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

The provided text describes a 510(k) premarket notification for a medical device, the PICC WAND™ Peelable Safety Introducer. The document focuses on demonstrating substantial equivalence to a predicate device, rather than defining and proving acceptance criteria for a novel AI or diagnostic device. Therefore, much of the requested information (e.g., sample size for test set, data provenance, ground truth establishment, MRMC study, training set details) is not applicable or cannot be extracted from this type of regulatory submission.

However, I can extract information related to the device performance and the study conducted to demonstrate equivalence.

Here's a summary based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a quantitative, pass/fail form for a new device's performance. Instead, it focuses on demonstrating equivalence to a predicate device. The "performance characteristics" and "requirements of the product design specification" serve as the de facto acceptance criteria, implying that the modified device must perform at least as well as, or be equivalent to, the predicate and meet established design requirements.

Acceptance Criteria Category (Implied)	Specific Performance Test/Characteristic	Intended Outcome (Acceptance Criteria)	Reported Device Performance
Mechanical Strength	Dilator Distal/tip columnar strength	Equivalent to predicate device	Testing conducted to demonstrate equivalence
Mechanical Strength	Dilator Tensile strength of union (tube to hub)	Equivalent to predicate device	Testing conducted to demonstrate equivalence
Mechanical Strength	Sheath Introducer Distal/tip columnar strength	Equivalent to predicate device	Testing conducted to demonstrate equivalence
Mechanical Strength	Sheath Introducer Tensile strength of union (tube to hub)	Equivalent to predicate device	Testing conducted to demonstrate equivalence
System Functionality	System insertability	Equivalent to predicate device	Testing conducted to demonstrate equivalence
Visual Indicators	System Intraluminal visual indicators	Equivalent or superior to predicate device	Testing conducted to verify (equivalent or superior)
Fast-flash Functionality	System Fast-flash function and timing	Equivalent or superior to predicate device	Testing conducted to verify (equivalent or superior)
Shelf Life	Shelf life (accelerated aging) to labeled expiration date	Meets labeled expiration date	Testing conducted to demonstrate (meets)
Size Compatibility (new model)	5 Fr model accommodation	Satisfies performance characteristics required to accommodate a 5 Fr PICC or midline catheter	Testing conducted to satisfy requirements

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

Sample Size for Test Set: Not specified in the document. The testing was "in vitro bench testing," implying laboratory-based testing rather than patient data.
Data Provenance: Not applicable in the context of patient data, as the tests were in vitro bench tests.

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

Not applicable. The "ground truth" for this device's performance is determined by physical measurements and functional tests in a laboratory setting, not by expert interpretation of data or images.

4. Adjudication Method for the Test Set

Not applicable. This device's performance is assessed through objective physical and functional tests, not by human adjudication of ambiguous results.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of results, often with AI assistance. The PICC WAND™ is a medical instrument, and its performance is evaluated through engineering and functional bench tests.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Not applicable. The PICC WAND™ is a physical medical device, not an algorithm, so the concept of "standalone performance" in this context does not apply.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this product is derived from engineering specifications, established physical testing methodologies, and performance standards for such introducer devices. For instance, "columnar strength" would be determined by a force gauge, and "Fast-flash function and timing" would be measured with a stopwatch or similar timing device under controlled conditions.

8. The Sample Size for the Training Set

Not applicable. This is not an AI or machine learning device, so there is no training set.

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

Not applicable, as there is no training set for this device.

Summary

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

r. Date Summary Prepared: April 22, 2010

11.2 DEVICE IDENTIFICATION

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

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

વર્ણ

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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 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

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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

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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/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 (800) 638-2041 or (301) 796-7100 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

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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

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).