(55 days)
The Spartan SC 069TM is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.
The Spartan SC 069™ is a support catheter designed for the introduction of interventional devices into the peripheral and neuro vasculature. The SC 069™ is a single lumen, flexible, variable stiffness composite catheter with a Nitinol structure. A radiopaque marker band on the distal tip of the device is used for visualization under fluoroscopy. The distal section of the catheter is coated with a hydrophilic coating to reduce the overall frictional force during intravascular use. The device is supplied sterile and intended for single use only.
The provided text describes the performance data for the Spartan SC 069™ support catheter. This device appears to be a medical device, and the information presented is from a 510(k) premarket notification to the FDA, which focuses on demonstrating substantial equivalence to a predicate device, rather than a clinical study evaluating the device's diagnostic performance. Therefore, many of the requested fields regarding diagnostic acceptance criteria, multi-reader multi-case studies, and human-in-the-loop performance are not applicable.
Here's the information extracted from the document:
1. A table of acceptance criteria and the reported device performance
The document lists various non-clinical bench tests and biocompatibility tests, with each test summary implying a pass/fail acceptance criterion. The results consistently state that the Spartan SC 069™ "met the acceptance criteria" or showed "acceptable" performance, or similar to the predicate device.
| Test | Test Method Summary (Implied Criteria) | Reported Device Performance |
|---|---|---|
| Coating Lubricity (Friction Force) | Acceptable friction force under simulated use conditions similar to predicate. | The Spartan SC 069™ 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 SC 069™ met the acceptance criteria for hub functional and dimensional requirements. |
| Torque Strength | Acceptable torsional strength similar to predicate in simulated path model. | The Spartan SC 069™ exhibited acceptable torsional strength similar to the predicate device. |
| Tensile | Meet ISO 10555-1:2013 Annex B. | The Spartan SC 069™ met the acceptance criteria for tensile strength. |
| Air Aspiration | Meet ISO 10555-1:2013(E) Annex D for air leakage. | The Spartan SC 069™ met the acceptance criteria for air aspiration. |
| Liquid Leak | Meet ISO 10555-1:2013(E) Annex C. | The Spartan SC 069™ met the acceptance criteria for liquid leakage. |
| Particulate and Coating Integrity | Acceptable particulate generation and coating integrity, substantially equivalent to predicate. | The Spartan SC 069™ met the acceptance criteria for particulate generation and coating integrity, and was found substantially equivalent to the predicate. |
| Stiffness | Meet acceptance criteria for catheter stiffness, substantially equivalent to predicate. | The Spartan SC 069™ met the acceptance criteria for catheter stiffness and found substantially equivalent to the predicate. |
| Kink Resistance | Meet acceptance criteria for kink resistance, substantially equivalent to predicate. | The Spartan SC 069™ met the acceptance criteria for kink resistance and was found substantially equivalent to the predicate. |
| Radiopacity | Meet acceptance criteria for radiopacity, substantially equivalent to predicate. | The Spartan SC 069™ met the acceptance criteria for radiopacity and was found substantially equivalent to the predicate. |
| Corrosion | Meet ISO 10555-1:2013(E) Annex A. | The Spartan SC 069™ met the acceptance criteria for corrosion resistance. |
| Static Burst Pressure | Meet ISO 10555-1:2013(E) Annex F for burst pressure. | The Spartan SC 069™ met the acceptance criteria for static burst pressure. |
| Buckling | Meet acceptance criteria for tip deflection and buckling, substantially equivalent to predicate. | The Spartan SC 069™ met the acceptance criteria for tip deflection and buckling and was found substantially equivalent to the predicate. |
| Design Validation | Meet requirements for interventional device introduction, trackability, stability, guidewire interaction, and overall device integrity in a challenging use setting. | The Spartan SC 069™ met the requirements for which it was designed and tested. |
| Dimensional Testing | Meet device specifications. | The Spartan SC 069™ met the dimensional requirements. |
| Visual Inspection | Meet acceptance criteria. | The Spartan SC 069™ met the visual inspection requirements. |
| Dead Space Volume | Measured and reported in labeling. | The Spartan SC 069™ dead space volume was measured. The dead space volume is reported in the labeling. |
