(50 days)
Not Found
No
The summary describes a standard medical device (sheath introducer) with no mention of AI, ML, image processing, or data-driven performance metrics.
No
A 'therapeutic device' is generally designed to treat a disease or condition. This device, a sheath introducer, is used for the "percutaneous introduction of catheters and other intravascular devices into the vasculature," which is an access facilitation, not a direct treatment.
No
The provided text states that the device is "indicated for use in percutaneous introduction of catheters and other intravascular devices into the vasculature." This describes a device used for access and delivery, not for identifying a disease or condition.
No
The device description clearly indicates it is a physical sheath introducer system made of materials and available in various sizes and lengths, with performance studies focused on physical properties like tensile strength and valve leakage. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "percutaneous introduction of catheters and other intravascular devices into the vasculature." This describes a device used in vivo (within the body) for accessing blood vessels.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. The device description and intended use do not involve analyzing such samples.
- Device Description: The description focuses on the physical characteristics of a sheath introducer, which is a tool for accessing the vasculature.
- Lack of IVD-related information: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory tests.
Therefore, this device is a medical device used for accessing the vasculature, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Sheath Introducer system is indicated for use in percutaneous introduction of catheters and other intravascular devices into the vasculature.
Product codes
DYB
Device Description
The materials of construction are consistent with introducers presently in Device Description. The product is available in 4 French to 9 French. The sheath lengths are 5cm to 110cm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vasculature
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)
Non-Clinical Tests: The results of these tests demonstrated that the functionality and performance of the introducers are comparable to the currently marketed introducers. Test performed included: tensile strength, and valve leakage.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
FEB - 9 2005
510(k) Summary of Safety and Effectiveness for Galt Medical Corp. Catheter Introducer
Ko43525
(Prepared in accordance with 21 CFRPart 807.92) Date 12/14/04
(1) Submitter: Galt Medical Corp. 2475 Merritt Drive Garland, TX 75041 (972) 271-5177 Contact Person: David Catlin
- (2) Device Name: Catheter Introducer Trade Name: No proprietary name has been established. Classification Name: Catheter Introducer Classification Code: DYB
- (3) Substantial Equivalency: Galt Medical Catheter Introducer is substantially equivalent to Catheter Introducers from:
K000313 Galt
- (4) Device Description: The materials of construction are consistent with introducers presently in Device Description. The product is available in 4 French to 9 French. The sheath lengths are 5cm to 110cm.
- (5) Technological Characteristics: Galt Medical's Catheter Introducer has the same indications for use and are otherwise technically the same as the predicate devices.
- (6) Non-Clinical Tests: The results of these tests demonstrated that the functionality and performance Non-Chilter Tistis. The introducers are comparable to the currently marketed introducers. Test performed included: tensile strength, and valve leakage.
- (7) Conclusions: Based on the information presented in this 510(k) premarket notification, Galt Medical's Coliciusious. Dasco on the internation provinally equivalent to the currently marketed predicate devices.
1
Image /page/1/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" arranged around the perimeter. Inside the circle is a stylized symbol resembling an abstract caduceus or a triple-stranded helix, rendered in black.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB - 9 2005
Mr. David G. Catlin Executive Vice President Galt Medical Corp. 2475 Merritt Drive Garland, TX 75041-6146
K043525 Re:
Trade/Device Name: Catheter Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Introducer Catheter Regulatory Class: II Product Code: DYB Dated: January 7, 2005 Received: January 10, 2005
Dear Mr. Catlin:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Securer 11 (2) the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass surver in the May 28, 1976, the enactment date of the Medical Device Amendments, or to conninered prior conner as 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 1 ou may, therefore, mains of the Act include requirements for annual registration, listing of general controls provision 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 r reaso be action and 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
2
Page 2 – Mr. David G. Catlin
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (2001). In the marketing your device as described in your Section 510(k) This letter will anow you to ough maniening of substantial equivalence of your device to a legally premarket notification: "The PDF intelligstification 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 If you desire specific advice for your at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain Misoraning of reference to presensibilities under the Act from the Division of Small other general international 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/industry/support/index.html.
Sincerely yours,
Duma R. de Anes
Bram D. Zuckerman, M.D. Director
Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): K043525
Device Name: Catheter Introducer
Indications For Use: The Sheath Introducer system is indicated for use in percutaneous manodione For See. Theatheters and other intravascular devices into the vasculature..
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)
Duna R. Vochner
(Division Sign-Off)
Division of Cardiovascular Devices
510(K) Number_K O
Page 1 of ____________________________________________________________________________________________________________________________________________________________________