(170 days)
Not Found
No
The document describes a mechanical device for facilitating catheter placement and does not mention any computational or data-driven features indicative of AI/ML.
No
The device is used to facilitate the placement of an intravascular catheter, which is a procedural tool rather than a therapeutic instrument itself. It does not directly treat or diagnose a disease.
No.
The WAND™ MicroAccess Safety Introducer is used to facilitate the placing of an intravascular catheter, which is a procedural function, not a diagnostic one. Its purpose is to introduce other devices into the body, not to detect, monitor, or identify a disease or condition.
No
The device description explicitly states it is an "integrated sterile, single-use intravascular catheter introducer" and lists physical components like an Introducer Needle, Guidewire, Dilator, and Introducer Sheath. This indicates it is a hardware medical device, not software-only.
Based on the provided information, the WAND™ MicroAccess Safety Introducer is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "facilitate the placing of an intravascular catheter through the skin into the peripheral circulatory system." This describes a procedure performed on the patient's body, not a test performed on a sample taken from the patient.
- Device Description: The device components (Introducer Needle, Guidewire, Dilator, Introducer Sheath) are all tools used for accessing a blood vessel within the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The WAND™ MicroAccess Safety Introducer is a surgical/procedural device used for accessing the circulatory system.
N/A
Intended Use / Indications for Use
The WAND™ MicroAccess Safety Introducer is used to facilitate the placing of an intravascular catheter through the skin into the peripheral circulatory system.
Product codes
DYB
Device Description
The WAND™ MicroAccess Safety Introducer is an integrated sterile, single-use intravascular catheter introducer. It is designed to incorporate a combination of devices into an all-in-one device that provides the clinician with a safe and simple approach to the Modified Seldinger technique, and thereby accelerate the procedure required to place indwelling intravascular catheters. The device includes an Introducer Needle, Guidewire, Dilator, and Introducer Sheath in a single integrated device, and incorporates a safety mechanism to guard against accidental needlestick.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A program of design verification testing including biocompatibility testing and in vitro bench testing is used to demonstrate the biological safety and biomechanical performance characteristics of the WAND™ MicroAccess Safety Introducer. Test results indicate that the device is equivalent to the predicate devices and satisfies mechanical performance requirements for its intended use. The results of testing demonstrate that the WAND™ MicroAccess Safety Introducer is substantially equivalent to the predicate devices in design, function, and indications for use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Arrow International Emergency Infusion Device K840455, BD Introsyte Precision Introducer K020834, Stiffer Coaxial Micro-Introducer Set K071574
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
Original 510(k) Premarket Notification The WAND™ MicroAccess Safety Introducer
510(K) SUMMARY
DEC 0 4 2008
Submitter Information 5.1
A. Company Name:
B. Company Address:
C. Company Phone:
D. Company Facsimile:
E. Contact Person:
Access Scientific, Inc.
12526 High Bluff Drive, Suite 360 San Diego, CA 92130
(858) 259-8333
(858) 259-5298
Albert Misajon Vice President, Regulatory Affairs and Quality Assurance amisajon@the-wand.com
Device Identification 5.2
| A. Device Trade Name: | The WAND™ MicroAccess Safety Introducer |
|---|---|
| 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 |
5.3 Identification of Predicate Devices
The WAND™ MicroAccess Safety Introducer is substantially equivalent to the following devices, which are cleared for commercial distribution in the United States:
- · Arrow International Emergency Infusion Device distributed under cleared 510(k) Number K840455
- · BD Introsyte Precision Introducer distributed under cleared 510(k) Number K020834 (Beckton Dickinson Infusion Therapy Systems, Inc.)
- · Stiffer Coaxial Micro-Introducer Set distributed under cleared 510(k) Number K071574 (Enpath Medical, Inc.)
Access Scientific, Inc.
1
Device Description 5.4
The WAND™ MicroAccess Safety Introducer is an integrated sterile, single-use intravascular catheter introducer. It is designed to incorporate a combination of devices into an all-in-one device that provides the clinician with a safe and simple approach to the Modified Seldinger technique, and thereby accelerate the procedure required to place indwelling intravascular catheters. The device includes an Introducer Needle, Guidewire, Dilator, and Introducer Sheath in a single integrated device, and incorporates a safety mechanism to guard against accidental needlestick.
5.5 Indications for Use
The WAND™ MicroAccess Safety Introducer is used to facilitate the placing of an intravascular catheter through the skin into the peripheral circulatory system.
Biocompatibility and Performance Testing ર્સ્ટ
A program of design verification testing including biocompatibility testing and in vitro bench testing is used to demonstrate the biological safety and biomechanical performance characteristics of the WAND™ MicroAccess Safety Introducer. Test results indicate that the device is equivalent to the predicate devices and satisfies mechanical performance requirements for its intended use.
5.7 Sterility
The WAND™ MicroAccess Safety Introducer is provided "STERILE" by ethylene oxide gas to a sterility assurance level of 106.
Conclusions Drawn from Studies 5.8
The results of testing demonstrate that the WAND™ MicroAccess Safety Introducer is substantially equivalent to the predicate devices in design, function, and indications for use.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 0 4 2008
Access Scientific, Inc. c/o Mr. Albert Misajon Vice President, Regulatory Affairs and Quality Assurance 12526 High Bluff Drive, Suite 360 San Diego, CA 92130
Re: K081697
Trade/Device Name: The WAND™ MicroAccess Safety Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Introducer, Catheter Regulatory Class: Class II Product Code: DYB Dated: October 31, 2009 Received: November 3, 2008
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality
3
Page 2 - Mr. Albert Misajon
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.
This letter will allow you to begin marketing your device as described in your Section 510/k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
ina R. buhner
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
510(k) Number: To Be Assigned By FDA LUS 1697
Device Name: The WAND™ MicroAccess Safety Introducer
Indications for Use: The WAND™ MicroAccess Safety Introducer is used to facilitate the placing of an intravascular catheter through the skin into the peripheral circulatory system.
Prescription Use X AND/OR Over-The-Counter Use (21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
sumer R. bo
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_408 16 97
Access Scientific, Inc.