The POWERWAND® 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 5 ml/sec at up to 300 psi fluid pressure.

Device Description

The POWERWAND® Safety Introducer with an Extended Dwell Catheter is an all-in-one preassembled intravascular catheter introducer with intravascular catheter that consists of the following basic components: Introducer Needle, Guidewire, Dilator and an Extended Dwell Catheter. 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 Extended Dwell Catheter allows for withdrawal of blood and the administration of fluids, including power injection of contrast media. 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

This is a 510(k) summary for a medical device (a catheter introducer), which is primarily focused on demonstrating substantial equivalence to a predicate device rather than presenting a study proving performance against explicit acceptance criteria in the way an AI/software as a medical device (SaMD) study would.

Therefore, many of the requested categories (2-9) which are typical for SaMD studies involving machine learning or sophisticated algorithms are not directly applicable or extractable from this document. The document describes engineering and design verification testing against internal product specifications for a physical device, not "performance" in the sense of diagnostic accuracy or clinical outcomes of an AI system.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" in a pass/fail format with corresponding "reported device performance" values for a clinical or diagnostic outcome as would be common for AI/SaMD. Instead, it lists various engineering tests performed to confirm the device's physical properties and functionality. The "acceptance criteria" here are implicitly tied to meeting the design specifications and demonstrating equivalence to the predicate device. The "reported performance" is that the device "satisfies performance requirements" and "is equivalent to the predicate device."

Component	Testing	Implicit Acceptance Criteria	Reported Device Performance
22 Gauge Needle	- Tensile Strength: Tube-to-Hub Bond- Resistance to Breakage	Meet specified strength and breakage resistance.	Equivalent to predicate; satisfies requirements.
0.012" Guidewire	- Fracture Test- Flex Test- Strength of Union: Core-to-Coil- Strength of Union: Wire-to-Cap	Meet specified resistance to fracture, flex, and union strength.	Equivalent to predicate; satisfies requirements.
Dilator	- Distal Tip Columnar Strength- Strength of Union: Tube-to-Hub- Insert Leak	Meet specified columnar strength, union strength, and no leaks.	Equivalent to predicate; satisfies requirements.
4 Fr IV Catheter – Standard Testing	- Collapse Pressure- Distal Tip Columnar Strength- Flow Rate- Tensile Strength- Priming Volume- Burst Pressure- Leakage Test - Liquid- Leakage Test - Air- Catheter Tip Movement during Power Injection	Meet specified pressures, strengths, flow rates, volumes, and leakage integrity.	Equivalent to predicate; satisfies requirements.
4 Fr IV Catheter – after Pre-Conditioning	- Visual Inspection- Fatigue Test- Power Injection- Elongation- Burst Pressure	Maintain integrity and performance after pre-conditioning, meet power injection specs.	Equivalent to predicate; satisfies requirements.
Introducer System	- Axial Forces- Fast-flash™ Evaluation- Insertability- Needle-Stick safety- Particulate Test	Meet specified axial forces, fast-flash feedback, ease of insertion, needle-stick safety, and particulate limits.	Equivalent to predicate; satisfies requirements.

Overall Conclusion: "The results of testing demonstrate that the modified POWERWAND® Safety Introducer with an Extended Dwell Catheter (4 Fr Model) is substantially equivalent to the predicate device in design, function, and indications for use."

2. Sample size used for the test set and the data provenance

The document specifies "Prospective testing conducted for the 4 Fr Model POWERWAND®" (Table 11.2) for the listed physical and performance tests. However, it does not provide specific sample sizes (e.g., number of devices tested for each parameter) for these engineering tests. It also does not mention data provenance in terms of country of origin or whether it's retrospective/prospective clinical data because this is not a clinical study, but rather engineering verification.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This summary relates to the clearance of a physical medical device (catheter introducer) based on engineering performance testing, not an AI/SaMD device that requires expert-established ground truth for diagnostic accuracy. The "ground truth" for these tests would be the measurement against a defined engineering specification or standard.

4. Adjudication method for the test set

Not applicable. See 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

Not applicable. This is a physical medical device; no human readers or AI assistance are involved in its operation or assessment in a diagnostic context.

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

Not applicable. This is a physical medical device; there is no algorithm in this context.

