The CVC WAND™ Safety Introducer with Valved Peelable Sheath (hereafter CVC WAND™) is a catheter introducer device that is virtually identical to the predicate device. the PICC WAND® Peelable Safety Introducer (K111138). When assembled for use, it is an all-in-one preassembled intravascular catheter introducer, that provides the clinician with a safe, simple, and accelerated approach to the Seldinger Technique for placing in-dwelling intravascular catheters. The device is composed of the following key components:

Introducer Needle
Guidewire
Dilator
Valved Peelable Sheath Introducer
Some of the components of the predicate device have been modified to facilitate the specific clinical requirements for peripheral access for the placement of a Central Venous Catheter (CVC). The primary modification to the predicate device is the addition of a valve within the body of the Peelable Sheath Introducer Hub. When the Guidewire, Needle and Dilator are removed from the Valved Peelable Sheath Introducer, as part of performing the Accelerated Seldinger Technique procedure, the valve in the hub is actuated (in the closed position) thus preventing air from entering into the venous circulatory system and conversely preventing blood from leaking out. The valve is designed to allow passage of the CVC through it into the central venous circulatory system. This valve provides a similar function as the Bard AirGuard™ Valved Introducer, the other predicate device (K042036). After confirmation of the proper CVC placement, the Valved Peelable Sheath Introducer is removed by breaking apart the Sheath Introducer hub and peeling the sheath off the CVC in the identical manner as the predicate PICC WAND® Peelable Sheath Introducer.
The CVC WAND™ Safety Introducer is individually packaged in a PETG, glycol modified polyethylene terephthalate, plastic tray. The tray is heat sealed with a Tyvek® lid. The device is provided 'STERILE'(ethylene oxide gas) and is for 'single-use` only.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the CVC WAND™ Safety Introducer with Valved Peelable Sheath, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text outlines the types of tests performed and states that the results "satisfied acceptance criteria as identified in applicable standards and the device design specification." However, it does not provide specific numerical acceptance criteria or the reported device performance metrics for these tests. It only lists the tests themselves.

Here's a table summarizing the tests, categorizing them implicitly based on the context:

Category	Acceptance Criteria (Not explicitly stated, assumed to be passing relevant standards)	Reported Device Performance (Not explicitly stated beyond "satisfied acceptance criteria")
Biocompatibility Testing	Passing all relevant provisions of ISO 10993 standards	Results satisfied the acceptance criteria of the relevant ISO 10993 standards
Component-Specific Testing (Valved Peelable Sheath Introducer - Prospective)	Passing relevant design specifications and standards for each test parameter	Results satisfied the acceptance criteria as identified in applicable standards and the device design specification
- Distal Tip Columnar Strength
- Strength of Union: Tube-to-Hub, Valve-to-Lower-Hub
- Split/Peel Force of Hub/Sheath
- Valve Flexibility/Patency
- Valve Integrity
- Valve Liquid Leakage
- Valve Air Leakage
System-Level Testing (Introducer System - Prospective)	Passing relevant design specifications and standards for each test parameter	Results satisfied the acceptance criteria as identified in applicable standards and the device design specification
- Axial Forces
- "Fast-flash™" Evaluation
- Insertability
- Protective Cover Removal Force – Dilator, Sheath Introducer
- Needle Cover Functional Evaluation and Removal Force
- Needle Cover Silicone Migration Evaluation
- Particulate Matter

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

The document does not explicitly state the sample sizes (number of units) used for the prospective bench testing (Table 5.3) or the biocompatibility testing (Table 5.1).

Data provenance is not mentioned beyond the fact that the tests were conducted. There's no indication of country of origin or whether the studies were retrospective or prospective, though the term "Prospective testing" is used for the performance testing in Table 5.3.

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

This information is not applicable to the provided document. The studies described are bench tests and biocompatibility tests, not clinical studies involving expert assessment of images or patient data to establish ground truth.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where expert consensus is needed to establish ground truth for a test set, which is not the case here.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was mentioned. The studies focus on device performance characteristics and biocompatibility, not on the comparative effectiveness of human readers with or without AI assistance.

6. Standalone (Algorithm Only) Performance

This information is not applicable. The device is a physical medical introducer, not an AI algorithm.

7. Type of Ground Truth Used

The "ground truth" for the tests performed can be considered the established scientific/engineering principles, validated test methods (e.g., ISO standards), and the device design specifications. For example:

For biocompatibility, the ground truth is that the device material should not elicit adverse biological reactions as defined by ISO 10993.
For performance tests like "Valve Liquid Leakage," the ground truth would be that the valve should prevent leakage beyond a specified (but unstated) limit.

