(69 days)
Not Found
No
The description focuses on the physical mechanism of laser ablation and does not mention any computational or data-driven components indicative of AI/ML.
Yes
The device is described as being used "in the treatment of infrainguinal stenoses and occlusions" and "Laser energy photoablates or debulks the lesion material re-establishing blood flow within the vessel", which indicates a therapeutic purpose.
No
The device description and intended use clearly state that it is used for the treatment of infrainguinal stenoses and occlusions by delivering laser energy to photoablate or debulk lesion material, which is a therapeutic function, not a diagnostic one.
No
The device description clearly details a physical catheter with optical fibers and medical grade tubing, designed to deliver laser energy. This is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "For use in the treatment of infrainguinal stenoses and occlusions." This describes a therapeutic intervention performed directly on the patient's body to treat a medical condition.
- Device Description: The device description details a catheter that delivers laser energy to photoablate or debulk lesions within blood vessels. This is a physical treatment method.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This device does not perform such tests.
The device is a therapeutic medical device used for treating vascular blockages, not for diagnosing conditions using samples outside the body.
N/A
Intended Use / Indications for Use
The CLiRpath® Turbo and TURBO elite™ Excimer laser catheters: For use in the treatment of infrainguinal stenoses and occlusions.
Product codes (comma separated list FDA assigned to the subject device)
MCW, PDU
Device Description
The CLiRpath® Turbo excimer laser catheters and the TURBO elite™ excimer laser catheters 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 guidewire, allowing the operator to deliver laser energy targeted to a lesion in the vasculature. The CLiRpath® Turbo and TURBO elite™ excimer laser catheters are provide in models designed for "over-the-wire" (OTW) or "rapid exchange" (RX) interventional techniques. Laser energy photoablates or debulks the lesion material re-establishing blood flow within the vessel and permits placement of other interventional devices if needed.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
infrainguinal, vasculature
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)
Clinical data were collected in support of safety and efficacy for Spectranetics brand TURBO-Booster™ and CLiRpath® Turbo excimer laser catheters. Sixty-one (61) patients enrolled in the CELLO Study (CLiRoath Excimer Laser System to Enlarge Lumen Openings) approved as IDE #G060015. No major adverse events were recorded and the TURBO-Booster™ successfully facilitated placement of peripheral excimer laser catheters in 96.8% of the trial cases.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
96.8% successful facilitation of placement of peripheral excimer laser catheters by TURBO-Booster™.
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
K07/227
510(k) SUMMARY
'JUL 1 1 2007
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: 719-447-2040
- E. Contact Person: Kelly W. Elliott, RN, MS Vice President Clinical Affairs & Regulatory Submissions
DEVICE IDENTIFICATION
-
A. Device Trade Name(s): CLiRpath® Turbo Excimer Laser catheters and TURBO elite™ Excimer Laser Catheters
Device Common Name(s): Peripheral Laser Catheters -
B. Classification Name(s): Catheter, Peripheral, and Atherectorny
-
C. Device Class: Class II (per 21 CFR 870.4875)
-
D. Device Code(s): MCW
IDENTIFICATION OF PREDICATE DEVICES
Spectranetics TURBO elite™ excimer laser catheters are substantially equivalent to the same product line, TURBO elite™ excimer laser catheters (K060012). Spectranetics CLiRpath® Turbo excimer laser catheters are substantially equivalent to the same product line, CLiRpath® Turbo excimer laser catheter (K052296 and K052514)
1
DEVICE DESCRIPTION(S)
The CLiRpath® Turbo excimer laser catheters and the TURBO elite™ excimer laser catheters 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 guidewire, allowing the operator to deliver laser energy fargeted to a lesion in the vasculature. The CLiRpath® Turbo and TURBO elite™ excimer laser catheters are provide in models designed for "over-the-wire" (OTW) or "rapid exchange" (RX) interventional techniques. Laser energy photoablates or debulks the lesion material re-establishing blood flow within the vessel and permits placement of other interventional devices if needed.
INTENDED USE(S)
The CLiRpath® Turbo and TURBO elite™ Excimer laser catheters: For use in the treatment of infrainguinal stenoses and occlusions.
COMPARISON(S) TO PREDICATE DEVICES
Spectranetics brand CLiRpath® Turbo and TURBO elite™ excimer laser catheters are equivalent in form, fit, and function to other Spectranetics excimer laser catheters intended for peripheral use. All Spectranetics peripheral excimer laser catheters are minimally invasive interventional devices used to treat arterial plaque in the arteries of a patient's leg in order to re-establish blood flow to the lower extremities.
BIOCOMPATIBILITY, STERILIZATION, PACKAGING, AND BENCH TESTING
CLINICAL DATA
Clinical data were collected in support of safety and efficacy for Spectranetics brand TURBO-Booster™ and CLiRpath® Turbo excimer laser catheters. Sixty-one (61) patients enrolled in the CELLO Study (CLiRoath Excimer Laser System to Enlarge Lumen Openings) approved as IDE #G060015. No major adverse events were recorded and the TURBO-Booster™ successfully facilitated placement of peripheral excimer laser catheters in 96.8% of the trial cases.
CONCLUSION
The above statements establishes substantial equivalence between the CLiRpath® Turbo and TURBO elite TM excimer laser catheters.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
The Spectranetics Corporation c/o Ms. Kelly W. Elliot, RN, MS Vice President Clinical Affairs and Regulatory Submissions 96 Talamine Court Colorado Springs, CO 80907-5186
SEP 1 8 2013
Re: K071227
Trade/Device Name: CLiRpath Turbo and Turbo Elite Excimer Laser Catheters Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: PDU Dated: May 1, 2007 Received: May 3, 2007
Dear Ms. Elliot:
This letter corrects our substantially equivalent letter of July 11, 2007.
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
3
Page 2 - Ms. Kelly W. Elliot
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,
Zim.Zi
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
7. Statement of Indication for Use
Device Name: CLiRpath® Turbo Excimer Laser Catheter
Indication for Use
For use in the treatment of infrainguinal stenoses and occlusions.
Device Name: TURBO elite™ Excimer Laser Catheter
Indication for Use
For use in the treatment of infrainguinal stenoses and occlusions.
| 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 | K071227 |