PRO-LINE CT (BASIC TRAY) MODEL MR28036101

K093309 · Medcomp ( Medical Components) · LJS · Nov 24, 2009 · General Hospital

Device Facts

• Record ID: K093309
• Device Name: PRO-LINE CT (BASIC TRAY) MODEL MR28036101
• Applicant: Medcomp ( Medical Components)
• Product Code: LJS · General Hospital
• Decision Date: Nov 24, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5970
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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 Story

Polyurethane central venous catheter; purple pigment indicates power injection capability. Features include hub with suture wing, depth markings, extension tubes with clamps, and female luer connector. Used for central vein catheterization to administer fluids/medications or withdraw blood. Operates with power injectors up to 300 psi and 5cc/sec flow rate. Used by clinicians in clinical settings. Provides vascular access; enables contrast media delivery for imaging procedures.

Clinical Evidence

Bench testing only. Biocompatibility testing per ISO 10993; performance testing per ISO 10555-1 and ISO 594-2. No clinical data provided.

Technological Characteristics

Polyurethane catheter with purple pigment; hub with suture wing; extension tubes with clamps; female luer connector. Complies with ISO 10993 (biocompatibility), ISO 10555-1 (sterile intravascular catheters), and ISO 594-2 (luer fittings). Max pressure 300 psi; max flow rate 5cc/sec.

Indications for Use

Indicated for patients requiring short or long-term central venous access for administration of IV fluids, blood products, drugs, parenteral nutrition, blood withdrawal, and power injection of contrast media. No specific age or gender restrictions provided.

Regulatory Classification

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.

Special Controls

*Classification.* Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”

Predicate Devices

• PRO-LINE® CT Pressure Injectable CVC (K053345)
• PRO-PICCO® CT (K091953)

Submission Summary (Full Text)

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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®<br>1499 Delp Drive<br>Harleysville, PA 19438<br>Phone: [phone]<br>Fax: [phone] |
| Contact: | Jean Callow<br>Regulatory 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-Term<br>Greater 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 CVC<br>PRO-PICCO® <span style="vertical-align: super;">CT</span> |
|-------------------------|---------------------------------------------------------------------------------------------------|
| Common Name: | Peripherally Inserted Central Catheter (PICC) |
| Classification Name: | LJS - Catheter, Intravascular, Therapeutic, Long-<br>Term Greater than 30 Days |
| CFR Reference: | 21 CFR 880.5970, Class II |
| Classification Panel: | General Hospital |
| Premarket Notification: | K053345, concurrence date March 17, 2006<br>K091953, 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 [phone] or [phone] 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)

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## Concurrence of CDRH, Office of Device Evaluation (ODE)

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

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