(258 days)
Not Found
No
The device description and performance studies focus on the physical properties and functional performance of a mechanical dilator, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended to enlarge the opening of a vessel for the placement of a catheter, which directly supports a therapeutic procedure.
No
The device is described as a "Vessel Dilator" used for percutaneous entry and enlarging vessel openings to facilitate catheter placement. Its function is to prepare the anatomical site for another procedure, not to diagnose a condition. The performance studies focus on biocompatibility and functional testing of the dilator itself, not on diagnostic accuracy.
No
The device description explicitly states it is a physical dilator made of HDPE with a shaft and hub, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "percutaneous entry into a vessel in order to enlarge the opening of the vessel for the placement of a catheter in a vein or artery." This describes a surgical or interventional procedure performed directly on the patient's body.
- Device Description: The device is a physical tool (a dilator) used to manipulate tissue within the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a physiological state, health, or disease. This device does not perform any such analysis of specimens.
The description clearly indicates a medical device used for a procedural purpose, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The MEDRON Vessel Dilator is designed for percutaneous entry into a vessel in order to enlarge the opening of the vessel for the placement of a catheter in a vein or artery.
Product codes (comma separated list FDA assigned to the subject device)
DRE
Device Description
The MEDRON Vessel Dilator is a dilator consisting of a radiopaque HDPE (high density polyethylene) shaft with an overmolded HDPE Hub. The dilator comes in a variety of diameters ranging from 6F to 17.5F. It is also available in two models, a straight model and a stepped model. The straight model has a consistent diameter along the length of the shaft until it tapers at the distal tip. In the stepped model, the distal segment of the dilator shaft has a smaller diameter than the proximal segment as well as a taper at the distal tip.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessel (vein or artery)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Biocompatibility
- Study Type: Biocompatibility testing in accordance with ISO 10993-1:2009 and FDA's Guidance for Industry and Food and Drug Administration Staff Use of International Standard ISO 10993-1.
- Sample Size: Not specified.
- Key Results:
- Cytotoxicity: Non-cytotoxic.
- Sensitization: Negative for dermal sensitization.
- Irritation: Non-irritating.
- Acute Systemic Toxicity: Non-toxic.
- Materials-Mediated Pyrogenicity: Non-pyrogenic.
- Hemocompatibility (Hemolysis by Direct Contact and Extract): Non-hemolytic.
- Complement Activation (SC5b-9): Negative for complement system activation.
Functional Testing
- Study Type: Functional tests performed on unaged (t=0) and 1-year real time aged samples.
- Sample Size: Not specified.
- Key Results:
- Dimensional Verification: All devices met dimensional specifications.
- Hub Workmanship: All devices met acceptance criteria for size identification and were free of extraneous matter and process or surface defects.
- Inspection for luer taper: All samples met the criteria specified in ANSI/HIMA MD70.1-1983 and ISO 594-2.
- Tensile breakage: All devices met minimum force requirements specified in ISO 11070.
- Tip Workmanship: All device tips were free of deformation, discoloration and process or surface defects.
- Guidewire Test: All devices met acceptance criteria as the guidewire passed through the dilators from hub to tip without drag.
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.
Not Found
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 & 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.
May 6, 2020
MEDRON, LLC David Kujawa QARA Manager 1518 S Gladiola Street Salt Lake City, UT 84104
Re: K192283
Trade/Device Name: MEDRON Vessel Dilator Regulation Number: 21 CFR 870.1310 Regulation Name: Vessel Dilator For Percutaneous Catheterization Regulatory Class: Class II Product Code: DRE Dated: April 1, 2020 Received: April 2, 2020
Dear David Kujawa:
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 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
1
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 mediation-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,
for
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) K192283
Device Name MEDRON Vessel Dilator
Indications for Use (Describe)
The MEDRON Vessel Dilator is designed for percutaneous entry into a vessel in order to enlarge the opening of the vessel for the placement of a catheter in a vein or artery.
