The Power WAND™ Safety Introducer with an Extended Dwell Catheter is used to gain access to the vascular system to sample blood and administer fluids intravenously. May be used for power injection of contrast media at a rate of 5cc/sec at up to 300 psi fluid pressure.

Device Description

The Power WAND™ Safety Introducer with an Extended Dwell Catheter is an all-in-one pre-assembled device that combines the functionality of a catheter introducer system with an extended dwcll (> 72 hours but < 30 days) intravenous (IV) Catheter. The Power WAND™ Safety Introducer with an Extended Dwell Catheter is used to gain access to the vascular system to insert the IV Catheter. The IV Catheter may then be left in place for a period of < 30 days and used to sample blood and administer fluids intravenously. It can also be used to power inject contrast media up to a rate of 5 cc/sec. at a maximum of 300 psi fluid pressure.

The Power WAND™ Safety Introducer with an Extended Dwell Catheter is provided "STERILE" by cthylene oxide gas and is labeled "Nonpyrogenic" and for "Single-Use".

The device is composed of the following components:

Needle
Guidewire
Dilator
Extended Dwell IV Catheter

The Power WAND™ Safety Introducer with an Extended Dwell Catheter accesses the target vessel using the Accelerated Scldinger Technique (AST). Once the IV Catheter is positioned within the target circulatory vessel the Needle/Guidewire/Dilator are removed from the patient as a single unit. The remaining indwelling single-lumen IV Catheter is used to sample blood and administer fluids intravenously for a time period of < 30 days. It can also be used to power inject contrast media up to a rate of 5 cc/sec at a maximum fluid pressure of 300 psi. A catheter stabilization device, Statl.ock IV Ultra®, is provided as an accessory to securely anchor the IV Catheter in place during use.

AI/ML Overview

This document, K101422, describes the Power WAND™ Safety Introducer with an Extended Dwell Catheter. It focuses on demonstrating substantial equivalence to predicate devices through various testing. Here's an analysis of the provided information, specifically addressing the requested points regarding acceptance criteria and study details:

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

The document lists numerous tests conducted, but it does not explicitly state specific numerical acceptance criteria for each test. Instead, it generally concludes that the device "satisfied the acceptance criteria" or "satisfy performance requirements of the product specification and are equivalent to the predicate device."

Here's an attempt to present the information as requested, with the caveat that specific numerical acceptance criteria are not provided in the document:

