(27 days)
No reference devices were used in this submission.
No
The device description and performance studies focus on the physical and functional characteristics of a microcatheter, with no mention of AI or ML capabilities.
No.
The device is intended for the introduction of interventional devices or infusion of diagnostic agents, not for direct therapeutic intervention.
No
The device is intended for the introduction of interventional devices or infusion of diagnostic agents. While it facilitates the use of diagnostic agents, it is not described as performing a diagnostic function itself, but rather as a delivery tool.
No
The device description clearly states it is a "sterile single-use microcatheter device" with physical components like a Luer connector, a flexible body, radiopaque marker bands, and a shaping mandrel. The performance studies also focus on physical and material properties of the catheter.
Based on the provided information, the Spartan MC 0165™ is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the introduction of interventional devices or infusion of diagnostic agents into the neuro, peripheral, and coronary vasculatures. This describes a device used within the body for procedural or imaging purposes, not for testing samples outside the body.
- Device Description: The description details a microcatheter with a lumen for infusion and features for navigation and visualization within the vasculature. This aligns with an interventional or diagnostic tool used in vivo.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide diagnostic information based on such analysis. IVD devices are specifically designed for testing samples in vitro (outside the living organism).
Therefore, the Spartan MC 0165™ is a medical device used for procedures within the body, not an in vitro diagnostic device.
No.
The clearance letter explicitly states "Predetermined Change Control Plan (PCCP) - All Relevant Information: Not Found". This indicates that the device has not been authorized with a PCCP.
Intended Use / Indications for Use
The Spartan MC 0165™ is intended for the introduction of interventional devices or infusion of diagnostic agents into the neuro, peripheral and coronary vasculatures.
Product codes
QJP, DQY, KRA
Device Description
The Spartan MC 0165™ is a sterile single-use microcatheter device. On the proximal end is a Luer connector for infusion of diagnostic agents. The microcatheter has a single lumen of 0.0165" ID, has a flexible and variable stiffness composite body, and 2 radiopaque marker bands on the distal tip for visualization under fluoroscopy. It comes with a sterile stainless steel shaping mandrel to shape the distal portion of the catheter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
neuro, peripheral and coronary vasculatures
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
The following non-clinical bench testing was performed to evaluate the performance of the Spartan MC 0165™ . The passing result of the testing supports the substantial equivalence to the predicate device.
Test: Coating Lubricity (Friction Force)
Test Method Summary: The Spartan MC 0165™ and the predicate device were evaluated for coating lubricity under simulated use conditions.
Results: The Spartan MC 0165™ was found to have acceptable friction force under simulated use conditions similar to the predicate device.
Test: Hub Functional & Dimensional
Test Method Summary: The Spartan MC 0165™ was evaluated per ISO 594-1:1986-06-15 First edition and ISO 594-2:1998-09-01 Second edition.
Results: The Spartan MC 0165™ met the acceptance criteria for hub functional and dimensional requirements.
Test: Torque Strength
Test Method Summary: The Spartan MC 0165™ was evaluated for torsional strength during use in a simulated path model.
Results: The Spartan MC 0165™ exhibited acceptable torsional strength similar to the predicate device.
Test: Tensile
Test Method Summary: The Spartan MC 0165™ was evaluated per ISO 10555-1:2013 Annex B.
Results: The Spartan MC 0165™ met the acceptance criteria for tensile strength.
Test: Air Aspiration
Test Method Summary: The Spartan MC 0165™ was tested for air leakage into the hub during aspiration per ISO 10555-1:2013(E) Annex D.
Results: The Spartan MC 0165™ met the acceptance criteria for air aspiration.
Test: Liquid Leak
Test Method Summary: The Spartan MC 0165™ was tested per ISO 10555-1:2013(E) Annex C.
Results: The Spartan MC 0165™ met the acceptance criteria for liquid leakage.
Test: Particulate and Coating Integrity
Test Method Summary: The Spartan MC 0165™ was evaluated under simulated use conditions and compared with the predicate device to support substantial equivalence. The coating integrity was also visually examined after testing.
Results: The Spartan MC 0165™ met the acceptance criteria for particulate generation and coating integrity, and was found substantially equivalent to the predicate.