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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3
Vessel Dilator
510(k) Summary
| 510(k) Sponsor: | MEDRON, LLC
1518 S Gladiola Street
Salt Lake City, UT 84104 |
|-----------------|-------------------------------------------------------------------|
| Contact Person: | David Kujawa
Manager, QARA
Tel: 801-974-3010 |
E-mail: mike.kujawa@flexan.com
Date Prepared: March 31, 2020
Prepared by: Ryan O'Callaghan, MS, RAC Phil Triolo and Associates LC Tel: 801.699.9846 Fax: 801.328.2399 E-mail: ryano@philt.com
| Trade Name: | MEDRON Vessel Dilator |
|---|---|
| Common Name: | Vessel dilator |
| Classification Name: | Vessel dilator for percutaneous catheterization (21 CFR 870.1310) |
| Product Code: | DRE |
| Predicate Device: | Medcomp Vessel Dilator (K162389) |
1. Device Description
The MEDRON Vessel Dilator is a dilator consisting of a radiopaque HDPE (high density polyethylene) shaft with an overmolded HDPE Hub. The dilator comes in a variety of diameters ranging from 6F to 17.5F. It is also available in two models, a straight model and a stepped model. The straight model has a consistent diameter along the length of the shaft until it tapers at the distal tip. In the stepped model, the distal segment of the dilator shaft has a smaller diameter than the proximal segment as well as a taper at the distal tip.
4
2. Intended Use
The MEDRON Vessel Dilator is intended for short-term vascular access for percutaneous catheterization.
The intended use of the subject device is identical to the intended use of the predicate device.
3. Indications for Use
The MEDRON Vessel Dilator is designed for percutaneous entry into a vessel in order to enlarge the opening of the vessel for the placement of a catheter in a vein or artery. The subject device and predicate device have identical indications for use statements.
4. Technological Characteristics
As shown in the table below, the technological characteristics of the subject device, the MEDRON Vessel Dilator, are substantially equivalent to those of the predicate device, the Medcomp Vessel Dilator.
| Comparison between Subject & Predicate Device Technological Characteristics | |||
|---|---|---|---|
| Characteristic | Predicate Device | ||
| Medcomp Vessel Dilator | |||
| (K162389) | Subject Device | ||
| MEDRON Vessel Dilator | Comparison | ||
| Dimensions | O.D.: 4F to 24F | ||
| Length: 6", 8" | |||
| Guidewire Sizes: 0.025", | |||
| 0.035", 0.038" | O.D.: 6F - 17.5F | ||
| Length: 8.40 in - 8.66 in | |||
| Guidewire Sizes: 0.018", | |||
| 0.038" | Equivalent | ||
| Materials: | |||
| Dilator Body | High Density Polyethylene | High Density Polyethylene | Same |
| Materials: | |||
| Dilator Hub | High Density Polyethylene | High Density Polyethylene | Same |
5
| Comparison between Subject & Predicate Device Technological Characteristics | |||
|---|---|---|---|
| Characteristic | Predicate Device | ||
| Medcomp Vessel Dilator | |||
| (K162389) | Subject Device | ||
| MEDRON Vessel Dilator | Comparison | ||
| Sterilization Method | EO | EO | Same |
Results of tests performed on the subject demonstrate that it meets the requirements of relevant standards. Further, any differences in technological characteristics of the MEDRON Vessel Dilator when compared with predicate device characteristics do not raise different questions of safety and effectiveness.
5. Non-Clinical Performance Tests
Biocompatibility
Biocompatibility of the MEDRON Vessel Dilator has been verified in accordance with ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process and FDA's Guidance for Industry and Food and Drug Administration Staff Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" issued June 16, 2016.
The results of the following biological and toxicological safety evaluations verified the biocompatibility of the subject device when tested as an external communicating, blood contact, limited duration (≤24 hours) device:
- Cytotoxicity;
- . Sensitization;
- . Irritation/Intracutaneous Reactivity;
- . Acute Systemic Toxicity;
- . Materials-Mediated Pyrogenicity;
- . Hemocompatibility (Hemolysis by Direct Contact and Extract); and
- . Complement Activation (SC5b-9).
