(115 days)
Sidekick™, Usher™ Support Catheters
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a support catheter, with no mention of AI or ML capabilities. The GeoAlign™ Marking System is a simple physical ruler, not an AI-driven measurement system.
No
The device is described as a "support catheter" intended to "create a pathway for other devices," not to directly treat a condition.
No
The device is a support catheter intended to create a pathway for other devices and does not perform any diagnostic function.
No
The device description clearly describes a physical catheter with a lumen, hub, valve, radiopaque marker, and non-radiopaque markings. The performance studies focus on physical properties and biocompatibility, not software validation.
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 describes a device used within the body for a procedural purpose, not a device used outside the body to examine specimens from the body.
- Device Description: The description details a catheter designed for insertion into blood vessels, with features like a luer fitting, hemostatic valve, radiopaque marker, and external markings for measurement. These are characteristics of an invasive medical device used for interventional procedures.
- Anatomical Site: The device is intended for use in the "peripheral vasculature," which is a part of the human circulatory system.
- Performance Studies: The performance studies listed are related to the physical and mechanical properties of the catheter and its compatibility with other devices used in interventional procedures (e.g., trackability, crossing efficiency, burst strength). These are not studies related to the analysis of biological specimens.
IVD devices are specifically designed to be used in vitro (outside the body) for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Recon™ Support Catheters are single lumen catheters intended to create a pathway for other devices in the peripheral vasculature.
Product codes
DQY
Device Description
The Recon™ Support Catheters are single lumen catheters with a standard luer fitting hub and separate detachable hemostatic valve to guide and provide support for the Crosser™ Ultrasonic CTO Device. The product hub identifies the BD logo and sheath profile (6F) on one side and on the opposite side, the product hub identifies the working length of catheter in centimeters (110 cm) and S for Straight and A for Angled, and T for Tapered.
The Recon™ Support Catheters are available in angled and straight, tapered and non-tapered configurations in 110 cm working lengths. The Recon™ Support Catheter has a single radiopaque marker 1mm from the distal tip.
The GeoAlign™ Marking System is a non-radiopague ruler on the catheter shaft referenced from the distal tip. The GeoAlign™ markings are designated on the catheter shaft by 1 cm increment bands with an accuracy within ±1 mm. The distance from the distal catheter tip is labeled in 10 cm increments. Thicker bands denote the midway point (5 cm) 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 reqarding the location 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. The GeoAlign™ Marking System provides an approximation that may not be an exact representation of the actual distance traveled intravascularly and should be confirmed under fluoroscopy. The GeoAlign™ Marking System includes non-radiopaque white markings and is designed to be utilized outside the sheath.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
To demonstrate substantial equivalence of the subject device, the Recon™ Support Catheter, to the predicate devices, the technological characteristics and performance criterion were evaluated. Using FDA Guidance Documents on non-clinical testing of medical devices and internal Risk Assessment procedures, the following in vitro tests were performed:
- Interventional Device Testing Equipment (IDTE) Track
- Manual Track
- Kink Diameter
- Torsional Stiffness
- Hemostasis Valve Leakaqe
- Radiopacity
- Hub to Shaft Tensile
- Shaft Tensile
- Leakage
- Hub Positive Pressure Leak
- Hub Stress Cracking
- Hub Sub-Atmospheric Pressure Leak
- Luer Resistance to Axial Separation
- Luer Resistance to Unscrewing Torque
- Luer Resistance to Thread Override
- Particulate
- Guidewire Compatibility
- Sheath Compatibility
- Crossing Device Trackability through Recon™ Catheter
- Crossing Device Crossing Efficiency through Recon™ Catheter
- Burst Strength
- High Pressure Leak
- Packaging Tests (pouch visual, bubble emission leak, pouch tensile)
The following test performed for the predicate device was leveraged as an applicable test for the subject device for components which remained unchanged from the predicate device (performed as part of K161986):
- GeoAlign™ Testing (Legibility, Durability, Compatibility, Dimensional Analysis)
Biocompatibility tests were performed in accordance with ISO 10993-1:2018. "Biological Evaluation of Medical Devices Part 1: Evaluation and testing within a risk management process."
- Cytotoxicity
- Intracutaneous Reactivity
- Sensitization
- Acute Systemic Toxicity
- Material Mediated Pyrogenicity
- Hemolysis (Hemocompatibility)
- Complement Activation
- Partial Thromboplastin Time (PTT)
- In Vivo Thromboresistance
- Chemical Characterization (GC/LS/ICP)
Key Results: The Recon™ Support Catheter met all the predetermined acceptance criteria of design verification and validation as specified by applicable standards, quidance, test protocols and/or customer inputs. The conclusions drawn from the nonclinical tests that demonstrate that the Recon™ Support Catheter is as safe, as effective, and performs as well as or better than the Sidekick™ and Usher™ Support Catheters.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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).
0
Image /page/0/Picture/0 description: The image contains 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 the FDA logo, which 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.
March 1, 2021
C.R. Bard, Inc. % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114
Re: K203275
Trade/Device Name: Recon Support Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: DQY Dated: February 24, 2021 Received: February 25, 2021
Dear Prithul Bom:
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
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.
