(105 days)
No
The summary describes a physical medical device (a central venous catheter) and its materials, dimensions, and intended uses. There is no mention of software, algorithms, data processing, or any terms related to AI or ML. The performance studies are in vitro tests of the physical properties of the catheter.
No.
This device is a central venous catheter used for administering fluids, blood products, and drugs, and for blood withdrawal, not for therapy itself.
No
The device is a central venous catheter designed for administering fluids, blood products, drugs, parenteral nutrition solutions, blood withdrawal, and power injection of contrast media. It is not used to diagnose a medical condition.
No
The device description clearly describes a physical catheter made of polyurethane with various hardware components like lumens, hubs, clamps, and connectors. It also mentions in vitro testing of physical properties. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device for accessing the central venous system for administering fluids, blood products, drugs, parenteral nutrition, blood withdrawal, and power injection of contrast media. These are all procedures performed on the patient's body, not on samples taken from the patient's body to diagnose a condition.
- Device Description: The description details a catheter designed for insertion into a vein. This is a medical device used for direct patient care, not for testing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used in vivo (inside the body) for therapeutic and procedural purposes.
N/A
Intended Use / Indications for Use
The Medcomp PRO-LINE™ CT Power Injectable CVC is indicated for short or long term access to the central venous system. They are designed for administering I.V. fluids, blood products, drugs and parenteral nutrition solutions, as well as blood withdrawal and power injection of contrast media. The maximum recommended infusion rate is 5cc/sec. The maximum pressure of power injectors used with the PRO-LINE™ CT Power Injectable CVC may not exceed 300 psi.
Product codes
LJS
Device Description
The Medcomp® PRO-LINE™ CT Power Injectable CVC's are designed for central venous catheterization. The PRO-LINE™ CT Power Injectable CVC lumen is comprised of a soft radiopaque polyurethane material. The lumen is connected to the extensions via a soft pliable hub with suture wing for secure placement. Cuff attachment to the lumen provides for tissue ingrown. Clamps are provided on the extension tubes to prevent air/fluid communication. Female luer connectors provide the connection for intravenous administration. Purple colorant has been added to the catheter materials to differentiate it from other non-power injectable catheters and identify it as a power injectable catheter. The extensions also are printed with the words power injectable.
The PRO-LINE™ CT Power Injectable CVC's are available in 5F single lumen and 6F double lumen version. The catheters are 60 cm long with depth markings in 5cm increments. Stylet and adaptor sideport is provided to assist in catheter insertion.
The catheter product line is packaged with the necessary accessories to facilitate catheter 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
In vitro testing was performed on the Medcomp PRO-LINE™ CT Power Injectable CVC to assure reliable design and performance in accordance with ISO 10555-1 and 10555-3. Testing includes air/liquid leakage, cuff shear, force at break, elongation, gravity flow, static burst pressure, high pressure injection flow rate and chemical testing.
Clinical studies were not deemed necessary since in vitro testing was sufficient to demonstrate safety and effectiveness by way of comparison to legally marketed predicate device.
Biocompatibility testing on the Medcomp PRO-LINE™ CT Power Injectable CVC demonstrates that the materials used meet the requirements of ISO 10993 for a permanent contact device.
Key Metrics
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
MEDCOMP®
C.R. Bard, Inc. K051417 6Fr DL
PowerHohn™ and PowerLine™ Catheter
A. Submitter Information:
Submitter:
B.
C.
| Contact: | 1499 Delp Drive
Harleysville, PA 19438
(215) 256-4201 Telephone
(215) 256-9191 Fax
Jean Callow
Regulatory Specialist |
|-------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | November 30, 2005 |
| Trade Name: | Medcomp® PRO-LINE™ CT Power
Injectable CVC |
| Common Name: | Catheter, Intravascular, Therapeutic,
Long-Term |
| Classification: | LJS |
| C.F.R. Section: | 880.5970 Class II |
| Predicate Device: | C.R. Bard, Inc. K033389 PowerPICC™
Catheters and |
D. Device Description:
The Medcomp® PRO-LINE™ CT Power Injectable CVC's are designed for central venous catheterization. The PRO-LINE™ CT Power Injectable CVC lumen is comprised of a soft radiopaque polyurethane material. The lumen is connected to the extensions via a soft pliable hub with suture wing for secure placement. Cuff attachment to the lumen provides for tissue ingrown. Clamps are provided on the extension tubes to prevent air/fluid communication. Female luer connectors provide the connection for intravenous administration. Purple colorant has been added to the catheter materials to differentiate it from other non-power injectable catheters and identify it as a power injectable catheter. The extensions also are printed with the words power injectable.
The PRO-LINE™ CT Power Injectable CVC's are available in 5F single lumen and 6F double lumen version. The catheters are 60 cm long with depth markings in 5cm increments. Stylet and adaptor sideport is provided to assist in catheter insertion.
The catheter product line is packaged with the necessary accessories to facilitate catheter insertion.
ட். Intended Use:
The Medcomp PRO-LINE™ CT Power Injectable CVC is indicated for short or long term access to the central venous system. They are designed for administering I.V. fluids, blood products, drugs and parenteral nutrition solutions, as well as blood withdrawal and power injection of contrast media. The maximum recommended infusion rate is 5cc/sec. The maximum pressure of power injectors used with the PRO-LINE™ CT Power Injectable CVC may not exceed 300 psi.
1
K05-3345
The Medcomp PRO-LINE™ CT Power Injectable CVC is substantially equivalent to the predicate devices in terms of intended use, insertion method, anatomical location, design,
performance, labeling, manufacturing process and method of sterilization.
G. Performance Data:
In vitro testing was performed on the Medcomp PRO-LINE™ CT Power Injectable CVC to assure reliable design and performance in accordance with ISO 10555-1 and 10555-3. Testing includes air/liquid leakage, cuff shear, force at break, elongation, gravity flow, static burst pressure, high pressure injection flow rate and chemical testing.
Clinical studies were not deemed necessary since in vitro testing was sufficient to demonstrate safety and effectiveness by way of comparison to legally marketed predicate device.
Biocompatibility testing on the Medcomp PRO-LINE™ CT Power Injectable CVC demonstrates that the materials used meet the requirements of ISO 10993 for a permanent contact device.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three human profiles facing right, with flowing lines above them.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 7 2006
Ms. Jean Callow Regulatory Specialist MedComp 1499 Delp Drive Harleysville, Pennsylvania 19438
Re: K053345
Trade/Device Name: PRO-LINETM CT Power Injectable CVC Regulation Number: 880.5970 Regulation Name: Percutaneous, implanted, long-term intravascular catheter Regulatory Class: II Product Code: LJS Dated: February 17, 2006 Received: February 21, 2006
Dear Ms. Callow:
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 (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.
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
3
Page 2 - Ms. Jean Callow
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 continue 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/dsma/dsmamain.html
Sincerely yours,
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
4
Indications for Use
510(k) Number (if known): 053345
Device Name: PRO-LINE™ CT Power Injectable CVC
Indications for Use: The Medcomp PRO-LINE™ CT Power Injectable CVC is indicated for short or long term access to the central venous system. It is designed for administering 1.V. fluids, blood products, drugs and parenteral nutrition solutions, as well as blood withdrawal and power injection of contrast media. The maximum recommended infusion rate is 5cc/sec. The maximum pressure of power injectors used with the PRO-LINE™ CT Power Injectable CVC may not exceed 300 psi.
Prescription Use X (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)
Antony U.m
Pathology, General Hospital
Processed Dental Devices
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