THE POWERWAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER

K131300 · Access Scientific, LLC · DYB · Jun 7, 2013 · Cardiovascular

Device Facts

• Record ID: K131300
• Device Name: THE POWERWAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER
• Applicant: Access Scientific, LLC
• Product Code: DYB · Cardiovascular
• Decision Date: Jun 7, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

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 Story

The POWERWAND® is an all-in-one preassembled intravascular catheter introducer system. Components include an introducer needle, nitinol guidewire, dilator, and an extended dwell catheter. The device utilizes the Accelerated Seldinger Technique to facilitate percutaneous placement of an in-dwelling catheter into the circulatory system. It features a passive needle stick safety mechanism. Clinicians use the device to gain vascular access for blood sampling and fluid administration, including power injection of contrast media. The primary modification involves changing the female Luer hub material from polyurethane (Pellathane®) to polycarbonate (Makrolon®).

Clinical Evidence

Bench testing only. No clinical data provided. Verification testing included biocompatibility per ISO 10993-1:2009 and mechanical performance testing (tensile strength, burst pressure, hub gauging, leakage, and hub integrity) to demonstrate equivalence to the predicate device.

Technological Characteristics

Components: Introducer needle, nitinol guidewire, dilator, extended dwell catheter. Material: Female Luer hub constructed of Makrolon® (polycarbonate). Principle: Accelerated Seldinger Technique for vascular access. Passive needle stick safety mechanism included. Biocompatibility testing conducted per ISO 10993-1:2009.

Indications for Use

Indicated for patients requiring vascular access for blood sampling and intravenous fluid administration, including power injection of contrast media at rates up to 5 ml/sec and pressures up to 300 psi.

Regulatory Classification

Identification

A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.

Predicate Devices

• POWERWAND® Safety Introducer with an Extended Dwell Catheter (K111417)
• POWERWAND® Safety Introducer with an Extended Dwell Catheter (K121748)

Submission Summary (Full Text)

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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 200<br>San Diego, CA 92121 |
| C. | Company Phone: | [phone] |
| D. | Company Facsimile: | [phone] |
| E. | Contact Person: | Albert Misajon<br>Chief Compliance Officer<br>[e-mail] |
| F. | Date Summary Prepared: | May 6, 2013 |
| | <b>11.2 DEVICE IDENTIFICATION</b> | |
| A. | Device Trade Name: | the POWERWAND® Safety Introducer with ar<br>Extended Dwell Catheter |
| B. | Common Name: | Catheter Introducer<br>Intravascular 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

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

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

### 11.5 INDICATIONS FOR USE

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.

### 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 with<br>Makrolon® Luer Hub | Biocompatibility testing in accordance<br>with ISO 10993-1:2009 |
| IV Catheter with<br>Makrolon® Luer Hub --<br>Standard Performance<br>Testing | • Tensile Strength<br>• Burst Pressure<br>• Hub Gauging<br>• Leakage Test - Liquid<br>• Leakage Test - Air<br>• Air Leakage during Aspiration<br>• Hub Separation Force<br>• Hub Unscrewing Force<br>• Hub Ease of Assembly<br>• Hub Resistance to Overriding<br>• Hub Stress Cracking<br>• Strain Relief Cover Tensile Test<br>• Strain Relief Cover Flex Test |
| IV Catheter with<br>Makrolon® Luer Hub -<br>Testing after<br>Pre-Conditioning | • Visual Inspection<br>• Burst Pressure |
| Introducer System | • Dilator Hub to Catheter Hub Removal<br>Torque<br>• Dilator Hub to Catheter Hub Separation<br>Force |

### 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 [phone] or [phone] 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 [phone] or [phone] 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:

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.

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