The Slinky Catheter is indicated for general intravascular use. including the neuro and peripheral vasculature. It can be used to facilitate introduction of diagnostic agents and therapeutic devices. It is not intended for use in coronary arteries.

Device Description

The Slinky® Catheter is a single lumen, variable stiffness catheter with a coil and braid reinforcement. It has a radiopaque marker at the distal tip for enhanced fluoroscopic visualization, a lubricious inner, and a hydrophilic coating on the distal 35 cm to enhance lubricity and vascular navigation. The Slinky® Catheter is provided sterile via Ethylene Oxide (EO) sterilization, non-pyrogenic, and is for single use only.

AI/ML Overview

This document describes the premarket notification (510(k)) for the Anoxia Medical, Inc. Slinky Catheter. The primary purpose of the submission is to demonstrate substantial equivalence to a predicate device, the SOFIA PLUS/Distal Access Catheters (K150366). The document does not describe a study involving an AI component or the improvement of human readers with AI assistance. Instead, it focuses on the engineering and biocompatibility performance of the Slinky Catheter.

Since the prompt asks for details related to AI performance, multi-reader multi-case (MRMC) studies, and the use of expert consensus for ground truth in an AI context, and the provided text describes a medical device (a catheter) and its physical and biological performance, I will interpret the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, adapting the categories to fit the provided information on a physical medical device rather than an AI or software product.

Here's an analysis based on the provided text for the Slinky Catheter, focusing on its performance criteria and the studies conducted:

1. A table of acceptance criteria and the reported device performance

The document provides a table of various tests, their methods, and conclusions. The "Conclusions" column effectively serves as the "reported device performance" and implicitly indicates that the acceptance criteria were met, as all conclusions state the device performed as intended, met established criteria, or was comparable to the predicate.

