Spartan SC 069

K220716 · Spartan Micro, Inc. · DQY · May 5, 2022 · Cardiovascular

Device Facts

• Record ID: K220716
• Device Name: Spartan SC 069
• Applicant: Spartan Micro, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: May 5, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The Spartan SC 069TM is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.

Device Story

The Spartan SC 069 is a single-lumen, flexible, variable-stiffness support catheter; features Nitinol shaft reinforcement and a radiopaque distal marker band for fluoroscopic visualization; distal section includes a hydrophilic coating to reduce friction. Used by physicians in clinical settings to facilitate the introduction of interventional devices into peripheral and neuro vasculature. Device is supplied sterile for single use. Healthcare providers use the catheter under fluoroscopic guidance to navigate the vasculature; the device provides a pathway for interventional tools, potentially improving procedural access and patient outcomes.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing, including coating lubricity, hub functional/dimensional testing, torque strength, tensile strength, air aspiration, liquid leak, particulate/coating integrity, stiffness, kink resistance, radiopacity, corrosion, static burst pressure, buckling, and design validation in simulated use models.

Technological Characteristics

Single-lumen catheter; materials: Tecothane, polyether block amide, Nitinol reinforcement, platinum/iridium marker band, polycarbonate hub. Hydrophilic coating. Sterilization: Ethylene Oxide (EO) per ISO 11135:2014. Dimensions: 0.0815" proximal/distal OD, 0.069" proximal/distal ID. Complies with ISO 594-1/2 (hub), ISO 10555-1 (tensile, leak, burst, corrosion), and ISO 10993 (biocompatibility).

Indications for Use

Indicated for the introduction of interventional devices into the peripheral and neuro vasculature for patients requiring such procedures.

Regulatory Classification

Identification

A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

Predicate Devices

• React 68 Catheter (K180715)

Reference Devices

• Arc Intracranial Support Catheter (K150107)
• Arc Mini Intracranial Support Catheter (K150107)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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: [phone]

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™ is<br>indicated for the introduction<br>of interventional devices into<br>the peripheral and neuro<br>vasculature. | The React™ 68 Catheter is<br>indicated for the introduction<br>of interventional devices into<br>the peripheral and neuro<br>vasculature. | The Arc™ Intracranial Support<br>Catheter and Arc™ Mini<br>Intracranial Support Catheter<br>are indicated for the<br>introduction of interventional<br>devices into the peripheral<br>and 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<br>(K180715) | Arc™ Intracranial<br>Support Catheter<br>(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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Image /page/5/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." in smaller, sans-serif letters. The logo is simple and professional.

