(121 days)
No reference predicates were used in this submission.
No
The description focuses on the physical characteristics and function of a delivery catheter, with no mention of AI or ML capabilities.
No.
The "Intended Use" states it is for the "introduction of various types of catheters and pacing or defibrillator leads," which are tools for diagnosis or treatment, but the delivery catheter itself is not performing a therapeutic function.
No
The device description indicates it is used for "introduction of various types of catheters and pacing or defibrillator leads," which suggests an interventional or delivery function, not diagnosis. The "intended use" also reiterates this function.
No
The device description clearly details a physical catheter with various components (dilator, valve, tip) and physical characteristics (diameter, length, curves), indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the introduction of catheters and leads into the body. This is a procedural device used in vivo (within a living organism).
- Device Description: The description details a physical catheter designed for insertion into the vasculature.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVD devices are specifically designed for testing samples outside the body to aid in diagnosis or monitoring. This device is a tool for delivering other medical devices inside the body.
N/A
Intended Use / Indications for Use
The Delivery Catheter is indicated for the introduction of various types of catheters and pacing or defibrillator leads.
Product codes
DQY
Device Description
The Delivery Catheter is a single-use percutaneous catheter intended to introduce various types of catheters and pacing or defibrillator leads.
The Delivery Catheter is packaged with a dilator for introduction into the vasculature. Proximally, the Delivery Catheter is equipped with a hemostatic valve, and the distal soft, rounded, radiopaque tip facilitates imaging under fluoroscopy. The Delivery Catheter is designed to be slittable, thereby allowing its removal after device placement. A variety of curves and lengths are available to accommodate various anatomies and different lead locations. The Delivery Catheter has an inner diameter of 6.5F, an outer diameter of 8F, and the dilator is compatible with a 0.035" guidewire
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
All necessary performance testing has been conducted on the Delivery Catheter to assure substantial equivalence to the predicate devices and to demonstrate the device performs as intended. All testing was performed on test units representative of finished devices. The device passed the following tests: Biocompatibility, Bench testing (including dimensional evaluation, tensile testing, etc.), Simulated Use testing, In Vivo Testing.
Key Metrics
Not Found
Predicate Device(s)
Medtronic C315 Delivery Catheter, K101885
Reference Device(s)
No reference predicates were used in this submission.
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).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 28, 2019 CenterPoint Systems Marybeth Gamber Vice President, Regulatory & Quality 3338 Parkway Blvd West Valley City, Utah 84119
Re: K190475
Trade/Device Name: Delivery Catheter SSPC1, Delivery Catheter SSPC2, Delivery Catheter SSPC3, Delivery Catheter SSPC4 Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: June 4, 2019 Received: June 5, 2019
Dear Marybeth Gamber:
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.
1
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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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,
for
Jessica Paulsen Implantable Electrophysiology Devices Team Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices 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) K190475
Device Name Delivery Catheter
Indications for Use (Describe)
The Delivery Catheter is indicated for the introduction of various types of catheters and pacing or defibrillator leads.
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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5 510(K) SUMMARY
5.1 Submitter
| Name | CenterPoint Systems |
|---|---|
| Address | 3338 Parkway Blvd |
| West Valley City UT | |
| Phone | 877-848-0828 |
| Contact Person: | Marybeth Gamber, Vice President Regulatory Affairs & Quality Assurance |
| Date Prepared: | February 26, 2019 |
5.2 Device
| Name of Device: | Delivery Catheter |
|---|---|
| Common or Usual Name | Delivery Catheter |
| Classification Name: | Catheter, Percutaneous |
| Regulatory Class: | Class II per 21 CFR 870.1250 |
| Product Code: | DQY |
5.3 Predicate Device
Predicate Name and 510(k) Number: Medtronic C315 Delivery Catheter, K101885
This predicate has not been subject to a design-related recall.
No reference predicates were used in this submission.