Test	Test Method Summary	Acceptance Criteria (Implicit)	Reported Device Performance
Bench Performance Testing
Simulated Use	Test articles used by three trained interventional neuroradiologists in a tortuous anatomical bench test model, demonstrating compatibility with ancillary devices.	Device to perform as intended under simulated use conditions.	Device performed as intended under simulated use conditions.
Particulate Test	Test articles tracked multiple times through tortuous anatomical model with ancillary devices. Inspected for coating anomalies pre- and post-testing.	Particulate generation of subject device to be similar to predicate device.	Particulate generation of the subject device was similar to the predicate device.
Product Compatibility	Simulated use testing by three physicians using full-length silicone anatomical tortuous path model. Included use with worst-case ancillary devices.	Device to be compatible with ancillary devices.	The device was found to be compatible with ancillary devices.
Dimensional and Visual Attributes	Physical and dimensional attributes evaluated and measured.	Device to meet established dimensional and visual specifications.	Device met the established dimensional and visual specifications.
Kink Resistance	Distal, mid, and proximal sections wrapped around varying size pin gauges.	Device to meet established kink resistance criteria.	Device met the established kink resistance criteria.
Radio Detectability	Distal marker band and catheter body visibility evaluated under fluoroscopy.	Device radiopacity to be comparable to predicate device.	Device radiopacity comparable to the predicate device.
Catheter Hub	Hub functionality evaluated during simulated use, freedom from leakage, flow rate, dynamic burst, particulate, and other bench testing.	Device hub to meet requirements of ISO 80369-7.	Device hub meets the requirements of ISO 80369-7.
Durability/Lubricity of Hydrophilic Coating	Coating evaluated after simulated use for defects and friction force.	Device to meet established friction and lubricity criteria; friction force similar to predicate.	Device met the established friction and lubricity criteria. The friction force was similar to the predicate.
Tip Flexibility	Device tip stiffness characterized on a cantilever bend test.	Tip stiffness to be similar to predicate.	The tip stiffness was similar to the predicate.
Torque Strength	Devices pre-conditioned by simulated use and torqued to failure inside a tortuous anatomical model with distal tip fixed.	Device torque strength to be same as predicate device.	Device torque strength is the same as the predicate device.
Force at Break (Distal and Hub)	Catheter force at break averaged 8 lbf for hub and 5-6 lbf for mid and distal segments, exceeding acceptance criteria from withdrawal force measurements.	Tensile strength to meet acceptance criteria determined from withdrawal force measurements.	Tensile strength meets the test acceptance criteria.
Flow Rate	Characterized at 100 psi with diagnostic agents (e.g., saline, contrast media).	Device to meet specified requirements for delivery of diagnostic agents.	Device meets the specified requirements for delivery of diagnostic agents.
Static Burst Pressure	Device withstand static pressure above labeled 100 psi maximum with margin of safety.	Device integrity to be suitable for intended clinical use and meet requirements of ISO 10555-1.	Device integrity is suitable for intended clinical use and met requirements of ISO 10555-1.
Freedom from Leakage	Testing followed methods and criteria defined in EN ISO 10555-1 after pre-conditioning by simulated use.	Device integrity to be suitable for intended clinical use and meet requirements of ISO 10555-1.	Device integrity is suitable for intended clinical use and met requirements of ISO 10555-1.
Air Leakage	No air leakage at hub into syringe for 15 seconds.	Device integrity to be suitable for intended clinical use and meet requirements of ISO 10555-1.	Device integrity is suitable for intended clinical use and met requirements of ISO 10555-1.
Dynamic Burst	Devices pre-conditioned by simulated use. Test devices connected to pressurized fluid source, starting with 250 psi and increased every 10 seconds up to 600 psi.	Device to meet labeled maximum infusion pressure of 100 psi.	Device met labeled maximum infusion pressure of 100 psi.
Peak Tensile Force	Devices pre-conditioned by simulated use. Tensile testing conducted per methods defined in EN ISO 10555-1.	Device to meet acceptance criteria determined from withdrawal force testing.	Device met acceptance criteria determined from withdrawal force testing.
Biocompatibility Testing
Cytotoxicity (ISO 10993-5) - MEM Elution Assay	Cell culture observed for cytotoxic reactivity following exposure to test extract with Grade <2 as acceptable.	Non-cytotoxic (Grade <2).	Non-cytotoxic
Sensitization (ISO 10993-10) - Guinea Pig Maximization Sensitization	Observation of study animals exposed to test extracts for delayed dermal sensitization.	No sensitization reaction.	No sensitization reaction
Irritation (ISO 10993-10) - Intracutaneous Reactivity	Observations for dermal reactivity at 24, 48, and 72 hours after test extract injection. Test article sites not to show significantly greater biological reaction than control.	Non-irritant (no significantly greater biological reaction than control).	Non-irritant
Acute Systemic Toxicity (ISO 10993-11)	Study animals injected with subject device observed for abnormal clinical signs indicative of toxicity during 72-hour test period.	No signs of toxicity.	No signs of toxicity
Pyrogenicity (USP <151>, ISO 10993-11)	Study animals observed for individual temperature rise following intravenous injection of test extracts.	Non-pyrogenic.	Non-pyrogenic
Hemolysis (ASTM F756, ISO10993-4) – Direct and Indirect (extract) Hemolysis	Difference between hemolytic indexes of subject device and negative control evaluated after exposure to test extracts and direct exposure to test article.	Non-hemolytic.	Direct contact - Non-hemolytic; Indirect contact - Non-hemolytic
SC5b-9 Complement Activation Assay (ISO 10993-4)	Using an enzyme immunoassay, SC5b-9 concentration following exposure of test article extracts to normal human serum (NHS) compared to SC5b-9 of control article exposed to NHS.	Not considered to be a potential activator of the complement system.	Not considered to be a potential activator of the complement system
Thrombogenicity (ASTM F2382) - Partial Thromboplastin Time	Thrombogenicity potential of test article compared to control articles.	Acceptable results.	Acceptable results
Platelet and Leukocyte Count (ASTM F2888-19, ISO 10993-4) In vitro Blood Loop	(Test Method Summary Blank)	(Implied acceptable performance for blood compatibility)	(Conclusions blank, but generally implied to be acceptable based on overall summary)
Sterilization and Shelf-Life
Sterilization	Validated process to achieve a minimum sterility assurance level (SAL) of 10^-6.	SAL of 10^-6.	Achieved minimum sterility assurance level (SAL) of 10^-6.
Shelf-Life	Studies conducted to demonstrate product and packaging remain functional and sterile.	Product and packaging remain functional and sterile for 12 months.	Demonstrates functionality and sterility for 12 months.

2. Sample size used for the test set and the data provenance

Sample Size for Bench Tests:
- Simulated Use, Product Compatibility, Torque Strength, Dynamic Burst, Peak Tensile Force, Freedom from Leakage, Durability/Lubricity: Not explicitly stated as a number, but "Test articles" and "Devices" implies multiple units were used for each test.
- Simulated Use, Product Compatibility: "Test articles were used by three trained interventional neuroradiologists."
Sample Size for Biocompatibility Tests: Not explicitly stated as numbers (e.g., how many guinea pigs, how many cell cultures). The phrase "Study animals" is used.
Data Provenance: The document does not specify the country of origin for the data. The tests performed are standard bench tests and regulated biocompatibility studies, following ISO and ASTM standards. The studies were conducted in accordance with 21 CFR Part 58 Good Laboratory Practices, which are US regulations. It's a prospective test in the sense that these tests are performed on the manufactured device models to demonstrate their performance characteristics for regulatory submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

For Simulated Use and Product Compatibility bench testing: three trained interventional neuroradiologists were used. Their specific years of experience are not mentioned, but they are identified as "trained interventional neuroradiologists."
For other tests, "ground truth" is established by adherence to specified test methods (e.g., ISO, ASTM standards) and their quantitative or qualitative pass/fail criteria, rather than expert consensus on, for example, image interpretation.

