Spartan MC 0165

K213451 · Spartan Micro · QJP · Nov 22, 2021 · Cardiovascular

Device Facts

• Record ID: K213451
• Device Name: Spartan MC 0165
• Applicant: Spartan Micro
• Product Code: QJP · Cardiovascular
• Decision Date: Nov 22, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Spartan MC 0165™ is intended for the introduction of interventional devices or infusion of diagnostic agents into the neuro, peripheral and coronary vasculatures.

Device Story

Spartan MC 0165 is a sterile, single-use microcatheter; features 0.0165" ID single lumen; variable stiffness composite body; 2 radiopaque distal marker bands for fluoroscopic visualization. Includes stainless steel shaping mandrel for distal tip customization. Used by physicians in clinical settings for neuro, peripheral, and coronary vascular interventions. Operates via manual insertion over guidewire (max 0.014" OD) to deliver interventional devices or diagnostic agents. Luer connector at proximal end facilitates infusion. Provides trackability and stability during procedures. Benefits patient by enabling targeted delivery of diagnostic agents or interventional tools to specific vascular sites.

Clinical Evidence

No clinical data. Substantial equivalence supported by extensive non-clinical bench testing, including coating lubricity, hub functionality (ISO 594), torque/tensile strength, air aspiration, liquid leak, particulate/coating integrity, tip shapeability, stiffness, kink resistance, radiopacity, corrosion, burst pressure, and design validation in simulated use models. Biocompatibility testing (ISO 10993) confirmed non-sensitizing, non-mutagenic, non-genotoxic, non-cytotoxic, non-irritant, non-pyrogenic, and hemocompatible status.

Technological Characteristics

Microcatheter; 0.0165" ID; 0.031" proximal OD; 158 cm length. Materials: PTFE, Pebax, Grilamid, Nitinol braid reinforcement, Pt/Ir marker bands, polypropylene hub, liquid silicone rubber strain relief. Hydrophilic coating on distal 120cm. Steam-shapeable tip. Sterilized via Ethylene Oxide (ISO 11135). Connectivity: None (manual).

Indications for Use

Indicated for patients requiring introduction of interventional devices or infusion of diagnostic agents into neuro, peripheral, and coronary vasculatures.

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

• Phenom Catheters (K151638)

Submission Summary (Full Text)

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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 ([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) 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: [phone]

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™<br>(K213451) | Phenom™ Catheter (17)<br>(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™<br>(K213451) | Phenom™ Catheter (17)<br>(K151638) |
|-----------------|--------------------------------------------------------------------|------------------------------------|
| Shaft Materials | PTFE, Polyether block<br>amide (Pebax) and<br>Polyamide (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™<br>(K213451) | Phenom™ Catheter (17)<br>(K151638) |
|---------------------|-------------------------------|-----------------------------------------------------------------|
| Strain Relief | Liquid Silicone Rubber | Thermoplastic elastomer |
| Shaft Reinforcement | Nitinol braid | Metallic (Stainless Steel) reinforced |
| Marker Band | Radiopaque marker band | same |
| Tip Markers | Radiopaque Pt/Ir | radiopaque |
| Tip Shaping | Steam shapeable straight tip | Steam shapeable straight tip, and<br>Pre-shaped 45°, 90°, and J |
| Coating | Distal 120cm hydrophilic | Distal 100cm hydrophilic |
| Packaging | Spartan MC 0165™<br>(K213451) | Phenom™ Catheter (17)<br>(K151638) |
| Pouch Material | PET/Tyvek | PET/Tyvek |
| Pouch Dimensions | 10"x10.5" | 11" x 12" |
| Carton | Cardboard | Cardboard, solid bleach<br>sulfate |

| Accessories | Spartan MC 0165™<br>(K213451) | Phenom™ Catheter (17)<br>(K151638) |
|-------------------|-------------------------------|------------------------------------|
| Shaping Mandrel | Yes | same |
| Introducer Sheath | No | No |

| Sterilization | Spartan MC 0165™<br>(K213451) | Phenom™ Catheter (17)<br>(K151638) |
|---------------|-------------------------------|------------------------------------|
| Method | Ethylene Oxide (EO) | same |
| Shelf Life | 1 year | 36 Months |

The differences in technological characteristics do not raise new questions of safety and effectiveness.