8. Sample Size for the Training Set

This information is not applicable. There is no AI component mentioned, and thus no "training set" in the context of machine learning. The studies described are physical device testing.

9. How Ground Truth for the Training Set Was Established

This information is not applicable, as there is no training set for an AI/algorithm.

Summary

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510(K) SUMMARY

5.1 SUBMITTER INFORMATION

A. Company Name:	Access Scientific, LLC
B. Company Address:	3910 Sorrento Valley Blvd. Suite 200.San Diego, CA 92121
C. Company Phone:	(858) 259-8333
D. Company Facsimile:	(858) 259-5298
E. Contact Person:	Albert MisajonChief Compliance Officeramisajon@the-wand.com
F. Date:	April 22, 2013

DEVICE IDENTIFICATION 5.2

A. Device Trade Name:	the CVC WAND™ Safety Introducer with ValvedPeelable Sheath
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(s):	DYB
G. Advisory Panel:	Cardiovascular

5.3 IDENTIFICATION OF PREDICATE DEVICES

The CVC WAND™ Safety Introducer with Valved Peelable Sheath is substantially equivalent to the following devices, which are cleared for commercial distribution in the United States:

The PICC WAND® Peelable Safety Introducer manufactured by Access Scientific and cleared for commercial distribution under 510(k) K111138
The AirGuard™ Valved Introducer manufactured by Bard Access Systems, Inc. and cleared for commercial distribution under 510(k) K042036

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5.4 DEVICE DESCRIPTION

Introducer Needle
Guidewire
Dilator
Valved Peelable Sheath Introducer

Some of the components of the predicate device have been modified to facilitate the specific clinical requirements for peripheral access for the placement of a Central Venous Catheter (CVC). The primary modification to the predicate device is the addition of a valve within the body of the Peelable Sheath Introducer Hub. When the Guidewire, Needle and Dilator are removed from the Valved Peelable Sheath Introducer, as part of performing the Accelerated Seldinger Technique procedure, the valve in the hub is actuated (in the closed position) thus preventing air from entering into the venous circulatory system and conversely preventing blood from leaking out. The valve is designed to allow passage of the CVC through it into the central venous circulatory system. This valve provides a similar function as the Bard AirGuard™ Valved Introducer, the other predicate device (K042036). After confirmation of the proper CVC placement, the Valved Peelable Sheath Introducer is removed by breaking apart the Sheath Introducer hub and peeling the sheath off the CVC in the identical manner as the predicate PICC WAND® Peelable Sheath Introducer.

The CVC WAND™ Safety Introducer is individually packaged in a PETG, glycol modified polyethylene terephthalate, plastic tray. The tray is heat sealed with a Tyvek® lid. The device is provided 'STERILE'(ethylene oxide gas) and is for 'single-use` only.

5.5 INDICATIONS FOR USE

The CVC WAND™ Safety Introducer with Valved Peelable Sheath is indicated for use in percutaneous insertion of catheters into the venous system.

5.6 TECHNOLOGICAL CHARACTERISTICS

The CVC WAND™ Valved Safety Introducer with Valved Peelable Sheath has equivalent technological characteristics as the predicate devices in terms of components. materials. design, and performance. The Needle is the same component as is used in the predicate PICC WAND® Peelable Safety Introducer. The Guidewire is manufactured from the same materials and has the same outside diameter as that used in the predicate PICC WAND® Peelable Safety Introducer. The length of the Guidewire has been shortened to be compatible with the dimensional characteristics of the new device. The Dilator is

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manufactured from equivalent materials as the predicate PICC WAND® Peelable Safety Introducer and has been modified in dimensional characteristics to make it compatible with the Valved Peelable Sheath Introducer. The Valved Peelable Sheath Introducer component is equivalent to the Sheath Introducer of the predicate devices in materials and dimensions. and incorporates a valve in the hub to reduce the risk of blood loss and air intake during the catheterization procedure.

5.7 SUMMARY OF TESTING

A program of design verification testing, including biocompatibility testing and in vitro bench testing, was conducted to demonstrate the biological safety and biomechanical performance characteristics of the CVC WAND™ Safety Introducer with Valved Peelable Sheath.

