The VersaD™ Delivery Catheter is intended for use with compatible guide catheters in facilitating the insertion and guidance of catheters into selected blood vessels in the neuro and peripheral vascular systems.

Device Description

The VersaD™ Delivery Catheter is a single-lumen, variable stiffness catheter with a long, tapered tip delineated by radiopaque markers. The proximal end has a luer hub, and the distal portion has a hydrophilic coating to reduce friction. The delivery catheter is designed specifically for use with compatible catheters.

AI/ML Overview

The provided text describes the acceptance criteria and the study that proves the Unity Medical VersaD™ Delivery Catheter meets these criteria. It applies to a medical device, not an AI/ML product, so some of the requested information (like multi-reader multi-case studies, expert ground truth for AI, training sets, etc.) is not applicable and thus cannot be provided from this document.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this medical device are primarily defined by successful completion of various performance tests, biocompatibility tests, and sterilization/shelf-life validations. The "Conclusion" column in the tables below indicates whether the device met these criteria.

Performance Testing - Bench

Test	Test Method Summary	Acceptance Criteria (Implicit)	Reported Device Performance (Conclusion)
Surface Integrity	The surface of the catheter was evaluated for surface defects.	No surface defects present.	The device met the established criteria.
Coating Uniformity	The surface of the catheter was evaluated for coating defects and voids.	No coating defects or voids present.	The device met the established criteria.
Device Compatibility	A full-length silicone neurovascular model was used to simulate use. The procedure included using a test catheter with worst-case ancillary devices.	Compatible with ancillary devices in simulated use.	The device was found to be compatible with ancillary devices.
Push/Track	Simulated use was performed, and the catheter was tracked through a challenge neurovascular model to determine the deliverability of the subject catheter and compatibility with ancillary devices.	Performed as intended under simulated use conditions.	The device performed as intended under simulated use conditions.
Torque Response	The catheter was constrained, torqued, and evaluated.	Maintained integrity and functionality under torque.	The device met the established criteria.
Particulate	The catheter was tracked through the tortuous neurovascular model with ancillary devices, and particulate generation was measured.	Particle generation similar to predicate device.	Device particulate generation was similar to the predicate device.
Coating Adhesion	The surface of the catheter was evaluated for coating voids after simulated use.	No coating voids after simulated use.	The device met the established criteria.
Tip Inspection	The distal tip of the catheter was evaluated.	Distal tip met design specifications.	The device met the established criteria.
Dimensional Verification	The catheter dimensional attributes were evaluated and measured.	Dimensions met specified requirements.	The device met the established criteria.
Kink Resistance	The proximal and distal sections of the catheter were evaluated using a radius apparatus.	Resistant to kinking under specified conditions.	The device met the established criteria.
Liquid Leak Under Pressure	The catheter was evaluated by holding hydrostatic pressure.	No liquid leak under pressure.	The device met the established criteria.
Air Leak Under Aspiration	The catheter was evaluated for air leakage into the hub assembly during aspiration.	No air leakage into the hub assembly during aspiration.	The device met the established criteria.
Burst Strength	The catheter was pressurized to burst with fluid.	Withstood pressure without bursting up to a specified limit.	The device met the established criteria.
Tip Stiffness	The tip buckling force of the catheter was evaluated in comparison with the predicate.	Tip buckling force similar to the predicate.	The tip buckling force was similar to the predicate.
Tensile Strength (Tip, Mid Joints, and Hub)	The force required to separate the joints in the catheter was evaluated.	Joints maintained integrity under specified tensile force.	The device met the established criteria.
Corrosion	The catheter was evaluated for corrosion.	No corrosion observed.	No corrosion was noted on the catheter.
Radiopacity	The catheter marker bands visibility were evaluated under fluoroscopy.	Marker bands visible under fluoroscopy.	The device was visible under fluoroscopy.
Delivery and Retrieval Force	The forces to deliver and retrieve the catheter within a neurovascular model were measured.	Delivery and retrieval forces comparable to predicate device.	Delivery and retrieval forces were comparable to the predicate device.

