Turbo capability. Thus successful treatment often required several trains of 10-second laser pulses. The CLiRpath Turbo feature of the new CLiRpath catheter models allows interventions to proceed without the delay in treatment entailed due to a programmed on-off sequence, using catheter tip dimensions over a range from 0.9 mm to 2.3 mm.
CLiRoath Turbo laser products are fiber optic catheters with working lengths to choose from between 120 cm and 150 cm. Tip diameters range from 0.9 mm to 2.3 mm. The catheters deliver excimer laser energy at 308 nm to an occlusion within a patient's targeted perioheral artery. Delivered energy disrupts occlusive material, such as arterial plaque, and permits its removal via the patient's reticuloendothelial system. The pathway opened by either the predicate device or the Turbo catheter, facilitates subsequent placement of other devices and interventions, and re-establishes blood flow within the diseased vessel.
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BIOCOMPATIBILITY, STERILIZATION, PACKAGING, AND BENCH TESTING
CLiRpath Turbo excimer laser catheters are built from the same components and materials of construction as other, already-marketed, Spectranetics products. Therefore, micronal or usinor both component materials and the finished CLiRpath Turbo catheters have been previously confirmed in accord with the ISO 10993 series of standards, Biological Evaluation of Medical Devices. Spectranetics conducts and maintains valid ethylene oxide sterilization processes in accord with ISO 11135, Medical Devices -Validation and Routine Control of Ethylene Oxide Sterilization. Package integrity is initially validated, and, in addition, visually verified for 100% of Spectranetics devices prior to transfer to finished goods inventory.
Device integrity and functionality were qualified and/or validated using samples produced under routine manufacturing conditions. All CLiRpath Turbo excimer laser catheter models meet or exceed both Spectranetics in-house requirements, and requirements listed in ISO 10555-1, Sterile, Single-use Intravascular Catheters - Part 1: General Requirements.
CONCLUSION
The above statements establish substantial equivalence between the CLiRpath predicate devices, including 2.5 mm Turbo model, and the full line of CLiRpath Turbo excimer laser catheters.
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Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized symbol resembling a bird or abstract human figure, with flowing lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Spectranetics Corporation c/o Mr. Neil Burris Clinical Data Services 96 Talamine Court Colorado Springs, CO 80907
SEP 1 8 2013
Re: K052296
Trade/Device Name: CLiRpath Turbo Excimer Laser Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: PDU Dated: August 22, 2005 Received: August 23, 2005
Dear Mr. Burris:
This letter corrects our substantially equivalent letter of September 2, 2005.
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
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CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Zrim.Z=
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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7. Statement of Indication for Use
Device Name: Spectranetics CLiRpath Turbo™ Excimer Laser Catheter
Indications for Use
For use in the endovascular treatment of symptomatic infrainguinal lower
s and the endover and take total shatstructions on not be crossed For use in the endovascular treathoit of Sympton
extremity vascular disease where total obstructions can not be crossed with standard guide wires.
Prescription Use XXXX (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K052296
§ 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).