(209 days)
No
The document describes a physical medical device (introducer sheath) and its materials, with no mention of software, algorithms, or AI/ML capabilities.
No
The device itself is an introducer sheath, used to percutaneously introduce other devices (which can be diagnostic or therapeutic) into the vasculature. Its function is to facilitate the introduction of other devices, not to provide therapy itself.
No
The device is an introducer sheath used for the percutaneous introduction of other devices (diagnostic or therapeutic), not for diagnosing conditions itself.
No
The device description clearly states it is a physical assembly consisting of an outer peelable sheath and a dilator, and the performance studies involve functional and biocompatibility testing of physical components and materials. There is no mention of software as the primary or sole component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "percutaneous introduction of diagnostic or therapeutic devices, such as catheters and pacing leads, into the vasculature." This describes a device used in vivo (within the body) to facilitate other procedures, not a device used in vitro (outside the body) to examine specimens from the body.
- Device Description: The description details a physical device (sheath and dilator) used for insertion into the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other typical components or processes associated with in vitro diagnostics.
Therefore, this device is a medical device used for vascular access, not an IVD.
N/A
Intended Use / Indications for Use
Tearaway introducer sheath: These introducers are used for the percutaneous introduction of diagnostic or therapeutic devices, such as catheters and pacing leads, into the vasculature.
MicroSlide™ Tearaway introducers are used for the procedures to introduce catheters and other intravascular devices into the coronary and peripheral vasculature of adult and pediatric patients of all ages.
Product codes
DYB
Device Description
The Galt Medical Tearaway Introducer Sheath assembly consists of an outer peelable sheath and a dilator. The tear-away sheath has a winged hub to initiate the tear in the sheath. The design of the tearaway introducer sheath is unchanged from the current line of Tearaway Introducer Sheaths (K000313), and the pediatric version MicroSlide™ Tearaway Introducer (K123430). The subject and current marketed predicate devices are identical with the exception of the material used in the sheath hub.
The Galt Tearaway Introducer Sheath (K000313) and Galt MicroSlide™ Tearaway Introducer (K123430) have been previously determined to be substantially equivalent. In this bundled submission, Galt Medical Corp will establish that the subject devices Tearaway Introducer Sheath & MicroSlide™ Tearaway Introducer with the replacement hub material is substantially equivalent to the current marketed devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vasculature, coronary and peripheral vasculature
Indicated Patient Age Range
adult and pediatric patients of all ages.
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)
Functional testing on aged product was conducted to verify that the Tearaway Introducer Sheath and MiroSlide™ Tearaway Introducer with replacement hub material met product specifications and is substantial equivalent to the current marketed predicate devices. Testing was conducted according to protocols based on international standards and Galt Medical requirements. Functional Testing included the following:
- Hub Break Force
- . Perpendicular Pull Force
- Dilator Insertion Test
- Hub Dimensional
Biocompatibility testing was performed on the Tearaway Introducer Sheath with replacement hub material. Biocompatibility Testing included the following:
- Cytotoxicity
- Sensitivity
- Irritation
- Systemic Toxicity ●
- Hemocompatibility (Hemolysis)
- Pyrogen (Materials Mediated)
- EO Residuals
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is an abstract symbol that resembles a stylized caduceus or a family of people.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 5, 2016
Galt Medical Corp. David Derrick Director of Quality and Regulatory Affairs 2220 Merritt Dr. Garland, TX 75041
Re: K153533
Trade/Device Name: Tearaway Introducer Sheath and MicroSlide Tearaway Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: May 31, 2016 Received: June 1, 2016
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. 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 801): medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/ReportaProblem/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Brian D. Pullin -S
for Bram D. Zuckerman, MD Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K153533
Device Name Tearaway Introducer Sheath MicroSlide Tearaway Introducer
Indications for Use (Describe)
Tearaway introducer sheath: These introducers are used for the percutaneous introduction of diagnostic or therapeutic devices, such as catheters and pacing leads, into the vasculature.