4. Adjudication method for the test set

The document does not describe an adjudication method in the context of multiple expert readers or interpretations. For the "Simulated Use" and "Product Compatibility" tests where three neuroradiologists participated, it's not stated how disagreements, if any, were resolved; however, the conclusion states the device "performed as intended" and "was found to be compatible," suggesting a consensus or successful outcome observed by all. This is not a formal adjudication process as would be seen in an imaging study.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study was not done. This submission is for a physical medical device (a catheter), not an AI or software device. Therefore, the concept of human readers improving with AI assistance is not applicable to this document. The "three trained interventional neuroradiologists" participated in simulated use bench testing to evaluate the physical interaction and performance of the catheter in a model, not to read images or interpret data generated by the device in terms of AI output.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable as the device is a physical catheter, not an algorithm or AI product.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the catheter's performance is established through bench testing against established engineering and biocompatibility standards (ISO, ASTM) and comparison to the predicate device's characteristics.
- For dimensional and physical properties: direct measurement and adherence to specifications.
- For functional properties (e.g., kink resistance, torque strength, flow rate): performance against defined quantitative criteria or qualitative observations (e.g., performs as intended).
- For biocompatibility: results from standardized biological assays performed on animal models, cell cultures, or blood samples, with pass/fail criteria defined by the ISO 10993 series and other relevant standards.
- For simulated use: observation by trained physicians against expected performance.
The overall "ground truth" for regulatory clearance is substantial equivalence to the predicate device, demonstrated by meeting comparable performance characteristics through these tests.

8. The sample size for the training set

This question is not applicable. This document describes performance testing for a physical medical device, not the development or validation of an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

This question is not applicable for the same reason as above.

Summary

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December 1, 2023

Image /page/0/Picture/1 description: The image shows 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.

Anoxia Medical, Inc. % Bosmat Friedman, MSc Regulatory Consultant ProMedoss, Inc. 3521 Hatwynn Road Charlotte, North Carolina 28269

Re: K231179

Trade/Device Name: Slinky Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: QJP, DQY, DQO Dated: November 1, 2023 Received: November 1, 2023

Dear Bosmat Friedman:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Naira Muradyan -S

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

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Indications for Use

510(k) Number (if known) K231179

Device Name Slinky Catheter

Indications for Use (Describe)

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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510(k) Summary

510(k) Number: K231179

Date Prepared: November 30, 2023

Submitter/Manufacturer	Anoxia Medical, Inc.
	3475 Investment Boulevard, Suite #9
	Hayward, CA 94545
Contact	Henry Nita
	Telephone: 650-430-2045
Trade Name	Slinky Catheter
Common/Usual Name	Distal Access Catheter
Regulation Description	Percutaneous Catheter
Regulation Number	21 CFR 870.1250; 21 CFR 870.1200
Product Code	QJP, DQY, DQO
Device Class	Class II
Classification Panel	Neurology, Cardiovascular
Predicate Devices	SOFIA PLUS/Distal Access Catheters (K150366)

Device Description:

Indications for Use:

The Slinky Catheter is indicated for general intravascular use, including the neuro and peripheral vasculature. It can be used to facilitate introduction of diagnostic agents and therapeutic devices. It is not intended for use in coronary arteries.

Comparison of Technological Characteristics with the Predicate Device:

The Slinky® Catheter has similar indications for use and technological characteristics as the predicate device as presented in the following table. The differences do not raise new questions of safety or effectiveness.

