(66 days)
No
The device description and performance studies focus on the physical properties and function of a sheath introducer system, with no mention of AI or ML.
No.
The device is described as a sheath introducer system used to facilitate placing catheters and other intravascular devices into the vasculature, not to provide therapy itself.
No
Explanation: The device is a sheath introducer system indicated for facilitating the placement of catheters and other intravascular devices, not for diagnosing conditions.
No
The device description clearly outlines physical components such as an introducer (valved sheath with sidearm and stopcock and dilator), guide wire, entry needle, guide wire inserter, and flushing syringe. It also mentions a hydrophilic coating and barium sulfate, indicating a physical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The description clearly states that the Galt Medical Corp Elite HV Radial is a "Sheath Introducer system" used to "introduce catheters and other intravascular devices into the vasculature." This is a device used within the body (in vivo) to facilitate a medical procedure.
- Intended Use: The intended use is to "facilitate placing a catheter through the skin into a vein or artery." This is a procedural device, not a diagnostic test performed on a sample.
The device is a tool used during a medical procedure, not a device that analyzes biological samples to diagnose or monitor a condition.
N/A
Intended Use / Indications for Use
The Galt Medical Corp Elite HV Radial is indicated to facilitate placing a catheter through the skin into a vein or artery including but not limited to the radial artery.
Product codes (comma separated list FDA assigned to the subject device)
DYB
Device Description
The Galt Medical Corp Elite HV product has been on the market since February of 2005, and was cleared under 510(k) K043525. The clearance included sizes from 4-9FR, and lengths from 5-110 cm with the following indication for use: The Sheath Introducer system is indicated for use in percutaneous procedures to introduce catheters and other intravascular devices into the vasculature.
The purpose of this 510(k) is to expand that indication for use for the Elite HV products to include radial placement. There were no design changes required as the current Galt offering included sizes which are appropriate for radial placement. The only limitation of the Radial placement claim is that the range of sizes is more limited due to the target anatomy.
The Elite HV and Elite HV Radial consists of an introducer (valved sheath with sidearm and stopcock and dilator), which are packaged together with a guide wire. The Elite HV product is configured with a silicone valve or a TPE valve cleared under 510(k) K152528. Some product configurations also include an entry needle, guide wire inserter and a flushing syringe. The Elite HV Radial is used to facilitate placing a catheter through the skin into a vein or artery including but not limited to the radial artery. The sheath is coated with hydrophilic coating to minimize frictional resistance when inserting or removing the sheath from the patient's blood vessel. In addition, the sheath and dilator contain barium sulfate, making these devices visible under fluoroscopy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vein or artery including but not limited to the radial artery.
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)
Bench and biocompatibility tests were conducted.
Functional Testing included:
- Particulate Test
- Mechanical Properties Test
- Lubricity Test
- Durability of coating
- Dimensional comparison test
Accelerated aging was performed on the subject devices to an equivalent age of 4 years, and the functional testing was repeated.
Biocompatibility testing performed in accordance with ISO 10993-1 included:
- Cytotoxicity (MEM Elution)
- Sensitization (Magnusson - Kligman)
- Irritation (Intracutaneous injection)
- Systemic Toxicity (Systemic injection)
- Hemolysis (Direct Contact)
- Hemocompatibility (Complement Activation)
- In-Vitro Hemocompatibility (Dog Thrombogenicity)
- Systemic Toxicity (Materials Mediated Pyrogen)
- EO Residuals (EO, ECH, & EG)
The subject device was adopted into the existing ethylene oxide sterilization cycle for the Galt product cleared under K043525 & K152528.
Key Results: The technological differences between the subject device and predicate device have been evaluated through bench and biocompatibility tests to provide evidence of substantial equivalence. The Elite HV Radial is substantially equivalent to the specified predicate device based on comparisons of the devices functionality, compatibility, technological characteristics, and indications for 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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 21, 2017
Galt Medical Corp. David Derrick Director of Quality and Regulatory Affairs 2220 Merritt Drive Garland, Texas 75087
Re: K173287
Trade/Device Name: Elite HV Radial Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: October 13, 2017 Received: October 16, 2017
Dear David Derrick:
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. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. 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.
