(55 days)
No
The device description and performance studies focus on the physical properties and performance of a support catheter, with no mention of AI or ML capabilities.
No
The device is a support catheter used to introduce other interventional devices, rather than directly treating a condition itself.
No
This device is described as a support catheter whose intended use is to introduce interventional devices into the vasculature. Its function is to facilitate other procedures, not to diagnose a condition.
No
The device description clearly outlines a physical catheter with a Nitinol structure, radiopaque marker band, and hydrophilic coating. The performance studies focus on bench testing of physical properties and biocompatibility, not software validation.
Based on the provided information, the Spartan SC 069™ is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the introduction of interventional devices into the peripheral and neuro vasculature. This describes a device used within the body for a procedural purpose, not for testing samples outside the body to diagnose a condition.
- Device Description: The description details a physical catheter designed for insertion into blood vessels. This aligns with an interventional medical device, not a diagnostic test.
- Lack of Diagnostic Testing: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health status. The performance data focuses on the physical and functional characteristics of the catheter itself.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The Spartan SC 069™ does not fit this definition.
N/A
Intended Use / Indications for Use
The Spartan SC 069TM is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.
Product codes (comma separated list FDA assigned to the subject device)
DQY, QJP
Device Description
The Spartan SC 069™ is a support catheter designed for the introduction of interventional devices into the peripheral and neuro vasculature. The SC 069™ is a single lumen, flexible, variable stiffness composite catheter with a Nitinol structure. A radiopaque marker band on the distal tip of the device is used for visualization under fluoroscopy. The distal section of the catheter is coated with a hydrophilic coating to reduce the overall frictional force during intravascular use. The device is supplied sterile and intended for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopy
Anatomical Site
Peripheral and neuro 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Data – Bench:
The following non-clinical bench testing was performed to evaluate the performance of the Spartan SC 069™. The passing result of the testing supports the substantial equivalence to the predicate.
Tests performed: Coating Lubricity (Friction Force), Hub Functional & Dimensional, Torque Strength, Tensile, Air Aspiration, Liquid Leak, Particulate and Coating Integrity, Stiffness, Kink Resistance, Radiopacity, Corrosion, Static Burst Pressure, Buckling, Design Validation, Dimensional Testing, Visual Inspection, Dead Space Volume, Pressure Flow Testing with Contrast Media.
Results: All tests met acceptance criteria and demonstrated substantial equivalence to the predicate where applicable.
BioCompatibility:
Tests for the following biocompatibility endpoints were performed on the Spartan SC 069™: Sensitization (Guinea Pig Maximization Test), Genotoxicity (Mouse Lymphoma Mutagenesis Assay, Salmonella Typhimurium and Escherichia Coli Reverse Mutation Assay), Cytotoxicity (L929 MEM Elution Test), Irritation/Intracutaneous Reactivity (Intracutaneous Injection Test), Acute Systemic Toxicity (Systemic Injection Test), Pyrogenicity (Rabbit Pyrogen Test, Limulus Amebocyte Lysate (LAL)), Hemocompatibility (Rabbit Blood Hemolysis Test, Partial Thromboplastin Time Test, SC5B-9 Complement Activation Test, Platelet and Leukocyte Binding Test).
Results: All tests passed and demonstrated non-sensitizer, non-mutagenic, non-genotoxic, non-cytotoxic, non-irritant, no systemic toxicity, non-pyrogenic, non-hemolytic, and hemocompatible properties.
Sterilization: EO sterilization validation testing performed with reference to ISO 11135:2014, following the overkill (half cycle) approach to a Sterility Assurance Level of 10-6.
Pyrogenicity: Tests for pyrogens and endotoxins performed, yielding acceptable levels.
Shelf Life: Accelerated aging equivalent to 2-year real time performed (55 °C, 75 days). Packaged devices subjected to simulated shipping and remained safe and effective after at least 2 years.
Performance Data – Animal: No animal testing was conducted.
Performance Data - Clinical: No clinical testing was conducted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.1250 Percutaneous catheter.
(a)
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.(b)
Classification. Class II (performance standards).
