MODIFICATION TO SECURACATH, MODEL: SPK01

K083081 · Interrad Medical, Inc. · OKC · Mar 4, 2009 · General Hospital

Device Facts

• Record ID: K083081
• Device Name: MODIFICATION TO SECURACATH, MODEL: SPK01
• Applicant: Interrad Medical, Inc.
• Product Code: OKC · General Hospital
• Decision Date: Mar 4, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5970
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SecurAcath PICC is indicated for short or long term peripheral access to the central venous system. The catheter may be used for intravenous therapy, power injection of contrast media, and blood sampling and/or infusion therapy.. The maximum recommended infusion rate is 5 ml/sec and the maximum pressure of power injectors may not exceed 300 psi. The Secur Acath PICC includes means to secure the catheter via a subcutaneous anchor below the insertion site.

Device Story

SecurAcath is a single-use, sterile, flexible dual-lumen PICC catheter (up to 55 cm length) featuring an integrated subcutaneous securement mechanism. Designed for peripheral access to the central venous system; used for IV therapy, blood sampling, and power injection of contrast media (max 5 ml/sec, 300 psi). Clinicians insert the catheter and deploy the subcutaneous anchor below the insertion site to stabilize the device. Compatible with 0.018" guidewires; MR conditional. Provides securement to prevent catheter migration, potentially reducing complications and improving patient outcomes during long-term venous access.

Clinical Evidence

Bench testing only. Performance data included biocompatibility testing, dimensional verification, securement reliability, catheter tensile strength, and power injection capabilities. Results demonstrate the device meets all product specifications and is safe and effective for its intended use.

Technological Characteristics

Dual-lumen flexible catheter; length up to 55 cm with 1 cm markings; integrated subcutaneous securement mechanism in Y-body; MR conditional; compatible with 0.018" guidewires; sterile, single-use.

Indications for Use

Indicated for patients requiring short or long-term peripheral access to the central venous system for intravenous therapy, power injection of contrast media, blood sampling, or infusion 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

• Interrad Medical SecurAcath (K082047)
• Bard PowerPICC (K051672)

Submission Summary (Full Text)

{0}------------------------------------------------

K083081

#### SECTION 3. 510(K) SUMMARY

MAR 4 2009

#### 3.1 ADMINISTRATIVE INFORMATION

# 3.1.1 Name and address

Sponsor: 181 Cheshire Lane, Suite 100 Plymouth, MN 55441 Tel: [phone] Fax: [phone]

Contact Person Sew-Wah Tay, PhD Regulatory Consultant 18555 37th Ave N, Plymouth, MN 55446

Tel: [phone] Fax: [phone] Email: [e-mail]

Date Prepared: December 24, 2008

## 3.1.2 Device Name

Trade Name Common Name Classification Name Classification SecurAcath Catheter Periphery Inserted Central Catheter (PICC) OKC - implanted subcutaneous securement catheter 21 CFR 880.5970 Class II SPK01

Model

## 3.1.3 Applicant

Applicant's Name: 181 Cheshire Lane, Suite 100 Plymouth, MN 55441 Tel: [phone] Fax: [phone]

### 3.2 INDICATION FOR USE

The SecurAcath PICC is indicated for short or long term peripheral access to the central venous system. The catheter may be used for intravenous therapy, power injection of contrast media, blood sampling and/or infusion therapy. The maximum recommended infusion rate is 5 m/sec and the maximum pressure of power injectors may not exceed 300 psi. The SecurAcath PICC includes means to secure the catheter via a subcutaneous anchor below the insertion site.

{1}------------------------------------------------

### 3.3 DEVICE DESCRIPTION

The SecurAcath is a single use, sterile, flexible PICC catheter with a useful lengths of up to 55 cm. The length of the catheter has markings at 1 cm interval to allow the user to trim the catheter to the required length. The catheter has a built in subcutaneous securement mechanism to stabilize and keep the catheter in place. The catheter has two lumens which are identical in properties and characteristics.

The device is compatible with all 0.018" and smaller guidewires. The proximal end of the catheter has the standard radiology PICC configuration plus the activation mechanism of the securement system built into the Y-body. The catheter has been tested to be compatible with MRI (MR conditional) and use with power contrast injectors.

#### 3.4 SUBSTANTIAL EQUIVALENCE

The SecurAcath Catheter device covered by this submission is substantially equivalent to the Interrad Medical SecurAcath K082047 and Bard PowerPICC K051672

The SecurAcath™ has the same indication for use, same principles of operation, and similar technological characteristics as the previously cleared predicate devices. The differences between this device and its predicate devices do not raise new questions of safety or efficacy.

## 3.5 PERFORMANCE DATA

The performance test data is provided in the 510(k) submission. The performance data demonstrates that the device meets all the product specifications. Performance testing included, biocompatibility testing, dimensional verification; securement reliability, catheter tensile strength and power injection capabilities. Test results demonstrate that the device is safe and effective for its intended use.

{2}------------------------------------------------

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird with outstretched wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the bird.

#### Public Health Service

MAR 4 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Interrad Medical, Incorporated C/o Sew-Wah Tay, Ph.D Regulatory Consultant Libra Medical LLC 18555 37th Avenue North Plymouth, Minnesota 55446

Re: K083081

Trade/Device Name: SecurAcath 5F Dual Lumen PICC 65cm with Subcutaneous Securement System Regulation Number: 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: II Product Code: OKC Dated: February 5, 2009 Received: February 6, 2009

Dear Dr. Tay:

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 such 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.

{3}------------------------------------------------

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrio's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,

Anthony D. anston for.
Ginette V. Michaud, M.D.

Ginette Y. Michaud. M.D. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

#### INDICATION FOR USE STATEMENT SECTION 2.

510(k) Number (if known): K083081

Device Name: SecurAcath PICC

Indications for Use:

The SecurAcath PICC is indicated for short or long term peripheral access to the central venous system. The catheter may be used for intravenous therapy, power injection of contrast media, and blood sampling and/or infusion therapy.. The maximum recommended infusion rate is 5 ml/sec and the maximum pressure of power injectors may not exceed 300 psi. The Secur Acath PICC includes means to secure the catheter via a subcutaneous anchor below the insertion site.

Prescription Use X Over-The-Counter Use AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number: K083081

· 10