(189 days)
Not Found
No
The summary describes a mechanical delivery catheter and its performance characteristics, with no mention of AI or ML capabilities.
No
The device is described as a delivery catheter intended for the insertion and guidance of other catheters, rather than directly diagnosing, treating, or preventing a disease or condition itself.
No
The device is a delivery catheter intended for facilitating the insertion and guidance of other catheters; it does not perform any diagnostic function.
No
The device description clearly outlines a physical catheter with material properties, a luer hub, and a hydrophilic coating, indicating it is a hardware device. The performance studies also focus on physical characteristics and material properties.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "facilitating the insertion and guidance of catheters into selected blood vessels." This is a procedural or interventional use, not a diagnostic one.
- Device Description: The description focuses on the physical characteristics and function of a catheter designed for delivery and guidance within blood vessels.
- Performance Studies: The performance studies evaluate the physical and material properties of the catheter (e.g., push/track, torque response, burst strength, biocompatibility, sterility). These are tests related to the device's ability to perform its intended function safely and effectively within the body, not its ability to diagnose a condition based on in vitro analysis of biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The VersaD™ Delivery Catheter is used in vivo (inside the body) to facilitate a medical procedure.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
QJP, DQY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
neuro and peripheral vascular systems
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)
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
- Surface Integrity: The surface of the catheter was evaluated for surface defects. Conclusion: The device met the established criteria.
- Coating Uniformity: The surface of the catheter was evaluated for coating defects and voids. Conclusion: 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. Conclusion: 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. Conclusion: The device performed as intended under simulated use conditions.
- Torque Response: The catheter was constrained, torqued, and evaluated. Conclusion: The device met the established criteria.
- Particulate: The catheter was tracked through the tortuous neurovascular model with ancillary devices, and particulate generation was measured. Conclusion: Device particulate generation was similar to the predicate device.
- Coating Adhesion: The surface of the catheter was evaluated for coating voids after simulated use. Conclusion: The device met the established criteria.
- Tip Inspection: The distal tip of the catheter was evaluated. Conclusion: The device met the established criteria.
- Dimensional Verification: The catheter dimensional attributes were evaluated and measured. Conclusion: The device met the established criteria.
- Kink Resistance: The proximal and distal sections of the catheter were evaluated using a radius apparatus. Conclusion: The device met the established criteria.
- Liquid Leak Under Pressure: The catheter was evaluated by holding hydrostatic pressure. Conclusion: The device met the established criteria.
- Air Leak Under Aspiration: The catheter was evaluated for air leakage into the hub assembly during aspiration. Conclusion: The device met the established criteria.
- Burst Strength: The catheter was pressurized to burst with fluid. Conclusion: The device met the established criteria.
- Tip Stiffness: The tip buckling force of the catheter was evaluated in comparison with the predicate. Conclusion: 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. Conclusion: The device met the established criteria.
- Corrosion: The catheter was evaluated for corrosion. Conclusion: No corrosion was noted on the catheter.
- Radiopacity: The catheter marker bands visibility were evaluated under fluoroscopy. Conclusion: The device was visible under fluoroscopy.
- Delivery and Retrieval Force: The forces to deliver and retrieve the catheter within a neurovascular model were measured. Conclusion: Delivery and retrieval forces were comparable to the predicate device.
Biocompatibility
Biocompatibility was assessed per ISO 10993-1 for an external communicating device directly contacting circulating blood for a limited (≤24 hours) duration.
- Cytotoxicity: MEM Elution with L-929 Cells (ISO 10993-5). Result: Non-Cytotoxic
- Irritation: Intracutaneous Reactivity Test (ISO 10993-23) - (saline and sesame oil extracts). Result: Non-Irritant
- Sensitization: Guinea Pig Maximization Sensitization Test (ISO 10993-10) — (saline and sesame oil extracts). Result: Non-Sensitizing
- Systemic Toxicity: Acute Systemic Injection Test (ISO 10993-11) - (saline and sesame oil extracts). Result: No evidence of Acute Systemic Toxicity
- Material-Mediated Pyrogenicity: Rabbit Pyrogen test (USP ). Result: Non-Pyrogenic
- Complement Activation: SC5b-9 Assay (with comparator control). Result: Non- Activator
- Thrombogenicity - In Vitro Blood Flow Loop Assay: In vitro blood flow loop with comparator control (ISO 10993-4 and In Vitro Blood Flow Loop System for Thrombogenicity Evaluation of Medical Devices and Biomaterial1). Result: Thromboresistant
- Thrombogenicity - Coagulation: Partial Thromboplastin Time (PTT) Assay Human Blood (ISO 10993-4 and ASTM 2382). Result: No effect on the PTT
- Thrombogenicity - Platelet Leukocyte: Direct contact Platelet Leukocyte Count Test (ISO 10993-4 and ASTM 2888). Result: No effect on the platelet and leukocyte count
- Hemolysis: Hemolysis Test (ASTM F756) – Indirect (Extract) and Direct Contact Method. Result: Non- Hemolytic
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.
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.
Route 92 Medical 088 Access System (K200121)
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
§ 870.1250 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).
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Image /page/0/Picture/0 description: The image shows the date January 17, 2025. The text is written in a clear, sans-serif font. The date is written in a standard format, with the month, day, and year clearly indicated. The text is centered and takes up most of the image.
Image /page/0/Picture/9 description: The image shows 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.
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.
1
2
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
3
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.
