(132 days)
SINC Support Catheters are intended to be used in conjunction with steerable guidewires to access discrete regions of the peripheral vasculature. They may be used to facilitate placement and exchange of guidewires and other interventional devices, and provide a conduit for delivery of saline solutions or diagnostic/ therapeutics agents.
The SINC™ (Selective Interventional Navigation Catheter) Support Catheters are single lumen catheters designed to access peripheral vasculature. These catheters are available in a variety of lengths and offer a side port. Each configuration has a braided support matrix and hydrophilic coating on the distal segment of the catheter. The distal tip is clearly distinguished by a radiopaque gold coated tip.
The SINC Support Catheters will also allow for exchange of guidewires and other interventional devices and provide a conduit for delivery of saline solutions or diagnostic contrast.
The provided text is a 510(k) summary for the Reflow Medical SINC Support Catheter. It outlines the device description, indications for use, and a comparison to a predicate device. However, it does not include information about a study proving the device meets acceptance criteria related to a standalone AI algorithm's performance, human-in-the-loop performance, or the nuances of AI model development (training/test sets, ground truth establishment, expert adjudication).
The document focuses on the physical and mechanical performance of the catheter itself, demonstrating substantial equivalence to a predicate device through non-clinical laboratory testing. The types of tests mentioned are:
- Simulated Use Testing
- Dimensional Verification
- Leak Testing
- Bond Integrity
- Component Integrity
- Corrosion Testing
- Kink Resistance
- Torque Testing
- Particulate
- Catheter Flow Rate and Burst Testing
- Lubricity Characterization
- Packaging Testing
- Design Validation
These tests are standard for medical devices like catheters to ensure their mechanical safety and functionality, not for AI/ML performance.
Therefore, I cannot provide accurate answers to most of your questions as they pertain to an AI/ML device study, which is not described in the given text.
However, I can extract information relevant to the device's mechanical performance to show what "acceptance criteria" and "performance" are mentioned for this type of device:
1. A table of acceptance criteria and the reported device performance
The document states: "The SINC™ Support Catheter met all specified criteria and did not raise new safety and performance questions." While specific quantitative acceptance criteria and reported values for each test (e.g., "Kink Resistance: Passed 1N force without kinking") are not detailed in this summary, the general statement indicates successful performance against pre-defined criteria for each test listed.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| All Specified Criteria | Met all specified criteria |
| Safety and Performance | Did not raise new safety and performance questions |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable to the non-clinical, mechanical testing described. The "test set" here refers to the physical units of the SINC Support Catheter used for the various lab tests (e.g., a certain number of catheters were subjected to torque testing, burst testing, etc.). The document does not specify the number of units tested for each category, nor is "data provenance" (country/retrospective/prospective) relevant to lab-based mechanical tests.
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 is not applicable. "Ground truth" in this context refers to the successful completion or failure of mechanical tests according to engineering specifications, not expert interpretation of medical images or patient outcomes. The "experts" would be the engineers and technicians conducting and evaluating the specified physical/mechanical tests according to established international standards (like ISO 10555-1, referenced in the document). Their qualifications would be in engineering, materials science, or related fields, not medical imaging.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing consensus on medical image interpretations or clinical outcomes, typically when ground truth is subjective or challenging to obtain. For mechanical tests, the results (e.g., pass/fail, measurable physical properties) are typically objective and determined by the test protocol itself.
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
Not applicable. No MRMC study was performed as this is a medical device (catheter), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. No standalone algorithm performance was assessed as this is a medical device (catheter), not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the mechanical tests listed, the "ground truth" is defined by the pass/fail criteria of the specified engineering and performance tests, often based on international standards (like ISO 10555-1 mentioned in the document) and the device's design specifications. For example, a "kink resistance" test would have an objective threshold for what constitutes a "kink" and the maximum force the catheter must withstand without kinking.
8. The sample size for the training set
Not applicable. This device does not involve a "training set" in the machine learning sense. The "training" for such a device involves its design, manufacturing processes, and quality control.
9. How the ground truth for the training set was established
Not applicable.
In summary, the provided document details the regulatory clearance of a physical medical device (a catheter) and its mechanical performance testing. It does not describe an AI/ML device or a study involving AI performance metrics or human-AI interaction.
