Micro Rx

K223728 · Imds Operations B.V. · DQY · Jul 13, 2023 · Cardiovascular

Device Facts

• Record ID: K223728
• Device Name: Micro Rx
• Applicant: Imds Operations B.V.
• Product Code: DQY · Cardiovascular
• Decision Date: Jul 13, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Micro Rx is a single-lumen, rapid-exchange guidewire support catheter used to facilitate guidewire placement in coronary and peripheral vasculature. The device features a 135 cm length, a stainless-steel proximal shaft, and a polymeric distal shaft with stainless-steel reinforcement. It includes a radiopaque distal tip for fluoroscopic visualization and positioning markers at 95 cm and 105 cm from the tip, with distal shaft exit markers at 110 cm and 120 cm. The device is operated by physicians in a clinical setting (e.g., cath lab) via femoral or brachial approach. By providing support for guidewire navigation to target lesions, the catheter assists in complex vascular interventions. The device is compatible with 0.014-inch guidewires and requires a minimum 5 Fr guiding catheter.

Clinical Evidence

Bench testing only. No clinical data provided. Verification testing included kink resistance, flexibility, deployment/retraction, radiopacity, tensile strength, torque robustness, and coating integrity. Biocompatibility testing performed per ISO 10993-1, including cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, and hemocompatibility. All tests met acceptance criteria.

Technological Characteristics

Rapid exchange single-lumen catheter; 135 cm length; stainless-steel proximal shaft; polymeric distal shaft with stainless-steel reinforcement; radiopaque distal tip; hydrophilic coating on distal shaft; MDX inner lumen coating; 1.0 mm shaft OD; 5 Fr minimum guiding catheter compatibility; 0.014" guidewire compatibility. Sterilization method not specified. No software or electronic components.

Indications for Use

Indicated for patients with coronary or peripheral artery disease requiring guide wire support during access of coronary and/or peripheral vasculature. Contraindicated for use in the 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

• Venture 0.014" Catheter (K182570)

Reference Devices

• NHancer Rx, IMDS Operations B.V. (K200324)

Submission Summary (Full Text)

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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 ([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) K223728

Device Name Micro Rx

Indications for Use (Describe)

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.

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: [phone] Fax: [phone]

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

### 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.

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 Rx<br>Guidewire support<br>catheter | Venture 0.014”<br>catheter |
|---|----------------------------|--------------------------------------------------------------|--------------------------------------------------------------|
| | Model number | RX135 | 5820 |
| 1 | Type clinically based | Rapid exchange single<br>lumen guidewire support<br>catheter | Rapid exchange single<br>lumen guidewire support<br>catheter |
| 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
- 2) Device introduction, deployment and retraction
- 3) Radiopacity
- 4) Distal tip length
- 5) Tensile strength
- 6) Effective length
- 7) Shaft inner diameter
- 8) Torque robustness
- 9) Outer diameter
- 10) Surface coating lubricity
- 11) Coating integrity
- 12) Coating particulate evaluation
- 13) 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.