(16 days)
No
The device description and performance studies focus on the physical characteristics and functionality of a support catheter and a marking system, with no mention of AI or ML.
No
The device is described as a "support catheter" intended to "create a pathway for other devices" in the peripheral vasculature. It is not designed to directly treat a medical condition.
No
The device is a support catheter intended to create a pathway for other devices, not to diagnose a condition.
No
The device is a physical catheter with a luer fitting hub, hemostatic valve, and radiopaque markers. It also includes a physical marking system on the catheter shaft. The description focuses entirely on the physical components and their performance.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "create a pathway for other devices in the peripheral vasculature." This is a procedural device used in vivo (within the body) to facilitate other medical interventions.
- Device Description: The description details a catheter designed for insertion into blood vessels. It mentions features like lumens, hubs, radiopaque markers, and a marking system for external measurement. These are all characteristics of devices used directly on a patient's anatomy.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The provided description does not mention any testing of biological samples or analysis of bodily fluids or tissues.
Therefore, the SIDEKICK® and USHER® Support Catheters are medical devices used for interventional procedures within the body, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The SIDEKICK® and USHER® Support Catheters are single lumen catheters intended to create a pathway for other devices in the peripheral vasculature.
Product codes
DQY
Device Description
The SIDEKICK® and USHER® Support Catheters are single lumen catheters with a standard luer fitting hub and separate attachable hemostatic valve to support the CROSSER® CTO Recanalization Catheters 14S and S6. The product hub identifies SD for SIDEKICK® Catheter, USH for USHER® Catheter, A for Angled and T for Tapered in addition to the sheath profile and working length in centimeters. A guidewire introducer is provided to facilitate the guidewire passage through the optional hemostatic valve. The guidewire introducer shaft color matches the shaft color of the recommended support catheter.
The SIDEKICK® Catheter is available in straight, angled, tapered and non-tapered configurations in 70cm and 110cm working lengths. The USHER® Catheter is tapered and is available in straight and angled configurations in 83cm and 130cm working lengths. The SIDEKICK® and straight USHER® Catheters have a single radiopaque marker 1mm from the distal tip. The angled USHER® Catheter configurations have three radiopaque markers at the distal tip for enhanced visualization of the catheter tip and angle under fluoroscopy. The third proximal radiopaque marker is located 15mm from the distal tip.
The GEOALIGN® Marking System is a non-radiopaque ruler on the catheter shaft measured from the distal tip. The GEOALIGN® Markings are designated on the catheter shaft by 1cm increment bands with an accuracy within ±1mm. The distance from the distal catheter tip is labeled in 10cm increments. Thicker bands denote the midway point (5cm) between the labeled distances. The GEOALIGN® Marking System is designed to be used as a tool to externally measure the intravascular advancement and/or retraction of the catheter. This can provide an intravascular reference regarding the location of the distal tip of the catheter or an approximate intravascular length measurement between two points. The GEOALIGN® Marking System may also facilitate geographic alignment of an adjunctive therapy that includes the same GEOALIGN® Marking System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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
To demonstrate substantial equivalence of the subject device to the predicate device. the technological characteristics and performance criteria were evaluated. Using the FDA guidance document, "Design Control Guidance for Medical Device Manufacturers," dated March 11, 1997, and internal risk assessment procedures, the following nonclinical tests were performed:
- GEOALIGN® Marking Legibility
- Dimensional Analysis:
- GEOALIGN® Marking Location (Distal Position)
- GEOALIGN® Marking Location (Proximal Position)
- GEOALIGN® Marking Spacing
- Catheter Outer Diameter (OD)
- GEOALIGN® Marking durability with Introducer Sheaths
- GEOALIGN® Marking compatibility with Introducer Sheaths
The results demonstrate that the technological characteristics and performance criteria of the SIDEKICK® and USHER® Support Catheters are comparable to the predicate device and that it performs substantially equivalent to the legally marketed predicate device.
Per ISO 10993-1:2009 CORR 1, biocompatibility and chemical characterization demonstrate the subject device is biocompatible and does not elicit any substances at levels of concern as result of this change.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 4, 2016
Bard Peripheral Vascular, Inc. Ms. Melanie Hadlock Regulatory Affairs Specialist 1625 West 3rd Street Tempe, AZ 85281
Re: K161986
Trade/Device Name: Sidekick and Usher Support Catheters Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: July 18, 2016 Received: July 19, 2016
Dear Ms. Hadlock:
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.
Sincerelv
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
510(k) Number (if known) K161986
Device Name
SIDEKICK® and USHER® Support Catheters
Indications for Use (Describe)
The SIDEKICK® and USHER® Support Catheters are single lumen catheters intended to create a pathway for other devices in the peripheral vasculature.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(k) Summary
[As required by 21 CFR 807.92(c)]
As required by the Safe Medical Devices Act of 1990, coded under Section 513, Part (I)(3)(A) of the Food, Drug and Cosmetic Act, a summary of the information upon which substantial equivalence determination is based is as follows:
1. Submitter Information:
| Applicant: | Bard Peripheral Vascular, Inc.
