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.

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.

AI/ML Overview

The provided document is a 510(k) summary for the MEDRON Vessel Dilator. It outlines an equivalency study comparing the MEDRON Vessel Dilator to a predicate device, the Medcomp Vessel Dilator (K162389). However, it does not describe a study involving an AI/Machine Learning device or its performance. Instead, it details non-clinical performance tests (biocompatibility and functional testing) for a traditional medical device (vessel dilator).

Therefore, I cannot provide information for all your requested points as they pertain to AI/ML device studies. I will address the relevant sections based on the available information for a conventional medical device.

Information based on the provided document:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria Category	Specific Test/Characteristic	Acceptance Criteria	Reported Device Performance
Biocompatibility	Cytotoxicity (L-929 MEM Elution)	Non-cytotoxic (Grade 0 reactivity)	Cell culture treated with test sample exhibited no reactivity (Grade 0). Result: Non-cytotoxic
	Sensitization (Magnusson-Kligman)	Negative for dermal sensitization	Challenge sites treated with test sample exhibited no erythema or edema (Grade 0). Result: Negative for dermal sensitization
	Irritation (Intracutaneous Toxicity)	Non-irritating (mean test score ≤ 1)	Mean test score in 0.9% Normal Saline extract was 0, and in Sesame Oil was 0.5. Result: Non-irritating
	Systemic Toxicity (Acute - Systemic Injection)	No abnormal clinical signs indicative of toxicity	No study animals were observed with abnormal clinical signs indicative of toxicity during the 72-hour test period. Result: Non-toxic
	Systemic Toxicity (Acute - Material Mediated Pyrogen)	Non-pyrogenic (temperature increases not exceeding acceptable limit)	Temperature increases for all test animals did not exceed the acceptable test limit for maximum individual temperature rise. Result: Non-pyrogenic
	Hemocompatibility (Hemolysis, direct contact)	Non-hemolytic (difference in hemolytic indices near 0%)	The difference between the hemolytic indices of the test article and the negative control was 0.00%. Result: Non-hemolytic
	Hemocompatibility (Hemolysis, Extract)	Non-hemolytic (difference in hemolytic indices near 0%)	The difference between the hemolytic indices of the test article and the negative control was 0.08%. Result: Non-hemolytic
	Complement Activation (SC5b-9)	Negative for complement system activation (activation similar to or lower than negative control)	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. Result: Negative for complement system activation
Functional Testing	Dimensional Verification	All devices meet dimensional specifications per engineering drawings	All devices met dimensional specifications.
	Hub Workmanship	All devices meet acceptance criteria for size identification and are free of 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.
	Inspection for Luer Taper	All samples meet criteria specified in ANSI/HIMA MD70.1-1983 and ISO 594-2	All samples met the criteria specified in ANSI/HIMA MD70.1-1983 and ISO 594-2.
	Tensile Strength (Hub and Shaft Joint)	All devices meet minimum force breakage requirements specified in ISO 11070	All devices met minimum force breakage requirements specified in ISO 11070.
	Tip Deformation, Discoloration, Workmanship	All device tips free of deformation, discoloration, and process or surface defects	All device tips were free of deformation, discoloration and process or surface defects.
	Guidewire Test (Compatibility)	Guidewire passes through dilator from hub to tip without drag	All devices met acceptance criteria as the guidewire passed through the dilators from hub to tip without drag from hub end to tip.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the sample sizes for each non-clinical test (biocompatibility and functional testing). It refers to "test samples," "study animals," and "all test animals" without providing specific numbers. The data provenance is not specified, but these are laboratory-based non-clinical tests, not human data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This section is not applicable as the document describes non-clinical performance and biocompatibility testing for a medical device, not an AI/ML system requiring expert-established ground truth from images or other clinical data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This section is not applicable for the reasons stated above. Adjudication methods are relevant for human interpretation tasks, not laboratory device testing.

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

This section is not applicable. The document describes a 510(k) submission for a physical medical device (vessel dilator) and its comparisons to a predicate device based on technological characteristics and non-clinical tests. It does not involve AI or human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This section is not applicable as the device is not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the biocompatibility tests, the "ground truth" is established by standard biological responses observed in laboratory models (e.g., cell cultures, animal models) under controlled conditions, and interpreted against predefined criteria (e.g., Grade 0 reactivity, no abnormal clinical signs). For functional tests, the "ground truth" is based on engineering specifications and adherence to relevant international standards (e.g., ANSI/HIMA MD70.1-1983, ISO 594-2, ISO 11070).

8. The sample size for the training set

This section is not applicable as the device is not an AI/ML system requiring a training set.

9. How the ground truth for the training set was established

This section is not applicable as the device is not an AI/ML system requiring a training set.

Summary

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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

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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

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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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Vessel Dilator

510(k) Summary

510(k) Sponsor:	MEDRON, LLC1518 S Gladiola StreetSalt Lake City, UT 84104
Contact Person:	David KujawaManager, QARATel: 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

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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 DeviceMedcomp Vessel Dilator(K162389)	Subject DeviceMEDRON Vessel Dilator	Comparison
Dimensions	O.D.: 4F to 24FLength: 6", 8"Guidewire Sizes: 0.025",0.035", 0.038"	O.D.: 6F - 17.5FLength: 8.40 in - 8.66 inGuidewire 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

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Comparison between Subject & Predicate Device Technological Characteristics
Characteristic	Predicate DeviceMedcomp Vessel Dilator(K162389)	Subject DeviceMEDRON 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.

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Vessel Dilator

Summaries of Biocompatibility Tests Conducted to Support this PremarketNotification
Test	Results	Conclusions
Cytotoxicity[L-929 MEM Elution]	Cell culture treated with testsample exhibited noreactivity (Grade 0).	Non-cytotoxic
Sensitization[Maximization(Magnusson-Kligman)]	Challenge sites treated withtest sample exhibited noerythema or edema (Grade0).	Negative for dermalsensitization
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 wereobserved with abnormalclinical signs indicative oftoxicity during the 72-hourtest period.	Non-toxic
Systemic Toxicity (Acute)[Material MediatedPyrogen in a RabbitModel]	Temperature increases forthe all test animals did notexceed the acceptable testlimit for maximum individualtemperature rise.	Non-pyrogenic
Hemocompatibility[Hemolysis, direct contact- device/material (humanblood)]	The difference between thehemolytic indices of the testarticle and the negativecontrol was 0.00%.	Non-hemolytic
Summaries of Biocompatibility Tests Conducted to Support this PremarketNotification
Test	Results	Conclusions
Hemocompatibility[Hemolysis, Extract -device/material (humanblood)]	The difference between thehemolytic indices of the testarticle and the negativecontrol was 0.08%.	Non-hemolytic
Complement Activation[SC5b-9]	The activation caused by thetest article was similar to theactivation caused by thenegative control after 30 and60 minutes exposure andlower than the activationcaused by the negativecontrol after 90 minutesexposure.	Negative for complementsystem activation

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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
DimensionalVerification	Dimensional inspection perengineering drawings	All devices met dimensionalspecifications.
HubWorkmanship	Visual inspection of hub forFrench size identification as wellas extraneous matter and processor surface defects	All devices met acceptance criteriafor size identification and were freeof extraneous matter and process orsurface defects

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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.

Vessel Dilator

Regulation Number and 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).