Spartan Center Wire

K220075 · Spartan Micro, Inc. · DQX · Apr 19, 2022 · Cardiovascular

Device Facts

• Record ID: K220075
• Device Name: Spartan Center Wire
• Applicant: Spartan Micro, Inc.
• Product Code: DQX · Cardiovascular
• Decision Date: Apr 19, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The Spartan Center Wire™ is indicated for general intravascular use in the peripheral vasculature. It can be deployed into the vessel to facilitate the selective placement of diagnostic or therapeutic catheters. The device is not intended for use in the coronary or neuro vasculature.

Device Story

The Spartan Center Wire™ is a stabilizing exchange wire used in peripheral vascular procedures to facilitate catheter exchange. It consists of a 0.015" pusher wire (350 cm length) with a distal self-expanding tubular mesh that conforms to the vessel wall upon deployment from an introducer sheath. The device features radiopaque markers (3 distal, 1 proximal) for fluoroscopic visualization. It is operated by a physician in a clinical setting. The mesh provides stability, preventing wire displacement during catheter exchanges or re-positioning. By maintaining wire position, the device simplifies the exchange of diagnostic or therapeutic catheters, potentially reducing procedure time and improving clinical efficiency.

Clinical Evidence

No clinical testing was conducted. Substantial equivalence was supported by non-clinical bench testing, including simulated use, dimensional inspection, tensile/torque strength, kink resistance, particulate evaluation, and biocompatibility (ISO 10993). Animal testing in a live porcine model was also performed to demonstrate performance equivalence.

Technological Characteristics

Materials: NiTi, 316 SS, Pt90/Ir10 marker bands, PET/Nylon12/PTFE sheath. Sensing/Actuation: Mechanical self-expanding mesh. Dimensions: 0.015" diameter, 350 cm length, 4mm/6mm mesh diameters. Connectivity: None. Sterilization: Ethylene Oxide (EO) per ISO 11135:2014. Software: None.

Indications for Use

Indicated for general intravascular use in the peripheral vasculature to facilitate selective placement of diagnostic or therapeutic catheters. Not for use in coronary or neuro vasculature.

Regulatory Classification

Identification

A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.

Special Controls

*Classification.* Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

Predicate Devices

• Transend™ 300 Floppy Guidewire, Model 46-815 (K022357)

Reference Devices

• Solitaire™ Platinum Revascularization Device (K193576)

Submission Summary (Full Text)

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April 19, 2022

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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Spartan Micro, Inc. Gary Avedovech Senior Director Quality and Compliance 3184 Airway Ave, Suite C Costa Mesa, California 92626

# Re: K220075

Trade/Device Name: Spartan Center Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: March 15, 2022 Received: March 21, 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 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,

for Lydia Glaw Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular 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) K220075

Device Name Spartan Center Wire™M

Indications for Use (Describe)

The Spartan Center Wire™ is indicated for general intravascular use in the peripheral vasculature. It can be deployed into the vessel to facilitate the selective placement of diagnostic or therapeutic catheters.

The device is not intended for use in the coronary or neuro vasculature.

Type of Use (Select one or both, as applicable)

| <span style="font-size:10px">☑</span> 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 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".

# 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.

3184 Airway Ave, Suite C Costa Mesa, CA 92626 Phone: [phone]

Contact Person: Gary Avedovech

Date Prepared: April 18, 2022

### II. DEVICE

Device Name: Spartan Center Wire™ Common Name: Catheter Guide Wire Regulatory Class: II Product Code: DQX Regulation Description: Catheter Guide Wire Regulation Number: 21 CFR 870.1330 Review Panel: Cardiovascular

### III. PREDICATE DEVICE

Name: Transend™ 300 Floppy Guidewire, Model 46-815 510(k) Number: K022357 Manufacturer: Boston Scientific, Target

This predicate has not been subject to a design-related recall.

