THE POWERWAND SAFETY INTRODUCER WITH AND EXTENDED DWELL

K121748 · Access Scientific, Inc. · DYB · Jul 27, 2012 · Cardiovascular

Device Facts

• Record ID: K121748
• Device Name: THE POWERWAND SAFETY INTRODUCER WITH AND EXTENDED DWELL
• Applicant: Access Scientific, Inc.
• Product Code: DYB · Cardiovascular
• Decision Date: Jul 27, 2012
• 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

All-in-one preassembled intravascular catheter introducer; includes introducer needle, guidewire, dilator, and extended dwell catheter. Used by clinicians to place in-dwelling intravascular catheters via Accelerated Seldinger Technique. Features Fast-flash™ mechanism providing visual feedback of intraluminal needle position; includes safety mechanism to prevent accidental needle sticks. Enables blood sampling and fluid/contrast media administration. Used in clinical settings for vascular access.

Clinical Evidence

Bench testing only. Design verification testing confirmed performance equivalence to the predicate device. Testing included corrosion resistance, tensile strength, fracture/flex tests, catheter hub testing, flow rate, burst pressure, collapse pressure, and Fast-flash™ evaluation.

Technological Characteristics

Components: 22G needle, 0.012" guidewire, 4 Fr catheter, dilator. Materials and chemical composition identical to predicate. Mechanical sensing via Fast-flash™ visual feedback. Manual operation. Sterile, single-use device.

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 (5 Fr Model) (K111417)

Submission Summary (Full Text)

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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 360<br>San Diego, CA 92130 |
| C. | Company Phone: | [phone] |
| D. | Company Facsimile: | [phone] |
| E. | Contact Person: | Albert Misajon<br>Chief Compliance Officer<br>[e-mail] |
| F. | Date Summary Prepared: | July 16, 2012 |
| 11.2 | DEVICE IDENTIFICATION | |
| A. | Device Trade Name: | the POWERWAND® Safety Introducer with an<br>Extended Dwell Catheter<br>4 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

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

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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

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 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 Access<br>Scientific 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<br>• Needle lock to Needle hub<br>separation force | K081697 | |
| Introducer System | · Dilator to Catheter fit-up<br>· Dilator Hub-Catheter Hub<br>removal torque<br>· Dilator Hub-Catheter Hub<br>separation force<br>· 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<br>• Resistance to Breakage |
| 0.012" Guidewire | • Fracture Test<br>• Flex Test<br>• Strength of Union: Core-to-Coil<br>• Strength of Union: Wire-to-Cap |
| Dilator | • Distal Tip Columnar Strength<br>• Strength of Union: Tube-to-Hub<br>• Insert Leak |
| 4 Fr IV Catheter –<br>Standard Testing | • Collapse Pressure<br>• Distal Tip Columnar Strength<br>• Flow Rate<br>• Tensile Strength<br>• Priming Volume<br>• Burst Pressure<br>• Leakage Test - Liquid<br>• Leakage Test - Air<br>• Catheter Tip Movement during Power Injection |
| 4 Fr IV Catheter – Testing<br>after Pre-Conditioning | • Visual Inspection<br>• Fatigue Test<br>• Power Injection<br>• Elongation<br>• Burst Pressure |
| Introducer System | • Axial Forces<br>• Fast-flashTM Evaluation<br>• Insertability<br>• Needle-Stick safety<br>• 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

M.A. Hilliker

f

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:

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)

CMA Killilea

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

510(k) Number K121748