(99 days)
No
The device description and performance studies focus on the mechanical and material properties of a physical wire and mesh, with no mention of software, algorithms, or data processing related to AI/ML.
No
Explanation: The device description states that the Spartan Center Wire™ is a "stabilizing exchange wire designed for temporary assistance in catheter exchange." Its purpose is to facilitate the placement of other catheters, not to provide therapy itself. While it can facilitate the placement of therapeutic catheters, the device itself does not perform therapy.
No
The "Intended Use / Indications for Use" section states that the device is used to "facilitate the selective placement of diagnostic or therapeutic catheters," implying it assists in diagnostic procedures rather than performing the diagnosis itself. The "Device Description" also describes it as a "stabilizing exchange wire" for "temporary assistance in catheter exchange," not for diagnostic imaging or measurement.
No
The device description clearly details physical components like a tubular mesh tip, pusher wire, and radiopaque markers, and the performance studies include bench testing on physical properties and animal studies, indicating it is a hardware device.
Based on the provided information, the Spartan Center Wire™ is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's for "general intravascular use in the peripheral vasculature" to "facilitate the selective placement of diagnostic or therapeutic catheters." This describes a device used within the body for procedural assistance, not for testing samples outside the body to diagnose conditions.
- Device Description: The description details a physical wire with a mesh tip designed to be deployed into a blood vessel. This is consistent with an interventional medical device, not a diagnostic test kit or instrument.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information based on laboratory testing.
Therefore, the Spartan Center Wire™ is an interventional medical device, not an IVD.
N/A
Intended Use / Indications for 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.
Product codes
DQX
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".
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Bench Tests:
- Simulated Use Testing: Tested in a model representing a challenging use setting and evaluated against the predicate or reference device for device introduction into the microcatheter (compared with Solitaire Platinum), device trackability (compared with Solitaire Platinum), device deployment (compared with Solitaire Platinum), device retraction (compared with Solitaire Platinum), device stability during exchange (compared to Transend 300 Floppy), device retrieval (compared to Transend 300 Floppy), device integrity (compared to Transend 300 Floppy). Results: The Spartan Center Wire™ met the requirements for which it was designed and tested.
- Simulated Shipping and Packaging Testing: Evaluated for packaging integrity and ability to withstand shipping and distribution. Results: The Spartan Center Wire™ met the acceptance criteria.
- Dimensional Inspection: Dimensional properties of the subject device were measured and compared to device specifications. Results: The Spartan Center Wire™ met the dimensional requirements.
- Visual Inspection: The subject device was visually inspected and compared to acceptance criteria. Results: The Spartan Center Wire™ met the visual inspection requirements.
- Af Temperature: The Af temperature of the subject device was measured. Results: The Spartan Center Wire™ met the Af temperature requirements.
- Chronic Outward Force: The Spartan Center Wire™ chronic outward force was measured at a minimum vessel diameter. Results: The Spartan Center Wire™ met the acceptance criteria for Chronic Outward Force.
- Tensile Test: Evaluated for tensile strength performance. Results: The Spartan Center Wire™ met the acceptance criteria for tensile strength.
- Tip Pull: The distal tip was evaluated for tensile strength. Results: The Spartan Center Wire™ met the acceptance criteria for tip pull.
- Corrosion Resistance: Evaluated for corrosion per ISO 11070. Results: The Spartan Center Wire™ met the acceptance criteria for corrosion resistance.
- Kink Resistance: The ability to withstand bends was measured at various points across the guidewire length by bending around sequentially smaller mandrels. Results: The Spartan Center Wire™ met the acceptance criteria for kink resistance.
- Torque Strength: Evaluated for torsional strength during use in a simulated path model. Results: The Spartan Center Wire™ exhibited acceptable torsional strength.
- Particulate Evaluation: Evaluated under simulated use conditions and compared with the predicate device to support substantial equivalence. Results: The Spartan Center Wire™ met the acceptance criteria for particulate generation and was found substantially equivalent to the predicate.
- Flex Test: Evaluated for resistance to damage by flexing per ISO 11070. Results: The Spartan Center Wire™ met the acceptance criteria.
- Fracture Test: Evaluated for guidewire resistance to fracture per ISO 11070. Results: The Spartan Center Wire™ met the acceptance criteria.
- Radiopacity: The visibility of the Spartan Center Wire™ under fluoroscopy was compared to the predicate device. Results: The Spartan Center Wire™ met the acceptance criteria for radiopacity and was found substantially equivalent to the predicate.
Biocompatibility Tests: - Sensitization Test (Kligman Maximization Test, ISO 10993-10): Spartan Center Wire™ elicited no reaction at the challenge (0% sensitization). Results: Non-sensitizer.
- Genotoxicity Test (Mouse Lymphoma Mutagenesis Assay, ISO 10993-3): The IMF of Test Article for all conditions was less than the GEF of 126 × 10-6. Results: Non-mutagenic.
