(65 days)
The Delivery Catheter is intended for the venous introduction of pacing or defibrillation leads.
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.
The FDA 510(k) summary for the SSPC NXT Delivery Catheter (K243180) outlines performance testing to ensure substantial equivalence to its predicate device.
1. Table of Acceptance Criteria and Reported Device Performance:
| Feature/Test | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Complies with ISO 10993-1 | SSPC NXT Delivery Catheter passed biocompatibility testing. |
| Sterilization Validation | Complies with ISO 11137 (SAL 10-6) | SSPC NXT Delivery Catheter passed sterilization validation (E-Beam Sterilization, SAL 10-6). |
| Packaging Validation | Complies with ANSI/AAMI/ISO 11607-1 | SSPC NXT Delivery Catheter passed packaging validation. |
| Visual Inspection | Device meets specified visual requirements | SSPC NXT Delivery Catheter passed visual inspection. |
| Simulated Use Testing (with ancillary devices) | Device performs as intended during simulated use and is compatible with ancillary devices. | SSPC NXT Delivery Catheter passed simulated use testing, including use/compatibility with ancillary devices. |
| Valve Liquid Leak Test | Valve prevents liquid leakage | SSPC NXT Delivery Catheter passed valve liquid leak test. |
| Tensile Tests | Device components withstand specified tensile forces | SSPC NXT Delivery Catheter passed tensile tests. |
| Sheath and Dilator Dimensional Verification (OD/ID, working length) | Dimensions conform to specifications | SSPC NXT Delivery Catheter passed sheath and dilator dimensional verification. |
| Flush Test | Device allows proper flushing | SSPC NXT Delivery Catheter passed flush test. |
| Intended Use | "For the venous introduction of pacing or defibrillation leads" | Same as predicate; device is for venous introduction of pacing or defibrillation leads. |
| Technological Characteristics | Substantially equivalent to predicate (K190475) | Proposed device is "substantially equivalent" to predicate given minor differences do not raise different questions of safety/effectiveness. |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the numerical sample size for each specific test set. It mentions tests were performed on "test units representative of finished devices."
The provenance of the data is internal to the manufacturer (CenterPoint Systems LLC), as these are performance data generated to support the 510(k) submission. The type of study is a pre-market performance validation study for regulatory clearance. It is retrospective in the sense that the data is collected prior to the submission, but it's a prospective testing program for the purpose of demonstrating device safety and effectiveness.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not provided in the document. The document describes engineering and biological performance tests, not clinical studies involving human experts to establish ground truth in the context of diagnostic accuracy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable to the type of performance testing described (engineering, mechanical, biocompatibility). These tests usually have objective pass/fail criteria based on standards and specifications, rather than requiring expert adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No, an MRMC comparative effectiveness study was not done. This device is a delivery catheter, not an AI-assisted diagnostic or imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No, a standalone algorithm performance study was not done. This device is a physical medical device (catheter), not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the performance tests described (biocompatibility, sterilization, mechanical, dimensional) are the established industry standards (e.g., ISO 10993-1, ISO 11137, ANSI/AAMI/ISO 11607-1) and internal design specifications for the device. For example, for tensile tests, the ground truth is the specified tensile strength the device must meet according to its design requirements.
8. The sample size for the training set:
Training set information is not applicable as this is a physical medical device, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for this device.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged in a circular pattern. To the right of the seal, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on top and "ADMINISTRATION" below. The logo is simple and professional, reflecting the FDA's role in regulating food and drugs.
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)
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:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"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."
{4}------------------------------------------------
K243180 510(k) Summary
1.1 Submitter
| Name | CenterPoint Systems LLC |
|---|---|
| Address | 3338 Parkway BlvdWest 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 DeliveryCatheter (proposeddevice) | Primary Predicate:SSPC Delivery Catheter(K190475) | Same / Different betweenProposed & Predicates |
|---|---|---|---|
| Intended Use | Percutaneous catheter forthe delivery of leads | Percutaneous catheter forthe delivery of cathetersand leads | Substantially equivalent |
| Indications for Use | The Delivery Catheter isintended for the venousintroduction of pacing ordefibrillation leads | The Delivery Catheter isintended for theintroduction of varioustypes of catheters andpacing or defibrillatorleads. | 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 |
| GuidewireCompatibility | 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 |
| ComponentsProvided | Catheter, Dilator | Catheter, Dilator | Same |
| Hydrophilic Liner | Yes | Yes | Substantially Equivalent |
| Feature | Modified DeliveryCatheter (proposeddevice) | Primary Predicate:SSPC Delivery Catheter(K190475) | Same / Different betweenProposed & Predicates |
| Radiopaque DistalTip | Yes | Yes | Same |
| Valve | Yes | Yes | Same |
| Shaft Materials | Vestamid and PEBAXwith Barium Sulfate andcolorants | PEBAX with BariumSulfate and colorants | Substantially Equivalent |
| BraidReinforcement | Yes | Yes | Same |
| Dilator | Yes | Yes | Same |
| Note: As discussed in the"Differences" sectionbelow, the new modelsinclude new lengths ofdilators to accommodate theincreased lengths of theDelivery Catheter | |||
| Multiple Distal EndShapes Available | Yes | Yes | Same |
| Sterility | E-Beam Sterilization, SAL10-6 | E-Beam Sterilization, SAL10-6 | Same |
| Number of Uses | Single patient use | Single patient use | Same |
| Principles ofOperation | After venous access isgained, the catheter anddilator are advanced over aguidewire to the desiredlocation. The dilator isremoved and a catheter orlead is placed through theDelivery Catheter. TheDelivery Catheter may beremoved by slitting. | After venous access isgained, the catheter anddilator are advanced over aguidewire to the desiredlocation. The dilator isremoved and a catheter orlead is placed through theDelivery Catheter. TheDelivery Catheter may beremoved 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.
§ 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).