VersaD Delivery Catheter

K242051 · Unity Medical, Inc. · QJP · Jan 17, 2025 · Cardiovascular

Device Facts

• Record ID: K242051
• Device Name: VersaD Delivery Catheter
• Applicant: Unity Medical, Inc.
• Product Code: QJP · Cardiovascular
• Decision Date: Jan 17, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

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 Story

VersaD Delivery Catheter is a single-lumen, variable stiffness catheter; features long, tapered tip with radiopaque markers; proximal luer hub; distal hydrophilic coating. Used in neuro and peripheral vascular systems to facilitate insertion/guidance of other catheters. Operated by clinicians in clinical settings. Device tracks through vasculature; hydrophilic coating reduces friction; radiopaque markers allow visualization under fluoroscopy. Benefits include improved access to target vessels during vascular procedures. Device is single-use, sterile, and EO-sterilized.

Clinical Evidence

Bench testing only. No clinical data. Performance evaluated via design verification (surface integrity, coating uniformity, device compatibility, push/track, torque response, particulate, kink resistance, burst strength, tensile strength, radiopacity, delivery/retrieval force) and biocompatibility (ISO 10993-1, cytotoxicity, irritation, sensitization, systemic toxicity, pyrogenicity, complement activation, thrombogenicity, hemolysis).

Technological Characteristics

Single-lumen catheter; shaft: stainless steel and Pebax; luer: Pebax; markers: Pebax/20% BaSO4. Hydrophilic coating. EO sterilization. Dimensions: 0.019" ID; 0.062" proximal OD; 0.082" distal OD; 140cm length. No software or electronic components.

Indications for Use

Indicated for use with compatible guide catheters to facilitate insertion and guidance of catheters into selected blood vessels in the neuro and peripheral vascular systems.

Regulatory Classification

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.

Predicate Devices

• Route 92 Medical 088 Access System (K200121)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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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Image /page/4/Picture/0 description: The image shows the logo for Unity Medical. The logo consists of the words "UNITY MEDICAL" in a blue, sans-serif font, arranged in an arc above three interlocking circles. The circles are colored blue, green, and purple, respectively. The overall design is simple and modern.

#### 510(k) Summary

#### 510(k) Number: K242051

#### Date Prepared: 17 January 2025

| Submitter/Manufacturer | Unity Medical, Inc.<br>6087 Washington Ave South<br>Edina, MN 55439 |
|------------------------|---------------------------------------------------------------------|
| Contact | Matthew Ogle<br>Phone: [phone] |
| 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) -<br>Delivery Catheter |

#### 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.

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Image /page/5/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 is an image of three interlocking circles, colored blue, green, and purple. The blue circle is on the left, the green circle is in the middle, and the purple circle is on the right.

## Indications for Use

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.

| Feature | Subject Device<br>VersaD Delivery Catheter<br>(K242051) | Predicate Device<br>Delivery Catheter from<br>Route 92 Medical 088 Access System<br>(K200121) |
|---------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation<br>Name | Percutaneous Catheter | Percutaneous Catheter |
| Regulation | 21 CFR 870.1250 | 21 CFR 870.1250 |
| Product Code | QJP - Catheter, Percutaneous,<br>Neurovasculature<br>DQY - Catheter, Percutaneous | QJP |
| Indications for<br>Use | The VersaD™ Delivery Catheter is<br>intended for use with compatible guide<br>catheters in facilitating the insertion<br>and guidance of catheters into selected<br>blood vessels in the neuro and<br>peripheral vascular systems. | The Route 92 Medical 088 Access<br>System, 110 cm, is indicated for use<br>with compatible guide catheters in<br>facilitating the insertion and guidance<br>of microcatheters into a selected blood<br>vessel in the neurovascular system. |
| Coating | Hydrophilic Coating | Hydrophilic Coating |
| Feature | Subject Device<br>VersaD Delivery Catheter<br>(K242051) | Predicate Device<br>Delivery Catheter from<br>Route 92 Medical 088 Access System<br>(K200121) |
| Materials | Polymers and metals commonly used<br>in the manufacture of medical devices.<br>Catheter Shaft: Stainless steel and<br>varying durometers of Pebax.<br>Luer: Pebax<br>Markers: Pebax / 20% BaSO4 | Polymers and metals commonly used<br>in the manufacture of medical devices.<br>Catheter Shaft: Stainless steel and<br>varying durometers of Pebax.<br>Luer: Polycarbonate<br>Markers: Tungsten/Pebax |
| Inner<br>Diameter | 0.019" | 0.019" |
| Outer<br>Diameter | Proximal: 0.062"<br>Distal: 0.082" | Proximal: 0.062"<br>Distal: 0.080" |
| Working<br>Length | 140cm | 151cm |
| Length of<br>Polymer<br>Section (non-<br>hypotube<br>section) | 62cm | 71cm |
| Hydrophilic<br>Coating<br>Length | 90cm | 90cm |
| Sterilization | Ethylene Oxide (EO) | EO |
| Packaging | The shelf carton contains one sterile<br>pouch containing a Delivery Catheter,<br>three wire insertion tools, and<br>Instructions for Use. | The shelf carton contains one sterile<br>pouch containing a Delivery Catheter<br>and one Instructions for Use. |

#### Comparison of Technological Characteristics with the Predicate Device

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Image /page/6/Picture/0 description: The image shows the logo for Unity Medical. The logo consists of the words "UNITY MEDICAL" in a blue, sans-serif font, arranged in an arc shape. Below the text are three interlocking circles, similar to the Olympic rings. The circles are colored blue, green, and purple.

