(109 days)
Not Found
No
The summary describes a mechanical guide extension catheter and its performance testing, with no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
No.
The device facilitates the placement of other interventional devices and provides support, but it does not directly treat a disease or condition itself.
No
The device description indicates its use for facilitating the placement of interventional devices and providing support, rather than for diagnosing conditions.
No
The device description and performance studies clearly indicate a physical catheter, not a software-only device. The testing includes bench testing on physical properties like deliverability, torque, and tensile strength, as well as biocompatibility testing.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to "access discrete regions of the coronary and/or peripheral vasculature, and to facilitate placement of interventional devices." This describes a device used within the body for a procedural purpose, not for testing samples outside the body.
- Device Description: The description details a "single-lumen rapid exchange catheter" designed to act as an "extension to a traditional guide catheter" and to "facilitate the delivery of interventional devices into the vasculature." This further reinforces its use as an invasive medical device for procedures.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing. The focus is entirely on its mechanical function within the vascular system.
- Performance Studies: The performance studies described are related to the physical and biological properties of the catheter itself (deliverability, tensile strength, biocompatibility, etc.), not the accuracy or reliability of diagnostic measurements.
In summary, the Telescope™ Guide Extension Catheter is a medical device used for interventional procedures within the body, not for in vitro diagnostic testing of samples.
N/A
Intended Use / Indications for Use
Telescope™ Guide Extension Catheter is intended to be used in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, and to facilitate placement of interventional devices.
Product codes (comma separated list FDA assigned to the subject device)
DQY
Device Description
The Telescope guide extension catheter is a single-lumen rapid exchange catheter. The guide extension catheter is designed to act as an extension to a traditional guide catheter and to facilitate the delivery of interventional devices into the vasculature. The guide extension catheter is intended to be used within the coronary and/or peripheral vasculature to provide support.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary and/or peripheral vasculature
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)
The technological differences between the subject and predicate devices have been evaluated through biocompatibility and design verification tests to provide evidence of substantial equivalence for the Telescope™ Guide Extension Catheter. The Telescope™ Guide Extension Catheter is substantially equivalent to the specified predicate devices based on comparisons of the device functionality, technological characteristics, and indications for use. The device design has been verified through the following:
Design Verification/In-Vitro Bench Testing included:
- Simulated Use
- Deliverability
- Tip compression
- Pushwire Integrity
- Torque
- Lumen Patency
- Maximum outer diameter
- Catheter effective length
- Kink resistance
- Tensile Strength
- Coating Integrity
- Coating Particulate
Biocompatibility Testing completed on the Telescope™ device in compliance with the requirements of ISO 10993-1: 2009/ Cor 1: 2010- Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process, included:
- Cytotoxicity
- Acute Systemic Toxicity
- Material Mediated Pyrogenicity
- ASTM Hemolysis
- Complement Activation
- Partial thromboplastin time
- In-vivo Thromboresistance
- Irritation / Intracutaneous Reactivity
- Sensitization
No clinical investigation has been performed for this device. No new safety or effectiveness issues were raised during the 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
§ 870.1250 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/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services seal on the left and the FDA acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a blue square and the full name in a larger font size.
Medtronic Inc. Elaine Gullane Principal Regulatory Affairs Specialist Parkmore Business Park West Galway, Ireland
Re: K183353
Trade/Device Name: Telescope™ Guide Extension Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: February 20, 2019 Received: February 22, 2019
Dear Elaine Gullane:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone
(1-800-638-2041 or 301-796-7100).
Sincerely.
