THE CVC WAND SAFETY INTRODUCER WITH VALVED PEELABLE SHEATH

K131148 · Access Scientific, LLC · DYB · Sep 4, 2013 · Cardiovascular

Device Facts

• Record ID: K131148
• Device Name: THE CVC WAND SAFETY INTRODUCER WITH VALVED PEELABLE SHEATH
• Applicant: Access Scientific, LLC
• Product Code: DYB · Cardiovascular
• Decision Date: Sep 4, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The CVC WAND™ Safety Introducer with Valved Peelable Sheath is indicated for use in percutaneous insertion of catheters into the venous system.

Device Story

The CVC WAND™ is an all-in-one preassembled intravascular catheter introducer used for the Seldinger Technique. It consists of an introducer needle, guidewire, dilator, and a valved peelable sheath introducer. The device is used by clinicians to place in-dwelling central venous catheters (CVCs). During the procedure, the needle, guidewire, and dilator are removed through the valved sheath; the integrated valve in the hub actuates to a closed position, preventing air embolism and blood leakage while allowing CVC passage. Once the CVC is placed, the sheath is broken apart and peeled away. The device is provided sterile for single-use. It facilitates a safe, simple, and accelerated approach to venous access.

Clinical Evidence

No clinical data. Substantial equivalence was demonstrated through a program of design verification testing, including biocompatibility testing (ISO 10993-1:2009) and in vitro bench testing. Biocompatibility tests included cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, hemolysis, pyrogenicity, thrombogenicity, partial thromboplastin time, platelet/leucocyte counts, and complement activation. Bench testing evaluated mechanical properties such as distal tip columnar strength, bond strengths, valve integrity, and leak resistance.

Technological Characteristics

Components include needle, guidewire, dilator, and valved peelable sheath. Materials are equivalent to predicate devices. The sheath hub incorporates a valve to reduce blood loss and air intake. Provided sterile via ethylene oxide gas. Single-use. Packaged in PETG tray with Tyvek® lid. Mechanical design follows the Seldinger Technique. No software or electronic components.

Indications for Use

Indicated for percutaneous insertion of catheters into the venous system. Prescription use only.

Regulatory Classification

Identification

A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.

Predicate Devices

• PICC WAND® Peelable Safety Introducer (K111138)
• AirGuard™ Valved Introducer (K042036)

Submission Summary (Full Text)

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

## 510(K) SUMMARY

#### 5.1 SUBMITTER INFORMATION

| A. Company Name: | Access Scientific, LLC |
|-----------------------|---------------------------------------------------------------------|
| B. Company Address: | 3910 Sorrento Valley Blvd. Suite 200.<br>San Diego, CA 92121 |
| C. Company Phone: | [phone] |
| D. Company Facsimile: | [phone] |
| E. Contact Person: | Albert Misajon<br>Chief Compliance Officer<br>[e-mail] |
| F. Date: | April 22, 2013 |

#### DEVICE IDENTIFICATION 5.2

| A. Device Trade Name: | the CVC WAND™ Safety Introducer with Valved<br>Peelable Sheath |
|----------------------------------|----------------------------------------------------------------|
| B. Common Name: | Catheter Introducer |
| C. Classification Name(s): | Introducer. Catheter |
| D. Classification Regulation(s): | 21 CFR 870.1340 |
| E. Device Class: | Class II |
| F. Product Code(s): | DYB |
| G. Advisory Panel: | Cardiovascular |

#### 5.3 IDENTIFICATION OF PREDICATE DEVICES

The CVC WAND™ Safety Introducer with Valved Peelable Sheath is substantially equivalent to the following devices, which are cleared for commercial distribution in the United States:

- > The PICC WAND® Peelable Safety Introducer manufactured by Access Scientific and cleared for commercial distribution under 510(k) K111138
- > The AirGuard™ Valved Introducer manufactured by Bard Access Systems, Inc. and cleared for commercial distribution under 510(k) K042036

