(14 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and traditional bench testing of a catheter, with no mention of AI or ML.
Yes
The device is intended to provide venous access for infusing medication, nutritional therapy, or blood therapy, which are all therapeutic interventions designed to treat or manage a patient's condition.
No
Explanation: The device is a catheter designed for venous access to infuse medications, nutritional therapy, or blood therapy, and for blood sampling. Its intended use focuses on therapeutic and sampling functions, not on diagnosing medical conditions.
No
The device description clearly details a physical catheter made of silicone elastomer with various hardware components (lumens, luer lock connectors, extension legs, clamps, suture wings, stylet). It is a tangible medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is for providing venous access to infuse medications, nutritional therapy, or blood therapy, and for blood sampling. These are all procedures performed on the patient's body, not on samples taken from the patient's body for diagnostic purposes.
- Device Description: The description details a catheter designed for insertion into the central venous system. This is a medical device used for treatment and access, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze biological samples (blood, urine, tissue, etc.) to diagnose a condition, monitor a disease, or determine compatibility.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or treatment decisions. This device is a tool for delivering substances into the body and taking samples from the body, not for analyzing those samples.
N/A
Intended Use / Indications for Use
The intended use of the Silicone Dual Lumen RadPICC Catheter is to provide venous access to infuse intravenous medication, nutritional therapy, or blood therapy.
The Indications for use is: The silicone RadPICC is indicated for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling. For blood therapy, utilize the larger lumen.
Product codes (comma separated list FDA assigned to the subject device)
LJS
Device Description
The RadPICC® catheters are open-ended dual lumen catheters that are made of soft silicone elastomer containing barium sulfate throughout the tubing for enhanced radiopacity.
. The RadPICC® catheters are 5, 6 Fr dual lumen x 60 cm usable length. The catheter lumens are nonsymmetrical rounded D shape for maximized flow and mechanical properties.
. The proximal end of the RadPICC catheters consists of two luer lock connectors, glued compression sleeves, clear silicone extension legs for visibility during use and non-removable mini thumb clamps. The extension legs are pre-printed with the lumen gauge size. The extension legs are molded into the bifurcation. StatLock® compatible suture wings are molded into the bifurcation to facilitate easy, secure placement. The bifurcation is embossed with identification text.
. The proximal end of the catheter tubing has a stepped strain relief that minimizes the potential for kinking at the catheter tubing / strain relief interface. The tubing is pre-molded into the bifurcation with a "0" mark that serves as a reference for the catheter insertion point. The catheter can be inserted up to the "0" mark, which is sized to the exit site, thereby allowing the clinician to "plug" the insertion site.
. The catheter tubing has depth markings in centimeter increments originating from the proximal end and running the full length of the catheter.
. A stand-along hydrophilic stylet is provided as a kit components and is loaded by the clinician during the placement procedure.
Catheters are provided sterile with kit components preferred by interventional radiologists.
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 according to the "Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters", dated 3/16/95, and corresponding ISO Standards. The tests included: Dimensions, Flow rate, Tensile (Tensile strength of catheter body, extension leg to hub attachment, extension leg to bifurcation, bifurcation to catheter body), Catheter stiffness (modulus), Catheter elongation, Leak (Leakage at hub, Leak at hub with burst, Catheter assembly leak), Catheter burst pressure (Assembly, Extension leg, Extension leg after clamping, Catheter shaft tubing), Catheter collapse, Catheter flexural fatigue tolerance, Priming volume, Radiopacity, Biocompatibility. Additional tests performed were Creep, Stylet withdrawal force, and Kink resulting in decreased flow. The results met the requirements and were similar to the predicate device. The Silicone RadPICC catheters met all the predetermined performance criteria of design verification.
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
Image /page/0/Picture/0 description: The image shows a sequence of alphanumeric characters, specifically "K030255". The characters are bold and appear to be handwritten or in a font that mimics handwriting. The characters are all uppercase, and the numbers are clearly distinguishable.