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
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Indications for Use
510(k) Number (if known) K203275
Device Name Recon™ Support Catheter
Indications for Use (Describe)
The Recon™ 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)
Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
K203275
Recon™ Support Catheter
510(k) Summary
21 CFR 807.92 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 510(K) summary upon which substantial equivalence determination is based is as follows:
Submitter Information:
| Applicant: | Bard Peripheral Vascular
1625 West 3rd Street
Tempe, Arizona 85281 |
|---------------------|--------------------------------------------------------------------------|
| Phone: | (480) 597-8252 |
| Fax: | (480) 449-2546 |
| Contact Person: | Andrew Quach, Regulatory Affairs Specialist |
| Date of Submission: | October 7, 2020 |
Subject Device Name:
| Name of Device: | Recon™ Support Catheter |
|---|---|
| Common or Usual Name: | Support Catheter |
| Classification Name: | Percutaneous catheter |
| Classification Panel: | Cardiovascular |
| Regulatory Class: | II |
| Regulation Number: | 870.1250 |
| Product Code: | DQY |
Predicate Device:
| 510(k) Number: | K161986 & K131493 |
|---|---|
| Name of Device: | Sidekick™ & Usher™ Support Catheters |
| Common or Usual Name: | Percutaneous catheter |
| Classification Name: | Catheter, Percutaneous |
| Regulatory Class: | II |
| Regulation Number: | 870.1250 |
Device Description:
The Recon™ Support Catheters are single lumen catheters with a standard luer fitting hub and separate detachable hemostatic valve to guide and provide support for the Crosser™ Ultrasonic CTO Device. The product hub identifies the BD logo and sheath profile (6F) on one side and on the opposite side, the product hub identifies the working length of catheter in centimeters (110 cm) and S for Straight and A for Angled, and T for Tapered.
4
The Recon™ Support Catheters are available in angled and straight, tapered and non-tapered configurations in 110 cm working lengths. The Recon™ Support Catheter has a single radiopaque marker 1mm from the distal tip.
The GeoAlign™ Marking System is a non-radiopague ruler on the catheter shaft referenced from the distal tip. The GeoAlign™ markings are designated on the catheter shaft by 1 cm increment bands with an accuracy within ±1 mm. The distance from the distal catheter tip is labeled in 10 cm increments. Thicker bands denote the midway point (5 cm) 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 reqarding the location 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. The GeoAlign™ Marking System provides an approximation that may not be an exact representation of the actual distance traveled intravascularly and should be confirmed under fluoroscopy. The GeoAlign™ Marking System includes non-radiopaque white markings and is designed to be utilized outside the sheath.
Intended Use/Indications for Use:
The Recon™ Support Catheters are single lumen catheters intended to create a pathway for other devices in the peripheral vasculature.
Contraindications:
The Recon™ Support Catheters are contraindicated for use with cutting/scoring balloons, pediatrics, neonatal and neurovascular patients.
Technological Comparison to Predicate Devices:
The Recon™ Support Catheter has the following similarities to the predicate devices:
- o Same intended use
- . Same indications for use
- . Same target population
- . Same fundamental scientific technology
- . Same operating principle
- Same sterility assurance level and method of sterilization .
- . Same colorant/materials for shaft as Usher™ Support Catheter
- . Same product configurations
The subject device, Recon™ Support Catheter, incorporates the following changes:
- o Hub design and materials
- Tip to use the same material/colorant as the shaft as a single extrusion .
- o Updated taper design
- o Changed hemostasis valve
- Guidewire introducer not included with product .
- Minor updates to packaging design and materials to accommodate product changes o
5
Performance Data:
To demonstrate substantial equivalence of the subject device, the Recon™ Support Catheter, to the predicate devices, the technological characteristics and performance criterion were evaluated. Using FDA Guidance Documents on non-clinical testing of medical devices and internal Risk Assessment procedures, the following in vitro tests were performed:
- Interventional Device Testing Equipment (IDTE) Track
- Manual Track
- Kink Diameter
- Torsional Stiffness
- o Hemostasis Valve Leakaqe
- Radiopacity ●
- . Hub to Shaft Tensile
- Shaft Tensile
- . Leakage
- Hub Positive Pressure Leak
- Hub Stress Cracking ●
- . Hub Sub-Atmospheric Pressure Leak
- Luer Resistance to Axial Separation
- Luer Resistance to Unscrewing Torque
- Luer Resistance to Thread Override
- Particulate
- Guidewire Compatibility
- . Sheath Compatibility
- Crossing Device Trackability through Recon™ Catheter ●
- Crossing Device Crossing Efficiency through Recon™ Catheter ●
- Burst Strength ●
- High Pressure Leak
- Packaging Tests (pouch visual, bubble emission leak, pouch tensile) o
The following test performed for the predicate device was leveraged as an applicable test for the subject device for components which remained unchanged from the predicate device (performed as part of K161986):
- GeoAlign™ Testing (Legibility, Durability, Compatibility, Dimensional Analysis) ●
6
Biocompatibility:
To demonstrate substantial equivalence of the subject device, the Recon™ Support Catheter, to the predicate device, biocompatibility tests were performed in accordance with ISO 10993-1:2018. "Biological Evaluation of Medical Devices Part 1: Evaluation and testing within a risk management process."
- Cytotoxicity
- Intracutaneous Reactivity ●
- o Sensitization
- Acute Systemic Toxicity
- o Material Mediated Pyrogenicity
- Hemolysis (Hemocompatibility) ●
- . Complement Activation
- Partial Thromboplastin Time (PTT)
- o In Vivo Thromboresistance
- Chemical Characterization (GC/LS/ICP) .
The results from these tests demonstrate that the technological characteristics and performance criteria of the Recon™ Support Catheter is comparable to the predicate devices and that it can perform in a manner equivalent to devices currently on the market for the similar intended use.
Conclusions:
The Recon™ Support Catheter met all the predetermined acceptance criteria of design verification and validation as specified by applicable standards, quidance, test protocols and/or customer inputs. The conclusions drawn from the nonclinical tests that demonstrate that the Recon™ Support Catheter is as safe, as effective, and performs as well as or better than the Sidekick™ and Usher™ Support Catheters.