(62 days)
Not Found
No
The device description and performance studies focus on the physical and functional characteristics of a support catheter, with no mention of AI or ML capabilities. The testing is based on standard medical device performance and biocompatibility standards, not AI/ML model validation.
No
The device is described as a "support catheter" intended for diagnostic and interventional procedures, facilitating wire guide exchange and delivery of solutions or contrast agents, rather than directly treating a condition.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the device is "intended for use in small vessel or superselective anatomy for diagnostic and interventional procedures".
No
The device description clearly outlines a physical catheter with specific dimensions, materials (braided, hydrophilic coating, radiopaque markers), and mechanical properties (kink-resistant, torque transmission, flexibility). The performance studies also focus on physical and material characteristics, not software functionality.
Based on the provided information, the Vericor Support Catheter is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states the device is for use in vivo (within the body) for diagnostic and interventional procedures in small vessels. IVD devices are used in vitro (outside the body) to examine specimens like blood, urine, or tissue.
- Device Description: The description details a catheter designed to be inserted into the body to facilitate procedures and deliver substances. This is consistent with an in vivo medical device, not an in vitro diagnostic test.
- Input Imaging Modality: The device is visualized using fluoroscopy, which is an in vivo imaging technique.
- Anatomical Site: The device is used in specific anatomical locations within the body.
Therefore, the Vericor Support Catheter is an invasive medical device used for diagnostic and interventional procedures within the body, not an IVD device.
N/A
Intended Use / Indications for Use
The Vericor Support Catheter is intended for use in small vessel or superselective anatomy for diagnostic and interventional procedures, including peripheral use.
Product codes
KRA
Device Description
The Vericor Support Catheter with hydrophilic coating is a braided, kink-resistant catheter designed to facilitate wire guide exchange, wire guide support and to provide a conduit for the delivery of saline solutions or diagnostic contrast agents. The Vericor Support Catheter will be available in three catheter lengths which are 90 cm, 135 cm and 150 cm. The proposed device is a single-lumen catheter. The hub of the catheter incorporates standard luer adapter to facilitate the attachment of accessories. The outer surface of the distal catheter has a hydrophilic coating. The catheter has three radiopaque markers at the distal end to facilitate fluoroscopic visualization. The device is provided in single use and sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
small vessel or superselective anatomy, peripheral use
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)
Non clinical tests were conducted to verify that the proposed device met all design specifications and was found to be Substantially Equivalent (SE) to the predicate device. The testing was conducted with methods and criteria (as applicable) for compliance with the following standards:
- ISO 10993-4: 2017 Biological evaluation of medical devices-Part 4: Selection of tests for interactions with blood
- ISO 10993-5: 2009 Biological evaluation of medical devices-Part 5: Tests for in vitro cytotoxicity
- ISO 10993-7:2008 Biological evaluation of medical devices-Part 7: Ethylene oxide sterilization residuals
- ISO 10993-10: 2010 Biological evaluation of medical devices-Part 10: Tests for irritation and skin sensitization
- ISO 10993-11: 2017 Biological evaluation of medical devices-Part 11: Tests for systemic toxicity
- USP Bacterial Endotoxins Test
- ASTM F756-17, Standard Practice for Assessment of Hemolytic Properties of Materials
- ASTM F2382-18, Standard Test Method for Assessment of Circulating Blood-Contacting Medical Device Materials on PTT
- ASTM D4169-16, Standard Practice for Performance Testing of Shipping Containers and System
- ASTM F1886/F1886M-16, Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection
- ASTM F1929-15, Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
- ASTM F88/F88M-15, Standard Test Method for Seal Strength of Flexible Barrier Materials
- ISO 10555-1: 2013, Intravascular catheters - Sterile and single-use intravascular catheters - Part 1: General requirements [Including AMENDMENT 1 (2017)]
- ISO 80369-7: 2021, Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
- USP, Pyrogen Test
- USP, Particulate Matter in Injections
- ASTM F640-20, Standard Test Methods for Determining Radiopacity for Medical Use
- ASTM F2606-08, Standard Guide for Three-Point Bending of Balloon-Expandable Vascular Stents and Stent Systems
Key results: The results of performance testing conducted on the Vericor Support Catheter demonstrate that it performs as designed, is suitable for its indication for use and is equivalent in performance to the identified predicate device.
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
§ 870.1210 Continuous flush catheter.
(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(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.
