(27 days)
Not Found
No
The description focuses on the physical characteristics and function of a catheter for delivering other devices, with no mention of AI or ML capabilities.
No.
The device is a delivery catheter, which is used to introduce other catheters or leads, but it does not provide any therapeutic effect itself.
No
The device is described as a "Delivery Catheter" indicated for "introduction of various types of catheters and pacing or defibrillator leads," which suggests an interventional or procedural role rather than a diagnostic one.
No
The device description clearly describes a physical catheter and associated hardware components (dilator, valve, tip). There is no mention of software as the primary or sole component.
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 various types of catheters and pacing or defibrillator leads." This describes a device used in vivo (within the body) for delivering other medical devices.
- Device Description: The description details a physical catheter designed for percutaneous insertion into the vasculature. It mentions features like a hemostatic valve, radiopaque tip for imaging, and compatibility with a guidewire. These are characteristics of devices used directly on patients, not for testing samples in vitro.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely for the delivery of other medical devices within 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. The proposed modified Delivery Catheter include introduction of new models which incorporate different curves and lengths, which are available to accommodate various anatomies. The proposed Delivery Catheter has an inner diameter of 7F, an outer diameter of 9F, 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
All necessary performance testing has been conducted on the Proposed Device to assure substantial equivalence to the predicate device and to demonstrate the device performs as intended. All performance testing was conducted in accordance with well-established methods, with data that can be reviewed in a summary. All testing was performed on test units representative of finished devices.
The proposed 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" (2020) |
| Bench testing, including sterile barrier testing, dimensional evaluation, and destructive/tensile testing | Confirm that the proposed changes to the device meet intended product specifications |
| Simulated Use testing | Confirm that the proposed changes to the device will perform as intended in a simulated environment |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
CenterPoint Systems SSPC Delivery Catheter, K190475
Reference Device(s)
Not Found
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 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 in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
March 9, 2023
CenterPoint Systems LLC Marybeth Gamber VP. Regulatory & Ouality 3338 Parkway Blvd West Valley City, Utah 84119
Re: K230363
Trade/Device Name: CPS Locator 3D Delivery Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: DOY Dated: February 8, 2023 Received: February 10, 2023
Dear Marybeth Gamber:
We have reviewed vour 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.
1
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 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 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.
Hetal-B. Patel -S
Hetal Odobasic Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known)
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)
Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
6 510(K) SUMMARY
6.1 Submitter
| Name | CenterPoint Systems LLC |
|---|---|
| Address | 3338 Parkway Blvd |
| West Valley City UT | |
| Phone | 877-848-0828 |
| Contact Person: | Marybeth Gamber, Vice President Regulatory Affairs & Quality Assurance |
| Date Prepared: | 08 February, 2023 |
6.2 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 |
6.3 Predicate Device
Predicate Name and 510(k) Number: CenterPoint Systems SSPC Delivery Catheter, K190475
This predicate has not been subject to a design-related recall.
No reference predicates were used in this submission.
Device Description 6.4
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. The proposed modified Delivery Catheter include introduction of new models which incorporate different curves and lengths, which are available to accommodate various anatomies. The proposed
510(k) Summary
4
Delivery Catheter has an inner diameter of 7F, an outer diameter of 9F, and the dilator is compatible with a 0.035" guidewire.
6.5 Indications for Use
The Delivery Catheter is indicated for the introduction of various types of catheters and pacing or defibrillator leads.
The indications for use statement is identical to the predicate device.
6.6 Comparison of Technological Characteristics with the Predicate Device
The Proposed Device and Predicate Device are identical in indications for use, intended use, and principals of operation, and similar in technological characteristics.
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
| Feature | Proposed Delivery Catheter | Predicate Delivery Catheter
(K190475) | Comparison between
Proposed & Predicate
Devices |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|
| Intended Use | Percutaneous catheter for the
delivery of catheters and leads | 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. | The Delivery Catheter is
indicated for the introduction of
various types of catheters and
pacing or defibrillator leads. | Same |
| Product Code | DQY | DQY | Same |
| Regulation
number | 21 CFR 870.1250 | 21 CFR 870.1250 | Same |
| Prescription
Device | Yes | Yes | Same |
| Catheter Type | Percutaneous Catheter | Percutaneous Catheter | Same |
| Guidewire
Compatibility | 0.035" | 0.035" | Same |
| Outer Diameter | 9.0F | 8.0F | Substantially
Equivalent |
| Inner Diameter | 7F | 6.5F | Substantially
Equivalent |
| Working
Length | 42cm, 45cm | 40cm | Substantially
Equivalent |
| Components
Provided | Catheter, Dilator | Catheter, Dilator | Same |
| Hydrophilic
Liner | Yes | Yes | Same |
| Radiopaque
Distal Tip | Yes | Yes | Same |
| Valve | Yes | Yes | Same |
21CFR807.92(a)(6) a summary of how the technological characteristics of the Proposed Device compares to the Predicate Device is provided below.
510(k) Summary
5
| Feature | Proposed Delivery Catheter | Predicate Delivery Catheter
(K190475) | Comparison between
Proposed & Predicate
Devices |
|--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|
| Braid
reinforcement | Yes | Yes | Same |
| Dilator | Yes | Yes | Same |
| Multiple Distal
End Shapes
Available | Yes | Yes | Same |
| Sterility | E-Beam sterilization, SAL 10-6 | E-Beam sterilization, SAL 10-6 | Same. |
| Number of uses | Single patient use | Single Patient Use | Same |
| 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. | 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 Proposed Device is used for the same intended use in the same anatomical location using the same principles of operation as the predicate device. Therefore, the Proposed Device can be considered substantially equivalent to the predicate device.
Performance Data 6.7
All necessary performance testing has been conducted on the Proposed Device to assure substantial equivalence to the predicate device and to demonstrate the device performs as intended. All performance testing was conducted in accordance with well-established methods, with data that can be reviewed in a summary. All testing was performed on test units representative of finished devices.
The proposed 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" (2020) | |
| Bench testing, including sterile | |
| barrier testing, dimensional | |
| evaluation, and | |
| destructive/tensile testing | Confirm that the proposed changes to the device meet |
| intended product specifications |
6
| Test | Consensus Standard/FDA Guidance/Description |
|---|---|
| Simulated Use testing | Confirm that the proposed changes to the device will |
| perform as intended in a simulated environment |
6.8 Conclusions
Upon reviewing the information provided in this submission and comparing the intended use, principle of operation and overall technological characteristics, the Proposed Delivery Catheter is substantially equivalent to existing legally marketed devices.
510(k) Summary