Test: Tip Shape
Test Method Summary: The Spartan MC 0165™ was evaluated for its ability to retain steam shaped tip shape and results compared to the predicate device.
Results: The Spartan MC 0165™ met the acceptance criteria for tip shapeability and was found substantially equivalent to the predicate.
Test: Stiffness
Test Method Summary: A stiffness profile across the catheter length was measured and compared to the predicate device's stiffness profile.
Results: The Spartan MC 0165™ met the acceptance criteria for catheter stiffness and was found substantially equivalent to the predicate.
Test: Kink Resistance
Test Method Summary: The ability of the Spartan MC 0165™ to withstand bends was measured at various points across the catheter length by bending the catheter shaft around sequentially smaller mandrels. Results were compared to test results from the predicate.
Results: The Spartan MC 0165™ met the acceptance criteria for kink resistance and was found substantially equivalent to the predicate.
Test: Radiopacity
Test Method Summary: The visibility of the Spartan MC 0165™ under fluoroscopy was compared to the predicate device.
Results: The Spartan MC 0165™ met the acceptance criteria for radiopacity and was found substantially equivalent to the predicate.
Test: Corrosion
Test Method Summary: The Spartan MC 0165™ was evaluated for corrosion per ISO 10555-1:2013(E) Annex A.
Results: The Spartan MC 0165™ met the acceptance criteria for corrosion resistance.
Test: Static Burst Pressure
Test Method Summary: The Spartan MC 0165™ was tested to evaluate the burst pressure under static conditions per ISO 10555-1:2013(E) Annex F.
Results: The Spartan MC 0165™ met the acceptance criteria for static burst pressure.
Test: Torque Response
Test Method Summary: The Spartan MC 0165™ was tested for its response to torque forces and results compared to the predicate device.
Results: The Spartan MC 0165™ met the acceptance criteria for torque response and was found substantially equivalent to the predicate.
Test: Buckling
Test Method Summary: The Spartan MC 0165™ was evaluated for its resistance to buckling and tip deflection properties and compared to the predicate device.
Results: The Spartan MC 0165™ met the acceptance criteria for tip deflection and buckling, and was found substantially equivalent to the predicate.
Test: Design Validation
Test Method Summary: The Spartan MC 0165™ was tested in a model representing a challenging use setting and evaluated against the predicate device for interventional device introduction, trackability, interaction with embolic coil, stability, guidewire interaction, and overall device integrity.
Results: The Spartan MC 0165™ met the requirements for which it was designed and tested.
Test: Dimensional Testing
Test Method Summary: Dimensional properties of the subject device were measured and compared to device specifications.
Results: The Spartan MC 0165™ met the dimensional requirements.
Test: Visual Inspection
Test Method Summary: The subject device was visually inspected and compared to acceptance criteria.
Results: The Spartan MC 0165™ met the visual inspection requirements.
Test: Dead Space Volume
Test Method Summary: The dead space volume was calculated following a dead space evaluation protocol.
Results: The Spartan MC 0165™ dead space volume was measured. The dead space volume is reported in the labeling.
Test: Pressure Flow Testing with Contrast Media
Test Method Summary: Flow pressure calculations were conducted following a protocol for 100% saline, 50% saline - 50% contrast media, and 100% contrast media solutions.
Results: The Spartan MC 0165™ pressure-flow performance was evaluated. Flow rates and pressures of various saline and contrast media solutions are reported in the labeling.
Biocompatibility:
Device is categorized as a limited exposure (
Results: Non-pyrogenic.
Effect: Hemocompatibility
Test Name: Rabbit Blood Hemolysis Test (Complete)
Standard: ISO 10993-4
Results: Non-hemolytic.
Effect: Hemocompatibility
Test Name: Unactivated Partial Thromboplastin Time Test (Direct Contact)
Standard: ISO 10993-4
Results: Hemocompatible.
Effect: Hemocompatibility
Test Name: SC5B-9 Complement Activation Test (Direct Contact)
Standard: ISO 10993-4
Results: Hemocompatible.
Effect: Hemocompatibility
Test Name: In Vitro Blood Flow Loop
Standard: ISO 10993-4
Results: Not Thrombogenic.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
No reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
0
November 22, 2021
Image /page/0/Picture/1 description: The image contains 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below.
