(58 days)
Not Found
No
The device description focuses on mechanical and optical components for atherectomy, with no mention of AI or ML terms, image processing, or data-driven performance metrics.
Yes
The device is indicated for atherectomy, which is a medical procedure to remove plaque from arteries to restore blood flow, thus directly treating a medical condition.
No
Explanation: The "Intended Use / Indications for Use" states that the device is "Indicated for atherectomy of infrainguinal arteries," which is a therapeutic procedure involving the removal of plaque from arteries, not a diagnostic one. The "Device Description" also describes it as a laser ablation catheter for treatment.
No
The device description clearly describes a physical medical device consisting of catheters and optical fibers, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The provided description clearly states that the Turbo-Tandem System is a laser ablation catheter used for atherectomy of infrainguinal arteries. This is a surgical procedure performed directly on the patient's arteries, not on a specimen outside the body.
- Intended Use: The intended use is "atherectomy of infrainguinal arteries," which is a treatment procedure, not a diagnostic test performed on a specimen.
The device is a therapeutic device used for a medical procedure, not a diagnostic device used for testing specimens.
N/A
Intended Use / Indications for Use
Indicated for atherectomy of infrainguinal arteries.
Product codes
DQY
Device Description
The Turbo-Tandern™ System (Laser Guide Catheter with Laser Ablation Catheter) is a laser ablation catheter constrained within a guiding catheter to facilitate the offset (biased position) of the laser ablation catheter. The guiding catheter portion of the Turbo-Tandem System is used to offset the distal end of the incorporated laser catheter from the central plane of the vessel lumen allowing for circumferential guidance and positioning of the laser catheter within the vessel. The Turbo-Tandem System is 7F sheath compatible with a maximum crossing profile of 0.160" (4.0mm) with the laser catheter extended or offset position. The incorporated laser catheter is constructed of multiple optical fibers arranged circumferentially around a guidewire lumen and has a fiber optic surface area similar to a 2.0mm laser catheter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
infrainguinal arteries
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 that the Turbo-Tandem System is equivalent to the predicate devices. All device integrity test results for the Spectranetics Turbo-Tandem System met specified requirements.
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
§ 870.1250 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
K091299 page 1 of 2
STED Summary of Substantial Equivalence
SUBMITTER INFORMATION
- A. Company Name: Spectranetics Corporation, Inc.
- B. Company Address: 9965 Federal Blvd Colorado Springs, CO 80921
JUL - 1 2009
- ். Company Phone: 719-633-8333/ 1-800-633-0960
- Company Facsimile: 719-447-2040 D.
DEVICE IDENTIFICATION
- A. Device Trade Name: Spectranetics Turbo-Tandem™ System
- B. Device Common Name: Percutaneous Laser Ablation Catheter
- C. Classification: Catheter, Percutaneous
- D. Device Class: Class II (per 21 CFR 870.1250)
- E. Device Code: DQY
- F. Establishment Registration Number: 3007284006
PERFORMANCE STANDARDS
Performance standards do no currently exist for these devices. None established under Section 514.
DEVICE DESCRIPTION
The Turbo-Tandern™ System (Laser Guide Catheter with Laser Ablation Catheter) is a laser ablation catheter constrained within a guiding catheter to facilitate the offset (biased position) of the laser ablation catheter. The guiding catheter portion of the Turbo-Tandem System is used to offset the distal end of the incorporated laser catheter from the central plane of the vessel lumen allowing for circumferential guidance and positioning of the laser catheter within the vessel. The Turbo-Tandem System is 7F sheath compatible with a maximum crossing profile of 0.160" (4.0mm) with the laser catheter extended or offset position. The incorporated laser catheter is constructed of multiple optical fibers arranged circumferentially around a guidewire lumen and has a fiber optic surface area similar to a 2.0mm laser catheter.
INDICATION FOR USE
Indicated for atherectomy of infrainguinal arteries.
1
K091279 page 2 of 2
SUBSTANTIALLY EQUIVALENT DEVICES
In Spectranetics' opinion, the Turbo-Tandem System is believed to be substantially equivalent to the following predicate devices currently in interstate commerce with respect to comparable features, materials of construction and intended use.
Labeling, packaging, and sterilization of the Spectranetics Turbo-Tandem System has not changed from the predicate devices listed above.
SUMMARY OF STUDIES
Spectranetics performed device integrity testing to support that the Turbo-Tandem System is equivalent to the predicate devices. All device integrity test results for the Spectranetics Turbo-Tandem System met specified requirements.
CONCLUSION (STATEMENT OF EQUIVALENCE)
Through data and information presented, numerous similarities support a determination of substantial equivalence, and therefore market clearance of the Spectranetics Turbo-Tandem™ System through this STED Premarket Notification.
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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Public Health Service
JUL -- 1 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Gracie Murguia Regulatory Affairs and Compliance Supervisor Spectranetics Corp. 9965 Federal Drive Colorado Springs, CO 80921
Re: K091299
Turbo-Tandem System Regulation Number: 21 CFR 870.1250 Regulation Name: Catheter, Percutaneous Regulatory Class: Class II Product Code: DQY Dated: May 1, 2009 Received: May 4, 2009
Dear Ms. Murguia:
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.
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.
3
Page 2 - Ms. Gracie Murguia
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 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 go 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 (240) 276-3150 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
R. Lochner
Bram D. Zuckerman, M.D.
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Statement of Indication for Use
Premarket Notification Number: IBD
Device Name: Turbo-Tandem™ System
Indication for Use
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Turbo-Tandem™ System is indicated for atherectomy of infrainguinal arteries.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
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510(k) Number K091271
Prescription Use: V (Part 21 CFR 801 Subpart D)
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OR
Over the Counter Use: 21 CFR 807 Subpart C