1625 West 3rd Street
Tempe, Arizona 85281 |
|------------|---------------------------------------------------------------------------------|
| Phone: | 480.350.6083 |
| Fax: | 480.449.2546 |
| Contact: | Melanie Hadlock, Regulatory Affairs Specialist |
| Date: | July 18, 2016 |
2. Subject Device:
| Device Trade Name: | SIDEKICK® and USHER® Support Catheters |
|---|---|
| Common Name: | Percutaneous Catheter |
| Device Classification | Class II |
| Classification Name: | Percutaneous Catheter |
| Classification Product | |
| Code: | DQY |
| Regulation Number: | 21 CFR 870.1250 |
| Review Panel: | Cardiovascular |
3. Predicate Device:
SIDEKICK® and USHER® Support Catheters (K131493)
Reference devices: ULTRAVERSE® 035 PTA Dilatation Catheter (K142261, cleared September 24, 2014); CROSSER® CTO Recanalization Catheter (K161208, cleared May 24, 2016).
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4. Summary of Change:
The GEOALIGN® Marking System has been added to the device. The GEOALIGN® Marking System is a non-radiopaque ruler on the catheter shaft measured from the distal tip.
5. Device Description:
The SIDEKICK® and USHER® Support Catheters are single lumen catheters with a standard luer fitting hub and separate attachable hemostatic valve to support the CROSSER® CTO Recanalization Catheters 14S and S6. The product hub identifies SD for SIDEKICK® Catheter, USH for USHER® Catheter, A for Angled and T for Tapered in addition to the sheath profile and working length in centimeters. A guidewire introducer is provided to facilitate the guidewire passage through the optional hemostatic valve. The guidewire introducer shaft color matches the shaft color of the recommended support catheter.
The SIDEKICK® Catheter is available in straight, angled, tapered and non-tapered configurations in 70cm and 110cm working lengths. The USHER® Catheter is tapered and is available in straight and angled configurations in 83cm and 130cm working lengths. The SIDEKICK® and straight USHER® Catheters have a single radiopaque marker 1mm from the distal tip. The angled USHER® Catheter configurations have three radiopaque markers at the distal tip for enhanced visualization of the catheter tip and angle under fluoroscopy. The third proximal radiopaque marker is located 15mm from the distal tip.
The GEOALIGN® Marking System is a non-radiopaque ruler on the catheter shaft measured from the distal tip. The GEOALIGN® Markings are designated on the catheter shaft by 1cm increment bands with an accuracy within ±1mm. The distance from the distal catheter tip is labeled in 10cm increments. Thicker bands denote the midway point (5cm) between the labeled distances. The GEOALIGN® Marking System is designed to be used as a tool to externally measure the intravascular advancement and/or retraction of the catheter. This can provide an intravascular reference regarding the location of the distal tip of the catheter or an approximate intravascular length measurement between two points. The GEOALIGN® Marking System may also facilitate geographic alignment of an adjunctive therapy that includes the same GEOALIGN® Marking System.
6. Indications for Use of Device:
The SIDEKICK® and USHER® Support Catheters are single lumen catheters intended to create a pathway for other devices in the peripheral vasculature.
Contraindications
The SIDEKICK and USHER® Support Catheters are contraindicated for use with cutting/scoring balloons, pediatrics, neonatal and neurovascular patients.
7. Technological Comparison to Predicate Devices:
The technological characteristics of the subject device are substantially equivalent to those of the predicate device because the two have the following similarities:
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- . Same intended use
- Same indications for use ●
- Same patient population o
- Same sheath compatibility .
- . Same fundamental scientific technology
- Same operating principal and mechanism of action
- Same packaqing configuration ●
- Same sterility assurance level and method of sterilization .
The subject device is a modification to the predicate device and is different as follows:
- The GEOALIGN® Marking System has been added to the device. The GEOALIGN® . Marking System is a non-radiopaque ruler on the catheter shaft measured from the distal tip. The markings have the same intended purpose, use the same ink formulation, and ink application process as the previously cleared reference devices of the same requlation number, the ULTRAVERSE® 035 PTA Balloon Dilatation Catheter (K142261, cleared September 24, 2014, Requlation Number 870.1250) and the CROSSER® CTO Recanalization (K161208, cleared May 24, 2016, Regulation Number 870.1250).
8. Performance Testing Summary:
To demonstrate substantial equivalence of the subject device to the predicate device. the technological characteristics and performance criteria were evaluated. Using the FDA guidance document, "Design Control Guidance for Medical Device Manufacturers," dated March 11, 1997, and internal risk assessment procedures, the following nonclinical tests were performed:
- GEOALIGN® Marking Legibility ●
- Dimensional Analysis: ●
- o GEOALIGN® Marking Location (Distal Position)
- o GEOALIGN® Marking Location (Proximal Position)
- o GEOALIGN® Marking Spacing
- Catheter Outer Diameter (OD) о
- GEOALIGN® Marking durability with Introducer Sheaths ●
- GEOALIGN® Marking compatibility with Introducer Sheaths .
The results demonstrate that the technological characteristics and performance criteria of the SIDEKICK® and USHER® Support Catheters are comparable to the predicate device and that it performs substantially equivalent to the legally marketed predicate device.
Per ISO 10993-1:2009 CORR 1, biocompatibility and chemical characterization demonstrate the subject device is biocompatible and does not elicit any substances at levels of concern as result of this change.
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9. Conclusion:
The SIDEKICK® and USHER® Support Catheters are substantially equivalent to the legally marketed predicate devices, the SIDEKICK® and USHER® Support Catheters (K131493, cleared August 2, 2013).