Test	Acceptance Criteria (as implied)	Reported Device Performance
Biocompatibility Testing (Table 5.1)	All materials meet ISO standards for biocompatibility.	"All materials satisfied the acceptance criteria of the biocompatibility testing."
Cytotoxicity (ISO MEM Elution)	Non-toxic / No cytotoxic effects	Satisfied acceptance criteria (implied)
Sensitization (ISO 10993-10:2002)	No significant sensitization	Satisfied acceptance criteria (implied)
Intracutaneous Reactivity (ISO 10993-10:2002)	No significant intracutaneous reactivity	Satisfied acceptance criteria (implied)
Acute Systemic Toxicity (ISO 10993-11:2006)	No significant acute systemic toxicity	Satisfied acceptance criteria (implied)
Hemolysis - Direct Contact (ISO10993-4:2002)	Acceptable levels of hemolysis	Satisfied acceptance criteria (implied)
Hemolysis - Extract (ISO10993-4:2002)	Acceptable levels of hemolysis	Satisfied acceptance criteria (implied)
Material Mediated Pyrogenicity (ISO 10993-11:2006)	Non-pyrogenic	Satisfied acceptance criteria (implied)
In Vivo Thrombogenicity (ISO 10993-4:2002)	No significant thrombogenicity	Satisfied acceptance criteria (implied)
Complement Activation (ISO 10993-4:2002)	Acceptable levels of complement activation	Satisfied acceptance criteria (implied)
Genotoxicity: Bacterial Reverse Mutation (Ames) (ISO 10993-3:2003)	Non-genotoxic	Satisfied acceptance criteria (implied)
Genotoxicity: In Vitro Mouse Lymphoma (ISO10993-3:2003)	Non-genotoxic	Satisfied acceptance criteria (implied)
Genotoxicity: In Vivo Mouse Micronucleus (ISO10993-3:2003)	Non-genotoxic	Satisfied acceptance criteria (implied)
Subchronic Intravenous Toxicity (ISO 10993-11:2006)	No significant subchronic intravenous toxicity	Satisfied acceptance criteria (implied)
Subacute Intraperitoneal Toxicity (ISO 10993-11:2006)	No significant subacute intraperitoneal toxicity	Satisfied acceptance criteria (implied)
Subcutaneous Implant (ISO 10993-6:2007)	Acceptable tissue response to implant	Satisfied acceptance criteria (implied)
Performance Testing (Implied Predicate Equivalence & Specifications)	Meets product specifications and performance equivalent to predicate devices.	"in vitro performance testing has demonstrated that the IV Catheter materials are non-toxic and that the IV Catheter performance characteristics satisfy performance requirements of the product specification and are equivalent to the predicate device." "Test results indicate that the device satisfies all performance requirements for its intended use."
Lumen patency (21-Gauge Needle)	Maintained patency	Satisfied (Leveraged from K081697)
Tensile strength: tube-to-hub bond (21-Gauge Needle)	Adequate bond strength	Satisfied (Leveraged from K081697)
Air leak/resistance to stress cracking (21-Gauge Needle)	No air leaks, resistance to cracking	Satisfied (Leveraged from K081697)
Corrosion resistance (21-Gauge Needle)	Corrosion resistant	Satisfied (Leveraged from K081697)
Fracture testing (0.018" Guidewire)	Resists fracture	Satisfied (Leveraged from K093022)
Flex testing (0.018" Guidewire)	Maintains integrity under flexion	Satisfied (Leveraged from K093022)
Strength of union: core-to-coil (0.018" Guidewire)	Adequate union strength	Satisfied (Leveraged from K093022)
Strength of union: wire-to-cap (0.018" Guidewire)	Adequate union strength	Satisfied (Leveraged from K093022)
Corrosion resistance (0.018" Guidewire)	Corrosion resistant	Satisfied (Leveraged from K093022)
Needle-stick safety (Introducer System)	Meets safety requirements	Satisfied (Leveraged from K081697)
Guidewire cap snap-on force (Introducer System)	Adequate snap-on force	Satisfied (Leveraged from K081697)
Needle lock to Needle hub separation force (Introducer System)	Adequate separation force (to prevent accidental separation)	Satisfied (Leveraged from K081697)
Distal tip columnar strength (Dilator)	Adequate strength to resist buckling	Satisfied
Strength of union: tube-to-hub (Dilator)	Adequate bond strength	Satisfied
Collapse Pressure (IV Catheter)	Resists collapse under pressure	Satisfied
Distal tip columnar strength (IV Catheter)	Adequate strength to resist buckling	Satisfied
Catheter Flow Rate (IV Catheter)	Meets specified flow rates	Satisfied
Tensile Strength (IV Catheter)	Adequate tensile strength	Satisfied
Priming Volume (IV Catheter)	Meets specified priming volume	Satisfied
Catheter Burst Pressure (IV Catheter)	Resists bursting up to a specified pressure	Satisfied
Catheter-Hub Gauging (IV Catheter)	Correct gauging	Satisfied
Catheter-Hub Liquid Leakage (IV Catheter)	No liquid leakage	Satisfied
Catheter-Hub Air Leakage (IV Catheter)	No air leakage	Satisfied
Catheter-Hub Separation Force (IV Catheter)	Adequate separation force (to prevent accidental separation)	Satisfied
Catheter-Hub Stress Cracking (IV Catheter)	Resists stress cracking	Satisfied
Catheter-Hub Unscrewing Torque (IV Catheter)	Appropriate unscrewing torque	Satisfied
Catheter-Hub Ease of Assembly (IV Catheter)	Easy assembly	Satisfied
Catheter-Hub Resistance to Overriding (IV Catheter)	Resists overriding	Satisfied
Infusion Induced Catheter Movement (IV Catheter)	Minimal movement during infusion	Satisfied
"Worst-case" pre-conditioning (IV Catheter)	Maintains performance after pre-conditioning	Satisfied
Visual Inspection (after pre-conditioning)	No significant degradation	Satisfied
Fatigue Testing (after pre-conditioning)	Resists fatigue	Satisfied
Power Injection (after pre-conditioning)	Performs as specified for power injection (up to 5cc/sec, 300 psi)	Satisfied
Catheter Elongation (after pre-conditioning)	Within acceptable elongation limits	Satisfied
Catheter Burst Pressure (after pre-conditioning)	Resists bursting up to a specified pressure	Satisfied
Integrated System Testing	System functions as intended	Satisfied
Catheter Hub-StatLock IV Ultra® Securement Device Separation Force	Adequate force to prevent accidental separation of secured catheter	Satisfied
Dilator to Catheter Fit-up	Proper fit	Satisfied
Dilator Hub-Catheter Hub Removal Torque	Appropriate removal torque	Satisfied
Dilator Hub-Catheter Hub Separation Force	Adequate force to separate components	Satisfied
Axial Forces	Within acceptable axial force limits	Satisfied
Fast-flash Evaluation	Proper fast-flash response	Satisfied
Introducer System Insertability	Easy and safe insertion	Satisfied
Needle Cover Removal Force	Appropriate removal force	Satisfied
Needle to Dilator Fit-up	Proper fit	Satisfied

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

The document does not provide specific sample sizes for any of the tests mentioned. It only states that a "program of design verification testing" was conducted.