Silicone RadPICC 510(k)
Section 6
FEB 0 7 2003
Silicone Dual Lumen RadPICC Catheter
510(k) Summary of Safety and Effectiveness Information 21 CFR 807.92
Submitter Information 1 .
| Submitter Name: | Bard Access Systems, Inc. (Subsidiary of C.R. Bard, Inc.) |
|---|---|
| Address: | 5425 W. Amelia Earhart Drive Salt Lake City, UT 84116 |
| Telephone Number: | (801) 595-0700, Ext. 4903 |
| Fax Number: | (801) 595-5425 |
| Contact Person: | Peggy Keiffer |
| Date of Preparation: | December 27, 2002 |
Device Name 2.
| Device Name: | Silicone Dual Lumen RadPICC® Catheter |
|---|---|
| Trade Name: | RadPICC® Catheter |
| Common/Usual Name: | Peripherally Inserted Central Catheter (PICC) |
| Classification Name: | Class II, 80 LJS - Long Term Intravascular Catheter |
| 21 CFR 880.5970 | |
| Classification Panel: | General Hospital |
3 Predicate Device Name:
| Device Name: | Per-Q-Cath and Per-Q-Cath Dual Lumen PICC Catheter |
|---|---|
| Trade Name: | Per-Q-Cath and Per-Q-Cath Dual Lumen Catheter, Trays and |
| accessory devices | |
| Common/Usual Name: | Peripherally Inserted Central Venous Catheter (PICC) |
| Classification Name: | Class II, 80 LJS - Long Term Intravascular Catheter |
| Classification Panel: | General Hospital |
6. Device Description
The device description of the subject Silicone Dual Lumen RadPICC Catheter is as follows:
- The RadPICC® catheters are open-ended dual lumen catheters that are made of soft silicone elastomer containing barium sulfate throughout the tubing for enhanced radiopacity.
- . The RadPICC® catheters are 5, 6 Fr dual lumen x 60 cm usable length. The catheter lumens are nonsymmetrical rounded D shape for maximized flow and mechanical properties.
- . The proximal end of the RadPICC catheters consists of two luer lock connectors, glued compression sleeves, clear silicone extension legs for visibility during use and non-removable mini thumb clamps. The extension legs are pre-printed with the lumen gauge size. The extension legs are molded into the bifurcation. StatLock® compatible suture wings are molded into the bifurcation to facilitate easy, secure placement. The bifurcation is embossed with identification text.
000023
1
- . The proximal end of the catheter tubing has a stepped strain relief that minimizes the potential for kinking at the catheter tubing / strain relief interface. The tubing is pre-molded into the bifurcation with a "0" mark that serves as a reference for the catheter insertion point. The catheter can be inserted up to the "0" mark, which is sized to the exit site, thereby allowing the clinician to "plug" the insertion site.
- . The catheter tubing has depth markings in centimeter increments originating from the proximal end and running the full length of the catheter.
- . A stand-along hydrophilic stylet is provided as a kit components and is loaded by the clinician during the placement procedure.
- Catheters are provided sterile with kit components preferred by interventional radiologists. .
5. Intended Use and Indication for Use
The intended use of the Silicone Dual Lumen RadPICC Catheter is to provide venous access to infuse intravenous medication, nutritional therapy, or blood therapy.
The Indications for use is: The silicone RadPICC is indicated for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling. For blood therapy, utilize the larger lumen.
6. Technological Characteristics Summary:
6.1 Does the new device have the same indication statement?
Yes, with minor modification.
6.2 Does the new device have the same technological characteristics, e.g. design, material, etc.?
Not in all regards. The Silicone RadPICC catheters have some minor differences from the predicate Per-Q-Cath PICC catheters. However, the basic fundamental scientific technology of the catheter has not changed.
6.3 Could the new characteristics affect safety or effectiveness?
Yes. The integrity of the minor design changes and materials could affect the safety or effectiveness of the device.
6.4 Do accepted characteristics raise new types of safety and effectiveness questions?
No. There are no new issues of safety and effectiveness.
