The Micro Rx catheter with hydrophilic coating is intended to support a guide wire during access of coronary and/or peripheral vasculature. The device is contraindicated for use in the neurovasculature.

Device Description

The Micro Rx is a guide wire support catheter intended to be used in the coronary and/ or peripheral vasculature for patients suffering from coronary or peripheral artery disease. The target lesion can be reached by using the femoral or brachial approach. The Micro Rx is a single lumen 0.014" rapid exchange catheter. The 135 cm long device has a stainless-steel shaft section. The stainless-steel shaft is followed distally by a 15 cm lumen section. The Micro Rx catheter has a radiopaque distal tip which enables visibility while using standard fluoroscopic methods. The device has two positioning marks located at 95cm from the distal tip, respectively. Furthermore, two distal shaft exit markers are located at 110 cm and 120 cm to indicate the distal shaft exit.

AI/ML Overview

The provided document is an FDA 510(k) clearance letter for a medical device called "Micro Rx," a guidewire support catheter. It details the device's characteristics, intended use, and comparison to a predicate device, as well as the summary of studies conducted to demonstrate substantial equivalence.

However, the document does not contain the kind of information typically found in studies for AI/ML-based medical devices or devices where performance is measured against a ground truth using expert readers. The provided text is for a mechanical medical device (a catheter), and the "studies" mentioned are performance and biocompatibility tests for that physical device, not studies involving image analysis or expert adjudication.

Therefore, many of the requested items (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth type, training set details) are not applicable to this type of device and the information provided in this 510(k) document.

I will populate the table and answer the questions based on the information that is available in the provided text, and explicitly state when information is not present or applicable.

Acceptance Criteria and Device Performance for Micro Rx Catheter

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

The document lists "verification tests" that were performed and states that "The results of the verification tests met the specified acceptance criteria." However, it does not provide the specific numerical acceptance criteria or the numerical results for each test. It simply states that they passed.

Performance Characteristic	Acceptance Criteria (Not Explicitly Stated Numerically)	Reported Device Performance (Summary Statement)
Kink resistance/flexibility	Met requirements	Results met specified acceptance criteria.
Device introduction, deployment, and retraction	Met requirements	Results met specified acceptance criteria.
Radiopacity	Met requirements	Results met specified acceptance criteria.
Distal tip length	Met requirements	Results met specified acceptance criteria.
Tensile strength	Met requirements	Results met specified acceptance criteria.
Effective length	Met requirements	Results met specified acceptance criteria.
Shaft inner diameter	Met requirements	Results met specified acceptance criteria.
Torque robustness	Met requirements	Results met specified acceptance criteria.
Outer diameter	Met requirements	Results met specified acceptance criteria.
Surface coating lubricity	Met requirements	Results met specified acceptance criteria.
Coating integrity	Met requirements	Results met specified acceptance criteria.
Coating particulate evaluation	Met requirements	Results met specified acceptance criteria.
Packaging integrity	Met requirements	Results met specified acceptance criteria.
Biocompatibility
Cytotoxicity	Met ISO 10993-1 requirements	Results met specified acceptance criteria and requirements for biocompatibility in accordance with ISO 10993-1.
Sensitization	Met ISO 10993-1 requirements	Results met specified acceptance criteria and requirements for biocompatibility in accordance with ISO 10993-1.
Irritation	Met ISO 10993-1 requirements	Results met specified acceptance criteria and requirements for biocompatibility in accordance with ISO 10993-1.
Systemic toxicity	Met ISO 10993-1 requirements	Results met specified acceptance criteria and requirements for biocompatibility in accordance with ISO 10993-1.
Pyrogenicity	Met ISO 10993-1 requirements	Results met specified acceptance criteria and requirements for biocompatibility in accordance with ISO 10993-1.
Hemocompatibility	Met ISO 10993-1 requirements	Results met specified acceptance criteria and requirements for biocompatibility in accordance with ISO 10993-1.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: The document does not specify the sample sizes (number of units tested) for each of the performance or biocompatibility tests.
Data Provenance: Not specified. These are laboratory/bench tests, not clinical studies involving patient data from specific countries. The manufacturing company, IMDS Operations B.V., is located in Roden, Drenthe, Netherlands.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. This device is a mechanical catheter. The "ground truth" for its performance is established by engineering specifications, physical measurements, and adherence to ISO standards (e.g., ISO 10993-1 for biocompatibility), not by expert human interpretation or consensus.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. No human adjudication of results in the traditional sense (e.g., for image interpretation) is mentioned or relevant for these types of engineering and biocompatibility tests. The tests yield objective, measurable data.

