(99 days)
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.
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".
The provided text describes the performance data for the Spartan Center Wire™ medical device, primarily focusing on bench testing, biocompatibility, sterilization, pyrogenicity, shelf life, and animal studies. However, it does not contain information about acceptance criteria or studies related to an AI/ML-driven device's performance in a diagnostic context, MRMC studies, or multi-reader studies. The device in question is a physical catheter guidewire, not a medical AI software.
Therefore, I cannot extract the requested information regarding acceptance criteria and performance of an AI/ML device from the provided text. The prompt asks for details that are not present in the document.
The document explicitly states: "No clinical testing was conducted." and "No torque device is needed or supplied with the Spartan Center Wire™." This reinforces that the evaluation is for a physical device, not an AI/ML software.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
| ☑ 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: 512-270-8501
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 FloppyGuidewire, Model 46-815 |
|---|---|
| The Spartan Center Wire™ is indicatedfor general intravascular use in theperipheral vasculature. It can bedeployed into the vessel to facilitate theselective placement of diagnostic ortherapeutic catheters.The device is not intended for use in thecoronary or neuro vasculature. | The Transend™ 300 ES Guidewire andTransend™ 300 Floppy Guidewire areintended for general intravascular use,including the neuro and peripheralvasculature. The guidewires can betorqued to facilitate the selectiveplacement of diagnostic or therapeuticcatheters. These devices are not intendedfor use in coronary arteries. A torquedevice (pin vise) is included to facilitatedirectional manipulation of theguidewires. |
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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 CenterWire™ | Transend™ 300FloppyGuidewire(K022357) | Solitaire™PlatinumRevascularizationDevice (K193576) |
|---|---|---|---|
| Diameter (wire) | 0.015" | 0.014" | 0.016" |
| Length | 350 cm | 300 cm | 180 cm |
| Distal MeshDiameter,Expanded | 4mm6mm | n/a (no distal mesh) | 4mm6mm |
| Distal MeshLength, Expanded | 15mm30mm | n/a (no distal mesh) | 20mm24mm40mm |
| Materials | Spartan CenterWire™ | Transend™ 300FloppyGuidewire(K022357) | Solitaire™ PlatinumRevascularizationDevice (K193576) |
|---|---|---|---|
| Pusher Wire | NiTi, SS | SS | NiTi |
| Marker Bands | Pt90/Ir10 | Pt | Pt90/Ir10 |
| Sheath | PET, Nylon12, PTFE | Polytetrafluoroethylene, polyurethane | PTFE/Grilamid |
| Coating | None. | Lubricious coating | None. |
| Distal Mesh | NiTi, 316 SS, Loctite3972 | None. | Nitinol |
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| Packaging | Spartan CenterWire™ | Transend™ 300FloppyGuidewire(K022357) | Solitaire™ PlatinumRevascularizationDevice (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 CenterWire™ | Transend™ 300FloppyGuidewire(K022357) | Solitaire™PlatinumRevascularizationDevice (K193576) |
|---|---|---|---|
| Torque Aid | None | Pin Vise | None |
| Sterilization | Spartan CenterWire™ | Transend™ 300FloppyGuidewire(K022357) | Solitaire™PlatinumRevascularizationDevice (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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Image /page/7/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 below the line is the text "MICRO, INC." in a smaller font size. The logo is simple and professional.
| Test | Test Method Summary | Results |
|---|---|---|
| Simulated Use Testing | The Spartan Center Wire™ wastested in a model representing achallenging use setting andevaluated against the predicate orreference device for:-Device introduction into themicrocatheter (compared withSolitaire Platinum)-Device Trackability (comparedwith Solitaire Platinum)-Device Deployment (comparedwith Solitaire Platinum)-Device Retraction (comparedwith Solitaire Platinum)-Device Stability During Exchange(compared to Transend 300Floppy)-Device Retrieval (compared toTransend 300 Floppy)-Device Integrity (compared toTransend 300 Floppy) | The Spartan CenterWire™ met therequirements for whichit was designed andtested. |
| Simulated Shipping andPackaging Testing | The Spartan Center Wire™ wasevaluated for packaging integrityand ability to withstand shippingand distribution. | The Spartan CenterWire™ met theacceptance criteria. |
| Dimensional Inspection | Dimensional properties of thesubject device were measuredand compared to devicespecifications. | The Spartan CenterWire™ met thedimensionalrequirements. |
| Visual Inspection | The subject device was visuallyinspected and compared toacceptance criteria. | The Spartan CenterWire™ met the visualinspectionrequirements. |
| Test | Test Method Summary | Results |
| Af Temperature | The Af temperature of thesubject device was measured. | The Spartan CenterWire™ met the Aftemperaturerequirements. |
| Chronic Outward Force | The Spartan Center Wire™chronic outward force wasmeasured at a minimum vesseldiameter. | The Spartan CenterWire™ met theacceptance criteria forChronic Outward Force. |
| Tensile Test | The Spartan Center Wire™ wasevaluated for tensile strengthperformance. | The Spartan CenterWire™ met theacceptance criteria fortensile strength. |
