(63 days)
Not Found
No
The summary describes a laser atherectomy catheter and its connection to a laser system. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The performance studies focus on device integrity and physical characteristics.
Yes
The device is intended for "treatment, including atherectomy, of infrainguinal stenoses and occlusions," which directly describes a therapeutic application.
No
The device description clearly states its intended use is 'for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions', indicating a therapeutic, rather than diagnostic, purpose.
No
The device description clearly details a physical atherectomy catheter with optical fibers, a guidewire lumen, and connections to a laser system, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "in the treatment, including atherectomy, of infrainguinal stenoses and occlusions." This describes a therapeutic procedure performed directly on the patient's body to treat a medical condition.
- Device Description: The device is a "laser atherectomy catheter" used in conjunction with a laser system. This is a surgical/interventional device used for physical treatment.
- Lack of Diagnostic Activity: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide diagnostic information. This device is designed for direct therapeutic intervention.
N/A
Intended Use / Indications for Use
The Turbo Elite is intended for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions.
Product codes (comma separated list FDA assigned to the subject device)
MCW
Device Description
The Turbo-Elite Atherectomy Catheter is a laser atherectomy catheter constructed of multiple optical fibers arranged circumferentially around a guidewire lumen (0.014 and 0.018, presently). Turbo Elite Laser Catheters are available in Over the Wire (OTW) and Rapid Exchange (RX) configurations. The proposed catalog additions are over-the-wire (OTW) 0.035" guidewire compatible with crossing profiles of 2.3mm and 2.5mm.
The laser catheter is connected to the Spectranetics CVX-300 Excimer Laser System by means of an optical coupler and tail-tubing.
The Turbo Elite, OTW catheters include a luer adapter located at the proximal end of the usable length facilitates the use of the laser catheter over the appropriate sized guidewire.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
infrainguinal
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)
Spectranetics performed device integrity testing to support the claim that the substantially equivalent to the predicate device. All device integrity tests for the over-the-wire (OTW) 0.035" guidewire compatible 2.3mm and 2.5mm Turbo Elite Atherectory Catheters met the specified requirements, which consisted of:
- Visual Inspection and Dimensional Testing
- In vitro Liquid Leak Pressure Testing
- Tensile Strength
- In vitro Track Testing
- Laser testing
- Accelerated age testing
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
510(k) Summary (As Required By 21 CFR 807.92)
JAN 2 5 2013
This 510(k) Summary for the Spectranetics 0.035" compatible, 2.3mm TurboElite Atherectorny Catheters is submitted in accordance with the requirements of the SMDA 1990 and following guidance concerning the organization and content of a 510(k) summary.
Submitter Information
| Company name: | Spectranetics Corporation |
|---|---|
| Company address: | 9965 Federal Drive |
| Colorado Springs, CO 80921 | |
| Company phone: | (719) 477-2000 |
| (800) 633-0960 | |
| Company fax: | (719) 447-2040 |
Device Identification
| Device trade name: | 2.3mm and 2.5mm TurboElite 0.035" Atherectomy Catheters |
|---|---|
| Device common name: | Laser atherectomy catheter |
| Classification: | Intraluminal Artery Stripper |
| Device class: | Class II (per 21 CFR 870.4875) |
| Device code: | MCW |
| Establishment Registration number: | 3007284006 |
Performance Standards
There are no performance standards applicable to this device.
Device Description
The Turbo-Elite Atherectomy Catheter is a laser atherectomy catheter constructed of multiple optical fibers arranged circumferentially around a guidewire lumen (0.014 and 0.018, presently). Turbo Elite Laser Catheters are available in Over the Wire (OTW) and Rapid Exchange (RX) configurations. The proposed catalog additions are over-the-wire (OTW) 0.035" guidewire compatible with crossing profiles of 2.3mm and 2.5mm.
The laser catheter is connected to the Spectranetics CVX-300 Excimer Laser System by means of an optical coupler and tail-tubing.
The Turbo Elite, OTW catheters include a luer adapter located at the proximal end of the usable length facilitates the use of the laser catheter over the appropriate sized guidewire.
Indication for Use
The Turbo Elite is intended for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions.
1
Substantially Equivalent Device
The Turbo Elite (previously referred to as CLiRpath Excimer Laser Catheter) was originally cleared by the FDA through a Premarket Notification in the US in 2004. Between 2005 and 2007, Spectranetics filed various 510(k) applications to modify features and indications. The most recently cleared 510(k) application (K071227) serves as our predicate for this 510(k) application.
The intended use, intended patient population, and mode of operation are comparable to the predicate device. The materials of construction, packaging, biocompatibility, sterilization, and shelf-life are identical to the predicate device.
Summary of Studies
Spectranetics performed device integrity testing to support the claim that the substantially equivalent to the predicate device. All device integrity tests for the over-the-wire (OTW) 0.035" guidewire compatible 2.3mm and 2.5mm Turbo Elite Atherectory Catheters met the specified requirements, which consisted of:
- Visual Inspection and Dimensional . Testing
- In vitro Liquid Leak Pressure Testing .
- Tensile Strength .
- In vitro Track Testing .
- Laser testing .
- Accelerated age testing �
Conclusion
Numerous similarities support a determination of substantial equivalence of the 0.035" compatible 2.3mm and 2.5mm Turbo Elite to the currently cleared 0.018" compatible 2.3mm and 2.5mm TurboElite devices. Based on data and information presented, it can be concluded that the 0.035" compatible 2.3mm and 2.5mm Turbo Elite Laser Atherectomy Catheters are as safe, as effective, and perform substantially equivalent to the predicate device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
JAN 2 5 2013
Spectranetics Corp. c/o Ms. Christine Godleski Senior Regulatory Affairs Specialist 9665 Federal Drive Colorado Springs, CO 80921
Re: K123632
Trade/Device Name: 2.3mm and 2.5mm Turbo Elite 0.035" Atherectomy Catheters Regulation Number: 21 CFR 870.4875 Regulation Name: Intraluminal artery stripper Regulatory Class: Class II Product Code: MCW Dated: November 15, 2012 Received: November 23, 2012
Dear Ms. Godleski:
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. However, we remind you 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
3
or any Federal statutes and regulations administered by other Federal agencies. You must or uny 1 vith 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 Or ice rated 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 11 Jou to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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,
Matthew G. Hillebrenner
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K1236.32
Indications for Use 510(k) Number (if known): TBD Device Name: Turbo Elite 035 Indications For Use:
The Turbo Elite is intended for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions.
AND/OR Over-The-Counter Use _ x Prescription Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1
M.J. Hellek
(Division Sign-Off) Division of Cardiovascular Devices
11-12-3632 510(k) Number