THE PICC WAND PEELABLE SAFETY INTRODUCER

K093022 · Access Scientific, Inc. · DYB · Jan 20, 2010 · Cardiovascular

Device Facts

• Record ID: K093022
• Device Name: THE PICC WAND PEELABLE SAFETY INTRODUCER
• Applicant: Access Scientific, Inc.
• Product Code: DYB · Cardiovascular
• Decision Date: Jan 20, 2010
• Decision: SESE
• Submission Type: Traditional
• 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

The PICC WAND® Peelable Safety Introducer is a sterile, single-use, integrated intravascular catheter introducer. It combines an introducer needle, guidewire, dilator, and peelable sheath into an all-in-one device. Designed for use by clinicians to perform the Modified Seldinger technique, it simplifies and accelerates the placement of indwelling intravascular catheters. The device incorporates a safety mechanism to prevent accidental needlesticks during the procedure. It is used in clinical settings to provide vascular access, benefiting the patient by streamlining the catheter insertion process and enhancing safety for the healthcare provider.

Clinical Evidence

Bench testing only. No clinical data provided. Biocompatibility and in vitro performance testing demonstrated that the device meets mechanical requirements and is equivalent to the predicate.

Technological Characteristics

Integrated sterile, single-use intravascular catheter introducer. Components: introducer needle, guidewire, dilator, peelable sheath. Safety mechanism included for needlestick prevention. Sterilization: ethylene oxide gas (SAL 10^-9).

Indications for Use

Indicated for facilitating the placement of an intravascular catheter 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

• WAND® MicroAccess Safety Introducer (K090372)

Submission Summary (Full Text)

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KC93022

# 510(K) SUMMARY

JAN 20 2010

#### 11.1 SUBMITTER INFORMATION

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

#### DEVICE IDENTIFICATION 11.2

| 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 PICC WAND® Peelable Safety Introducer is substantially equivalent to the WAND® MicroAccess Safety Introducer manufactured by Access Scientific, Inc. and cleared for commercial distribution under 510(k) K090372.

#### 11.4 DEVICE DESCRIPTION

The PICC WAND® Peelable Safety Introducer is an integrated sterile, single-use intravascular catheter introducer. It is designed to incorporate a combination of devices into an all-in-one device that provides the clinician with a safe and simple approach to the Modified Seldinger technique, and thereby accelerate the procedure required to place indwelling intravascular catheters. The device includes an Introducer Needle, Guidewire, Dilator, and a Peelable Sheath Introducer in a single integrated device, and incorporates a safety mechanism to guard against accidental needlestick.

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### 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 BIOCOMPATIBILITY AND PERFORMANCE TESTING

A program of design verification testing including biocompatibility testing and in vitro bench testing has been completed to demonstrate the biological safety and biomechanical performance characteristics of the PICC WAND® Peelable Safety Introducer. Test results indicate that the device is equivalent to the predicate device and satisfies mechanical performance requirements for its intended use.

# 11.7 STERILITY

The PICC WAND® Peelable Safety Introducer is provided 'STERILE' by ethylene oxide gas to a sterility assurance level of 10-9.

## 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.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring; MD 20993-0002

JAN 2 0 2010

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

Re: K093022

Trade Name: PICC WAND Peelable Safety Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II (two) Product Code: DYB Dated: December 15, 2009 Received: December 16, 2009

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. Drue, 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 2 - Mr. Albert Misajon

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 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

en R. balmer

Bram D. Zuckerman, M.D. Director

Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K093022

Device Name:

the PICC WAND® Peelable Safety Introducer

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.

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)

Dummer R. Salunes

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_K 69 30 22