(27 days)
The Spartan MC 0165™ is intended for the introduction of interventional devices or infusion of diagnostic agents into the neuro, peripheral and coronary vasculatures.
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.
The Spartan MC 0165™ is a microcatheter device. The provided text describes several performance studies conducted to demonstrate its substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Coating Lubricity (Friction Force) | Acceptable friction force under simulated use conditions similar to the predicate device. | The Spartan MC 0165™ was found to have acceptable friction force under simulated use conditions similar to the predicate device. |
| Hub Functional & Dimensional | Meet ISO 594-1:1986-06-15 and ISO 594-2:1998-09-01 requirements. | The Spartan MC 0165™ met the acceptance criteria for hub functional and dimensional requirements. |
| Torque Strength | Acceptable torsional strength similar to the predicate device during simulated use. | The Spartan MC 0165™ exhibited acceptable torsional strength similar to the predicate device. |
| Tensile | Meet ISO 10555-1:2013 Annex B requirements. | The Spartan MC 0165™ met the acceptance criteria for tensile strength. |
| Air Aspiration | Meet ISO 10555-1:2013(E) Annex D requirements for air leakage. | The Spartan MC 0165™ met the acceptance criteria for air aspiration. |
| Liquid Leak | Meet ISO 10555-1:2013(E) Annex C requirements for liquid leakage. | The Spartan MC 0165™ met the acceptance criteria for liquid leakage. |
| Particulate and Coating Integrity | Meet acceptance criteria for particulate generation and coating integrity, and be substantially equivalent to the predicate. | The Spartan MC 0165™ met the acceptance criteria for particulate generation and coating integrity, and was found substantially equivalent to the predicate. |
| Tip Shape | Retain steam-shaped tip shape and be substantially equivalent to the predicate device. | The Spartan MC 0165™ met the acceptance criteria for tip shapeability and was found substantially equivalent to the predicate. |
| Stiffness | Meet acceptance criteria for catheter stiffness and be substantially equivalent to the predicate. | The Spartan MC 0165™ met the acceptance criteria for catheter stiffness and was found substantially equivalent to the predicate. |
| Kink Resistance | Withstand bends and be substantially equivalent to the predicate. | The Spartan MC 0165™ met the acceptance criteria for kink resistance and was found substantially equivalent to the predicate. |
| Radiopacity | Be visible under fluoroscopy and be substantially equivalent to the predicate device. | The Spartan MC 0165™ met the acceptance criteria for radiopacity and was found substantially equivalent to the predicate. |
| Corrosion | Meet ISO 10555-1:2013(E) Annex A requirements. | The Spartan MC 0165™ met the acceptance criteria for corrosion resistance. |
| Static Burst Pressure | Meet ISO 10555-1:2013(E) Annex F requirements. | The Spartan MC 0165™ met the acceptance criteria for static burst pressure. |
| Torque Response | Meet acceptance criteria for torque response and be substantially equivalent to the predicate. | The Spartan MC 0165™ met the acceptance criteria for torque response and was found substantially equivalent to the predicate. |
| Buckling | Meet acceptance criteria for tip deflection and buckling, and be substantially equivalent to the predicate. | The Spartan MC 0165™ met the acceptance criteria for tip deflection and buckling, and was found substantially equivalent to the predicate. |
| Design Validation | Meet requirements for which it was designed and tested in a challenging use setting. | The Spartan MC 0165™ met the requirements for which it was designed and tested. |
| Dimensional Testing | Meet device specifications. | The Spartan MC 0165™ met the dimensional requirements. |
| Visual Inspection | Meet visual inspection requirements. | The Spartan MC 0165™ met the visual inspection requirements. |
| Dead Space Volume | Dead space volume to be measured and reported in labeling. | The Spartan MC 0165™ dead space volume was measured and is reported in the labeling. |
| Pressure Flow Testing with Contrast Media | Flow rates and pressures for various solutions to be evaluated and reported in labeling. | The Spartan MC 0165™TM pressure-flow performance was evaluated, and flow rates and pressures of various saline and contrast media solutions are reported in the labeling. |
