1.9F X 20CM VASCU-PICC, 1.9F X 50CM VASCU-PICC, MODEL VPI.9S20, VPI.9S50

K091466 · Medcomp · LJS · Jun 17, 2009 · General Hospital

Device Facts

• Record ID: K091466
• Device Name: 1.9F X 20CM VASCU-PICC, 1.9F X 50CM VASCU-PICC, MODEL VPI.9S20, VPI.9S50
• Applicant: Medcomp
• Product Code: LJS · General Hospital
• Decision Date: Jun 17, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5970
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The 1.9F Vascu-PICC® is a long term catheter intended for central venous access via peripheral insertion in neonates, infants, and children. It may be used for administration of fluids, medication, and nutritional therapy.

Device Story

1.9F Vascu-PICC is a long-term, peripherally inserted central catheter (PICC) designed for neonates, infants, and children. Device consists of a polyurethane catheter, a hub with suture wings for securement, an extension tube with a clamp to prevent air/fluid communication, and a female luer connector for intravenous administration. Used in clinical settings for central venous access to deliver fluids, medications, and nutritional therapy. Operated by healthcare professionals. Device facilitates long-term venous access, reducing the need for repeated peripheral venipuncture.

Clinical Evidence

Bench testing only. No clinical data provided. Performance testing conducted per ISO 10555-1, ISO 10555-3, and ISO 594-2. Biocompatibility testing performed per ISO 10993.

Technological Characteristics

Polyurethane catheter; hub with suture wings; extension tube with clamp; female luer connector. Standards: ISO 10555-1 (general requirements), ISO 10555-3 (central venous catheters), ISO 594-2 (luer lock fittings), ISO 10993 (biocompatibility).

Indications for Use

Indicated for central venous access in neonates, infants, and children for the administration of fluids, medication, and nutritional therapy.

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

• 1.9F Vascu-PICC™ (K061986)

Submission Summary (Full Text)

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# 510(k) Summary

1.9F Vascu-PICC® Summary of Safety and Effectiveness Prepared May 15, 2009

#### General Information

Submitter:

JUN 17 2009

MEDCOMP® 1499 Delp Drive Harleysville, PA 19438 Phone: [phone] Fax: [phone]

| Contact: | Susan Pileggi |
|----------|-----------------------|
| | Regulatory Specialist |

| Device Trade Name: | 1.9F Vascu-PICC® |
|-----------------------|-------------------------------------------------------------------------------|
| Common Name: | Peripherally Inserted Central Catheter (PICC) |
| Classification Name: | LJS - Catheter, Intravascular, Therapeutic, Long-Term<br>Greater then 30 Days |
| CFR Reference: | 21 CFG 880.5970, Class II |
| Classification Panel: | General Hospital |

## Predicate Device:

| Device Trade Name: | 1.9F Vascu-PICC™ |
|-------------------------|------------------------------------------------------------------------------|
| Common Name: | Peripherally Inserted Central Catheter (PICC) |
| Classification Name: | LJS-Catheter, Intravascular, Therapeutic, Long-<br>Term Greater then 30 Days |
| CFR Reference: | 21 CFR 880.5970, Class II |
| Classification Panel: | General Hospital |
| Premarket Notification: | K061986, concurrence date August 15, 2006 |

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

Indications for Use: The 1.9F Vascu-PICC® is a long term catheter intended for central venous access via peripheral insertion in neonates, infants, and children. It may be used for administration of fluids, medication, and nutritional therapy.

### Device Description:

- Designed for peripheral vein catherization .
- Comprised of a polyurethane material .
- The lumen is connected to the extensions by a hub with a suture wing for . placement.
- A clamp is provided on the extension tube to prevent air/fluid communication. .
- A female luer connector provides the connection for intravenous administration. .

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# 1091464

# 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 1.9F Vascu-PICC® were previously cleared for similar applications by Medcomp, Inc.

Performance testing of the 1.9F Vascu-PICC® was conducted in accordance with the following international standards:

- ISO 10555-1: 1997: Sterile Single Use-Intravascular Catheters, General � Requirements
- ISO 10555-3: 1997, Sterile Single Use-Intravascular Catheters, Central Venous . Catheters
- 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 1.9F Vascu-PICC® is substantially equivalent to the cited predicate device.

### Summary of Substantial Equivalence

Based on the indications for use and safety and performance testing, the 1.9F Vascu-PICC® meets the requirements that are considered for its intended use and is substantially equivalent in design materials, sterilization, and indications for use to the predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure.

#### Public Health Service

JUN 1 7 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Susan Pileggi Regulatory Specialist MedCOMP 1499 Delp Drive Harleysville, Pennsylvania 19438

Re: K091466

Trade/Device Name: 1.9F Vascu-PICC® Regulation Number: 21 CFR 880.5970 . Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: May 15, 2009 Received: May 18, 2009

Dear Ms. Pileggi:

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. Pileggi

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 (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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/Centers Offices/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/cdrh/mdr/ 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/cdrh/industry/support/index.html.

Sincerely vours.

Anthony O. Arthur 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

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# Indications for Use

510(k) Number (if known):

Device Name: 1.9F Vascu-PICC®

Indications for Use:

The 1.9F Vascu-PICC® is a long term catheter intended for central venous access via peripheral insertion in neonates, infants, and children. It may be used for administration of fluids, medication, and nutritional therapy.

Prescription Use X Over-The-Counter Use Prescription Ose (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)

(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

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510(k) Number: K091466

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