| Pressure Flow Testing with Contrast Media | Evaluated flow rates and pressures of various solutions; reported in labeling. | The Spartan SC 069™ pressure-flow performance was evaluated. Flow rates and pressures of various saline and contrast media solutions are reported in the labeling. |
| Biocompatibility Tests | ||
| Sensitization (Guinea Pig) | No reaction at challenge; classified as non-sensitizer per ISO 10993-10. | Non-sensitizer. |
| Genotoxicity (Mouse Lymphoma) | IMF of Test Article < GEF; considered non-mutagenic per ISO 10993-3. | Non-mutagenic. |
| Genotoxicity (Salmonella Typhimurium & Escherichia Coli) | No statistically significant increase in revertant colonies compared to negative controls per ISO 10993-3. | Non-genotoxic. |
| Cytotoxicity (L929 MEM Elution) | No cell lysis or reduction of cell growth at 24/48 hours; considered non-cytotoxic per ISO 10993-5. | Non-cytotoxic. |
| Irritation/Intracutaneous Reactivity | No significantly greater biological reaction than control per ISO 10993-10. | Non-irritant. |
| Acute Systemic Toxicity | No significantly greater biological reaction than control extracts per ISO 10993-11. | No systemic toxicity. |
| Pyrogenicity (Rabbit Pyrogen Test) | Temperature increases did not exceed test limit; considered non-pyrogenic per ISO 10993-11. | Non-pyrogenic. |
| Hemocompatibility (Rabbit Blood Hemolysis) | Hemolysis < 5% (direct and indirect contact) per ISO 10993-4. | Non-hemolytic. |
| Hemocompatibility (Partial Thromboplastin Time) | Test article clotting time not significantly different from comparison article per ASTM International F2382-18 and ISO 10993-4. | Hemocompatible. |
| Hemocompatibility (SC5B-9 Complement Activation) | No statistically significant increase in SC5b-9 concentrations compared to controls per ISO 10993-4. | Hemocompatible. |
| Hemocompatibility (Platelet and Leukocyte Binding) | No effect on platelet and leukocyte concentrations per ISO 10993-4. | Hemocompatible. |
| Sterilization | ||
| Sterilization Validation | Achieved a Sterility Assurance Level of 10-6 using overkill (half cycle) approach per ISO 11135:2014. | Successful validation. |
| Shelf Life | ||
| Accelerated Aging | Maintained safety and effectiveness after 2-year equivalent accelerated aging (55 °C, 75 days) and simulated shipping. | Confirmed 2-year shelf life. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document relates to non-clinical bench testing and biocompatibility assessments of a medical device (catheter). It does not involve a "test set" in the context of diagnostic accuracy, human subjects, or data provenance like country of origin. The tests were performed in a laboratory setting for regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable as the study involves bench testing and biocompatibility of a medical device, not diagnostic performance requiring expert ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the study involves bench testing and biocompatibility of a medical device, not diagnostic performance requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable. This is a 510(k) submission for a physical medical device (catheter), not an AI-assisted diagnostic tool. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This is a 510(k) submission for a physical medical device (catheter), not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for these performance studies is established by the specifications and standards (e.g., ISO standards, internal design requirements) that the device must meet, as well as comparison to the predicate device. For biocompatibility, it's about not eliciting adverse biological responses.
8. The sample size for the training set
This information is not applicable. There is no "training set" as this is not an AI/machine learning study.
9. How the ground truth for the training set was established
This information is not applicable. There is no "training set" as this is not an AI/machine learning study.
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May 5, 2022
Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services and the U.S. Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Spartan Micro, Inc. Gary Avedovech Senior Director Quality and Compliance 3184 Airway Avenue, Suite C Costa Mesa, California 92626
Re: K220716
Trade/Device Name: Spartan SC 069 Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY, QJP Dated: March 10, 2022 Received: March 11, 2022
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 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-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) K220716
Device Name Spartan SC 069TM
Indications for Use (Describe)
The Spartan SC 0697M is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.
