ReCross

K210431 · Imds Operations B.V. · DQY · Jul 15, 2021 · Cardiovascular

Device Facts

• Record ID: K210431
• Device Name: ReCross
• Applicant: Imds Operations B.V.
• Product Code: DQY · Cardiovascular
• Decision Date: Jul 15, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

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.

Device Story

ReCross is a 0.014" Over-The-Wire (OTW) dual-lumen guide wire support catheter; used in coronary and peripheral vasculature. Device features two OTW lumens, three radiopaque markers for positioning, and a removable stylet for loading. Distal shaft has hydrophilic coating to reduce friction; inner lumens have MDX (silicone) coating. Operated by physicians in clinical settings to support guide wire placement, facilitate guide wire exchange, and deliver diagnostic contrast agents. Radiopaque markers allow visualization under fluoroscopy to guide placement. Benefits include improved access to complex vascular anatomy and streamlined guide wire exchange.

Clinical Evidence

Bench testing only. No clinical data. Verification testing included kink resistance, flexibility, guide wire insertion, radiopacity, tensile strength, catheter body burst, contrast flow rate, leak testing, dimensional verification, surface lubricity, coating integrity, particulate evaluation, and packaging integrity. Biocompatibility testing performed per ISO 10993-1, including cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, and hemocompatibility. All tests met acceptance criteria.

Technological Characteristics

Dual-lumen OTW catheter; polymeric shaft with stainless steel stiffening wire and braiding. 0.014" guide wire compatibility. Hydrophilic distal shaft coating; MDX (silicone) inner lumen coating. Tungsten radiopaque markers. 140 cm length. 5 Fr minimum guiding catheter size. Hub/Luer lock conforms to NEN EN ISO 80369-7. Sterilization method not specified.

Indications for Use

Indicated for patients requiring guide wire support during access of coronary and/or peripheral vasculature, guide wire exchange, or delivery of diagnostic contrast agents. Not for use in neurovasculature.

Regulatory Classification

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.

Predicate Devices

• NHancer Rx (K200324)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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# 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)

| <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|--------------------------------------------------------------------------------------|
| □ Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 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: [phone] Fax: [phone]

### 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<br>OTW dual lumen<br>guidewire support<br>catheter | NHancer Rx<br>dual lumen<br>guidewire support<br>catheter |
|---|-----------------------|------------------------------------------------------------|-----------------------------------------------------------|
| | Model number | RC1414025 | NRX1413518 |
| 1 | Type clinically based | Dual lumen guidewire<br>support catheter | Dual lumen guidewire<br>support catheter |
| 2 | Shaft material | Polymeric | Polymeric |

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| 3 | Shaft reinforcement | Stainless steel stiffening<br>wire & braiding | Stainless steel stiffening<br>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<br>screw conform NEN EN<br>ISO 80369-7 | Female, 6% taper and<br>screw conform NEN EN<br>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.

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### 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:

- 1) Kind resistance/ flexibility
- 2) Guide wire insertion
- 3) Radiopacity
- 4) Distal tip length
- 5) Tensile strength
- 6) Catheter body burst
- 7) Contrast medium flow rate
- 8) Leak testing
- 9) Effective length
- 10) Shaft inner diameter
- 11) Outer diameter
- 12) Surface coating lubricity
- 13) Coating Integrity
- 14) Coating Particulate Evaluation
- 15) 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.