November 7, 2022
VascuPatent Medical (Shenzhen) Co. Ltd. c/o Dr. Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, Guangdong 200120 China
Re: K222679
Trade/Device Name: Vericor Support Catheter Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II Product Code: KRA Dated: September 14, 2022 Received: September 14, 2022
Dear Diana Hong:
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
1
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 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 (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 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,
Gregory W. Digitally signed by
Gregory W. Gregory W. O'connell -S O'connell -S Date: 2022.11.07
Gregory O'Connell 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: K222679
Device Name Vericor Support Catheter
Indications for Use (Describe)
The Vericor Support Catheter is intended for use in small vessel or superselective anatomy for diagnostic and interventional procedures, including peripheral use.
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
This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
The assigned 510(k) Number: K222679
-
- Date of Preparation: 09/02/2022
-
- Sponsor Identification
VascuPatent Medical (Shenzhen) Co. Ltd.
Room 314 & 316, Building A, Branch 3, Leibai Zhongcheng Life Science Park, No.22 Jinxiu East Road, Jinsha Community, Pingshan District, Shenzhen, Guangdong Province, P.R.China
Establishment Registration Number: Not registered
Contact Person: Heather Li Position: Director of QA & RA Tel: +86- 18922846103 Fax: +86- 755-89666170 Email: hli@vascupatent.com
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Tingting Su (Alternative Contact Person)
- Designated Submission Correspondent
Mid-Link Consulting Co., Ltd
P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850, Fax: 360-925-3199 Email: info@mid-link.net
4
4. Identification of Proposed Device
Trade Name: Vericor Support Catheter Common Name: Continuous Flush Catheter
Regulatory Information Classification Name: Continuous flush catheter Classification: II Product Code: KRA Regulation Number: 21CFR 870.1210 Review Panel: Cardiovascular
Indication for Use:
The Vericor Support Catheter is intended for use in small vessel or superselective anatomy for diagnostic and interventional procedures, including peripheral use.
Device Description
The Vericor Support Catheter with hydrophilic coating is a braided, kink-resistant catheter designed to facilitate wire guide exchange, wire guide support and to provide a conduit for the delivery of saline solutions or diagnostic contrast agents. The Vericor Support Catheter will be available in three catheter lengths which are 90 cm, 135 cm and 150 cm. The proposed device is a single-lumen catheter. The hub of the catheter incorporates standard luer adapter to facilitate the attachment of accessories. The outer surface of the distal catheter has a hydrophilic coating. The catheter has three radiopaque markers at the distal end to facilitate fluoroscopic visualization. The device is provided in single use and sterile.
-
న. Identification of Predicate Devices
Predicate Device 510(k) Number: K160884 Product Name: CXI Support Catheter -
- Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications and was found to be Substantially Equivalent (SE) to the predicate device. The testing was conducted with methods and criteria (as applicable) for compliance with the following standards:
- Non-Clinical Test Conclusion
-
ISO 10993-4: 2017 Biological evaluation of medical devices-Part 4: Selection of tests for interactions with blood
-
ISO 10993-5: 2009 Biological evaluation of medical devices-Part 5: Tests for in vitro cytotoxicity
5
- A ISO 10993-7:2008 Biological evaluation of medical devices-Part 7: Ethylene oxide sterilization residuals
-
ISO 10993-10: 2010 Biological evaluation of medical devices-Part 10: Tests for irritation and skin sensitization
-
ISO 10993-11: 2017 Biological evaluation of medical devices-Part 11: Tests for systemic toxicity
-
USP Bacterial Endotoxins Test
-
ASTM F756-17, Standard Practice for Assessment of Hemolytic Properties of Materials
-
ASTM F2382-18, Standard Test Method for Assessment of Circulating Blood-Contacting Medical Device Materials on PTT
- A ASTM D4169-16, Standard Practice for Performance Testing of Shipping Containers and System
-
ASTM F1886/F1886M-16, Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection
-
ASTM F1929-15, Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
- A ASTM F88/F88M-15, Standard Test Method for Seal Strength of Flexible Barrier Materials
- A ISO 10555-1: 2013, Intravascular catheters - Sterile and single-use intravascular catheters - Part 1: General requirements [Including AMENDMENT 1 (2017)]
-
ISO 80369-7: 2021, Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
- A USP, Pyrogen Test
-
USP, Particulate Matter in Injections
-
ASTM F640-20, Standard Test Methods for Determining Radiopacity for Medical Use
-
