(44 days)
These dilators are used for the percutaneous introduction of guidewires into the peripheral vasculature.
The dilator introducer consists of a tipped radiopaque tube with a molded hub that accepts up to a .038-inch guidewire
The provided text is a 510(k) premarket notification for a medical device (Sterile Dilator) and focuses on establishing substantial equivalence to predicate devices based on non-clinical performance testing. It does not contain information about AI/ML algorithm performance, human reader studies, or image-based diagnostic applications. Therefore, I cannot provide details on:
- Acceptance criteria related to algorithm performance (e.g., sensitivity, specificity, AUC).
- Sample sizes for algorithm test sets (image data).
- Data provenance for AI/ML models.
- Number of experts for ground truth establishment in an AI context.
- Adjudication methods for AI ground truth.
- MRMC comparative effectiveness studies.
- Standalone algorithm performance.
- Type of ground truth (e.g., pathology, outcomes data).
- Training set sample size or how ground truth was established for training data.
The document discusses acceptance criteria and studies related to the physical and mechanical performance of the Sterile Dilator itself, ensuring it is equivalent to the predicate devices for its intended use (percutaneous introduction of guidewires).
Here's the information that can be extracted regarding the physical device's performance testing:
1. A table of acceptance criteria and the reported device performance
The document presents performance testing conducted on the Galt sterile dilators.
| Attributed Tested | Specification | Reported Device Performance (Results) |
|---|---|---|
| Dimensional | Comparison between predicate device and subject device, including specific ranges for ID at Tip, Effective length, and Through hole ID for various dilator sizes (e.g., Min size 3F, Most common long length 9F, Max size 16F). | Passed: All sampled dilator sizes within spec range |
| Descriptive | Comparison to predicate including labeling (labels, IFU, promotional materials), intended use and instructions, and materials 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 5lbs; Tensile 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 within range. |
| Packaging Test | Packaged should not be damaged after all tests. Seal must remain intact. Shipping test Pouch Test worst case scenario Atmospheric conditioning ISTA 2A-2011 Partial simulation performance test procedure for packaged products 150lb (68kg) or less. | Passed: No package was damaged. Visual inspection passed. No pouches were damaged. |
2. Sample sizes used for the test set and the data provenance
The document does not specify exact sample sizes (N numbers) for each physical/mechanical test. It generally states a qualitative "All sampled dilator sizes" or "Test article."
- Data Provenance: The tests were conducted to evaluate the Galt sterile dilators against pre-defined product specifications, which were based on existing predicate devices (K172487, K153533, K173287). The context implies these are laboratory-based, non-clinical tests. No country of origin for test data is mentioned, but the manufacturer is Galt Medical Corporation, Garland, TX, USA. The study design is implied to be prospective testing for device validation rather than retrospective data analysis.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This concept is not applicable to the non-clinical, physical/mechanical testing described. Ground truth for these tests is established by engineering specifications, material properties, and standardized testing protocols (e.g., tensile strength, dimensional measurements, particulate levels). No human expert interpretation of results (like in an AI imaging study) is mentioned or implied beyond standard laboratory personnel conducting and verifying tests.
4. Adjudication method for the test set
Not applicable. The tests are objective quantitative measurements or visual inspections against predetermined engineering specifications, not subjective assessments requiring expert consensus or adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI/ML device or a diagnostic device involving human readers or image interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the device's performance is based on established engineering specifications, mechanical test standards, and equivalence to the performance of predicate devices as measured through physical and simulated use tests. For example:
- Dimensional: Measured dimensions compared against specified ranges derived from predicate devices.
- Mechanical: Measured tensile strength compared against minimum force requirements.
- Particulate: Measured particulate levels compared against acceptable limits derived from predicate device performance.
- Simulated Use: Measured insertion force compared against a specified percentage (≤ 20%) of the predicate's force.
- Packaging: Visual inspection and performance against established packaging integrity standards (ISTA 2A-2011).
8. The sample size for the training set
Not applicable. This is not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set for an AI/ML model.
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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.
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
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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
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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)
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| 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 DerrickDirector of Quality and Regulatory AffairsGalt Medical Corporation2220 Merritt Dr.Garland, TX 75041Phone: 214-778-1306Fax: 972-271-4706dderrick@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 TearawayIntroducer Sheath & MicroSlide™ Tearaway Introducerwith new material hub K153533 and Elite HV Radial(CathLab Introducer) K173287 |
| Manufacturer: | Galt Medical2220 Merritt DriveGarland, TX 75041 |
| EstablishmentRegistration 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
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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.
