(57 days)
Not Found
No
The device description focuses on the physical components and mechanical function of a guiding catheter. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The device is a guiding catheter that directs and supports a laser catheter, which is the therapeutic device used to treat stenoses and occlusions.
No
The device is described as a "guiding catheter" designed for "directing and supporting" laser catheters to treat blockages. Its function is to facilitate a therapeutic procedure (ablation), not to diagnose a condition.
No
The device description clearly outlines physical components like a luer hub, strain relief, shaft, hydrophilic coating, and tip, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Function: The Spectranetics TURBO-Booster™ guiding catheter is a device used inside the body (in vivo) to guide and support another medical device (a laser catheter) during a surgical procedure to treat blockages in blood vessels.
- Intended Use: The intended use clearly describes a procedure performed within the patient's vasculature, not a laboratory test on a sample.
- Device Description: The description details the physical components of a catheter designed for insertion into blood vessels.
- Performance Studies: The performance studies describe clinical trials involving patients and the device's performance during a procedure, not the accuracy of a diagnostic test.
The TURBO-Booster™ is an invasive medical device used for a therapeutic procedure, not a diagnostic test performed on a sample outside the body.
N/A
Intended Use / Indications for Use
The Spectranetics TURBO-Booster™ guiding catheter is designed for directing and supporting Spectranetics laser catheters for use in the treatment of infrainguinal stenoses and occlusions.
Not for use in the carotid and coronary vasculature.
Product codes
DQY, PDU
Device Description
The TURBO-Booster™ is comprised of a luer hub, strain relief, shaft, hydrophilic coating, and a tip. The strain relief acts as a transition point between the stiff luer hub and flexible shaft.
The shaft is comprised of three different components: an FEP inner liner, a stainless steel braid and a Pebax outer jacket. The stainless steep braid improves the torque response of the device and overall strength of the shaft.
The tip is constructed of Pebax with varying stiffness (durometer). The proximal portion of the tip includes the biasing ramp that offsets the laser catheter to create the bias. The distal portion provides an atraumatic tip for the device.
A hydrophilic coating is applied to the outer surface of the device to reduce friction A nyarophilie device and the crossover sheath. It also provides lubrication during use through the body's vasculature.
The TURBO-Booster™ is used to bias (offset) a Spectranetics laser catheter from the central axis (guiding wire axis) during ablation. This allows for a larger lumen to be created than can be created with a laser catheter alone.
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
Clinical data were collected in support of safety and efficacy for Spectranetics brand TURBO-Booster™ guiding catheters. Approximately sixty (60) patients enrolled in the CELLO Study (CLiRpath 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 laser catheters in 96.8% of the trial cases.
Key Metrics
96.8% successful facilitation of placement of laser catheters
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
K071226 a Lof 3
510(k) SUMMARY
JUN 2 9 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 Elliott Vice President Clinical Affairs and Regulatory Submissions
DEVICE IDENTIFICATION
- A. Device Trade Name: TURBO-Booster™ Guiding Catheter
- B. Device Common Name: Guiding Catheter or Guide Catheter
- C. Classification Name: Percutaneous Catheter
- D. Device Class: Class II (per 21 CFR 870.1250)
- E. Device Code: DQY
IDENTIFICATION OF PREDICATE DEVICES
Spectranetics TURBO-Booster™ guiding catheters are substantially equivalent to many Similar devices currently on the market. Spectranetics deems the Cordis Vista Brite Tip® Guiding Catheter (K971572) to be the primary predicate for the TURBO-Booster™ Additional predicates are the Scheidner Guider Softip® Guide Catheter (K980453) and the Boston Scientific Mach 1 Guiding Catheter (K020028).
1
DEVICE DESCRIPTION
The TURBO-Booster™ is comprised of a luer hub, strain relief, shaft, hydrophilic coating, and a tip. The strain relief acts as a transition point between the stiff luer hub and flexible shaft.
The shaft is comprised of three different components: an FEP inner liner, a stainless steel braid and a Pebax outer jacket. The stainless steep braid improves the torque response of the device and overall strength of the shaft.
The tip is constructed of Pebax with varying stiffness (durometer). The proximal portion of the tip includes the biasing ramp that offsets the laser catheter to create the bias. The distal portion provides an atraumatic tip for the device.
A hydrophilic coating is applied to the outer surface of the device to reduce friction A nyarophilie device and the crossover sheath. It also provides lubrication during use through the body's vasculature.
The TURBO-Booster™ is used to bias (offset) a Spectranetics laser catheter from the central axis (guiding wire axis) during ablation. This allows for a larger lumen to be created than can be created with a laser catheter alone.
INTENDED USE
The Spectranetics TURBO-Booster™ guiding catheter is designed for directing and supporting Spectranetics laser catheters for use in the treatment of infrainguinal stenoses and occlusions.
COMPARISON TO PREDICATE DEVICES
Spectranetics brand TURBO-Booster™ guiding catheters are equivalent in form, fit, and function to the previously marketed Cordis Vista Brite Tip, Schneider Guider Softip, and Boston Scientific Mach 1 guiding catheters, the cited predicates. All of these guide cathers help to guide and position other interventional devices within a patients' vasculature, and in particular the peripheral vascular.
BIOCOMPATIBILITY, STERILIZATION, PACKAGING, AND BENCH TESTING
TURBO-Booster™ guiding catheters are built from the same components and materials of construction as other, already-marketed, Spectranetics products. Therefore, biocompatibility of both component materials and the finished TURBO-Booster™ guiding catheters have been previously confirmed in accord with the ISO 10993 series of standards, Biological Evaluation of Medical Devices. Spectranetics conducts and maintains valid ethylene oxide sterilization processes in accord with ISO 11135, Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization. Package integrity is initially validated in conjunction with sterilization studies.
2
Device integrity and functionality were qualified and/or validated using samples produced under routine manufacturing conditions. All TURBO-Booster™ guiding catheter models meet or exceed both Spectranetics in-house requirements, and requirements listed in ISO 1055-1, Sterile, Single-use Intravascular Catheters - Part 1: General Requirements.
CLINICAL DATA
Clinical data were collected in support of safety and efficacy for Spectranetics brand TURBO-Booster™ guiding catheters. Approximately sixty (60) patients enrolled in the CELLO Study (CLiRpath 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 laser catheters in 96.8% of the trial cases.
CONCLUSION
The above statements establish substantial equivalence between the TURBO-Booster™ and predicate devices.
3
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of a human figure with outstretched arms, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Spectranetics Corp., Inc. 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: K071226
Trade/Device Name: 8Fr and 7Fr Turbo Booster Guiding Catheter 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 June 29, 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
4
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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Fm.2-
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
7. Statement of Indication for Use
Device Name: TURBO-Booster™ Guiding Catheter
Indications for Use
The Spectranetics TURBO-Booster™ guiding catheter is designed for directing and supporting Spectranetics laser catheters for use in the treatment of infrainguinal stenoses and occlusions.
Not for use in the carotid and coronary vasculature.
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)
e R. Laines
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_Ko 3122 مك