Biocompatibility

Test Category	Method	Acceptance Criteria (Implicit)	Result (Reported Device Performance)
Cytotoxicity	MEM Elution with L-929 Cells (ISO 10993-5)	No cytotoxic effects.	Non-Cytotoxic
Irritation	Intracutaneous Reactivity Test (ISO 10993-23)	No irritant reaction.	Non-Irritant
Sensitization	Guinea Pig Maximization Sensitization Test (ISO 10993-10)	No sensitizing reaction.	Non-Sensitizing
Systemic Toxicity	Acute Systemic Injection Test (ISO 10993-11)	No evidence of acute systemic toxicity.	No evidence of Acute Systemic Toxicity
Material-Mediated Pyrogenicity	Rabbit Pyrogen test (USP <151>)	Non-pyrogenic.	Non-Pyrogenic
Complement Activation	SC5b-9 Assay (with comparator control)	No complement activation.	Non- Activator
Thrombogenicity - In Vitro Blood Flow Loop Assay	In vitro blood flow loop (ISO 10993-4)	Thromboresistant.	Thromboresistant
Thrombogenicity - Coagulation	Partial Thromboplastin Time (PTT) Assay Human Blood	No significant effect on PTT.	No effect on the PTT
Thrombogenicity - Platelet Leukocyte	Direct contact Platelet Leukocyte Count Test	No significant effect on platelet and leukocyte count.	No effect on the platelet and leukocyte count
Hemolysis	Hemolysis Test (ASTM F756)	Non-hemolytic.	Non- Hemolytic

Sterilization and Shelf Life

Test Category	Acceptance Criteria (Implicit)	Reported Device Performance
Sterilization	Minimum sterility assurance level (SAL) of 10⁻⁶.	EO sterilized to achieve a minimum sterility assurance level (SAL) of 10⁻⁶.
Shelf Life (12-month)	Product and packaging remain functional and sterile.	Product and packaging remain functional and sterile for 12 months.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify exact sample sizes for each bench test or biocompatibility test. It indicates that testing was performed to demonstrate substantial equivalence.

Regarding data provenance:

Country of Origin: Not specified. Standard medical device testing labs and animal models would typically be used.
Retrospective or Prospective: All testing described is prospective bench and lab testing conducted specifically for this 510(k) submission. It's not based on retrospective clinical data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as the device is a physical medical catheter, not an AI/ML product requiring expert annotation for ground truth. The "ground truth" for this device is defined by passing established engineering specifications, biocompatibility standards, and sterility validations.

4. Adjudication Method for the Test Set

This is not applicable for a physical medical device. Testing results are typically quantitatively measured or visually assessed against predefined acceptance criteria by qualified personnel, not "adjudicated" by multiple experts in a consensus manner as would be done for image annotation in AI/ML.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC study was not conducted because this is a physical delivery catheter, not an AI-assisted diagnostic device. The study described focuses on the physical and biological performance of the catheter itself, demonstrating substantial equivalence to a predicate device through bench, biocompatibility, and sterility testing.

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

Not Applicable. This is a physical medical device, not an algorithm or software. The "standalone" performance refers to the engineering and biological performance of the catheter independent of human user skill in the tests performed (e.g., measuring burst strength of the catheter itself).

7. The Type of Ground Truth Used

The "ground truth" for this medical device is established by:

Engineering Specifications/Standards: The device must meet predefined dimensional tolerances, mechanical strength requirements (e.g., tensile strength, burst strength), and functional performance (e.g., push/track, torque response, liquid/air leak).
Biocompatibility Standards (ISO 10993): Adherence to established biological safety profiles (e.g., non-cytotoxic, non-irritant, non-sensitizing).
Sterilization Standards: Achieving a specified sterility assurance level.
Comparison to Predicate Device: Many tests (e.g., particulate generation, tip stiffness, delivery/retrieval force) compare the subject device's performance to that of the legally marketed predicate device to demonstrate substantial equivalence.

It does not involve expert consensus, pathology, or outcomes data in the context of diagnostic interpretation, as it's a delivery catheter.

8. The Sample Size for the Training Set

Not Applicable. This is a physical medical device, not an AI/ML system, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not Applicable. As there is no training set for a physical medical device, the concept of establishing ground truth for it does not apply.

Summary

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Unity Medical, Inc. % Prithul Bom Most Responsible Person Regulatory Technology Services 1000 Westgate Drive, Suite #510k Saint Paul, Minnesota 55114

Re: K242051

Trade/Device Name: VersaD Delivery Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: QJP, DQY Dated: December 2, 2024 Received: December 2, 2024

Dear Prithul Bom:

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 (the 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 available 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory

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assistance/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,

Naira Muradyan -S

Naira Muradyan, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional, and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine 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) K242051

Device Name VersaD Delivery Catheter

Indications for Use (Describe)

The VersaD Delivery Catheter is intended for use with compatible guide catheters in facilitating the insertion and guidance of catheters into selected blood vessels in the neuro and peripheral vascular systems.

