2.6F X 20CM VASCU-PICC, 2.6F X 50CM VASCU-PICC

K102966 · Medcomp · LJS · Dec 21, 2010 · General Hospital

Device Facts

• Record ID: K102966
• Device Name: 2.6F X 20CM VASCU-PICC, 2.6F X 50CM VASCU-PICC
• Applicant: Medcomp
• Product Code: LJS · General Hospital
• Decision Date: Dec 21, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5970
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The 2.6F Vascu-PICC® catheters are indicated for short or long term access to the central venous system via peripheral insertion in neonates, infants, and children. It may be used for administration of fluids, medication, and nutritional therapy.

Device Story

2.6F Vascu-PICC is a peripherally inserted central catheter (PICC) designed for central venous access in pediatric populations (neonates, infants, children). Device consists of a polyurethane catheter with a hub, suture wing for placement, extension tube with clamp, and female luer connectors. Used by clinicians for administration of fluids, medications, and nutritional therapy. Operates as a passive conduit for intravenous delivery. Safety and performance validated through biocompatibility and mechanical testing.

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; female luer connectors; suture wing; extension tube with clamp. Standards: ISO 10555-1 (general catheter requirements), ISO 10555-3 (central venous catheters), ISO 594-2 (luer lock fittings), ISO 10993 (biocompatibility), ISO 14971 (risk management).

Indications for Use

Indicated for short or long-term central venous access in neonates, infants, and children for 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® (K091466)

Submission Summary (Full Text)

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DEC 2 1 2010

## 510(k) Summary 2.6F Vascu-PICC®

Summary of Safety and Effectiveness Prepared October 1, 2010

K102966

#### 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: | 2.6F Vascu-PICC® |
| Common Name: | Peripherally Inserted Central Catheter (PICC) |
| 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: | 1.9F Vascu-PICC® |
|-------------------------|--------------------------------------------------------------------------|
| 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: | K091466 |

Indications for Use: The 2.6F Vascu-PICC® catheters are indicated for short or long term access to the central venous system via peripherally 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 o
- The lumen is connected to the extensions by a hub with a suture wing for ◆ placement.
- Clamps are provided on the extension tube to prevent air/fluid communication. 0
- Female luer connectors provide the connection for intravenous administration. 0

Safety and Performance Tests

Medcomp 2.6F Vascu-PICC® 510(k) Summary Page 1 of 2

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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 of the 2.6F 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 a Certain Other Medical Equipment - Part 2: Lock Fittings

Subject product testing has vielded acceptable safety and performance outcomes.

Risk Management of the subject device was conducted in accordance with an internal protocol based on ISO 14971: 2000, Medical Devices – Risk Management for Medical Devices. The analysis did not identify any new types or safety or efficacy questions for the proposed device.

The results of these tests, in conjunction with the substantial equivalence claims effectively demonstrate that the 2.6F 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 2.6F 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 features a stylized eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle, emphasizing the department's name and national affiliation. The logo is simple, using a black and white color scheme.

Food and Drug Administration 10903 New Hamoshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

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

DEC 2 1 2010

Re: K102966 Trade/Device Name: 2.6F Vascu-PICC® Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: December 1, 2010 Received: December 2, 2010

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 -- Ms Callow

Enclosure .

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/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,

fas

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, İnfection Control and Dental Devices Office of Device Eyaluation Center for Devices and Radiological Health

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# Indications for Use

DEC 2 1 2010

510(k) Number (if known): Kl 0296 6

Device Name: 2.6F Vascu-PICC®

Indications for Use:

The 2.6F Vascu-PICC® catheters are indicated for short or long term access to the central venous system via peripheral insertion in neonates, infants, and children. It may be used for administration of fluids, medication, and nutritional therapy.

Prescription Use X_
(Part 21 CFR 801 Subpart D) AND/OR (21 CFR 801 Subpart C (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)

Rild C. Chay 12/20
(Division Sign-Off)

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10(k) Number: K102966