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

Designed for central vein catherization .
Comprised of a polyurethane material with purple pigment to indicate it for power injection.
The lumen is connected to the extensions by a hub with a suture wing for . placement.
Depth markings on the lumen and French size on the hub. ●
Clamps are provided on the extension tubes to prevent air/fluid communication. ●
A female luer connector provides the connection for intravenous administration. .
Maximum recommended pressure limit setting 300 psi. ●
Maximum indicated power injection flow rate 5cc/sec. .

AI/ML Overview

This document describes a 510(k) submission for the PRO-LINE® CT Pressure Injectable CVC. The submission aims to demonstrate substantial equivalence to previously cleared devices. It does not contain information about an AI/ML device or a study designed to evaluate its performance against specific acceptance criteria in the context of diagnostic accuracy, which would typically involve sensitivity, specificity, or similar metrics for an AI medical device.

Therefore, the following information is not present in the provided text:

Acceptance Criteria Table and Reported Device Performance: This document describes a medical device (a CVC) and its physical properties and intended use. There are no performance metrics specified in terms of diagnostic accuracy that would typically be associated with AI/ML device acceptance criteria (e.g., sensitivity, specificity, AUC). The performance tests mentioned are related to biocompatibility and compliance with general catheter standards, not AI performance.
Sample Size Used for Test Set and Data Provenance: No test set is described as this is not an AI/ML device.
Number of Experts Used to Establish Ground Truth and Qualifications: Not applicable as there is no diagnostic AI/ML device or ground truth establishment.
Adjudication Method: Not applicable.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable.
Standalone Performance Study (Algorithm Only): Not applicable.
Type of Ground Truth Used: Not applicable.
Sample Size for the Training Set: Not applicable.
How Ground Truth for the Training Set Was Established: Not applicable.

What is present in the document:

The device's performance is demonstrated through compliance with established international standards for medical devices and biocompatibility, as well as substantial equivalence to predicate devices.

Summary of Safety and Performance Tests (as described):

The document states that:

Biocompatibility requirements of ISO 10993 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing for externally communicating, blood contacting, long-term devices were met.
Performance testing was conducted in accordance with:
- ISO 10555-1: 1997, Sterile Single Use-Intravascular Catheters, General Requirements
- ISO 594-2: Conical Fittings with a 6% (Luer) Taper for Syringes, Needles, and Certain Other Medical Equipment - Part 2: Lock Fittings
Results of these tests, in conjunction with substantial equivalence claims, effectively demonstrate that the PRO-LINE® CT Pressure Injectable CVC is substantially equivalent to the cited predicate device.

Conclusion:

This 510(k) summary is for a physical medical catheter, not an AI/ML-driven medical device. Therefore, the questions posed about acceptance criteria, study design, and ground truth establishment, which are typically relevant for AI/ML performance evaluation, are not applicable to the provided document. The "study" here refers to the performed biocompatibility and performance tests against existing medical device standards to prove substantial equivalence.

Summary

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510(k) Summary

· PRO-LINE® CT Pressure Injectable CVC Summary of Safety and Effectiveness Prepared October 21, 2009

NOV 2 4 2009

General Information:
Submitter:	MEDCOMP®1499 Delp DriveHarleysville, PA 19438Phone: (215) 256-4201Fax: (215) 256-9191
Contact:	Jean CallowRegulatory Specialist
Device Trade Name:	PRO-LINE® CT Pressure Injectable CVC
Common Name:	Percutaneous, implanted, long-term intravascular catheter
Classification Name:	LJS - Catheter, Intravascular, Therapeutic, Long-TermGreater than 30 Days
CFR Reference:	21 CFG 880.5970, Class II
Classification Panel:	General Hospital

Predicate Devices:

Device Trade Name:	PRO-LINE® CT Pressure Injectable CVCPRO-PICCO® CT
Common Name:	Peripherally Inserted Central Catheter (PICC)
Classification Name:	LJS - Catheter, Intravascular, Therapeutic, Long-Term Greater than 30 Days
CFR Reference:	21 CFR 880.5970, Class II
Classification Panel:	General Hospital
Premarket Notification:	K053345, concurrence date March 17, 2006K091953, concurrence date September 16, 2009.

Performance Standards: Performance standards have not been established by FDA under section 514 of the Federal Food, Drug, and Cosmetic Act.

Indications for 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. 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:

Designed for central vein catherization .

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Comprised of a polyurethane material with purple pigment to indicate it for power injection.
The lumen is connected to the extensions by a hub with a suture wing for . placement.
Depth markings on the lumen and French size on the hub. ●
Clamps are provided on the extension tubes to prevent air/fluid communication. ●
A female luer connector provides the connection for intravenous administration. .
Maximum recommended pressure limit setting 300 psi. ●
Maximum indicated power injection flow rate 5cc/sec. .

Safety and Performance Tests

Biocompatibility requirements of ISO 10993 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing for externally communicating, blood contacting, long-term devices were met. All materials used in the manufacture of the PRO-PICC® were previously cleared for similar applications by Medcomp, Inc.

Performance testing of the PRO-PICC® was conducted in accordance with the following international standards:

ISO 10555-1: 1997, Sterile Single Use-Intravascular Catheters, General . Requirements
ISO 594-2: Conical Fittings with a 6% (Luer) Taper for Syringes, Needles, and . Certain Other Medical Equipment - Part 2: Lock Fittings

Subject product testing has vielded acceptable safety and performance outcomes.

The results of these tests, in conjunction with the substantial equivalence claims effectively demonstrate that the PRO-LINE® CT Pressure Injectable CVC is substantially equivalent to the cited predicate device.

Summary of Substantial Equivalence

Based on the indications for use and safety and performance festing, the PRO-LINE® CT Pressure Injectable CVC meets the requirements that are considered for its intended use and is substantially equivalent in design materials, sterilizations for use to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's emblem, which is a stylized representation of an eagle with three lines extending from its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the emblem in a circular fashion.

Public Health Service

NOV 2 4 2009

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Ms. Jean Callow Regulatory Specialist Medcomp 1499 Delp Drive Harleysville, Pennsylvania 19438

Re: K093309

く

Trade/Device Name: PRO-LINE™ CT Power Injectable CVC Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term intravascular Catheter Regulatory Class: II Product Code: LJS Dated: October 21, 2009 Received: October 28, 2009

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 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 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.

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Page 2 - Ms. Callow

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 (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.

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 /CDRHOffices/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.

Wh for

Susan Runner, D.D.S., M.A. Acting Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): _ KQ933209__________________________________________________________________________________________________________________________________________

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 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 Iniectable CVC mo mot 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)

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(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

Page ___ of __________________________________________________________________________________________________________________________________________________________________

510(k) Number:

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.”