0
May 5, 2022
Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services and the U.S. Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Spartan Micro, Inc. Gary Avedovech Senior Director Quality and Compliance 3184 Airway Avenue, Suite C Costa Mesa, California 92626
Re: K220716
Trade/Device Name: Spartan SC 069 Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY, QJP Dated: March 10, 2022 Received: March 11, 2022
Dear Gary Avedovech:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
Indications for Use
510(k) Number (if known) K220716
Device Name Spartan SC 069TM
Indications for Use (Describe)
The Spartan SC 0697M is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Image /page/3/Picture/1 description: The image shows the logo for Spartan Micro, Inc. The word "SPARTAN" is written in large, bold, sans-serif letters. Below the word "SPARTAN" is a horizontal line, and to the right of the line is the text "MICRO, INC." The text "MICRO, INC." is written in a smaller, sans-serif font.
510(k) Summary
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92(c) and follows FDA guidance document titled The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)], Appendix B. The 510(k) Summary Document Requirements issued July 28, 2014.
I. SUBMITTER
Spartan Micro, Inc. 3184 Airway Ave, Suite C Costa Mesa, CA 92626
Phone: 949-409-8581
Contact Person: Gary Avedovech Date Prepared: May 4, 2022
II. DEVICE
Name of Device: Spartan SC 069™ Common or Usual Name: Support Catheter Regulatory Class: II Product Codes: DQY Percutaneous catheter (21 CFR 870.1250) QJP Percutaneous catheter, neurovasculature (21 CFR 870.1250) Review Panel: Cardiovascular, Neurology
III. PREDICATE and REFERENCE DEVICES
Predicate: React™ 68 Catheter 510(k) Number: K180715 Manufacturer: Micro Therapeutics, Inc. d/b/a/ ev3 Neurovascular This device has not been subject to a design-related recall.
Reference: Arc™ Intracranial Support Catheter and Arc™ Mini Intracranial Support Catheter 510(k) Number: K150107 Manufacturer: Micro Therapeutics, Inc. d/b/a/ ev3 Neurovascular This device has not been subject to a design-related recall.
4
Image /page/4/Picture/1 description: The image shows the logo for Spartan Micro, Inc. The word "SPARTAN" is written in large, bold, sans-serif letters. Below the word "SPARTAN" is a horizontal line, and to the right of the line is the text "MICRO, INC." The text "MICRO, INC." is written in a smaller, sans-serif font.
IV. DEVICE DESCRIPTION
The Spartan SC 069™ is a support catheter designed for the introduction of interventional devices into the peripheral and neuro vasculature. The SC 069™ is a single lumen, flexible, variable stiffness composite catheter with a Nitinol structure. A radiopaque marker band on the distal tip of the device is used for visualization under fluoroscopy. The distal section of the catheter is coated with a hydrophilic coating to reduce the overall frictional force during intravascular use. The device is supplied sterile and intended for single use only.
V. INDICATIONS FOR USE
| Subject Device | Predicate | Reference |
|---|---|---|
| K220716; DQY, QJP | K180715; DQY | K150107; DQY |
| The Spartan SC 069™ is | ||
| indicated for the introduction | ||
| of interventional devices into | ||
| the peripheral and neuro | ||
| vasculature. | The React™ 68 Catheter is | |
| indicated for the introduction | ||
| of interventional devices into | ||
| the peripheral and neuro | ||
| vasculature. | The Arc™ Intracranial Support | |
| Catheter and Arc™ Mini | ||
| Intracranial Support Catheter | ||
| are indicated for the | ||
| introduction of interventional | ||
| devices into the peripheral | ||
| and neurovasculature. |
The indications for use are the same for the subject device and the predicate device.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE AND REFERENCE DEVICES
| Dimensions | Spartan SC 069™ | React™ 68 Catheter
(K180715) | Arc™ Intracranial
Support Catheter
(K150107) |
|------------------|-----------------|---------------------------------|----------------------------------------------------|
| Proximal OD | 0.0815" | 0.083" | 0.0825" |
| Distal OD | 0.0815" | 0.083" | 0.071" |
| Proximal ID | 0.069" | 0.068" | 0.069" |
| Distal ID | 0.069" | 0.068" | 0.061" |
| Effective Length | 95, 115, 133 cm | 132 cm | 132 – 135 cm |
| Inner Lumen | PTFE lined | same | same |
| Number of Lumens | Single lumen | same | same |
| Coating Length | 60cm | 40cm | unknown |
5
Image /page/5/Picture/1 description: The image shows the logo for Spartan Micro, Inc. The word "SPARTAN" is written in large, bold, sans-serif letters. Below the word "SPARTAN" is a horizontal line, and to the right of the line is the text "MICRO, INC." in smaller, sans-serif letters. The logo is simple and professional.