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, sans-serif letters. Below the word "SPARTAN" is a horizontal line, and to the right of the line is the text "MICRO, INC." The text "MICRO, INC." is written in a smaller, sans-serif font.
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.
I. SUBMITTER
Spartan Micro, Inc. 3184 Airway Ave, Suite C Costa Mesa, CA 92626
Phone: 949-409-8581
Contact Person: Gary Avedovech Date Prepared: May 4, 2022
II. DEVICE
Name of Device: Spartan SC 069™ Common or Usual Name: Support Catheter Regulatory Class: II Product Codes: DQY Percutaneous catheter (21 CFR 870.1250) QJP Percutaneous catheter, neurovasculature (21 CFR 870.1250) Review Panel: Cardiovascular, Neurology
III. PREDICATE and REFERENCE DEVICES
Predicate: React™ 68 Catheter 510(k) Number: K180715 Manufacturer: Micro Therapeutics, Inc. d/b/a/ ev3 Neurovascular This device has not been subject to a design-related recall.
Reference: Arc™ Intracranial Support Catheter and Arc™ Mini Intracranial Support Catheter 510(k) Number: K150107 Manufacturer: Micro Therapeutics, Inc. d/b/a/ ev3 Neurovascular This device has not been subject to a design-related recall.
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Image /page/4/Picture/1 description: The image shows the logo for Spartan Micro, Inc. The word "SPARTAN" is written in large, bold, sans-serif letters. Below the word "SPARTAN" is a horizontal line, and to the right of the line is the text "MICRO, INC." The text "MICRO, INC." is written in a smaller, sans-serif font.
IV. DEVICE DESCRIPTION
The Spartan SC 069™ is a support catheter designed for the introduction of interventional devices into the peripheral and neuro vasculature. The SC 069™ is a single lumen, flexible, variable stiffness composite catheter with a Nitinol structure. A radiopaque marker band on the distal tip of the device is used for visualization under fluoroscopy. The distal section of the catheter is coated with a hydrophilic coating to reduce the overall frictional force during intravascular use. The device is supplied sterile and intended for single use only.
V. INDICATIONS FOR USE
| Subject Device | Predicate | Reference |
|---|---|---|
| K220716; DQY, QJP | K180715; DQY | K150107; DQY |
| The Spartan SC 069™ isindicated for the introductionof interventional devices intothe peripheral and neurovasculature. | The React™ 68 Catheter isindicated for the introductionof interventional devices intothe peripheral and neurovasculature. | The Arc™ Intracranial SupportCatheter and Arc™ MiniIntracranial Support Catheterare indicated for theintroduction of interventionaldevices into the peripheraland neurovasculature. |
The indications for use are the same for the subject device and the predicate device.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE AND REFERENCE DEVICES
| Dimensions | Spartan SC 069™ | React™ 68 Catheter(K180715) | Arc™ IntracranialSupport Catheter(K150107) |
|---|---|---|---|
| Proximal OD | 0.0815" | 0.083" | 0.0825" |
| Distal OD | 0.0815" | 0.083" | 0.071" |
| Proximal ID | 0.069" | 0.068" | 0.069" |
| Distal ID | 0.069" | 0.068" | 0.061" |
| Effective Length | 95, 115, 133 cm | 132 cm | 132 – 135 cm |
| Inner Lumen | PTFE lined | same | same |
| Number of Lumens | Single lumen | same | same |
| Coating Length | 60cm | 40cm | unknown |
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| Materials | Spartan SC 069™ | React™ 68 Catheter(K180715) | Arc™ IntracranialSupport Catheter(K150107) |
|---|---|---|---|
| Shaft Materials | Tecothane andpolyether block amide | Grilamid™ Pebax® | Polymetric plasticmaterial |
| Hub | Polycarbonate | Trogamid | unknown |
| Strain Relief | RNF | DynaFlex | unknown |
| Shaft Reinforcement | Nitinol | same | same |
| Marker Band | Platinum/Iridium | Platinum/Iridium | Platinum |
| Coating | Hydrophilic | same | same |
| Packaging | Spartan SC 069TM | ReactTM 68 Catheter(K180715) | ArcTM IntracranialSupport Catheter(K150107) |
|---|---|---|---|
| Pouch Material | PET/PE/Tyvek | same | same |
| Packaging Card | HDPE | Polyethylene | same |
| Packaging Hoop | HDPE | Polyethylene | same |
| Sterilization | Spartan SC 069™ | React™ 68 Catheter(K180715) | Arc™ IntracranialSupport Catheter(K150107) |
|---|---|---|---|
| Method | Ethylene Oxide (EO) | same | same |
| Shelf Life | 2 years | 3 months* | 6 months |
*Shelf life based on Riptide Aspiration System (React 68 Catheter) per K180705.