MicroSlide™ Tearaway introducers are used for the procedures to introduce catheters and other intravascular devices into the coronary and peripheral vasculature of adult and pediatric patients of all ages
| 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) |
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| Application Date: | December 04, 2015 |
|---|---|
| Application Type: | Bundled 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: | Tearaway Introducer Sheath & MicroSlide™ Tearaway |
| Introducer | |
| Device Model Number: | TBD |
| Classification Name: | Catheter Introducer (DYB), |
| 21 CFR 870.1340 | |
| Device Classification: | Class II (Cardiovascular) |
| Predicate Device: | Tearaway Introducer Sheath (K000313) |
| MicroSlide™ Tearaway Introducer (K123430) | |
| Manufacturer: | Galt Medical |
| 2220 Merritt Drive | |
| Garland, TX 75041 | |
| Phone: 214-778-5177 | |
| Fax: 972-271-4706 | |
| Establishment | |
| Registration Number: | 1649395 |
Intended Use Tearaway Introducer Sheath: These introducers are used for the percutaneous introduction of diagnostic or therapeutic devices, such as catheters and pacing leads, into the vasculature.
Intended Use MicroSlide™ Tearaway Introducer: These introducers are used for the procedures to introduce catheters and other intravascular devices into the coronary and peripheral vasculature of adult and pediatric patients of all ages.
4
Device Description: The Galt Medical Tearaway Introducer Sheath assembly consists of an outer peelable sheath and a dilator. The tear-away sheath has a winged hub to initiate the tear in the sheath. The design of the tearaway introducer sheath is unchanged from the current line of Tearaway Introducer Sheaths (K000313), and the pediatric version MicroSlide™ Tearaway Introducer (K123430). The subject and current marketed predicate devices are identical with the exception of the material used in the sheath hub.
The Galt Tearaway Introducer Sheath (K000313) and Galt MicroSlide™ Tearaway Introducer (K123430) have been previously determined to be substantially equivalent. In this bundled submission, Galt Medical Corp will establish that the subject devices Tearaway Introducer Sheath & MicroSlide™ Tearaway Introducer with the replacement hub material is substantially equivalent to the current marketed devices.
Comparison of Technological Characteristics: The Tearaway Introducer Sheath with the replacement hub material is substantially equivalent to the current marketed predicate in construction, material, and device performance.
| Subject devices | Predicate Device | Predicate Device | |
|---|---|---|---|
| Mfr. / | |||
| Product | Galt Tearaway Introducer | ||
| Sheath & MicroSlide™ | |||
| Tearaway Introducer with | |||
| the new hub material | Galt Tearaway | ||
| Introducer Sheath | |||
| (K000313) | Galt MiroSlide™ | ||
| Tearaway Introducer | |||
| (K123430) | |||
| 510(k) | |||
| Number | K153533 | K000313 | K123430 |
| Device | |||
| Classification | |||
| n | 870.1340 | 870.1340 | 870.1340 |
| Product | |||
| Code | DYB | DYB | DYB |
| Intended | |||
| use | Adult Only - Tearaway | ||
| Introducer Sheath: The | |||
| introducer is used for the | |||
| percutaneous introduction of | |||
| diagnostic or therapeutic | |||
| devices, such as catheters | |||
| and pacing leads, into the | |||
| vasculature | |||
| Adult & Pediatric - | |||
| MicroSlide™ Tearaway | |||
| Introducer: The introducer is | |||
| used for the procedures to | |||
| introduce catheters and | |||
| other intravascular devices | |||
| into the coronary and | |||
| peripheral vasculature of | The introducer is used | ||
| for the percutaneous | |||
| introduction of | |||
| diagnostic or | |||
| therapeutic devices, | |||
| such as catheters and | |||
| pacing leads into the | |||
| vasculature. | The introducer is used | ||
| for the procedures to | |||
| introduce catheters | |||
| and other | |||
| intravascular devices | |||
| into the coronary and | |||
| peripheral vasculature | |||