| Sensitization (Kligman Maximization Test) | Classified as a non-sensitizer (0% sensitization). | Spartan MC 0165 elicited no reaction at the challenge (0% sensitization), classified as a non-sensitizer. |
| Genotoxicity (Mouse Lymphoma Mutagenesis Assay) | Non-mutagenic (IMF of Test Article < GEF of $126 \times 10^{-6}$). | The IMF of Test Article for all conditions was less than the GEF of $126 \times 10^{-6}$, considered non-mutagenic. |
| Genotoxicity (Salmonella Typhimurium and Escherichia Coli Reverse Mutation Assay) | No statistically significant increase in revertant colonies compared to negative controls. | Neither of the test article extracts induced a statistically significant increase in the number of revertant colonies as compared to the negative controls. Non-genotoxic. |
| Cytotoxicity (L929 MEM Elution Test) | Non-cytotoxic (no cultures with greater than Mild reactivity - Grade 2). | 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). Considered non-cytotoxic. |
| Irritation/Intracutaneous Reactivity | Not show a significantly greater biological reaction than control sites (mean score difference = 0). | The test article sites did not show a significantly greater biological reaction than the sites injected with the control article (mean score difference = 0). Non-irritant. |
| Acute Systemic Toxicity | Not induce a significantly greater biological reaction than control extracts. | The extracts of the test article did not induce a significantly greater biological reaction than the control extracts. No systemic toxicity. |
| Pyrogenicity (Rabbit Pyrogen Test) | Temperature increase for test animals not to exceed test limit (0.0 °C observed). | The temperature increase for all test animals was 0.0 °C and did not exceed the test limit. The control animal also showed 0.0 °C. Non-pyrogenic. |
| Hemocompatibility (Rabbit Blood Hemolysis Test) | Hemolysis above negative < 5%. | For direct and indirect contact testing, hemolysis above negative were 0.13% and 0%, respectively, both < 5%. Non-hemolytic. |
| Hemocompatibility (Unactivated Partial Thromboplastin Time Test) | No statistically significant decrease between UPTT of plasma exposed to test article and controls. | There was no statistically significant decrease found between the Unactivated Partial Thromboplastin Time (UPTT) of the plasma exposed to the test article and that of the plasma exposed to both the negative control article and the untreated control. Hemocompatible. |
| Hemocompatibility (SC5B-9 Complement Activation Test) | No statistically significant increase between SC5b-9 concentrations in plasma exposed to test article and controls. | There was no statistically significant increase found between the SC5b-9 concentrations in the plasma exposed to the test article and that of the plasma exposed to both the negative control article and untreated control. Hemocompatible. |
| Hemocompatibility (In Vitro Blood Flow Loop) | Thrombus Formation Score of zero (Minimal to nonexistent thrombus formation). | All devices tested received a Thrombus Formation Score of zero which means Minimal to nonexistent thrombus formation (1% or less). Not Thrombogenic. |
| Sterilization | Achieves a Sterility Assurance Level of 10-6. | EO sterilization validation testing performed to ISO 11135:2014, following an overkill (half cycle) approach, achieved a Sterility Assurance Level of 10-6. |
| Shelf Life | Safe and effective after at least 1 year (after accelerated aging and simulated shipping). | Accelerated aging (55 °C, 38 days for 1-year equivalent) and simulated shipping were performed, and devices remained safe and effective. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for each test. The results are presented as general compliance (e.g., "The Spartan MC 0165™ met the acceptance criteria"). However, standard testing protocols for medical devices typically involve a representative sample size to ensure statistical validity.
- Data Provenance: The studies are "non-clinical bench testing" and "biocompatibility evaluation." This indicates controlled laboratory experiments using specific test methodologies (e.g., ISO standards, simulated use conditions). The data is generated prospectively under these controlled conditions. The testing was performed in vitro (bench, simulated models, and various biological assays) and in vivo for some biocompatibility tests (e.g., Kligman Maximization Test, Mouse Lymphoma Mutagenesis Assay, Rabbit Pyrogen Test, Rabbit Blood Hemolysis Test, Systemic Injection Test). There is no mention of country of origin for the data, but the standards cited are international (ISO) and US (USP).