Sample Size: Not specified.
Data Provenance: The studies are described as "design verification testing," "biocompatibility testing," and "in vitro bench testing." This indicates they were prospective tests conducted by the manufacturer, Access Scientific, Inc., which is based in San Diego, CA, USA. The country of origin for the data is implicitly the USA.

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 section is not applicable as the described studies are physical and chemical bench tests (biocompatibility and performance testing) of a medical device, not diagnostic studies requiring expert interpretation or ground truth establishment in a clinical context.

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

This section is not applicable for the same reasons as point 3. No clinical interpretation or adjudication by multiple experts was required for these types of engineering and biocompatibility tests.

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 section is not applicable. This submission is for a physical medical catheter and introducer system, not an AI-powered diagnostic or assistive device. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed or relevant.

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

This section is not applicable. As stated above, this is not an AI algorithm but a physical medical device.

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

For the biocompatibility tests, the "ground truth" is defined by adherence to specific ISO standards (e.g., ISO 10993 series) and their respective criteria for non-toxicity, non-pyrogenicity, etc.

For performance tests, the "ground truth" or reference is defined by product specifications and comparison to the performance characteristics of the predicate devices. The goal was to show that the new device "satisfy performance requirements of the product specification and are equivalent to the predicate device."

8. The sample size for the training set

This section is not applicable. There is no "training set" as this is not an AI/machine learning device. The "training" in a manufacturing context refers to manufacturing process development and validation, not data-driven model training.

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

This section is not applicable as there is no training set or ground truth in the context of AI/machine learning.

Summary

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K101422

510(K) SUMMARY

MAR 2 2 2011

Submitter Information 5.1

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:	January 20, 2011

5.2 Device Identification

A. Device Trade Name:	the Power WAND™ Safety Introducer with anExtended Dwell Catheter
B. Common Name:	Catheter Introducer, Intravascular Catheter
C. Classification Name(s):	Catheter IntroducerCatheter, Intravascular, Therapeutic, Short-Term, < 30Days
D. Classification Regulation(s):	21 CFR 870.134021 CFR 880.5200
E. Device Class:	Class II
F. Product Code(s):	DYB, FOZ
G. Advisory Panel:	General Hospital

Identification of Predicate Devices 5.3

The Power WAND™ Safety Introducer with an Extended Dwell Catheter is substantially cquivalent to the following devices, which are cleared for commercial distribution in the United States:

The WAND™ MicroAccess Safety Introduccr manufactured by Access Scientific and cleared for commercial distribution under 510(k) (K081697)
The PICC WAND™ Peelable Safety Introducer manufactured by Access Scientific, Inc. and cleared for commercial distribution under 510(k) K093022

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The Introcan Safety" IV Catheter manufactured by B. Braun Medical, Inc. and cleared for commercial distribution under 510(k) K020785
The BD OneCath™ manufactured by Becton Dickinson Infusion Therapy Systems. Inc. and cleared for commercial distribution under 510(k) K042862

5.4 Device Description

The Power WAND™ Safety Introducer with an Extended Dwell Catheter is provided "STERILE" by cthylene oxide gas and is labeled "Nonpyrogenic" and for "Single-Use".

The device is composed of the following components:

Needle
Guidewire
Dilator
Extended Dwell IV Catheter ﺮ ﺍ

ર્સ્ટ Indications for Use

Technological Characteristics 5.6

The Power WAND™ Safety Introducer with an Extended Dwell Catheter has the same technological characteristics as the predicate devices in terms of components, materials, chemical composition, and design. The Needle and Guidewire are the same components as those used in the predicate PICC WAND™ Peclable Safety Introducer. The Dilator is

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KID/422

manufactured from the same materials as the predicate PICC WAND™ Peelable Safety Introducer and has only been modified in minor dimensional characteristics to make it fully compatible with the IV Catheter. The extended dwell IV Catheter is manufactured from slightly different materials and has different length than the predicate Introcan Safety® IV Catheter. Biocompatibility testing and in vitro performance testing has demonstrated that the IV Catheter materials are non-toxic and that the IV Catheter performance characteristics satisfy performance requirements of the product specification and are equivalent to the predicate device.

Summary of Testing Performed 5.7

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 Power WAND™ Safety Introducer with an Extended Dwell Catheter.

Biocompatibility testing conducted is summarized in Table 5.1. All materials satisfied the acceptance criteria of the biocompatibility testing.