6.5 Do accepted scientific methods exist for assessing effects of the new characteristics?
Yes. The FDA's "Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters", dated 3/16/95, and corresponding ISO Standards were used to evaluate the device's performance.
Biocompatibility meets the requirements of ISO-10993, "Biological Evaluation of Medical Devices Part-1: Evaluation and Testing" and the FDA Modified ISO 10993 Test Profile for externally communicating blood contacting long term devices.
6.6 Are performance data available to assess effects of new characteristics?
Yes. Bench testing was performed according to the above referenced guidance and standards. The results met the requirements and were similar to the predicate device.
2
Are performance data available to assess effects of new characteristics? 6.7
Yes. Performance data demonstrate that the silicone dual lumen RadPICC Catheter is substantially equivalent to the predicate Per-Q-Cath PICC Catheter, K954104.
Performance Data (if applicable). 6.8
The following Catheter guidance tests were performed in accordance with "Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters", dated 3/16/95:
- Dimensions .
- Flow rate ●
- Tensile: .
- Tensile strength of catheter body
- . Tensile strength of extension leg to hub attachment (luer connector) Tensile strength of extension leg to bifurcation
- Tensile strength of bifurcation to catheter body
- . Catheter stiffness (modulus) ●
- . Catheter elongation
- Leak: ●
- Leakage at hub Leak at hub with burst Catheter assembly leak
- . Catheter burst pressure: Assembly Extension leg Extension leg after clamping Catheter shaft tubing
- . Catheter collapse
- Catheter flexural fatigue tolerance .
- Priming volume .
- Radiopacity .
- Biocompatibility .
The following additional tests were performed:
- . Creep
- . Stylet withdrawal force
- Kink resulting in decreased flow .
The following catheter guidance tests were NOT required for this product change:
- Catheter tip (distal) attachment strength (there is no tip attachment) .
Conclusion 6.9
The Silicone RadPICC catheters met all the predetermined performance criteria of design verification. Based on FDA's decision tree, the silicone RadPICC catheters are substantially equivalent to the predicate device, the Per-Q-Cath PICC catheters, K954104, concurrence date November 21, 1995.
000031
3
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of a human figure with its head tilted back, with three lines representing the body. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 0 7 2003
C.R. Bard, Incorporated Ms. Peggy Keiffer Senior Regulatory Affairs Manager Bard Access Systems, Incorporated 5425 West Amelia Earhart Drive Salt Lake City, Utah 84116
Re: K030255
Trade/Device Name: Silicone Dual Lumen RadPICC® Catheter Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous Implanted, Long-term IntravascularCatheter Regulatory Class: II Product Code: LJS Dated: January 23, 2003 Received: January 24, 2003
Dear Ms. Keiffer:
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.
4
Page 2 - Ms. Keiffer
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 (OS) 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 vour 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 (301) 594-4618. 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/dsma/dsmamain.html
Sincerely vours.
Susan Gunser
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Section 1.2
Silicone Dual Lumen RadPICC® Catheter 510(k)
INDICATION(S) FOR USE STATEMENT*
I state in my capacity as Senior Regulatory Affairs Manager of Bard Access Systems, that this notification [510(k)] for the following devices, Silicone Dual Lumen RadPICC Catheters, are indicated for the following:
The RadPICCs are indicated for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling. For blood therapy, utilize the larger lumen.
Signature of 510(k) Submitter:
Quggy Arff
Printed Name of Submitter: Peggy Keiffer
Date:
1.03
*Suggested language and format to meet the requirements of sections 513(i) of the Federal Food, Drug, and Cosmetic Act, as amended, and sections 807.92(a)(5) and 801.4 of the Code of Federal Regulations, Title 21.
Concurrence of Office of Device Evaluation
OR
510(k) Number
Division Sign-Off Office of Device Evaluation
Prescription Use
Over-The-Counter Use
Patricio Cucent
510(k) Number: KD30253
000000