(25 days)
Not Found
No
The summary describes a standard medical device (introducer sheath) with no mention of AI/ML capabilities, image processing, or data-driven performance metrics.
No.
The device, an Introducer, is used for inserting catheters into the venous system, which is a procedural step rather than a direct therapeutic action to treat a disease or condition.
No
The device is an introducer, used for the percutaneous insertion of catheters in the venous system, which is a procedural/interventional function rather than a diagnostic one.
No
The device description explicitly states it is a physical introducer with a PTFE sheath, available in different sizes and lengths, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for use in the percutaneous insertion of catheters in the venous system." This describes a procedure performed directly on a patient, not a test performed on a sample taken from a patient.
- Device Description: The device is a "Valved Introducer" with a sheath, designed for inserting catheters. This is a physical tool used in a medical procedure.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical/interventional tool.
N/A
Intended Use / Indications for Use
"The AirGuard™ Valved Introducer is indicated for use in the percutaneous insertion of catheters in the venous system."
Product codes
DYB
Device Description
AirGuard™ Valved Introducers have a PTFE sheath and are available in 15Fr and 16.5Fr sizes, and in lengths of 13cm and 18cm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
venous system
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
Design verification testing was conducted in conformance to in-house protocols, and performed or evaluated based on the following standards:
- AAMI/ANSI/ISO-10993-1: 1997, Biological evaluation of medical devices Part 1: Evaluation . and testing, and the FDA Modified ISO 10993 Test Profile
- . AAMI/ANSI/ISO 11135:1994, Medical devices – Validation and routine control of elhylene oxide sterilization
- . ISO 11070:1998(E), Sterile single-use intravascular catheter introducers
Results from biocompatibility testing met the requirements of ISO-10993, "Biological Evaluation of Medical Devices Part-1: Evaluation and Testing" and the FDA Modified ISO 10993 Test Profile for externally communicating, direct blood-contacting, limited-exposure devices. All test results confirm the subject device to be substantially equivalent to the predicate device.
Key Metrics
Not Found
Predicate Device(s)
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
AUG 2 3 2004
AirCinard 510(k)
AirGuard™ Valved Introducer 510(k) Summary of Safety and Effectiveness 21 CFR 807.92(a).
General Information:
| Submitter Name: | Bard Access Systems, Inc. (BAS)
[Wholly owned Subsidiary of C. R. Bard, Inc.] |
|----------------------|----------------------------------------------------------------------------------|
| Address: | 5425 W. Amelia Earhart Drive
Salt Lake City, UT 84116 |
| Telephone Number: | (801) 595-0700 ext. 5525 |
| Fax Number: | (801) 595-5425 |
| Contact Person: | Glenn Norton |
| Date of Preparation: | August 20, 2004 |
Device Information:
| Device Name: | AirGuard™ Valved Introducer |
|---|---|
| Trade Name: | AirGuard™ |
| Common/Usual Name: | Catheter Introducer |
| Classification Name: | 74DYB - Introducer, Catheter |
| 21 CFR 870.1340 - Class II | |
| Classification Panel: | Cardiovascular and Respiratory Devices |
Predicate Device:
MedAmicus FlowGuard™Peelable Introducer, 510(k) K040150, FDA clearance date 02/18/2004
Summary of Change:
The modification to the MedAmicus FlowGuard™Peelable Introducer is a passive valve design for improved reduction of air and blood leakage during percutaneous catheter placement.
Device Description:
AirGuard™ Valved Introducers have a PTFE sheath and are available in 15Fr and 16.5Fr sizes, and in lengths of 13cm and 18cm.
Intended Use of Devices:
AirGuard is recommended for use in the percutaneous insertion of cathelers in the venous system.
Technological Comparison to Predicate Devices:
The technological characteristics of the AirGuard Valved Introducer are substantially equivalent to those of the predicate FlowGuard Peelable Introducer in terms of intended use, application, user population, basic design, performance, labeling, packaging, and sterilization method. Bench performance test results met all requirements and were comparable to the predicate device.
1
Air Juarc 510(k)
Non-Clinical Performance Data
Design verification testing was conducted in conformance to in-house protocols, and performed or evaluated based on the following standards:
- AAMI/ANSI/ISO-10993-1: 1997, Biological evaluation of medical devices Part 1: Evaluation . and testing, and the FDA Modified ISO 10993 Test Profile
- . AAMI/ANSI/ISO 11135:1994, Medical devices – Validation and routine control of elhylene oxide sterilization
- . ISO 11070:1998(E), Sterile single-use intravascular catheter introducers
Results from biocompatibility testing met the requirements of ISO-10993, "Biological Evaluation of Medical Devices Part-1: Evaluation and Testing" and the FDA Modified ISO 10993 Test Profile for externally communicating, direct blood-contacting, limited-exposure devices.
All test results confirm the subject device to be substantially equivalent to the predicate device.
Conclusion
AirGuard Valved Introducers met all performance criteria of design verification as specified by applicable standards, test protocols and/or customer inputs. Based on FDA's decision trees, the AirGuard Valved Introducer is substantially equivalent to the legally marketed predicate device, the MedAmicus FlowGuard™ Peelable Introducer, 510(k)# K040150, clearance date 02/18/2004.
2
Image /page/2/Picture/1 description: The image shows a circular logo with text around the perimeter and a stylized bird design in the center. The text is small and difficult to read, but it appears to be arranged in a circular fashion around the top half of the logo. The bird design consists of three parallel, curved lines that resemble the shape of a bird in flight. The lines are thicker at the top and taper towards the bottom, giving the impression of movement or speed.
Public Health Service
AUG 2 3 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Bard Access Systems, Inc. (BAS) c/o Mr. Robert Mosenkis President CITECH 5200 Butler Pike Plymouth Meeting, PA 19462-1298
- Re: K042036
Trade/Device Name: AirGuard™ Valved Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Introducer, Catheter Regulatory Class: Class II Product Code: DYB Dated: July 27, 2004 Received: July 29, 2004
Dear Mr. Mosenkis:
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 for associous 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 (IPMA). 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 I rease of a novel 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
3
Page 2 - Mr. Robert Mosenkis
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic rend wt 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) I ms lotter will and in yourse finding of substantial equivalence of your device to a legally premated predicate device results in a classification for your device and th . . 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 in you a some of Compliance at (301) 594-4648. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other generalional and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address
http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
p
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Air( juard く 】 ・ 】 ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・
Section 1-B
AirGuard™ Valved Introduccr 510(K)
INDICATION(S) FOR USE STATEMENT*
I state in my capacity as Senior Regulatory Affairs Specialist of Bard Access Systems, that this notification [510(k)] for the AirGuard™ Valved Introducer is indicated for the following:
"The AirGuard™ Valved Introducer is indicated for use in the percutaneous insertion of catheters in the venous system."
Signature of 510(k) Submitter:
Printed Name of Submitter:
Glenn Norton
Date:
7-7-04
*Suggested language and format to meet the requirements of sections 513(i) of the Federal Food, Drug, and Cosmetic Act, as amended, and sections 807.92(a)(5) and 801. 4 of the Code of Federal Regulations, Title 21.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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)
510(k) Number
510(k) Number
Division Sign-Off
Office of Device Evaluation
000005