(111 days)
Not Found
No
The 510(k) summary describes a standard catheter introducer kit and its components. There is no mention of AI, ML, image processing, or any other technology that would suggest the use of AI/ML. The performance studies focus on bench testing and biocompatibility, typical for this type of device, and do not involve data analysis or algorithms characteristic of AI/ML.
No
The device, an introducer sheath, is used to facilitate percutaneous vascular access for placing a catheter, not to provide therapy itself.
No
Explanation: The device, InTRAkit™ Catheter Introducer, is used to facilitate percutaneous vascular access for procedures like cardiac catheterization. It is an access device, not a device used to determine a medical condition or diagnose a disease.
No
The device description clearly outlines physical components (Needles, Mini-Guidewires, Introducer Sheath, Dilator) and the performance studies focus on bench testing and biocompatibility, which are typical for hardware medical devices. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device used to physically access a vein or artery for the purpose of introducing a catheter. This is a procedural device used in vivo (within the body).
- Device Description: The description confirms it's a Catheter Introducer Kit, designed to facilitate percutaneous vascular access. It lists components like needles, guidewires, sheaths, and dilators, all of which are used for physical access and manipulation within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening. IVDs are typically used in a laboratory setting or at the point of care to analyze biological samples.
Therefore, the InTRAkit™ device, as described, is a medical device used for a surgical/interventional procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The introducer sheath is used to facing a catheter through the skin and into a vein or artery, including, but not limited to, the radial artery. The micropuncture needle or IV catheter is used to gain access to a vein or artery, including, but not limited to, the radial artery, for placement of the mini-guidewire is used for placement of the sheath into a vein or artery, including, but not limited to, the radial artery.
Product codes
DYB
Device Description
Medtronic's InTRAkit™ device is a Catheter Introducer (PCI) which is intended to facilitate percutaneous vascular access into a vein or artery, performed as part of the Cardiac catheterization procedure. The InTRAkit™ Catheter Introducers are designed to facilitate access into the vasculature from different access sites including but not limited to the radial arteries. InTRAkit™ Catheter Introducers are single-use use devices sold in a sterile condition. The InTRAkit™ Access Kit includes four main type of components required for percutaneous vascular access procedure:
- Needles
- Mini-Guidewires
- Introducer Sheath
- Dilator
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vein or artery, including, but not limited to, the radial artery.
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
The following non-clinical testing was performed on Medtronic's InTRAkit™ device:
-
Design Verification Testing/ In-vitro bench testing: Design Verification (DV) testing was completed on the InTRAkit™ device in accordance with the requirements of the ISO 11070: 2014 - Sterile single-use intravascular introducers, dilators and guidewires.
-
Biocompatibility Testing: The following Biocompatibility Testing was completed on InTRAkit™ device in compliance with the 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 testing
- Sensitization testing
- Intracutaneous reactivity testing
- Acute systemic toxicity testing
- Pyrogenicity testing
- Genotoxicity testing
- Hemolysis testing
- C3a and SC5b-9 Complement Activation study
- Partial Thromboplastin Time study
- In-vivo Thromboresistance testing
No clinical investigation was performed on the subject device (InTRAkit™).
Key results: No new risks or concerns relevant to the device's intended use were raised during the testing. The bench testing qualification and biocompatibility testing demonstrated that InTRAkit™ is substantially equivalent to the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).
0
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 17, 2016
Medtronic Vascular Nisarg Shah Senior Regulatory Affairs Specialist 37A Cherry Hill Drive Danvers, Massachusetts 01923
Re: K162097
Trade/Device Name: InTRAkit Access Kit Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: October 18, 2016 Received: October 19, 2016
Dear Nisarg Shah:
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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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,
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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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Indications for Use
510(k) Number (if known) K162097
Device Name InTRAkit™ Access Kit
Indications for Use (Describe)
The introducer sheath is used to facing a catheter through the skin and into a vein or artery, including, but not limited to, the radial artery. The micropuncture needle or IV catheter is used to gain access to a vein or artery, including, but not limited to, the radial artery, for placement of the mini-guidewire is used for placement of the sheath into a vein or artery, including, but not limited to, the radial artery.