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

510(k) Number: K242051

Date Prepared: 17 January 2025

Submitter/Manufacturer	Unity Medical, Inc.6087 Washington Ave SouthEdina, MN 55439
Contact	Matthew OglePhone: 612-381-7674
Trade Name	VersaD™ Delivery Catheter
Common/Usual Name	Percutaneous Catheter
Regulation Description	Percutaneous Catheter
Regulation Number	21 CFR 870.1250
Product Code	QJP, DQY
Device Class	Class II
Classification Panel	Neurology, Cardiovascular
Predicate Device	Route 92 Medical 088 Access System (K200121) -Delivery Catheter

Device Description

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Indications for Use

Feature	Subject DeviceVersaD Delivery Catheter(K242051)	Predicate DeviceDelivery Catheter fromRoute 92 Medical 088 Access System(K200121)
RegulationName	Percutaneous Catheter	Percutaneous Catheter
Regulation	21 CFR 870.1250	21 CFR 870.1250
Product Code	QJP - Catheter, Percutaneous,NeurovasculatureDQY - Catheter, Percutaneous	QJP
Indications forUse	The VersaD™ Delivery Catheter isintended for use with compatible guidecatheters in facilitating the insertionand guidance of catheters into selectedblood vessels in the neuro andperipheral vascular systems.	The Route 92 Medical 088 AccessSystem, 110 cm, is indicated for usewith compatible guide catheters infacilitating the insertion and guidanceof microcatheters into a selected bloodvessel in the neurovascular system.
Coating	Hydrophilic Coating	Hydrophilic Coating
Feature	Subject DeviceVersaD Delivery Catheter(K242051)	Predicate DeviceDelivery Catheter fromRoute 92 Medical 088 Access System(K200121)
Materials	Polymers and metals commonly usedin the manufacture of medical devices.Catheter Shaft: Stainless steel andvarying durometers of Pebax.Luer: PebaxMarkers: Pebax / 20% BaSO4	Polymers and metals commonly usedin the manufacture of medical devices.Catheter Shaft: Stainless steel andvarying durometers of Pebax.Luer: PolycarbonateMarkers: Tungsten/Pebax
InnerDiameter	0.019"	0.019"
OuterDiameter	Proximal: 0.062"Distal: 0.082"	Proximal: 0.062"Distal: 0.080"
WorkingLength	140cm	151cm
Length ofPolymerSection (non-hypotubesection)	62cm	71cm
HydrophilicCoatingLength	90cm	90cm
Sterilization	Ethylene Oxide (EO)	EO
Packaging	The shelf carton contains one sterilepouch containing a Delivery Catheter,three wire insertion tools, andInstructions for Use.	The shelf carton contains one sterilepouch containing a Delivery Catheterand one Instructions for Use.

Comparison of Technological Characteristics with the Predicate Device

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Image /page/7/Picture/0 description: The image shows the logo for Unity Medical. The logo features the words "UNITY MEDICAL" in a curved, sans-serif font at the top. Below the text are three interlocking circles, similar to the Olympic rings. The circles are colored blue, green, and purple.

Performance Testing

To demonstrate substantial equivalence of the subject VersaD Delivery Catheter to the predicate Route 92 Medical 088 Access System Delivery Catheter, the bench performance, biocompatibility, and sterility of the VersaD Delivery Catheter were evaluated via the following test assessments:

. Design Verification Bench Testing
. Biocompatibility
. Shelf-Life
. Sterilization
. Packaging Validation

Performance Testing - Bench

Test	Test Method Summary	Conclusion
Surface Integrity	The surface of the catheter wasevaluated for surface defects.	The device met theestablished criteria.
Coating Uniformity	The surface of the catheter wasevaluated for coating defects and voids.	The device met theestablished criteria.
Device Compatibility	A full-length silicone neurovascularmodel was used to simulate use. Theprocedure included using a testcatheter with worst-case ancillarydevices.	The device was found tobe compatible withancillary devices.
Push/Track	Simulated use was performed, and thecatheter was tracked through achallenge neurovascular model todetermine the deliverability of thesubject catheter and compatibility withancillary devices.	The device performed asintended undersimulated useconditions.
Torque Response	The catheter was constrained, torqued,and evaluated.	The device met theestablished criteria.
Particulate	The catheter was tracked through thetortuous neurovascular model withancillary devices, and particulategeneration was measured.	Device particulategeneration was similarto the predicate device.
Test	Test Method Summary	Conclusion
Coating Adhesion	The surface of the catheter wasevaluated for coating voids aftersimulated use.	The device met theestablished criteria.
Tip Inspection	The distal tip of the catheter wasevaluated.	The device met theestablished criteria.
DimensionalVerification	The catheter dimensional attributes wereevaluated and measured.	The device met theestablished criteria.
Kink Resistance	The proximal and distal sections of thecatheter were evaluated using a radiusapparatus.	The device met theestablished criteria.
Liquid Leak UnderPressure	The catheter was evaluated by holdinghydrostatic pressure.	The device met theestablished criteria.
Air Leak UnderAspiration	The catheter was evaluated for airleakage into the hub assembly duringaspiration.	The device met theestablished criteria.
Burst Strength	The catheter was pressurized to burstwith fluid.	The device met theestablished criteria.
Tip Stiffness	The tip buckling force of the catheterwas evaluated in comparison with thepredicate.	The tip buckling force wassimilar to the predicate.
Tensile Strength (Tip,Mid Joints, and Hub)	The force required to separate the jointsin the catheter was evaluated.	The device met theestablished criteria.
Corrosion	The catheter was evaluated forcorrosion.	No corrosion was notedon the catheter.
Radiopacity	The catheter marker bands visibility wereevaluated under fluoroscopy.	The device was visibleunder fluoroscopy.
Delivery and RetrievalForce	The forces to deliver and retrieve thecatheter within a neurovascular modelwere measured.	Delivery and retrievalforces were comparableto the predicate device.

