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 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.

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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Medcomp® PRO-LINE™ CT Power Injectable CVC:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Test Performed	Acceptance Criteria (Implied)	Reported Device Performance
Mechanical Performance	Air/Liquid Leakage	No air/liquid leakage	Reliable design and performance (met)
	Cuff Shear	Sufficient cuff integrity	Reliable design and performance (met)
	Force at Break	Sufficient strength	Reliable design and performance (met)
	Elongation	Appropriate flexibility/durability	Reliable design and performance (met)
	Gravity Flow	Adequate flow rate	Reliable design and performance (met)
	Static Burst Pressure	Withstand specified pressure	Reliable design and performance (met)
	High Pressure Injection Flow Rate	Maximum infusion rate of 5cc/sec and pressure of 300 psi	Reliable design and performance (met); specifically designed for these parameters
Biocompatibility	Biocompatibility Testing	Meet requirements of ISO 10993 for permanent contact device	Materials meet ISO 10993 requirements

Key takeaway for Table: The document states that testing was performed in accordance with ISO 10555-1 and 10555-3 for mechanical performance, and ISO 10993 for biocompatibility. These ISO standards inherently contain the "acceptance criteria" for various tests, which the device is reported to have met. The document, however, does not explicitly list the numerical or qualitative acceptance criteria for each specific test (e.g., "burst pressure must be >X psi"), but rather states that the device "assure[s] reliable design and performance" and "demonstrates that the materials used meet the requirements."

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: The document does not specify the exact sample size for the in vitro tests. It only mentions "in vitro testing was performed."
Data Provenance: The data is from in vitro testing. No country of origin is mentioned, as it's not clinical data. The study is not applicable as retrospective or prospective given it's laboratory testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

Not Applicable. This information is for clinical studies. The study described is an in vitro study, meaning it was conducted in a lab setting and relied on standardized test methods (ISO standards) rather than expert interpretation of clinical data. Therefore, there was no "ground truth" established by human experts in the context of this submission.

4. Adjudication Method for the Test Set:

Not Applicable. As this was an in vitro mechanical and biocompatibility study, there was no adjudication method involving multiple human reviewers or experts. The results would be based on instrument readings and adherence to pre-defined test protocols within the ISO standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No. An MRMC study was not conducted. The document explicitly states: "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."

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done:

Not Applicable. This device is a physical medical device (catheter), not an algorithm or AI system. Therefore, the concept of "standalone algorithm performance" is not relevant.

7. The Type of Ground Truth Used:

Standardized Test Results/Compliance with ISO Standards. For the in vitro tests, the "ground truth" was established by the methodologies and pass/fail criteria outlined in the relevant ISO standards (ISO 10555-1, 10555-3, and ISO 10993). The device's performance was measured against these predefined, objective standards.

8. The Sample Size for the Training Set:

Not Applicable. This is not an AI or machine learning device. There is no concept of a "training set." The testing involved physical samples of the catheters.

9. How the Ground Truth for the Training Set Was Established:

Not Applicable. As there is no training set for this type of device, no ground truth needed to be established in that context.

Summary

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MEDCOMP®

C.R. Bard, Inc. K051417 6Fr DL

PowerHohn™ and PowerLine™ Catheter

A. Submitter Information:

Submitter:

Contact:	1499 Delp DriveHarleysville, PA 19438(215) 256-4201 Telephone(215) 256-9191 FaxJean CallowRegulatory Specialist
Date Prepared:	November 30, 2005
Trade Name:	Medcomp® PRO-LINE™ CT PowerInjectable 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 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.

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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.

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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

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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

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K053345

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

Page _ of _

Regulation Number and Section

§ 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.”