6087 Washington Ave South
Edina, MN 55439 |
|------------------------|---------------------------------------------------------------------|
| Contact | Matthew Ogle
Phone: 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
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
VersaD Delivery Catheter
(K242051) | Predicate Device
Delivery Catheter from
Route 92 Medical 088 Access System
(K200121) |
|---------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation
Name | Percutaneous Catheter | Percutaneous Catheter |
| Regulation | 21 CFR 870.1250 | 21 CFR 870.1250 |
| Product Code | QJP - Catheter, Percutaneous,
Neurovasculature
DQY - Catheter, Percutaneous | QJP |
| 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. | The Route 92 Medical 088 Access
System, 110 cm, is indicated for use
with compatible guide catheters in
facilitating the insertion and guidance
of microcatheters into a selected blood
vessel in the neurovascular system. |
| Coating | Hydrophilic Coating | Hydrophilic Coating |
| Feature | Subject Device
VersaD Delivery Catheter
(K242051) | Predicate Device
Delivery Catheter from
Route 92 Medical 088 Access System
(K200121) |
| Materials | Polymers and metals commonly used
in the manufacture of medical devices.
Catheter Shaft: Stainless steel and
varying durometers of Pebax.
Luer: Pebax
Markers: Pebax / 20% BaSO4 | Polymers and metals commonly used
in the manufacture of medical devices.
Catheter Shaft: Stainless steel and
varying durometers of Pebax.
Luer: Polycarbonate
Markers: Tungsten/Pebax |
| Inner
Diameter | 0.019" | 0.019" |
| Outer
Diameter | Proximal: 0.062"
Distal: 0.082" | Proximal: 0.062"
Distal: 0.080" |
| Working
Length | 140cm | 151cm |
| Length of
Polymer
Section (non-
hypotube
section) | 62cm | 71cm |
| Hydrophilic
Coating
Length | 90cm | 90cm |
| Sterilization | Ethylene Oxide (EO) | EO |
| Packaging | The shelf carton contains one sterile
pouch containing a Delivery Catheter,
three wire insertion tools, and
Instructions for Use. | The shelf carton contains one sterile
pouch containing a Delivery Catheter
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 | |
| evaluated for surface defects. | The device met the | |
| established criteria. | ||
| Coating Uniformity | The surface of the catheter was | |
| evaluated for coating defects and voids. | 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. | 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. | The device performed as | |
| intended under | ||
| simulated use | ||
| conditions. | ||
| Torque Response | The catheter was constrained, torqued, | |
| and evaluated. | The device met the | |
| established criteria. | ||
| Particulate | The catheter was tracked through the | |
| tortuous neurovascular model with | ||
| ancillary devices, and particulate | ||
| generation was measured. | Device particulate | |
| generation was similar | ||
| to the predicate device. | ||
| Test | Test Method Summary | Conclusion |
| Coating Adhesion | The surface of the catheter was | |
| evaluated for coating voids after | ||
| simulated use. | The device met the | |
| established criteria. | ||
| Tip Inspection | The distal tip of the catheter was | |
| evaluated. | The device met the | |
| established criteria. | ||
| Dimensional | ||
| Verification | The catheter dimensional attributes were | |
| evaluated and measured. | The device met the | |
| established criteria. | ||
| Kink Resistance | The proximal and distal sections of the | |
| catheter were evaluated using a radius | ||
| apparatus. | The device met the | |
| established criteria. | ||
| Liquid Leak Under | ||
| Pressure | The catheter was evaluated by holding | |
| hydrostatic pressure. | The device met the | |
| established criteria. | ||
| Air Leak Under | ||
| Aspiration | The catheter was evaluated for air | |
| leakage into the hub assembly during | ||
| aspiration. | The device met the | |
| established criteria. | ||
| Burst Strength | The catheter was pressurized to burst | |
| with fluid. | The device met the | |
| established criteria. | ||
| Tip Stiffness | The tip buckling force of the catheter | |
| was evaluated in comparison with 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. | The device met the | |
| established criteria. | ||
| Corrosion | The catheter was evaluated for | |
| corrosion. | No corrosion was noted | |
| on the catheter. | ||
| Radiopacity | The catheter marker bands visibility were | |
| evaluated 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 were comparable | ||
| 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.
9
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- |
-
- (saline and sesame oil extracts) | Non-Irritant |
| Sensitization | Guinea Pig Maximization Sensitization Test
(ISO 10993-10) — (saline and sesame oil
extracts) | Non-Sensitizing |
| Systemic Toxicity | Acute Systemic Injection Test (ISO 10993-
- (saline and sesame oil extracts) | Non-Irritant |
-
- (saline and sesame oil extracts) | No evidence of Acute
Systemic Toxicity |
| Material-Mediated
Pyrogenicity | Rabbit Pyrogen test (USP ) | Non-Pyrogenic |
| Complement Activation | SC5b-9 Assay (with comparator control) | Non- Activator |
| Thrombogenicity -
In Vitro Blood Flow
Loop Assay | In vitro blood flow loop with comparator
control (ISO 10993-4 and In Vitro Blood
Flow Loop System for Thrombogenicity
Evaluation of Medical Devices and
Biomaterial1) | Thromboresistant |
| Thrombogenicity -
Coagulation | Partial Thromboplastin Time (PTT) Assay
Human Blood (ISO 10993-4 and ASTM 2382) | No effect on the PTT |
| Thrombogenicity -
Platelet Leukocyte | Direct contact Platelet Leukocyte Count
Test (ISO 10993-4 and ASTM 2888) | No effect on the platelet
and leukocyte count |
| Hemolysis | Hemolysis Test (ASTM F756) – Indirect
(Extract) and Direct Contact Method | Non- Hemolytic |
- (saline and sesame oil extracts) | No evidence of Acute
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.