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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the PICC WAND® Peelable Safety Introducer, structured to answer your questions:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in a quantitative, pass/fail manner. Instead, it describes a series of performance tests conducted to confirm that the modified device satisfies "performance requirements" and is "equivalent to the predicate device." The reported performance is implicitly the successful completion of these tests, demonstrating substantial equivalence.

Performance Area	Implied Acceptance Criteria (Demonstrated)	Reported Device Performance (Implicit from Study Conclusion)
Special 510(k) Modification (New)
Needle Hub and Dilator Hub Attachment	Attachment/detachment mechanism works as intended and is equivalent to predicate.	Satisfies performance requirements; substantially equivalent to predicate.
Needle Hub to Dilator Separation Force	Forces within acceptable range, equivalent to predicate.	Satisfies performance requirements; substantially equivalent to predicate.
Needle Hub to Dilator Removal Force	Forces within acceptable range, equivalent to predicate.	Satisfies performance requirements; substantially equivalent to predicate.
Axial Force Testing (New Mechanism)	Axial forces within acceptable range, equivalent to predicate.	Satisfies performance requirements; substantially equivalent to predicate.
Letter-to-file Modifications (Existing)
Dimensional Changes to Components	New dimensions do not negatively impact function; performance equivalent to predicate.	Satisfies performance requirements; substantially equivalent to predicate.
- Axial Force Tests (Dimensional)	Axial forces remain within acceptable range.	Satisfies performance requirements.
- Insertability Tests (Dimensional)	Device can be inserted successfully.	Satisfies performance requirements.
- Fast Flash Evaluation	Fast-flash feature functions correctly and provides timely feedback.	Satisfies performance requirements.
Change to Packaging	New packaging maintains sterility, integrity, and protects the device, equivalent to predicate packaging.	Satisfies performance requirements; substantially equivalent to predicate.
- Seal Testing	Packaging seals maintain integrity.	Satisfies performance requirements.
- Sterile Barrier/Bubble Leak Testing	Packaging maintains sterile barrier (no leaks).	Satisfies performance requirements.
- Shipping and Shelf Life Testing	Device and packaging integrity maintained after shipping and over shelf life duration.	Satisfies performance requirements.
- Sterilization Cycle Adoption Study	New sterilization cycle effectively sterilizes while maintaining device integrity.	Satisfies performance requirements.
Added 4 Fr. & 6 Fr. Sizes	New sizes perform comparably to existing sizes and predicate device.	Satisfies performance requirements; substantially equivalent to predicate.
- Dilator Distal/Tip Columnar Strength	New sizes meet columnar strength requirements.	Satisfies performance requirements.
- Dilator Tensile Strength of Union (Tube to Hub)	New sizes meet tensile strength requirements.	Satisfies performance requirements.
- Sheath Introducer Distal/Tip Columnar Strength	New sizes meet columnar strength requirements.	Satisfies performance requirements.
- Sheath Introducer Tensile Strength of Union (Tube to Hub)	New sizes meet tensile strength requirements.	Satisfies performance requirements.
- System Insertability	New sizes can be inserted successfully.	Satisfies performance requirements.
- System Intraluminal Visual Indicators	Visual indicators function correctly across new sizes.	Satisfies performance requirements.
- System Fast-flash Function and Timing	Fast-flash functions correctly across new sizes, providing timely feedback.	Satisfies performance requirements.
- Shelf Life (Accelerated Aging)	Device maintains performance characteristics for its labeled expiration date.	Satisfies performance requirements.

2. Sample Sizes Used for the Test Set and Data Provenance

The document does not provide specific sample sizes (e.g., number of devices tested for each parameter) for the test set. It merely lists the types of tests conducted.

The data provenance is internal to the manufacturer (Access Scientific, Inc.) and is prospective in the sense that these tests were performed on the modified device to demonstrate its performance for this specific 510(k) submission. There is no mention of external data, clinical data, or data provenance in terms of country of origin.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This information is not provided. The testing described appears to be primarily engineering and physical performance testing (e.g., force, dimensional, seal integrity, shelf life) rather than subjective evaluation requiring clinical experts to establish ground truth.

4. Adjudication Method for the Test Set

This is not applicable and not mentioned. The tests are objective physical and functional measurements, not requiring adjudication by multiple readers or reviewers in the traditional sense of clinical studies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission focuses on demonstrating substantial equivalence through direct performance testing and comparison to a predicate device, not on assessing human reader performance with or without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

No, this is not applicable. The device is a physical medical introducer, not a software algorithm or AI-driven system. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

The ground truth used for these tests is implicitly the engineering specifications and performance characteristics of the predicate device, as well as relevant industry standards and design specifications for such devices. The goal was to show that the modified device "satisfies performance requirements" and is "equivalent to the predicate device." The "truth" is whether the measured physical properties and functional performance meet pre-defined benchmarks or match those of the predicate.

8. The Sample Size for the Training Set

This is not applicable. The device is a physical medical device, not an AI/ML algorithm that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

This is not applicable, as there is no training set for a physical device.

Summary

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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 360San Diego, CA 92130
C.	Company Phone:	(858) 259-8333
D.	Company Facsimile:	(858) 259-5298
E.	Contact Person:	Albert MisajonVice President, Regulatory Affairs andQuality Assuranceamisajon@the-wand.com

F. Date Summary Prepared: June 3, 2011

11.2 DEVICE IDENTIFICATION

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

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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")
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.

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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
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

Regulation Number and Section

§ 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).