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Comparison to the Predicate Device
Characteristic	Predicate DeviceSOFIA PLUS/Distal AccessCathetersK150366	Subject DeviceSlinky® CatheterK231179
Classification,Product Code	Class II, DQY, DQO	Class II, QJP, DQY, DQO
Generic Name	Percutaneous Catheter	Same
RegulationNumber	21 CFR 870.1250; 21 CFR 870.1200	Same
ClassificationPanel	Neurology, Cardiovascular	Same
IndicationsFor Use	The SOFIA PLUS/Distal AccessCatheters are indicated for generalintravascular use, including the neuroand peripheral vasculature. It can beused to facilitate introduction ofdiagnostic and therapeutic agents. It isnot intended for use in coronaryarteries.	The Slinky Catheter is indicated forgeneral intravascular use, includingthe neuro and peripheral vasculature.It can be used to facilitate introductionof diagnostic agents and therapeuticdevices. It is not intended for use incoronary arteries.
DIMENSIONS:
Catheter Size	6F	6F
CatheterEffective Length	115-135 cm	132 cm
Proximal ID	0.070"	0.075"
Proximal OD	0.0825"	0.086"
Tip Configuration	Steam shapeable by user	Straight-cut or 30°-cut atraumatic softtip configurations
MATERIALS:
Catheter BodyOuter Layer	Polyurethane elastomer (Polyblendand Pellethane), polyether block amide(Pebax) and polyamide (Grilamid)	Pebax® 55D, Pebax® 63D, Grilamid™L25, QFLEX 85A/Polyblend 60A,Pellathane® 80A, Pebax® 35D
Catheter BodyInner Layer	Stainless steel braid/coil, PTFE andpolyolefin elastomer	Braid and coil: 304 V Stainless Steel,PTFE, QFLEX 75A/Polyblend 60A
Marker	Platinum/Iridium	Platinum/Iridium
Hub	Nylon	Acrylic
Strain Relief	Polyurethane	Polyolefin
Shaping Mandrel	Stainless steel	N/A
Coating	Hydrophilic coating: Hydak®	Hydrophilic coating: Harland
GuidewireCompatibility	0.035"	0.014", 0.035", 0.038"
Method ofSupply	Sterile and Single Use	Same
Sterilization Method	Ethylene oxide	Same
Packaging Card	Polyethylene	Same
Packaging Hoop	HDPE	Polyethylene
Packaging Pouch	Tyvek®	Nylon and LDPE (top)Tyvek® 1073B (bottom)
Packaging Carton Box	Pouch and IFU placed in carton box	Same
Shelf Life	Not specified	12 Months
Accessories Included	Introducer sheath, shaping mandrel	None

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Performance Testing:

To demonstrate the substantial equivalence of the subject Slinky® Catheter to the predicate device, the SOFIA PLUS/Distal Access Catheters, the performance, biocompatibility, and sterility of the Slinky® Catheter were evaluated via the following tests and assessments:

Design Verification Bench Testing ●
Biocompatibility .
Shelf-Life .
Sterilization ●
Packaging Validation ●