The Valved Peelable Sheath Introducer is the only component that contains not previously included in the predicate devices. Biocompatibility testing of this component was conducted in accordance with the provisions of ISO 10993-1:2009. This testing is summarized in Table 5.1. The results of all biocompatibility testing satisfied the acceptance criteria of the relevant ISO 10993 standards.

Test	Test Method/Standard
Cytotoxicity	ISO ElutionISO 10993-5:2009
Sensitization	ISO MaximizationISO 10993-10:2010
Intracutaneous Reactivity	ISO Intracutaneous ReactivityISO 10993-10:2010
Acute Systemic Toxicity	USP Systemic InjectionISO 10993-11:2006
Hemolysis - Direct Contact	ISO10993-4:2002Direct Contact
Material Mediated Pyrogenicity	ISO 10993-11:2006Rabbit Pyrogen Test
In Vivo Thrombogenicity	ISO 10993-4:20024-Hour Thromboresistance in Dogs
Partial Thromboplastin Time	ISO 10993-4:2002
In Vitro Platelet and LeucocyteCounts	ISO 10993-4:2002
Complement Activation	ISO 10993-4:2002Using Both C3a and SC5b-9

TABLE 5.1: BIOCOMPATIBILITY TESTING OF THE VALVED PEELABLE SHEATH INTRODUCER COMPONENT

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510(k) Summary K131148, page 4 of 5

Design verification performance testing leveraged from previously cleared predicate devices by Access Scientific is summarized in Table 5.2. Prospective testing conducted for the CVC WAND™ Safety Introducer with Valved Peelable Sheath is shown in Table 5.3. The results of design verification performance testing satisfy acceptance criteria as identified in applicable standards and the device design specification.

TABLE 5.2: PRIOR APPLICABLE TESTING CONDUCTED ON PREDICATE DEVICES MANUFACTURED BY ACCESS SCIENTIFIC

Component	Testing	Applicable AccessScientific 510(k)
21-Gauge Needle	• Lumen patency• Tensile strength: tube-to-hub bond• Air leak/resistance to stress cracking• Corrosion resistance	K081697
0.018" Guidewire	• Fracture testing• Flex testing• Strength of union: core-to-coil• Strength of union: wire-to-cap• Corrosion resistance	K093022 K111138
Introducer System	• Needle-stick safety• Guidewire cap snap-on force• Needle lock to Needle hubseparation force	K081697

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Component	Testing
Dilator	• Distal Tip Columnar Strength• Strength of Union: Tube-to-Hub
Valved Peelable SheathIntroducer	• Distal Tip Columnar Strength• Strength of Union: Tube-to-Hub.Valve-to-Lower-Hub• Split/Peel Force of Hub/Sheath• Valve Flexibility/Patency• Valve Integrity• Valve Liquid Leakage• Valve Air Leakage
Introducer System	• Axial Forces• “Fast-flash™” Evaluation• Insertability• Protective Cover Removal Force –Dilator, Sheath Introducer• Needle Cover Functional Evaluationand Removal Force• Needle Cover Silicone MigrationEvaluation• Particulate Matter

TABLE 5.3: PROSPECTIVE TESTING CONDUCTED ON THE CVC WAND™ SAFETY INTRODUCER WITH VALVED PEELABLE SHEATH.

5.8 CONCLUSIONS DRAWN FROM STUDIES

The results of testing demonstrate that the CVC WAND™ Safety Introducer with Valved Peelable Sheath is substantially equivalent to the predicate devices in design, function, and indications for use.

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized symbol resembling an abstract human figure with outstretched arms, accompanied by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The symbol is black, and the text is also black.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

September 4. 2013

Access Scientific, LLC C/O Albert Misajon 3910 Sorrento Valley Blvd. Suite 200 San Diego, CA 92121 US

K131148 Re:

Trade/Device Name: The CVC WAND™ Safety Introducer with Valved Peelable

Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: July 29, 2013 Received: July 30, 2013

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 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

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Page 2 - Mr. Albert Misajon

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 vours.

M. L. Gillem

for

for 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): K131148, page 1 of 1

INDICATIONS FOR USE

510(k) Number: To Be Assigned By FDA [ K131148 ]

Device Name: the CVC WAND™ Safety Introducer with Valved Peelable Sheath

Indications for Use:

The CVC WAND™ Safety Introducer with Valved Peelable Sheath is indicated for use in percutaneous insertion of catheters into the venous system.

AND/OR Over-The-Counter Use __________________________________________________________________________________________________________________________________________________ Prescription Use × (21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

M.A. Hillerman

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).