{0}------------------------------------------------
February 8, 2024
Image /page/0/Picture/1 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, 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.
Reflow Medical, Inc. Lori Grace Sr. Director Regulatory Affairs 208 Avenida Fabricante #100 San Clemente, California 92672
Re: K233350
Trade/Device Name: SINC Support Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: January 12, 2024 Received: January 12, 2024
Dear Lori Grace:
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" (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).
{1}------------------------------------------------
2
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.
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-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,
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
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K233350
Device Name SINC Support Catheter
Indications for Use (Describe)
SINC Support Catheters are intended to be used in conjunction with steerable guidewires to access discrete regions of the peripheral vasculature. They may be used to facilitate placement and exchange of guidewires and other interventional devices, and provide a conduit for delivery of saline solutions or diagnostic/ therapeutics agents.
| 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."
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the logo for Reflow Medical. The logo consists of a blue, heart-shaped design made up of interconnected circles. Below the design, the words "REFLOW MEDICAL" are written in a bold, sans-serif font.
510(k) Summary (21 CFR 807.92)
The following 510(k) Summary is submitted in accordance with the requirements of 21 CFR 807.92:
| 510(k) Summary: | K233350 |
|---|---|
| Sponsor/Submitter: | ReFlow Medical, Inc. |
| 208 Avenida Fabricante, Suite 100 | |
| San Clemente, CA 92672 | |
| Contact Person: | Ms. Lori Grace |
| Sr. Director, Regulatory Affairs | |
| lgrace@reflowmedical.com | |
| 612-749-6031 | |
| Date Prepared: | January 25, 2024 |
| Device Trade Name(s): | SINCT™ Support Catheter |
| Common Name: | Percutaneous Catheter |
| Device Classification: | Class II |
| Regulation Number: | 21 CFR 870.1250 |
| Classification Name: | Catheter, Percutaneous |
| Product Code: | DQY |
| Primary Predicate Device: NAME | spex LP |
| Secondary Predicate Device: NAME | Not applicable |
Device Description
The SINC™ (Selective Interventional Navigation Catheter) Support Catheters are single lumen catheters designed to access peripheral vasculature. These catheters are available in a variety of lengths and offer a side port. Each configuration has a braided support matrix and hydrophilic coating on the distal segment of the catheter. The distal tip is clearly distinguished by a radiopaque gold coated tip.
The SINC Support Catheters will also allow for exchange of guidewires and other interventional devices and provide a conduit for delivery of saline solutions or diagnostic contrast.
Indications for Use
The SINC™ Support Catheters are intended to be used in conjunction with steerable guidewires to access discrete regions of the peripheral vasculature. They may be used to facilitate placement and exchange of guidewires and other interventional devices and provide a conduit for delivery of saline solutions or diagnostic/ therapeutics agents.
Indications for Use Comparison
The SINC™ Support Catheter indications for use are identical to the predicate device indications for use.
{4}------------------------------------------------
REFLOW MEDICAL
Technological Comparison
The SINC™ Support Catheter is nearly identical to the predicate device platform (spex LP, K200094). Like the predicate device, the SINC™ Support Catheter is intended for use in the peripheral vasculature to facilitate placement and exchange of guidewires. .
The subject and predicate devices are based on the following identical technological elements:
- all delivered to the target site using an over-the-wire percutaneous technique .
- . all have a through lumen to allow passage and exchange of guidewires
- all have a smooth inner lumen to provide reduced friction for guidewire movement .
- . all have a polymer catheter shaft with specific geometry to control the torque and push movements associated with lesion crossing
The following technological differences exist between the subject and predicate devices:
- The distal tip of the SINC support catheter has been modified to include a side port. ●
Non-Clinical and/or Clinical Tests Summary & Conclusions
The following performance data were provided in support of the substantial equivalence (reference ISO 10555-1).
- Simulated Use Testing
- Dimensional Verification ●
- Leak Testing
- Bond Integrity
- Component Integrity
- Corrsion Testing
- Kink Resistance
- Torque Testing
- Particulate
- Catheter Flow Rate and Burst Testing
- Lubricity Characterization ●
- Packaging Testing
- Design Validation ●
The SINC™ Support Catheter met all specified criteria and did not raise new safety and performance questions. Based on the performance testing, the SINC™ Support Catheter was found to have a safety and effectiveness profile that 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).