(90 days)
No
The device description and performance studies focus on the physical characteristics and mechanical 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" and its intended use is to "support a guide wire during access of coronary and/or peripheral vasculature." It does not provide therapy itself but assists in procedural access.
No
The device description clearly states its purpose is to "support a guide wire during access of coronary and/or peripheral vasculature." It is a mechanical support tool for guiding other instruments, not for identifying or investigating health conditions.
No
The device description clearly outlines a physical catheter with a stainless-steel shaft, lumen, radiopaque tip, and positioning marks. The performance studies also focus on physical characteristics and biocompatibility, not software functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "support a guide wire during access of coronary and/or peripheral vasculature." This describes a device used in vivo (within the body) for a medical procedure.
- Device Description: The description details a catheter designed to be inserted into blood vessels. This is consistent with an in vivo device.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The provided information does not mention any testing of samples or analysis of biological materials.
Therefore, the ShapelT catheter is a medical device used for interventional procedures within the body, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ShapelT catheter with hydrophilic coating is intended to support a guide wire during access of coronary and and/or peripheral vasculature.
The device is contraindicated for use in the neurovasculature.
Product codes
DQY
Device Description
The ShapelT 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 ShapelT 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 ShapeIT distal end is preshaped to support guidewire redirection in bifurcations.
The ShapelT catheter has a radiopaque distal tip which enables visibility while using standard fluoroscopic methods. The device has two positioning marks located at 95cm and 105cm 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
Not Found
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 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 ShapelT 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
- Corrosion resistance
- Visual inspection
- Torque robustness
- Shape retention
- Redirecting a guidewire in a bifurcation
- Outer diameter
- Surface coating lubricity
- Coating integrity
- Coating particulate evaluation
- Packaging integrity
ShapeIT 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
Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
September 3, 2024
IMDS Operations B.V. Edwin Schulting CEO Ceintuurbaan Noord 150 Roden. NL9301NZ Netherlands
Re: K241611
Trade/Device Name: ShapeIT Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: June 5, 2024 Received: June 5, 2024
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-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, Digitally signed by Lydia S. Glaw -S Date: 2024.09.03 14:40:08 -04'00'
Lydia Glaw Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality
2
Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K241611
Device Name ShapeIT
Indications for Use (Describe)
The ShapelT 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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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4
510(k) Summary
[As required by 21 CFR 807.92]
Date Prepared: May 30, 2024
Submitter's Name / Contact Person Manufacturer IMDS Operations BV Ceintuurbaan Noord 150
9301 NZ Roden, The Netherlands Establishment Registration #3007740583 Contact Person Aljosja Kot Director Quality Assurance and Regulatory Affairs Tel: 0031651453880 Fax: 0031508200231
General Information Trade Name ShapeIT Common/ Usual Name Classification Name Predicate Device Reference Device Reference Device
Catheter Catheter, percutaneous K223728, Micro Rx Catheter, IMDS Operations B.V. K182570. Venture 0.014 Catheter. Vascular Solutions. LLC K210647, SuperCross 120°angled tip, Vascular Solutions, LLC
Device Description
The ShapelT 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 ShapelT 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 ShapeIT distal end is preshaped to support guidewire redirection in bifurcations.
The ShapelT catheter has a radiopaque distal tip which enables visibility while using standard fluoroscopic methods. The device has two positioning marks located at 95cm and 105cm 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.
Intended Use
The ShapelT 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 ShapelT 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.
5
| # | Item | ShapeIT
Guidewire
support catheter | Micro Rx
Guidewire
support catheter | Equivalent* |
|----|------------------------------------------|-----------------------------------------------------------------|-----------------------------------------------------------------|-------------|
| | Model number | SI014135 | RX135 | |
| 1 | Type clinically based | Rapid exchange
single lumen
guidewire support
catheter | Rapid exchange
single lumen
guidewire support
catheter | Y |
| 2 | Distal shaft material | Pebax /
Polyethylene | Pebax /
Polyethylene | Y |
| 3 | Distal shaft reinforcement | Stainless steel | Stainless steel | Y |
| 4 | Proximal shaft | Stainless steel | Stainless steel | Y |
| 5 | Rapid Exchange guidewire
lumens | 1 | 1 | Y |
| 6 | Number of guidewire distal
exit ports | 1 | 1 | Y |
| 7 | Radiopaque marker
material | TPE / Tungsten | TPE / Tungsten | Y |
| 8 | Effective Length or Usable
Length | 135 cm | 135 cm | Y |
| 9 | Exit Marker location (from
tip) | 95 and 105 cm | 95 and 105 cm | Y |
| 10 | Guidewire compatibility | 0.014 inch | 0.014 inch | Y |
| 11 | Distal shaft outer diameter | 1.1 mm | 1.1 mm | Y |
| 12 | Minimum Guiding Catheter
size | 5 Fr | 5 Fr | Y |
| 13 | Tip design / shape | Angulated | Straight | D |
| 14 | Shapeable distal section | Yes | No | D |
| 15 | Hydrophilic coating distal
shaft | present | present | Y |
| 16 | Hydrophilic coating
material | PUR / PVP
hydrophilic coating | PUR / PVP
hydrophilic coating | Y |
| 17 | Inner lumen coating | MDX | MDX | Y |
With the exception of the angulated tip and shapeable distal section, the ShapelT is similar in design and technological characteristics to the predicate device. An angulated tip and shapeable distal section are known feature as evaluated from the references device and was successfully evaluated in performance tests.
6
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 ShapelT 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
-
- Corrosion resistance
-
- Visual inspection
-
- Torque robustness
-
- Shape retention
-
- Redirecting a guidewire in a bifurcation
-
- Outer diameter
-
- Surface coating lubricity
-
- Coating integrity
-
- Coating particulate evaluation
-
- Packaging integrity
ShapeIT 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 ShapelT guide wire support catheter is substantially equivalent to the predicate device.