THE PICC WAND (R) PEELABLE SAFETY INTRODUCER

K111138 · Access Scientific, Inc. · DYB · Jun 22, 2011 · Cardiovascular

Device Facts

• Record ID: K111138
• Device Name: THE PICC WAND (R) PEELABLE SAFETY INTRODUCER
• Applicant: Access Scientific, Inc.
• Product Code: DYB · Cardiovascular
• Decision Date: Jun 22, 2011
• 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 an introducer needle, nitinol guidewire, dilator, and peelable sheath introducer. Used by clinicians to place PICCs and midline catheters via the Accelerated Seldinger Technique. Features a Fast-flash™ mechanism providing visual feedback of needle intraluminal position within the blood vessel. Includes a safety mechanism to prevent accidental needle sticks. Device facilitates catheter placement through the skin into the circulatory system, potentially improving safety and procedural speed for the clinician.

Clinical Evidence

Bench testing only. No clinical data presented. Verification testing included needle-to-dilator separation/removal force, axial force, insertability, Fast-flash function/timing, packaging integrity (seal, bubble leak, shipping, shelf life), and mechanical strength (tensile/columnar) for new 4Fr and 6Fr sizes.

Technological Characteristics

All-in-one preassembled introducer system. Components: Nitinol guidewire, dilator, peelable sheath, needle. Features Fast-flash visual indicator. Packaging: Thermoformed tray with Tyvek lid. Sterilization: Not specified. Connectivity: None. Software: None.

Indications for Use

Indicated for patients requiring placement of an intravascular catheter, including peripherally inserted central catheters (PICC) and midline catheters, into the circulatory system.

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 (K101150)

Submission Summary (Full Text)

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## 510(K) SUMMARY

K111138 JUN 2 2 2 2011

#### SUBMITTER INFORMATION 11.1

| 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] |

F. Date Summary Prepared: June 3, 2011

### 11.2 DEVICE IDENTIFICATION

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

- Catheter Introducer B. Common Name:
- Introducer, Catheter C. Classification Name(s):
- D. Classification Regulation(s): 21 CFR 870.1340
- Device Class: Class II E.
- DYB Product Code: F.
- Cardiovascular Advisory Panel: G.

### 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) K101150.

### 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

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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 changes to the device are in the mechanism of attaching/detaching the Needle Hub to the Dilator Hub. Performance testing has been conducted to confirm that the modified device satisfies performance requirements.

In addition to the changes identified above, the following changes have been implemented via letter-to-file since the clearance of the 510(k) for the predicate PICC WAND Peelable Safety Introducer:

- 1. Dimensional changes to Components:
- · Length of Guidewire reduced from 9.45" to 9.045" (Δ=0.405")
- · Length of Dilator reduced from 5.056" to 4.383" (Δ=0.673")
- · Length of Sheath Introducer reduced from 4.054" to 3.380" (Δ=0.674")
- · Fast-flash hole in Needle sidewall moved from 4.487" distal to hub to 3.380" distal to hub (Δ=0.835")
- 2. Changed packaging from Tyvek® pouch to thermoformed tray with Tyvek® lid
- 3. Added 4Fr. & 6Fr. sizes
- Removed numbers from the Dilator Hub, Dilator Nut, and Guidewire Cap 4.
- 5. Modified Labels and DFU for clarity to insure easier, safer, and more effective use

Performance testing has been conducted, as necessary, to confirm that the modified device satisfied performance requirements.

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#### SUMMARY OF TESTING 11.7

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:

### Special 510(k) Modification:

- 1. Needle Hub and Dilator Hub Attachment
Testing to qualify Special 510(k) modification

- 1. Needle Hub to Dilator Separation Force and Removal Force
- 2. Axial force Testing

### Letter-to-file Modifications (i.e. changes that have been implemented via letter-to-file since the clearance of the 510(k) for the predicate PICC WAND Peelable Safety Introducer):

- 1. Dimensional changes to components
- 2. Change to packaging from Pouch to Tray
- 3. Added 4 Fr. & 6 Fr. sizes

### Testing to qualify letter-to-file modifications:

- 1. Dimensional changes to components
- · Axial force tests
- · Insertability tests
- Fast Flash evaluation
- 2. Change packaging from Pouch to Tray
- · Packaging
- i. Seal testing
- ii. Sterile Barrier/Bubble leak testing
- iii. Shipping and shelf life testing
- · Sterilization cycle adoption study
- 3. Added 4 Fr. and 6 Fr. sizes
- · 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

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## 11.8 CONCLUSIONS DRAWN FROM STUDIES

The results of testing demonstrate that the modified 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 -WO66-G609 Silver Spring, MD 20993-0002

Access Scientific, Inc. C/O Albert Misajon 12526 High Bluff Drive, Suite 360 San Diego, CA 92130

JUN 2 2 2011

Re: K111138

Trade/Device Name: The PICC WAND® Peelable Safety Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Introducer, Catheter Regulatory Class: Class II Product Code: DYB Dated: June 3, 2011 Received: June 6, 2011

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

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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/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Prem Zuckerman, M.D.

Bram 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):

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)

Signature

Sivision Sign-Off) Division of Cardiovascular Devices 510(k) Number(" 11/ 38