The differences in technological characteristics do not raise new questions of safety or effectiveness.
VII. PERFORMANCE DATA
Performance Data – Bench:
The following non-clinical bench testing was performed to evaluate the performance of the Spartan SC 069™. The passing result of the testing supports the substantial equivalence to the predicate.
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Image /page/6/Picture/1 description: The image shows the logo for Spartan Micro, Inc. The word "SPARTAN" is in large, bold, sans-serif font. Below the word "SPARTAN" is a horizontal line, and to the right of the line is the text "MICRO, INC." in a smaller, sans-serif font.
| Test | Test Method Summary | Results |
|---|---|---|
| Coating Lubricity (FrictionForce) | The Spartan SC 069™ and thepredicate device were evaluatedfor coating lubricity undersimulated use conditions. | The Spartan SC 069™ wasfound to have acceptablefriction force under simulateduse conditions similar to thepredicate device. |
| Hub Functional &Dimensional | The Spartan SC 069™ wasevaluated per ISO 594-1:1986-06-15 First edition and ISO 594-2:1998-09-01 Second edition. | The Spartan SC 069™ met theacceptance criteria for hubfunctional and dimensionalrequirements. |
| Torque Strength | The Spartan SC 069™ wasevaluated for torsional strengthduring use in a simulated pathmodel. | The Spartan SC 069™ exhibitedacceptable torsional strengthsimilar to the predicate device. |
| Tensile | The Spartan SC 069™ wasevaluated per ISO 10555-1:2013Annex B. | The Spartan SC 069™ met theacceptance criteria for tensilestrength. |
| Air Aspiration | The Spartan SC 069™ was testedfor air leakage into the hubduring aspiration per ISO 10555-1:2013(E) Annex D. | The Spartan SC 069™ met theacceptance criteria for airaspiration. |
| Liquid Leak | The Spartan SC 069™ was testedper ISO 10555-1:2013(E) Annex C. | The Spartan SC 069™ met theacceptance criteria for liquidleakage. |
| Particulate and CoatingIntegrity | The Spartan SC 069™ wasevaluated under simulated useconditions and compared withthe predicate device to supportsubstantial equivalence. Thecoating integrity was also visuallyexamined after testing. | The Spartan SC 069™ met theacceptance criteria forparticulate generation andcoating integrity, and wasfound substantially equivalentto the predicate. |
| Stiffness | A stiffness profile across thecatheter length was measuredand compared to the predicatedevice stiffness profile. | The Spartan SC 069™ met theacceptance criteria forcatheter stiffness and foundsubstantially equivalent to thepredicate. |
| Test | Test Method Summary | Results |
| Kink Resistance | The ability of the Spartan SC069™ to withstand bends wasmeasured at various pointsacross the catheter length bybending the catheter shaftaround sequentially smallermandrels. Results werecompared to test results fromthe predicate. | The Spartan SC 069™ met theacceptance criteria for kinkresistance and was foundsubstantially equivalent to thepredicate. |
| Radiopacity | The visibility of the Spartan SC069™ under fluoroscopy wascompared to the predicatedevice. | The Spartan SC 069™ met theacceptance criteria forradiopacity and was foundsubstantially equivalent to thepredicate. |
| Corrosion | The Spartan SC 069™ wasevaluated for corrosion perISO 10555-1:2013(E) Annex A. | The Spartan SC 069™ met theacceptance criteria forcorrosion resistance. |
| Static Burst Pressure | The Spartan SC 069™ was testedto evaluate the burst pressureunder static conditions per ISO10555-1:2013(E) Annex F. | The Spartan SC 069™ met theacceptance criteria for staticburst pressure. |
| Buckling | The Spartan SC 069™ wasevaluated for its resistance tobuckling and tip deflectionproperties and compared to thepredicate device. | The Spartan SC 069™ met theacceptance criteria for tipdeflection and buckling andwas found substantiallyequivalent to the predicate. |
| Design Validation | The Spartan SC 069™ was testedin a model representing achallenging use setting andevaluated against the predicatedevice on interventional deviceintroduction, trackability,stability, guidewire interaction,and overall device integrity. | The Spartan SC 069™ met therequirements for which it wasdesigned and tested. |