Reference Device: Solitaire™ Platinum Revascularization Device 510(k) Number: K193576 Product Codes: POL, NRY

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Regulation: 882.5600 Regulation Name: Neurovascular Mechanical Thrombectomy Device for Acute Ischemic Stroke Treatment

#### IV. DEVICE DESCRIPTION

The Spartan Center Wire™ is a stabilizing exchange wire designed for temporary assistance in catheter exchange. The device is comprised of a tubular mesh tip attached to a pusher wire of adequate length to accommodate the exchanging of catheters commonly used for access, stabilization, or aspiration. The pusher wire diameter is 0.015" (0.38 mm) with length 350 cm to allow for the exchange of therapeutic devices without the use of extension wires or other exchange devices. The distal end is a permanently attached self-expanding mesh that is deployed out of an introducer sheath and into the vessel where it conforms to the vessel wall. There are 3 distal radiopaque markers and 1 proximal radiopaque marker visible under fluoroscopy. The deployed and stable mesh ensures that the wire is not displaced from the desired position and can be advantageously utilized in multiple exchanges or re-positioning of catheters. The Spartan Center Wire™ is offered in 2 available sizes to accommodate common vascular sizing. There is a 4 mm diameter basket with 15 mm useable length and a 6 mm basket with 30 mm useable length. Both sizes are compatible with catheters that have a minimum I.D. of 0.027".

### V. INDICATIONS FOR USE

| Spartan Center Wire™ | Predicate K022357 Transend™ 300 Floppy<br>Guidewire, Model 46-815 |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| The Spartan Center Wire™ is indicated<br>for general intravascular use in the<br>peripheral vasculature. It can be<br>deployed into the vessel to facilitate the<br>selective placement of diagnostic or<br>therapeutic catheters.<br>The device is not intended for use in the<br>coronary or neuro vasculature. | The Transend™ 300 ES Guidewire and<br>Transend™ 300 Floppy Guidewire are<br>intended for general intravascular use,<br>including the neuro and peripheral<br>vasculature. The guidewires can be<br>torqued to facilitate the selective<br>placement of diagnostic or therapeutic<br>catheters. These devices are not intended<br>for use in coronary arteries. A torque<br>device (pin vise) is included to facilitate<br>directional manipulation of the<br>guidewires. |

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The Spartan Center Wire™ is indicated for use in the peripheral vasculature while the Transend™ 300 Floppy Guidewire is for use in the peripheral and neuro vasculature.

No torque device is needed or supplied with the Spartan Center Wire™.

# VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE AND REFERENCE DEVICE

| Dimensions | Spartan Center<br>Wire™ | Transend™ 300<br>Floppy<br>Guidewire<br>(K022357) | Solitaire™<br>Platinum<br>Revascularization<br>Device (K193576) |
|--------------------------------------|-------------------------|---------------------------------------------------|-----------------------------------------------------------------|
| Diameter (wire) | 0.015" | 0.014" | 0.016" |
| Length | 350 cm | 300 cm | 180 cm |
| Distal Mesh<br>Diameter,<br>Expanded | 4mm<br>6mm | n/a (no distal mesh) | 4mm<br>6mm |
| Distal Mesh<br>Length, Expanded | 15mm<br>30mm | n/a (no distal mesh) | 20mm<br>24mm<br>40mm |

| Materials | Spartan Center<br>Wire™ | Transend™ 300<br>Floppy<br>Guidewire<br>(K022357) | Solitaire™ Platinum<br>Revascularization<br>Device (K193576) |
|--------------|-------------------------------|---------------------------------------------------|--------------------------------------------------------------|
| Pusher Wire | NiTi, SS | SS | NiTi |
| Marker Bands | Pt90/Ir10 | Pt | Pt90/Ir10 |
| Sheath | PET, Nylon12, PTFE | Polytetrafluoroethy<br>lene, polyurethane | PTFE/Grilamid |
| Coating | None. | Lubricious coating | None. |
| Distal Mesh | NiTi, 316 SS, Loctite<br>3972 | None. | Nitinol |

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Image /page/6/Picture/1 description: The image shows the logo for Spartan Micro, Inc. The word "SPARTAN" is written in large, bold, sans-serif letters. A horizontal line is underneath the word "SPARTAN", and the words "MICRO, INC." are written in smaller letters to the right of the line. The logo is simple and professional.