Spartan Micro, Inc. Gary Avedovech Senior Director Quality and Compliance 3167 Skyway Court Fremont, California 94539
Re: K213451
Trade/Device Name: Spartan MC 0165 Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: QJP, DQY, KRA Dated: October 25, 2021 Received: October 26, 2021
Dear Gary Avedovech:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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
2
Indications for Use
510(k) Number (if known) K213451
Device Name Spartan MC 0165™M
Indications for Use (Describe)
The Spartan MC 0165™ is intended for the introduction of interventional devices or infusion of diagnostic agents into the neuro, peripheral and coronary vasculatures.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Image /page/3/Picture/1 description: The image shows the logo for Spartan Micro, Inc. The word "SPARTAN" is written in large, bold, black letters. Below the word "SPARTAN" is a horizontal line, and below the line is the text "MICRO, INC." The text "MICRO, INC." is written in a smaller font size than the word "SPARTAN."
510(k) Summary
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92(c) and follows FDA guidance document titled The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)], Appendix B. The 510(k) Summary Document Requirements, issued July 28, 2014.
l. SUBMITTER
Spartan Micro, Inc. 3167 Skyway Court, Fremont, CA 94539
Phone: 512-270-8501
Contact Person: Gary Avedovech Date Prepared: November 20, 2021
== DEVICE
Name of Device: Spartan MC 0165™ Common or Usual Name: Microcatheter Regulatory Class: II Product Codes: DQY Catheter, Percutaneous (21 CFR 870.1250) KRA Catheter, Continuous Flush (21 CFR 870.1210) QJP Catheter, Percutaneous, Neurovasculature (21 CFR 870.1250) Review Panels: Cardiovascular, Neurology
III. PREDICATE DEVICE
Phenom Catheters 510(k) Number: K151638 Manufacturer: Cathera, Inc.
This predicate has not been subject to a design-related recall.
No reference devices were used in this submission.
4
Image /page/4/Picture/1 description: The image shows the word "SPARTAN" in large, bold, black letters. Below the word "SPARTAN" is a horizontal line, and below the line is the text "MICRO, INC." in a smaller font size. The text "MICRO, INC." is also in black.
IV. DEVICE DESCRIPTION
The Spartan MC 0165™ is a sterile single-use microcatheter device. On the proximal end is a Luer connector for infusion of diagnostic agents. The microcatheter has a single lumen of 0.0165" ID, has a flexible and variable stiffness composite body, and 2 radiopaque marker bands on the distal tip for visualization under fluoroscopy. It comes with a sterile stainless steel shaping mandrel to shape the distal portion of the catheter.
V. INDICATIONS FOR USE
| Subject Device | Predicate |
|---|---|
| K213451 | K151638 |
| The Spartan MC 0165™ is intended for | The Phenom Catheters are intended for the |
| the introduction of interventional | introduction of interventional devices and |
| devices or infusion of diagnostic agents | infusion of diagnostic or therapeutic agents |
| into the neuro, peripheral and coronary | into the neuro, peripheral, and coronary |
| vasculatures. | vasculatures. |
The Spartan MC 0165 is intended for introduction of interventional device or infusion of diagnostic agents whereas the predicate is intended for the introduction of interventional devices and infusion of diagnostic or therapeutic agents.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
| Dimensions | Spartan MC 0165™
(K213451) | Phenom™ Catheter (17)
(K151638) |
|------------------|------------------------------------------------------|------------------------------------|
| Proximal OD | 0.031" (2.4F) | 0.029" (2.2F) |
| Distal OD | 0.024" (1.8F) | Same |
| ID | 0.0165" (0.42mm) | 0.017" (0.43mm) |
| Max Guidewire OD | ≤ 0.014" | Same |
| Effective Length | 158 cm | 150 cm |
| Inner Lumen | Lined with PTFE | Same |
| Number of Lumens | Single | Same |
| Shaft | Progressively softer from proximal end to distal tip | Same |
| Materials | Spartan MC 0165™
(K213451) | Phenom™ Catheter (17)
(K151638) |
|-----------------|--------------------------------------------------------------------|------------------------------------|
| Shaft Materials | PTFE, Polyether block
amide (Pebax) and
Polyamide (Grilamid) | PTFE and Pebax |
| Hub | Polypropylene | Polyamide |
5
Image /page/5/Picture/1 description: The image shows the logo for Spartan Micro, Inc. The word "SPARTAN" is written in large, bold, black letters. Below the word "SPARTAN" is the phrase "MICRO, INC." in smaller, thinner, black letters. A horizontal line underlines both the word "SPARTAN" and the phrase "MICRO, INC."