5.4 Device Description
The Delivery Catheter is a single-use percutaneous catheter intended to introduce various types of catheters and pacing or defibrillator leads.
The Delivery Catheter is packaged with a dilator for introduction into the vasculature. Proximally, the Delivery Catheter is equipped with a hemostatic valve, and the distal soft, rounded, radiopaque tip facilitates imaging under fluoroscopy. The Delivery Catheter is designed to be slittable, thereby allowing its removal after device placement. A variety of curves and lengths are available to accommodate various anatomies and different lead locations. The Delivery Catheter has an inner diameter of 6.5F, an outer diameter of 8F, and the dilator is compatible with a 0.035" guidewire
510(k) Summary
4
Indications for Use ર.5
The Delivery Catheter is indicated for the introduction of various types of catheters and pacing or defibrillator leads.
Comparison of Technological Characteristics with the Predicate Device 5.6
The Proposed Device and Predicate Device are similar in indications for use, intended use, technological characteristics, and principles of operation.
The differences between the Proposed Device and the Predicate Device are minor, thus it was concluded that the Proposed Device is substantially equivalent to the Predicate Device. In accordance with 21CFR807.92(a)(6) a summary of how the technological characteristics of the Proposed Device compares to the Predicate Device is provided below.
| Feature | Delivery Catheter
(proposed device) | Medtronic C315 Delivery
Catheter (K101885) |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|
| Intended Use | Percutaneous catheter for the delivery
of catheters and leads | Same |
| Indications for Use | The Delivery Catheter is indicated for
the introduction of various types of
catheters and pacing or defibrillator
leads. | Same |
| Device Class | Class II | Same |
| Product Code | DQY, 21 CFR 870.1250 | Same |
| Prescription device | Yes | Same |
| Catheter Type | Percutaneous Catheter | Same |
| Guidewire compatibility | 0.035" | Same |
| Catheter Outer Diameter | 8.0F | 7.0F Substantially equivalent |
| Catheter Inner Diameter | 6.5F | 5.4F Substantially equivalent |
| Catheter Length | 30 - 40cm | 20 – 43cm Substantially
equivalent |
| Hydrophilic Liner | Yes | Same |
| Radiopaque Catheter | Yes | Same |
| Distal Tip | | |
| Hemostasis valve | Yes | Same |
| Components Provided | Catheter, Dilator | Same |
| Multiple Distal End | Yes | Same |
| Shapes Available | | |
| Sterility | Provided Sterile | Same |
| Number of uses | Single patient use | Same |
510(k) Summary
5
| Feature | Delivery Catheter
(proposed device) | Medtronic C315 Delivery
Catheter (K101885) |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|
| Principals of Operation | After venous access is gained, the
catheter and dilator are advanced over a
guidewire to the desired location. The
dilator is removed and a catheter or lead
is placed through the Delivery Catheter.
The Delivery Catheter may be removed
by slitting. | Same |
The Delivery Catheter is used for the same intended use in the same anatomical location using the same principles of operation as the predicate device. Therefore, the Delivery Catheter can be considered substantially equivalent to the predicate device.
5.7 Performance Data
All necessary performance testing has been conducted on the Delivery Catheter to assure substantial equivalence to the predicate devices and to demonstrate the device performs as intended. All testing was performed on test units representative of finished devices.
The device passed the following tests, which were conducted in accordance with noted standards:
| Test | Consensus Standard/FDA Guidance/Description |
|---|---|
| Biocompatibility | FDA Final Guidance Document, "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" (June 2016) |
| Bench testing, including dimensional evaluation, tensile testing, etc | Confirm that the device meets intended product specifications |
| Simulated Use testing | Confirm that the device will perform as intended in a simulated environment |
| In Vivo Testing | Confirm the device will perform as intended in an in vivo model. |
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5.8 Conclusions
Upon reviewing the information provided in this submission and comparing the intended use, principle of operation and overall technological characteristics, the Delivery Catheter is substantially equivalent to existing legally marketed devices.
510(k) Summary