Bench Performance Testing

Test	Test Method Summary	Conclusions
Simulated Use	Test articles were used by three trained interventionalneuroradiologists in a tortuous anatomical bench testmodel, demonstrating compatibility with ancillarydevices including introducers, microcatheters, andguidewires.	Device performed as intendedunder simulated use conditions.
Particulate Test	Test articles were tracked multiple times through thetortuous anatomical model with ancillary devices.Devices were inspected for coating anomalies pre- andpost-testing.	Particulate generation of thesubject device was similar tothe predicate device.
Product Compatibility	Simulated use testing by three physicians wasconducted, using a full-length silicone anatomicaltortuous path model. The procedure included using thetest catheter along with worst case ancillary devices(i.e., smallest ID introducer, largest OD guidewire,stiff micro guidewire, large stent-retriever).	The device was found to becompatible with ancillarydevices.
Dimensional and VisualAttributes	The physical and dimensional attributes wereevaluated and measured.	Device met the establisheddimensional and visualspecifications.
Test	Test Method Summary	Conclusions
Kink Resistance	The distal, mid, and proximal sections of the catheterwere wrapped around varying size pin gauges.	Device met the establishedkink resistance criteria.
Radio Detectability	The distal marker band and catheter body visibilitywere evaluated under fluoroscopy.	Device radiopacity comparableto the predicate device.
Catheter Hub	The hub functionality was evaluated during simulateduse, freedom from leakage, flow rate, dynamic burst,particulate, and other bench testing completed.	Device hub meets therequirements of ISO 80369-7.
Durability/Lubricity ofHydrophilic Coating	Lubricious coating on the catheter surface wasevaluated after simulated use for defects and forfriction force.	Device met the establishedfriction and lubricity criteria.The friction force was similarto the predicate.
Tip Flexibility	Device tip stiffness was characterized on a cantileverbend test.	The tip stiffness was similar tothe predicate.
Torque Strength	Devices were pre-conditioned by simulated use andtorqued to failure inside a tortuous anatomical modelwith the distal tip held fixed.	Device torque strength is thesame as the predicate device.
Force at Break (Distaland Hub)	Catheter force at break averaged 8 lbf for the hub and5-6 lbf for the mid and distal segments and exceedsacceptance criteria determined from withdrawal forcemeasurements.	Tensile strength meets the testacceptance criteria.
Flow Rate	Flow rate was characterized at 100 psi with diagnosticagents (e.g., saline, contrast media).	Device meets the specifiedrequirements for delivery ofdiagnostic agents.
Static Burst Pressure	Device can withstand static pressure above labeled100 psi maximum with margin of safety.	Device integrity is suitable forintended clinical use and metrequirements of ISO 10555-1.
Freedom from Leakage	Testing followed the methods and criteria defined inEN ISO 10555-1 after pre-conditioning by simulateduse.	Device integrity is suitable forintended clinical use and metrequirements of ISO 10555-1.
Air Leakage	No air leakage at hub into syringe for 15 seconds.	Device integrity is suitable forintended clinical use and metrequirements of ISO 10555-1.
Dynamic Burst	Devices were pre-conditioned by simulated use. Testdevices were then connected to a pressurized fluidsource, starting with 250 psi and further increasedevery 10 seconds until a maximum of 600 psi wasapplied.	Device met labeled maximuminfusion pressure of 100 psi.
Peak Tensile Force	Devices were pre-conditioned by simulated use.Tensile testing was then conducted per the methodsdefined in EN ISO 10555-1.	Device met acceptance criteriadetermined from withdrawalforce testing.
Test	Test Method Summary	Conclusions
Cytotoxicity (ISO10993-5) - MEMElution Assay	Cell culture observed for cytotoxic reactivityfollowing exposure to test extract with Grade<2 as acceptable.	Non-cytotoxic
Sensitization (ISO10993-10) - Guinea PigMaximizationSensitization	Observation of study animals exposed to testextracts for delayed dermal sensitization.	No sensitization reaction
Irritation (ISO 10993-10) - IntracutaneousReactivity	Observations for dermal reactivity wereconducted at 24, 48, and 72 hours after testextract injection. Test article sites should notshow a significantly greater biological reactionthan sites injected with control article.	Non-irritant
Acute SystemicToxicity (ISO 10993-11)	Study animals injected with the subject deviceobserved for abnormal clinical signs indicativeof toxicity during the 72-hour test period.	No signs of toxicity
Pyrogenicity (USP<151>, ISO 10993-11)	Study animals observed for individualtemperature rise following intravenousinjection of test extracts.	Non-pyrogenic
Hemolysis (ASTMF756, ISO10993-4) –Direct and Indirect(extract) Hemolysis	The difference between the hemolytic indexesof the subject device and the negative controlwas evaluated after exposure to test extractsand direct exposure to test article.	Direct contact - Non-hemolyticIndirect contact - Non-hemolytic
SC5b-9 ComplementActivation Assay (ISO10993-4)	Using an enzyme immunoassay, SC5b-9concentration following exposure of test articleextracts to normal human serum (NHS)compared to SC5b-9 concentration of thecontrol article exposed to NHS.	Not considered to be a potentialactivator of the complement system
Thrombogenicity(ASTM F2382) - PartialThromboplastin Time	Thrombogenicity potential of test articlecompared to control articles.	Acceptable results
Platelet and LeukocyteCount (ASTM F2888-19,ISO 10993-4)In vitro Blood Loop

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Biocompatibility

Biocompatibility was assessed in accordance with ISO 10993-1 guidelines for a limited exposure (< 24 hours), externally communicating device with circulating blood contact. All studies were conducted according to 21 CFR Part 58 Good Laboratory Practices.

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Sterilization and Shelf-Life

The Slinky® Catheter is labeled as a single-use sterile device with shelf-life of 12 months. The sterilization process has been validated and process monitoring controls are in place to assure that the device is EO sterilized to achieve a minimum sterility assurance level (SAL) of 10 ° Shelf-life studies have been conducted and demonstrate that the product and packaging remain functional and sterile for the shelf-life period of 12 months.

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Conclusion:

The Slinky® Catheter has the same intended use and similar technological characteristics and principles of operation as the currently marketed predicate SOFIA PLUS/Distal Access Catheters. Any differences between the subject and predicate device do not raise new questions of safety and effectiveness. The subject device was evaluated through design verification and validation, biocompatibility, and sterility testing. Based on the information submitted in this 510(k) submission, the subject Slinky® Catheter is substantially equivalent to the currently marketed predicate SOFIA PLUS/Distal Access Catheters.

Regulation Number and Section

§ 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).