| Materials | Spartan MC 0165™
(K213451) | Phenom™ Catheter (17)
(K151638) |
|---------------------|-------------------------------|-----------------------------------------------------------------|
| Strain Relief | Liquid Silicone Rubber | Thermoplastic elastomer |
| Shaft Reinforcement | Nitinol braid | Metallic (Stainless Steel) reinforced |
| Marker Band | Radiopaque marker band | same |
| Tip Markers | Radiopaque Pt/Ir | radiopaque |
| Tip Shaping | Steam shapeable straight tip | Steam shapeable straight tip, and
Pre-shaped 45°, 90°, and J |
| Coating | Distal 120cm hydrophilic | Distal 100cm hydrophilic |
| Packaging | Spartan MC 0165™
(K213451) | Phenom™ Catheter (17)
(K151638) |
| Pouch Material | PET/Tyvek | PET/Tyvek |
| Pouch Dimensions | 10"x10.5" | 11" x 12" |
| Carton | Cardboard | Cardboard, solid bleach
sulfate |
| Accessories | Spartan MC 0165™
(K213451) | Phenom™ Catheter (17)
(K151638) |
|-------------------|-------------------------------|------------------------------------|
| Shaping Mandrel | Yes | same |
| Introducer Sheath | No | No |
| Sterilization | Spartan MC 0165™
(K213451) | Phenom™ Catheter (17)
(K151638) |
|---------------|-------------------------------|------------------------------------|
| Method | Ethylene Oxide (EO) | same |
| Shelf Life | 1 year | 36 Months |
The differences in technological characteristics do not raise new questions of safety and effectiveness.
VII. PERFORMANCE DATA
Performance Data – Bench:
The following non-clinical bench testing was performed to evaluate the performance of the Spartan MC 0165™ . The passing result of the testing supports the substantial equivalence to the predicate device.
| Test | Test Method Summary | Results |
|---|---|---|
| Coating Lubricity (Friction Force) | The Spartan MC 0165™ and the predicate device were evaluated for coating lubricity | The Spartan MC 0165™ was found to have acceptable friction force under |
| Test | Test Method Summary | Results |
| under simulated use conditions. | simulated use conditions | |
| similar to the predicate | ||
| device. | ||
| Hub Functional & | ||
| Dimensional | The Spartan MC 0165™ was | |
| evaluated per ISO 594-1:1986- | ||
| 06-15 First edition and ISO | ||
| 594-2:1998-09-01 Second | ||
| edition. | The Spartan MC 0165™ met | |
| the acceptance criteria for | ||
| hub functional and | ||
| dimensional requirements. | ||
| Torque Strength | The Spartan MC 0165™ was | |
| evaluated for torsional | ||
| strength during use in a | ||
| simulated path model. | The Spartan MC 0165™ | |
| exhibited acceptable | ||
| torsional strength similar to | ||
| the predicate device. | ||
| Tensile | The Spartan MC 0165™ was | |
| evaluated per ISO 10555- | ||
| 1:2013 Annex B. | The Spartan MC 0165™ met | |
| the acceptance criteria for | ||
| tensile strength. | ||
| Air Aspiration | The Spartan MC 0165™ was | |
| tested for air leakage into the | ||
| hub during aspiration per ISO | ||
| 10555-1:2013(E) Annex D. | The Spartan MC 0165™ met | |
| the acceptance criteria for | ||
| air aspiration. | ||
| Liquid Leak | The Spartan MC 0165™ was | |
| tested per ISO 10555- | ||
| 1:2013(E) Annex C. | The Spartan MC 0165™ met | |
| the acceptance criteria for | ||
| liquid leakage. | ||
| Particulate and | ||
| Coating Integrity | The Spartan MC 0165™ was | |
| evaluated under simulated | ||
| use conditions and compared | ||
| with the predicate device to | ||
| support substantial | ||
| equivalence. The coating | ||
| integrity was also visually | ||
| examined after testing. | The Spartan MC 0165™ met | |
| the acceptance criteria for | ||
| particulate generation and | ||
| coating integrity, and was | ||
| found substantially | ||
| equivalent to the predicate. | ||