| Tip Pull | The Spartan Center Wire™ distaltip was evaluated for tensilestrength. | The Spartan CenterWire™ met theacceptance criteria fortip pull. |
| Corrosion Resistance | The Spartan Center Wire™ wasevaluated for corrosion per ISO11070. | The Spartan CenterWire™ met theacceptance criteria forcorrosion resistance. |
| Kink Resistance | The ability of the Spartan CenterWire™ to withstand bends wasmeasured at various pointsacross the guidewire length bybending around sequentiallysmaller mandrels. | The Spartan CenterWire™ met theacceptance criteria forkink resistance. |
| Torque Strength | The Spartan Center Wire™ wasevaluated for torsionalstrength during use in asimulated path model. | The Spartan CenterWire™ exhibitedacceptable torsionalstrength. |
| Test | Test Method Summary | Results |
| Particulate Evaluation | The Spartan Center Wire™ wasevaluated under simulated useconditions and compared withthe predicate device to supportsubstantial equivalence. | The Spartan CenterWire™ met theacceptance criteria forparticulate generationand was foundsubstantially equivalentto the predicate. |
| Flex Test | The Spartan Center Wire™ wasevaluated for resistance todamage by flexing per ISO 11070. | The Spartan CenterWire™ met theacceptance criteria. |
| Fracture Test | The Spartan Center Wire™ wasevaluated for guidewireresistance to fracture per ISO11070. | The Spartan CenterWire™ met theacceptance criteria. |
| Radiopacity | The visibility of the SpartanCenter Wire™ under fluoroscopywas compared to the predicatedevice. | The Spartan CenterWire™ met theacceptance criteria forradiopacity and wasfound substantiallyequivalent to thepredicate. |
| Test | Test Method Summary | Results |
| Effect: SensitizationTest Name: KligmanMaximization TestStandard: ISO 10993-10 | Spartan Center Wire™ elicitedno reaction at the challenge(0% sensitization), followingan induction phase. Therefore,as defined by the grading scaleof the USP, the test article isclassified as a non-sensitizer. | Non-sensitizer. |
| Effect: GenotoxicityTest Name: MouseLymphoma MutagenesisAssay with confirmationStandard: ISO 10993-3 | The IMF of Test Article for allconditions was less than theGEF of 126 × 10-6. Therefore,the test article meets therequirements of the test andis considered 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 coloniesas compared to the negativecontrols in both non-activatedand activated conditions. | Non-genotoxic. |
| Effect: CytotoxicityTest Name: L929 MEMelution TestStandard: ISO 10993-5 | The test article meets therequirements of the test andthere were no cultures treatedwith the test article showedgreater than a Mild reactivity(Grade 2). Therefore, the testarticle is considered asnoncytotoxic. | Non-cytotoxic. |
| Test | Test Method Summary | Results |
| Effect:Irritation/IntracutaneousReactivityTest Name:Intracutaneous InjectionTestStandard: ISO 10993-10 | The test article sites did notshow a significantly greaterbiological reaction than thesites injected with the controlarticle (mean score difference =0). Based on the criteria of theprotocol, the test article meetsthe requirements of the test. | Non-irritant. |
| Effect: Acute SystemicToxicityName:TestSystemicInjection TestStandard: ISO 10993-11 | The extracts of test article didnot induce a significantlygreater biological reaction thanthe control extracts following asingle dose to Albino Swissmice. Therefore, the testarticle meets the requirementsof the test. | No systemic toxicity. |
| Effect: PyrogenicityTest Name: RabbitPyrogen Test (MaterialMediated)Standard: ISO 10993-11Continuing Testing:Limulus AmebocyteLysate (LAL)Standard: USP <85> | The temperature increase forall the test animals was 0.0 °C.The increases did not exceedthe test limit for the maximumindividual temperature rise.The temperature increase ofthe control animal was 0.2 °C.Therefore, the test articlemeets the requirement of thetest and to be considerednonpyrogenic. | Non-pyrogenic |
| Effect:HemocompatibilityTest Name: Rabbit BloodHemolysis Test(Complete)Standard: ISO 10993-4 | For direct contact and indirectcontact testing, the Hemolysisabove negative were 0.20%and 0%, respectively. Both are< 5%. Therefore, the test articlemeets therequirements of the test and isconsidered non-hemolytic. | Non-hemolytic. |
| Test | Test Method Summary | Results |
| Effect:HemocompatibilityTest Name: SC5B-9Complement ActivationTest (Direct Contact)Standard: ISO 10993-4 | There was no statisticallysignificant increase foundbetween the SC5b-9concentrations in the plasmaexposed to the test article andthat of the plasma exposed toboth the negative controlarticle and untreated controlBased 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: DogThrombogenicityStandard: ISO 10993-4 | The test article implanted in 2dogs did not show significantthrombosis unlike the controlarticle. | Not Thrombogenic |
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Image /page/8/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 below the line is the text "MICRO, INC." in a smaller font size. The logo is simple and professional.
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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™.
§ 870.1330 Catheter guide wire.
(a)
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.(b)
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.