NMI PICC

K091261 · Navilyst Medical, Inc. · LJS · May 12, 2009 · General Hospital

Device Facts

• Record ID: K091261
• Device Name: NMI PICC
• Applicant: Navilyst Medical, Inc.
• Product Code: LJS · General Hospital
• Decision Date: May 12, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5970
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The proposed device is indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media.

Device Story

Flexible peripherally inserted central catheter (PICC); features proximally located luer lock adapters with pressure-activated safety valve, extension tubes, and suture wing for securement. Available in single (4 Fr) and dual (5 Fr, 6 Fr) lumen configurations; 55 cm length. Radiopaque material with depth indicators; colored hubs differentiate lumen size. Used by clinicians for peripheral access to central venous system. Provides pathway for intravenous therapy, blood sampling, and power injection of contrast media. Benefits include reliable venous access for various clinical needs.

Clinical Evidence

Bench testing only. Testing included in-vitro evaluation per ISO 10555-3, high-pressure injection flow rate verification, valve integrity testing, and biocompatibility evaluation per ISO 10993-1.

Technological Characteristics

Flexible radiopaque catheter; single (4 Fr) and dual (5 Fr, 6 Fr) lumen configurations; 55 cm length. Features pressure-activated safety valve, luer lock adapters, and suture wings. Biocompatibility per ISO 10993-1; mechanical testing per ISO 10555-3. No software or electronic components.

Indications for Use

Indicated for patients requiring short or long-term peripheral access to the central venous system for intravenous therapy, including fluid, medication, and nutrient administration, blood sampling, and power injection of contrast media.

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

• Peripherally Inserted Central Catheter (PICC) (K070002)
• Peripherally Inserted Central Catheter (PICC) (K021704)

Submission Summary (Full Text)

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K091261

Image /page/0/Picture/1 description: The image shows the logo for Navilyst Medical. The logo consists of a stylized globe on the left, followed by the company name "Navilyst" in a sans-serif font. Below "Navilyst" is the word "Medical" in a smaller, italicized font. The overall design is simple and professional.

MAY 12 2009

> 26 Forest Street Marlborough, MA 01752 Tel [phone]

www.navilystmedical.com

# 510(k) Summary

## A. Sponsor

Navilyst Medical, Inc 26 Forest Street Marlborough, MA 01752

## B. Contact

Nicholas Condakes Manager, Regulatory Affairs or 508-658-7931

Lorraine M. Hanley Director, Global Regulatory Affairs 508-658-7945

#### C. Device Name

| Tradename: | To be determined |
|----------------------|---------------------------------------------------------------------|
| Common/usual name: | Peripherally Inserted Central Catheter (PICC) |
| Classification Name: | LJS - Long term intravascular catheter<br>21 CFR 880.5970, Class II |

#### D. Predicate Device(s)

Peripherally Inserted Central Catheter (PICC) Common/usual name: Classification Name: LJS- Long term intravascular catheter, 21 CFR 880.5970, Class II Premarket Notification(s): K070002, K021704

#### E. Device Description

The proposed PICC has similar technological characteristics as the predicate devices. lt is a flexible catheter with proximally located luer lock adapter(s) with a pressure activated safety valve, extension tube(s) and suture wing for catheter securement; available in single and dual lumen configurations (4 Fr SL, 5 Fr DL, 6 Fr DL, 6 Fr DL) and effective (usable) length of 55 cm. The radiopaque catheter is marked with depth indicators along its length. The lumens are differentiated by proximally located colored hubs that indicate lumen size. Maximum power injection flow rates are indicated on the luer adapter(s). The proposed PICC may be provided as a stand alone device or in kits with other legally marketed products as a convenience to the user to accommodate their particular needs.

## F. Intended Use

The proposed device is indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media.

#### G. Performance Data

Performance testing included in-virro testing in accordance with ISO 10555-3; high pressure injection flow rates; and valve integrity testing; and biocompatibility evaluation in accordance with ISO 10993-1.

## H. Substantial Equivalence

Based on responses to questions posed in FDA's 510(k) Decision Making Tree, the proposed device is determined to be substantially equivalent to the predicates.

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Public Health Service

Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three legs, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white.

MAY 12 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Nicholas Condakes Regulatory Affairs Manager Navilyst Medical, Incorporated 26 Forest Street Marlborough, Massachusetts 01752

Re: K091261

Trade/Device Name: Undetermined Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: April 28, 2009 Received: April 29, 2009

Dear Mr. Condakes:

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.

Please be advised that FDA's issuance of a substantial equivalence determination docs 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- Mr. Condakes

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 (Scctions 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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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 yours,

Antony O, me for

Susan Runner, D.D.S., MA Acting 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):

Device Name:

To be determined

Indications For Use: For short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media.

______________________________________________________________________________________________________________________________________________________________________________ Prescription Use AND/OR Over-The-Counter Use_

(21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Light Illusions for ABC LCDR Colburn 05/10/2009
(Division Sign-Off)

Division of Anesthesionogy, General Hospital Infection Control, Dential Devices

510(k) Number: