(106 days)
The Anchor Dual Lumen Guidewire Catheter is intended for use in the peripheral, coronary, and neuro vasculature for the intravascular introduction of interventional devices.
The Anchor Dual Lumen Guidewire Catheter, model AQ8001, is a single use, sterile (EO), 8F, 110 cm (working length of 100 cm) biocompatible, flexible, radiopaque, dual lumen catheter with a 6F, C shaped tip. The shaft utilizes a braided wire design with multiple Pebax durometer extrusions reflowed over PTFE liner. The distal tip includes radiopaque marker bands for visibility under fluoroscopy. The larger lumen accommodates an 0.035" guidewire and other interventional devices; the smaller lumen allows a 0.014" guidewire to exit the catheter at the curve to provide stabilization of the catheter. The hub, with Luer fittings, is compatible with standard syringes and is leak proof. The hub is marked to identify the lumens.
The Aqure Medical, Inc. Anchor Dual Lumen Guidewire Catheter (K201076)
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria (Implicit from "met specifications" or "met acceptance criteria") | Reported Device Performance |
|---|---|---|
| Physical and Mechanical Performance | ||
| Visual Inspection | Absence of defects (smooth, no nicks or sharp edges). Measured at 2.5x magnification per ISO 10555-1. | All devices met the acceptance criteria and were smooth with no nicks or sharp edges. |
| Dimensions | Device dimensions (working/usable lengths, lumen IDs, catheter/tip ODs, curve tip length, curve angle) within specified tolerances. | Devices met their specifications. |
| System Surface, Atraumatic Tip & Lumen Transition | Surface free from extraneous matter and sharp edges; catheter tips and distal openings without points or sharp edges. Inspected at 2.5x magnification per ISO 10555-1. | Devices met their specifications. Surface was free from extraneous matter and sharp edges, catheter tips and distal openings point or sharp edges. |
| Proximal Hub Compatibility | Hub dimensions compatible with ISO 80369-7 standards after conditioning in distilled water. | Devices met acceptance criteria. |
| Buckle | Distal tip buckling force under compressive load met strength requirements. | Devices met their specifications. |
| Flexibility and Kink | No kinking observed when wrapped around a decreasing mandrel. | Devices met their specifications. |
| Torque | With distal end fixed, torque until failure met design specifications. | Devices met their specifications. |
| Liquid Leakage | No liquid leakage detected per ISO 10555-2. | Device met acceptance criteria. |
| Air Leakage | No air leakage detected per ISO 10555-1, Annex D. | Device met acceptance criteria. |
| Contrast Flow Rate | Ability to inject a minimum of 25ml Visipaque through the large lumen over 5 seconds, with a measured amount of contrast collected meeting specifications. | Devices met acceptance criteria. |
| Tensile Strength | All joints met tensile strength requirements per ISO 10555-1. | Devices met accept criteria. |
| Particulate | Met specifications per ISO14708-1:2014 & EN45502-1:2015. | Devices met accept criteria. |
| Functional Performance | ||
| Functionality, Stabilization, Guidewire Compatibility, ID obstruction/delamination | Performance in a simulated use model demonstrated specified functionality, stabilization, guidewire compatibility, and absence of ID obstruction/delamination. Specifically, lower retropulsion compared to the predicate. | All devices met the acceptance criteria. The Anchor Dual Lumen Guidewire Catheter demonstrated 78% less retropulsion than the predicate. No obstruction or delamination was observed. |
| Physician Simulated Use | Performance deemed acceptable by physicians, with acceptable guidewire and treatment device compatibility, and minimal retropulsion compared to the predicate. | Physicians deemed the performance of the subject device acceptable and experienced significantly less retropulsion than the predicate. Five (5) predicate devices backed out of position and one (1) predicate kinked. The Anchor Dual Lumen Guidewire Catheter was compatible with the size labeled guidewires and treatment devices. |
| Durability and Packaging | ||
| Shelf Life Testing | Met all acceptance criteria after 6 months of accelerated aging per ASTM F1980:2016. | All devices met the acceptance criteria post accelerated aging. |
| Packaging Testing | Packages met specifications (distribution, environmental, aging) with visual inspection, dye leak, and seal strength tests per relevant ASTM and ISO standards. | Packages met specifications (subject devices met accept criteria as described above) post Distribution, Environmental and Aging of Packages. |
| Biocompatibility | ||
| Cytotoxicity | Non-cytotoxic per MEM Extraction Cytotoxicity Assay (ISO 10993-5:2009). | Non-cytotoxic. |
| Sensitization | Non-sensitizing per Guinea Pig Maximization Test (ISO 10993-10:2010). | Non-sensitizing. |
| Irritation | Non-irritant per Intracutaneous Reactivity Test (ISO 10993-10:2010). | Non-irritant. |
| Toxicity (Pyrogen) | Non-pyrogenic per Materials Mediated Rabbit Pyrogen Test (ISO 10993-11:2017). | Non-pyrogenic. |
| Toxicity (Systemic) | Non-toxic per Acute Systemic Toxicity (ISO 10993-11:2017). | Non-toxic. |
| Hemocompatibility (Hemolysis) | Non-hemolytic per ASTM Hemolysis Assay (Direct and Extract Methods per ISO 10993-4:2017). | Non-hemolytic. |
| Hemocompatibility (Complement Activation) | C3a and SC5b-9 complement proteins considered non-activated compared to negative control per ISO 10993-4:2017. | C3a and SC5b-9 complement proteins were considered to be non-activated as compared to the negative control. |
| Hemocompatibility (PTT) | Expanded assay and comparison article must pass (test article's p-value ≥ 0.05 when compared to negative plasma control or negative reference control) per ISO 10993-4:2017. | The expanded assay and comparison article: Pass (the test article's p-value was ≥ 0.05 when compared to the negative plasma control or negative reference control). |
| Hemocompatibility (Thrombogenicity) | Equivalent thromboresistant characteristics to the predicate in a 4-Hour Thrombogenicity Study in Canine per ISO 10993-4:2017. | Equivalent thromboresistant characteristics as the predicate. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state numerical sample sizes for most of the tests. It typically refers to "All devices" or "Devices" met the criteria.
- Physician Simulated Use: Two physicians used "subject and predicate devices." The number of devices used by each physician is not specified.
- Functionality/Stabilization: "Subject and predicate devices were tested."
- Shelf Life Testing: "Devices were subjected to all testing post 6 month accelerated aging."
- Packaging Testing: Implies sufficient packages were tested to ensure compliance.
- Biocompatibility Tests: These tests follow ISO standards, which typically specify sample sizes for biological evaluations. The document does not provide the specific numbers of samples tested, but states that the tests were performed per the referenced ISO standards. For instance, the "4-Hour Thrombogenicity Study in Canine" would involve a number of animal subjects.
The data provenance is not explicitly stated in terms of country of origin or whether the studies were retrospective or prospective, beyond the fact that these were laboratory and simulated use studies conducted as part of the device's development and premarket notification. These are assumed to be prospective studies conducted specifically for this regulatory filing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Physician Simulated Use: "Two physicians" were actively involved in judging the performance of the device in a simulated use model. Their specific qualifications (e.g., years of experience, specialty) are not detailed in this document.
For other performance tests like visual inspection, dimensional measurements, buckle, flexibility, torque, leakage, flow rate, tensile strength, and particulate tests, the "ground truth" is established by adherence to recognized national and international standards (e.g., ISO, ASTM) and the device's own internal specifications. The experts are implied to be qualified technical personnel carrying out these standardized tests.
4. Adjudication Method for the Test Set:
- Physician Simulated Use: The two physicians "deemed the performance of the subject device acceptable." This suggests a consensus or agreement among the two on the acceptability of the device's performance, but no formal adjudication method like 2+1 or 3+1 is described. For the objective metrics (e.g., retropulsion), direct measurement provided the "ground truth."
- For the vast majority of the other tests (e.g., visual, dimensions, mechanical, biocompatibility), the adjudication method is based on meeting the quantitative or qualitative criteria of the referenced ISO/ASTM standards or the device's internal specifications. There is no mention of a multi-observer adjudication process for these tests; rather, they are objective measurements or pass/fail assessments against established criteria.
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:
This information is not applicable to the Aqure Medical, Inc. Anchor Dual Lumen Guidewire Catheter. This device is a physical medical instrument (a guidewire catheter), not an artificial intelligence (AI) or software-as-a-medical-device (SaMD) product. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done:
This information is not applicable for the same reason as point 5. The device is not an algorithm or AI system.
7. The Type of Ground Truth Used:
The ground truth for most of the tests is established through a combination of:
- Objective Measurements: For aspects like dimensions, contrast flow rate, tensile strength, and some biocompatibility metrics (e.g., p-value for PTT).
- Pass/Fail Criteria based on Established Standards: Adherence to ISO, ASTM, and EN standards for physical, mechanical, chemical, and biological properties.
- Expert Opinion/Acceptability: For the physician simulated use, the "acceptable" performance was a qualitative judgment by the physicians.
- Comparative Performance to Predicate: For certain aspects like retropulsion and thrombogenicity, the performance was compared directly to predicate devices and found to be superior or equivalent, respectively.
8. The Sample Size for the Training Set:
This information is not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI. The term "training set" is generally used for data used to train AI algorithms. For a physical device, development typically involves prototypes, iterative design, and testing, but not a "training set" in the computational sense.
9. How the Ground Truth for the Training Set Was Established:
This question is not applicable for the same reason as point 8.
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August 6, 2020
Aqure Medical, Inc. % Prithul Bom Responsible Third Party Official Regulatory Technology Services, LLC 1000 Westgate Drive. Suite #510k Saint Paul, MN 55114
Re: K201076
Trade/Device Name: Anchor Dual Lumen Guidewire Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: QJP, DQY Dated: July 24, 2020 Received: July 27, 2020
Dear Prithul Bom:
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
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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 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 (OS) 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,
Naira Muradyan, Ph.D. Assistant Director (Acting) 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
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Indications for Use
510(k) Number (if known) K201076
Device Name
Anchor Dual Lumen Guidewire Catheter
Indications for Use (Describe)
The Anchor Dual Lumen Guidewire Catheter is intended for use in the peripheral, coronary, and neuro vasculature for the intravascular introduction of interventional devices.
| 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 a logo for "AQURE MEDICAL INC." The word "AQURE" is in a large, bold, silver font with a blue outline. Below it, "MEDICAL INC." is written in a smaller, blue font. The background is white with a soft, blue glow emanating from behind the text, creating a futuristic or technological feel.
Aqure Medical, Inc. 12560 Fletcher Lane, Suite 300 Rogers, MN 55374 USA Ph: 763-762-6946 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
510(k) SUMMARY
Submitter:
Aqure Medical, Inc. Jie Xia 12560 Fletcher Lane, Suite 300 Rogers, MN 55374 Telephone: 763-762-6946 Email: aquremedical@outlook.com
Primary Contact:
Laurie Lewandowski Consultant, Honkanen Consulting 738 Saddle Wood Drive Eagan, MN 55123 612-770-4038 (cell) Telephone: Email: lalew207@gmail.com
DATE PREPARED:
August 04, 2020
NAME OF MEDICAL DEVICE:
Proprietary Name: Anchor Dual Lumen Guidewire Catheter Common/Usual Name: Catheter, Percutaneous
DEVICE CLASSIFICATION:
| Classification Name: | Percutaneous Catheter |
|---|---|
| Regulatory Class: | II |
| Product Code: | QJP, DQY |
| Regulation Number: | 21 CFR 870.1250 |
PRIMARY PREDICATE DEVICE:
| Proprietary Name: | ENVOY® Distal Access (DA) Guiding Catheter |
|---|---|
| Common/Usual Name: | Catheter, Percutaneous |
| Classification Name: | Percutaneous Catheter |
Aqure Medical, Inc. Anchor Dual Lumen Guidewire Catheter
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| 510K Number: | K140080 |
|---|---|
| -------------- | --------- |
PREDICATE DEVICE:
| Proprietary Name: | MIVI Mi-Axus™ Guide Catheter |
|---|---|
| Common/Usual Name: | Catheter, Percutaneous |
| Classification Name: | Percutaneous Catheter |
| 510K Number: | K151396 |
DEVICE DESCRIPTION:
The Anchor Dual Lumen Guidewire Catheter, model AQ8001, is a single use, sterile (EO), 8F, 110 cm (working length of 100 cm) biocompatible, flexible, radiopaque, dual lumen catheter with a 6F, C shaped tip. The shaft utilizes a braided wire design with multiple Pebax durometer extrusions reflowed over PTFE liner. The distal tip includes radiopaque marker bands for visibility under fluoroscopy. The larger lumen accommodates an 0.035" guidewire and other interventional devices; the smaller lumen allows a 0.014" guidewire to exit the catheter at the curve to provide stabilization of the catheter. The hub, with Luer fittings, is compatible with standard syringes and is leak proof. The hub is marked to identify the lumens.
INTENDED USE/INDICATION FOR USE:
The Anchor Dual Lumen Guidewire Catheter is intended for use in the peripheral, coronary, and neuro vasculature for the intravascular introduction of interventional devices.
