(209 days)
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.
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 provided text is a 510(k) premarket notification for a medical device called the "Tearaway Introducer Sheath and MicroSlide Tearaway Introducer." The purpose of this submission is to demonstrate that the device with a new hub material is substantially equivalent to previously marketed predicate devices.
Acceptance Criteria and Study for the Device:
The core of this submission revolves around demonstrating that changing the hub material of an already cleared device does not negatively impact its safety and effectiveness. Therefore, the "acceptance criteria" are essentially the established performance specifications of the predicate devices. The study conducted is a series of non-clinical tests to show that the new device meets these specifications.
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't present a formal table of "acceptance criteria" with explicit numerical targets, but rather lists the functional tests performed to demonstrate substantial equivalence to the predicate devices. The "reported device performance" is implied to have met these predicate device specifications, as the conclusion states substantial equivalence.
| Acceptance Criterion (Implied: Meet Predicate Device Performance) | Reported Device Performance (Implied: Met) |
|---|---|
| Hub Break Force | Passed |
| Perpendicular Pull Force | Passed |
| Dilator Insertion Test | Passed |
| Hub Dimensional | Passed |
| Biocompatibility (Cytotoxicity, Sensitivity, Irritation, Systemic Toxicity, Hemocompatibility, Pyrogen, EO Residuals) | Passed |
| Sterilization Cycle Performance | Verified |
| Packaging Performance (Shelf Life) | Unchanged from predicate, previously verified |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the exact sample sizes (e.g., number of units tested) for each non-clinical test. It only states that functional testing was conducted on "aged product."
- Sample Size: Not specified.
- Data Provenance: The tests were conducted internally by Galt Medical Corporation ("Galt Medical requirements") according to protocols "based on international standards." This indicates that the data is from prospective testing performed by the manufacturer to support this specific 510(k) submission. There is no indication of country of origin of the data beyond the manufacturer being in the USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This is a non-clinical device submission focused on performance and material equivalence. Therefore, there are no "experts" in the clinical sense (e.g., radiologists) used to establish ground truth. The "ground truth" for the test set is established by recognized international standards and the performance specifications of the predicate devices. The expertise involved would be in engineering, materials science, and testing methodology, likely performed by the manufacturer's qualified personnel.
4. Adjudication Method for the Test Set:
Not applicable. This is not a study requiring human interpretation or adjudication for the test set. The tests are objective, measurable physical and chemical properties.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No. This is a non-clinical submission for a physical medical device. MRMC studies are typically for diagnostic imaging devices or software.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device, not a software algorithm.
7. The Type of Ground Truth Used:
The ground truth used for these non-clinical tests is based on:
- Device specifications: Established performance parameters for the device (e.g., specific force values for hub break, dimensional tolerances).
- International standards: Adherence to relevant ISO or other recognized standards for medical device testing.
- Predicate device performance: The performance of the previously cleared Galt Tearaway Introducer Sheath (K000313) and Galt MicroSlide™ Tearaway Introducer (K123430) serves as the benchmark.
8. The Sample Size for the Training Set:
Not applicable. There is no "training set" as this is not an artificial intelligence/machine learning device. The "training" for the device, in a manufacturing sense, would be the established manufacturing process and quality control, which is addressed by the quality system regulation (21 CFR Part 820).
9. How the Ground Truth for the Training Set was Established:
Not applicable. As there is no training set as understood in AI/ML, there's no ground truth established for it in that context.
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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
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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
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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 Corporation2220 Merritt Dr.Garland, TX 75041Phone: 214-778-1306Fax: 972-271-4706 |
| Official Contact: | David DerrickDirector of Quality and Regulatory AffairsGalt Medical Corporation2220 Merritt Dr.Garland, TX 75041Phone: 214-778-1306Fax: 972-271-4706dderrick@galtmedical.com |
| Device Name: | Tearaway Introducer Sheath & MicroSlide™ TearawayIntroducer |
| 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 Medical2220 Merritt DriveGarland, TX 75041Phone: 214-778-5177Fax: 972-271-4706 |
| EstablishmentRegistration 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.
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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 IntroducerSheath & MicroSlide™Tearaway Introducer withthe new hub material | Galt TearawayIntroducer Sheath(K000313) | Galt MiroSlide™Tearaway Introducer(K123430) |
| 510(k)Number | K153533 | K000313 | K123430 |
| DeviceClassificationn | 870.1340 | 870.1340 | 870.1340 |
| ProductCode | DYB | DYB | DYB |
| Intendeduse | Adult Only - TearawayIntroducer Sheath: Theintroducer is used for thepercutaneous introduction ofdiagnostic or therapeuticdevices, such as cathetersand pacing leads, into thevasculatureAdult & Pediatric -MicroSlide™ TearawayIntroducer: The introducer isused for the procedures tointroduce catheters andother intravascular devicesinto the coronary andperipheral vasculature of | The introducer is usedfor the percutaneousintroduction ofdiagnostic ortherapeutic devices,such as catheters andpacing leads into thevasculature. | The introducer is usedfor the procedures tointroduce cathetersand otherintravascular devicesinto the coronary andperipheral vasculatureof adult and pediatricpatients of all ages. |
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| Subject devices | Predicate Device | Predicate Device | |
|---|---|---|---|
| adult and pediatric patientsof all ages. | |||
| Design | The Galt Tearaway IntroducerSheath assembly with new hubmaterial consists of an outerpeelable sheath and a dilator.The tear-away sheath has awinged hub to initiate the tearin the sheath. | The Galt TearawayIntroducer Sheathassembly consists of anouter peelable sheathand a dilator. The tear-away sheath has awinged hub to initiatethe tear in the sheath. | The Galt MiroSlide™Tearaway Introducerassembly consists of anouter peelable sheathand a dilator. The tear-away sheath has awinged hub to initiatethe tear in the sheath. |
| Color | Sheath: Color coded wingedhub, gray cannula.Dilator: White hub, greencannula | Sheath: Color codedwinged hub, graycannula.Dilator: White hub,green cannula | Sheath: Color codedwinged hub, graycannula.Dilator: White hub,green cannula |
| Shape | Sheath: winged hub,cylindrical cannulaDilator: Round hub,cylindrical cannula | Sheath: winged hub,cylindrical cannulaDilator: Round hub,cylindrical cannula | Sheath: winged hub,cylindrical cannulaDilator: Round hub,cylindrical cannula |
| Sizes | Adult Only - Galt TearawayIntroducer Sheath3F - 16F5 cm and 30 cm&Adult/Pediatric - GaltMicroSlide™ TearawayIntroducer2F - 3F3 cm and 7 cm | Adult - Galt TearawayIntroducer Sheath3F - 16F5cm to 30cm lengths | Adult/Pediatric - GaltMicroSlide™ TearawayIntroducer2F-3F3cm 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
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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
§ 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).