| Tip Shape | The Spartan MC 0165™ was | |
| evaluated for its ability to | ||
| retain steam shaped tip | ||
| shape and results compared | ||
| to the predicate device. | The Spartan MC 0165™ met | |
| the acceptance criteria for | ||
| tip shapeability and was | ||
| found substantially | ||
| equivalent to the predicate. | ||
| Stiffness | A stiffness profile across the | |
| catheter length was measured | ||
| and compared to the | ||
| predicate device's stiffness | ||
| profile. | The Spartan MC 0165™ met | |
| the acceptance criteria for | ||
| catheter stiffness and was | ||
| found substantially | ||
| equivalent to the predicate. | ||
| Kink Resistance | The ability of the Spartan MC | |
| 0165™ to withstand bends | The Spartan MC 0165™ met | |
| the acceptance criteria for | ||
| Test | Test Method Summary | Results |
| was measured at various | ||
| points across the catheter | ||
| length by bending the | ||
| catheter shaft around | ||
| sequentially smaller mandrels. | ||
| Results were compared to test | ||
| results from the predicate. | kink resistance and was | |
| found substantially | ||
| equivalent to the predicate. | ||
| Radiopacity | The visibility of the Spartan | |
| MC 0165™ under fluoroscopy | ||
| was compared to the | ||
| predicate device. | The Spartan MC 0165™ met | |
| the acceptance criteria for | ||
| radiopacity and was found | ||
| substantially equivalent to | ||
| the predicate. | ||
| Corrosion | The Spartan MC 0165™ was | |
| evaluated for corrosion per | ||
| ISO 10555-1:2013(E) Annex A. | The Spartan MC 0165™ met | |
| the acceptance criteria for | ||
| corrosion resistance. | ||
| Static Burst Pressure | The Spartan MC 0165™ was | |
| tested to evaluate the burst | ||
| pressure under static | ||
| conditions per ISO 10555- | ||
| 1:2013(E) Annex F. | The Spartan MC 0165™ met | |
| the acceptance criteria for | ||
| static burst pressure. | ||
| Torque Response | The Spartan MC 0165™ was | |
| tested for its response to | ||
| torque forces and results | ||
| compared to the predicate | ||
| device. | The Spartan MC 0165™ met | |
| the acceptance criteria for | ||
| torque response and was | ||
| found substantially | ||
| equivalent to the predicate. | ||
| Buckling | The Spartan MC 0165™ was | |
| evaluated for its resistance to | ||
| buckling and tip deflection | ||
| properties and compared to | ||
| the predicate device. | The Spartan MC 0165™ met | |
| the acceptance criteria for | ||
| tip deflection and buckling, | ||
| and was found substantially | ||
| equivalent to the predicate. | ||
| Design Validation | The Spartan MC 0165™ was | |
| tested in a model representing | ||
| a challenging use setting and | ||
| evaluated against the | ||
| predicate device for | ||
| interventional device | ||
| introduction, trackability, | ||
| interaction with embolic coil, | ||
| stability, guidewire | ||
| interaction, and overall device | ||
| integrity. | The Spartan MC 0165™ met | |
| the requirements for which | ||
| it was designed and tested. | ||
| Test | Test Method Summary | Results |
| Dimensional Testing | Dimensional properties of the | |
| subject device were measured | ||
| and compared to device | ||
| specifications. | The Spartan MC 0165™ met | |
| the dimensional | ||
| requirements. | ||
| Visual Inspection | The subject device was | |
| visually inspected and | ||
| compared to acceptance | ||
| criteria. | The Spartan MC 0165™ met | |
| the visual inspection | ||
| requirements. | ||
| Dead Space Volume | The dead space volume was | |
| calculated following a dead | ||
| space evaluation protocol. | The Spartan MC 0165™ | |
| dead space volume was | ||
| measured. The dead space | ||
| volume is reported in the | ||
