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. It may be used for power injection of contrast media up to a rate of 8 ml/sec and at a maximum of 325 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 principle 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 also incorporates a mechanism that provides passive needle stick safety.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the POWERWAND® Safety Introducer with an Extended Dwell Catheter (3 Fr Model). This device is substantially equivalent to a predicate device and does not involve AI or algorithms, and therefore does not have acceptance criteria or a study design in the context of an AI/ML device.

However, I can extract information related to the device's performance testing to demonstrate its equivalence to the predicate device and satisfaction of product design specifications.

Here's a breakdown of the information that can be extracted, framed as device performance rather than AI acceptance criteria:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a formal "acceptance criteria" table in the AI/ML sense, but it lists various performance tests conducted. For a traditional medical device, these tests are designed to demonstrate that the device meets its design specifications and is safe and effective for its intended use. The Reported Device Performance column would generally indicate that the device passed or met the requirements for each test.

Component / Characteristic	Testing	Reported Device Performance (Implied)
24 Gauge Needle	Strength of union between needle hub and needle tube	Met specifications
24 Gauge Needle	Resistance to Breakage	Met specifications
Dilator	Dilator Column Strength	Met specifications
Dilator	Strength of Union (Hub to Tube)	Met specifications
3 Fr IV Catheter – Standard Testing	Collapse Pressure	Met specifications
3 Fr IV Catheter – Standard Testing	Catheter Column Strength	Met specifications
3 Fr IV Catheter – Standard Testing	Flowrate	Met specifications
3 Fr IV Catheter – Standard Testing	Catheter Force at Break	Met specifications
3 Fr IV Catheter – Standard Testing	Priming Volume	Met specifications
3 Fr IV Catheter – (continued)	Burst Pressure	Met specifications
3 Fr IV Catheter – (continued)	Freedom from Leakage	Met specifications
3 Fr IV Catheter – (continued)	Chemical Compatibility	Met specifications
3 Fr IV Catheter – Testing after Pre-Conditioning	Bending Fatigue	Met specifications
3 Fr IV Catheter – Testing after Pre-Conditioning	Power Injection (up to a rate of 8 ml/sec and at a maximum of 325 psi fluid pressure)	Met specifications (as per Indications)
3 Fr IV Catheter – Testing after Pre-Conditioning	Burst Pressure	Met specifications
Introducer System	Axial Forces	Met specifications
Introducer System	Fast-flash™ Evaluation	Met specifications
Introducer System	Insertability	Met specifications
Introducer System	Needle-Stick safety	Met specifications
Introducer System	Intraluminal Positioning Visual Indicators	Met specifications
Introducer System	PM Content	Met specifications

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

Test Set Sample Size: The document does not specify the exact sample sizes (N) for each individual test conducted. It generically refers to "Prospective testing conducted for the 3 Fr Model POWERWAND®."
Data Provenance: The document does not indicate the country of origin of the data or whether it was retrospective or prospective in the clinical sense. However, the testing indicated ("Prospective testing conducted for the 3 Fr Model POWERWAND®") implies that the tests were carried out on newly manufactured 3 Fr Model devices (i.e., prospective device testing, not clinical data provenance).

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

Not Applicable. This is a physical medical device clearance, not an AI/ML device requiring expert ground truth for image interpretation or diagnosis. The "ground truth" for these performance tests is based on engineering specifications and physical measurements.

4. Adjudication Method for the Test Set:

Not Applicable. As this is not an AI/ML device, there is no need for adjudication of results by multiple experts. Device performance is determined by meeting pre-defined engineering and safety specifications through objective measurements.

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

No, an MRMC study was not done. This type of study is relevant for AI/ML diagnostic devices where human readers' performance is compared with and without AI assistance. This device is an introducer with a catheter; it's a tool for medical procedures, not a diagnostic AI.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Not Applicable. This device does not have an algorithm or AI component. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used:

Engineering Specifications and Physical Measurements. For each test (e.g., strength of union, flow rate, burst pressure), the "ground truth" is established by the documented design specifications and industry standards for medical devices of this type. The device's performance is measured against these objective criteria using calibrated equipment.

