(227 days)
Not Found
No
The description focuses on the physical characteristics and intended uses of a catheter, with no mention of AI or ML.
No
The device is a peripherally inserted central catheter (PICC) used for intravenous therapy, blood sampling, infusion, and contrast media injection. It facilitates access to the central venous system but does not itself provide a therapeutic effect.
No
The device is a peripherally inserted central catheter (PICC) used for intravenous therapy, blood sampling, infusion, contrast media injection, and central venous pressure monitoring. While it monitors central venous pressure, it does not analyze or interpret information to diagnose a condition.
No
The device description clearly states it is a catheter, which is a physical hardware component. The summary also describes bench testing of the catheter's ability to monitor pressure, further indicating it is a hardware device.
Based on the provided information, the ArrowADVANTAGE TM Pressure Injectable PICC is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- The ArrowADVANTAGE TM Pressure Injectable PICC is a catheter designed for direct access to the central venous system within the body. Its purpose is to deliver substances (intravenous therapy, contrast media), withdraw substances (blood sampling), and monitor pressure within the body.
The device's function is to interact directly with the patient's circulatory system, not to analyze samples taken from the patient.
N/A
Intended Use / Indications for Use
The ArrowADVANTAGE TM Pressure Injectable PICC is indicated for short-term or longterm 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 ArrowADVANTAGE TM Pressure Injectable PICC may not exceed 300 psi.
Product codes (comma separated list FDA assigned to the subject device)
LJS
Device Description
The ArrowADVANTAGE TM Pressure Injectable PICC 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 Fr. single lumen and 5 Fr. double lumen configurations with usable lengths of 40 - 55 cm. The catheters can be used for the injection of contrast media. The maximum recommended infusion rate for the distal lumen is 5 mL/sec.
The catheters will be packaged sterile in both nursing and radiology configurations. Both configurations will include components to facilitate insertion.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
central venous system
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)
Bench testing was performed to demonstrate the ability of the proposed ArrowADVANTAGE TM Pressure Injectable PICC to effectively monitor for Central Venous Pressure.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.”
0
JUN 2 1 2012
Image /page/0/Picture/1 description: The image shows the logo for Arrow International. The word "ARROW" is in large, bold, white letters on a black background. Below the word "ARROW" is the word "INTERNATIONAL" in smaller, white letters. The logo is simple and clean, and it is likely used to represent a company or organization.
5. 510(K) SUMMARY
1. Submitter Information
| Name: | Arrow International, Inc (subsidiary of Teleflex 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) 478-3179 |
| Email: | tracy.maddock@teleflex.com |
November 4, 2011
2. Device Name
Date Prepared:
| Device Trade Name: | ArrowADVANTAGE TM Pressure Injectable Peripherally
Inserted Central Catheter (PICC) |
|----------------------|---------------------------------------------------------------------------------------------------|
| Common Name: | Peripherally Inserted Central Catheter |
| Classification Name: | Percutaneous, implanted, long-term intravascular catheter |
3. Predicate Devices
| Predicate 1: Pressure Injectable PICC (K061289) |
|---|
| Predicate 2: Pressure Injectable PICC V2.0 (K073451) |
| Predicate 3: 6F 3L Pressure Injectable PICC (K080604) |
4. Device Description
The ArrowADVANTAGE TM Pressure Injectable PICC 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 Fr. single lumen and 5 Fr. double lumen configurations with usable lengths of 40 - 55 cm. The catheters can be used for the injection of contrast media. The maximum recommended infusion rate for the distal lumen is 5 mL/sec.
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 ArrowADVANTAGE *** Pressure Injectable PICC is indicated for short-term or long-term peripheral access to the central venous system for intravenous therapy,
1
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 ArrowADVANTAGE TM Pressure Injectable PICC may not exceed 300 psi.
6. Technological Characteristics and Substantial Equivalence
The ArrowADVANTAGE TM Pressure Injectable PICC has the same indications for use, principles of operation and technological characteristics making it substantially equivalent to the Arrow predicate devices.
7. Nonclinical Testing
Bench testing was performed to demonstrate the ability of the proposed ArrowADVANTAGE TM Pressure Injectable PICC to effectively monitor for Central Venous Pressure.
8. Conclusions
Comparative analysis of technological characteristics between proposed and predicate devices and results of verification testing performed demonstrate that the subject device is substantially equivalent to the legally marketed predicate PICC devices. Any differences between the proposed and predicate devices do not raise new issues of safety and effectiveness.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUN 2 1 2012
Ms. Tracy Maddock Regulatory Affairs Specialist Arrow International, Inc. 2400 Bernville Rd. Reading, PA 19605
Re: K113277
Trade/Device Name: Arrow Advantages JM Pressure Injectable Peripherally Inserted Central Catheter (PICC)
Regulation Number: 21 CFR 880.5970
Regulation Name: Percutaneous, implanted, long-term intravascular catheter Regulatory Class: II Product Code: LJS Dated: June 12, 2012 Received: June 13, 2012
Dear Ms. 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 approvisions 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.
3
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/CDRH0ffices/ 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,
h 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
4
Indications for Use
510(k) Number (if known):
Device Name: ArrowADVANTAGE TM Pressure Injectable Peripherally Inserted Central Catheter (PICC)
Indications for Use:
The ArrowADVANTAGES TM Pressure Injectable PICC is indicated for short-term or longterm 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 ArrowADVANTAGE TM Pressure Injectable PICC may not exceed 300 psi.
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 of CDRH, Office of Device Evaluation (ODE)
2012 (Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
14113277 510(k) Number:
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