| labeling. | ||
| Pressure Flow Testing | ||
| with Contrast Media | Flow pressure calculations | |
| were conducted following a | ||
| protocol for 100% saline, 50% | ||
| saline - 50% contrast media, | ||
| and 100% contrast media | ||
| solutions. | The Spartan MC 0165™TM pressure-flow performance | |
| was evaluated. Flow rates | ||
| and pressures of various | ||
| saline and contrast media | ||
| solutions are reported in the | ||
| labeling. | ||
| Test | Test Method Summary | Results |
| Effect: Sensitization | ||
| Test Name: Kligman | ||
| Maximization Test | ||
| Standard: ISO 10993-10 | Spartan MC 0165 elicited no reaction at the challenge (0% sensitization), following an induction phase. Therefore, as defined by the grading scale of the USP, the test article is classified as a non-sensitizer. | Non-sensitizer. |
| Effect: Genotoxicity | ||
| Test Name: Mouse | ||
| Lymphoma Mutagenesis | ||
| Assay with confirmation | ||
| Standard: ISO 10993-3 | The IMF of Test Article for all conditions was less than the GEF of $126 \times 10^{-6}$ . Therefore, the test article meets the requirements of the test and is considered non-mutagenic. | Non-mutagenic. |
| Effect: Genotoxicity | ||
| Test Name: Salmonella | ||
| Typhimurium and | ||
| Escherichia Coli Reverse | ||
| Mutation Assay | ||
| without Confirmation | ||
| Standard: ISO 10993-3 | The results of primary assay (plate incorporation) showed that neither of the test article extracts induced a statistically significant increase in the number of revertant colonies as compared to the negative controls in both non-activated and activated conditions. | Non-genotoxic. |
| Effect: Cytotoxicity | ||
| Test Name: L929 | ||
| MEM Elution Test | ||
| Standard: ISO 10993-5 | The test article meets the requirements of the test and there were no cultures treated with the test article that showed greater than a Mild reactivity (Grade 2). Therefore, the test article is considered non-cytotoxic. | Non-cytotoxic. |
| Effect: | ||
| Irritation/Intracutaneous | ||
| Reactivity | ||
| Test Name: | ||
| Intracutaneous Injection | ||
| Test | ||
| Standard: ISO 10993-10 | The test article sites did not show a significantly greater biological reaction than the sites injected with the control article (mean score difference = 0). Based on the criteria of the protocol, the test article meets the requirements of the test | Non-irritant. |
| Effect: Acute Systemic | ||
| Toxicity | ||
| Test Name: Systemic | ||
| Injection Test | ||
| Standard: ISO 10993-11 | The extracts of test article did | |
| not induce a significantly | ||
| greater biological reaction | ||
| than the control extracts | ||
| following a single dose to | ||
| Albino Swiss mice. Therefore, | ||
| the test article meets the | ||
| requirements of the test. | No systemic toxicity. | |
| Effect: Pyrogenicity | ||
| Test Name: Rabbit | ||
| Pyrogen Test (Material | ||
| Mediated) | ||
| Standard: ISO 10993-11 | ||
| Continuing Testing: | ||
| Limulus Amebocyte | ||
| Lysate (LAL) | ||
| Standard: USP | The temperature increase for | |
| all the test animals was 0.0 °C. | ||
| The increases did not exceed | ||
| the test limit for the maximum | ||
| individual temperature rise. | ||
| The temperature increase of | ||
| the control animal was 0.0 °C. | ||
| Therefore, the test article | ||
| meets the requirement of the | ||
| test and is considered non- | ||
| pyrogenic. | Non-pyrogenic. | |
| Effect: | ||
| Hemocompatibility | ||
| Test Name: Rabbit Blood | ||
| Hemolysis Test | ||
| (Complete) | ||
| Standard: ISO 10993-4 | For direct contact and indirect | |
| contact testing, the Hemolysis | ||
| above negative were 0.13% | ||
| and 0%, respectively, both are |