(44 days)
No
The description focuses on physical and mechanical properties of a dilator, with no mention of AI/ML terms, image processing, or data-driven performance metrics.
No
The device is described as a dilator for introducing guidewires, which is an accessory function for a medical procedure, not a therapeutic intervention itself.
No
Explanation: The device description states it is used for "percutaneous introduction of guidewires," which is a procedural function, not a diagnostic one. No diagnostic claims or functions like disease detection or assessment are mentioned.
No
The device description clearly states it is a "tipped radiopaque tube with a molded hub," which are physical hardware components. The performance studies also focus on physical and mechanical testing of these components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "percutaneous introduction of guidewires into the peripheral vasculature." This describes a procedure performed directly on a patient's body, not a test performed on a sample taken from the body.
- Device Description: The device is a "tipped radiopaque tube with a molded hub." This is a physical instrument used for insertion into the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device is a surgical/interventional tool.
N/A
Intended Use / Indications for Use
These dilators are used for the percutaneous introduction of guidewires into the peripheral vasculature.
Product codes (comma separated list FDA assigned to the subject device)
DRE
Device Description
The dilator introducer consists of a tipped radiopaque tube with a molded hub that accepts up to a .038-inch guidewire
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
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, 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 |
| Packaging Test | Packaged should not be damaged after all test. 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. |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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)
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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