- Genotoxicity Test (Salmonella Typhimurium and Escherichia Coli Reverse Mutation Assay, ISO 10993-3): Neither of the test article extracts induced a statistically significant increase in the number of revertant colonies as compared to the negative controls. Results: Non-genotoxic.
- Cytotoxicity Test (L929 MEM elution Test, ISO 10993-5): No cultures treated with the test article showed greater than a Mild reactivity (Grade 2). Results: Non-cytotoxic.
- Irritation/Intracutaneous Reactivity Test (Intracutaneous Injection Test, 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). Results: Non-irritant.
- Acute Systemic Toxicity Test (Systemic Injection Test, ISO 10993-11): The extracts of test article did not induce a significantly greater biological reaction than the control extracts. Results: No systemic toxicity.
- Pyrogenicity Test (Rabbit Pyrogen Test and Limulus Amebocyte Lysate (LAL), ISO 10993-11 and USP ): The temperature increase for all the test animals was 0.0 °C and did not exceed the test limit. Results: Non-pyrogenic.
- Hemocompatibility Test (Rabbit Blood Hemolysis Test, ISO 10993-4): For direct and indirect contact testing, Hemolysis above negative were 0.20% and 0%, respectively (both
§ 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.
0
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
1
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
2
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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3
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 Floppy
Guidewire, Model 46-815 |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 Transend™ 300 ES Guidewire and
Transend™ 300 Floppy Guidewire are
intended for general intravascular use,
including the neuro and peripheral
vasculature. The guidewires can be
torqued to facilitate the selective
placement of diagnostic or therapeutic
catheters. These devices are not intended
for use in coronary arteries. A torque
device (pin vise) is included to facilitate
directional manipulation of the
guidewires. |
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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 below the line is the text "MICRO, INC." in a smaller font size. The logo is simple and professional.
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
Wire™ | Transend™ 300
Floppy
Guidewire
(K022357) | Solitaire™
Platinum
Revascularization
Device (K193576) |
|--------------------------------------|-------------------------|---------------------------------------------------|-----------------------------------------------------------------|
| Diameter (wire) | 0.015" | 0.014" | 0.016" |
| Length | 350 cm | 300 cm | 180 cm |
| Distal Mesh
Diameter,
Expanded | 4mm
6mm | n/a (no distal mesh) | 4mm
6mm |
| Distal Mesh
Length, Expanded | 15mm
30mm | n/a (no distal mesh) | 20mm
24mm
40mm |
| Materials | Spartan Center
Wire™ | Transend™ 300
Floppy
Guidewire
(K022357) | Solitaire™ Platinum
Revascularization
Device (K193576) |
|--------------|-------------------------------|---------------------------------------------------|--------------------------------------------------------------|
| Pusher Wire | NiTi, SS | SS | NiTi |
| Marker Bands | Pt90/Ir10 | Pt | Pt90/Ir10 |
| Sheath | PET, Nylon12, PTFE | Polytetrafluoroethy
lene, polyurethane | PTFE/Grilamid |
| Coating | None. | Lubricious coating | None. |
| Distal Mesh | NiTi, 316 SS, Loctite
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
Wire™ | Transend™ 300
Floppy
Guidewire
(K022357) | Solitaire™ Platinum
Revascularization
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
Wire™ | Transend™ 300
Floppy
Guidewire
(K022357) | Solitaire™
Platinum
Revascularization
Device (K193576) |
|-------------|-------------------------|---------------------------------------------------|-----------------------------------------------------------------|
| Torque Aid | None | Pin Vise | None |
| Sterilization | Spartan Center
Wire™ | Transend™ 300
Floppy
Guidewire
(K022357) | Solitaire™
Platinum
Revascularization
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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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™ was | |
| tested in a model representing a | ||
| challenging use setting and | ||
| evaluated against the predicate or | ||
| reference device for: | ||
| -Device introduction into the | ||
| microcatheter (compared with | ||
| Solitaire Platinum) | ||
| -Device Trackability (compared | ||
| with Solitaire Platinum) | ||
| -Device Deployment (compared | ||
| with Solitaire Platinum) | ||
| -Device Retraction (compared | ||
| with Solitaire Platinum) | ||
| -Device Stability During Exchange | ||
| (compared to Transend 300 | ||
| Floppy) | ||
| -Device Retrieval (compared to | ||
| Transend 300 Floppy) | ||
| -Device Integrity (compared to | ||
| Transend 300 Floppy) | The Spartan Center | |
| Wire™ met the | ||
| requirements for which | ||
| it was designed and | ||
| tested. | ||
| Simulated Shipping and | ||
| Packaging Testing | The Spartan Center Wire™ was | |
| evaluated for packaging integrity | ||