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

## 5.4 DEVICE DESCRIPTION

The CVC WAND™ Safety Introducer with Valved Peelable Sheath (hereafter CVC WAND™) is a catheter introducer device that is virtually identical to the predicate device. the PICC WAND® Peelable Safety Introducer (K111138). When assembled for use, it is an all-in-one preassembled intravascular catheter introducer, that provides the clinician with a safe, simple, and accelerated approach to the Seldinger Technique for placing in-dwelling intravascular catheters. The device is composed of the following key components:

- > Introducer Needle
- > Guidewire
- > Dilator
- > Valved Peelable Sheath Introducer

Some of the components of the predicate device have been modified to facilitate the specific clinical requirements for peripheral access for the placement of a Central Venous Catheter (CVC). The primary modification to the predicate device is the addition of a valve within the body of the Peelable Sheath Introducer Hub. When the Guidewire, Needle and Dilator are removed from the Valved Peelable Sheath Introducer, as part of performing the Accelerated Seldinger Technique procedure, the valve in the hub is actuated (in the closed position) thus preventing air from entering into the venous circulatory system and conversely preventing blood from leaking out. The valve is designed to allow passage of the CVC through it into the central venous circulatory system. This valve provides a similar function as the Bard AirGuard™ Valved Introducer, the other predicate device (K042036). After confirmation of the proper CVC placement, the Valved Peelable Sheath Introducer is removed by breaking apart the Sheath Introducer hub and peeling the sheath off the CVC in the identical manner as the predicate PICC WAND® Peelable Sheath Introducer.

The CVC WAND™ Safety Introducer is individually packaged in a PETG, glycol modified polyethylene terephthalate, plastic tray. The tray is heat sealed with a Tyvek® lid. The device is provided 'STERILE'(ethylene oxide gas) and is for 'single-use` only.

## 5.5 INDICATIONS FOR USE

The CVC WAND™ Safety Introducer with Valved Peelable Sheath is indicated for use in percutaneous insertion of catheters into the venous system.

## 5.6 TECHNOLOGICAL CHARACTERISTICS

The CVC WAND™ Valved Safety Introducer with Valved Peelable Sheath has equivalent technological characteristics as the predicate devices in terms of components. materials. design, and performance. The Needle is the same component as is used in the predicate PICC WAND® Peelable Safety Introducer. The Guidewire is manufactured from the same materials and has the same outside diameter as that used in the predicate PICC WAND® Peelable Safety Introducer. The length of the Guidewire has been shortened to be compatible with the dimensional characteristics of the new device. The Dilator is

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

manufactured from equivalent materials as the predicate PICC WAND® Peelable Safety Introducer and has been modified in dimensional characteristics to make it compatible with the Valved Peelable Sheath Introducer. The Valved Peelable Sheath Introducer component is equivalent to the Sheath Introducer of the predicate devices in materials and dimensions. and incorporates a valve in the hub to reduce the risk of blood loss and air intake during the catheterization procedure.

### 5.7 SUMMARY OF TESTING

A program of design verification testing, including biocompatibility testing and in vitro bench testing, was conducted to demonstrate the biological safety and biomechanical performance characteristics of the CVC WAND™ Safety Introducer with Valved Peelable Sheath.

The Valved Peelable Sheath Introducer is the only component that contains not previously included in the predicate devices. Biocompatibility testing of this component was conducted in accordance with the provisions of ISO 10993-1:2009. This testing is summarized in Table 5.1. The results of all biocompatibility testing satisfied the acceptance criteria of the relevant ISO 10993 standards.

| Test | Test Method/Standard |
|--------------------------------------------------|------------------------------------------------------|
| Cytotoxicity | ISO Elution<br>ISO 10993-5:2009 |
| Sensitization | ISO Maximization<br>ISO 10993-10:2010 |
| Intracutaneous Reactivity | ISO Intracutaneous Reactivity<br>ISO 10993-10:2010 |
| Acute Systemic Toxicity | USP Systemic Injection<br>ISO 10993-11:2006 |
| Hemolysis - Direct Contact | ISO10993-4:2002<br>Direct Contact |
| Material Mediated Pyrogenicity | ISO 10993-11:2006<br>Rabbit Pyrogen Test |
| <i>In Vivo</i> Thrombogenicity | ISO 10993-4:2002<br>4-Hour Thromboresistance in Dogs |
| Partial Thromboplastin Time | ISO 10993-4:2002 |
| <i>In Vitro</i> Platelet and Leucocyte<br>Counts | ISO 10993-4:2002 |
| Complement Activation | ISO 10993-4:2002<br>Using Both C3a and SC5b-9 |

