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 CVC WAND™ Safety Introducer with Valved Peelable Sheath, cleared for commercial distribution under 510(k) K131148. When assembled for use, it is an all-inone preassembled intravascular catheter introducer, that provides the clinician with a 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

The CVC WAND™ includes a 21-gauge microaccess needle, nylon tissue dilator, FEP peelable sheath and Nitinol guidewire. This device has an integrated valve within the body of the Peelable Sheath Introducer hub which is designed to reduce inflow of air into the bloodstream and outflow of blood when the guidewire, introducer needle and dilator are removed, but it is not a hemostasis valve. The device also has a blood flashback window proximal to the needle's tip which allows the clinician to observe blood flashback upon entering the vessel with the Safety Introducer. The microaccess needle is echogenic and provides the pathway for the guidewire insertion, while the dilator facilitates placement of the peelable sheath and ultimately catheter placement.

The CVC WAND™ is individually packaged in a PETG. glvcol 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

The FDA 510(k) summary for "The CVC WAND Safety Introducer with Valved Peelable Sheath" (K182243) does not describe a study involving AI or human readers. The summary focuses on validating a material change in a component of the device (from silicone to thermoplastic elastomer in the valve of the peelable sheath introducer) and demonstrating its substantial equivalence to a previously cleared predicate device (K131148). Therefore, many of the requested categories are not applicable to this submission.

Here's a breakdown of the information provided based on your request, with an emphasis on what is not applicable due to the nature of the device and the submission:

1. A table of acceptance criteria and the reported device performance

The document describes various tests conducted and generally states that the results "satisfied the acceptance criteria of the relevant ISO 10993 standards" or "satisfy acceptance criteria identified in applicable standards and/or the device design specification." However, specific numerical acceptance criteria or detailed performance metrics are not explicitly provided in a table format as requested. The document primarily lists the tests performed and a high-level outcome of meeting criteria.

Test Category	Specific Tests Mentioned	Reported Device Performance
Biocompatibility (New Material)	- Cytotoxicity (ISO 10993-5:2009)	Satisfied acceptance criteria of relevant ISO 10993 standards. (GLP conducted for applicable tests)
	- Sensitization (ISO 10993-10:2010)
	- Intracutaneous Reactivity (ISO 10993-10:2010)
	- Acute Systemic Toxicity (ISO 10993-11:2006)
	- Hemolysis (ASTM, ISO 10993-4:2002)
	- Material Mediated Pyrogenicity (ISO 10993-11:2006)
	- Partial Thromboplastic Time (PTT) (ISO 10993-4:2002)
	- In Vitro Platelet and Leucocyte Counts (ISO 10993-4:2002)
	- Complement Activation (ISO 10993-4:2002)
Performance Testing (New Valve)	- Valve Air Leakage	Satisfied acceptance criteria identified in applicable standards and/or device design specification.
	- Valve Liquid Leakage
	- Valve Flexibility
	- Valve Patency
	- Valve Integrity
Device System Testing	- Particulate Matter USP <788> (Reference only)	Satisfied acceptance criteria identified in applicable standards and/or device design specification.
Leveraged Predicate Testing	Lumen patency, Tensile strength, Air leak, Corrosion resistance, Distal Tip Columnar Strength, Strength of Union, Fracture testing, Flex testing, Axial Forces, "Fast-Flash™" Evaluation, Insertability, Needle-stick safety, Guidewire cap snap-on force, Protective Cover Removal Force, Needle lock to Needle hub separation force.	Results from the predicate device (K131148) were considered acceptable and leveraged as these aspects were not affected by the material change in the valve.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not explicitly stated for any of the individual tests. The submission describes conducting "designed verification testing."
Data Provenance: The document indicates that tests were conducted according to ISO and ASTM standards, and some were GLP (Good Laboratory Practice) compliant. This suggests controlled laboratory settings. It doesn't specify a country of origin for the data or whether the data was retrospective or prospective, though performance testing is inherently prospective for the device being tested.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable. The device is a medical instrument (catheter introducer), not a diagnostic imaging device or an AI algorithm requiring expert ground truth for its performance assessment. Its performance is evaluated through physical, chemical, and biological tests against established standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable. See the explanation for point 3.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. This device is a physical medical instrument, not an AI system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. This device is a physical medical instrument, not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the biocompatibility and performance testing, the "ground truth" or reference for comparison are established international standards (ISO, ASTM, USP) and the device's own design specifications for functional requirements. For example, for biocompatibility, the reference is what constitutes a non-toxic or non-irritating response according to ISO 10993. For mechanical tests, it's meeting specified engineering tolerances.

8. The sample size for the training set

This is not applicable. This is a physical medical device, not an AI system with a training set.

9. How the ground truth for the training set was established

This is not applicable. See the explanation for point 8.

In summary, the K182243 submission focuses on demonstrating the safety and performance of a modified medical device through standard engineering and biocompatibility testing, rather than the evaluation of an AI-powered diagnostic tool. Therefore, many of your questions related to AI studies and their methodologies are not relevant to this particular FDA submission.

