(130 days)
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a microcatheter, with no mention of AI or ML capabilities.
No
The device is used to support and facilitate the placement of guidewires, exchange guidewires, and deliver contrast media. These are procedural aids, not direct treatments for disease.
No
Explanation: The device is a microcatheter used for facilitating guidewire placement, exchanging guidewires, and delivering contrast media. These are procedural/interventional functions, not diagnostic ones, even though delivery of contrast media might be for diagnostic imaging. The device itself is not performing the diagnosis.
No
The device description clearly details a physical catheter with specific dimensions, materials, and coatings, indicating it is a hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used within the body for supporting guidewires, exchanging guidewires, and delivering contrast media. These are all interventional procedures performed directly on the patient.
- Device Description: The description details a physical catheter designed for insertion into blood vessels.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used to perform tests outside the body on samples taken from a patient. This device is used inside the body for therapeutic and diagnostic imaging purposes (delivery of contrast media).
N/A
Intended Use / Indications for Use
The COREPASS FLEX/CONTROL microcatheters are indicated for: supporting and facilitating the placement of guidewires in the coronary and peripheral vasculature (not intended for neurovasculature). exchanging guidewires in the coronary and peripheral vasculature. the delivery of contrast media into the coronary, peripheral, and abdominal vasculature.
Product codes (comma separated list FDA assigned to the subject device)
DQY
Device Description
The COREPASS FLEX/ CONTROL microcatheters are singe lumen catheters, offered in two shaft sizes (2.2F and 2.5F) with working lengths of 135cm or 150cm, designed for use in coronary, peripheral, and abdominal vasculature. The COREPASS FLEX/CONTROL share identical shaft profile 2.5F (0.032'') but different distal profile, including 2.2F (0.028'') for the 2.2F configuration (COREPASS FLEX) and 2.5F (0.032'') for the 2.5F configuration (COREPASS CONTROL). The catheter consists of five sections: hub with a female luer connector, catheter body shaft, proximal section, distal section, and tip. The distal most 60cm of the outer surface is coated with a hydrophilic polymer to increase lubricity and the lumen of catheter is lined with a fluoropolymer to facilitate movement of the guidewire. The catheter is compatible with a standard 0.014 inch (0.36mm) guidewire.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary, peripheral, and abdominal vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The following performance data were provided in support of the substantial equivalence determination.
Sterilization
Shelf-Life Performance Testing
Particulate Evaluation
Visual Inspection
Dimension Inspection
Media Flow Rate
Shaft Vacuum/ Leak Test
Simulated Use
Shaft Burst Pressure
Guidewire Compatibility
Coating Integrity
Flexibility and Kinking
Corrosion Resistance
Torque Strength
Tensile Strength
Radiopacity
Biocompatibility testing:
Cytotoxicity
Sensitization
Intracutaneous Reactivity
Acute Systemic Toxicity
Hemocompatibility
Direct and Indirect Hemolysis
Complement Activation (SCb5-9)
In vitro Thrombogenicity
Material Mediated Pyrogenicity
The test results of COREPASS Modular Microcatheter met all acceptance criteria, which are same or similar to the predicate device and reference device. It ensures that the design and construction of COREPASS Modular Microcatheter are suitable for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Teleport XT Microcatheter (K231608, DQY, cleared Jan 7, 2024)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Teleport Microcatheter (K182360, DQY, cleared Nov 9, 2018), Turnpike LP Catheter (K191560, DQY, cleared Aug 09, 2019)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 shows the date January 7, 2025. The text is in a simple, sans-serif font. The date is written out in full, with the month, day, and year clearly visible. The text is black against a white background.
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OrbusNeich Medical (Shenzhen) Co., Ltd. Dora Zhang FDA Supervisor of Regulatory Affairs No.1 Jinkui Road Futian Free Trade Zone Shenzhen, 518038, China
Re: K242588
Trade/Device Name: COREPASS Modular Microcatheter (FLEX): COREPASS Modular Microcatheter (CONTROL) Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: August 30, 2024 Received: December 6, 2024
Dear Dora Zhang:
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"
1
(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).
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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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).
