(60 days)
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
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 design of the subject device, Coaxial Dilator Set (Micro-Introducer) is unchanged from the current line of Coaxial Dilators (K000737). The subject and current marketed predicate devices are identical with the exception of the addition of an optional depth marker, optional outer hub & sheath material and additional lengths.
The provided text is a 510(k) premarket notification for a medical device called the "Coaxial Dilator Set (Micro-Introducer)". This document outlines the manufacturer's claim that their new device is "substantially equivalent" to an existing, legally marketed predicate device.
It is crucial to understand that this document describes a traditional medical device (a physical dilator set) and not an AI/software-based device. Therefore, the concepts of acceptance criteria for AI model performance, sample sizes for test/training sets, expert ground truth, MRMC studies, or standalone algorithm performance are not applicable to this submission.
The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the bench testing and biocompatibility testing performed to demonstrate that the new physical device performs comparably to the predicate device and is safe for its intended use.
Here's an interpretation based on the provided document, but tailored to the context of a traditional medical device. Many of your requested points are irrelevant for this type of submission.
Acceptance Criteria and Device Performance for the Coaxial Dilator Set (Micro-Introducer)
Since this is a submission for a traditional medical device (Coaxial Dilator Set) and not an AI/software device, the "acceptance criteria" relate to engineering specifications, performance tests, and biocompatibility, rather than algorithmic metrics. The "study" refers to the bench tests and biocompatibility tests conducted.
1. Table of Acceptance Criteria and Reported Device Performance
The document lists the types of tests conducted, implying that the device met internal Galt Medical Corp. requirements and international standards. Specific numerical acceptance criteria and reported results are not provided in this public summary. They would typically be detailed in the full submission.
| Acceptance Criterion Type | Implied Performance Outcome |
|---|---|
| Functional/Performance Testing | |
| Product Insertion Force | Met predefined force limits for smooth and safe insertion. |
| Marking Durability | Markings (e.g., depth markers) remained legible under specified conditions. |
| Hub Dimensional Accuracy | Hub dimensions conformed to design specifications for proper fit and function. |
| Tip Dimensional Accuracy | Tip dimensions conformed to design specifications for smooth introduction and minimal trauma. |
| Hub to Cannula Tensile Force | The connection between the hub and cannula withstood specified tensile forces without separation. |
| Particulate Matter Generation | Device generated particulate matter below specified thresholds to ensure patient safety. |
| Biocompatibility Testing (per ISO 10993-1) | |
| Cytotoxicity | Device materials were non-toxic to cells. |
| Sensitization | Device materials did not induce allergic reactions. |
| Irritation | Device materials did not cause local irritation. |
| Systemic Toxicity | Device materials did not cause systemic toxic effects. |
| Hemocompatibility (Hemolysis, Complement Activation, In-Vitro) | Device materials were compatible with blood, causing minimal or no hemolysis or complement activation. |
| Pyrogen (Materials Mediated) | Device materials were non-pyrogenic. |
| EO Residuals (if sterilized with Ethylene Oxide) | Ethylene Oxide residuals were below hazardous levels after sterilization. |
| Sterilization Efficacy | |
| Adopted into existing ethylene oxide sterilization cycle (K000737) | The sterilization process was effective in rendering the device sterile. |
| Packaging Shelf Life | |
| Unchanged from predicate device, with prior testing | The packaging maintained device integrity and sterility over its stated shelf life. |
2. Sample Size for the Test Set and Data Provenance
- Sample Size: Not explicitly stated, as these are engineering and chemical tests, not clinical studies with "test sets" in the AI sense. Samples would have been specimens of the device.
- Data Provenance: The tests were conducted internally by Galt Medical Corp. ("Design testing was conducted according to protocols based on international standards and Galt Medical requirements."). This is laboratory bench testing and biocompatibility testing, not human subject data from specific countries or retrospective/prospective studies.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not applicable. This relates to human expert review for clinical data, which is not part of this type of submission for a physical device where "ground truth" is established by direct measurement (e.g., tensile strength, dimensions) and laboratory analysis (e.g., biocompatibility assays).
4. Adjudication Method for the Test Set
- Not applicable. This concept typically applies to clinical image or data review by multiple experts for AI ground truth establishment. For physical device testing, results are typically objective measurements against predefined specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. MRMC studies are for evaluating the performance of diagnostic devices, often AI-assisted. This is a physical interventional device, not a diagnostic one.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This device is a physical instrument, not an algorithm.
7. The Type of Ground Truth Used
- Bench Test Results: Direct physical measurements (e.g., force, dimensions) against engineering specifications.
- Biocompatibility Assay Results: Laboratory test outcomes (e.g., cell viability, chemical analysis) against established international standards (ISO 10993-1).
8. The Sample Size for the Training Set
- Not applicable. There is no "training set" as this is not an AI or machine learning device. The design and manufacturing process for the physical device are based on established engineering principles and prior knowledge.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. See point 8.