TECHNOLOGICAL COMPARISON TO PREDICATE DEVICES:
The Anchor Dual Lumen Guidewire Catheter is similar to ENVOY® Distal Access (DA) Guiding Catheter (K140080) and to the MIVI Mi-Axus™ Guide Catheter (K151396) in terms of indications for use, design, materials, technology and performance with the exception that the Anchor Dual Lumen Guidewire Catheter has a second lumen and is not coated whereas the predicates are coated and do not have a second lumen. In addition, the use of contrast is supported by the Asahi Fubuki (K141981).
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| Characteristic | Aqure Medical, Inc.Anchor Dual Lumen GuidewireCatheter (subject device) | ENVOY® Distal Access (DA)Guiding Catheter (K140080)Primary Predicate | MIVI Mi-Axus™ GuideCatheter(K151396)Predicate Device |
|---|---|---|---|
| Intended Use | To provide intravascular access forpatients undergoing intravascularprocedures. | Identical | Identical |
| Indications for use | The Anchor Dual Lumen GuidewireCatheter is intended for use in theperipheral, coronary, and neurovasculature for the intravascularintroduction of interventionaldevices. | Similar:The ENVOY Distal Access(DA) Guiding Catheter isintended for use in theperipheral, coronary, and neurovasculature for the intravascularintroduction ofinterventional/diagnosticdevices. | Similar;The MIVI Mi-Axus™ GuideCatheter is indicated for use infacilitating the insertion andguidance of microcathetersinto a selected blood vessel inthe peripheral, coronary andneuro vascular systems. |
| Technology | |||
| Dimensions | Tip OD = 6F (0.083")Tip ID = 0.067"Catheter OD = 8F (0.105")Large lumen (A) ID ≥ 0.067" | Catheter OD =6.0F (0.082")ID = 0.071" | Catheter OD= 8F (2.7mm or0.108")Proximal ID = 6.8F (2.26mm or0.089") |
| Small lumen (B) ID ≥ 0.016" | Lengths (cm)= 75 ± .5 or 85 |
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| Characteristic | Aqure Medical, Inc.Anchor Dual Lumen GuidewireCatheter (subject device) | ENVOY® Distal Access (DA)Guiding Catheter (K140080)Primary Predicate | MIVI Mi-Axus™ GuideCatheter(K151396)Predicate Device |
|---|---|---|---|
| Working Length (cm) | 100 | Working Lengths (cm) =95 and105 | $\pm .5$ |
| Curve Shape | C | Identical | Not Listed |
| Tip | Atraumatic with marker bands | Identical | Identical |
| Shaft | Braided and coiled shaft withmultiple Pebax durometer extrusionsreflowed over PTFE liner | Identical | Identical |
| Coating | N/A | Hydrophilic | Hydrophilic |
| Packaging | Card mounted inserted in a sterilebarrier pouch and shelf box | Identical | Not Listed |
| Sterilization | Ethylene Oxide | Identical | Identical |
The Anchor Dual Lumen Guidewire Catheter is the same as the primary predicate ENVOY® Distal Access (DA) Guiding Catheter (K140080) with the addition of the second lumen, that terminates at the curve, to provide stability. The physician can introduce interventional devices or contrast per current practice. The catheter tip French size remains consistent with the remaining portion of the shaft increase to 8F to accommodate the second lumen. This is supported by the SF, MIVI Mi-Axus Guide Catheter (K151396) predicate. Contrast use with the subject device is supported by the reference device, the Asahi Fubuki (K141981).
The length of the Anchor Dual Lumen Cutheter falls within the two lengths provided by the predicate. The subject device is not coated while the predicate devices have a hydrophilic coating. Testing demonstrated that the subject device simulated
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model in an equivalent manner to the predicate device and that typical treatment devices can be inserted and withdrawn to meet specifications.
The different technological characteristics of the new device do not raise different questions of safety and effectiveness.
