(139 days)
The r4 Pherocious 14 apheresis triple lumen catheter is designed for short and long term (>30 days) apheresis, intravenous infusion, blood sampling and CECT via the jugular veins or subclavian vein. The maximum recommended flow rate is 5 ml/sec for power injection of contrast media. The maximum pressure of the power injector utilized should not exceed 300 psi.
The r4 Vascular, Inc Pherocious™ is a family of apheresis triple lumen catheters designed to perform apheresis, intravenous infusion, blood sampling and power injection. The catheters, made of radiopaque polyurethane tubing are inserted via jugular, subclavian or femoral veins. Pherocious™ has a kink resistant, atraumatic, staggered tip design. The lumen with the purple connector, extension leg, and clamp may be used for CT injection as denoted by the text, "power injectable," printed on the extension leg. The remaining lumens with the red and blue connectors and blue and red or white clamps are for blood products. The catheters include female luer locking adapters and a tissue ingrowth cuff for fixing the catheters in a subcutaneous tunnel. The Pherocious™ kit includes a catheter and introduction components. The catheter is supplied sterile and non-pyrogenic. The Pherocious 110 product line has catheters in 10.5 Fr and 12.5 Fr triple lumen. The catheters come in a variety of lengths for patient specificity. The Pherocious 10 is similar to Bard TriFusion with the addition of the ability to CECT inject that is substantially equivalent to the Zeus.
The provided text describes a 510(k) premarket notification for the r4 Vascular, Inc. Pherocious™ intravascular catheter. The submission asserts substantial equivalence to predicate devices and includes information about performance testing.
However, the provided text does not contain the specific details required to fully address all parts of your request, particularly regarding acceptance criteria and a detailed study report for AI/machine learning device performance. This document is for a medical device (catheter), not specifically an AI/ML diagnostic or prognostic tool. Therefore, the questions related to AI device performance (MRMC studies, standalone performance, training set, experts for ground truth) are not applicable or cannot be answered from this text.
Here's the information that can be extracted and a clear indication of what is missing based on your request:
1. Table of Acceptance Criteria and Reported Device Performance:
The document broadly states:
| Performance Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Overall Performance | Met established criteria of safety and effectiveness | "Met all established acceptance criteria for performance testing and design verification testing." |
| CECT Injection Flow Rate | Maximum recommended flow rate 5 ml/sec | The device is designed for this flow rate. |
| CECT Injection Pressure | Maximum pressure not to exceed 300 psi | The device is designed for this pressure. |
| Biocompatibility | Requirements according to ISO-10993 Part 1 for externally communicating, blood-contacting, long-term devices | Test profiles for these requirements will be met. (Implies met, but no specific data presented) |
| Standards Compliance | ISO 10555-1:1997, ISO 594, ISO 10993 | "Testing was based on FDA guidance documents and recognized standards... and other standards were used to determine the appropriate methods for evaluating the device's performance." "Pherocious™ met the performance criteria of safety and effectiveness testing performed." |
Missing Information:
- Specific numerical acceptance criteria for each test performed (e.g., tensile strength, flow resistance, leakage rates, etc.).
- Detailed quantitative results of the device performance against each specific criterion. The document only provides a high-level qualitative statement that criteria were met.
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "Performance testing was generated in accordance with the above referenced guidance document and standards."
However, no specific sample size for a test set (e.g., number of catheters tested) is provided.
No information on data provenance (e.g., country of origin, retrospective/prospective) is available, as this is a physical medical device, not a data-driven diagnostic.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. This document describes a physical medical device (catheter) evaluation, not a study involving expert-established ground truth for an AI/ML algorithm.
4. Adjudication Method for the Test Set:
Not applicable. As above, this is for a physical device, not an AI/ML algorithm requiring expert adjudication of results.
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. This section describes a physical medical device. No AI component is mentioned, and therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed or reported.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. The device is a physical catheter, not an algorithm.
7. The Type of Ground Truth Used:
For a physical device like a catheter, "ground truth" typically refers to established engineering principles, material science specifications, and performance requirements outlined in recognized standards (e.g., ISO, FDA guidance documents). For instance, burst pressure, tensile strength, flow rates, and biocompatibility are measured against predefined acceptable limits. The document states:
- "Testing was based on FDA guidance documents and recognized standards to evaluate the devices' performance."
- Referenced standards include: FDA's Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters, ISO 10555-1:1997, ISO 594, ISO 10993 Part 1.
8. The Sample Size for the Training Set:
Not applicable. This relates to AI/ML devices. The Pherocious™ is a physical catheter, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As above, this is for a physical device, not an AI/ML algorithm.
