(115 days)
Not Found
No
The 510(k) summary describes a physical medical device (a catheter) and its performance characteristics. There is no mention of software, algorithms, image processing, AI, ML, or any related concepts. The performance studies are bench tests evaluating physical properties.
No.
This device is a catheter used for accessing the central venous system for various medical procedures, including intravenous therapy, blood sampling, infusion, contrast media injection, and central venous pressure monitoring. While these procedures are part of medical treatment, the catheter itself does not directly treat or diagnose a disease or condition; it is a tool for delivering or withdrawing substances or monitoring physiological parameters.
Yes
The device is indicated for "central venous pressure monitoring," which is involved in assessing the health and function of the cardiovascular system, thus serving a diagnostic purpose.
No
The device description clearly outlines a physical catheter made of radiopaque polyurethane, with specific dimensions and features, and the performance studies involve bench tests on physical properties. There is no mention of software as the primary or sole component of the device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use of this device is to provide access to the central venous system for therapy, sampling, infusion, and monitoring within the patient's body.
- The device description and performance studies focus on the physical properties and functionality of the catheter itself. They do not describe any tests or analyses performed on biological samples.
- The intended use clearly describes a medical device used for direct patient care.
This device is a medical device, specifically a catheter, used for therapeutic and diagnostic purposes in vivo (within a living organism).
N/A
Intended Use / Indications for Use
The Arrow International Pressure Injectable PICC is intended for short-term or long-term peripheral access to the central venous system for intravenous therapy and blood sampling.
The 6 Fr. Triple Lumen Pressure Injectable Peripherally Inserted Central Catheter is indicated for short-term or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, power injection of contrast media, and allows for central venous pressure monitoring. The maximum pressure of power injector equipment used with the pressure injectable PICC may not exceed 300 psi.
Product codes
LJS
Device Description
The Pressure Injectable Peripherally Inserted Central Catheters have the following characteristics:
- Radiopaque polyurethane catheters
- 6 Fr Triple Lumen BlueFlex® Tip
- Usable length of catheters are 40 cm to 55 cm
- Catheters are provided in sterile kit configurations
- The 6 Fr BlueFlex® Tip catheter is labeled for "6 ml/sec, pressure injectable" on the Luer hub to facilitate the proper use of the device
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)
The following tests were performed to demonstrate substantial equivalence:
- Liquid Leakage Under Pressure
- Air Leakage During Aspiration
- Air Leakage Under Pressure
- Catheter and Blue Flex Tip Stiffness
- Catheter Collapse
- . Tensile Testing
- Catheter Radiopacity
- Non-Pressure Injectable Lumen Static Burst Pressure
- Repeat Pressure Injection
- Static Burst Pressure under power injection
- Central Venous Pressure Monitoring .
The Arrow International Pressure Injectable PICC met performance criteria of the safety and effectiveness tests performed based on FDA recognized standards and guidance. The results of bench tests demonstrate that Arrow's PICC's are as safe and effective as compared to the predicate Arrow International Pressure Injectable PICC (K073451) and Bard Access Systems, 6 Fr Triple Lumen PowerPICC® (K053501) and Central Venous Pressure Monitoring (K051991).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(k) Summary
JUN 2 7 2008
Arrow International, Inc. 2400 Bernville Road Reading, PA 19605-9607 USA
Contact person: Julie Lawson Regulatory Affairs Specialist Phone: 610-378-0131 Fax: 610-478-3172 Email: julie.lawson@teleflexmedical.com February 29, 2008 Date summary prepared:
Device trade name:
Pressure Injectable Peripherally Inserted Central Catheter (21 CFR 880.5970, Product Code LJS)
PICC Device common name:
Device classification name: Catheter, intravascular, therapeutic, long-term greater than 30 days
Arrow International's Peripherally Inserted Central Legally marketed devices Catheter (K073451) and Bard Access Systems, 6 Fr Triple Lumen which the device is PowerPICC® (K053501) and Central Venous Pressure substantially equivalent: Monitoring (K051991).
Description of the device:
The Pressure Injectable Peripherally Inserted Central Catheters have the following characteristics:
- Radiopaque polyurethane catheters ●
- 6 Fr Triple Lumen BlueFlex® Tip t
- Usable length of catheters are 40 cm to 55 cm
- Catheters are provided in sterile kit configurations �
- The 6 Fr BlueFlex® Tip catheter is labeled for "6 ml/sec, � pressure injectable" on the Luer hub to facilitate the proper use of the device
Intended use of the device:
The Arrow International Pressure Injectable PICC is intended for short-term or long-term peripheral access to the central venous system for intravenous therapy and blood sampling.
1
Performance tests:
The following tests were performed to demonstrate substantial equivalence:
1080604
- Liquid Leakage Under Pressure .
- Air Leakage During Aspiration .
- Air Leakage Under Pressure ●
- Catheter and Blue Flex Tip Stiffness .
- Catheter Collapse .
- . Tensile Testing
- Catheter Radiopacity
- Non-Pressure Injectable Lumen Static Burst Pressure .
- Repeat Pressure Injection ●
- Static Burst Pressure under power injection .
- Central Venous Pressure Monitoring .
The Arrow International Pressure Injectable PICC met performance criteria of the safety and effectiveness tests performed based on FDA recognized standards and guidance. The results of bench tests demonstrate that Arrow's PICC's are as safe and effective as compared to the predicate Arrow International Pressure Injectable PICC (K073451) and Bard Access Systems, 6 Fr Triple Lumen PowerPICC® (K053501) and Central Venous Pressure Monitoring (K051991).
Arrow International's 6 Fr. Triple Lumen Pressure Injectable Peripherally Inserted Central Catheter (PICC) has the same intended use as the predicate device, Arrow International's PICC. Based on the assessment of non-clinical performance data, Arrow International's Pressure Injectable Peripherally Inserted Central Catheter (PICC) is substantially equivalent to the legally marketed predicate devices.
Assessment of non-clinical performance data:
Summary:
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" around the perimeter. In the center of the logo is an abstract symbol that resembles an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 7 2008
Ms. Juie Lawson Regulatory Affairs Specialist Arrow International, Incorporated 2400 Bernville Road Reading, Pennsylvania 19605-9607
Re: K080604
Trade/Device Name: Pressure Injectable PICC Regulation Number: 21 CFR 880.5970 Regulation Name: Percutancous, Implanted, Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: June 5, 2008 Received: June 9, 2008
Dear Ms. Lawson:
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 such 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. Lawson
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Cers
Chiu Lin, Ph.D. 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 Statement
510(k) Number: K 08()(004
Device Name: 6 French Triple Lumen Pressure Injectable PICC
Indications For Use:
The 6 Fr. Triple Lumen Pressure Injectable Peripherally Inserted Central Catheter is indicated for short-term or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, power injection of contrast media, and allows for central venous pressure monitoring. The maximum pressure of power injector equipment used with the pressure injectable PICC may not exceed 300 psi.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR ·
Over-The-Counter Use (21CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE)
fo for APN
(Divisible Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K680604