ASTM F2606-08, Standard Guide for Three-Point Bending of Balloon-Expandable Vascular Stents and Stent Systems
The results of performance testing conducted on the Vericor Support Catheter demonstrate that it performs as designed, is suitable for its indication for use and is equivalent in performance to the identified predicate device. A summary of the tests performed is provided in the table below:
Test | Test Method Summary | Results and Conclusion |
---|---|---|
Visual inspection | Observe the catheter by naked eyes or under microscope of X2.5 magnification for any structural or mechanical damage. | The catheter met acceptance criteria. |
Corrosion Resistance | The proposed device was evaluated per ISO 10555 - 1:2013. To demonstrate that the device meets the corrosion resistance. | Corrosion resistance met acceptance criteria. |
Dimensional verification | Verify dimensions using specified measurement tools. Record measurements. | Size verification met acceptance criteria. |
Flowrate | The proposed device was evaluated per ISO 10555-1:2013. To demonstrate that the device | The flowrate of the Vericor catheter size verification met |
determination test | meets the flowrate requirements. | acceptance criteria. |
Compatibility test | Simulated use testing with compatible devices in a vascular model was performed. | The device can be used as intended. |
Simulated use | Simulated use testing in a vascular model was performed | The device can be used as intended. |
Power injection | The proposed device was evaluated per ISO 10555 - 1:2013. To demonstrate that the device meets the power injection requirements. | The catheters were free of leakage, rupture or other failure modes during power injection test, and the test result met acceptance criteria. |
Torque transmission | Fix the distal end of the catheter and rotate the proximal. | Torque transmission met acceptance criteria. |
Air leakage | The proposed device was evaluated per ISO 10555 - 1 to demonstrate that the product meets the hub aspiration air leakage requirements. | No air leakage |
Liquid leakage | The proposed device was evaluated per ISO 10555 - 1. To demonstrate that the device meets the liquid leakage under pressure requirements. | No liquid leakage |
Static burst pressure | Burst pressure tests were performed at pressures greater than the maximum injection pressures. | Burst pressure met acceptance criteria. |
Friction of coating | The test simulates the change in coating friction of the product before and after use | Friction met acceptance criteria |
Coating integrity | After simulating the use with compatible devices, the coating is dyed and observe coating defects with magnification. | Coating integrity met acceptance criteria. |
Flexibility | The proposed device was evaluated per ASTM F2606-2008. To demonstrate that the device meets the flexibility requirements. | Tip flexibility met acceptance criteria. |
Kink resistance | One end of the test piece was fixed on the stator of kink resistance fixture, and the other was fixed on the mover that could move axially in a fixture. The radius gradually decreased when the mover moves axially. Recorded the total length of the catheter body with fixed ends. | Kink resistance met acceptance |
Peak tensile force | Use a tensile test machine to apply a tensile | |
load to the sample and determine whether the | ||
maximum tensile force meets the acceptance | ||
criteria. | Peak tensile force met | |
acceptance criteria. | ||
Catheter tip twist to | ||
damage test | Fixed the end of the tip with a Torsional | |
Meter. Rotated the proximal end of the | ||
catheter until the tip or body deformed or | ||
failed | Tip twist met acceptance | |
Radiopacity | The radiopaque marker on the catheter tip | |
should be visible under X - ray. | The radiopaque marker on | |
the catheter tip is visible | ||
under X - ray. | ||
Catheter body axial | ||
compression test | The lower jaw clamped the fixture, and the | |
upper jaw clamped one test piece of the | ||
catheter. Recorded the force-deflection curve | ||
and peak force value of the catheter body | ||
during test. | Catheter body axial force met | |
acceptance criteria. | ||
Delivery and retrieval | ||
forces test | The proposed device was evaluated per FDA | |
Guidance - Non-Clinical Engineering Tests and | ||
Recommended Labeling for Intravascular | ||
Stents and Associated Delivery Systems. To | ||
demonstrate that the device meets the delivery | ||
and retrieval requirements. | Deliver and retrieval force | |
met acceptance criteria. | ||
Particulate testing | After simulating the use with compatible | |
devices, determine the quantity and size of the | ||
particles generated. | The number and size of the | |
particles | ||
met | ||
acceptance | ||
criteria. | ||
Connector | ||
performance | The proposed device was evaluated per ISO | |
80369-7 to demonstrate that the product meets | ||
the requirements for small bore connectors. | Connector performance met | |
acceptance criteria. |
6
7
-
- Clinical Test Conclusion
No clinical study is included in this submission.
