Who is the manufacturer of Sterile Dilator?

Galt Medical Corp. filed the 510(k) submission for Sterile Dilator (K192195).

What is the FDA product code for Sterile Dilator?

DRE. It is classified under 21 CFR 870.1310 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for Sterile Dilator?

510(k) clearance (submission type: Special).

What are the predicate devices for Sterile Dilator?

Coaxial Dilator Set (Micro-Introducer) (K172487).

Who can help prepare an FDA 510(k) submission like Sterile Dilator?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Sterile Dilator

K192195 · Galt Medical Corp. · DRE · Sep 26, 2019 · Cardiovascular

Device Facts

Record ID	K192195
Device Name	Sterile Dilator
Applicant	Galt Medical Corp.
Product Code	DRE · Cardiovascular
Decision Date	Sep 26, 2019
Decision	SESE
Submission Type	Special
Regulation	21 CFR 870.1310
Device Class	Class 2

Intended Use

These dilators are used for the percutaneous introduction of guidewires into the peripheral vasculature.

Device Story

Sterile Dilator is a single-patient-use, disposable device consisting of a tipped radiopaque tube with a molded hub. It accepts guidewires up to 0.038 inches. Used by clinicians in clinical settings to facilitate percutaneous access to the peripheral vasculature. The device functions as a mechanical tool to dilate the entry site, allowing for the subsequent introduction of guidewires. It is provided as a standalone component, whereas similar designs were previously cleared as part of introducer assembly sets. The device benefits patients by providing a reliable means to establish vascular access for diagnostic or therapeutic procedures.

Clinical Evidence

Bench testing only. No clinical data. Performance testing included design verification, dimensional analysis, mechanical tensile strength testing (min 5 lbs), particulate testing, and simulated use insertion force testing. Packaging validation was performed per ISTA 2A-2011 standards on un-aged and 4-year aged product. All tests passed successfully, demonstrating equivalence to predicate devices.

Technological Characteristics

Materials: Pebax 7233 SA01 (for 5.5F and smaller) and HDPE (for 6F and above). Radiopaque tube with molded hub. Sizes: 3F-16F; lengths: 10cm-30cm. Connectivity: None. Sterilization: Not specified. Software: None. Mechanical principle: Vessel dilation via tapered tip.

Indications for Use

Indicated for percutaneous introduction of guidewires into the peripheral vasculature in patients requiring vascular access.

Regulatory Classification

Identification

A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.

Predicate Devices

Coaxial Dilator Set (Micro-Introducer) (K172487)

Reference Devices

Galt Tearaway Introducer Sheath & MicroSlide™ Tearaway Introducer (K153533)
Elite HV Radial (CathLab Introducer) (K173287)

Related Devices

K162389 — Medcomp Vessel Dilator · Medcomp ( Medical Components) · Jun 1, 2017
K963388 — VESSEL DILATOR · Maxxim Medical · Mar 11, 1997
K974640 — COAXIAL DILATOR SET · Boston Scientific Corp · Mar 13, 1998
K103421 — ARSTASIS DILATOR ADAPTER · Arstasis, Inc. · May 24, 2011
K172487 — Coaxial Dilator Set (Micro-Introducer) · Galt Medical Corp. · Oct 16, 2017

