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K Number
K111138
Device Name
THE PICC WAND (R) PEELABLE SAFETY INTRODUCER
Manufacturer
ACCESS SCIENTIFIC, INC.
Date Cleared
2011-06-22

(61 days)

Product Code
DYB
Regulation Number
870.1340
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 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 intraluminal position within the blood vessel. The device also incorporates a safety mechanism to guard against accidental needle stick.
More Information

K101150

Not Found

No
The device description and performance studies focus on mechanical and physical properties, with no mention of AI or ML.

No.
The device facilitates the placement of an intravascular catheter but does not itself provide therapy.

No

Explanation: The device, a PICC WAND® Peelable Safety Introducer, is used to facilitate the placement of an intravascular catheter, not to diagnose a condition. It provides feedback on needle position but does not offer diagnostic information about a patient's health.

No

The device description clearly outlines physical components like a needle, guidewire, dilator, and sheath introducer, and the performance studies focus on physical characteristics and testing of these hardware components. There is no mention of software as a component or its function.

Based on the provided information, the PICC WAND® Peelable Safety Introducer is not an In Vitro Diagnostic (IVD) device.

Here's why:

  • Intended Use: The intended use is to "facilitate the placing of an intravascular catheter through the skin into the circulatory system." This describes a procedure performed on the patient's body, not a test performed on a sample taken from the body.
  • Device Description: The description details components like needles, guidewires, dilators, and sheaths, all of which are used for accessing and introducing devices into the circulatory system. There is no mention of reagents, assays, or any components used for analyzing biological samples.
  • Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, tissue, etc.), diagnostic testing, or providing information about a patient's health status based on sample analysis.

IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The PICC WAND® is a procedural device used for accessing the circulatory system.

N/A

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

DYB

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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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
        1. 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
      1. Change to packaging from Pouch to Tray
      1. 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
      1. 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
      1. 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

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K101150

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 870.1340 Catheter introducer.

(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).

0

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
San Diego, CA 92130
C.Company Phone:(858) 259-8333
D.Company Facsimile:(858) 259-5298
E.Contact Person:Albert Misajon
Vice President, Regulatory Affairs and
Quality Assurance
amisajon@the-wand.com

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

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 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")
    1. Changed packaging from Tyvek® pouch to thermoformed tray with Tyvek® lid
    1. Added 4Fr. & 6Fr. sizes
  • Removed numbers from the Dilator Hub, Dilator Nut, and Guidewire Cap 4.
    1. 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.

2

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
    1. 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
    1. Change to packaging from Pouch to Tray
    1. 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
    1. 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
    1. 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 (800) 638-2041 or (301) 796-7100 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