7. The type of ground truth used

The "ground truth" for this device's testing would be defined by engineering specifications, industry standards, and regulatory requirements (e.g., ISO standards for medical devices, ASTM standards for material properties, etc.). For example, a "burst pressure" test would have an internal specification for the minimum pressure it must withstand, which serves as the ground truth.

8. The sample size for the training set

Not applicable. This is not an AI/SaMD device; there is no "training set."

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

Not applicable. See point 8.

Summary

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510(K) SUMMARY

JUL 2 7 2012

11.1	SUBMITTER INFORMATION
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 MisajonChief Compliance Officeramisajon@the-wand.com
F.	Date Summary Prepared:	July 16, 2012
11.2	DEVICE IDENTIFICATION
A.	Device Trade Name:	the POWERWAND® Safety Introducer with anExtended Dwell Catheter4 Fr Model
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 POWERWAND® Safety Introducer with an Extended Dwell Catheter (5 Fr Model) that was cleared for commercial distribution under 510(k) K 111417.

DEVICE DESCRIPTION 11.4

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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.

11.5 INDICATIONS FOR USE

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 impact the dimensions of the components required to add a 4 Fr Model of the device. Performance testing has been conducted to confirm that the modified device satisfies performance requirements.

11.7 SUMMARY OF TESTING

Design verification testing was conducted to demonstrate that the performance characteristics of the modified POWERWAND® Safety Introducer with an Extended Dwell Catheter (4 Fr Model) is equivalent to the predicate device and satisfy the requirements of the product design specification for its intended use.

Testing leveraged from previously cleared predicate devices by Access Scientific, Inc. is summarized in Table 11.1.

Prospective testing conducted for the 4 Fr Model POWERWAND® is shown in Table 11.2.

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Component	Testing	Applicable AccessScientific 510(k)
22 Gauge Needle	Corrosion resistance	K081697
0.012" Guidewire	Corrosion resistance	K093022
4 Fr IV Catheter	Catheter Hub Testing	K101422
	· Guidewire cap snap-on force• Needle lock to Needle hubseparation force	K081697
Introducer System	· Dilator to Catheter fit-up· Dilator Hub-Catheter Hubremoval torque· Dilator Hub-Catheter Hubseparation force· Needle to Dilator fit-up	K101422

. . . . . . . .

TABLE 11.1: PRIOR APPLICABLE TESTING CONDUCTED ON PREDICATE DEVICES MANUFACTURED BY ACCESS SCIENTIFIC, INC.

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Component	Testing
22 Gauge Needle	• Tensile Strength: Tube-to-Hub Bond• Resistance to Breakage
0.012" Guidewire	• Fracture Test• Flex Test• Strength of Union: Core-to-Coil• Strength of Union: Wire-to-Cap
Dilator	• Distal Tip Columnar Strength• Strength of Union: Tube-to-Hub• Insert Leak
4 Fr IV Catheter –Standard Testing	• Collapse Pressure• Distal Tip Columnar Strength• Flow Rate• Tensile Strength• Priming Volume• Burst Pressure• Leakage Test - Liquid• Leakage Test - Air• Catheter Tip Movement during Power Injection
4 Fr IV Catheter – Testingafter Pre-Conditioning	• Visual Inspection• Fatigue Test• Power Injection• Elongation• Burst Pressure
Introducer System	• Axial Forces• Fast-flashTM Evaluation• Insertability• Needle-Stick safety• Particulate Test

TABLE 11.2: PROSPECTIVE TESTING OF THE 4 FR POWERWAND®

11.8 Conclusions Drawn from Studies

The results of testing demonstrate that the modified POWERWAND® Safety Introducer with an Extended Dwell Catheter (4 Fr Model) is substantially equivalent to the predicate device in design, function, and indications for use.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight, composed of three curved lines.

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

JUL 2 7 2012

Access Scientific, Inc. Mr. Albert Misajon Chief Compliance Officer 12526 High Bluff Drive, Suite 360 San Diego, CA 92130

Re: K121748

Trade/Device Name: The POWERWAND Safety Introducer with an Extended Dwell Catheter Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: July 16, 2012 Received: July 17, 2012

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.

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Page 2 – Mr. Albert Misajon

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 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 vours.

M.A. Hilliker

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): K121748

Device Name:

the POWERWAND® Safety Introducer with an Extended Dwell Catheter

Indications for Use:

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)

CMA Killilea

(Division Sign-Off) (Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number K121748

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).