| Test | Test Method Summary | Results |
| Dimensional Testing | Dimensional properties of thesubject device were measuredand compared to devicespecifications. | The Spartan SC 069™ met thedimensional requirements. |
| Visual Inspection | The subject device was visuallyinspected and compared toacceptance criteria. | The Spartan SC 069™ met thevisual inspectionrequirements. |
| Dead Space Volume | The dead space volume wascalculated following a deadspace evaluation protocol. | The Spartan SC 069™ deadspace volume was measured.The dead space volume isreported in the labeling. |
| Pressure Flow Testing withContrast Media | Flow pressure calculations wereconducted following a protocolfor 100% saline, 50% saline -50% contrast media, and 100%contrast media solutions. | The Spartan SC 069™ pressure-flow performance wasevaluated. Flow rates andpressures of various saline andcontrast media solutions arereported in the labeling. |
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Image /page/7/Picture/1 description: The image shows the word "SPARTAN" in large, bold, sans-serif font. Below the word "SPARTAN" is a horizontal line, and to the right of the line is the text "MICRO, INC." in a smaller, sans-serif font. The text is all in black and white.
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Image /page/8/Picture/1 description: The image shows the logo for Spartan Micro, Inc. The word "SPARTAN" is in large, bold, sans-serif font. Below the word "SPARTAN" is a horizontal line, and to the right of the line is the text "MICRO, INC." in a smaller, sans-serif font. The logo is simple and modern.
Biocompatibility
The biocompatibility evaluation for the Spartan SC 069™ support catheter was conducted in accordance with the FDA guidance, "Use of International Standard ISO 10993-1, '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 SC 069™.
| Test | Test Method Summary | Results |
|---|---|---|
| Effect: SensitizationTest Name: Guinea Pig | Spartan SC 069 elicited no reaction at the challenge following an induction phase. | Non-sensitizer. |
| Maximization TestStandard: ISO 10993-10 | Therefore, as defined by the acceptance criteria the test article is classified as a non-sensitizer. | |
| Test | Test Method Summary | Results |
| Effect: GenotoxicityTest Name: MouseLymphoma MutagenesisAssay with confirmationStandard: ISO 10993-3 | The IMF of Test Article for allconditions was less than the GEFof 126 × 10-6. Therefore, the testarticle meets the requirementsof the test and isconsidered non-mutagenic. | Non-mutagenic. |
| Effect: GenotoxicityTest Name: SalmonellaTyphimurium andEscherichia Coli ReverseMutation Assay withoutconfirmationStandard: ISO 10993-3 | The results of primary assay(plate incorporation) showedthat neither of the test articleextracts induced a statisticallysignificant increase in thenumber of revertant colonies ascompared to the negativecontrols in both non-activatedand activated conditions. | Non-genotoxic. |
| Effect: CytotoxicityTest Name: L929 MEMElution TestStandard: ISO 10993-5 | No reactivity was observed until72 hours; therefore, no cell lysisor reduction of cell growth wasobserved in the triplicate wells at24 and 48 hours. The test articlemeets the requirements of thetest. Therefore, the test article isconsidered as non-cytotoxic. | Non-cytotoxic. |
| Effect:Irritation/IntracutaneousReactivityTest Name:Intracutaneous InjectionTestStandard: ISO 10993-10 | The test article sites did notshow a significantly greaterbiological reaction than the sitesinjected with the control article.Based on the criteria of theprotocol, the test article meetsthe requirements of the test. | Non-irritant. |
| Effect: Acute SystemicToxicityName:SystemicTestInjection TestStandard: ISO 10993-11 | The extracts of test article didnot induce a significantly greaterbiological reaction than thecontrol extracts. Therefore, thetest article meets therequirements of the test. | No systemic toxicity. |
| Test | Test Method Summary | Results |