In summary: The provided document is a 510(k) submission for a conventional medical device. The "acceptance criteria" are implied by the list of tests performed, which confirmed the device's functional integrity, dimensions, material properties, and biocompatibility, demonstrating its substantial equivalence to a predicate device. The "study" refers to the bench and biocompatibility testing conducted in a laboratory setting.
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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.
October 16, 2017
Galt Medical Corp. David Derrick Director of Quality and Regulatory Affairs 2220 Merritt Dr. Garland, Texas 75041
Re: K172487
Trade/Device Name: Coaxial Dilator Set (Micro-Introducer) Regulation Number: 21 CFR 870.1310 Regulation Name: Vessel Dilator For Percutaneous Catheterization Regulatory Class: Class II Product Code: DRE Dated: August 15, 2017 Received: August 17, 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 (DICE) 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. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) 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.
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
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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 COAXIAL DILATOR SET (Micro-Introducer)
Indications for Use (Describe)
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
| Type of Use (Select one or both, as applicable) |
|---|
| For use in connection with OFF-Highway Business |
| For use in connection with OFF-Road Recreation |
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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| Application Date: | August 15, 2017 |
|---|---|
| Application Type: | 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: | Coaxial Dilator Set (Micro-Introducer) |
| Device Model Number: | TBD |
| Classification Name: | Dilator, Vessel, for percutaneous catheterization (DRE),21 CFR 870.1310 |
| Device Classification: | Class II (Cardiovascular) |
| Predicate Device: | Coaxial Dilator Set (K000737) |
| Manufacturer: | Galt Medical2220 Merritt DriveGarland, TX 75041Phone: 214-778-5177Fax: 972-271-4706 |
| Establishment |
Registration Number: 1649395
Intended Use Coaxial Dilator Set: 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.
Device Description: 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 design of the subject
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device, Coaxial Dilator Set (Micro-Introducer) is unchanged from the current line of Coaxial Dilators (K000737). The subject and current marketed predicate devices are identical with the exception of the addition of an optional depth marker, optional outer hub & sheath material and additional lengths.
Comparison of Technological Characteristics: The subject device Coaxial Dilator Set (Micro-Introducer) and the predicate device have identical indication statements and are of identical design. The subject and predicate device are available in identical configurations.
| Mfr. /Product | Subject Device | Predicate Device |
|---|---|---|
| 510(k)Number | Coaxial Dilator Set (Micro-Introducer) with optional depth marking, optional outer Hub & sheath material and additional length | Coaxial Dilator Set |
| DeviceClassification | K172487 | K000737 |
| ProductCode | 870.1310 | 870.1310 |
| Intendeduse | DRE | DRE |
| 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 | 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 | |
| Design | Same as predicate with the addition of optional depth marker, optional outer hub & sheath material and additional length. | The Coaxial Dilator Set 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 |
| Color | Inner Dilator: White round hub with clear spin-lock connector, blue cylindrical cannula.Outer Sheath: Red or Grey round hub, White cylindrical cannula | Inner Dilator: White round hub with clear spin-lock connector, blue cylindrical cannula.Outer Sheath: Red or Grey round hub, White cylindrical cannula |
| Sizes | 4F - 5F5cm to 45cm lengths | 4F - 5F5cm to 10cm lengths |
| Dilator Lock | Dilator is retained | Dilator is retained |
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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 Coaxial Dilator Set (Micro-Introducer) with optional depth marking, optional outer Hub & sheath material and additional lengths is substantially equivalent to the specified predicate device based on comparisons of the devices functionality, compatibility, technological characteristics, and indications for use.
Design testing was conducted according to protocols based on international standards and Galt Medical requirements. Functional Testing included the following:
- Product Insertion Force
- Marking Durability
- 0 Hub Dimensional
- . Tip Dimensional
- Hub to Cannula Tensile Force
- Particulate Matter Generation
Biocompatibility testing was performed on the subject device in accordance with ISO 10993-1. Biocompatibility testing included the following:
- Cytotoxicity
- Sensitization
- . Irritation
- Systemic Toxicity
- Hemocompatibility (Hemolysis) .
- Complement Activation
- In-Vitro Hemocompatibility
- Pyrogen (Materials Mediated)
- . EO Residuals
Additionally the subject device was adopted into the existing ethylene oxide sterilization cycle for the Galt Coaxial Dilator cleared under K000737.
Packaging of the subject device will remain unchanged from the predicated device. 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 Coaxial Dilator Set (Micro-Introducer) with optional depth marking, optional outer sheath material and additional lengths and the predicate devices do not raise any new questions regarding safety and effectiveness. The Galt Coaxial Dilator Set (Micro-Introducer) with optional depth marking, optional outer sheath material and additional lengths as designed and manufactured is determined to be substantially equivalent to the current marketed predicate device.
End of Section
§ 870.1310 Vessel dilator for percutaneous catheterization.
(a)
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.(b)
Classification. Class II (performance standards).