PICC WAND PEELABLE SAFETY INTRODUCER

K101150 · Access Scientific, Inc. · DYB · Aug 13, 2010 · Cardiovascular

Device Facts

• Record ID: K101150
• Device Name: PICC WAND PEELABLE SAFETY INTRODUCER
• Applicant: Access Scientific, Inc.
• Product Code: DYB · Cardiovascular
• Decision Date: Aug 13, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The PICC WAND™ Peelable Safety Introducer is used to facilitate the placing of an intravascular catheter through the skin into the circulatory system.

Device Story

PICC WAND™ Peelable Safety Introducer is an all-in-one preassembled intravascular catheter introducer. Components include introducer needle, nitinol guidewire, dilator, and peelable sheath. Used by clinicians to place PICC or midline catheters via Accelerated Seldinger Technique. Features Fast-flash™ technology providing visual feedback of intraluminal needle position via blood flow observation between needle and dilator. Includes safety mechanism to prevent accidental needle sticks. Device facilitates catheter placement, potentially reducing procedural time and improving safety.

Clinical Evidence

Bench testing only. Testing included dilator and sheath distal/tip columnar strength, tensile strength of union, system insertability, system intraluminal visual indicators, Fast-flash function and timing, and accelerated aging shelf-life testing.

Technological Characteristics

Components: Introducer needle, nitinol guidewire, dilator, peelable sheath. Features Fast-flash™ visual indicator for intraluminal positioning. Modified blood flow path compared to predicate. Available in 5 Fr model. Non-powered, mechanical device.

Indications for Use

Indicated for facilitating the placement of an intravascular catheter (PICC or midline) through the skin into the circulatory system in patients requiring such access.

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 (K093022)

Submission Summary (Full Text)

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

K 10 450

### 510(K) SUMMARY

#### SUBMITTER INFORMATION 11.1

# AUG 1 3 2010

A. Company Name: Access Scientific, Inc. B. Company Address: 12526 High Bluff Drive, Suite 360 San Diego, CA 92130 [phone] ﻥ ﺍﻟﻤﺮﺍﺟﻊ Company Phone: D. Company Facsimile: [phone] E. Contact Person: Albert Misajon Vice President, Regulatory Affairs and Quality Assurance [e-mail]

r. Date Summary Prepared: April 22, 2010

#### 11.2 DEVICE IDENTIFICATION

| A. | Device Trade Name: | the PICC WAND™ Peelable Safety Introducer |
|----|--------------------|-------------------------------------------|
|----|--------------------|-------------------------------------------|

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: DYB

G. Advisory Panel: Cardiovascular

## 11.3 IDENTIFICATION OF PREDICATE DEVICE

The predicate device is the PICC WAND™ Peelable Safety Introducer that was cleared for commercial distribution under 510(k) K093022.

### 11.4 DEVICE DESCRIPTION

The PICC WAND™ Peelable Safety Introducer is an all-in-one preassembled intravascular catheter introducer that consists of the following basic introducer components: Introducer Needle, Nitinol Guidewire, Dilator and a peelable Sheath Introducer. It is intended to provide the clinician with a safe, simple and accelerated approach, using the Accelerated Seldinger Technique, to place an in-dwelling intravascular catheter through the skin into the circulatory system. The peelable Sheath Introducer allows for the placement of peripherally inserted central catheters (PICC) and midline catheters. The device includes a Fast-flash™ feature that provides the clinician with feedback that the introducer needle is in the

Access Scientific, Inc. PICC WANDTM Peelable Safety Introducer Special 510(k) Premarket Notification

વર્ણ

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

intraluminal position within the blood vessel. The device also incorporates a safety mechanism to guard against accidental needle stick.

## 11.5 INDICATIONS FOR USE

The PICC WAND™ Peelable Safety Introducer is used to facilitate the placing of an intravascular catheter through the skin into the circulatory system.

#### 11.6 TECHNOLOGICAL CHARACTERISTICS

The proposed modified device has the same technological characteristics as the predicate device in terms of components, materials, chemical composition, and design. The only changes to the device are in the path of blood flow through the device to implement the Fastflash™ feature of the device, and the addition of a 5 Fr model. In the predicate device the blood flowed through windows in the Needle and the Dilator and was observed between the Dilator and the Sheath Introducer. In the modified device the blood flows through a window in the Needle and is observed between the Needle and the Dilator. Performance testing has been conducted to verify that the visual indicators and timing of the blood flow is equivalent or superior to the predicate device, and that the 5 FT model satisfies performance characteristics required to accommodate a 5 Fr PICC or midline catheter.

#### 11.7 PERFORMANCE TESTING

Design verification testing was conducted to demonstrate that the performance characteristics of the modified PICC WAND™ Peelable Safety Introducer are equivalent to the predicate device and satisfy the requirements of the product design specification for its intended use. This testing included the following in vitro bench testing:

- · Dilator Distal/tip columnar strength
- · Dilator Tensile strength of union (tube to hub)
- Sheath Introducer Distal/tip columnar strength
- · Sheath Introducer -- Tensile strength of union (tube to hub)
- System insertability
- System Intraluminal visual indicators
- System Fast-flash function and timing
- Shelf life (accelerated aging) to labeled expiration date

## 11.8 CONCLUSIONS DRAWN FROM STUDIES

The results of testing demonstrate that the PICC WAND™ Peelable Safety Introducer is substantially equivalent to the predicate device in design, function, and indications for use.

Access Scientific, Inc. PICC WAND™ Peelable Safety Introducer Special 510(k) Premarket Notification

47

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

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is a stylized image of a bird.

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

AUG 1 3 2010

Mr. Albert Misajon Vice President, Regulatory Affairs and Quality Assurance Access Scientific, Inc. 12526 High Bluff Drive, Suite 360 San Diego. CA 92130

Re: K101150

Trade Names: PICC WAND™ Peelable Safety Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: July 16, 2010 Received: July 19, 2010

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

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

Page 2 - Mr. Albert Misajon

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/CDRH0ffices/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,

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

Enclosure

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

# INDICATIONS FOR USE

AUG 1 3 2010

K101150 510(k) Number (if known):

the PICC WAND™ Peelable Safety Introducer

Indications for Use:

Device Name:

The PICC WAND™ Peelable Safety Introducer is used to facilitate the placing of an intravascular catheter through the skin into the circulatory system.

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

10/ 150

(Division Sign-Off)
Division of Cardiovascular Devices

Access Scientific, Inc. PICC WANDTM Peelable Safety Introducer Special 510(k) Premarket Notification

510(k) Number

21