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains 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, 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. September 26, 2019 Galt Medical Corp. David Derrick Director of Quality and Regulatory Affairs 2220 Merritt Dr. Garland, TX 75041 Re: K192195 Trade/Device Name: Sterile Dilator Regulation Number: 21 CFR 870.1310 Regulation Name: Vessel Dilator For Percutaneous Catheterization Regulatory Class: Class II Product Code: DRE Dated: September 18, 2019 Received: September 19, 2019 Dear Mr. 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 {1}------------------------------------------------ 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 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 medical devices and radiation-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, Misti Malone Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: 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) K192195 Device Name STERILE DILATOR Indications for Use (Describe) These dilators are used for the percutaneous introduction of guidewires into the peripheral vasculature. 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) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *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: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ | Application Date: | August 12, 2019 | |---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Application Type: | Special 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: | Sterile Dilator | | Device Model Number: | TBD | | Classification Name: | Dilator, Vessel, for percutaneous catheterization (DRE), | | | 21 CFR 870.1310 | | Device Classification: | Class II (Cardiovascular) | | Predicate Device: | Primary predicate device: Coaxial Dilator Set (Micro- Introducer) K172487. Reference Devices: Galt Tearaway Introducer Sheath & MicroSlide™ Tearaway Introducer with new material hub K153533 and Elite HV Radial (CathLab Introducer) K173287 | | Manufacturer: | Galt Medical 2220 Merritt Drive Garland, TX 75041 | | Establishment Registration Number: | 1649395 | Intended Use: These dilators are used for the percutaneous introduction of guidewires into the peripheral vasculature. Device Description: The dilator introducer consists of a tipped radiopaque tube with a molded hub that accepts up to a .038-inch guidewire {4}------------------------------------------------ Comparison of Technological Characteristics: The Dilator is substantially equivalent to the unmodified predicate in construction, materials, and device performance. As per indication of use, the subject device just as the predicate will also accept up to 0.38inch guidewire. And although it doesn't mention the introduction of catheters like the predicate device does, this difference in indication of use does not in any way affect substantial equivalence of the device to the primary predicate. {5}------------------------------------------------ | | Subject device | Primary Predicate device | Reference Predicate Device | Reference Predicate Device | |--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Mfr. / Product | Sterile Dilator | Coaxial Dilator Set (Micro-Introducer) | Galt Tearaway Introducer Sheath & MicroSlide™ Tearaway Introducer with new material hub | Elite HV Radial (CathLab Introducer) | | 510(k) Number | | K172487 | K153533 | K173287 | | Device Classification | 870.1310 | 870.1310 | 870.1340 | 870.1340 | | Product Code | DRE | DRE | DYB | DYB | | Intended use | These dilators are used for the percutaneous introduction of guidewires into the peripheral vasculature | These Coaxial Dilator Sets are intended to introduce up to a 0.038 in. guidewire or catheter into the vascular system following a small gauge needle stick | 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 Introducer: These introducers are used for the procedures to introduce catheters and other intravascular devices into the coronary and peripheral vasculature of adult and | 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 | | | Subject device | Primary Predicate device | Reference | Reference | | | | | Predicate Device pediatric patients of all ages. | Predicate Device | | Design | The dilator is composed of hub over-molded onto a tube. The material for 5.5F and smaller dilators is Pebax 7233 SA01. And 6F and above dilators are made with HDPE. The dilator introducer consists of a tipped radiopaque tube with a molded hub that accepts up to a .038 inch guidewire | The Coaxial Dilator Set (Micro-Introducer) assembly consists of an inner dilator within a slightly shorter outer sheath which is connected to the inner dilator using a spin-lock type connector. The inner and outer dilators are made from radiopaque material so they are visible under fluoroscopy. | 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. | Introducer with valved sheath and dilator in a range of sizes and lengths | | | Subject device | Primary Predicate device | Reference Predicate Device | Reference Predicate Device | | Color | Dilator: White or Grey hub, green cannula | Inner Dilator: White round hub with clear spin-lock, blue cylindrical cannula Outer Sheath: Red or Grey round hub, white cylindrical cannula | Sheath: Color coded winged hub, gray cannula. Dilator: White hub, green cannula | Sheath Hub – White 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 | | Shape | Cylindrical cannula with round hub | Inner Dilator: round hub with spin-lock, cylindrical cannula Outer Sheath: round hub, cylindrical cannula | Sheath: winged hub, cylindrical cannula Dilator: Round hub, cylindrical cannula | | | Sizes | 3F-16F 10cm to 30 cm lengths | 4F- SF 5cm to 45cm lengths | Adult Only - Galt Tearaway Introducer Sheath 3F - 16F 5 cm and 30 cm & Adult/Pediatric - Galt MicroSlide™ | 4F - 6F 5cm to 25cm lengths | | Packaging | Pouch- Uncoated 10738 Tyvek, 92 GA PET/ 3 mil LDPE (4 mil total) | Pouch- Uncoated 10738 Tyvek, 92 GA PET/ 3 mil LDPE (4 mil total) | Pouch- Uncoated 10738 Tyvek, 92 GA PET/ 3 mil LDPE (4 mil total) | Pouch- Uncoated 10738 Tyvek, 92 GA PET/ 3 mil LDPE (4 mil total) | {6}------------------------------------------------ {7}------------------------------------------------ Use Type: The Galt Sterile Dilator is a single patient use, disposable device. Summary of Non-Clinical Data Submitted: Performance testing done to evaluate the Galt sterile dilators included Design Verification and packaging validation testing on un-aged and 4 year aged product. This demonstrates that the Galt sterile dilators as stand-alone products meet the pre-defined product specification to those found in the primary predicates introducer assembly device Coaxial Dilator set cleared under 510(k) K172487, {8}------------------------------------------------ as well as predicate reference devices Galt Tearaway Introducer Sheath & MicroSlide™ Tearaway Introducer K153533 and Elite HV Radial (CathLab Introducer) K173287. | Testing was conducted according to protocols based on international standards and Galt | |-----------------------------------------------------------------------------------------| | Medical requirements. The following physical and mechanical test were done and all test | | passed successfully: | | Attributed Tested | Specification | Results | |------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------| | Dimensional | Comparison between predicate device and subject device. Including; Dimensional Comparison: Predicate Spec range: Min size dilator 3F ID at Tip; 0.012' -0.020'Effective length; 12.05' - 12.45'Through hole ID; 0.021' - 0.025'Most common long length: 9F ID at Tip; 0.038' -0.040'Effective length; 33.48' - 34.12'Through hole ID; N/AMax size dilator 16F ID at Tip: 0.038' -0.040'Effective length; 17.55' - 17.85'Through hole ID; N/A | Passed: All sampled dilator sizes within spec range | | Descriptive | Comparison to predicate including; labeling (labels, IFU, promotional materials)Intended use and instructions including anatomical placement for the distal tipMaterials used to fabricate the devices | Passed: All labeling, IFU and promotional materials were identical to predicate. | | Mechanical specifications | Predicate Spec range Tensile strength of dilator body-min 5lbsTensile strength of dilator body to hub- min 5lbs | Passed: All sampled dilator sizes passed test within acceptance range | | Particulate Test | Confirm acceptable levels of particulate | Passed: Test article exhibited particulate levels equal to or less than predicate equal | | Simulated use Test | Measure Insertion force; Force must be ≤ 20% of predicate | Passed: All sampled dilators with range | {9}------------------------------------------------ | Packaging Test | Packaged should not be damaged | Passed: | |----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------| | | after all test. Seal must remain | No package was damaged. | | | intact. | Visual inspection passed. No | | | Shipping test Pouch Test worst case scenario Atmospheric conditioning ISTA 2A-2011 Partial simulation performance test procedure for packaged products 150lb (68kg) or less. | pouches were damaged. | Conclusion: It will be shown in this 510(k) submission that Galt sterile dilators as standalone products are favorably compared with those found in the assembly sets of the predicates introducer devices. All Galt dilators have been manufactured and marketed for many years as a component of various introducers assemblies, and their use in the market as a stand-alone sterile dilator is substantially equivalent to listed predicates. End of Section