- Clinical Test Conclusion
8
8. Substantially Equivalent (SE) Comparison
Item | Proposed Device | Predicate Device K160884 | Remark | |
---|---|---|---|---|
Classification | II | II | Same | |
Product Code | KRA | KRA | Same | |
Regulation Number | 21 CFR 870.1210 | 21 CFR 870.1210 | Same | |
Indication for Use | The Vericor Support Catheter is | |||
intended for use in small vessel or | ||||
superselective anatomy for diagnostic | ||||
and interventional procedures, | ||||
including peripheral use. | The CXI TM Support Catheter is | |||
intended for use in small vessel or | ||||
superselective anatomy for | ||||
diagnostic and interventional | ||||
procedures, including peripheral use. | Same | |||
Component | Hub | |||
Strain relief | ||||
Distal shaft | ||||
Proximal shaft | ||||
Marker bands | ||||
Radiopaque tip | Multi layers with hydrophilic | |||
coating | ||||
Distal tip and hub | Different | |||
Inner Diameter | 0.0215inch | 0.0215inch | Same | |
Outer Diameter | Proximal: 2.5Fr (0.83mm) | |||
Distal: 2.4Fr (0.80mm) | 2.6Fr (0.87mm) | |||
4.0Fr (1.23mm) | Different | |||
Effective length | 90cm, 135cm, 150cm | 65cm, 90cm, 135cm, 150cm | Similar | |
Maximum Guidewire | 0.018inch | 0.018inch | Same | |
Radiopaque Marker | Yes | Yes | Same | |
Single Use | Yes | Yes | Same | |
Labeling | Conform with Part 801 | Conform with Part 801 | Same | |
Patient-contact Material | ||||
Tip | Tip Outer | |||
Body | Polyether block amide (PEBA) | |||
Tungsten | Different | |||
Tip Inner | ||||
Body | Polyether block amide (PEBA) | |||
PTFE | Poly tetra fluoroethylene (PTFE) | |||
Liner | Poly tetra fluoroethylene (PTFE) | Unknown | ||
Marker Band | Polyamide | |||
Tungsten | ||||
Proxim | ||||
al Shaft | Proximal | |||
Outer | ||||
Body | Polyethylene terephthalate (PET) | |||
PTFE | Poly tetra fluoroethylene (PTFE) | |||
Liner | ||||
Distal | Polyamide | |||
Distal | ||||
Shaft | Outer | |||
Body 1 | Polyether block amide (PEBA) | |||
Distal | ||||
Outer | ||||
Body 2 | Polyamide | |||
PTFE | ||||
Liner | Poly tetra fluoroethylene (PTFE) | |||
Hydrophilic Coating | Ethanol | |||
2-Hydroxy-1-[4-(2-hydroxyethoxy) | ||||
phenyl]-2-methyl-1-propanone | ||||
Ethanol | ||||
Water | ||||
Polyvinylpyrrolidone | ||||
Hub | Polycarbonate (PC) | |||
Biocompatibility | ||||
Cytotoxicity | No cytotoxicity | Same | ||
Skin Sensitization | No skin sensitization | |||
Intracutaneous | ||||
Reactivity | No irritation | |||
Systemic Toxicity | No systemic toxicity | |||
Pyrogen | No pyrogen | |||
Complement | ||||
Activation | No significant difference to control | |||
group | Conform with ISO 10993 standards | |||
In Vivo | ||||
Thromboresistance | Minimal thrombosis | |||
Hemolysis | No hemolysis | |||
Partial | ||||
Thromboplastin Time | No significant difference to control | |||
group | ||||
Sterilization | Ethylene oxide | Ethylene oxide | Same | |
SAL | 10-6 | 10-6 | Same |
9
Analysis Different - Component
The components for the proposed device are different from predicate device. The component name for different manufacturer maybe different from each other. Each component of the proposed device is written in more detail. However, the differences in component name will not affect indication for use or raise any safety issues. In addition, a comparative performance test was conducted between the proposed device and the predicate device, and the test results showed that the performance of the two devices was
10
similar. Therefore, this difference does not raise new safety and efficacy issues.
Analysis Different -Outer Diameter
The outer diameter of the proposed device is different from predicate device. The proposed device is designed with unequal outer diameter, while the predicate device is designed with equal outer diameter. The predicate device has two sizes of outer diameter, while the proposed device has only one. However, the proposed proximal outer diameter is very similar to the predicate device and this difference is small. The comparative performance test was conducted between the proposed device and the predicate device, and the test results showed that the performance of the two devices was similar. Therefore, this difference does not raise new safety and efficacy issues.
Analysis Similar-Effective length
The outer diameter of the proposed device is similar to predicate device. The proposed devices are available in three effective lengths, which are 90cm, 135cm and 150cm. The predicate devices are available in four effective lengths, which are 65cm, 90cm, 135cm and 150cm. The effective length for the proposed device is covered by the range of lengths for the predicate device. Therefore, this difference does not raise new safety and efficacy issues.
Analysis Different- Patient-contact Material
The materials of subject device may be different from predicate device. However, biocompatibility and other bench tests were performed on the proposed device and the test results showed that there was no adverse effect. Therefore, this difference does not raise new safety and efficacy issues.
Substantially Equivalent (SE) Conclusion 9.
Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.