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, Nitinol 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 presented document describes the 510(k) premarket notification for the POWERWAND® Safety Introducer with an Extended Dwell Catheter. This submission is for a modified device with a change in the material of the female Luer hub from Pellathane® (polyurethane) to Makrolon® (polycarbonate). The aim of the submission is to demonstrate substantial equivalence to the predicate device, not to introduce a new AI-powered diagnostic or assistive tool.

Therefore, many of the typical acceptance criteria and study aspects related to AI/ML devices (such as sample size for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types) are not applicable to this medical device submission.

Here's an analysis based on the provided text, focusing on the device's performance through engineering verification testing:

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

The document does not explicitly state numerical acceptance criteria for each test. Instead, it describes "performance requirements" and "satisfies requirements of the product design specification," implying that the modified device met pre-defined internal benchmarks based on the predicate device's performance. The reported "performance" is that the device passed these tests and was found to be substantially equivalent to the predicate.

Component / Test Area	Specific Tests Conducted	Acceptance Criteria (Implied)	Reported Device Performance
IV Catheter with Makrolon® Luer Hub	Biocompatibility testing in accordance with ISO 10993-1:2009	Meets ISO 10993-1:2009 standards for biocompatibility.	Passed (implied by "substantially equivalent" conclusion)
IV Catheter with Makrolon® Luer Hub - Standard Performance Testing	• Tensile Strength• Burst Pressure• Hub Gauging• Leakage Test - Liquid• Leakage Test - Air• Air Leakage during Aspiration• Hub Separation Force• Hub Unscrewing Force• Hub Ease of Assembly• Hub Resistance to Overriding• Hub Stress Cracking• Strain Relief Cover Tensile Test• Strain Relief Cover Flex Test	Meets product design specifications and is equivalent to predicate device performance for each metric.	Passed for all listed tests (implied by "substantially equivalent" conclusion)
IV Catheter with Makrolon® Luer Hub - Testing after Pre-Conditioning	• Visual Inspection• Burst Pressure	Maintains integrity and specified burst pressure after pre-conditioning, equivalent to predicate.	Passed for all listed tests (implied by "substantially equivalent" conclusion)
Introducer System	• Dilator Hub to Catheter Hub Removal Torque• Dilator Hub to Catheter Hub Separation Force	Meets product design specifications and is equivalent to predicate device performance for these forces.	Passed for all listed tests (implied by "substantially equivalent" conclusion)

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: The document does not specify the sample size for any of the performance tests conducted. For device verification testing, sample sizes are typically determined by statistical methods or industry standards.
Data Provenance: The testing was "prospective" in the sense that it was conducted specifically for this submission to verify the new material. "TABLE 11.1: PROSPECTIVE TESTING OF THE POWERWAND®" indicates the testing was planned and executed for the modified device. The country of origin of the data is not specified, but the submitter is Access Scientific, LLC. (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 question is not applicable. The device is a physical medical instrument, and its performance is assessed through engineering and bench testing, not through expert-evaluated clinical data or image interpretation. "Ground truth" in this context refers to the physical properties and performance characteristics measured against established standards or specifications, not expert consensus on medical findings.

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

This question is not applicable. Adjudication methods like 2+1 or 3+1 refer to human expert review processes for clinical data, which were not part of this device's performance testing.

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 question is not applicable. An MRMC study is relevant to AI/ML-driven diagnostic or assistive devices involving human readers (e.g., radiologists interpreting images). This submission is for a physical medical device (an introducer with a catheter) and does not involve AI or human readers for diagnosis.

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

This question is not applicable. The device is a physical medical instrument and does not involve an algorithm working in "standalone" mode.

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

The "ground truth" for this device's performance is based on established engineering and materials science standards, regulatory requirements (e.g., ISO 10993-1 for biocompatibility), and internal product design specifications derived from the predicate device's performance. It is not based on expert consensus, pathology, or outcomes data in the medical diagnostic sense.

8. The sample size for the training set

This question is not applicable. This is a modified physical medical device, not an AI/ML model that requires a training set.

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

This question is not applicable. As this is not an AI/ML device, there is no training set or associated ground truth in that context.

Summary

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510(K) SUMMARY

11.1 SUBMITTER INFORMATION

JUN 0 7 2013

A.	Company Name:	Access Scientific, LLC.
B.	Company Address:	3910 Sorrento Valley Boulevard, Suite 200San 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 Summary Prepared:	May 6, 2013
	11.2 DEVICE IDENTIFICATION
A.	Device Trade Name:	the POWERWAND® Safety Introducer with arExtended Dwell Catheter
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 (5 Fr Models) cleared for commercial distribution under Premarket Notification Numbers K111417 and K121748.

11.4 DEVICE DESCRIPTION

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contrast media. The device also incorporates a mechanism that provides passive needle stick safety.

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 material of the female Luer hub on the IV Catheter, which has been changed from Pellathane® (polyurethane) to Makrolon® (polycarbonate). 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 (Makrolon Model) is equivalent to the predicate device and satisfy the requirements of the product design specification for its intended use.

The testing conducted for the POWERWAND® with IV Catheter with Makrolon® Hub is shown in Table 11.1.

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Component	Testing
IV Catheter withMakrolon® Luer Hub	Biocompatibility testing in accordancewith ISO 10993-1:2009
IV Catheter withMakrolon® Luer Hub --Standard PerformanceTesting	• Tensile Strength• Burst Pressure• Hub Gauging• Leakage Test - Liquid• Leakage Test - Air• Air Leakage during Aspiration• Hub Separation Force• Hub Unscrewing Force• Hub Ease of Assembly• Hub Resistance to Overriding• Hub Stress Cracking• Strain Relief Cover Tensile Test• Strain Relief Cover Flex Test
IV Catheter withMakrolon® Luer Hub -Testing afterPre-Conditioning	• Visual Inspection• Burst Pressure
Introducer System	• Dilator Hub to Catheter Hub RemovalTorque• Dilator Hub to Catheter Hub SeparationForce

TABLE 11.1: PROSPECTIVE TESTING OF THE POWERWAND®

11.8 CONCLUSIONS DRAWN FROM STUDIES

The results of testing demonstrate that the modified POWERWAND® Safety Introducer with an Extended Dwell Catheter (IV Catheter with Makrolon® Luer Hub) is substanially equivalent to the predicate device in design, function, and indications for use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three wing-like shapes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the bird symbol.

Public Health Service

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

June 7, 2013

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

Re: K131300

Trade/Device Name: POWERWAND® Safety Introducer with an Extended Dwell Catheter Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Intravascular Catheter, Therapeutic, Short-Term Regulatory Class: Class II Product Code: DYB Dated: May 8, 2013 Received: May 9, 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.

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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 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/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 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Matthew G. Hillebrenner

for
Bram D. Zuckerman, Ph.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): K131300

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)

Matthew GJWillebrenner

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).