| Materials | Spartan SC 069™ | React™ 68 Catheter<br>(K180715) | Arc™ Intracranial<br>Support Catheter<br>(K150107) |
|---------------------|----------------------------------------|---------------------------------|----------------------------------------------------|
| Shaft Materials | Tecothane and<br>polyether block amide | Grilamid™ Pebax® | Polymetric plastic<br>material |
| 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<br>(K180715) | ArcTM Intracranial<br>Support Catheter<br>(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<br>(K180715) | Arc™ Intracranial<br>Support Catheter<br>(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 (Friction<br>Force) | The Spartan SC 069™ and the<br>predicate device were evaluated<br>for coating lubricity under<br>simulated use conditions. | The Spartan SC 069™ was<br>found to have acceptable<br>friction force under simulated<br>use conditions similar to the<br>predicate device. |
| Hub Functional &<br>Dimensional | The Spartan SC 069™ was<br>evaluated per ISO 594-1:1986-<br>06-15 First edition and ISO 594-<br>2:1998-09-01 Second edition. | The Spartan SC 069™ met the<br>acceptance criteria for hub<br>functional and dimensional<br>requirements. |
| Torque Strength | The Spartan SC 069™ was<br>evaluated for torsional strength<br>during use in a simulated path<br>model. | The Spartan SC 069™ exhibited<br>acceptable torsional strength<br>similar to the predicate device. |
| Tensile | The Spartan SC 069™ was<br>evaluated per ISO 10555-1:2013<br>Annex B. | The Spartan SC 069™ met the<br>acceptance criteria for tensile<br>strength. |
| Air Aspiration | The Spartan SC 069™ was tested<br>for air leakage into the hub<br>during aspiration per ISO 10555-<br>1:2013(E) Annex D. | The Spartan SC 069™ met the<br>acceptance criteria for air<br>aspiration. |
| Liquid Leak | The Spartan SC 069™ was tested<br>per ISO 10555-1:2013(E) Annex C. | The Spartan SC 069™ met the<br>acceptance criteria for liquid<br>leakage. |
| Particulate and Coating<br>Integrity | The Spartan SC 069™ was<br>evaluated under simulated use<br>conditions and compared with<br>the predicate device to support<br>substantial equivalence. The<br>coating integrity was also visually<br>examined after testing. | The Spartan SC 069™ met the<br>acceptance criteria for<br>particulate generation and<br>coating integrity, and was<br>found substantially equivalent<br>to the predicate. |
| Stiffness | A stiffness profile across the<br>catheter length was measured<br>and compared to the predicate<br>device stiffness profile. | The Spartan SC 069™ met the<br>acceptance criteria for<br>catheter stiffness and found<br>substantially equivalent to the<br>predicate. |
| Test | Test Method Summary | Results |
| Kink Resistance | The ability of the Spartan SC<br>069™ to withstand bends was<br>measured at various points<br>across the catheter length by<br>bending the catheter shaft<br>around sequentially smaller<br>mandrels. Results were<br>compared to test results from<br>the predicate. | The Spartan SC 069™ met the<br>acceptance criteria for kink<br>resistance and was found<br>substantially equivalent to the<br>predicate. |
| Radiopacity | The visibility of the Spartan SC<br>069™ under fluoroscopy was<br>compared to the predicate<br>device. | The Spartan SC 069™ met the<br>acceptance criteria for<br>radiopacity and was found<br>substantially equivalent to the<br>predicate. |
| Corrosion | The Spartan SC 069™ was<br>evaluated for corrosion per<br>ISO 10555-1:2013(E) Annex A. | The Spartan SC 069™ met the<br>acceptance criteria for<br>corrosion resistance. |
| Static Burst Pressure | The Spartan SC 069™ was tested<br>to evaluate the burst pressure<br>under static conditions per ISO<br>10555-1:2013(E) Annex F. | The Spartan SC 069™ met the<br>acceptance criteria for static<br>burst pressure. |
| Buckling | The Spartan SC 069™ was<br>evaluated for its resistance to<br>buckling and tip deflection<br>properties and compared to the<br>predicate device. | The Spartan SC 069™ met the<br>acceptance criteria for tip<br>deflection and buckling and<br>was found substantially<br>equivalent to the predicate. |
| Design Validation | The Spartan SC 069™ was tested<br>in a model representing a<br>challenging use setting and<br>evaluated against the predicate<br>device on interventional device<br>introduction, trackability,<br>stability, guidewire interaction,<br>and overall device integrity. | The Spartan SC 069™ met the<br>requirements for which it was<br>designed and tested. |
| Test | Test Method Summary | Results |
| Dimensional Testing | Dimensional properties of the<br>subject device were measured<br>and compared to device<br>specifications. | The Spartan SC 069™ met the<br>dimensional requirements. |
| Visual Inspection | The subject device was visually<br>inspected and compared to<br>acceptance criteria. | The Spartan SC 069™ met the<br>visual inspection<br>requirements. |
| Dead Space Volume | The dead space volume was<br>calculated following a dead<br>space evaluation protocol. | The Spartan SC 069™ dead<br>space volume was measured.<br>The dead space volume is<br>reported in the labeling. |