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

No. This is a mechanical device, not an AI/ML-driven diagnostic or image analysis tool. Therefore, an MRMC study and AI assistance are not relevant.

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

Not Applicable. This is a mechanical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance is based on engineering specifications, direct physical measurements, and adherence to established international standards (e.g., ISO 10993-1 for biocompatibility). There is no "expert consensus" or "pathology" in the context of diagnostic accuracy.

8. The sample size for the training set

Not Applicable. This is not an AI/ML device that requires a training set.

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

Not Applicable. This is not an AI/ML device that requires a training set or its associated ground truth establishment.

Summary

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July 13, 2023

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".

IMDS Operations B.V. Edwin Schulting CEO Ceintuurbaan Noord 150 Roden, Drenthe 9301NZ, Netherlands

Re: K223728

Trade/Device Name: Micro Rx Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: June 12, 2023 Received: June 12, 2023

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 medical devices and radiation-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.

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) K223728

Device Name Micro Rx

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

X 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: November 10th, 2022

Submitter's Name / Contact Person Manufacturer IMDS Operations BV Ceintuurbaan Noord 150

General Information

Common/ Usual Name

Classification Name Predicate Device

Reference Device

Trade Name

9301 NZ Roden, The Netherlands Establishment Registration #3007740583 Contact Person Florence Wagter Principle Associate Quality Assurance/ Regulatory Affairs Tel: 0031651453880 Fax: 0031508200231

Catheter Catheter, percutaneous K182570, Venture 0.014" Catheter, Vascular Solutions, LLC K200324 NHancer Rx, IMDS Operations B.V.

Device Description

The Micro Rx catheter has a radiopaque distal tip which enables visibility while using standard fluoroscopic methods. The device has two positioning marks located at 95cm from the distal tip, respectively. Furthermore, two distal shaft exit markers are located at 110 cm and 120 cm to indicate the distal shaft exit.

Micro Rx

Intended Use

The Micro Rx catheter with hydrophilic coating is intended to support a guide wire during access of coronary and/or peripheral vasculature.

The device is contraindicated for use in the neurovasculature.

Technological Characteristics Comparison

The Micro Rx is similar in design to the predicate device and both are rapid exchange single lumen, percutaneous catheters intended to access discrete regions of the coronary and peripheral vasculature and facilitate placement of guidewires.

#	Item	Micro RxGuidewire supportcatheter	Venture 0.014”catheter
	Model number	RX135	5820
1	Type clinically based	Rapid exchange singlelumen guidewire supportcatheter	Rapid exchange singlelumen guidewire supportcatheter
2	Distal shaft material	Polymeric	Polymeric
3	Distal shaft reinforcement	Stainless steel	Stainless steel

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4	Proximal shaft	Stainless steel	Stainless steel
5	Rapid Exchange guidewire lumens	1	1
6	Number of guidewire distal exit ports	1	1
7	Radiopaque marker	Present	Present
8	Effective Length or Usable Length	135 cm	145 cm
9	Exit Marker location (from tip)	95 and 105 cm	95 and 105 cm
10	Guidewire compatibility	0.014 inch	0.014 inch
11	Shaft outer diameter	1.0 mm	1.37 mm
12	Minimum Guiding Catheter size	5 Fr	6 Fr
13	Tip design / shape	Straight	Straight
14	Hydrophilic coating distal shaft	present	present
15	Hydrophilic coating material	Hydrophilic	Hydrophilic
16	Inner lumen coating	MDX	Not known

With the exception of dimensional configuration differences, the Micro Rx 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 Micro Rx guide wire support 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. Kink resistance/ flexibility
1. Device introduction, deployment and retraction
1. Radiopacity
1. Distal tip length
1. Tensile strength
1. Effective length
1. Shaft inner diameter
1. Torque robustness
1. Outer diameter
1. Surface coating lubricity
1. Coating integrity
1. Coating particulate evaluation
1. Packaging integrity

Micro Rx 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 Micro Rx guide wire support 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).