| Materials | Spartan SC 069™ | React™ 68 Catheter
(K180715) | Arc™ Intracranial
Support Catheter
(K150107) |
|---------------------|----------------------------------------|---------------------------------|----------------------------------------------------|
| Shaft Materials | Tecothane and
polyether block amide | Grilamid™ Pebax® | Polymetric plastic
material |
| Hub | Polycarbonate | Trogamid | unknown |
| Strain Relief | RNF | DynaFlex | unknown |
| Shaft Reinforcement | Nitinol | same | same |
| Marker Band | Platinum/Iridium | Platinum/Iridium | Platinum |
| Coating | Hydrophilic | same | same |
| Packaging | Spartan SC 069TM | ReactTM 68 Catheter
(K180715) | ArcTM Intracranial
Support Catheter
(K150107) |
|----------------|------------------|----------------------------------|-----------------------------------------------------|
| Pouch Material | PET/PE/Tyvek | same | same |
| Packaging Card | HDPE | Polyethylene | same |
| Packaging Hoop | HDPE | Polyethylene | same |
| Sterilization | Spartan SC 069™ | React™ 68 Catheter
(K180715) | Arc™ Intracranial
Support Catheter
(K150107) |
|---------------|---------------------|---------------------------------|----------------------------------------------------|
| Method | Ethylene Oxide (EO) | same | same |
| Shelf Life | 2 years | 3 months* | 6 months |
*Shelf life based on Riptide Aspiration System (React 68 Catheter) per K180705.
The differences in technological characteristics do not raise new questions of safety or effectiveness.
VII. PERFORMANCE DATA
Performance Data – Bench:
The following non-clinical bench testing was performed to evaluate the performance of the Spartan SC 069™. The passing result of the testing supports the substantial equivalence to the predicate.
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Image /page/6/Picture/1 description: The image shows the logo for Spartan Micro, Inc. The word "SPARTAN" is in large, bold, sans-serif font. Below the word "SPARTAN" is a horizontal line, and to the right of the line is the text "MICRO, INC." in a smaller, sans-serif font.
| Test | Test Method Summary | Results |
|---|---|---|
| Coating Lubricity (Friction | ||
| Force) | The Spartan SC 069™ and the | |
| predicate device were evaluated | ||
| for coating lubricity under | ||
| simulated use conditions. | The Spartan SC 069™ was | |
| found to have acceptable | ||
| friction force under simulated | ||
| use conditions similar to the | ||
| predicate device. | ||
| Hub Functional & | ||
| Dimensional | The Spartan SC 069™ was | |
| evaluated per ISO 594-1:1986- | ||
| 06-15 First edition and ISO 594- | ||
| 2:1998-09-01 Second edition. | The Spartan SC 069™ met the | |
| acceptance criteria for hub | ||
| functional and dimensional | ||
| requirements. | ||
| Torque Strength | The Spartan SC 069™ was | |
| evaluated for torsional strength | ||
| during use in a simulated path | ||
| model. | The Spartan SC 069™ exhibited | |
| acceptable torsional strength | ||
| similar to the predicate device. | ||
| Tensile | The Spartan SC 069™ was | |
| evaluated per ISO 10555-1:2013 | ||
| Annex B. | The Spartan SC 069™ met the | |
| acceptance criteria for tensile | ||
| strength. | ||
| Air Aspiration | The Spartan SC 069™ was tested | |
| for air leakage into the hub | ||
| during aspiration per ISO 10555- | ||
| 1:2013(E) Annex D. | The Spartan SC 069™ met the | |
| acceptance criteria for air | ||
| aspiration. | ||
| Liquid Leak | The Spartan SC 069™ was tested | |
| per ISO 10555-1:2013(E) Annex C. | The Spartan SC 069™ met the | |
| acceptance criteria for liquid | ||
| leakage. | ||
| Particulate and Coating | ||
| Integrity | The Spartan SC 069™ was | |
| evaluated under simulated use | ||
| conditions and compared with | ||
| the predicate device to support | ||
| substantial equivalence. The | ||
| coating integrity was also visually | ||
| examined after testing. | The Spartan SC 069™ met the | |
| acceptance criteria for | ||
| particulate generation and | ||
| coating integrity, and was | ||
| found substantially equivalent | ||
| to the predicate. | ||
| Stiffness | A stiffness profile across the | |
| catheter length was measured | ||
| and compared to the predicate | ||
| device stiffness profile. | The Spartan SC 069™ met the | |
| acceptance criteria for | ||
| catheter stiffness and found | ||
| substantially equivalent to the | ||
| predicate. | ||
| Test | Test Method Summary | Results |