### VII. PERFORMANCE DATA

### Performance Data – Bench:

The following non-clinical bench testing was performed to evaluate the performance of the Spartan MC 0165™ . The passing result of the testing supports the substantial equivalence to the predicate device.

| Test | Test Method Summary | Results |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Coating Lubricity (Friction Force) | The Spartan MC 0165™ and the predicate device were evaluated for coating lubricity | The Spartan MC 0165™ was found to have acceptable friction force under |
| Test | Test Method Summary | Results |
| | under simulated use conditions. | simulated use conditions<br>similar to the predicate<br>device. |
| Hub Functional &<br>Dimensional | The Spartan MC 0165™ was<br>evaluated per ISO 594-1:1986-<br>06-15 First edition and ISO<br>594-2:1998-09-01 Second<br>edition. | The Spartan MC 0165™ met<br>the acceptance criteria for<br>hub functional and<br>dimensional requirements. |
| Torque Strength | The Spartan MC 0165™ was<br>evaluated for torsional<br>strength during use in a<br>simulated path model. | The Spartan MC 0165™<br>exhibited acceptable<br>torsional strength similar to<br>the predicate device. |
| Tensile | The Spartan MC 0165™ was<br>evaluated per ISO 10555-<br>1:2013 Annex B. | The Spartan MC 0165™ met<br>the acceptance criteria for<br>tensile strength. |
| Air Aspiration | The Spartan MC 0165™ was<br>tested for air leakage into the<br>hub during aspiration per ISO<br>10555-1:2013(E) Annex D. | The Spartan MC 0165™ met<br>the acceptance criteria for<br>air aspiration. |
| Liquid Leak | The Spartan MC 0165™ was<br>tested per ISO 10555-<br>1:2013(E) Annex C. | The Spartan MC 0165™ met<br>the acceptance criteria for<br>liquid leakage. |
| Particulate and<br>Coating Integrity | The Spartan MC 0165™ was<br>evaluated under simulated<br>use conditions and compared<br>with the predicate device to<br>support substantial<br>equivalence. The coating<br>integrity was also visually<br>examined after testing. | The Spartan MC 0165™ met<br>the acceptance criteria for<br>particulate generation and<br>coating integrity, and was<br>found substantially<br>equivalent to the predicate. |
| Tip Shape | The Spartan MC 0165™ was<br>evaluated for its ability to<br>retain steam shaped tip<br>shape and results compared<br>to the predicate device. | The Spartan MC 0165™ met<br>the acceptance criteria for<br>tip shapeability and was<br>found substantially<br>equivalent to the predicate. |
| Stiffness | A stiffness profile across the<br>catheter length was measured<br>and compared to the<br>predicate device's stiffness<br>profile. | The Spartan MC 0165™ met<br>the acceptance criteria for<br>catheter stiffness and was<br>found substantially<br>equivalent to the predicate. |
| Kink Resistance | The ability of the Spartan MC<br>0165™ to withstand bends | The Spartan MC 0165™ met<br>the acceptance criteria for |
| Test | Test Method Summary | Results |
| | was measured at various<br>points across the catheter<br>length by bending the<br>catheter shaft around<br>sequentially smaller mandrels.<br>Results were compared to test<br>results from the predicate. | kink resistance and was<br>found substantially<br>equivalent to the predicate. |
| Radiopacity | The visibility of the Spartan<br>MC 0165™ under fluoroscopy<br>was compared to the<br>predicate device. | The Spartan MC 0165™ met<br>the acceptance criteria for<br>radiopacity and was found<br>substantially equivalent to<br>the predicate. |
| Corrosion | The Spartan MC 0165™ was<br>evaluated for corrosion per<br>ISO 10555-1:2013(E) Annex A. | The Spartan MC 0165™ met<br>the acceptance criteria for<br>corrosion resistance. |
| Static Burst Pressure | The Spartan MC 0165™ was<br>tested to evaluate the burst<br>pressure under static<br>conditions per ISO 10555-<br>1:2013(E) Annex F. | The Spartan MC 0165™ met<br>the acceptance criteria for<br>static burst pressure. |
| Torque Response | The Spartan MC 0165™ was<br>tested for its response to<br>torque forces and results<br>compared to the predicate<br>device. | The Spartan MC 0165™ met<br>the acceptance criteria for<br>torque response and was<br>found substantially<br>equivalent to the predicate. |
| Buckling | The Spartan MC 0165™ was<br>evaluated for its resistance to<br>buckling and tip deflection<br>properties and compared to<br>the predicate device. | The Spartan MC 0165™ met<br>the acceptance criteria for<br>tip deflection and buckling,<br>and was found substantially<br>equivalent to the predicate. |
| Design Validation | The Spartan MC 0165™ was<br>tested in a model representing<br>a challenging use setting and<br>evaluated against the<br>predicate device for<br>interventional device<br>introduction, trackability,<br>interaction with embolic coil,<br>stability, guidewire<br>interaction, and overall device<br>integrity. | The Spartan MC 0165™ met<br>the requirements for which<br>it was 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 MC 0165™ met<br>the dimensional<br>requirements. |