Results of these tests are summarized in the following table.
6
Vessel Dilator
| Summaries of Biocompatibility Tests Conducted to Support this Premarket
| Notification | |||
|---|---|---|---|
| Test | Results | Conclusions | |
| Cytotoxicity | |||
| [L-929 MEM Elution] | Cell culture treated with test | ||
| sample exhibited no | |||
| reactivity (Grade 0). | Non-cytotoxic | ||
| Sensitization | |||
| [Maximization | |||
| (Magnusson-Kligman)] | Challenge sites treated with | ||
| test sample exhibited no | |||
| erythema or edema (Grade | |||
| 0). | Negative for dermal | ||
| sensitization | |||
| Irritation | |||
| [Intracutaneous Toxicity | |||
| (ISO)] | The mean test score in 0.9% | ||
| Normal Saline extract was 0, | |||
| and in Sesame Oil was 0.5. | Non-irritating | ||
| Systemic Toxicity (Acute) | |||
| [Systemic Injection (ISO)] | No study animals were | ||
| observed with abnormal | |||
| clinical signs indicative of | |||
| toxicity during the 72-hour | |||
| test period. | Non-toxic | ||
| Systemic Toxicity (Acute) | |||
| [Material Mediated | |||
| Pyrogen in a Rabbit | |||
| Model] | Temperature increases for | ||
| the all test animals did not | |||
| exceed the acceptable test | |||
| limit for maximum individual | |||
| temperature rise. | Non-pyrogenic | ||
| Hemocompatibility | |||
| [Hemolysis, direct contact |
- device/material (human
blood)] | The difference between the
hemolytic indices of the test
article and the negative
control was 0.00%. | Non-hemolytic | |
| Summaries of Biocompatibility Tests Conducted to Support this Premarket
Notification | | | |
| Test | Results | Conclusions | |
| Hemocompatibility
[Hemolysis, Extract -
device/material (human
blood)] | The difference between the
hemolytic indices of the test
article and the negative
control was 0.08%. | Non-hemolytic | |
| Complement Activation
[SC5b-9] | The activation caused by the
test article was similar to the
activation caused by the
negative control after 30 and
60 minutes exposure and
lower than the activation
caused by the negative
control after 90 minutes
exposure. | Negative for complement
system activation | |
7
Vessel Dilator
Functional Testing
The following table summarizes the functional tests performed on unaged (t=0) and 1year real time aged samples and results obtained to demonstrate substantial equivalence to the predicate device.
| Summaries of Functional Tests Conducted to Support this Premarket Notification | |||
|---|---|---|---|
| Test | Test Method Summary | Results | |
| Dimensional | |||
| Verification | Dimensional inspection per | ||
| engineering drawings | All devices met dimensional | ||
| specifications. | |||
| Hub | |||
| Workmanship | Visual inspection of hub for | ||
| French size identification as well | |||
| as extraneous matter and process | |||
| or surface defects | All devices met acceptance criteria | ||
| for size identification and were free | |||
| of extraneous matter and process or | |||
| surface defects |
8
Summaries of Functional Tests Conducted to Support this Premarket Notification Test Test Method Summary Results Inspection for luer taper in All samples met the criteria accordance with ANSI/HIMA specified in ANSI/HIMA MD70.1-Luer Taper MD70.1-1983 and ISO 594-2 1983 and ISO 594-2 All devices met minimum force Tensile testing at hub and shaft Tensile breakage requirements specified in ioint per ISO 11070 Strength ISO 11070. Visual inspection of dilator tips All device tips were free of Tip deformation, discoloration or deformation, discoloration and Workmanship process or surface defects process or surface defects Compatibility with standard All devices met acceptance criteria guidewires evaluated by passing as the guidewire passed through the Guidewire Test guidewire through the dilator dilators from hub to tip without drag from hub end to tip
6. Conclusion
MEDRON, LLC has presented information in this premarket notification supporting its contention that the MEDRON Vessel Dilator is substantially equivalent with respect to technological characteristics and indications for use to the predicate device.