(306 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of a catheter and introducer system. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device's intended use includes administering fluids intravenously, which falls under therapeutic use. While it also samples blood, the administration of fluids directly constitutes a therapeutic action.
No
Explanation: The device is used to gain access to the vascular system for sampling blood, administering fluids, and power injection of contrast media. These are all therapeutic or interventional functions, not diagnostic ones. While blood sampling can be part of a diagnostic process, the device itself is a tool for obtaining the sample, not for performing the diagnosis.
No
The device description explicitly lists hardware components (Needle, Guidewire, Dilator, Extended Dwell IV Catheter) and describes physical interactions and performance testing related to these hardware elements. There is no mention of software as a component or function of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "gain access to the vascular system to sample blood and administer fluids intravenously." This describes a device used in vivo (within the body) for therapeutic and diagnostic sample collection purposes, not for testing samples in vitro (outside the body).
- Device Description: The description details a catheter and introducer system designed for insertion into the vascular system and remaining in place for a period of time. This is consistent with an in vivo medical device.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze or test biological samples outside the body. IVD devices are typically used in laboratories or point-of-care settings to perform tests on blood, urine, tissue, etc.
The device is clearly designed for direct interaction with the patient's vascular system for procedures like blood sampling and fluid administration, which are not functions of an IVD.
N/A
Intended Use / Indications for Use
The Power WAND™ 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 5cc/sec at up to 300 psi fluid pressure.
Product codes (comma separated list FDA assigned to the subject device)
DYB, FOZ
Device Description
The Power WAND™ Safety Introducer with an Extended Dwell Catheter is an all-in-one pre-assembled device that combines the functionality of a catheter introducer system with an extended dwcll (> 72 hours but Needle
-
Guidewire
-
Dilator
- Extended Dwell IV Catheter
The Power WAND™ Safety Introducer with an Extended Dwell Catheter accesses the target vessel using the Accelerated Scldinger Technique (AST). Once the IV Catheter is positioned within the target circulatory vessel the Needle/Guidewire/Dilator are removed from the patient as a single unit. The remaining indwelling single-lumen IV Catheter is used to sample blood and administer fluids intravenously for a time period of
§ 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).
0
510(K) SUMMARY
MAR 2 2 2011
Submitter Information 5.1
| A. | Company Name: | Access Scientific, Inc. | |
|---|---|---|---|
| B. | Company Address: | 12526 High Bluff Drive, Suite 360 | |
| San Diego, CA 92130 | |||
| C. | Company Phone: | (858) 259-8333 | |
| D. | Company Facsimile: | (858) 259-5298 | |
| E. | Contact Person: | Albert Misajon | |
| Vice President, Regulatory Affairs and | |||
| Quality Assurance | |||
| amisajon@the-wand.com | |||
| F. | Date: | January 20, 2011 |
5.2 Device Identification
| A. Device Trade Name: | the Power WAND™ Safety Introducer with an
Extended Dwell Catheter |
|----------------------------------|---------------------------------------------------------------------------------------|
| B. Common Name: | Catheter Introducer, Intravascular Catheter |
| C. Classification Name(s): | Catheter Introducer
Catheter, Intravascular, Therapeutic, Short-Term, The WAND™ MicroAccess Safety Introduccr manufactured by Access Scientific and cleared for commercial distribution under 510(k) (K081697)
-
The PICC WAND™ Peelable Safety Introducer manufactured by Access Scientific, Inc. and cleared for commercial distribution under 510(k) K093022
1
- The Introcan Safety" IV Catheter manufactured by B. Braun Medical, Inc. and cleared for commercial distribution under 510(k) K020785
- The BD OneCath™ manufactured by Becton Dickinson Infusion Therapy Systems. Inc. and cleared for commercial distribution under 510(k) K042862
5.4 Device Description
The Power WAND™ Safety Introducer with an Extended Dwell Catheter is an all-in-one pre-assembled device that combines the functionality of a catheter introducer system with an extended dwcll (> 72 hours but Needle
-
Guidewire
-
Dilator
- Extended Dwell IV Catheter ﺮ ﺍ
The Power WAND™ Safety Introducer with an Extended Dwell Catheter accesses the target vessel using the Accelerated Scldinger Technique (AST). Once the IV Catheter is positioned within the target circulatory vessel the Needle/Guidewire/Dilator are removed from the patient as a single unit. The remaining indwelling single-lumen IV Catheter is used to sample blood and administer fluids intravenously for a time period of In Vivo Thrombogenicity | ISO 10993-4:2002
(Direct Contact) |
| 9 | Complement Activation | ISO 10993-4:2002
(C3a and SC5b-9 Complexes) |
| 10 | Genotoxicity: Bacterial Reverse Mutation
(Ames) | ISO 10993-3:2003
(Saline and PEG extracts) |
| 11 | Genotoxicity: In Vitro Mouse Lymphoma | ISO10993-3:2003
(Saline and PEG Extracts) |
| 12 | Genotoxicity: In Vivo Mouse
Micronucleus | ISO10993-3:2003
(Saline and Cottonseed Oil Extracts) |
| 13 | Subchronic Intravenous Toxicity | ISO 10993-11:2006
(Saline Extract) |
| 14 | Subacute Intraperitoneal Toxicity | ISO 10993-11:2006
(Cottonseed Oil Extract) |
| 15 | Subcutaneous Implant | ISO 10993-6:2007
(Direct Contact) |
TABLE 5.1: BIOCOMPATIBILITY TEST PROGRAM
Performance characteristic testing was conducted to evaluate the performance requirements I the Power WAND™ Safety Introducer with an Extended Dwell Cather. - Testing
leveraged from the previously cleared predicated evices is summarized in Table 5.2.
