(247 days)
No
The device description and performance studies focus on the mechanical properties and biocompatibility of a simple wire stylet, with no mention of AI/ML or related concepts.
No
The device is described as a percutaneous catheter stylet used to stiffen a device for placement or extraction. Its function is to facilitate the delivery or removal of another medical device, rather than directly treat a disease or condition.
No
The device is described as a stylet used to stiffen other devices for placement or extraction, which is a procedural aid, not a diagnostic tool.
No
The device description explicitly states it is comprised of a stainless steel twisted/braided wire and can be bonded to a hub, indicating it is a physical hardware device.
Based on the provided information, the GaltTWS Stylet is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "percutaneous catheter stylet placed inside a catheter, lead, or cannula to stiffen the device for placement or extraction." This describes a device used in vivo (within the body) to facilitate the placement or manipulation of other medical devices.
- IVD Definition: In vitro diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The GaltTWS Stylet does not perform any such tests on bodily samples.
- Device Description: The description focuses on the physical components and configuration of the stylet itself, not on any reagents, test strips, or analytical components typically associated with IVDs.
- Performance Studies: The performance studies described are bench tests and biocompatibility tests, which are relevant for in vivo medical devices, not typically for the analytical performance of an IVD.
Therefore, the GaltTWS Stylet is a medical device intended for use within the body, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The GaltTWS Stylet is a percutaneous catheter stylet placed inside a catheter, lead, or cannula to stiffen the device for placement or extraction.
Product codes
DRB
Device Description
The GaltTWS stylet is comprised of a stainless steel twisted/braided wire of varying diameters (0.012-0.015 inch), and varying length (30-72cm). The GaltTWS stylet can be configured as a Twisted/Braided wire bonded to a hub, flushable hub, or connected to a flushable adjustable hub using the Galt Gateway Hemostasis Valve (K152528).
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)
The technological differences between the subject devices and predicate devices have been evaluated through bench and biocompatibility tests to provide evidence of substantial equivalence. The GaltTWS Stylet is substantially equivalent to the predicate devices based on comparisons of the devices functionality, compatibility, technological characteristics, and indications for use.
Functional Testing included the following:
- Particulate Test
- Mechanical Properties Test
- Leak Test
- Tortuous Path Test (In Vitro)
Additionally, accelerated aging was performed on the subject devices to an equivalent age of 4 years, and the physical and functional testing was repeated.
Biocompatibility testing was performed on the subject device in accordance with ISO 10993-1. Biocompatibility testing included the following:
- Cytotoxicity (MEM Elution)
- Sensitization (Magnusson Kligman)
- Irritation (Intracutaneous injection)
- Systemic Toxicity (Systemic injection)
- Hemolysis (In Direct Contact)
- Systemic Toxicity (Materials Mediated Pyrogen)
- EO Residuals (EO, ECH, & EG)
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
§ 870.1380 Catheter stylet.
(a)
Identification. A catheter stylet is a wire that is run through a catheter or cannula to render it stiff.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 30, 2019 Galt Medical Corp. David Derrick Director of Quality and Regulatory Affairs 2220 Merritt Drive Garland, Texas 75087
Re: K182660
Trade/Device Name: GaltTWS Regulation Number: 21 CFR 870.1380 Regulation Name: Catheter Stylet Regulatory Class: Class II Product Code: DRB Dated: April 29, 2019 Received: April 30, 2019
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for
Matthew Hillebrenner Acting Division Director Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K182660
Device Name GaltTWS Stylet
Indications for Use (Describe)
The GaltTWS Stylet is a percutaneous catheter stylet placed inside a catheter, lead, or cannula to stiffen the device for placement or extraction.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
| Application Date: | November 13, 2018 |
|---|---|
| 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: | GaltTWS Stylet |
| Device Model Number: | TBD |
| Classification Name: | Catheter Stylet (DRB), |
| 21 CFR 870.1380 | |
| Device Classification: | Class II (Cardiovascular) |
| Predicate Device: | TFX Medical Coated Stylet (K992664) |
| Guidewire (K982559) | |
| Gateway Hemostasis Valve (152528) | |
| Manufacturer: | Galt Medical |
| 2220 Merritt Drive | |
| Garland, TX 75041 | |
| Phone: 214-778-5177 |
Establishment Registration Number: 1649395
Intended Use: The GaltTWS Stylet is a percutaneous catheter stylet placed inside a catheter, lead, or cannula to stiffen the device for placement or extraction.