| Packaging | Spartan Center<br>Wire™ | Transend™ 300<br>Floppy<br>Guidewire<br>(K022357) | Solitaire™ Platinum<br>Revascularization<br>Device (K193576) |
|------------------|-------------------------|---------------------------------------------------|--------------------------------------------------------------|
| Pouch Material | PET/Tyvek | Not Listed | Not Listed |
| Pouch Dimensions | 10"x10.5" | Not Listed | Not Listed |
| Carton | Cardboard | Not Listed | Not Listed |

| Accessories | Spartan Center<br>Wire™ | Transend™ 300<br>Floppy<br>Guidewire<br>(K022357) | Solitaire™<br>Platinum<br>Revascularization<br>Device (K193576) |
|-------------|-------------------------|---------------------------------------------------|-----------------------------------------------------------------|
| Torque Aid | None | Pin Vise | None |

| Sterilization | Spartan Center<br>Wire™ | Transend™ 300<br>Floppy<br>Guidewire<br>(K022357) | Solitaire™<br>Platinum<br>Revascularization<br>Device (K193576) |
|---------------|-------------------------|---------------------------------------------------|-----------------------------------------------------------------|
| Method | Ethylene Oxide (EO) | Ethylene Oxide (EO) | Ethylene Oxide (EO) |
| Shelf Life | 1 year | Not Listed | Not Listed |

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 Center Wire™. The passing result of the testing supports the substantial equivalence to the predicate device.