2
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
3
Indications for Use
510(k) Number (if known) K242588
Device Name
COREPASS Modular Microcatheter (FLEX) and COREPASS Modular Microcatheter (CONTROL)
Indications for Use (Describe)
The COREPASS FLEX/CONTROL microcatheters are indicated for:
· supporting and facilitating the placement of guidewires in the coronary and peripheral vasculature (not intended for neurovasculature).
· exchanging guidewires in the coronary and peripheral vasculature.
· the delivery of contrast media into the coronary, peripheral, and abdominal vasculature.
| 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
This 510(k) Summary is submitted in accordance with 21 CFR 807.92.
| Submitter: | OrbusNeich Medical (Shenzhen) Co., Ltd.
No.1 Jinkui Road
Futian Free Trade Zone
Shenzhen 518038, China |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Phone: +86-755-83580181-8326
Fax: +86-755-83580169 |
| Contact Person: | Name: Dora Zhang
Job Title: FDA Supervisor of Regulatory Affairs
Email: dorazhang@orbusneich.com |
| Date Prepared: | August 27, 2024 |
| Device: | Name of Device: COREPASS Modular Microcatheter
Common Name: Microcatheter
Classification Name: Percutaneous catheter (21
CFR
870.1250)
Regulatory Class: II
Product Code: DQY |
| Predicate Device: | Teleport XT Microcatheter (K231608, DQY, cleared Jan 7,
2024)
This predicate has not been subject to a design-related recall. |
| Reference Devices: | Teleport Microcatheter (K182360, DQY, cleared Nov 9,
2018)
Turnpike LP Catheter (K191560, DQY, cleared Aug 09,
2019) |
| Device Description: | The COREPASS FLEX/ CONTROL microcatheters are
singe lumen catheters, offered in two shaft sizes (2.2F and
2.5F) with working lengths of 135cm or 150cm, designed for
use in coronary, peripheral, and abdominal vasculature. The
COREPASS FLEX/CONTROL share identical shaft profile
2.5F (0.032'') but different distal profile, including 2.2F
(0.028'') for the 2.2F configuration (COREPASS FLEX) and
2.5F (0.032'') for the 2.5F configuration (COREPASS
CONTROL). The catheter consists of five sections: hub
with a female luer connector, catheter body |
| | shaft, proximal section, distal section, and tip. The distal most 60cm of the outer surface is coated with a hydrophilic polymer to increase lubricity and the lumen of catheter is lined with a fluoropolymer to facilitate movement of the guidewire. The catheter is compatible with a standard 0.014 inch (0.36mm) guidewire. |
| Indications For Use: | The COREPASS FLEX/CONTROL microcatheters are indicated for: supporting and facilitating the placement of guidewires in the coronary and peripheral vasculature (not intended for neurovasculature). exchanging guidewires in the coronary and peripheral vasculature. the delivery of contrast media into the coronary, peripheral, and abdominal vasculature. |
| Technological
Characteristics: | The subject device has the following similarities to the predicate devices: Same indications for use Similar catheter design Similar materials of construction Same hydrophilic coating Same method of sterilization The following technological differences exist between the |
| | subject and predicate device: specific materials selected exact dimensions of components |
| Performance Data: | The following performance data were provided in support of the substantial equivalence determination. Sterilization Shelf-Life Performance Testing Particulate Evaluation Visual Inspection Dimension Inspection Media Flow Rate Shaft Vacuum/ Leak Test Simulated Use |
5
-
Shaft Burst Pressure
-
Guidewire Compatibility
-
Coating Integrity
6
- Flexibility and Kinking A
-
Corrosion Resistance
-
Torque Strength
-
Tensile Strength
-
Radiopacity
- Biocompatibility testing ●
-
Cytotoxicity
-
Sensitization
-
Intracutaneous Reactivity
-
Acute Systemic Toxicity
-
Hemocompatibility
- Direct and Indirect Hemolysis .
- . Complement Activation (SCb5-9)
- . In vitro Thrombogenicity
-
Material Mediated Pyrogenicity
-
The test results of COREPASS Modular Microcatheter met all acceptance criteria, which are same or similar to the predicate device and reference device. It ensures that the design and construction of COREPASS Modular Microcatheter are suitable for its intended use.
Conclusion: This information supports a determination of substantial equivalence between the COREPASS Modular Microcatheter and the predicate device described above.