| Effect: PyrogenicityTest Name: RabbitPyrogen Test (MaterialMediated)Standard: ISO 10993-11Continuing Testing:Limulus AmebocyteLysate (LAL)Standard:USP <85> BacterialEndotoxin Test | The temperature increases forthe test animals did not exceedthe test limit for the maximumindividual temperature rise.Therefore, the test article meetsthe requirement of the test to beconsidered 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% and 0%,respectively. Both are <5% whichis the threshold for acceptance. | Non-hemolytic. |
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Image /page/9/Picture/1 description: The image shows the logo for Spartan Micro, Inc. The word "SPARTAN" is in large, bold, sans-serif font. Below the word "SPARTAN" is a horizontal line, and to the right of the line is the text "MICRO, INC."
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Image /page/10/Picture/1 description: The image shows the logo for Spartan Micro, Inc. The word "SPARTAN" is in large, bold, sans-serif font. Below the word "SPARTAN" is a horizontal line, and below that is the text "MICRO, INC." in a smaller, sans-serif font.
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K220716
Spartan SC 069™ Premarket Notification 510(k)
Image /page/11/Picture/2 description: The image shows the word "SPARTAN" in large, bold, sans-serif font. 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 black on a white background.
| Effect:HemocompatibilityTest Name:Partial ThromboplastinTime Test (DirectContact)Standard: ISO 10993-4 | The study was conducted incompliance to ASTMInternational F2382-18: StandardTest Method for Assessment ofCirculating Blood- ContactingMedical Device Materials onPartial Thromboplastin Time(PTT). When comparing the testarticle clotting time to thecomparison article clotting timewith ANOVA, the results for thetest article and the comparisonarticle are not significantlydifferent from each other.• The test article average clottime was greater than thevehicle control. | Hemocompatible. |
|---|---|---|
| Test | Test Method Summary | Results |
| • The test article average clottime was not significantlydifferent (p ≥ 0.05) from thevehicle control. | ||
| 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 control articleand untreated control.Based on the criteria of theprotocol, the test article meetsthe requirements of the test,and is not considered to haveactivated the complementsystem in human plasma. | Hemocompatible. |
| Effect:HemocompatibilityTest Name:Platelet and LeukocyteBinding Test (DirectContact) - ISOStandard: ISO 10993-4 | The reduction of humanplatelets and leukocytes werestudied to assess the ability ofthe test and comparison articleto induce thrombus formation.The test article, based on criteriaof the protocol, is notconsidered to have an effect onplatelet and leukocyteconcentrations. | Hemocompatible. |
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Image /page/12/Picture/1 description: The image shows the logo for Spartan Micro, Inc. The word "SPARTAN" is in large, bold, sans-serif font. Below the word "SPARTAN" is a horizontal line, and below that is the text "MICRO, INC." in a smaller, sans-serif font.
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.
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Image /page/13/Picture/1 description: The image shows the logo for Spartan Micro, Inc. The word "SPARTAN" is written in large, bold, sans-serif font. Below the word "SPARTAN" is a horizontal line, and to the right of the line is the text "MICRO, INC." The text "MICRO, INC." is written in a smaller, sans-serif font.
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 2-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, 75 days) to achieve the 2-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 2 years.
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 device do not raise new questions of safety and effectiveness. The non-clinical bench testing using wellestablished 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 SC 069™.
§ 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).