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
1
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Kenneth J. Cavanaugh -S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below
510(k) Number (if known)
Device Name ELITE HV RADIAL
Indications for Use (Describe)
The Galt Medical Corp Elite HV Radial is indicated to facilitate placing a catheter through the skin into a vein or artery including but not limited to the radial artery.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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3
K173287
Section 5 – 510(k) Summary
| Application Date: | October 13, 2017 |
|---|---|
| Application Type: | Traditional 510(k) |
| Applicant Information | Galt Medical Corporation |
| 2220 Merritt Dr. | |
| Garland, TX 75041 | |
| Phone: 214-778-1306 | |
| Fax: 972-271-4706 | |
| Official Contact: | David Derrick |
| Director of Quality and Regulatory Affairs | |
| Galt Medical Corporation | |
| 2220 Merritt Dr. | |
| Garland, TX 75041 | |
| Phone: 214-778-1306 | |
| Fax: 972-271-4706 | |
| dderrick@galtmedical.com | |
| Device Name: | Elite HV Radial |
| Device Model Number: | TBD |
| Classification Name: | Catheter Introducer (DYB), |
| 21 CFR 870.1340 | |
| Device Classification: | Class II (Cardiovascular) |
| Predicate Device: | Glidesheath (K152173) |
| Elite HV (K043525 | |
| Gateway Hemostasis Valve (152528) | |
| Manufacturer: | Galt Medical |
| 2220 Merritt Drive | |
| Garland, TX 75041 | |
| Phone: 214-778-5177 | |
| Fax: 972-271-4706 |
Establishment Registration Number: 1649395
Intended Use: The Galt Medical Corp Elite HV Radial is indicated to facilitate placing a catheter through the skin into a vein or artery including but not limited to the radial artery.
Device Description: The Galt Medical Corp Elite HV product has been on the market since February of 2005, and was cleared under 510(k) K043525. The clearance included sizes from 4-9FR, and lengths from 5-110 cm with the following indication for use:
4
The Sheath Introducer system is indicated for use in percutaneous procedures to introduce catheters and other intravascular devices into the vasculature.
The purpose of this 510(k) is to expand that indication for use for the Elite HV products to include radial placement. There were no design changes required as the current Galt offering included sizes which are appropriate for radial placement. The only limitation of the Radial placement claim is that the range of sizes is more limited due to the target anatomy.
The Elite HV and Elite HV Radial consists of an introducer (valved sheath with sidearm and stopcock and dilator), which are packaged together with a guide wire. The Elite HV product is configured with a silicone valve or a TPE valve cleared under 510(k) K152528. Some product configurations also include an entry needle, guide wire inserter and a flushing syringe. The Elite HV Radial is used to facilitate placing a catheter through the skin into a vein or artery including but not limited to the radial artery. The sheath is coated with hydrophilic coating to minimize frictional resistance when inserting or removing the sheath from the patient's blood vessel. In addition, the sheath and dilator contain barium sulfate, making these devices visible under fluoroscopy.
Comparison of Technological Characteristics: The subject device Elite HV Radial and the predicate device Terumo Glidesheath have identical indication statements and are of similar design. The subject and predicate device are available in similar configurations.