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| Test | Test Method Summary | Results |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Simulated Use Testing | The Spartan Center Wire™ was<br>tested in a model representing a<br>challenging use setting and<br>evaluated against the predicate or<br>reference device for:<br>-Device introduction into the<br>microcatheter (compared with<br>Solitaire Platinum)<br>-Device Trackability (compared<br>with Solitaire Platinum)<br>-Device Deployment (compared<br>with Solitaire Platinum)<br>-Device Retraction (compared<br>with Solitaire Platinum)<br>-Device Stability During Exchange<br>(compared to Transend 300<br>Floppy)<br>-Device Retrieval (compared to<br>Transend 300 Floppy)<br>-Device Integrity (compared to<br>Transend 300 Floppy) | The Spartan Center<br>Wire™ met the<br>requirements for which<br>it was designed and<br>tested. |
| Simulated Shipping and<br>Packaging Testing | The Spartan Center Wire™ was<br>evaluated for packaging integrity<br>and ability to withstand shipping<br>and distribution. | The Spartan Center<br>Wire™ met the<br>acceptance criteria. |
| Dimensional Inspection | Dimensional properties of the<br>subject device were measured<br>and compared to device<br>specifications. | The Spartan Center<br>Wire™ met the<br>dimensional<br>requirements. |
| Visual Inspection | The subject device was visually<br>inspected and compared to<br>acceptance criteria. | The Spartan Center<br>Wire™ met the visual<br>inspection<br>requirements. |
| Test | Test Method Summary | Results |
| Af Temperature | The Af temperature of the<br>subject device was measured. | The Spartan Center<br>Wire™ met the Af<br>temperature<br>requirements. |
| Chronic Outward Force | The Spartan Center Wire™<br>chronic outward force was<br>measured at a minimum vessel<br>diameter. | The Spartan Center<br>Wire™ met the<br>acceptance criteria for<br>Chronic Outward Force. |
| Tensile Test | The Spartan Center Wire™ was<br>evaluated for tensile strength<br>performance. | The Spartan Center<br>Wire™ met the<br>acceptance criteria for<br>tensile strength. |
| Tip Pull | The Spartan Center Wire™ distal<br>tip was evaluated for tensile<br>strength. | The Spartan Center<br>Wire™ met the<br>acceptance criteria for<br>tip pull. |
| Corrosion Resistance | The Spartan Center Wire™ was<br>evaluated for corrosion per ISO<br>11070. | The Spartan Center<br>Wire™ met the<br>acceptance criteria for<br>corrosion resistance. |
| Kink Resistance | The ability of the Spartan Center<br>Wire™ to withstand bends was<br>measured at various points<br>across the guidewire length by<br>bending around sequentially<br>smaller mandrels. | The Spartan Center<br>Wire™ met the<br>acceptance criteria for<br>kink resistance. |
| Torque Strength | The Spartan Center Wire™ was<br>evaluated for torsional<br>strength during use in a<br>simulated path model. | The Spartan Center<br>Wire™ exhibited<br>acceptable torsional<br>strength. |
| Test | Test Method Summary | Results |
| Particulate Evaluation | The Spartan Center Wire™ was<br>evaluated under simulated use<br>conditions and compared with<br>the predicate device to support<br>substantial equivalence. | The Spartan Center<br>Wire™ met the<br>acceptance criteria for<br>particulate generation<br>and was found<br>substantially equivalent<br>to the predicate. |
| Flex Test | The Spartan Center Wire™ was<br>evaluated for resistance to<br>damage by flexing per ISO 11070. | The Spartan Center<br>Wire™ met the<br>acceptance criteria. |
| Fracture Test | The Spartan Center Wire™ was<br>evaluated for guidewire<br>resistance to fracture per ISO<br>11070. | The Spartan Center<br>Wire™ met the<br>acceptance criteria. |
| Radiopacity | The visibility of the Spartan<br>Center Wire™ under fluoroscopy<br>was compared to the predicate<br>device. | The Spartan Center<br>Wire™ met the<br>acceptance criteria for<br>radiopacity and was<br>found substantially<br>equivalent to the<br>predicate. |
| Test | Test Method Summary | Results |
| Effect: Sensitization<br>Test Name: Kligman<br>Maximization Test<br>Standard: ISO 10993-10 | Spartan Center Wire™ elicited<br>no reaction at the challenge<br>(0% sensitization), following<br>an induction phase. Therefore,<br>as defined by the grading scale<br>of the USP, the test article is<br>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<br>conditions was less than the<br>GEF of 126 × 10-6. Therefore,<br>the test article meets the<br>requirements of the test and<br>is 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<br>as 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 | The test article meets the<br>requirements of the test and<br>there were no cultures treated<br>with the test article showed<br>greater than a Mild reactivity<br>(Grade 2). Therefore, the test<br>article is considered as<br>noncytotoxic. | Non-cytotoxic. |
| Test | Test Method Summary | Results |
| 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<br>sites injected with the control<br>article (mean score difference =<br>0). 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>Test<br>Systemic<br>Injection Test<br>Standard: ISO 10993-11 | The extracts of test article did<br>not induce a significantly<br>greater biological reaction than<br>the control extracts following a<br>single dose to Albino Swiss<br>mice. Therefore, the test<br>article meets the requirements<br>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 0.2 °C.<br>Therefore, the test article<br>meets the requirement of the<br>test and to be considered<br>nonpyrogenic. | 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 0.20%<br>and 0%, respectively. Both are<br>< 5%. Therefore, the test article<br>meets the<br>requirements of the test and is<br>considered non-hemolytic. | Non-hemolytic. |
| Test | Test Method Summary | Results |
| 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 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: Dog<br>Thrombogenicity<br>Standard: ISO 10993-4 | The test article implanted in 2<br>dogs did not show significant<br>thrombosis unlike the control<br>article. | Not Thrombogenic |

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### Biocompatibility

The biocompatibility evaluation for the Spartan Center Wire™ was conducted in accordance with the FDA guidance, "Use of International Standard ISO10993, '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 Center Wire™.

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Spartan Center Wire™ Premarket Notification 510(k) K220075

Image /page/13/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." in a smaller font size. The logo is simple and professional.

### 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 nonendotoxin 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 (60 °C, 27 days) to achieve the 1year equivalent in accelerated aging. The packaged devices were also subjected to simulated shipping and then tested thoroughly to ensure they remain as safe and effective as the predicate device after at least 1 year.

#### Performance Data – Animal

The substantial equivalence of the Spartan Center Wire™ was demonstrated through use in a live porcine model. A comparison side by side with the predicate device and reference device support that the Spartan Center Wire™ is substantially equivalent.

#### 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 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 Center Wire™.