(65 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a catheter, with no mention of AI or ML technologies.
No.
This device is a delivery catheter intended for the introduction of other devices (pacing or defibrillation leads) into the body, rather than directly providing a therapeutic effect itself.
No
The device is a delivery catheter intended for the venous introduction of pacing or defibrillation leads. Its function is to facilitate the placement of other medical devices, not to diagnose a medical condition.
No
The device description clearly outlines a physical catheter with various components (dilator, hemostatic valve, radiopaque tip) and mentions physical testing (tensile tests, dimensional verification), indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body (in vitro).
- Device Function: The description clearly states the device is a "Delivery Catheter" intended for the "venous introduction of pacing or defibrillation leads." This is a device used within the body (in vivo) to facilitate a medical procedure.
- Lack of Diagnostic Testing: There is no mention of this device being used to analyze samples or provide diagnostic information. Its purpose is purely procedural.
The information provided describes a medical device used for a therapeutic or procedural purpose, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Delivery Catheter is intended for the venous introduction of pacing or defibrillation leads.
Product codes
DQY
Device Description
The modified Delivery Catheter (SSPC NXT Delivery Catheter) is a single-use percutaneous catheter intended for venous introduction of pacing or defibrillation leads.
The modified Delivery Catheter is packaged with a dilator for introduction into the vasculature. Proximally, the modified Delivery Catheter is equipped with a hemostatic valve, and the distal soft, rounded, radiopaque tip facilitates imaging under fluoroscopy. The modified 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 locations.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
venous
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 SSPC NXT 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:
- Biocompatibility testing per 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" (2023)
- Sterilization validation per ISO 11137
- Packaging validation per ANSI/AAMI/ISO 11607-1
- Visual Inspection
- Simulated use testing, including use/compatibility with ancillary devices
- Valve liquid leak test
- Tensile tests
- Sheath and Dilator Dimensional verification, including OD/ID, working length
- Flush test
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
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December 4, 2024
CenterPoint Systems LLC Conner Johnson Senior Regulatory Specialist 3338 Parkway Blvd West Valley City, Utah 84119
Re: K243180
Trade/Device Name: SSPC NXT Delivery Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: September 30, 2024 Received: November 4, 2024
Dear Conner Johnson:
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.
1
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).
Your device is also subject to, among other requirements, the Quality System (OS) 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 QS 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 Rule"). 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-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 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-regulatory
2
assistance/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,
Jessica L. Batista -S
for
Sara Royce Assistant Director 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
3
Indications for Use
Submission Number (if known)
Device Name
SSPC NXT Delivery Catheter
Indications for Use (Describe)
The Delivery Catheter is intended for the venous introduction of pacing or defibrillation 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)
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K243180 510(k) Summary
1.1 Submitter
| Name | CenterPoint Systems LLC |
|---|---|
| Address | 3338 Parkway Blvd |
| West Valley City UT | |
| Phone | 801-602-1923 |
| Contact Person: | Conner Johnson, Senior Regulatory Specialist |
| Date Prepared: | 30 September 2024 |
1.2 Device
| Name of Device: | SSPC NXT Delivery Catheter |
|---|---|
| Classification Name: | Percutaneous Catheter |
| Regulatory Class: | Class II per 21 CFR 870.1250 |
| Product Code: | DQY |
1.3 Predicate Device
Predicate Name and 510(k) Number: SSPC Delivery Catheter, K190475
This predicate has not been subject to a design-related recall.
1.4 Device Description
The modified Delivery Catheter (SSPC NXT Delivery Catheter) is a single-use percutaneous catheter intended for venous introduction of pacing or defibrillation leads.
The modified Delivery Catheter is packaged with a dilator for introduction into the vasculature. Proximally, the modified Delivery Catheter is equipped with a hemostatic valve, and the distal soft, rounded, radiopaque tip facilitates imaging under fluoroscopy. The modified 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 locations.
1.5 Indications for Use
The Delivery Catheter is intended for the venous introduction of pacing or defibrillation leads.
5
Comparison of Technological Characteristics with the Predicate Devices 1.6
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 and raise no different questions of safety and effectiveness. 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 | Modified Delivery
Catheter (proposed
device) | Primary Predicate:
SSPC Delivery Catheter
(K190475) | Same / Different between
Proposed & Predicates |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------|
| Intended Use | Percutaneous catheter for
the delivery of leads | Percutaneous catheter for
the delivery of catheters
and leads | Substantially equivalent |
| Indications for Use | The Delivery Catheter is
intended for the venous
introduction of pacing or
defibrillation leads | The Delivery Catheter is
intended for the
introduction of various
types of catheters and
pacing or defibrillator
leads. | Substantially equivalent |
| 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 | 40cm, 42cm, 45cm | 40cm | Substantially Equivalent |
| Components
Provided | Catheter, Dilator | Catheter, Dilator | Same |
| Hydrophilic Liner | Yes | Yes | Substantially Equivalent |
| Feature | Modified Delivery
Catheter (proposed
device) | Primary Predicate:
SSPC Delivery Catheter
(K190475) | Same / Different between
Proposed & Predicates |
| Radiopaque Distal
Tip | Yes | Yes | Same |
| Valve | Yes | Yes | Same |
| Shaft Materials | Vestamid and PEBAX
with Barium Sulfate and
colorants | PEBAX with Barium
Sulfate and colorants | Substantially Equivalent |
| Braid
Reinforcement | Yes | Yes | Same |
| Dilator | Yes | Yes | Same |
| Note: As discussed in the
"Differences" section
below, the new models
include new lengths of
dilators to accommodate the
increased lengths of the
Delivery Catheter | | | |
| 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 |
| Principles 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 |
6
The modified Delivery Catheter is used for the same intended use in the same anatomical location using the same principles of operation as the predicate device.
7
1.7 Performance Data
All necessary performance testing has been conducted on the SSPC NXT 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:
- Biocompatibility testing per 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" (2023)
- Sterilization validation per ISO 11137 ●
- Packaging validation per ● ANSI/AAMI/ISO 11607-1
- Visual Inspection ●
- . Simulated use testing, including use/compatibility with ancillary devices
- Valve liquid leak test ●
- Tensile tests .
- . Sheath and Dilator Dimensional verification, including OD/ID, working length
- Flush test .
8
1.8 Conclusions
Based on the similarity of the subject and predicate devices in terms of the intended use, principle of operation and overall technological characteristics, and the results of the testing summariezed in section 1.7, the modified Delivery Catheter is substantially equivalent to the predicate device.