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 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

AI/ML Overview

The provided text is a 510(k) summary for the ReCross Dual Lumen guide wire support catheter. It discusses the device's technical characteristics and studies performed to demonstrate its substantial equivalence to a predicate device. However, it does not contain information about an AI/ML-based device, nor does it detail acceptance criteria related to algorithmic performance metrics (like accuracy, sensitivity, specificity, etc.) or clinical study designs involving human readers or standalone AI performance.

Therefore, many of the requested details, such as the number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set information, are not present in this document. This document focuses on the mechanical and material performance of a medical device (a catheter), not a diagnostic algorithm.

Based on the provided text, here's what can be extracted regarding acceptance criteria and performance:

1. A table of acceptance criteria and the reported device performance:

The document lists various performance tests and states that "The results of the verification tests met the specified acceptance criteria and did not raise new safety or performance issues." However, the specific numerical acceptance criteria for each test are not explicitly provided in this summary, nor are the numerical results for each test. Instead, it indicates that the device passed these tests.

Test Category	Specific Test	Acceptance Criteria (Not explicitly quantified in the document, but met)	Reported Device Performance (Implied as "Met")
Mechanical/Physical	Kink resistance/flexibility	Met specified requirements	Met
	Guide wire insertion	Met specified requirements	Met
	Radiopacity	Met specified requirements	Met
	Distal tip length	Met specified requirements	Met
	Tensile strength	Met specified requirements	Met
	Catheter body burst	Met specified requirements	Met
	Contrast medium flow rate	Met specified requirements	Met
	Leak testing	Met specified requirements	Met
	Effective length	Met specified requirements	Met
	Shaft inner diameter	Met specified requirements	Met
	Outer diameter	Met specified requirements	Met
	Surface coating lubricity	Met specified requirements	Met
	Coating Integrity	Met specified requirements	Met
	Coating Particulate Evaluation	Met specified requirements	Met
	Packaging integrity	Met specified requirements	Met
Biocompatibility	Cytotoxicity	Met ISO 10993-1 requirements	Met
	Sensitization	Met ISO 10993-1 requirements	Met
	Irritation	Met ISO 10993-1 requirements	Met
	Systemic toxicity	Met ISO 10993-1 requirements	Met
	Pyrogenicity	Met ISO 10993-1 requirements	Met
	Hemocompatibility	Met ISO 10993-1 requirements	Met

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified in the summary. The tests performed are engineering and material verification tests, which typically involve a specified number of samples for each test (e.g., n=3, n=5, n=10 per batch), but this detail isn't included here.
Data Provenance: Not applicable in the context of clinical data for an AI/ML device. These are laboratory verification tests on the physical catheter device, likely performed at the manufacturer's facility (IMDS Operations B.V., Roden, The Netherlands) or by a qualified testing lab. The data would be prospective in the sense that the tests were conducted specifically for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This is not applicable to this document. The "ground truth" here is meeting engineering specifications and biocompatibility standards, not clinical diagnostic labels established by medical experts for image interpretation or similar tasks.

4. Adjudication method for the test set:

This is not applicable. There's no clinical imaging data or human interpretation involved that would require an adjudication method. The verification tests have objective pass/fail criteria.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This is not applicable. This document describes a physical medical device (catheter), not an AI/ML diagnostic or assistive tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This is not applicable. There is no algorithm being evaluated here.

7. The type of ground truth used:

The "ground truth" for these tests are established engineering specifications, material standards (like ISO 10993-1 for biocompatibility), and internal quality control criteria for the device's physical and functional properties.

8. The sample size for the training set:

This is not applicable. This is a physical device, not an AI/ML model that requires training data.

9. How the ground truth for the training set was established:

This is not applicable.

Summary

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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 (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

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Indications for Use

510(k) Number (if known) K210431

Device Name ReCross

Indications for Use (Describe)

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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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

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

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	ReCrossOTW dual lumenguidewire supportcatheter	NHancer Rxdual lumenguidewire supportcatheter
	Model number	RC1414025	NRX1413518
1	Type clinically based	Dual lumen guidewiresupport catheter	Dual lumen guidewiresupport catheter
2	Shaft material	Polymeric	Polymeric

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3	Shaft reinforcement	Stainless steel stiffeningwire & braiding	Stainless steel stiffeningwire & 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 andscrew conform NEN ENISO 80369-7	Female, 6% taper andscrew conform NEN ENISO 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
1. Guide wire insertion
1. Radiopacity
1. Distal tip length
1. Tensile strength
1. Catheter body burst
1. Contrast medium flow rate
1. Leak testing
1. Effective length
1. Shaft inner diameter
1. Outer diameter
1. Surface coating lubricity
1. Coating Integrity
1. Coating Particulate Evaluation
1. 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.

Regulation Number and Section

§ 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).