(29 days)
No
The document describes a physical medical device (a guide catheter) and its performance characteristics. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML.
No.
The device is described as providing a pathway for other therapeutic devices, not as a therapeutic device itself.
Yes
The device description explicitly states, "The guide catheter is designed to provide a pathway for diagnostic and therapeutic devices in the coronary and peripheral vasculature." This indicates its role in facilitating diagnostic procedures.
No
The device description clearly describes a physical catheter, a cylindrical tube with a lumen, proximal and distal ends, and side holes, which is a hardware 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 to "provide a pathway through which therapeutic devices are introduced" and is used "in the coronary or peripheral vascular system." This describes a device used within the body for a therapeutic purpose, not a device used to examine specimens outside the body to diagnose a condition.
- Device Description: The description details a physical catheter designed to be inserted into blood vessels. This aligns with an interventional medical device, not an IVD.
- 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.
IVDs are devices used to perform tests on specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Medtronic Guide Catheter is designed to provide a pathway through which therapeutic devices are introduced. The guide catheter is intended to be used in the coronary or peripheral vascular system.
Product codes (comma separated list FDA assigned to the subject device)
DQY
Device Description
The Sherpa NX Balanced Guide Catheter design is fundamentally the same for both sizes of the device. The guide catheter is designed to provide a pathway for diagnostic and therapeutic devices in the coronary and peripheral vasculature. The basic design of Sherpa Guide Catheters is a cylindrical tube with a proximal and distal end. A single lumen extends from the proximal to the distal end of the catheter. The distal end of the catheter is towards the tip and the proximal end is towards the hub and strain relief. The catheter shaft has side holes present towards the distal end depending on the model. The Sherpa NX Balanced product line has two French sizes available, 6F and 7F. Sherpa is available in a range of lengths from 47 cm to 110 com.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary or peripheral vascular system.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
No clinical testing data was required for this special 510k submission.
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 following tests were performed to evaluate and demonstrate substantial equivalence. The necessary tests performed met the acceptance criteria and demonstrated that there are not safety or effectiveness concerns. The following tests were performed:
Biocompatibility Assessment:
The biocompatibility evaluation for Sherpa NX Balanced Guide Catheters was conducted in accordance with the FDA Guidance "Use of International Standard ISO 10993-1, "Biological evaluation of Medical Devices- Part 1: Evaluation and Testing Within in a Risk Management Process" dated September 04, 2020. The biological evaluation included the following:
-
- Cytotoxicity
-
- Sensitization
-
- Intracutaneous Reactivity
-
- Material-Mediated Pyrogenicity
-
- Hemocompatibility
-
- Acute Systemic Toxicity
Product Performance Evaluation [Dimensional & Performance]
-
- Inner Diameters (shaft, tip, & hub*)
-
- Outer Diameters (shaft, segment, soft tip sleeve, & segment/shaft overlap)
-
- Total Segment Length
- Effective Length* 4)
-
- Exposed Tip Length
- Luer Connector Performance* 6)
-
- Leak Resistance*
- Draw-through stiffness of primary and secondary curve 8)
- Shaft bending stiffness & bending kink resistance (Body temperature and room temperature) 9)
- Arch bending stiffness & bending kink resistance (Body temperature and room temperature) 10)
-
- Shaft & distal segment crush resistance
- Torsional Stiffness, Rotational Kink Angle, and Rotations to Separation 12)
-
- Curve retention after simulated seating
-
- Soft tip stiffness
-
- Peak shaft & segment tensile load
-
- Peak soft tip tensile load
-
- Peak hub/shaft tensile load*
- Internal lubricity* 18)
- These tests were performed on the subject device to demonstrate substantial equivalence to the predicate device for the modifications in this premarket notification. Relevant standards for these tests detailed below:
Luer Connector Performance testing conducted in accordance with the following standards:
- ISO 594-1 First edition 1986-06-15 Conical fittings with a 6% (Luer) taper for syringes, needles ● and certain other medical equipment - Part 1: General requirements
- . ISO 594-2 Second edition 1998-09-01 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings
- EN ISO 80369-7 Second edition 2021-05 Small-bore connectors for liquids and gases in ● healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
Leak Resistance and Peak Hub/Shaft Tensile Load testing conducted in accordance with the following standard:
- ISO 10555-1 Second Edition 2013+A1:2017 Intravascular Catheters Sterile and Single-Use ● Catheters - Part 1: General Requirements - Amendment 1
The performance testing along with biocompatibility testing demonstrated that the subject device Sherpa Guide Catheter is substantially equivalent to the predicate device.
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.