| Lydia S. | Digitally signed by
Lydia S. Glaw -S |
|----------|-----------------------------------------|
| Glaw -S | Date: 2019.03.22
12:09:56 -04'00' |
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | |
|---|---|
| Food and Drug Administration | |
| Indications for Use | Form Approved: OMB No. 0910-0120 |
| Expiration Date: 06/30/2020 | |
| See PRA Statement below. | |
| 510(k) Number ( if known ) | K183353 |
| Device Name | Telescope™ Guide Extension Catheter |
| Indications for Use ( Describe ) | Telescope™ Guide Extension Catheter is intended to be used in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, and to facilitate placement of interventional devices. |
| Type of Use ( Select one or both, as applicable ) | |
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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| FORM FDA 3881 (7/17) | Page of | PSC Publishing Services (301) 443-6740 EF |
|---|---|---|
| ---------------------- | --------- | ------------------------------------------- |
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510(k) Summary per 21 CRF 807.92
| Date Prepared: | 30th November 2018 |
|---|---|
| Applicant: | Medtronic Ireland |
| Parkmore Business Park West | |
| Galway | |
| Ireland | |
| Official | |
| Correspondent: | Elaine Gullane |
| Principal Regulatory Affairs Specialist | |
| Medtronic Ireland | |
| Parkmore Business Park West | |
| Galway | |
| Ireland | |
| Phone: (353) 91 708682 | |
| Fax: (353) 91 708672 | |
| Email: elaine.gullane@medtronic.com | |
| Proprietary | |
| Name: | Telescope™ Guide Extension Catheter |
| Common | |
| Name: | Guide Catheter |
| Device | |
| Classification: | Class II |
| Regulation | |
| Number: | 21 CFR 870.1250 |
| Classification | |
| Name: | Percutaneous catheter |
| Product Code: | DOY |
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Device The Telescope guide extension catheter is a single-lumen rapid exchange Description: catheter. The guide extension catheter is designed to act as an extension to a traditional guide catheter and to facilitate the delivery of interventional devices into the vasculature. The guide extension catheter is intended to be used within the coronary and/or peripheral vasculature to provide support.
The Telescope™ Guide Extension Catheter is offered in sizes compatible with 6F and 7F guide catheters as indicated by the product model numbers below.
| Size | Product Model Number |
|---|---|
| 6F | TELE6F |
| 7F | TELE7F |
Indications For Telescope™ Guide Extension Catheter is intended to be used in conjunction with guide catheters to access discrete regions of the coronary and/or Use: peripheral vasculature, and to facilitate placement of interventional devices.
Substantially GuideLiner V3 Catheter (K172090, cleared October 20, 2017).
Equivalent Device:
Summary of The following outlines the differences and similarities between the subject device - Telescope™ Guide Extension Catheter and the predicate device -Technological GuideLiner V3 Catheter: Differences to the
Predicate Device:
- Similar Intended Use ●
- Similar Device Design Component/Construction ●
- Different device materials
- Similar Packaging ●
- Similar Sterilization Method .
Medtronic's Telescope™ Guide Extension Catheter is substantially equivalent to the predicate device based on similarities in intended use and technological characteristics. The testing performed demonstrates that the technological differences in the new device do not raise new questions of safety and effectiveness.
Summary of Non-The technological differences between the subject and predicate devices Clinical Data: have been evaluated through biocompatibility and design verification tests to provide evidence of substantial equivalence for the Telescope™ Guide Extension Catheter. The Telescope™ Guide Extension Catheter is substantially equivalent to the specified predicate devices based on comparisons of the device functionality, technological characteristics, and indications for use. The device design has been verified through the following:
5
Design Verification/In-Vitro Bench Testing
The Design Verification Testing included in-vitro bench testing and included:
- . Simulated Use
- Deliverability ●
- Tip compression .
- Pushwire Integrity ●
- Torque .
- Lumen Patency ●
- Maximum outer diameter ●
- Catheter effective length ●
- Kink resistance ●
- Tensile Strength ●
- Coating Integrity ●
- Coating Particulate ●
Biocompatibility Testing
The following Biocompatibility Testing was completed on the Telescope™ device in compliance with the requirements of ISO 10993-1: 2009/ Cor 1: 2010- Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
- . Cytotoxicity
- Acute Systemic Toxicity ●
- Material Mediated Pyrogenicity ●
- ASTM Hemolysis ●
- Complement Activation ●
- Partial thromboplastin time .
- In-vivo Thromboresistance .
- Irritation / Intracutaneous Reactivity ●
- . Sensitization
No new safety or effectiveness issues were raised during the testing. Therefore, the Telescope™ Guide Extension Catheter is substantially equivalent to the predicate device.
Summary of No clinical investigation has been performed for this device.
Clinical Data:
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| Sterilization | The Telescope™ Guide Extension Catheter will be sterilized and validated |
|---|---|
| Validation: | for EtO sterilization in accordance with ISO11135 and EN556 to achieve a |
| minimum Sterility Assurance Level (SAL) of 10-6. | |
| Conclusion: | The data provided in this 510(k) premarket notification demonstrated that |
| the subject device Telescope™ Guide Extension Catheter is substantially | |
| equivalent to the predicate device. |