| 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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3
510(k) Summary - K162097
| Submitter: | Medtronic Vascular
37A Cherry Hill Drive,
Danvers, Massachusetts 01923, USA | | |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|-----------------------|
| Contact Person: | Nisarg Shah
Senior Regulatory Affairs Specialist
37A Cherry Hill Drive
Danvers, MA 01923, USA
Phone: (978) 739-6632
Fax: (978) 750-8204
Email: nisarg.g.shah@medtronic.com | | |
| Date Prepared: | November 16, 2016 | | |
| Trade Name(s): | InTRAkit™ Access Kit | | |
| Common Name: | Catheter Introducer | | |
| Classification Name: | Catheter Introducer
Class II per 21 CFR §870.1340
Product Code: DYB | | |
| Predicate Device: | Device Name | Manufacturer | 510(k)
clearance # |
| | Glidesheath® Catheter
Introducer | Terumo Medical
Corporation | K082644 |
Medtronic's InTRAkit™ device is a Catheter Introducer (PCI) Device Description: which is intended to facilitate percutaneous vascular access into a vein or artery, performed as part of the Cardiac catheterization procedure. The InTRAkit™ Catheter Introducers are designed to facilitate access into the vasculature from different access sites including but not limited to the radial arteries. InTRAkit™ Catheter Introducers are single-use use devices sold in a sterile condition. The InTRAkit™ Access Kit includes four main type of components required for percutaneous vascular access procedure:
4
| | 1) Needles
2) Mini-Guidewires
3) Introducer Sheath
4) Dilator |
|-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Statement of
Intended Use: | The introducer sheath is used to facilitate placing a catheter
through the skin and into a vein or artery, including, but not
limited to, the radial artery. The micropuncture needle or IV
catheter is used to gain access to a vein or artery, including,
but not limited to, the radial artery, for placement of the mini-
guidewire. The mini-guidewire is used for placement of the
sheath into a vein or artery, including, but not limited to, the
radial artery. |
| Summary of
Technological
Characteristics: | Medtronic's InTRAkit™ device components comprise of
following technological characteristics: |
| | Introducer Sheath and Dilator: Sheath size: 4French to 6French Sheath length: 7 to 23cm Needles: Micropuncture Needles Gauge size: 18 to 21G IV Catheter Needles Gauge size: 20 to 22G Mini-Guidewires Diameter size: 0.021" Length: 45- 80cm |
| Comparison to the
predicate devices: | The following information outlines the differences and
similarities between the subject device and the predicate
device: Similar Intended Use/ Indication for Use Similar Device Design Component/ Construction Different device materials |
| | Medtronic's InTRAkit™ Access Kit is substantially |
equivalent to the predicate device based on similarities in intended use and technological characteristics. The testing
5
on the InTRAkit™ Catheter performed Introducers demonstrates that the technological differences do not raise any new concerns or risks relevant to the intended use of the device.
The following non-clinical testing was performed on Summary of Non-Medtronic's InTRAkit™ device: clinical Data:
1. Design Verification Testing/ In-vitro bench testing:
Design Verification (DV) testing was completed on the InTRAkit™ device in accordance with the requirements of the ISO 11070: 2014 - Sterile single-use intravascular introducers, dilators and guidewires.
2. Biocompatibility Testing:
The following Biocompatibility Testing was completed on InTRAkit™ device in compliance with the 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 testing ●
- Sensitization testing ●
- Intracutaneous reactivity testing ●
- Acute systemic toxicity testing ●
- Pyrogenicity testing
- Genotoxicity testing ●
- Hemolysis testing
- C3a and SC5b-9 Complement Activation study ●
- Partial Thromboplastin Time study ●
- In-vivo Thromboresistance testing ●
No new risks or concerns relevant to the device's intended use were raised during the testing. The bench testing qualification and biocompatibility testing demonstrated that InTRAkit™ is substantially equivalent to the predicate device.
Summary of No clinical investigation was performed on the subject device Clinical Data: (InTRAkit™).
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| Conclusion from | The data provided in this 510(k) premarket notification |
|---|---|
| Data: | demonstrated that the subject device is substantially |
| equivalent to the predicate device. |