| Visual Inspection | The subject device was<br>visually inspected and<br>compared to acceptance<br>criteria. | The Spartan MC 0165™ met<br>the visual inspection<br>requirements. |
| Dead Space Volume | The dead space volume was<br>calculated following a dead<br>space evaluation protocol. | The Spartan MC 0165™<br>dead space volume was<br>measured. The dead space<br>volume is reported in the<br>labeling. |
| Pressure Flow Testing<br>with Contrast Media | Flow pressure calculations<br>were conducted following a<br>protocol for 100% saline, 50%<br>saline - 50% contrast media,<br>and 100% contrast media<br>solutions. | The Spartan MC 0165™TM pressure-flow performance<br>was evaluated. Flow rates<br>and pressures of various<br>saline and contrast media<br>solutions are reported in the<br>labeling. |
| Test | Test Method Summary | Results |
| Effect: Sensitization<br>Test Name: Kligman<br>Maximization Test<br>Standard: ISO 10993-10 | Spartan MC 0165 elicited no reaction at the challenge (0% sensitization), following an induction phase. Therefore, as defined by the grading scale of the USP, the test article is classified as a non-sensitizer. | Non-sensitizer. |
| Effect: Genotoxicity<br>Test Name: Mouse<br>Lymphoma Mutagenesis<br>Assay with confirmation<br>Standard: ISO 10993-3 | The IMF of Test Article for all conditions was less than the GEF of $126 \times 10^{-6}$ . Therefore, the test article meets the requirements of the test and is considered non-mutagenic. | Non-mutagenic. |
| Effect: Genotoxicity<br>Test Name: Salmonella<br>Typhimurium and<br>Escherichia Coli Reverse<br>Mutation Assay<br>without Confirmation<br>Standard: ISO 10993-3 | The results of primary assay (plate incorporation) showed that neither of the test article extracts induced a statistically significant increase in the number of revertant colonies as compared to the negative controls in both non-activated and activated conditions. | Non-genotoxic. |
| Effect: Cytotoxicity<br>Test Name: L929<br>MEM Elution Test<br>Standard: ISO 10993-5 | The test article meets the requirements of the test and there were no cultures treated with the test article that showed greater than a Mild reactivity (Grade 2). Therefore, the test article is considered non-cytotoxic. | Non-cytotoxic. |
| Effect:<br>Irritation/Intracutaneous<br>Reactivity<br>Test Name:<br>Intracutaneous Injection<br>Test<br>Standard: ISO 10993-10 | The test article sites did not show a significantly greater biological reaction than the sites injected with the control article (mean score difference = 0). Based on the criteria of the protocol, the test article meets the requirements of the test | Non-irritant. |
| | | |
| Effect: Acute Systemic<br>Toxicity<br>Test Name: Systemic<br>Injection Test<br>Standard: ISO 10993-11 | The extracts of test article did<br>not induce a significantly<br>greater biological reaction<br>than the control extracts<br>following a single dose to<br>Albino Swiss mice. Therefore,<br>the test article meets the<br>requirements of the test. | No systemic toxicity. |
| 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: USP <85> | The temperature increase for<br>all the test animals was 0.0 °C.<br>The increases did not exceed<br>the test limit for the maximum<br>individual temperature rise.<br>The temperature increase of<br>the control animal was 0.0 °C.<br>Therefore, the test article<br>meets the requirement of the<br>test and is considered non-<br>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 0.13%<br>and 0%, respectively, both are<br>< 5%. Therefore, the test<br>article meets the<br>requirements of the test and<br>is considered non-hemolytic. | Non-hemolytic. |
| Effect:<br>Hemocompatibility<br>Test Name: Unactivated<br>Partial Thromboplastin<br>Time Test (Direct<br>Contact)<br>Standard: ISO 10993-4 | There was no statistically<br>significant decrease found<br>between the Unactivated<br>Partial Thromboplastin Time<br>(UPTT) of the plasma exposed<br>to the test article and that of<br>the plasma exposed to both<br>the negative control article<br>and the untreated control.<br>Based on the criteria of the<br>protocol, the test article<br>meets the requirements of the<br>test, and is not considered to<br>have an effect on coagulation<br>of human plasma via<br>measurement of the UPTT. | Hemocompatible. |
| 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<br>article and untreated control.<br>Based on the criteria of the<br>protocol, the test article<br>meets the requirements of the<br>test, and is not considered to<br>have activated the<br>complement system in human<br>plasma. | Hemocompatible. |
| Effect:<br>Hemocompatibility<br>Test Name: In Vitro Blood<br>Flow Loop<br>Standard: ISO 10993-4 | An in-vitro Blood Flow Loop<br>Assay study was performed<br>using both the subject device<br>and predicate to evaluate<br>their thrombogenic potential.<br>All devices tested received a<br>Thrombus Formation Score of<br>zero which means Minimal to<br>nonexistent thrombus<br>formation (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™.