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
August 22, 2023
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters FDA in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Medtronic Vascular Colleen Gentile Senior Regulatory Affairs Specialist 37A Cherry Hill Drive Danvers, Massachusetts 01923
Re: K232190
Trade/Device Name: 6F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: July 21, 2023 Received: July 24, 2023
Dear Colleen Gentile:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Samuel G. Raben -S
for Lydia Glaw
Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K232190
Device Name
6F Sherpa NX Balanced 7F Sherpa NX Balanced
Indications for Use (Describe)
The Medtronic Guide Catheter is designed to provide a pathway through which therapeutic devices are introduced. The Guide Catheter is intended to be used in the coronary or peripheral vascular system.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Medtronic
Coronary & Renal Denervation
Medtronic Vascular 37A Cherry Hill Drive Danvers, MA 01923 USA
Tel: 1.234.567.8900 Ext 000 Fax: 1.234.567.8900
510(k) Summary (As required by 21 CFR 807.92)
Submitter: Medtronic Vascular 37A Cherry Hill Drive Danvers, Massachusetts 01923, USA
1.) Name: Colleen Gentile Contact Person(s): Designation: Senior Regulatory Affairs Specialist Email: Colleen.Gentile(@medtronic.com Phone: (508)-843-6178
2.) Name: Elaine O'Connor Designation: Senior Regulatory Affairs Manager Email: elaine.oconnor@medtronic.com Phone: +35391708990
July 17th, 2023 Date Prepared:
Trade Names: 1. 6F Sherpa NX Balanced Guide Catheter 2.7F Sherpa NX Balanced Guide Catheter
Common Name: Percutaneous Guide Catheter
Classification Name: Percutaneous, Catheter Class II per 21 CFR §870.1250 Product Code: DQY
4
Predicate Device:
| 510(k) Number | Device Name | Manufacturer | Product Code |
|---|---|---|---|
| K051846 (2005) | 7F Sherpa NX | ||
| Balanced Guide | |||
| Catheter | Medtronic Vascular | DQY | |
| This predicate has not been subject to a design-related recall. |
Reference Device:
| 510(k) Number | Device Name | Manufacturer | Product Code |
|---|---|---|---|
| K042489 (2004) | 6F Sherpa NX | ||
| Balanced Guide | |||
| Catheter | Medtronic Vascular | DQY | |
| This predicate has not been subject to a design-related recall. |
Device Description:
The Sherpa NX Balanced Guide Catheter design is fundamentally the same for both sizes of the device. The guide catheter is designed to provide a pathway for diagnostic and therapeutic devices in the coronary and peripheral vasculature. The basic design of Sherpa Guide Catheters is a cylindrical tube with a proximal and distal end. A single lumen extends from the proximal to the distal end of the catheter. The distal end of the catheter is towards the tip and the proximal end is towards the hub and strain relief. The catheter shaft has side holes present towards the distal end depending on the model. The Sherpa NX Balanced product line has two French sizes available, 6F and 7F. Sherpa is available in a range of lengths from 47 cm to 110 com.
Intended Use/Indications for Use:
The Medtronic Guide Catheter is designed to provide a pathway through which therapeutic devices are introduced. The guide catheter is intended to be used in the coronary or peripheral vascular system.
Comparison to the predicate devices:
The subject devices and predicate device are substantially equivalent. The predicate device is Medtronic Vascular's own legally marketed device. The indications for use/intended use of the subject device and predicate device is same. The catheter shaft design of subject devices is identical to that of predicate device. The components of catheter shaft, distal end and proximal end are the same and the devices have same fundamental operating principle. There are no changes to the sterilization method, sterility assurance level, packaging process, packaging materials, packaging configuration and shelf life of the subject devices in comparison to the predicate devices. The differences in catheter's dimensional, performance and materials related technological characteristics identified between the subject (modified) devices and the predicate (previously cleared) device do not raise different questions of safety and effectiveness.
Summary of Performance/Non-Clinical Testing
The following tests were performed to evaluate and demonstrate substantial equivalence. The necessary tests performed met the acceptance criteria and demonstrated that there are not safety or effectiveness concerns. The following tests were performed:
Biocompatibility Assessment:
5
The biocompatibility evaluation for Sherpa NX Balanced Guide Catheters was conducted in accordance with the FDA Guidance "Use of International Standard ISO 10993-1, "Biological evaluation of Medical Devices- Part 1: Evaluation and Testing Within in a Risk Management Process" dated September 04, 2020. The biological evaluation included the following:
-
- Cytotoxicity
-
- Sensitization
-
- Intracutaneous Reactivity
-
- Material-Mediated Pyrogenicity
-
- Hemocompatibility
-
- Acute Systemic Toxicity
Product Performance Evaluation [Dimensional & Performance]
-
- Inner Diameters (shaft, tip, & hub*)
-
- Outer Diameters (shaft, segment, soft tip sleeve, & segment/shaft overlap)
-
- Total Segment Length
- Effective Length* 4)
- ર) Exposed Tip Length
- Luer Connector Performance* 6)
-
- Leak Resistance*
- Draw-through stiffness of primary and secondary curve 8)
- Shaft bending stiffness & bending kink resistance (Body temperature and room temperature) 9)
- Arch bending stiffness & bending kink resistance (Body temperature and room temperature) 10)
-
- Shaft & distal segment crush resistance
- Torsional Stiffness, Rotational Kink Angle, and Rotations to Separation 12)
-
- Curve retention after simulated seating
-
- Soft tip stiffness
- ાર) Peak shaft & segment tensile load
-
- Peak soft tip tensile load
-
- Peak hub/shaft tensile load*
- Internal lubricity* 18)
- These tests were performed on the subject device to demonstrate substantial equivalence to the predicate device for the modifications in this premarket notification. Relevant standards for these tests detailed below:
Luer Connector Performance testing conducted in accordance with the following standards:
- ISO 594-1 First edition 1986-06-15 Conical fittings with a 6% (Luer) taper for syringes, needles ● and certain other medical equipment - Part 1: General requirements
- . ISO 594-2 Second edition 1998-09-01 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings
- EN ISO 80369-7 Second edition 2021-05 Small-bore connectors for liquids and gases in ● healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
Leak Resistance and Peak Hub/Shaft Tensile Load testing conducted in accordance with the following standard:
6
- ISO 10555-1 Second Edition 2013+A1:2017 Intravascular Catheters Sterile and Single-Use ● Catheters - Part 1: General Requirements - Amendment 1
The performance testing along with biocompatibility testing demonstrated that the subject device Sherpa Guide Catheter is substantially equivalent to the predicate device.
Summary of Clinical Data:
No clinical testing data was required for this special 510k submission.
Conclusion from Testing Data:
The differences between subject devices and predicate devices have been evaluated through non-clinical testing. Based on the results of the testing performed, the subject devices are demonstrated as substantially equivalent to the predicate device.