3. Number of experts used to establish the ground truth for the test set and their qualifications:
Not applicable. These are performance tests for a physical medical device, not a diagnostic device requiring expert interpretation of results to establish ground truth. The "ground truth" is defined by the acceptance criteria of the referenced ISO standards and specific test protocols.
4. Adjudication method for the test set:
Not applicable. These are objective performance tests with predefined pass/fail criteria based on standards and test methods. There is no subjective interpretation requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
No. This is a performance evaluation of a physical medical device (microcatheter), not a diagnostic or AI-assisted system that would typically involve a multi-reader multi-case study.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithm or AI system.
7. The type of ground truth used:
The ground truth is established by the specified international and national standards (e.g., ISO 594, ISO 10555, ISO 10993, USP) and predefined acceptance criteria within the Spartan Micro, Inc. test protocols. For comparative tests, the predicate device's performance also serves as a benchmark for "substantial equivalence."
8. The sample size for the training set:
Not applicable. This is a physical medical device undergoing performance testing, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established:
Not applicable. This is a physical medical device undergoing performance testing, not a machine learning model.
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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
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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) 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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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.
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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 blockamide (Pebax) andPolyamide (Grilamid) | PTFE and Pebax |
| Hub | Polypropylene | Polyamide |
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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, andPre-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 bleachsulfate |
| 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 conditionssimilar to the predicatedevice. | |
| Hub Functional &Dimensional | The Spartan MC 0165™ wasevaluated per ISO 594-1:1986-06-15 First edition and ISO594-2:1998-09-01 Secondedition. | The Spartan MC 0165™ metthe acceptance criteria forhub functional anddimensional requirements. |
| Torque Strength | The Spartan MC 0165™ wasevaluated for torsionalstrength during use in asimulated path model. | The Spartan MC 0165™exhibited acceptabletorsional strength similar tothe predicate device. |
| Tensile | The Spartan MC 0165™ wasevaluated per ISO 10555-1:2013 Annex B. | The Spartan MC 0165™ metthe acceptance criteria fortensile strength. |
| Air Aspiration | The Spartan MC 0165™ wastested for air leakage into thehub during aspiration per ISO10555-1:2013(E) Annex D. | The Spartan MC 0165™ metthe acceptance criteria forair aspiration. |
| Liquid Leak | The Spartan MC 0165™ wastested per ISO 10555-1:2013(E) Annex C. | The Spartan MC 0165™ metthe acceptance criteria forliquid leakage. |
| Particulate andCoating Integrity | The Spartan MC 0165™ wasevaluated under simulateduse conditions and comparedwith the predicate device tosupport substantialequivalence. The coatingintegrity was also visuallyexamined after testing. | The Spartan MC 0165™ metthe acceptance criteria forparticulate generation andcoating integrity, and wasfound substantiallyequivalent to the predicate. |
| Tip Shape | The Spartan MC 0165™ wasevaluated for its ability toretain steam shaped tipshape and results comparedto the predicate device. | The Spartan MC 0165™ metthe acceptance criteria fortip shapeability and wasfound substantiallyequivalent to the predicate. |
| Stiffness | A stiffness profile across thecatheter length was measuredand compared to thepredicate device's stiffnessprofile. | The Spartan MC 0165™ metthe acceptance criteria forcatheter stiffness and wasfound substantiallyequivalent to the predicate. |
| Kink Resistance | The ability of the Spartan MC0165™ to withstand bends | The Spartan MC 0165™ metthe acceptance criteria for |
| Test | Test Method Summary | Results |
| was measured at variouspoints across the catheterlength by bending thecatheter shaft aroundsequentially smaller mandrels.Results were compared to testresults from the predicate. | kink resistance and wasfound substantiallyequivalent to the predicate. | |