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KID472

	Test	Test Method/Standard
1	Cytotoxicity	ISO MEM ElutionISO 10993-5:2009
2	Sensitization	ISO 10993-10:2002(Saline and Cottonseed Oil Extracts)
3	Intracutaneous Reactivity	ISO 10993-10:2002(Saline and Cottonseed Oil Extracts)
4	Acute Systemic Toxicity	ISO 10993-11:2006(Saline and Cottonseed Oil Extracts)
5	Hemolysis - Direct Contact	ISO10993-4:2002(Direct Contact)
6	Hemolyis - Extract	ISO10993-4:2002(Phosphate Buffered Saline Extract)
7	Material Mediated Pyrogenicity	ISO 10993-11:2006(Saline Extract)
8	In Vivo Thrombogenicity	ISO 10993-4:2002(Direct Contact)
9	Complement Activation	ISO 10993-4:2002(C3a and SC5b-9 Complexes)
10	Genotoxicity: Bacterial Reverse Mutation(Ames)	ISO 10993-3:2003(Saline and PEG extracts)
11	Genotoxicity: In Vitro Mouse Lymphoma	ISO10993-3:2003(Saline and PEG Extracts)
12	Genotoxicity: In Vivo MouseMicronucleus	ISO10993-3:2003(Saline and Cottonseed Oil Extracts)
13	Subchronic Intravenous Toxicity	ISO 10993-11:2006(Saline Extract)
14	Subacute Intraperitoneal Toxicity	ISO 10993-11:2006(Cottonseed Oil Extract)
15	Subcutaneous Implant	ISO 10993-6:2007(Direct Contact)

TABLE 5.1: BIOCOMPATIBILITY TEST PROGRAM

Performance characteristic testing was conducted to evaluate the performance requirements I the Power WAND™ Safety Introducer with an Extended Dwell Cather. - Testing
leveraged from the previously cleared predicated evices is summarized in Table 5.2.

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

TABLE 5.2: PRIOR APPLICABLE TESTING CONDUCTED FOR THE PREDICATE DEVICES MANUFACTURED BY ACCESS SCIENTIFIC, INC.

Prospective testing of the Dilator included the following testing:

Distal tip columnar strength
· Strength of union: tube-to-hub

Prospective testing of the IV Catheter included the following testing:

· Collapse Pressure
Distal tip columnar strength
· Catheter Flow Ratc
· Tensile Strength
Priming Volume
· Catheter Burst Pressure
Catheter-Hub Gauging
· Catheter-Hub Liquid Leakage
· Catheter-Hub Air Leakage
· Catheter-Hub Separation Force
· Catheter-Hub Stress Cracking
· Catheter-Hub Unscrewing Torque
· Catheter-Hub Ease of Assembly

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· Catheter-Hub Resistance to Overriding
· Infusion Induced Catheter Movement

Prospective testing of the IV Catheter following "worst-case" pre-conditioning included the following:

KIO1422

· Visual Inspection
· Fatigue Testing
· Power Injection
· Catheter Elongation
· Catheter Burst Pressure

Prospective testing of the integrated Power WAND™ Safety Introducer with an Extended Dwell Catheter included the following:

· Catheter Hub- StatLock IV Ultra® Securement Device Separation Force
· Dilator to Catheter Fit-up
· Dilator Hub-Catheter Hub Removal Torque
Dilator Hub-Catheter Hub Separation Force e
· Axial Forces
· Fast-flash Evaluation
Introducer System Insertability a
· Needle Cover Removal Force
· Needle to Dilator Fit-up

Test results indicate that the device satisfies all performance requirements for its intended use.

Conclusions Drawn from Studies 5.8

The results of testing demonstrate that the Power WAND™ Safety Introducer with an Extended Dwcll Catheter is substantially equivalent to the predicate devices in design, function, and indications for use.

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Image /page/6/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized depiction of an eagle or bird-like figure, with flowing lines suggesting movement or flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the central emblem.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. Albert Misaion Vice President, Regulatory Affairs 12526 High Bluff Drive Suite 2360 San Diego, CA 92130

MAR 2 2 2011

Re: K101422

Trade/Device Name: Regulation Number: 21 CFR 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: March 11, 2011 Received: March 14, 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 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

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Page 2 - Mr. Albert Misajon

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,

R. Vahner

ABram 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: To Bc Assigned By FDA KIDI422

Device Name: the Power WAND™ Safety Introducer with an Extended Dwell Catheter

Indications for Use:

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

PLEASE DO NOT WRITE BEI.OW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

priva 2. Jacksones

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_K10 1422

Access Scientific, Inc. Original 510(k) Premarket Notification Original Stority Front Safety Introducer with an Extended Dwell Catheter

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).