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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 was<br>evaluated for surface defects. | The device met the<br>established criteria. |
| Coating Uniformity | The surface of the catheter was<br>evaluated for coating defects and voids. | The device met the<br>established criteria. |
| Device Compatibility | A full-length silicone neurovascular<br>model was used to simulate use. The<br>procedure included using a test<br>catheter with worst-case ancillary<br>devices. | The device was found to<br>be compatible with<br>ancillary devices. |
| Push/Track | Simulated use was performed, and the<br>catheter was tracked through a<br>challenge neurovascular model to<br>determine the deliverability of the<br>subject catheter and compatibility with<br>ancillary devices. | The device performed as<br>intended under<br>simulated use<br>conditions. |
| Torque Response | The catheter was constrained, torqued,<br>and evaluated. | The device met the<br>established criteria. |
| Particulate | The catheter was tracked through the<br>tortuous neurovascular model with<br>ancillary devices, and particulate<br>generation was measured. | Device particulate<br>generation was similar<br>to the predicate device. |
| Test | Test Method Summary | Conclusion |
| Coating Adhesion | The surface of the catheter was<br>evaluated for coating voids after<br>simulated use. | The device met the<br>established criteria. |
| Tip Inspection | The distal tip of the catheter was<br>evaluated. | The device met the<br>established criteria. |
| Dimensional<br>Verification | The catheter dimensional attributes were<br>evaluated and measured. | The device met the<br>established criteria. |
| Kink Resistance | The proximal and distal sections of the<br>catheter were evaluated using a radius<br>apparatus. | The device met the<br>established criteria. |
| Liquid Leak Under<br>Pressure | The catheter was evaluated by holding<br>hydrostatic pressure. | The device met the<br>established criteria. |
| Air Leak Under<br>Aspiration | The catheter was evaluated for air<br>leakage into the hub assembly during<br>aspiration. | The device met the<br>established criteria. |
| Burst Strength | The catheter was pressurized to burst<br>with fluid. | The device met the<br>established criteria. |
| Tip Stiffness | The tip buckling force of the catheter<br>was evaluated in comparison with the<br>predicate. | The tip buckling force was<br>similar to the predicate. |
| Tensile Strength (Tip,<br>Mid Joints, and Hub) | The force required to separate the joints<br>in the catheter was evaluated. | The device met the<br>established criteria. |
| Corrosion | The catheter was evaluated for<br>corrosion. | No corrosion was noted<br>on the catheter. |
| Radiopacity | The catheter marker bands visibility were<br>evaluated under fluoroscopy. | The device was visible<br>under fluoroscopy. |
| Delivery and Retrieval<br>Force | The forces to deliver and retrieve the<br>catheter within a neurovascular model<br>were measured. | Delivery and retrieval<br>forces were comparable<br>to 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-<br>23) - (saline and sesame oil extracts) | Non-Irritant |
| Sensitization | Guinea Pig Maximization Sensitization Test<br>(ISO 10993-10) — (saline and sesame oil<br>extracts) | Non-Sensitizing |
| Systemic Toxicity | Acute Systemic Injection Test (ISO 10993-<br>11) - (saline and sesame oil extracts) | No evidence of Acute<br>Systemic Toxicity |
| Material-Mediated<br>Pyrogenicity | Rabbit Pyrogen test (USP <151>) | Non-Pyrogenic |
| Complement Activation | SC5b-9 Assay (with comparator control) | Non- Activator |
| Thrombogenicity -<br>In Vitro Blood Flow<br>Loop Assay | In vitro blood flow loop with comparator<br>control (ISO 10993-4 and <i>In Vitro Blood</i><br>Flow Loop System for Thrombogenicity<br>Evaluation of Medical Devices and<br>Biomaterial1) | Thromboresistant |
| Thrombogenicity -<br>Coagulation | Partial Thromboplastin Time (PTT) Assay<br>Human Blood (ISO 10993-4 and ASTM 2382) | No effect on the PTT |
| Thrombogenicity -<br>Platelet Leukocyte | Direct contact Platelet Leukocyte Count<br>Test (ISO 10993-4 and ASTM 2888) | No effect on the platelet<br>and leukocyte count |
| Hemolysis | Hemolysis Test (ASTM F756) – Indirect<br>(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.