| Radiopacity | The visibility of the SpartanMC 0165™ under fluoroscopywas compared to thepredicate device. | The Spartan MC 0165™ metthe acceptance criteria forradiopacity and was foundsubstantially equivalent tothe predicate. |
| Corrosion | The Spartan MC 0165™ wasevaluated for corrosion perISO 10555-1:2013(E) Annex A. | The Spartan MC 0165™ metthe acceptance criteria forcorrosion resistance. |
| Static Burst Pressure | The Spartan MC 0165™ wastested to evaluate the burstpressure under staticconditions per ISO 10555-1:2013(E) Annex F. | The Spartan MC 0165™ metthe acceptance criteria forstatic burst pressure. |
| Torque Response | The Spartan MC 0165™ wastested for its response totorque forces and resultscompared to the predicatedevice. | The Spartan MC 0165™ metthe acceptance criteria fortorque response and wasfound substantiallyequivalent to the predicate. |
| Buckling | The Spartan MC 0165™ wasevaluated for its resistance tobuckling and tip deflectionproperties and compared tothe predicate device. | The Spartan MC 0165™ metthe acceptance criteria fortip deflection and buckling,and was found substantiallyequivalent to the predicate. |
| Design Validation | The Spartan MC 0165™ wastested in a model representinga challenging use setting andevaluated against thepredicate device forinterventional deviceintroduction, trackability,interaction with embolic coil,stability, guidewireinteraction, and overall deviceintegrity. | The Spartan MC 0165™ metthe requirements for whichit was designed and tested. |
| Test | Test Method Summary | Results |
| Dimensional Testing | Dimensional properties of thesubject device were measuredand compared to devicespecifications. | The Spartan MC 0165™ metthe dimensionalrequirements. |
| Visual Inspection | The subject device wasvisually inspected andcompared to acceptancecriteria. | The Spartan MC 0165™ metthe visual inspectionrequirements. |
| Dead Space Volume | The dead space volume wascalculated following a deadspace evaluation protocol. | The Spartan MC 0165™dead space volume wasmeasured. The dead spacevolume is reported in thelabeling. |
| Pressure Flow Testingwith Contrast Media | Flow pressure calculationswere conducted following aprotocol for 100% saline, 50%saline - 50% contrast media,and 100% contrast mediasolutions. | The Spartan MC 0165™TM pressure-flow performancewas evaluated. Flow ratesand pressures of varioussaline and contrast mediasolutions are reported in thelabeling. |
| Test | Test Method Summary | Results |
| Effect: SensitizationTest Name: KligmanMaximization TestStandard: 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: GenotoxicityTest Name: MouseLymphoma MutagenesisAssay with confirmationStandard: 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: GenotoxicityTest Name: SalmonellaTyphimurium andEscherichia Coli ReverseMutation Assaywithout ConfirmationStandard: 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: CytotoxicityTest Name: L929MEM Elution TestStandard: 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/IntracutaneousReactivityTest Name:Intracutaneous InjectionTestStandard: 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 SystemicToxicityTest Name: SystemicInjection TestStandard: ISO 10993-11 | The extracts of test article didnot induce a significantlygreater biological reactionthan the control extractsfollowing a single dose toAlbino Swiss mice. Therefore,the test article meets therequirements of the test. | No systemic toxicity. |
| Effect: PyrogenicityTest Name: RabbitPyrogen Test (MaterialMediated)Standard: ISO 10993-11Continuing Testing:Limulus AmebocyteLysate (LAL)Standard: USP <85> | The temperature increase forall the test animals was 0.0 °C.The increases did not exceedthe test limit for the maximumindividual temperature rise.The temperature increase ofthe control animal was 0.0 °C.Therefore, the test articlemeets the requirement of thetest and is considered non-pyrogenic. | Non-pyrogenic. |
| Effect:HemocompatibilityTest Name: Rabbit BloodHemolysis Test(Complete)Standard: ISO 10993-4 | For direct contact and indirectcontact testing, the Hemolysisabove negative were 0.13%and 0%, respectively, both are< 5%. Therefore, the testarticle meets therequirements of the test andis considered non-hemolytic. | Non-hemolytic. |
| Effect:HemocompatibilityTest Name: UnactivatedPartial ThromboplastinTime Test (DirectContact)Standard: ISO 10993-4 | There was no statisticallysignificant decrease foundbetween the UnactivatedPartial Thromboplastin Time(UPTT) of the plasma exposedto the test article and that ofthe plasma exposed to boththe negative control articleand the untreated control.Based on the criteria of theprotocol, the test articlemeets the requirements of thetest, and is not considered tohave an effect on coagulationof human plasma viameasurement of the UPTT. | Hemocompatible. |