Device Description: The GaltTWS stylet is comprised of a stainless steel twisted/braided wire of varying diameters (0.012-0.015 inch), and varying length (30-72cm). The GaltTWS stylet can be configured as a Twisted/Braided wire bonded to a hub, flushable
4
hub, or connected to a flushable adjustable hub using the Galt Gateway Hemostasis Valve (K152528).
Comparison of Technological Characteristics: The subject device GaltTWS Stylet and the predicate device TFX Medical Coated Catheter Stylet have same indication and are of similar design. The subject and predicate device are available in similar configurations.
| Mfr. / Product | Subject Device | Predicate Device | Predicate Device | Predicate Device |
|---|---|---|---|---|
| Galt Medical / | ||||
| GaltTWS Stylet | TFX Medical / TFX | |||
| Medical Coated | ||||
| Catheter Stylet | Galt Medical / | |||
| Guidewire | Galt Medical / | |||
| Gateway Hemostasis | ||||
| Valve | ||||
| 510(k) | ||||
| Number | N/A | K992664 | K982559 | K152528 |
| Device | ||||
| Classification | 870.1380 | 870.1380 | 870.1340 | 870.4290 |
| Product Code | DRB | DRB | DQX | DTL |
| Intended use | The Galt Medical | |||
| Corp. GaltTWS Stylet | ||||
| is a percutaneous | ||||
| catheter stylet placed | ||||
| inside a catheter, | ||||
| lead, or cannula to | ||||
| stiffen the device for | ||||
| placement or | ||||
| extraction. | The TFX Medical stylet | |||
| is intended for use in | ||||
| conjunction with | ||||
| catheters or other | ||||
| devices, which require | ||||
| the aid of a stylet to | ||||
| render it stiff for | ||||
| placement. | The guidewire is | |||
| intended for use in | ||||
| percutaneous | ||||
| procedures to | ||||
| introduce and | ||||
| position catheter and | ||||
| other interventional | ||||
| devices within the | ||||
| coronary and | ||||
| peripheral | ||||
| vasculature. | 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 | A stainless steel | |||
| twisted/braided wire | ||||
| bonded to a hub, | ||||
| flushable hub in a range | ||||
| of sizes and lengths. | A twisted/braided wire | |||
| bonded to a hub in a | ||||
| range of sizes and | ||||
| lengths. | Guidewire with a tightly | |||
| wound coil over a | ||||
| tapered core and a | ||||
| ribbon. The ribbon is | ||||
| welded to the coil at | ||||
| both ends. The core is | ||||
| welded to the coil at | ||||
| the proximal end. | Introducer with valved | |||
| hub and luer lock | ||||
| connector | ||||
| Sizes | Diameter - (0.012-0.015 | |||
| inch) | ||||
| Length (30-72cm) | N/A | Diameter - (0.014-0.065 | ||
| inch) | ||||
| Length (15-400cm) | Maximum 8FR |
5
Substantial Equivalence and Summary of Bench Testing: The technological differences between the subject devices and predicate devices have been evaluated through bench and biocompatibility tests to provide evidence of substantial equivalence. The GaltTWS Stylet is substantially equivalent to the predicate devices 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:
- 0 Particulate Test
- o Mechanical Properties Test
- 0 Leak Test
- 0 Tortuous Path Test (In Vitro)
Additionally, accelerated aging was performed on the subject devices to an equivalent age of 4 years, and the physical and 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) 0
- Sensitization (Magnusson Kligman) 0
- Irritation (Intracutaneous injection) O
- 0 Systemic Toxicity (Systemic injection)
- 0 Hemolysis (In Direct Contact)
- 0 Systemic Toxicity (Materials Mediated Pyrogen)
- o EO Residuals (EO, ECH, & EG)
Additionally the subject device was adopted into the existing ethylene oxide sterilization cycle for the Galt product cleared under K982559 & K152528.
Packaging of the subject device will remain unchanged from the Galt Medical Guidewire and Gateway Hemostasis Valve. Current packaging shelf life testing was provided in the predicate submissions.
Conclusion: The GaltTWS Stylet as designed and manufactured is determined to be substantially equivalent to the current marketed predicate devices.
End of Section