(153 days)
None
No
The device description and performance studies focus on the physical and mechanical properties of a guide wire support catheter, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is a guide wire support catheter intended to facilitate access and exchange of guide wires and deliver contrast agents, acting as an accessory to a therapeutic procedure rather than a therapeutic device itself.
No
The device is a guide wire support catheter intended for physical support and delivery of contrast agents, not for diagnosing conditions.
No
The device description clearly details a physical catheter with lumens, coatings, radiopaque markers, and a stylet, indicating it 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 clearly describes a device used in vivo (inside the body) to support a guide wire, exchange guide wires, and deliver contrast agents within the coronary and peripheral vasculature.
- Device Description: The description details a physical catheter designed for insertion into blood vessels.
- 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 diagnostic purposes. IVDs are typically used in a laboratory or point-of-care setting to analyze biological samples.
This device is a medical device used for interventional procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ReCross Dual Lumen guide wire support catheter with hydrophilic coating is intended to support a guide wire during access of coronary and/or peripheral vasculature and allows for exchange of guide wires and provides a conduit for the delivery of diagnostic contrast agents. The catheter is not intended for use in the neurovasculature.
Product codes
DQY
Device Description
The ReCross is a dual lumen catheter intended to use in the coronary and/or peripheral vasculature. The ReCross is a 0.014" Over The Wire (OTW) guide wire support catheter. The ReCross has two over the wire OTW lumens that runs the length of the catheter. The ReCross has two depth markings located at 95 cm and 105 cm from the distal tip. The ReCross has a radiopaque marker identifying the distal end of the catheter, a second radiopaque marker in the stylet lumen located 8 mm from the distal tip identifies the distal end of the OTW lumen and a third radiopaque marker in the tip lumen located at 12 mm from the distal tip indentifying the side port.
To reduce friction in the guide catheter and vasculature, the distal shaft is fitted with a hydrophilic coating. To reduce friction of the guide wire in the lumens of the ReCross are coated with MDX (silicone) coating. To ease catheter loading into the hemostasis device and the guiding catheter a removable stylet is placed in the stylet lumen
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary and/or 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
The technological differences between the subject and predicate devices have been evaluated through performance and biocompatibility tests and results did not raise new questions of safety or effectiveness. The ReCross dual lumen catheter is substantially equivalent to the specified predicate device based on comparisons of the device functionality, technological characteristics, and indications for use. The device design has been verified through the following tests:
-
- Kind resistance/ flexibility
-
- Guide wire insertion
-
- Radiopacity
-
- Distal tip length
-
- Tensile strength
-
- Catheter body burst
-
- Contrast medium flow rate
-
- Leak testing
-
- Effective length
-
- Shaft inner diameter
-
- Outer diameter
-
- Surface coating lubricity
-
- Coating Integrity
-
- Coating Particulate Evaluation
-
- Packaging integrity
ReCross is meeting the requirements for biocompatibility in accordance with ISO 10993-1:
- Cytotoxicity ●
- Sensitization
- Irritation ●
- Systemic toxicity
- Pyrogenicity
- Hemocompatibility
The results of the verification tests met the specified acceptance criteria and did not raise new safety or performance issues.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
None
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
July 15, 2021
Image /page/0/Picture/1 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
IMDS Operations B.V. Edwin Schulting, CEO Ceintuurbaan Noord 150 Roden, Drenthe 9301 NZ Netherlands
Re: K210431
Trade/Device Name: ReCross Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: February 9, 2021 Received: February 12, 2021
Dear Edwin Schulting:
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-regulatory-assistance/contact-usdivision-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) K210431
Device Name ReCross
Indications for Use (Describe)
The ReCross Dual Lumen guide wire support catheter with hydrophilic coating is intended to support a guide wire during access of coronary and/or peripheral vasculature and allows for exchange of guide wires and provides a conduit for the delivery of diagnostic contrast agents. The catheter is not intended for use in the neurovasculature.
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
[As required by 21 CFR 807.92]
Date Prepared: February 8th , 2021
Submitter's Name / Contact Person Manufacturer IMDS Operations BV Ceintuurbaan Noord 150 9301 NZ Roden, The Netherlands Establishment Registration #3007740583
Contact Person Florence Wagter Director of Quality and Regulatory Tel: 0031651453880 Fax: 0031508200231
General Information
Trade Name Common/ Usual Name Classification Name Predicate Device Reference Device
ReCross Dual lumen catheter Catheter, percutaneous K200324, NHancer Rx, dual lumen catheter, IMDS Operations B.V. None
Device Description
The ReCross is a dual lumen catheter intended to use in the coronary and/or peripheral vasculature. The ReCross is a 0.014" Over The Wire (OTW) guide wire support catheter. The ReCross has two over the wire OTW lumens that runs the length of the catheter. The ReCross has two depth markings located at 95 cm and 105 cm from the distal tip. The ReCross has a radiopaque marker identifying the distal end of the catheter, a second radiopaque marker in the stylet lumen located 8 mm from the distal tip identifies the distal end of the OTW lumen and a third radiopaque marker in the tip lumen located at 12 mm from the distal tip indentifying the side port.