8. The Sample Size for the Training Set:

Not Applicable. This device is not an AI/ML device and therefore does not have a "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set Was Established:

Not Applicable. Since there is no training set for an AI/ML model, the concept of establishing ground truth for it is irrelevant for this traditional medical device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of a bird or abstract human figure, with three wavy lines below it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.

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

November 17, 2016

Access Scientific, LLC Mr. Walter Cordiglia Senior Director, Quality Engineering and Regulatory Affairs 3910 Sorrento Valley Blvd., Suite 200 San Diego, California 92121

Re: K162322

Trade/Device Name: POWERWAND Safety Introducer with an Extended Dwell Catheter, 3 Fr. Model Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: September 19, 2016 Received: September 20, 2016

Dear Mr. Cordiglia:

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Brian D. Pullin -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) K162322

Device Name

The POWERWAND® Safety Introducer with an Extended Dwell Catheter (3 Fr Model)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

11.1 SUBMITTER INFORMATION

A.	Company Name:	Access Scientific, LLC.
B.	Company Address:	3910 Sorrento Valley Blvd., Suite 200San Diego, CA 92121
C.	Company Phone:	(858) 480-0216
D.	Company Facsimile:	(858) 259-5298
E.	Contact Person:	Walter CordigliaSr. Director of Quality Engineering and Regulatory Affairswcordiglia@accesscientific.com
F.	Date Summary Prepared:	November 17, 2016
11.2	DEVICE IDENTIFICATION
A.	Device Trade Name:	the POWERWAND® Safety Introducer with an ExtendedDwell Catheter (3 Fr Model)
B.	Common Name:	Catheter IntroducerIntravascular Catheter, Therapeutic, Short-term
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 (4 & 5 Fr Models) that were cleared for commercial distribution under 510(k) K131300.

The NovaCath™ Secure IV Catheter System cleared for commercial distribution under 510(k) K160374 was used as reference device as part of this submission.

11.4 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

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following principle 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 also incorporates a mechanism that provides passive needle stick safety.

11.5 INDICATIONS FOR USE

TECHNOLOGICAL CHARACTERISTICS 11.6

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 axial dimensions of the components required to create a 3 Fr Model of the device, modifying (reducing) the effective length of the IV Catheter and adding different foam inserts in the final device packaging. Performance testing has been conducted to confirm that the modified device satisfies performance requirements.

SUMMARY OF TESTING 11.7

Design verification testing was conducted to demonstrate that the performance characteristics of the modified POWERWAND® Safety Introducer with an Extended Dwell Catheter (3 Fr Model) is equivalent to the predicate devices and satisfy the requirements of the product design specification for its intended use.

Prospective testing conducted for the 3 Fr Model POWERWAND® is shown in Table 11.1.

Component	Testing
24 Gauge Needle	• Strength of union between needle huband needle tube
24 Gauge Needle	• Resistance to Breakage
Dilator	• Dilator Column Strength
Dilator	• Strength of Union (Hub to Tube)
3 Fr IV Catheter –Standard Testing	• Collapse Pressure
3 Fr IV Catheter –Standard Testing	• Catheter Column Strength
3 Fr IV Catheter –Standard Testing	• Flowrate
3 Fr IV Catheter –Standard Testing	• Catheter Force at Break
3 Fr IV Catheter –Standard Testing	• Priming Volume

TABLE 11.1: PROSPECTIVE TESTING OF THE 3 FR POWERWAND®

Access Scientific, LLC. the POWERWAND® Safety Introducer with an Extended Dwell Catheter (3 Fr Model) 510(k) Premarket Notification

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Component	Testing
	• Burst Pressure
	• Freedom from Leakage
	• Chemical Compatibility
3 Fr IV Catheter – Testingafter Pre-Conditioning	· Bending Fatigue
	• Power Injection
	• Burst Pressure
Introducer System	• Axial Forces
	• Fast-flash™ Evaluation
	· Insertability
	· Needle-Stick safety
	• Intraluminal Positioning Visual
	Indicators
	• PM Content

11.8 CONCLUSIONS DRAWN FROM STUDIES

The results of testing demonstrate that the modified POWERWAND® Safety Introducer with an Extended Dwell Catheter (3 Fr Model) is substantially equivalent to the predicate device (4 & 5 Fr Models) 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).