| Pressure Flow Testing with<br>Contrast Media | Flow pressure calculations were<br>conducted following a protocol<br>for 100% saline, 50% saline -<br>50% contrast media, and 100%<br>contrast media solutions. | The Spartan SC 069™ pressure-<br>flow performance was<br>evaluated. Flow rates and<br>pressures of various saline and<br>contrast media solutions are<br>reported 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: Sensitization<br>Test Name: Guinea Pig | Spartan SC 069 elicited no reaction at the challenge following an induction phase. | Non-sensitizer. |
| Maximization Test<br>Standard: 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: Genotoxicity<br>Test Name: Mouse<br>Lymphoma Mutagenesis<br>Assay with confirmation<br>Standard: ISO 10993-3 | The IMF of Test Article for all<br>conditions was less than the GEF<br>of 126 × 10-6. Therefore, the test<br>article meets the requirements<br>of the test and is<br>considered non-mutagenic. | Non-mutagenic. |
| Effect: Genotoxicity<br>Test Name: Salmonella<br>Typhimurium and<br>Escherichia Coli Reverse<br>Mutation Assay without<br>confirmation<br>Standard: ISO 10993-3 | The results of primary assay<br>(plate incorporation) showed<br>that neither of the test article<br>extracts induced a statistically<br>significant increase in the<br>number of revertant colonies as<br>compared to the negative<br>controls in both non-activated<br>and activated conditions. | Non-genotoxic. |
| Effect: Cytotoxicity<br>Test Name: L929 MEM<br>Elution Test<br>Standard: ISO 10993-5 | No reactivity was observed until<br>72 hours; therefore, no cell lysis<br>or reduction of cell growth was<br>observed in the triplicate wells at<br>24 and 48 hours. The test article<br>meets the requirements of the<br>test. Therefore, the test article is<br>considered as non-cytotoxic. | Non-cytotoxic. |
| Effect:<br>Irritation/Intracutaneous<br>Reactivity<br>Test Name:<br>Intracutaneous Injection<br>Test<br>Standard: ISO 10993-10 | The test article sites did not<br>show a significantly greater<br>biological reaction than the sites<br>injected with the control article.<br>Based on the criteria of the<br>protocol, the test article meets<br>the requirements of the test. | Non-irritant. |
| Effect: Acute Systemic<br>Toxicity<br>Name:<br>Systemic<br>Test<br>Injection Test<br>Standard: ISO 10993-11 | The extracts of test article did<br>not induce a significantly greater<br>biological reaction than the<br>control extracts. Therefore, the<br>test article meets the<br>requirements of the test. | No systemic toxicity. |
| Test | Test Method Summary | Results |
| Effect: Pyrogenicity<br>Test Name: Rabbit<br>Pyrogen Test (Material<br>Mediated)<br>Standard: ISO 10993-11<br>Continuing Testing:<br>Limulus Amebocyte<br>Lysate (LAL)<br>Standard:<br>USP <85> Bacterial<br>Endotoxin Test | The temperature increases for<br>the test animals did not exceed<br>the test limit for the maximum<br>individual temperature rise.<br>Therefore, the test article meets<br>the requirement of the test to be<br>considered non-pyrogenic. | Non-pyrogenic. |
| Effect:<br>Hemocompatibility<br>Test Name: Rabbit Blood<br>Hemolysis Test<br>(Complete)<br>Standard: ISO 10993-4 | For direct contact and indirect<br>contact testing, the Hemolysis<br>above negative were 0% and 0%,<br>respectively. Both are <5% which<br>is 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:<br>Hemocompatibility<br><br>Test Name:<br>Partial Thromboplastin<br>Time Test (Direct<br>Contact)<br><br>Standard: ISO 10993-4 | The study was conducted in<br>compliance to ASTM<br>International F2382-18: Standard<br>Test Method for Assessment of<br>Circulating Blood- Contacting<br>Medical Device Materials on<br>Partial Thromboplastin Time<br>(PTT). When comparing the test<br>article clotting time to the<br>comparison article clotting time<br>with ANOVA, the results for the<br>test article and the comparison<br>article are not significantly<br>different from each other.<br>• The test article average clot<br>time was greater than the<br>vehicle control. | Hemocompatible. |
|-----------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|
| Test | Test Method Summary | Results |
| | • The test article average clot<br>time was not significantly<br>different (p ≥ 0.05) from the<br>vehicle control. | |
| Effect:<br>Hemocompatibility<br>Test Name: SC5B-9<br>Complement Activation<br>Test (Direct Contact)<br>Standard: ISO 10993-4 | There was no statistically<br>significant increase found<br>between the SC5b-9<br>concentrations in the plasma<br>exposed to the test article and<br>that of the plasma exposed to<br>both the negative control article<br>and untreated control.<br>Based on the criteria of the<br>protocol, the test article meets<br>the requirements of the test,<br>and is not considered to have<br>activated the complement<br>system in human plasma. | Hemocompatible. |
| Effect:<br>Hemocompatibility<br>Test Name:<br>Platelet and Leukocyte<br>Binding Test (Direct<br>Contact) - ISO<br>Standard: ISO 10993-4 | The reduction of human<br>platelets and leukocytes were<br>studied to assess the ability of<br>the test and comparison article<br>to induce thrombus formation.<br>The test article, based on criteria<br>of the protocol, is not<br>considered to have an effect on<br>platelet and leukocyte<br>concentrations. | 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™.