To reduce friction in the guide catheter and vasculature, the distal shaft is fitted with a hydrophilic coating. To reduce friction of the guide wire in the lumens of the ReCross are coated with MDX (silicone) coating. To ease catheter loading into the hemostasis device and the guiding catheter a removable stylet is placed in the stylet lumen
Intended Use
The ReCross Dual Lumen guide wire support catheter with hydrophilic coating is intended to support a guide wire during access of coronary and/or peripheral vasculature and allows for exchange of guide wires and provides a conduit for the delivery of diagnostic contrast agents. The catheter is not intended for use in the neurovasculature.
Technological Characteristics Comparison
The ReCross is similar in design to the predicate device and both are dual lumen, percutaneous catheters intended to access discrete regions of the coronary and peripheral vasculature, facilitate placement and exchange of guidewires and sub selectively infuse agents.
| # | Item | ReCross
OTW dual lumen
guidewire support
catheter | NHancer Rx
dual lumen
guidewire support
catheter |
|---|-----------------------|------------------------------------------------------------|-----------------------------------------------------------|
| | Model number | RC1414025 | NRX1413518 |
| 1 | Type clinically based | Dual lumen guidewire
support catheter | Dual lumen guidewire
support catheter |
| 2 | Shaft material | Polymeric | Polymeric |
4
| 3 | Shaft reinforcement | Stainless steel stiffening
wire & braiding | Stainless steel stiffening
wire & braiding |
|----|---------------------------------------|-------------------------------------------------------------|-------------------------------------------------------------|
| 4 | OTW Guidewire lumens | 2 | 1 |
| 5 | Rapid Exchange guidewire lumens | 0 | 1 |
| 6 | Number of guidewire distal exit ports | 3 | 2 |
| 7 | Strain Relief | present | present |
| 8 | Hub and Luer Lock | Female, 6% taper and
screw conform NEN EN
ISO 80369-7 | Female, 6% taper and
screw conform NEN EN
ISO 80369-7 |
| 9 | Radiopaque marker material | Tungsten | Tungsten |
| 10 | Effective Length or Usable Length | 140 cm | 135 cm |
| 11 | Exit Marker location (from tip) | 95 and 105 cm | 95 and 105 cm |
| 12 | Guidewire compatibility | 0.014 inch | 0.014 inch |
| 13 | Maximum injection pressure | 150 psi | 300 psi |
| 14 | Shaft cross sectional area | 0.58 mm² | 0.58 mm² |
| 15 | Minimum Guiding Catheter size | 5 Fr | 5 Fr |
| 16 | Tip design / shape | Straight | Straight |
| 17 | Tip material | Polymeric | Polymeric |
| 18 | Hydrophilic coating distal shaft | present | present |
| 19 | Hydrophilic coating material | Hydrophilic coating | Hydrophilic coating |
| 20 | Inner lumen coating | Yes | Yes |
With the exception of dimensional configuration differences, the ReCross is similar in design and technological characteristics to the predicate device. The dimensional, material and package configuration differences were successfully evaluated in performance tests.
5
Substantial Equivalence and Summary of Studies
The technological differences between the subject and predicate devices have been evaluated through performance and biocompatibility tests and results did not raise new questions of safety or effectiveness. The ReCross dual lumen catheter is substantially equivalent to the specified predicate device based on comparisons of the device functionality, technological characteristics, and indications for use. The device design has been verified through the following tests:
-
- Kind resistance/ flexibility
-
- Guide wire insertion
-
- Radiopacity
-
- Distal tip length
-
- Tensile strength
-
- Catheter body burst
-
- Contrast medium flow rate
-
- Leak testing
-
- Effective length
-
- Shaft inner diameter
-
- Outer diameter
-
- Surface coating lubricity
-
- Coating Integrity
-
- Coating Particulate Evaluation
-
- Packaging integrity
ReCross is meeting the requirements for biocompatibility in accordance with ISO 10993-1:
- Cytotoxicity ●
- Sensitization
- Irritation ●
- Systemic toxicity
- Pyrogenicity
- Hemocompatibility
The results of the verification tests met the specified acceptance criteria and did not raise new safety or performance issues.
Therefore, the ReCross dual lumen catheter is substantially equivalent to the predicate device.