Summary

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September 18, 2018

Access Scientific, LLC Martina Nguyen Regulatory Affairs / Quality Assurance Specialist 3910 Sorrento Valley Boulevard, Suite 200 San Diego, California 92121

Re: K182243

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: August 16, 2018 Received: August 20, 2018

Dear Martina Nguyen:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Misti L. Malone -S

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) Number (if known) K182243

Device Name

The CVC WANDSafety Introducer with Valved Peelable Sheath

Indications for Use (Describe)

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

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) SUMMARY

1. SUBMITTER INFORMATION

Company Name:	Access Scientific, LLC
Company Address:	3910 Sorrento Valley BoulevardSuite 200San Diego, CA 92121
Company Phone:	(858) 259-8333
Company Facsimile:	(858) 259-5298
Contact Person:	Martina NguyenRegulatory Affairs & Quality Assurance Specialistmnguyen@accessscientific.com
Date:	August 16, 2018

2. PROPOSED DEVICE IDENTIFICATION

Trade Name:	The CVC WAND™ Safety Introducer with ValvedPeelable Sheath
Common Name:	Catheter Introducer
Classification Name:	Introducer, Catheter
Classification Regulation:	21 CFR 870.1340
Device Class:	Class II
Product Code(s):	DYB
Advisory Panel:	Cardiovascular

3. PREDICATE DEVICE IDENTIFICATION

The CVC WAND™ Safety Introducer with Valved Peelable Sheath is substantially equivalent to the following Access Scientific device, which is cleared for commercial distribution under 510(k) K131148:

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

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Common Name:	Catheter Introducer
Classification Name:	Introducer, Cathete-
Classification Regulation:	21 CFR 870.1340
Device Class:	Class II
Product Code(s):	DYB
Advisory Panel:	Cardiovascular

4. DEVICE DESCRIPTION

Introducer Needle
Guidewire
Dilator
Valved Peelable Sheath Introducer

5. INDICATION FOR USE

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

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6. TECHNOLOGICAL CHARACTERISTICS

The CVC WAND™ has equivalent technological characteristics as the predicate devices in terms of components, design, and performance. The Needle, Guidewire, and Dilator are the same components used in the predicate device. The Valved Peelable Sheath Introducer component is equivalent to the predicate device with the exception of the valve subcomponent found within the hub to reduce the risk of blood and air intake during the catheterization procedure. The valve subcomponent is manufactured with a new material, thermoplastic elastomer, rather then the existing silicone material.

7. SUMMARY OF TESTING

A program with designed verification testing, including biocompatibility testing, was conducted to demonstrate the biological safety and biomechanical performance characteristics of the CVC WANDIM.

The only device modification was to the Valved Peelable Sheath Introducer component. The modification was a material change to the valve found within the hub of the Valve Peelable Sheath Introducer component. The material of the valve changed from silicone to thermoplastic elastomer. Therefore, biocompatibility testing of this component with the new material was conducted in accordance with the provisions of ISO 10993-1:2009 and summarized in Table 4.1. The results of the biocompatibility testing satisfied the acceptance criteria of the relevant ISO 10993 standards.

Table 4.1: Biocompatibility Testing of the Valved Peelable Sheath IntroducerComponent
Test	Test Method/Standard
Cytotoxicity	ISO MEM Elution Using L-929 MouseFibroblast Cells (GLP)ISO 10993-5:2009
Sensitization	ISO Guinea Pig Maximization SensitizationTest (GLP – 2 Extracts)ISO 10993-10:2010
Intracutaneous Reactivity	ISO Intracutaneous Irritation Test (GLP – 2Extract)ISO 10993-10:2010
Acute Systemic Toxicity	USP Systemic Injection (Normal Saline andCottonseed Oil Extract)ISO 10993-11:2006
Hemolysis	ASTM Hemolysis Assay – Direct Contactand Extract Method (GLP)ISO 10993-4:2002
Material Mediated Pyrogenicity	Normal Saline ExtractISO 10993-11:2006
Partial Thromboplastic Time (PTT)	Direct Contact

Toble 4 1; Riogampotibility Tosting of the Volved Pooloble Shooth Introducar

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Component	Test	Test Method/Standard
		ISO 10993-4:2002
	In Vitro Platelet and Leucocyte Counts	Direct Contact
		ISO 10993-4:2002
	Complement Activation	C3a and Sc5b-9 Complexes
		ISO 10993-4:2002

Table 4.1: Biocompatibility Testing of the Valved Peelable Sheath Introducer

Some design verification performance testing was leveraged from the predicate device manufactured by Access Scientific and are summarized in Table 4.2. These specific performance testing were leveraged from the predicate device, cleared for commercial distribution under 510(k) K131148, because these performance criteria of the device were not affected as a result of the material change.

Prospective design verification performance testing conducted for the device modification of CVC WAND™ is shown in Table 4.3. The results of the design verification performance testing satisfy acceptance criteria identified in applicable standards and/or the device design specification.

Table 4.2: Prior Applicable Testing Conducted on the Predicate Device (K131148)
Component	Testing
Introducer Needle	• Lumen patency• Tensile strength: tube-to-hub bond• Air leak/resistance to stress cracking• Corrosion resistance
Dilator	• Distal Tip Columnar Strength• Strength of Union: Tube-to-Hub
Guidewire	• Fracture testing• Flex testing• Strength of union: core-to-coil• Strength of union: wire-to-cap• Corrosion resistance
Valved Peelable SheathIntroducer	• Distal Tip Columnar Strength• Strength of Union: Tube-to Hub, Valve-to-Lower-Hub• Split/Feel Force of Hub/Sheath
Device System	• Axial Forces• “Fast-Flash™” Evaluation• Insertability• Needle-stick safety• Guidewire cap snap-on force

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Table 4.2: Prior Applicable Testing Conducted on the Predicate Device (K131148)
Component	Testing
	Protective Cover Removal Force – Dilator, Sheath Introducer Needle Cover Functional Evaluation and Removal Force Needle Cover Silicone Migration Evaluation Needle lock to Needle hub separation force

Table 4.3 Prospective Testing Conducted on the CVC WAND™ Safety Introducer with Valved Peelable Sheath

Component	Testing
Valved Peelable SheathIntroducer	• Valve Air Leakage• Valve Liquid Leakage• Valve Flexibility• Valve Patency• Valve Integrity
Device System	• Particulate Matter USP <788>(Reference only)

8. CONCLUSIONS

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

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).