(113 days)
Not Found
No
The summary describes a mechanical device for facilitating catheter placement and does not mention any software, algorithms, or data processing that would indicate AI/ML.
No
The device facilitates the placement of a catheter, but it does not directly treat a condition or restore a function.
No
Explanation: The device description states its purpose is to "facilitate the placing of an intravascular catheter," and it includes components like an introducer needle, guidewire, dilator, and peelable sheath introducer. These are tools for performing a medical procedure (catheter placement), not for diagnosing a condition or disease.
No
The device description clearly states it is an integrated sterile, single-use intravascular catheter introducer that includes physical components like an Introducer Needle, Guidewire, Dilator, and Peelable Sheath Introducer. It is a hardware device used to facilitate a medical procedure.
Based on the provided information, this device 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 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, Peelable Sheath Introducer) are all tools used for accessing the circulatory system, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, tissue, or any other biological sample. There is no mention of detecting or measuring substances in a sample.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device is a procedural tool used for accessing the circulatory system.
N/A
Intended Use / Indications for Use
The PICC WAND® Peelable Safety Introducer is used to facilitate the placing of an intravascular catheter through the skin into the circulatory system.
Product codes (comma separated list FDA assigned to the subject device)
DYB
Device Description
The PICC WAND® Peelable 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 a Peelable Sheath Introducer 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 has been completed to demonstrate the biological safety and biomechanical performance characteristics of the PICC WAND® Peelable Safety Introducer. Test results indicate that the device is equivalent to the predicate device and satisfies mechanical performance requirements for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
KC93022
510(K) SUMMARY
JAN 20 2010
11.1 SUBMITTER INFORMATION
| 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 |
DEVICE IDENTIFICATION 11.2
| A. | Device Trade Name: | the PICC WAND® Peelable 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 |
11.3 IDENTIFICATION OF PREDICATE DEVICE
The PICC WAND® Peelable Safety Introducer is substantially equivalent to the WAND® MicroAccess Safety Introducer manufactured by Access Scientific, Inc. and cleared for commercial distribution under 510(k) K090372.
11.4 DEVICE DESCRIPTION
The PICC WAND® Peelable 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 a Peelable Sheath Introducer in a single integrated device, and incorporates a safety mechanism to guard against accidental needlestick.
1
11.5 INDICATIONS FOR USE
The PICC WAND® Peelable Safety Introducer is used to facilitate the placing of an intravascular catheter through the skin into the circulatory system.
11.6 BIOCOMPATIBILITY AND PERFORMANCE TESTING
A program of design verification testing including biocompatibility testing and in vitro bench testing has been completed to demonstrate the biological safety and biomechanical performance characteristics of the PICC WAND® Peelable Safety Introducer. Test results indicate that the device is equivalent to the predicate device and satisfies mechanical performance requirements for its intended use.
11.7 STERILITY
The PICC WAND® Peelable Safety Introducer is provided 'STERILE' by ethylene oxide gas to a sterility assurance level of 10-9.
11.8 CONCLUSIONS DRAWN FROM STUDIES
The results of testing demonstrate that the PICC WAND® Peelable Safety Introducer is substantially equivalent to the predicate device in design, function, and indications for use.
2
Image /page/2/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 eagle with its wings spread, symbolizing protection and service. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA", indicating the department's name and national affiliation.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring; MD 20993-0002
JAN 2 0 2010
Access Scientific, Inc c/o Mr. Albert Misajon Vice President, Regulatory Affairs and Quality Assurance 12526 High Bluff Drive, Ste 360 San Diego, CA 92130
Re: K093022
Trade Name: PICC WAND Peelable Safety Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II (two) Product Code: DYB Dated: December 15, 2009 Received: December 16, 2009
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. Drue, 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.
3
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 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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
en R. balmer
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 (if known): K093022
Device Name:
the PICC WAND® Peelable Safety Introducer
Indications for Use:
The PICC WAND® Peelable Safety Introducer is used to facilitate the placing of an intravascular catheter through the skin into the circulatory system.
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)
Dummer R. Salunes
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_K 69 30 22