(223 days)
The ArrowEVOLUTION™ Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology is indicated for short-term or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, pressure injection of contrast media, and allows for central venous pressure monitoring. The maximum pressure of pressure injector equipment used with the ArrowEVOLUTION™ Pressure Injectable PICC may not exceed 300 psi.
Chlorag+ard Technology treatment on the external surface of the catheter body as well as the entire fluid pathway of the catheter has been shown to be effective in reducing microbial colonization and thrombus accumulation on catheter surfaces. Antimicrobial and antithrombogenic effectiveness were evaluated using in vitro and in vivo test methods and no correlation between these testing methods and clinical outcome has currently been ascertained. It is not intended to be used for the treatment of existing infections or vein thrombosis.
The ArrowEVOLUTIONTM Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology is a short-term or long-term, single use catheter designed to provide access to the central venous system. It consists of a non-tapered, radiopaque polyurethane extruded catheter body with a softer, contoured Blue Flex Tip. The catheter is available in 4.5 Fr. single lumen and 5.5 Fr. double lumen configurations with usable lengths of 40 - 5 5 em. The catheters can be used for the injection of contrast media. The maximum recommended infusion rate is 5 rnL/sec. The external catheter body and the internal fluid path of the device are treated with Chlorhexidine based solution technology. Studies have shown the technology to possess both antimicrobial and antithrombogenic properties. The catheters will be packaged sterile in both nursing and radiology configurations. Both configurations will include components to facilitate insertion.
This is a 510(k) premarket notification for a medical device (PICC). It does not appear to describe a study proving the device meets acceptance criteria in the format requested. The document primarily focuses on establishing substantial equivalence to predicate devices based on non-clinical testing (in vitro and in vivo animal studies) for antithrombogenic effectiveness, and antimicrobial properties.
Therefore, I cannot provide the specific information requested in points 1 through 9 because the provided text does not contain details of a clinical study with acceptance criteria and reported device performance in terms of metrics like sensitivity, specificity, or reader improvement with AI.
The document states:
- Nonclinical Testing: "In vitro and in vivo testing was performed to assess the antithrombogenic effectiveness of the proposed device. Testing included in vitro thrombogenicity (platelet adhesion) and patency and in vivo animal studies comparing the proposed device and the predicate Zeus device. The ArrowEVOLUTION™ catheter performed as well as or better than the Zeus predicate device in both in vitro testing making the proposed device substantially equivalent to the Zeus predicate in terms of technological performance."
- No Correlation to Clinical Outcome: "Antimicrobial and antithrombogenic effectiveness were evaluated using in vitro and in vivo test methods and no correlation between these testing methods and clinical outcome has currently been ascertained."
This indicates that the evaluation was primarily based on laboratory and animal studies, not a human clinical trial that would typically define acceptance criteria based on performance metrics against a ground truth established by experts.
Summary of available information relevant to your request, but not meeting all points:
- Study described: Non-clinical (in vitro and in vivo animal studies) comparing the proposed device to a predicate device (Zeus™ CT PICC, K083763).
- Purpose of study: To assess antithrombogenic effectiveness and support substantial equivalence.
- Outcome: The proposed device performed "as well as or better than" the predicate device in in vitro testing.
- Ground Truth: In this context, the "ground truth" would be the direct measurement of thrombogenicity (platelet adhesion) or patency in the laboratory/animal models, rather than a clinical outcome or expert consensus on images.
- No human-in-the-loop or standalone AI: This is a physical medical device, not an AI/software device.
{0}------------------------------------------------
MAY 1 0 201
Image /page/0/Picture/2 description: The image shows the logo for Arrow International. The word "ARROW" is in large, bold, white letters on a black background. Below "ARROW" is the word "INTERNATIONAL" in smaller, white letters.
510(k) SUMMARY
SUMMARY OF SAFETY AND EFFECTIVENESS FOR ARROWEVOLUTIONT!It PRESSURE INJECTABLE PICC WITH CHLORAG+ARD ANTIMICROBIAL AND ANTITHROMBOGENIC TECHNOLOGY
1. Submitter Information
| Name: | Arrow International, Inc (subsidiary ofTeleflex Inc.) |
|---|---|
| Address: | 2400 Bernville Road |
| Reading, PA 19605-9607 | |
| Telephone Number: | (610) 378-0131 |
| Contact Person: | Tracy Maddock |
| Regulatory Affairs Specialist | |
| Telephone Number: | (610) 378-0131 Extension 3384 |
| Fax Number: | (610) 374-5360 |
| Email: | tracy.maddock@teleflex.com |
- Date Prepared: September 30, 2011
-
- Device Narne
| Device Trade Name: | AnowEVOLUTION™ Pressure Injectable PICC with Chlorag+ardAntimicrobial and Antithrombogenic Technology |
|---|---|
| Common Name: | Peripherally Inserted Central Catheter |
| Classification Name: | Percutaneous, implanted, long-term intravascular catheter(21 CFR 880.5970, Product Code LJS) |
3. Predicate Devices
Predicate 1: Arrow Antimicrobial Pressure Injectable PICC (K100635) Predicate 2: PICC 4 Fr and 5 Fr Single and Dual Lumen (K083763)
4. Device Description
The ArrowEVOLUTIONTM Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology is a short-term or long-term, single use catheter designed to provide access to the central venous system. It consists of a non-tapered, radiopaque polyurethane extruded catheter body with a softer, contoured Blue Flex Tip. The catheter is available in 4.5 Fr. single lumen and 5.5 Fr. double lumen configurations with usable lengths of 40 - 5 5 em. The catheters can be used for the injection of contrast media. The maximum recommended infusion rate is 5 rnL/sec. The external catheter body and the internal fluid path of the device are treated with Chlorhexidine based solution technology. Studies have shown the technology to possess both antimicrobial and antithrombogenic properties.