| of adult and pediatric | |||
| patients of all ages. |
5
| Subject devices | Predicate Device | Predicate Device | |
|---|---|---|---|
| adult and pediatric patients | |||
| of all ages. | |||
| Design | The Galt Tearaway Introducer | ||
| Sheath assembly with new hub | |||
| material consists of an outer | |||
| peelable sheath and a dilator. | |||
| The tear-away sheath has a | |||
| winged hub to initiate the tear | |||
| in the sheath. | The Galt Tearaway | ||
| Introducer Sheath | |||
| assembly consists of an | |||
| outer peelable sheath | |||
| and a dilator. The tear- | |||
| away sheath has a | |||
| winged hub to initiate | |||
| the tear in the sheath. | The Galt MiroSlide™ | ||
| Tearaway Introducer | |||
| assembly consists of an | |||
| outer peelable sheath | |||
| and a dilator. The tear- | |||
| away sheath has a | |||
| winged hub to initiate | |||
| the tear in the sheath. | |||
| Color | Sheath: Color coded winged | ||
| hub, gray cannula. | |||
| Dilator: White hub, green | |||
| cannula | Sheath: Color coded | ||
| winged hub, gray | |||
| cannula. | |||
| Dilator: White hub, | |||
| green cannula | Sheath: Color coded | ||
| winged hub, gray | |||
| cannula. | |||
| Dilator: White hub, | |||
| green cannula | |||
| Shape | Sheath: winged hub, | ||
| cylindrical cannula | |||
| Dilator: Round hub, | |||
| cylindrical cannula | Sheath: winged hub, | ||
| cylindrical cannula | |||
| Dilator: Round hub, | |||
| cylindrical cannula | Sheath: winged hub, | ||
| cylindrical cannula | |||
| Dilator: Round hub, | |||
| cylindrical cannula | |||
| Sizes | Adult Only - Galt Tearaway | ||
| Introducer Sheath | |||
| 3F - 16F | |||
| 5 cm and 30 cm | |||
| & | |||
| Adult/Pediatric - Galt | |||
| MicroSlide™ Tearaway | |||
| Introducer | |||
| 2F - 3F | |||
| 3 cm and 7 cm | Adult - Galt Tearaway | ||
| Introducer Sheath | |||
| 3F - 16F | |||
| 5cm to 30cm lengths | Adult/Pediatric - Galt | ||
| MicroSlide™ Tearaway | |||
| Introducer | |||
| 2F-3F | |||
| 3cm to 7cm lengths | |||
| Dilator Lock | Dilator is retained | Dilator is retained | Dilator is retained |
Use Type: The Galt Tearaway Introducer Sheath and MiroSlide™ Tearaway Introducer is a single patient use, disposable device.
Summary of Non-Clinical Data Submitted: Functional testing on aged product was conducted to verify that the Tearaway Introducer Sheath and MiroSlide™ Tearaway Introducer with replacement hub material met product specifications and is substantial equivalent to the current marketed predicate devices. Testing was conducted according to protocols based on international standards and Galt Medical requirements. Functional Testing included the following:
- Hub Break Force
- . Perpendicular Pull Force
- Dilator Insertion Test
- Hub Dimensional
6
Additionally the Tearaway Introducer Sheath and MiroSlide™ Tearaway Introducer with replacement hub material was adopted into the existing ethylene oxide sterilization cycle for the Galt Tearaway Introducer Sheath cleared under K000313 and Galt MiroSlide™ Tearaway Introducer cleared under K123430.
Biocompatibility testing was performed on the Tearaway Introducer Sheath with replacement hub material. Biocompatibility Testing included the following:
- Cytotoxicity
- Sensitivity
- Irritation
- Systemic Toxicity ●
- Hemocompatibility (Hemolysis)
- Pyrogen (Materials Mediated)
- EO Residuals
Packaging will remain unchanged from the predicated devices. Current packaging shelf life testing was provided in the predicate submissions.
Conclusion: It will be shown in this 510(k) submission that the differences between the Galt Tearaway Introducer Sheath & MicroSlide™ Tearaway Introducer with replacement hub material and the predicate devices do not raise any questions regarding safety and effectiveness. The Galt Tearaway Introducer Sheath & MicroSlide™ Tearaway Introducer with replacement hub material as designed and manufactured is determined to be substantially equivalent to the current marketed predicate devices.
End of Section