(109 days)
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.
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.
The Telescope™ Guide Extension Catheter is offered in sizes compatible with 6F and 7F guide catheters as indicated by the product model numbers below.
The provided text describes the 510(k) premarket notification for the Medtronic Telescope™ Guide Extension Catheter. It outlines the device's indications for use, its substantial equivalence to a predicate device, and the non-clinical testing performed to establish this equivalence.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly list specific quantitative "acceptance criteria" in the format of a table with numerical thresholds. Instead, it describes various "Design Verification/In-Vitro Bench Testing" and "Biocompatibility Testing" categories that were performed to demonstrate substantial equivalence to the predicate device. The implied acceptance criterion for each test is that the device's performance is acceptable and does not raise new questions of safety and effectiveness, making it comparable to the predicate.
Here's an interpreted table based on the testing categories mentioned:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Design Verification/In-Vitro Bench Testing: | |
| Simulated Use | No new safety or effectiveness issues raised. |
| Deliverability | No new safety or effectiveness issues raised. |
| Tip compression | No new safety or effectiveness issues raised. |
| Pushwire Integrity | No new safety or effectiveness issues raised. |
| Torque | No new safety or effectiveness issues raised. |
| Lumen Patency | No new safety or effectiveness issues raised. |
| Maximum outer diameter | No new safety or effectiveness issues raised. |
| Catheter effective length | No new safety or effectiveness issues raised. |
| Kink resistance | No new safety or effectiveness issues raised. |
| Tensile Strength | No new safety or effectiveness issues raised. |
| Coating Integrity | No new safety or effectiveness issues raised. |
| Coating Particulate | No new safety or effectiveness issues raised. |
| Biocompatibility Testing (in compliance with ISO 10993-1): | |
| Cytotoxicity | No new safety or effectiveness issues raised. |
| Acute Systemic Toxicity | No new safety or effectiveness issues raised. |
| Material Mediated Pyrogenicity | No new safety or effectiveness issues raised. |
| ASTM Hemolysis | No new safety or effectiveness issues raised. |
| Complement Activation | No new safety or effectiveness issues raised. |
| Partial thromboplastin time | No new safety or effectiveness issues raised. |
| In-vivo Thromboresistance | No new safety or effectiveness issues raised. |
| Irritation / Intracutaneous Reactivity | No new safety or effectiveness issues raised. |
| Sensitization | No new safety or effectiveness issues raised. |
2. Sample Size Used for the Test Set and the Data Provenance:
The document does not specify the exact sample sizes used for each individual test within the "Design Verification/In-Vitro Bench Testing" and "Biocompatibility Testing." It broadly states that "non-clinical data" was generated.
The data provenance is from Medtronic Ireland, the manufacturer, through in-vitro bench testing and biocompatibility testing. This is typically considered prospective for the purposes of generating data to support the 510(k) submission, as the tests were specifically conducted for the purpose of demonstrating substantial equivalence of the new device. The country of origin for the data generation would be Ireland, where Medtronic Ireland is located.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
This information is not provided in the document. The document describes bench testing and biocompatibility testing, which typically involve laboratory personnel and engineers, rather than clinical experts establishing ground truth in the context of diagnostic interpretation.
4. Adjudication Method for the Test Set:
This information is not applicable and not provided. The testing described is objective, technical testing (e.g., tensile strength, lumen patency) and biocompatibility testing against defined standards. It does not involve human interpretation or adjudication of results in the way a clinical study would.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical investigation has been performed for this device."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This concept is not applicable to this device. The Telescope™ Guide Extension Catheter is a physical medical device, not a software algorithm or AI model. Therefore, "standalone algorithm performance" is not a relevant metric.
7. The Type of Ground Truth Used:
For the "Design Verification/In-Vitro Bench Testing," the ground truth is established by engineering specifications, industry standards, and internal Medtronic test protocols that ensure the device meets its functional and performance requirements. For "Biocompatibility Testing," the ground truth is established by international standards, specifically ISO 10993-1: 2009/ Cor 1: 2010, which outlines the requirements for biological evaluation of medical devices.
8. The Sample Size for the Training Set:
This information is not applicable and not provided. As this is a physical medical device submission and no AI/machine learning component is mentioned, there is no "training set" in the context of an algorithm.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as there is no training set for an AI/machine learning algorithm.
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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
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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 byLydia S. Glaw -S |
|---|---|
| Glaw -S | Date: 2019.03.2212:09:56 -04'00' |
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| 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 IrelandParkmore Business Park WestGalwayIreland |
| OfficialCorrespondent: | Elaine GullanePrincipal Regulatory Affairs SpecialistMedtronic IrelandParkmore Business Park WestGalwayIrelandPhone: (353) 91 708682Fax: (353) 91 708672Email: elaine.gullane@medtronic.com |
| ProprietaryName: | Telescope™ Guide Extension Catheter |
| CommonName: | Guide Catheter |
| DeviceClassification: | Class II |
| RegulationNumber: | 21 CFR 870.1250 |
| ClassificationName: | 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:
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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 aminimum Sterility Assurance Level (SAL) of 10-6. |
| Conclusion: | The data provided in this 510(k) premarket notification demonstrated thatthe subject device Telescope™ Guide Extension Catheter is substantiallyequivalent to the predicate device. |
§ 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).