(26 days)
Indicated for atherectomy of infrainguinal arteries.
The Turbo-Tandem™ System (Laser Guide Catheter with Laser Ablation Catheter) is a laser atherectorny catheter constrained within a guiding catheter to facilitate the offset (biased position) of the laser ablation catheter. The Turbo-Tandem System is designed to directionally ablate infrainguinal concentric and eccentric lesions in vessels 5mm or greater at or above the knee. The Turbo-Tandem System is not designed to be used in total or sub-total occlusions. In the event of a total or sub-total occlusion a pilot channel is recommended. 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 0.014" (0.35mm) quidewire compatible lumen and has a fiber optic surface area similar to a 2.0mm laser catheter. The laser catheter is connected to the Spectranetics CVX-300® Excimer Laser System by means of an optical coupler and tail-tubing catheter portion of the Turbo-Tandem™ System is comprised of a handle with an incorporated flush port, proximal coupler, tail tubing, strain relief tubing, braided shaft with a hydrophilic coating, two radiopaque marker bands in the distal tip with a platform, and one radiopaque marker band at the distal end of the laser catheter.
The provided text describes a 510(k) premarket notification for the Spectranetics Turbo-Tandem™ System, a laser atherectomy catheter. However, it does not contain information about specific acceptance criteria, a study proving the device meets those criteria, or any of the detailed aspects commonly associated with clinical performance studies involving AI or expert review.
The submission focuses on establishing substantial equivalence to a predicate device, primarily through device integrity testing, rather than clinical performance evaluation against predefined criteria.
Therefore, most of the requested information cannot be extracted from the provided text.
Here's an analysis based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document. The submission relies on substantial equivalence based on device integrity testing. | "All device integrity test results for the Spectranetics Turbo-Tandem System met specified requirements." (The specific requirements are not detailed.) |
2. Sample Size Used for the Test Set and Data Provenance
No information is provided about a "test set" in the context of clinical performance, sample size, or data provenance (e.g., country of origin, retrospective/prospective). The studies mentioned were "device integrity testing."
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
Not applicable. The submission does not describe a study involving expert review or the establishment of ground truth for a clinical dataset. The "ground truth" seems to be implied by successful device integrity testing against internal requirements.
4. Adjudication Method for the Test Set
Not applicable. No test set requiring adjudication by experts is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. No MRMC study or comparison of human readers with or without AI assistance is mentioned. This device is a physical medical device, not an AI-based diagnostic tool.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This is a physical medical device, not an algorithm.
7. Type of Ground Truth Used
The "ground truth" for this submission appears to be successful device integrity testing against internal specifications and engineering requirements, demonstrating functional and safety equivalence to the predicate device. There is no mention of clinical ground truth like pathology, outcomes data, or expert consensus related to patient outcomes for this 510(k) submission.
8. Sample Size for the Training Set
Not applicable. This device is not an AI algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This device is not an AI algorithm.
Summary of what the document does provide:
- Device Type: Laser atherectomy catheter system.
- Purpose of Submission: Demonstrate substantial equivalence to a predicate device (Spectranetics first generation Turbo Tandem System K091299).
- Basis for Equivalence: Device integrity testing.
- Conclusion: Device integrity tests met specified requirements, supporting substantial equivalence.
The provided document is typical for a 510(k) for a physical medical device where the primary focus is on engineering and performance testing to demonstrate equivalence rather than a clinical trial or AI performance validation.
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JAN 2 5 2010
510(k) Summary
SUBMITTER INFORMATION
- A. Company Name: Spectranetics Corporation, Inc.
- B. Company Address: 9965 Federal Blvd Colorado Springs, CO 80921
- ். Company Phone: 719-447-2000/ 1-800-633-0960
- D. · Company Facsimile: 719-447-2040
DEVICE IDENTIFICATION
- Device Trade Name: Spectranetics Turbo-Tandem™ System A.
- Device Common Name: Percutaneous Laser Ablation Catheter B.
- C. Classification: Catheter, Percutaneous
- D. Device Class: Class II (per 21 CFR 870.1250)
- E. Device Code: DQY
F. Establishment Registration Number: 3007284006 (Federal Facility ) and 1721279 (Cascade Facility)
PERFORMANCE STANDARDS
Performance standards do not currently exist for these devices. None established under Section 514.
DEVICE DESCRIPTION
The Turbo-Tandem™ System (Laser Guide Catheter with Laser Ablation Catheter) is a laser atherectorny catheter constrained within a guiding catheter to facilitate the offset (biased position) of the laser ablation catheter. The Turbo-Tandem System is designed to directionally ablate infrainguinal concentric and eccentric lesions in vessels 5mm or greater at or above the knee. The Turbo-Tandem System is not designed to be used in total or sub-total occlusions. In the event of a total or sub-total occlusion a pilot channel is recommended. 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 0.014" (0.35mm) quidewire compatible lumen and has a fiber optic surface area similar to a 2.0mm laser catheter. The laser catheter is connected to the Spectranetics CVX-300® Excimer Laser System by means of an optical coupler and tail-tubing catheter portion of the Turbo-Tandem™ System is comprised of a handle with an incorporated flush port, proximal coupler, tail tubing, strain relief tubing, braided shaft with a hydrophilic coating, two radiopaque marker bands in the distal tip with a platform, and one radiopaque marker band at the distal end of the laser catheter. Figure 1 describes the location of the Turbo-Tandem™ System components.
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INDICATION FOR USE
Indicated for atherectomy of infrainguinal arteries.
SUBSTANTIALLY EQUIVALENT DEVICES
In Spectranetics' opinion, the Turbo-Tandem System is believed to be substantially equivalent to the following predicate device currently in interstate commerce with respect to comparable features, materials of construction and intended use.
- Spectranetics first generation Turbo Tandem System K091299 .
Labeling, packaging, and sterilization of the Spectranetics Turbo-Tandem System have not changed from the predicate device listed above. The IFU has been modified to reflect the new handle, hydrophilic coating and flush port modifications for the second generation Turbo-Tandem.
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 second generation Spectranetics Turbo-Tandem™ System through this 510(k) Premarket Notification.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The eagle is positioned to the right of a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged around the circumference of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
JAN 2 5 2010
Spectranctics Corporation c/o Mr. Michael Handley Chief Compliance Officer and Vice President, Global Regulatory Affairs 9965 Federal Drive Colorado Springs, CO 80921
Re: K094036
Trade Name: 7FR Turbo-Tandem™ Catheter System Regulation Number: 21 CFR 870.4875 Regulation Name: Intraluminal artery stripper Regulatory Class: Class II (two) Product Code: MCW, DQY Dated: December 28, 2009 Received: December 30, 2009
Dear Mr. Handley:
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.
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
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Page 2 - Mr. Michael Handley
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 (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/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,
una R. Vidmer
Image /page/3/Picture/7 description: The image shows a signature. The signature is in black ink and appears to be a stylized letter. The letter has a loop at the top and a line extending from the bottom.
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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Statement of Indication for Use
Premarket Notification Number: FBD |< 694 م 3 0 40
Device Name: Turbo-Tandem™ System
Indication for Use
Turbo-Tandem™ System is indicated for atherectomy of infrainguinal arteries.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
unar R. v. chuner
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_KO 94036
Prescription Use: v (Part 21 CFR 801 Subpart D) OR
Over the Counter Use: (21 CFR 807 Subpart C)
§ 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).