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Image /page/8/Picture/0 description: The image shows the logo for Unity Medical. The logo consists of the words "UNITY MEDICAL" in an arc above three interlocking circles. The circles are colored blue, green, and purple, respectively.

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Image /page/9/Picture/0 description: The image shows the logo for Unity Medical. The logo consists of the words "UNITY MEDICAL" in a curved, sans-serif font, with the word "UNITY" above the word "MEDICAL". Below the text are three interlocking circles, similar to the Olympic rings. The circles are colored blue, green, and purple.

Biocompatibility

Biocompatibility was assessed per ISO 10993-1 for an external communicating device directly contacting circulating blood for a limited (≤24 hours) duration.

Test Category	Method	Result
Cytotoxicity	MEM Elution with L-929 Cells (ISO 10993-5)	Non-Cytotoxic
Irritation	Intracutaneous Reactivity Test (ISO 10993-23) - (saline and sesame oil extracts)	Non-Irritant
Sensitization	Guinea Pig Maximization Sensitization Test(ISO 10993-10) — (saline and sesame oilextracts)	Non-Sensitizing
Systemic Toxicity	Acute Systemic Injection Test (ISO 10993-11) - (saline and sesame oil extracts)	No evidence of AcuteSystemic Toxicity
Material-MediatedPyrogenicity	Rabbit Pyrogen test (USP <151>)	Non-Pyrogenic
Complement Activation	SC5b-9 Assay (with comparator control)	Non- Activator
Thrombogenicity -In Vitro Blood FlowLoop Assay	In vitro blood flow loop with comparatorcontrol (ISO 10993-4 and In Vitro BloodFlow Loop System for ThrombogenicityEvaluation of Medical Devices andBiomaterial1)	Thromboresistant
Thrombogenicity -Coagulation	Partial Thromboplastin Time (PTT) AssayHuman Blood (ISO 10993-4 and ASTM 2382)	No effect on the PTT
Thrombogenicity -Platelet Leukocyte	Direct contact Platelet Leukocyte CountTest (ISO 10993-4 and ASTM 2888)	No effect on the plateletand leukocyte count
Hemolysis	Hemolysis Test (ASTM F756) – Indirect(Extract) and Direct Contact Method	Non- Hemolytic

1 FDA Catalog of Regulatory Science Tools to Help Assess New Medical Devices

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Image /page/10/Picture/0 description: The image shows the logo for Unity Medical. The logo consists of the words "UNITY MEDICAL" in a slightly curved, sans-serif font, positioned above three interlocking circles. The circles are colored blue, green, and purple, respectively. The overall design is simple and modern.

Sterilization and Shelf Life

The VersaD™ Delivery Catheter is labeled as a single-use sterile device with a shelf life of 12 months. The sterilization process has been validated, and process monitoring controls are in place to ensure the device is EO sterilized to achieve a minimum sterility assurance level (SAL) of 10 °. Shelf-life studies have demonstrated that the product and packaging remain functional and sterile for 12 months.

Conclusions

The VersaD™ Delivery Catheter has the same intended use and similar technological characteristics and principles of operation as the currently marketed predicate Delivery Catheter from the Route 92 Medical 088 Access System. Any differences between the subject and predicate devices do not raise new questions of safety and effectiveness. The subject device was evaluated through design verification, biocompatibility, and sterility testing. Based on the information submitted in this 510(k) submission, the VersaD™ Delivery Catheter is substantially equivalent to the currently marketed Delivery Catheter from the Route 92 Medical 088 Access System.

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).