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| Subject device | Primary Predicate device | ReferencePredicate Device | ReferencePredicate Device | |
|---|---|---|---|---|
| Mfr. / Product | Sterile Dilator | Coaxial Dilator Set(Micro-Introducer) | Galt TearawayIntroducerSheath &MicroSlide™TearawayIntroducer withnew material hub | Elite HV Radial(CathLabIntroducer) |
| 510(k) Number | K172487 | K153533 | K173287 | |
| DeviceClassification | 870.1310 | 870.1310 | 870.1340 | 870.1340 |
| Product Code | DRE | DRE | DYB | DYB |
| Intended use | These dilators are used forthe percutaneousintroduction of guidewiresinto the peripheralvasculature | These Coaxial Dilator Setsare intended to introduceup to a 0.038 in.guidewire or catheter intothe vascular systemfollowing a small gaugeneedle stick | TearawayIntroducerSheath: Theseintroducers areused for thepercutaneousintroduction ofdiagnostic ortherapeuticdevices, such ascatheters andpacing leads, intothe vasculature.MicroSlide™TearawayIntroducer: Theseintroducers areused for theprocedures tointroducecatheters andotherintravasculardevices into thecoronary andperipheralvasculature ofadult and | Elite HV Radial isindicated tofacilitate placinga catheterthrough the skininto a vein orartery includingbut not limited tothe radial artery |
| Subject device | Primary Predicate device | Reference | Reference | |
| Predicate Devicepediatric patientsof all ages. | Predicate Device | |||
| Design | The dilator is composed ofhub over-molded onto atube. The material for5.5F and smaller dilators isPebax 7233 SA01. And 6Fand above dilators aremade with HDPE.The dilator introducerconsists of a tippedradiopaque tube with amolded hub that acceptsup to a .038 inchguidewire | The Coaxial Dilator Set(Micro-Introducer)assembly consists of aninner dilator within aslightly shorter outersheath which is connectedto the inner dilator using aspin-lock type connector.The inner and outerdilators are made fromradiopaque material sothey are visible underfluoroscopy. | The GaltTearawayIntroducer Sheathassembly consistsof an outerpeelable sheathand a dilator. Thetear-away sheathhas a winged hubto initiate thetear in thesheath. | Introducer withvalved sheathand dilator in arange of sizesand lengths |
| Subject device | Primary Predicate device | ReferencePredicate Device | ReferencePredicate Device | |
| Color | Dilator: White or Greyhub, green cannula | Inner Dilator: White roundhub with clear spin-lock,blue cylindrical cannulaOuter Sheath: Red or Greyround hub, whitecylindrical cannula | Sheath: Colorcoded wingedhub, graycannula. Dilator:White hub, greencannula | Sheath Hub –White Sheathcannula- WhiteSheath cap-Variousindicating Fr sizeDilator hub-White Dilatorcannula- BlueSidearm withstopcock - ClearValve silicone -clear naturalValve TPE - clearnatural |
| Shape | Cylindrical cannula withround hub | Inner Dilator: round hubwith spin-lock, cylindricalcannulaOuter Sheath: round hub,cylindrical cannula | Sheath: wingedhub, cylindricalcannula Dilator:Round hub,cylindricalcannula | |
| Sizes | 3F-16F10cm to 30 cm lengths | 4F- SF5cm to 45cm lengths | Adult Only - GaltTearawayIntroducerSheath 3F - 16F 5cm and 30 cm &Adult/Pediatric -Galt MicroSlide™ | 4F - 6F 5cm to25cm lengths |
| Packaging | Pouch- Uncoated 10738Tyvek, 92 GA PET/ 3 milLDPE (4 mil total) | Pouch- Uncoated 10738Tyvek, 92 GA PET/ 3 milLDPE (4 mil total) | Pouch- Uncoated10738 Tyvek, 92GA PET/ 3 milLDPE (4 mil total) | Pouch- Uncoated10738 Tyvek, 92GA PET/ 3 milLDPE (4 mil total) |
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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,
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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 3FID at Tip; 0.012' -0.020'Effective length; 12.05' - 12.45'Through hole ID; 0.021' - 0.025'Most common long length: 9FID 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. |
| Mechanicalspecifications | Predicate Spec rangeTensile 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 |
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| 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
§ 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).