| Kink Resistance | The ability of the Spartan SC | |
| 069™ to withstand bends was | ||
| measured at various points | ||
| across the catheter length by | ||
| bending the catheter shaft | ||
| around sequentially smaller | ||
| mandrels. Results were | ||
| compared to test results from | ||
| the predicate. | The Spartan SC 069™ met the | |
| acceptance criteria for kink | ||
| resistance and was found | ||
| substantially equivalent to the | ||
| predicate. | ||
| Radiopacity | The visibility of the Spartan SC | |
| 069™ under fluoroscopy was | ||
| compared to the predicate | ||
| device. | The Spartan SC 069™ met the | |
| acceptance criteria for | ||
| radiopacity and was found | ||
| substantially equivalent to the | ||
| predicate. | ||
| Corrosion | The Spartan SC 069™ was | |
| evaluated for corrosion per | ||
| ISO 10555-1:2013(E) Annex A. | The Spartan SC 069™ met the | |
| acceptance criteria for | ||
| corrosion resistance. | ||
| Static Burst Pressure | The Spartan SC 069™ was tested | |
| to evaluate the burst pressure | ||
| under static conditions per ISO | ||
| 10555-1:2013(E) Annex F. | The Spartan SC 069™ met the | |
| acceptance criteria for static | ||
| burst pressure. | ||
| Buckling | The Spartan SC 069™ was | |
| evaluated for its resistance to | ||
| buckling and tip deflection | ||
| properties and compared to the | ||
| predicate device. | The Spartan SC 069™ met the | |
| acceptance criteria for tip | ||
| deflection and buckling and | ||
| was found substantially | ||
| equivalent to the predicate. | ||
| Design Validation | The Spartan SC 069™ was tested | |
| in a model representing a | ||
| challenging use setting and | ||
| evaluated against the predicate | ||
| device on interventional device | ||
| introduction, trackability, | ||
| stability, guidewire interaction, | ||
| and overall device integrity. | The Spartan SC 069™ met the | |
| requirements for which it was | ||
| designed and tested. | ||
| Test | Test Method Summary | Results |
| Dimensional Testing | Dimensional properties of the | |
| subject device were measured | ||
| and compared to device | ||
| specifications. | The Spartan SC 069™ met the | |
| dimensional requirements. | ||
| Visual Inspection | The subject device was visually | |
| inspected and compared to | ||
| acceptance criteria. | The Spartan SC 069™ met the | |
| visual inspection | ||
| requirements. | ||
| Dead Space Volume | The dead space volume was | |
| calculated following a dead | ||
| space evaluation protocol. | The Spartan SC 069™ dead | |
| space volume was measured. | ||
| The dead space volume is | ||
| reported in the labeling. | ||
| Pressure Flow Testing with | ||
| Contrast Media | Flow pressure calculations were | |
| conducted following a protocol | ||
| for 100% saline, 50% saline - | ||
| 50% contrast media, and 100% | ||
| contrast media solutions. | The Spartan SC 069™ pressure- | |
| flow performance was | ||
| evaluated. Flow rates and | ||
| pressures of various saline and | ||
| contrast media solutions are | ||
| reported in the labeling. |
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Image /page/7/Picture/1 description: The image shows the word "SPARTAN" in large, bold, sans-serif font. Below the word "SPARTAN" is a horizontal line, and to the right of the line is the text "MICRO, INC." in a smaller, sans-serif font. The text is all in black and white.
8
Image /page/8/Picture/1 description: The image shows the logo for Spartan Micro, Inc. The word "SPARTAN" is in large, bold, sans-serif font. Below the word "SPARTAN" is a horizontal line, and to the right of the line is the text "MICRO, INC." in a smaller, sans-serif font. The logo is simple and modern.
Biocompatibility
The biocompatibility evaluation for the Spartan SC 069™ support catheter was conducted in accordance with the FDA guidance, "Use of International Standard ISO 10993-1, 'Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process'," and ISO 10993-1: "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process." The device is categorized as a limited exposure ( Bacterial
Endotoxin Test | The temperature increases for
the test animals did not exceed
the test limit for the maximum
individual temperature rise.
Therefore, the test article meets
the requirement of the test to be
considered non-pyrogenic. | 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% and 0%,
respectively. Both are