(237 days)
Not Found
No
The summary describes a mechanical introducer system with a hemostasis valve and does not mention any software, algorithms, or AI/ML capabilities.
No.
The device is an introducer system used to facilitate the placement of other catheters or devices, rather than directly treating a condition itself.
No
The device's intended use and description explicitly state its purpose is to introduce catheters and other intravascular devices into the peripheral vasculature, not to diagnose medical conditions. It functions as an access tool for interventional procedures.
No
The device description explicitly states it is a "tear-away introducer" and describes its physical construction and materials, indicating it is a hardware device. The performance studies also focus on physical characteristics like force testing and biocompatibility.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to introduce catheters and other intravascular devices into the peripheral vasculature for percutaneous procedures. This is a direct medical intervention on a patient, not a test performed on a sample taken from a patient.
- Device Description: The device is a tear-away introducer used to facilitate the insertion of other devices into the body. This is a surgical/interventional tool.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, providing diagnostic information, or being used in a laboratory setting.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Introducer System is intended for use in percutaneous procedures to introduce catheters and other intravascular devices into the peripheral vasculature.
Product codes (comma separated list FDA assigned to the subject device)
DYB
Device Description
The finished device is a tear-away introducer for use in percutaneous procedures to introduce or position catheters or other interventional devices into the peripheral vasculature. The unmodified predicate introducers are constructed of the same or similar materials. The device is being modified to add a tear-away hemostasis valve. The combined performance characteristics of the predicate devices are unchanged and are consistent with other legally marketed predicate devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral 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)
Design verification included leak testing, force testing, hub break force, perpendicular pull and shelf-life test. The following biocompatibility tests were also performed: cytotoxicity, sensitization, irritation, systemic toxicity, hemolysis, and hemocompatibility (complement activation and in-vivo thrombogenicity.) The results of the DV testing confirmed that design inputs were achieved and the cumulative test results demonstrated the functionality, safety and effectiveness of the Valved Tearaway Introducer, as well as its substantial equivalence to the predicate devices.
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
Image /page/0/Picture/0 description: The image shows the text "APR 12 2012" on the left side. On the right side, the text "K112398 Page 1 of 1" is present. The text appears to be handwritten and is likely part of a document or form.
510(k) SUMMARY (as required by section 807.92(c))
| Device Name: | GaltVTI™ Valved Tearaway Introducer |
|---|---|
| Device Models: | The GaltVTI™ is offered with a standard or a flexible dilator and an |
| optional side port. The products are offered sterile or bulk non-sterile. | |
| Classification Name: | Catheter Introducer (DYB), 21 CFR 870.1340 |
| Device Classification: | Class II (Cardiovascular) |
| Predicate Devices: | Tearaway Introducer Sheath, K000313 |
| Catheter Introducer, K043525 | |
| Manufacturer: | Galt Medical |
| 2220 Merritt Drive | |
| Garland, TX 75041 | |
| Establishment | Registration Number: |
| Registration Number: | 1649395 |
| Official Contact: | Betsy Cortelloni |
| Corporate Director of Quality and Regulatory Affairs | |
| Theragenics Corporation | |
| 5203 Bristol Industrial Way | |
| Buford, GA 30518 | |
| Phone: 770-831-4294; Fax: 770-831-4369 | |
| cortellb@theragenics.com |
Intended Use: The Introducer System is intended for use in percutaneous procedures to introduce catheters and other intravascular devices into the peripheral vasculature.
Device Description: The finished device is a tear-away introducer for use in percutaneous procedures to introduce or position catheters or other interventional devices into the peripheral vasculature. The unmodified predicate introducers are constructed of the same or similar materials. The device is being modified to add a tear-away hemostasis valve. The combined performance characteristics of the predicate devices are unchanged and are consistent with other legally marketed predicate devices.
Comparison of Technological Characteristics: The GaltVTI™ Valved Tearaway Introducer is substantially equivalent to the unmodified predicates in materials, construction, and in device performance.
Use Type: The Valved Tearaway Introducer is a single patient use, disposable device.
Performance Testing: Design verification included leak testing, force testing, hub break force, perpendicular pull and shelf-life test. The following biocompatibility tests were also performed: cytotoxicity, sensitization, irritation, systemic toxicity, hemolysis, and hemocompatibility (complement activation and in-vivo thrombogenicity.)
Conclusion: The results of the DV testing confirmed that design inputs were achieved and the cumulative test results demonstrated the functionality, safety and effectiveness of the Valved Tearaway Introducer, as well as its substantial equivalence to the predicate devices.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
APR 1 2 2012
Theragenics Corporation c/o Ms. Betsy Cortelloni Corporate Director of Quality and Regulatory Affairs 5203 Bristol Industrial Wav Buford, GA 30518
Re: K112398
Trade/Device Name: GaltVTI™ Valved Tearaway Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: March 9, 2012 Received: March 13, 2012
Dear Ms. Cortelloni:
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 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
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Page 2 - Ms. Betsy Cortelloni
(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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/CDRH0ffices/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/ReportalProblem/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 (240) 276-3150 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
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 FORM
510(K) number (if known):_____________________________________________________________________________________________________________________________________________________ K112398
GaltVTI™ Valved Tearaway Introducer Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
The Introducer System is intended for use in percutaneous procedures to introduce The Introducer Dystant to as a more of the peripheral vasculature.
× Prescription Use_ (Per 21 CFR 801 Subpart D) OR
Over-The-Counter Use (Per 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)
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K112398
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