(78 days)
The SOFIA Distal Access Catheter is intended for general intravascular use, including the neuro and peripheral vasculature. It can be used to facilitate the introduction of diagnostic agents. It is not intended for use in coronary arteries.
The SOFIA™ Distal Access Catheter is a single-lumen, flexible catheter designed with coil and braid reinforcement. The distal segment is steam-shapeable and it has a hydrophilic coating for navigation through the vasculature. The radiopaque marker is located at the distal end of the catheter for visualization under fluoroscopy. An introducer sheath and shaping mandrel are also provided.
The provided document describes the SOFIA Distal Access Catheter and compares it to a predicate device (K131482). The submission aims to demonstrate substantial equivalence, not to prove clinical effectiveness or diagnostic accuracy in specific use cases as is common for AI/ML devices. Therefore, many of the requested criteria are not applicable, as this is a traditional medical device submission focused on bench testing and biocompatibility.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as pass/fail thresholds in a single table, but rather implied by the "Results" and "Conclusions" for each bench test and biocompatibility assessment. The reported device performance is outlined in the "Results" column.
| Test Name | Acceptance Criteria (Implied) | Reported Device Performance (Results) |
|---|---|---|
| Bench Testing | ||
| Simulated Use | Device performs as intended under simulated use conditions. | Test articles achieved a rating ≥ 3 for preparation/ease of assembly, introducer sheath interaction, introducer peel away, tracking with guidewire/microcatheter, microcatheter/guidewire lockup, lubricity and durability of hydrophilic coating, microcatheter/guidewire removal. Removal/ aspiration of clot, mechanical clot retriever and stent delivery with no particles. |
| Equipment Interface | Device compatible with recommended accessories commonly used in intravascular procedures. | Test articles compatible with 0.035-inch and 0.038-inch guidewires, 6F or larger guide catheter/guiding sheath, common RHVs using insertion tool, stopcocks and ≤ 0.027-inch microcatheters. |
| Dimensional and Physical Attributes | Device meets established dimensional and physical specifications. | Test articles met the specified dimensional requirements for catheter OD, catheter ID, overall working length, length of distal section, length of distal tip to marker band and total length of hub/strain relief. |
| Kink Resistance | Device resistant to kinking around small radii turns. | No kinks at 1 cm, 4 cm, 12 cm and 25 cm from distal tip when wrapped around 0.025-inch and 0.030-inch pin gauges. No kinks noted during simulated use testing. |
| Tip Shapeability | Shapeability of distal tip after steam shaping equivalent to competitive devices. | Tip angle of test article equivalent to competitive devices after steam shaping using mandrel with an angle of approximately 90°. |
| Radio Detectability | Device radiopacity equivalent to or better than predicate and competitive devices. | Distal marker band visible under fluoroscopy. |
| Gauging (ISO 594-2) | Device hub meets the requirements of ISO 594-2. | Gauging pin and hub align in limit planes. |
| Separation Force (ISO 594-2) | Device hub meets the requirements of ISO 594-2 (separation force greater than 25 N). | Mating parts separation force greater than 25 N. |
| Unscrewing Torque (ISO 594-2) | Device hub meets the requirements of ISO 594-2 (luer remains attached after applying a torque not less than 0.02 Nm for a minimum of 10 seconds). | Test article luer remains attached after applying an unscrewing torque not less than 0.02 Nm for a minimum of 10 seconds. |
| Stress Cracking (ISO 594-2) | Device hub meets the requirements of ISO 594-2 (no stress cracks). | No stress cracks on test article hub. |
| Ease of Assembly (ISO 594-2) | Device hub meets the requirements of ISO 594-2 (components fit securely with no resistance). | Components fit together securely with no resistance observed between test article luer and reference fitting. |
| Resistance to Overriding (ISO 594-2) | Device hub meets the requirements of ISO 594-2 (luer does not override reference fitting threads). | Test article luer does not override reference fitting threads. |
| Durability/Lubricity of Hydrophilic Coating | Device tracks easily with no coating cracking or separation (achieved a rating ≥ 3). | Test article achieved a rating of ≥ 3 during simulated use testing for coating durability and lubricity. |
| Catheter Stiffness | Device tracks in tortuous anatomy while advancing to target site (stiffness equivalent to predicate and competitive devices). | Device stiffness equivalent to predicate and competitive devices. |
| Torque Strength | Device torque strength same as predicate device (no catheter breakage after 50 rotations). | No catheter breakage after 50 rotations. |
| Catheter Flexural Fatigue | Device integrity suitable for intended clinical use (no flexural fatigue). | No flexural fatigue following repeated bending during simulated use testing and repeated hoop stress following pressure and air aspiration testing. |
| Surface Contamination | Device integrity suitable for intended clinical use (free from surface contaminants, smooth distal tip, PTFE inner layer not delaminated). | Test article free from surface contaminants from uncured coating surface particulates > 0.02 mm², embedded particulates. Distal tip smooth and tapered. PTFE inner layer not delaminated. |
| Force at Break (Distal and Hub) | Tensile strength test results equivalent to predicate and competitive devices (catheter force at break ≥ 2.25 lbf for distal section and hub/catheter junction). | Catheter force at break ≥ 2.25 lbf for distal section and hub/catheter junction. |
| Flow Rate | Device meets specified requirements for delivery of diagnostic agents (flow rate at 100 psi and 300 psi with diagnostic agents equivalent to predicate device). | Flow rate at 100 psi and 300 psi with diagnostic agents (e.g., saline, contrast media) equivalent to predicate device. |