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PERFORMANC TESTING
The Anchor Dual Lumen Guidewire Catheter has been tested and verified that the catheter performs as designed and is suitable for its intended use.
| Test | Test Method Summary | Results |
|---|---|---|
| Visual Inspection | Visually inspect device2.5x magnification perISO 10555-1. | All devices met the acceptance criteria and weresmooth with no nicks or sharp edges. |
| Dimensions | The working and usablelengths, ID of bothlumens, the catheter andtip ODs, curve tip lengthand curve angle weremeasured. | Devices met their specifications. |
| System Surface,Atraumatic Tip andLumen Transition | Inspect at 2.5xmagnification per ISO10555-1 | Devices met their specifications.Surface was free from extraneous matter andsharp edges, catheter tips and distal openingspoint or sharp edges, |
| Proximal HubCompatibility | Inspect to ISO 80369-7dimensions (using gages)after conditioning indistilled water | Devices met acceptance criteria |
| Buckle | Distal tip buckling forceunder compressive loadwas evaluated | Devices met their specifications |
| Flexibility and Kink | Observation for kinkwhen wrapped around adecreasing mandrel | Devices met their specifications |
| Torque | With the distal end fixedwithin the model, torqueuntil failure. | Devices met their specifications |
| Liquid Leakage | Leak test per ISO 10555-2 | Device met acceptance criteria |
| Air Leakage | Leak test per ISO 10555-1, Annex D | Device met acceptance criteria |
| Contrast Flow Rate | Connect a syringe filledwith a min of 25mlVisipaque to large lumen.Inject over 5 seconds;measure amount ofcontrast collected. | Devices met acceptance criteria |
| Tensile Strength | Tensile test all joints perISO 10555-1. | Devices met accept criteria. |
| Particulate | Testing per ISO14708-1:2014 & EN45502-1:2015 | Devices met accept criteria |
| • Functionality• Stabilization | Subject and predicatedevices were tested in a | All devices met the acceptance criteria. TheAnchor Dual Lumen Guidewire Catheter |
| Test | Test Method Summary | Results |
| • Guidewirecompatibility• ID obstruction /delamination | simulated use model forfunctionality, retropulsionand liner obstruction /delamination | demonstrated 78% less retropulsion than thepredicate. No obstruction or delamination wasobserved |
| Physician SimulatedUse | Subject and predicatedevices were used by twophysicians in a simulateduse model. This includedsmall and large lumencompatibility withguidewires and treatmentdevices. | Physicians deemed the performance of the subjectdevice acceptable and experienced significantlyless retropulsion than the predicate. Five (5)predicate devices backed out of position and one(1) predicate kinked. The Anchor Dual LumenGuidewire Catheter was compatible with the sizelabeled guidewires and treatment devices. |
| Shelf Life Testing | Devices were subjected toall testing post 6 monthaccelerated aging perASTM F1980:2016. | All devices met the acceptance criteria postaccelerated aging. |
| Packaging | ||
| Packaging Testing | Distribution,Environmental and Agingof Packages• Distribution Testing perISTA 2A:2011• Packaging Tests perASTM D4169:2016 andISO 11607-1:2006• Packaging Aging perASTM F1980:2016,o Visual per ASTMF1886-16o Dye Leak per ASTMF2096-11o Seal Strength perASTM F88/F88M-15 | Packages met specifications (subject devices metaccept criteria as described above) postDistribution, Environmental and Aging ofPackages |
| Biocompatibility | ||
| Cytotoxicity | MEM ExtractionCytotoxicity Assay per ISO10993-5:2009 | Non-cytotoxic |
| Sensitization | Guinea Pig MaximizationTest per ISO 10993-10:2010 | Non-sensitizing |
| Irritation | Intracutaneous ReactivityTest per ISO 10993-10:2010 | Non-irritant |
| Toxicity | Materials MediatedRabbit Pyrogen Test ISO10993-11:2017 | Non-pyrogenic |
| Test | Test Method Summary | Results |
| Toxicity | Acute Systemic Toxicityper ISO 10993-11:2017 | Non-toxic |
| Hemocompatibility | ASTM Hemolysis Assay:Direct and Extract Methodsper ISO 10993-4:2017 | Non-hemolytic |
| Hemocompatibility | Complement ActivationAssay - C3a and SC5b-9Methods per ISO 10993-4:2017 | C3a and SC5b-9 complement proteins wereconsidered to be non-activated as compared to thenegative control |
| Hemocompatibility | Partial ThromboplastinTime (PTT) Assay per ISO10993-4:2017 | The expanded assay and comparison article: Pass(the test article's p-value was ≥ 0.05 whencompared to the negative plasma control ornegative reference control) |
| Hemocompatibility | 4-Hour ThrombogenicityStudy in Canine per ISO10993-4:2017 | Equivalent thromboresistant characteristics as thepredicate. |
Performance testing included the following:
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CONCLUSIONS
The Anchor Dual Lumen Guidewire Catheter is substantially equivalent in design, materials, sterilization, principles of operation, performance and indications for use to the cited predicate devices.
§ 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).