(94 days)
Not Found
No
The description focuses on the mechanical and optical components of a laser atherectomy system and does not mention any AI or ML capabilities.
Yes
The device is indicated for atherectomy, which is a therapeutic procedure to remove plaque from arteries.
No
The device is an atherectomy system designed for physically removing plaque from arteries, not for diagnosing medical conditions.
No
The device description clearly details physical components such as catheters, optical fibers, a handle, a braided shaft, and a biasing tip, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "atherectomy of infrainguinal arteries." This is a therapeutic procedure performed directly on the patient's body to remove plaque from arteries.
- Device Description: The device is a physical catheter system designed to be inserted into the body and used with a laser system to perform a physical intervention (atherectomy).
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, urine, tissue) outside of the body to provide diagnostic information. IVDs are used to diagnose diseases or conditions by analyzing these types of samples.
The Turbo-Tandem® System is a medical device used for a therapeutic procedure, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Turbo-Tandem® System is indicated for atherectomy of infrainguinal arteries.
Product codes (comma separated list FDA assigned to the subject device)
DQY, MCW
Device Description
The Turbo-Tandem® System (Laser Guide Catheter with Laser Atherectomy Catheter) is a laser atherectomy catheter constrained within a guiding catheter to facilitate the offset (biased position) of the laser atherectorny catheter. Specifically, the guiding catheter portion of the Turbo-Tandem® System includes an angled biasing tip 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 incorporated laser catheter of Turbo-Tandem® System is constructed of multiple optical fibers arranged circumferentially around a 0.014" (0.35mm) guidewire compatible lumen and has a fiber optic surface area similar to a 2.0mm laser catheter. The laser catheter has a radiopaque marker bands at the distal tip. The laser catheter is connected to the Spectranetics CVX-300® Excimer Laser System by means of an optical coupler and tail-tubing.
The guiding catheter portion of the Turbo-Tandem® System is comprised of a handle with an incorporated flush port, a braided shaft with hydrophilic coating, and a biasing tip with two radiopaque marker bands. The handle features a six-position locking mechanism to position the laser catheter on the ramp of the biasing tip.
The Turbo-Tandem® System is provided sterile and is intended to be single-use.
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 the claim that the 8Fr Turbo-Tandem System is substantially equivalent to the predicate device integrity tests for the Spectranetics 8Fr Turbo-Tandem System met the specified requirements which consisted of:
- Dimensional test
- In vitro tip position functional test
- In vitro performance test
- Laser ablation performance test
- Physical test
- Accelerated age test
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
§ 870.1250 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
Image /page/0/Picture/0 description: The image shows the word "Spectranetics" in a stylized font. The text is white against a black background. The word appears to be slightly italicized, and there is a small apostrophe after the "s".
OCT 17 201
Ki 12032
p. 1 of 2
510(k) Summary
(As Required By 21 CFR 807.92)
This 510(k) Summary of safety and effectiveness for the Spectranetics 8Fr Turbo-Tandem® System 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: | 8Fr Turbo-Tandem® System |
|---|---|
| Device common name: | Percutaneous guide catheter with laser atherectomy catheter |
| Classification: | Catheter, percutaneous |
| Device class: | Class II (per 21 CFR 870.1250 and 870.4875) |
| Device code: | DQY and MCW |
| Establishment Registration number: | 3007284006 |
Performance Standards
There are no performance standards applicable to this device.
Device Description
The Turbo-Tandem® System (Laser Guide Catheter with Laser Atherectomy Catheter) is a laser atherectomy catheter constrained within a guiding catheter to facilitate the offset (biased position) of the laser atherectorny catheter. Specifically, the guiding catheter portion of the Turbo-Tandem® System includes an angled biasing tip 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 incorporated laser catheter of Turbo-Tandem® System is constructed of multiple optical fibers arranged circumferentially around a 0.014" (0.35mm) guidewire compatible lumen and has a fiber optic surface area similar to a 2.0mm laser catheter. The laser catheter has a radiopaque marker bands at the distal tip. The laser catheter is connected to the Spectranetics CVX-300® Excimer Laser System by means of an optical coupler and tail-tubing. ﺮ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺮﺍﺟﻊ
1
The guiding catheter portion of the Turbo-Tandem® System is comprised of a handle with an incorporated flush port, a braided shaft with hydrophilic coating, and a biasing tip with two radiopaque marker bands. The handle features a six-position locking mechanism to position the laser catheter on the ramp of the biasing tip.
The Turbo-Tandem® System is provided sterile and is intended to be single-use.
Indication for Use
The Turbo-Tandem® System is indicated for atherectomy of infrainguinal arteries.
Substantially Equivalent Device
The Spectranetics 7Fr Turbo-Tandem® System (K094036) is the predicate device to the 8Fr Turbo-Tandem System. The 8Fr Turbo-Tandem System is similar to the predicate device with regards to design, the only change being the size of the biasing tip (7Fr to 8Fr). The IFU have been modified to specify instructions for both the 7Fr and 8Fr models.
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 8Fr Turbo-Tandem System is substantially equivalent to the predicate device integrity tests for the Spectranetics 8Fr Turbo-Tandem System met the specified requirements which consisted of:
- . Dimensional test
- In vitro tip position functional test .
- In vitro performance test .
- . Laser ablation performance test
- Physical test
- Accelerated age test .
Conclusion
Numerous similarities support a determination of substantial equivalence to the 7Fr Turbo-Tandem. Based on data and information presented, it can be concluded that the 8Fr Turbo-Tandem that the device is as safe, as effective, and performs as well as or better than 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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20995-0002
OCT 1 7 2011
Spectranetics Corporation c/o Shelley Wilcox Senior Regulatory Affairs Specialist 9965 Federal Dr. Colorado Springs, CO 80921
Re: K112032
Trade/Device Name: 8Fr Turbo-Tandem System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY, MCW Dated: July 14, 2011 Received: July 15, 2011
Dear Ms. Wilcox:
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 nuay 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. Shellev Wilcox
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 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.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industrv/default.htm.
Sincerely vours.
/UU
Ja Bram Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): FBB- K 川谷 O3 ス
Device Name: 8Fr Turbo-Tandem® System
Indications For Use:
The Turbo-Tandem® System is indicated for atherectomy of infrainguinal arteries.
| Prescription Use | X |
|---|---|
| (Part 21 CFR 801 Subpart D) |
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrenge of CDRH, Office of Device Evaluation (ODE)
(Divisior Sign-Off) Division of Cardiovascular Devi
510(k) Number C112032
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