| Effect:HemocompatibilityTest Name: SC5B-9Complement ActivationTest (Direct Contact)Standard: ISO 10993-4 | There was no statisticallysignificant increase foundbetween the SC5b-9concentrations in the plasmaexposed to the test article andthat of the plasma exposed toboth the negative controlarticle and untreated control.Based on the criteria of theprotocol, the test articlemeets the requirements of thetest, and is not considered tohave activated thecomplement system in humanplasma. | Hemocompatible. |
| Effect:HemocompatibilityTest Name: In Vitro BloodFlow LoopStandard: ISO 10993-4 | An in-vitro Blood Flow LoopAssay study was performedusing both the subject deviceand predicate to evaluatetheir thrombogenic potential.All devices tested received aThrombus Formation Score ofzero which means Minimal tononexistent thrombusformation (1% or less). | Not Thrombogenic. |
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Image /page/6/Picture/1 description: The image shows the word "SPARTAN" in large, bold, black letters. Below the word "SPARTAN" is the phrase "MICRO, INC." in smaller, black letters. There is a black line above the phrase "MICRO, INC."
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Image /page/7/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."
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Image /page/8/Picture/0 description: The image shows the logo for Spartan Micro, Inc. The word "SPARTAN" is in large, bold, black letters. Below the word "SPARTAN" is the text "MICRO, INC." in a smaller font size. A horizontal line is underneath the word "SPARTAN" and above the text "MICRO, INC."
Biocompatibility
The biocompatibility evaluation for the Spartan MC 0165™ microcatheter was conducted in accordance with the FDA guidance, "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process'," and ISO 10993-1: "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process." The device is categorized as a limited exposure (<24 hrs), external communicating device contacting circulating blood. Tests for the following biocompatibility endpoints were performed on the Spartan MC 0165™.
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Image /page/9/Picture/0 description: The image shows the word "SPARTAN" in large, bold, black letters. Below the word "SPARTAN" is the phrase "MICRO, INC." in smaller, black letters. The phrase is centered below the word "SPARTAN". The image appears to be a logo or brand name.
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Image /page/10/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 is also in black.
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Image /page/11/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 is also in black.
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Image /page/12/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 smaller, black letters. The text is centered below the word "SPARTAN".
Sterilization
The EO sterilization validation testing was performed with reference to ISO 11135:2014 under the guidance provided for the adoption of new products into an existing validated cycle. The validation followed the overkill (half cycle) approach and was performed to a Sterility Assurance Level of 10-6.
Pyrogenicity
Tests for pyrogens and endotoxins have been performed yielding results of acceptable levels. The Rabbit Pyrogen Test was conducted to test for non-endotoxin pyrogens and the LAL (Limulus Amebocyte Lysate) or BET (Bacterial Endotoxin Test) was conducted to test for bacterial endotoxins.
Shelf Life
Accelerated aging equivalent to 1-year real time was performed on devices and tested to validate the shelf life. The Arrhenius Equation formed the basis of rationale for the aging parameters selected (55 °C, 38 days) to achieve the 1-year equivalent in accelerated aging. The packaged devices were also subjected to simulated shipping and then tested thoroughly to ensure they remain safe and effective after at least 1 year.
Performance Data – Animal:
No animal testing was conducted. The differences in technological characteristics do not raise new questions of safety and effectiveness.
Performance Data – Clinical:
No clinical testing was conducted. The differences in technological characteristics do not raise new questions of safety and effectiveness.
VIII. CONCLUSION
The differences in technological characteristics between the subject and the predicate devices do not raise new questions of safety and effectiveness. The non-clinical bench testing using well-established scientific methods demonstrates that the subject device performs similar to the predicate device. The information provided in this submission supports a determination of substantial equivalence for the Spartan MC 0165™.
§ 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).