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K 09 2010
SECTION 5
510(K) SUMMARY
NOV 1 8 2009
SUBMITTER:
r4 Vascular, Inc. 7550 Meridian Circle Suite 150 Maple Grove, Minnesota 55369
ESTABLISHMENT REGISTRATION NUMBER:
3006242715
CONTACT:
| Laurie Lewandowski | |
|---|---|
| Director, Quality and Regulatory Affairs | |
| Telephone: | (612) 770-4038 (cell) |
| Telephone: | (763) 494-8400 (office) |
| Fax: | (763) 494-8484 |
| Email: | lalew@r4vascular.com |
DATE PREPARED:
ENTER DATE
· NAME OF MEDICAL DEVICE:
| Proprietary Name: | Pherocious 1M |
|---|---|
| Regulation Name: | Percutaneous, implanted, long-term intravascular catheter |
| Common/Usual Name: | Long Term Intravascular Catheter |
| DEVICE CLASSIFICATION: | |
| Classification Panel: | General Hospital |
| Regulatory Class: | II |
| Product Code: | ו וצ |
| Regulation Number: | 21 CFR 880.5970 |
| PREDICATE DEVICES: | |
| Proprietary Name: | Hickman Long-Term Central Venous Catheter, Bard HickmanTriFusion |
| Common/Usual Name: | Long-Term Intravascular Catheter |
| Proprietary Name:Common/Usual Name: | Zeus™ CT PICCPeripherally Inserted Central Catheter (PICC), single and doublelumen |
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KO42040
DEVICE DESCRIPTION:
The r4 Vascular, Inc Pherocious™ is a family of apheresis triple lumen catheters designed to perform apheresis, intravenous infusion, blood sampling and power injection. The catheters, made of radiopaque polyurethane tubing are inserted via jugular, subclavian or femoral veins. Pherocious™ has a kink resistant, atraumatic, staggered tip design. The lumen with the purple connector, extension leg, and clamp may be used for CT injection as denoted by the text, "power injectable," printed on the extension leg. The remaining lumens with the red and blue connectors and blue and red or white clamps are for blood products. The catheters include female luer locking adapters and a tissue ingrowth cuff for fixing the catheters in a subcutaneous tunnel. The Pherocious™ kit includes a catheter and introduction components. The catheter is supplied sterile and non-pyrogenic.
The Pherocious 110 product line has catheters in 10.5 Fr and 12.5 Fr triple lumen. The catheters come in a variety of lengths for patient specificity.
The Pherocious 10 is similar to Bard TriFusion with the addition of the ability to CECT inject that is substantially equivalent to the Zeus.
INTENDED USE/INDICATION FOR USE:
The r4 Pherocious 10 apheresis triple lumen catheter is designed for short and long term (>30 days) apheresis, intravenous infusion, blood sampling and CECT via the jugular veins or subclavian vein. The maximum recommended flow rate is 5 ml/sec for power injection of contrast media. The maximum pressure of the power injector utilized should not exceed 300 psi.
TECHNOLOGICAL COMPARISON TO PREDICATE DEVICES:
New Device is compared to Marketed Device? Yes, it is compared to legally marketed predicates.
Does the New Device have the same indication statements? Substantially equivalent
Do the differences alter the intended therapeutic/diagnostic/etc. effect (i.e., deciding may consider impact on safety and effectiveness)? No, difference do not alter the intended use of the device
Does the New Device have the same technological characteristics, e.g., design, material, etc. ? Not in all regards. The principal of operation and basic design are the same as the predicate devices. The third lumen has been designed to enable CECT injection in addition to fluid delivery. CECT injection is substantially equivalent in performance to the Zeus CT PICC, one of the predicates.
Could the new characteristics affect safety or effectiveness? Yes. The changes may affect safety and effectiveness of the device.
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Do the new characteristics raise new types of safety and effectiveness questions? No. There are no new types of safety and effectiveness questions raised.
Do accepted scientific methods exist for assessing effects of the new characteristics?
Yes. Testing was based on FDA guidance documents and recognized standards to evaluate the devices' performance.
- The FDA's Guidance on Premarket Notification [510(k)] Submission for Short-Term and . Long-Term Intravascular Catheters, dated 3/16/95 was used to determine the appropriate methods for evaluating the device's performance.
- ISO 10555-1:1997 Sterile, Single-use Intravascular Catheters, General requirements; .
- ISO 594 Conical fittings with a 6% (Luer) taper for syringes, needles, and certain other . medical equipment-Part1: General requirements
- ISO 10993 Biological Evaluation of Medical Devices Part-1: Evaluation and Testing ●
Biocompatibility requirements according to of ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing. Test profiles for externally communicating, bloodcontacting, long-term devices will be met.
These and other standards were used to determine the appropriate methods for evaluating the device's performance.
Are performance date available to assess effects of new characteristics? Yes. Performance testing was generated in accordance with the above referenced guidance document and standards.
Do performance data demonstrate equivalence? Yes. Performance data gathered in design verification testing demonstrate that the Pherocious 100 met the performance criteria of safety and effectiveness testing performed and based on the FDA's decision tree is substantially equivalent to the noted predicate devices.
CONCLUSIONS
The Pherocious 10 met all established acceptance criteria for performance testing and design verification testing. This testing demonstrated that the Pherocious™ is safe and effective for its intended use, and based on FDA's decision tree is substantially equivalent to the predicate devices.
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Image /page/3/Picture/0 description: The image shows a logo for the U.S. Department of Health and Human Services. The logo includes a stylized graphic of an eagle or other bird-like figure. The text "HUMAN SERVICES USA" is arranged in an arc above the graphic. The word "DEPARTMENT" is also visible on the right side of the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
Ms. Laurie Lewandowski Director, Quality and Regulatory Affairs R4 Vascular, Incorporated 7550 Meridian Circle North, Suite 150 Maple Grove, Minnesota 55369
NOV 1 8 2009
K092040 Re: Trade/Device Name: Pherocious™ Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: November 5, 2009 Received: November 6, 2009
Dear Ms. Lewandowski:
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. 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.
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.
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Page 2 - Ms. Lewandowski
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Susan Power
Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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SECTION 4
INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Device Name:
Pherocious™
Indications for Use:
The r4 Pherocious 14 apheresis triple lumen catheter is designed for short and long term (>30 days) apheresis, intravenous infusion, blood sampling and CECT via the jugular veins or subclavian vein. The maximum recommended flow rate is 5 ml/sec for power injection of contrast media. The maximum pressure of the power injector utilized should not exceed 300 psi.
Prescription Use: X AND/OR Over-the-Counter Use: Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Cinthen Dinn
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K992940
§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.
(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”