| Subject Device | Predicate Device | Predicate Device | Predicate Device | |
|---|---|---|---|---|
| Mfr. / | ||||
| Product | Galt Medical / Elite | |||
| HV Radial | Galt Medical / Elite | |||
| HV | Terumo / | |||
| Glidesheath™ | Galt Medical / | |||
| Gateway Hemostasis | ||||
| Valve | ||||
| 510(k) | ||||
| Number | K043525 | K152173 | K152528 | |
| Device | ||||
| Classification | ||||
| n | 870.1340 | 870.1340 | 870.1340 | 870.4290 |
| Product | ||||
| Code | DYB | DYB | DYB | DTL |
| Intended | ||||
| use | The Galt Medical | |||
| Corp Elite HV Radial | ||||
| is indicated to | ||||
| facilitate placing a | ||||
| catheter through the | ||||
| skin into a vein or | ||||
| artery including but | ||||
| not limited to the | ||||
| radial artery. | The Galt Medical Corp | |||
| Elite HV is indicated | ||||
| for use in | ||||
| percutaneous | ||||
| procedures to | ||||
| introduce catheters | ||||
| and other | ||||
| intravascular devices | ||||
| into the vasculature. | The Glidesheath™ is | |||
| indicated to facilitate | ||||
| placing a catheter | ||||
| through the skin into | ||||
| a vein or artery | ||||
| including but not | ||||
| limited to the radial | ||||
| artery. | The attachable Cath | |||
| Lab Hemostasis Valve | ||||
| is indicated to | ||||
| minimize blood loss | ||||
| during introduction | ||||
| of catheters, | ||||
| guidewires and other | ||||
| intravascular devices | ||||
| into the vasculature. | ||||
| Design | Introducer with valved | |||
| sheath and dilator in a | ||||
| range of sizes and | ||||
| lengths | Introducer with valved | |||
| sheath and dilator in a | ||||
| range of sizes and | ||||
| lengths | Introducer with valved | |||
| sheath and dilator in a | ||||
| range of sizes and | ||||
| lengths | Introducer with valved | |||
| hub and luer lock | ||||
| connector | ||||
| Color | Sheath Hub – White | Sheath Hub - White | Sheath Hub - Various | Sheath Hub - White |
5
| Subject Device | Predicate Device | Predicate Device | Predicate Device | |
|---|---|---|---|---|
| Sheath cannula- | ||||
| White | ||||
| Sheath cap- Various | ||||
| indicating Fr size | ||||
| Dilator hub- White | ||||
| Dilator cannula- Blue | ||||
| Sidearm with | ||||
| stopcock - Clear | ||||
| Valve silicone - clear | ||||
| natural | ||||
| Valve TPE - clear | ||||
| natural | Sheath cannula- White | |||
| Sheath cap- Various | ||||
| indicating Fr size | ||||
| Dilator hub- White | ||||
| Dilator cannula- Blue | ||||
| Sidearm with stopcock |
- Clear
Valve silicone - clear
natural | Sheath cannula-
White
Sheath cap- Various
indicating Fr size
Dilator hub- Various
indicating Fr size
Dilator cannula- Blue
Sidearm with
stopcock - Clear
Valve - clear | Sheath cap- Various
indicating Fr size
Sidearm with
stopcock - Clear
Valve TPE - clear
natural |
| Sizes | 4F - 6F
5cm to 25cm lengths | 4F - 9F
5cm to 110cm lengths | 4F - 6F
10cm to 25cm
lengths | Maximum 8FR |
| Dilator Lock | Dilator is retained in
sheath cap | Dilator is retained in
sheath cap | Dilator is retained on
sheath cap | Not applicable |
6
Substantial Equivalence and Summary of Bench Testing: The technological differences between the subject device and predicate device have been evaluated through bench and biocompatibility tests to provide evidence of substantial equivalence. The Elite HV Radial is substantially equivalent to the specified predicate device based on comparisons of the devices functionality, compatibility, technological characteristics, and indications for use.
Testing was conducted according to protocols based on international standards and Galt Medical requirements. Functional Testing included the following:
- . Particulate Test
- Mechanical Properties Test
- Lubricity Test
- . Durability of coating
- . Dimensional comparison test
Additionally, accelerated aging was performed on the subject devices to an equivalent age of 4 years, and the functional testing was repeated.
Biocompatibility testing was performed on the subject device in accordance with ISO 10993-1. This was done in order to update the biocompatibility testing to current standards, and was not done as a result of any changes to the product. Biocompatibility testing included the following:
- Cytotoxicity (MEM Elution)
- Sensitization (Magnusson - Kligman)
- . Irritation (Intracutaneous injection)
- Systemic Toxicity (Systemic injection)
- Hemolysis (Direct Contact)
- Hemocompatibility (Complement Activation)
- In-Vitro Hemocompatibility (Dog Thrombogenicity)
- Systemic Toxicity (Materials Mediated Pyrogen)
- EO Residuals (EO, ECH, & EG)
Additionally the subject device was adopted into the existing ethylene oxide sterilization cycle for the Galt product cleared under K043525 & K152528.
Packaging of the subject device will remain unchanged from the Galt Elite HV products. Current packaging shelf life testing was provided in the predicate submission.
Conclusion: It will be shown in this 510(k) submission that the differences between the Galt Elite HV Radial and the predicate devices do not raise any new questions regarding safety and effectiveness. The Galt Elite HV Radial as designed and manufactured is determined to be substantially equivalent to the current marketed predicate device.
End of Section