{1}------------------------------------------------
The catheters will be packaged sterile in both nursing and radiology configurations. Both configurations will include components to facilitate insertion.
5. Indications for Use
The ArrowEVOLUTION™ Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology is indicated for short-term or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, pressure injection of contrast media, and allows for central venous pressure monitoring. The maximum pressure of pressure injector equipment used with the An owEVOLUTION™ Pressure Injectable PICC may not exceed 300 psi.
Chlorag+ard Technology treatment on the external surface of the catheter body as well as the entire fluid pathway of the catheter has been shown to be effective in reducing microbial colonization and thrombus accumulation on catheter surfaces. Antimicrobial and antithrombogenic effectiveness were evaluated using in vitro and in vivo test methods and no correlation between these testing methods and clinical outcome has currently been ascertained. It is not intended to be used for the treatment of existing infections or vein thrombosis.
6. Technological Characteristics and Substantial Equivalence
The ArrowEVOLUTION™ Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology is the same device as the Arrow Antimicrobial Pressure Injectable PICC cleared in KI00635. The indications for use for the proposed catheter are the same with the addition of the proposed catheter's effectiveness in reducing thrombus accumulation on catheter surfaces. In vitro and in vivo testing support this added performance claims.
The ArrowEVOLUTION™ Pressure Injectable PICC with Chlorageard Antimicrobial and Antithrombogenic Technology is substantially equivalent to the PICC (K083763) in terms of intended use, principles of operation, and technological performance. The Zeus™ CT PICCs coating reduces the risk of thrombus adhering to the catheter. The coating on the Arrow EVOLUTION has also been shown to provide a reduction in thrombus accumulation and has been shown to be as safe and effective as the Zeus™ CT PICC in comparative in vitro and in vivo performance testing.
7. Nonclinical Testing
In vitro and in vivo testing was performed to assess the antithrombogenic effectiveness of the proposed device. Testing included in vitro thrombogenicity (platelet adhesion) and patency and in vivo animal studies comparing the proposed device and the predicate Zeus device. The ArrowEVOLUTION™ catheter performed as well as or better than the Zeus predicate device in both in vitro testing making the proposed device substantially equivalent to the Zeus predicate in terms of technological performance.
{2}------------------------------------------------
8. Conclusions
The results of all testing performed on the ArrowEVOLUTION™ Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology device demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the predicate devices. The proposed device is therefore substantially equivalent to the cited predicate devices.
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Tracy Maddock Regulatory Affairs Specialist Arrow International (subsidiary of Teleflex Inc.) 2400 Bernville Road Reading, Pennsylvania 19605
MAY 1 0 2012
Re: K112896
Trade/Device Name: ArrowEVOLUTION™Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: April 26, 2012 Received: April 27, 2012
Dear Ms. Tracy Maddock:
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. 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.
{4}------------------------------------------------
Page 2 - Ms. Maddock
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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
λh for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
Indications for Use
510(k) Number (ifkuown): K112896
Device Name: ArrowEVOLUTION™ Pressure Injectable PICC with Chlorageard Antimicrobial and Antithrombogenic Technology
Indications for Use:
The ArrowEVOLUTION™ Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology is indicated for short-term or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, pressure injection of contrast media, and allows for central venous pressure monitoring. The maximum pressure of pressure injector equipment used with the ArrowEVOLUTION™ Pressure Injectable PICC may not exceed 300 psi.
Chlorag+ard Technology treatment on the external surface of the catheter body as well as the entire fluid pathway of the catheter has been shown to be effective in reducing microbial colonization and thrombus accumulation on catheter surfaces. Antimicrobial and antithrombogenic effectiveness were evaluated using in vitro and in vivo test methods and no correlation between these testing methods and clinical outcome has currently been ascertained. It is not intended to be used for the treatment of existing infections or vein thrombosis.
Prescription Use _ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use ,----(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence ofCDRH, Office of Device Evaluation (ODE)
Alil C. Ch 5/10/12
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Page I of _
510(k) Number: K112896
§ 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.”