### TABLE 5.1: BIOCOMPATIBILITY TESTING OF THE VALVED PEELABLE SHEATH INTRODUCER COMPONENT

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

## 510(k) Summary K131148, page 4 of 5

Design verification performance testing leveraged from previously cleared predicate devices by Access Scientific is summarized in Table 5.2. Prospective testing conducted for the CVC WAND™ Safety Introducer with Valved Peelable Sheath is shown in Table 5.3. The results of design verification performance testing satisfy acceptance criteria as identified in applicable standards and the device design specification.

# TABLE 5.2: PRIOR APPLICABLE TESTING CONDUCTED ON PREDICATE DEVICES MANUFACTURED BY ACCESS SCIENTIFIC

| Component | Testing | Applicable Access<br>Scientific 510(k) |
|-------------------|-----------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|
| 21-Gauge Needle | • Lumen patency<br>• Tensile strength: tube-to-hub bond<br>• Air leak/resistance to stress cracking<br>• Corrosion resistance | K081697 |
| 0.018" Guidewire | • Fracture testing<br>• Flex testing<br>• Strength of union: core-to-coil<br>• Strength of union: wire-to-cap<br>• Corrosion resistance | K093022<br>K111138 |
| Introducer System | • Needle-stick safety<br>• Guidewire cap snap-on force<br>• Needle lock to Needle hub<br>separation force | K081697 |

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

| Component | Testing |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Dilator | • Distal Tip Columnar Strength<br>• Strength of Union: Tube-to-Hub |
| Valved Peelable Sheath<br>Introducer | • Distal Tip Columnar Strength<br>• Strength of Union: Tube-to-Hub.<br>Valve-to-Lower-Hub<br>• Split/Peel Force of Hub/Sheath<br>• Valve Flexibility/Patency<br>• Valve Integrity<br>• Valve Liquid Leakage<br>• Valve Air Leakage |
| Introducer System | • Axial Forces<br>• “Fast-flash™” Evaluation<br>• Insertability<br>• Protective Cover Removal Force –<br>Dilator, Sheath Introducer<br>• Needle Cover Functional Evaluation<br>and Removal Force<br>• Needle Cover Silicone Migration<br>Evaluation<br>• Particulate Matter |

# TABLE 5.3: PROSPECTIVE TESTING CONDUCTED ON THE CVC WAND™ SAFETY INTRODUCER WITH VALVED PEELABLE SHEATH.

#### 5.8 CONCLUSIONS DRAWN FROM STUDIES

The results of testing demonstrate that the CVC WAND™ Safety Introducer with Valved Peelable Sheath is substantially equivalent to the predicate devices in design, function, and indications for use.

{5}------------------------------------------------

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized symbol resembling an abstract human figure with outstretched arms, accompanied by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The symbol is black, and the text is also black.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

September 4. 2013

Access Scientific, LLC C/O Albert Misajon 3910 Sorrento Valley Blvd. Suite 200 San Diego, CA 92121 US

K131148 Re:

Trade/Device Name: The CVC WAND™ Safety Introducer with Valved Peelable

Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: July 29, 2013 Received: July 30, 2013

#### Dear Mr. Misajon:

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.

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

{6}------------------------------------------------

Page 2 - Mr. Albert Misajon

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 vours.

M. L. Gillem

for

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{7}------------------------------------------------

## Indications for Use 510(k): K131148, page 1 of 1

#### INDICATIONS FOR USE

510(k) Number: To Be Assigned By FDA [ K131148 ]

Device Name: the CVC WAND™ Safety Introducer with Valved Peelable Sheath

Indications for Use:

The CVC WAND™ Safety Introducer with Valved Peelable Sheath is indicated for use in percutaneous insertion of catheters into the venous system.

AND/OR Over-The-Counter Use __________________________________________________________________________________________________________________________________________________ Prescription 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)

M.A. Hillerman