4
| Component | Testing | Applicable 510(k) |
|---|---|---|
| 21-Gauge Needle | • Lumen patency | |
| • Tensile strength: tube-to-hub | ||
| bond | ||
| • Air leak/resistance to stress | ||
| cracking | ||
| • Corrosion resistance | K081697 | |
| 0.018" Guidewire (Nitinol) | • Fracture testing | |
| • Flex testing | ||
| • Strength of union: core-to-coil | ||
| • Strength of union: wire-to-cap | ||
| • Corrosion resistance | K093022 | |
| Introducer System | • Needle-stick safety | |
| • Guidewire cap snap-on force | ||
| • Needle lock to Needle hub | ||
| separation force | K081697 |
TABLE 5.2: PRIOR APPLICABLE TESTING CONDUCTED FOR THE PREDICATE DEVICES MANUFACTURED BY ACCESS SCIENTIFIC, INC.
Prospective testing of the Dilator included the following testing:
- Distal tip columnar strength
- · Strength of union: tube-to-hub
Prospective testing of the IV Catheter included the following testing:
- · Collapse Pressure
- Distal tip columnar strength
- · Catheter Flow Ratc
- · Tensile Strength
- Priming Volume
- · Catheter Burst Pressure
- Catheter-Hub Gauging
- · Catheter-Hub Liquid Leakage
- · Catheter-Hub Air Leakage
- · Catheter-Hub Separation Force
- · Catheter-Hub Stress Cracking
- · Catheter-Hub Unscrewing Torque
- · Catheter-Hub Ease of Assembly
5
- · Catheter-Hub Resistance to Overriding
- · Infusion Induced Catheter Movement
Prospective testing of the IV Catheter following "worst-case" pre-conditioning included the following:
KIO1422
- · Visual Inspection
- · Fatigue Testing
- · Power Injection
- · Catheter Elongation
- · Catheter Burst Pressure
Prospective testing of the integrated Power WAND™ Safety Introducer with an Extended Dwell Catheter included the following:
- · Catheter Hub- StatLock IV Ultra® Securement Device Separation Force
- · Dilator to Catheter Fit-up
- · Dilator Hub-Catheter Hub Removal Torque
- Dilator Hub-Catheter Hub Separation Force e
- · Axial Forces
- · Fast-flash Evaluation
- Introducer System Insertability a
- · Needle Cover Removal Force
- · Needle to Dilator Fit-up
Test results indicate that the device satisfies all performance requirements for its intended use.
Conclusions Drawn from Studies 5.8
The results of testing demonstrate that the Power WAND™ Safety Introducer with an Extended Dwcll Catheter is substantially equivalent to the predicate devices in design, function, and indications for use.
6
Image /page/6/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized depiction of an eagle or bird-like figure, with flowing lines suggesting movement or flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the central emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Albert Misaion Vice President, Regulatory Affairs 12526 High Bluff Drive Suite 2360 San Diego, CA 92130
MAR 2 2 2011
Re: K101422
Trade/Device Name: Regulation Number: 21 CFR 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: March 11, 2011 Received: March 14, 2011
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.
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
7
Page 2 - Mr. Albert Misajon
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 yours,
R. Vahner
ABram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
8
INDICATIONS FOR USE
510(k) Number: To Bc Assigned By FDA KIDI422
Device Name: the Power WAND™ Safety Introducer with an Extended Dwell Catheter
Indications for Use:
The Power WAND™ 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 5cc/sec at up to 300 psi fluid pressure.
AND/OR Over-The-Counter Use __________________________________________________________________________________________________________________________________________________ × Prescription Use (21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BEI.OW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
priva 2. Jacksones
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_K10 1422
Access Scientific, Inc. Original 510(k) Premarket Notification Original Stority Front Safety Introducer with an Extended Dwell Catheter