(212 days)
"K182570"
No
The description focuses on the physical characteristics and performance of a guide wire support catheter, with no mention of AI or ML capabilities.
No
The device is described as a 'guide wire support catheter' intended to support a guide wire during access of vasculature, which is an accessory function for other procedures rather than providing a direct therapeutic effect.
No
The device is described as a guide wire support catheter intended to facilitate the access of coronary and/or peripheral vasculature, not to diagnose a condition.
No
The device description clearly outlines physical components like a stainless-steel shaft, lumen section, and radiopaque tip, indicating it is a physical medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Function: The description clearly states the Micro Rx catheter is intended to "support a guide wire during access of coronary and/or peripheral vasculature." This is a device used within the body during a medical procedure.
- Intended Use: The intended use is for accessing and navigating blood vessels, not for analyzing biological samples.
- Device Description: The description details the physical characteristics of a catheter designed for insertion into the body.
- Performance Studies: The performance studies focus on the physical and mechanical properties of the catheter (kink resistance, tensile strength, lubricity, etc.) and its biocompatibility, which are relevant for an implantable or interventional device, not an IVD.
The Micro Rx catheter is an interventional medical device used in procedures within the body.
N/A
Intended Use / Indications for 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.
Product codes
DQY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
fluoroscopic methods
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 device design has been verified through the following tests:
-
- Kink resistance/ flexibility
-
- Device introduction, deployment and retraction
-
- Radiopacity
-
- Distal tip length
-
- Tensile strength
-
- Effective length
-
- Shaft inner diameter
-
- Torque robustness
-
- Outer diameter
-
- Surface coating lubricity
-
- Coating integrity
-
- Coating particulate evaluation
-
- 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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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 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
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 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
2
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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3
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 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
Guidewire support
catheter | Venture 0.014”
catheter |
|---|----------------------------|--------------------------------------------------------------|--------------------------------------------------------------|
| | Model number | RX135 | 5820 |
| 1 | Type clinically based | Rapid exchange single
lumen guidewire support
catheter | Rapid exchange single
lumen guidewire support
catheter |
| 2 | Distal shaft material | Polymeric | Polymeric |
| 3 | Distal shaft reinforcement | Stainless steel | Stainless steel |
4
| 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.
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 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:
-
- Kink resistance/ flexibility
-
- Device introduction, deployment and retraction
-
- Radiopacity
-
- Distal tip length
-
- Tensile strength
-
- Effective length
-
- Shaft inner diameter
-
- Torque robustness
-
- Outer diameter
-
- Surface coating lubricity
-
- Coating integrity
-
- Coating particulate evaluation
-
- 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.