| and ability to withstand shipping | ||
| and distribution. | The Spartan Center | |
| Wire™ met the | ||
| acceptance criteria. | ||
| Dimensional Inspection | Dimensional properties of the | |
| subject device were measured | ||
| and compared to device | ||
| specifications. | The Spartan Center | |
| Wire™ met the | ||
| dimensional | ||
| requirements. | ||
| Visual Inspection | The subject device was visually | |
| inspected and compared to | ||
| acceptance criteria. | The Spartan Center | |
| Wire™ met the visual | ||
| inspection | ||
| requirements. | ||
| Test | Test Method Summary | Results |
| Af Temperature | The Af temperature of the | |
| subject device was measured. | The Spartan Center | |
| Wire™ met the Af | ||
| temperature | ||
| requirements. | ||
| Chronic Outward Force | The Spartan Center Wire™ | |
| chronic outward force was | ||
| measured at a minimum vessel | ||
| diameter. | The Spartan Center | |
| Wire™ met the | ||
| acceptance criteria for | ||
| Chronic Outward Force. | ||
| Tensile Test | The Spartan Center Wire™ was | |
| evaluated for tensile strength | ||
| performance. | The Spartan Center | |
| Wire™ met the | ||
| acceptance criteria for | ||
| tensile strength. | ||
| Tip Pull | The Spartan Center Wire™ distal | |
| tip was evaluated for tensile | ||
| strength. | The Spartan Center | |
| Wire™ met the | ||
| acceptance criteria for | ||
| tip pull. | ||
| Corrosion Resistance | The Spartan Center Wire™ was | |
| evaluated for corrosion per ISO |
-
| The Spartan Center
Wire™ met the
acceptance criteria for
corrosion resistance. |
| Kink Resistance | The ability of the Spartan Center
Wire™ to withstand bends was
measured at various points
across the guidewire length by
bending around sequentially
smaller mandrels. | The Spartan Center
Wire™ met the
acceptance criteria for
kink resistance. |
| Torque Strength | The Spartan Center Wire™ was
evaluated for torsional
strength during use in a
simulated path model. | The Spartan Center
Wire™ exhibited
acceptable torsional
strength. |
| Test | Test Method Summary | Results |
| Particulate Evaluation | The Spartan Center Wire™ was
evaluated under simulated use
conditions and compared with
the predicate device to support
substantial equivalence. | The Spartan Center
Wire™ met the
acceptance criteria for
particulate generation
and was found
substantially equivalent
to the predicate. |
| Flex Test | The Spartan Center Wire™ was
evaluated for resistance to
damage by flexing per ISO 11070. | The Spartan Center
Wire™ met the
acceptance criteria. |
| Fracture Test | The Spartan Center Wire™ was
evaluated for guidewire
resistance to fracture per ISO
11070. | The Spartan Center
Wire™ met the
acceptance criteria. |
| Radiopacity | The visibility of the Spartan
Center Wire™ under fluoroscopy
was compared to the predicate
device. | The Spartan Center
Wire™ met the
acceptance criteria for
radiopacity and was
found substantially
equivalent to the
predicate. |
| Test | Test Method Summary | Results |
| Effect: Sensitization
Test Name: Kligman
Maximization Test
Standard: ISO 10993-10 | Spartan Center Wire™ 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
Test Name: Mouse
Lymphoma Mutagenesis
Assay with confirmation
Standard: ISO 10993-3 | The IMF of Test Article for all
conditions was less than the
GEF of 126 × 10-6. Therefore,
the test article meets the
requirements of the test and
is considered non-mutagenic. | Non-mutagenic |
| Effect: Genotoxicity
Test Name: Salmonella
Typhimurium and
Escherichia Coli Reverse
Mutation Assay without
confirmation
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
Test Name: L929 MEM
elution Test
Standard: ISO 10993-5 | The test article meets the
requirements of the test and
there were no cultures treated
with the test article showed
greater than a Mild reactivity
(Grade 2). Therefore, the test
article is considered as
noncytotoxic. | Non-cytotoxic. |
| Test | Test Method Summary | Results |
| Effect:
Irritation/Intracutaneous
Reactivity
Test Name:
Intracutaneous Injection
Test
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
Toxicity
Name:
Test
Systemic
Injection Test
Standard: ISO 10993-11 | The extracts of test article did
not induce a significantly
greater biological reaction than
the control extracts following a
single dose to Albino Swiss
mice. Therefore, the test
article meets the requirements
of the test. | No systemic toxicity. |
| Effect: Pyrogenicity
Test Name: Rabbit
Pyrogen Test (Material
Mediated)
Standard: ISO 10993-11
Continuing Testing:
Limulus Amebocyte
Lysate (LAL)
Standard: USP | The temperature increase for
all the test animals was 0.0 °C.
The increases did not exceed
the test limit for the maximum
individual temperature rise.
The temperature increase of
the control animal was 0.2 °C.
Therefore, the test article
meets the requirement of the
test and to be considered
nonpyrogenic. | Non-pyrogenic |
| Effect:
Hemocompatibility
Test Name: Rabbit Blood
Hemolysis Test
(Complete)
Standard: ISO 10993-4 | For direct contact and indirect
contact testing, the Hemolysis
above negative were 0.20%
and 0%, respectively. Both are