| Static Burst Pressure | Device integrity suitable for intended clinical use and met requirements of ISO 10555-1 (no damage at 46 psi). | No damage of pressurized catheter at 46 psi. |
| Fluid Leakage at > 46 psi | Device integrity suitable for intended clinical use and met requirements of ISO 10555-1 (no liquid leakage from hub and catheter shaft at 46 psi for 30 seconds). | No liquid leakage from hub and catheter shaft at 46 psi for 30 seconds. |
| Air Leakage | Device integrity suitable for intended clinical use and met requirements of ISO 10555-1 (no air leakage at hub into syringe for 15 seconds). | No air leakage at hub into syringe for 15 seconds. |
| Dynamic Burst | Device met labeled maximum infusion pressure of 300 psi (did not burst at or below 300 psi). | Test articles did not burst at or below 300 psi. |
| Particulate Test | Device met specifications for maximum allowable particles (less than 25 particles > 10 microns/ml, less than 3 particles > 25 microns/ml, no particles > 70 microns). | Less than 25 particles greater than 10 microns per ml volume and less than 3 particles greater than 25 microns per ml volume. No particles greater than 70 microns. |
| Biocompatibility | ||
| Cytotoxicity (ISO 10993-5) - MEM elution assay | Non-cytotoxic (cell culture treated with test article exhibits only slight reactivity, Grade 1). | Cell culture treated with test article exhibited slight reactivity (Grade 1). |
| Sensitization/Irritation (ISO 10993-10) - Guinea pig maximization sensitization | Weak allergic potential or sensitizing capacity (extracts elicited no reaction at challenge, 0% sensitization, Grade 1). | Extracts of the test article elicited no reaction at the challenge (0% sensitization) following the induction phase (Grade 1). |
| Sensitization/Irritation (ISO 10993-10) - Intracutaneous reactivity | Non-irritant (extracts did not show a significantly greater biological reaction than control sites). | Extracts of the test article did not show a significantly greater biological reaction than the sites injected with the control article. |
| Hemocompatibility – Rabbit Blood Direct and Indirect Contact (ISO 10993-4) | Non-hemolytic (hemolysis index < acceptance criteria; not explicitly stated but typically < 2%). | The hemolysis index was 0.13% (direct contact) and 0.0% (indirect contact). |
| Hemocompatibility - Unactivated Partial Thromboplastin Time Assay Direct Contact (ISO 10993-4) | No effect on coagulation (no statistically significant difference in UPTT compared to controls). | No statistically significant difference found between the Unactivated Partial Thromboplastin Time (UPTT) of the plasma exposed to the test article and that of the plasma exposed to either the negative control or the untreated control. |
| Hemocompatibility - Complement Activation Assay (ISO 10993-4) | No effect on complement activation (C3a and SC5b-9 levels < negative and untreated controls). | C3a and SC5b-9 levels < negative and untreated controls. |
| Hemocompatibility - Thrombogenicity Study in Dogs (ISO 10993-4) | No significant thrombosis (minimal thrombosis, Grade 0). | Minimal thrombosis observed with a Grade 0 in two out of two test sites and two out of two control sites. |
| Systemic Toxicity - Systemic Injection Test (ISO 10993-11) | No toxic effects (extracts did not induce a significantly greater biological reaction than control extracts). | Extracts of test article did not induce a significantly greater biological reaction than the control extracts when injected in Swiss Albino mice. |
| Systemic Toxicity - Rabbit Pyrogen Test (ISO 10993-11) | Non-pyrogenic (temperature increases < acceptance criteria; typical < 0.5°C). | The temperature increases (maximum) was 0.03°C from baseline. |
Regarding the other requested information (2-9), most are not applicable because this is a 510(k) premarket notification for a traditional medical device, not an AI/ML diagnostic or prognostic device. The study presented is a technical verification and validation study against established standards and a predicate device, rather than a clinical effectiveness study.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated for each test, but it would be a reasonable number for bench testing (e.g., 3-10 samples per test, as per common medical device testing practices). The thrombogenicity study in dogs used "two out of two test sites and two out of two control sites" which implies 2 animals for the test and 2 for the control for that specific test.
- Data Provenance: The document does not specify the country of origin for the test data for the proposed device. For many tests, it explicitly states "(Prior test data from predicate device)" or "Biocompatibility was prior test data from predicate device," indicating the data was generated previously for the predicate device. This is a retrospective use of existing data for the current submission. The origin of those previous tests isn't detailed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. This is not a study requiring expert consensus or ground truth in the context of diagnostic accuracy. The "ground truth" for these tests comes from engineering specifications, ISO standards, and comparison to the predicate device's performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No adjudication method is described as this is not a diagnostic performance 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
- Not Applicable. This is not an AI/ML device, and no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable in the traditional sense. The "ground truth" for the tests performed are primarily:
- Engineering Specifications: Internal design requirements for dimensions, strength, flow rate, etc.
- International Standards: e.g., ISO 594-2 for luer connectors, ISO 10993 series for biocompatibility, ISO 10555-1 for sterile single-use intravascular catheters. These standards define acceptance criteria.
- Predicate Device Performance: Direct comparison of the proposed device's performance to that of the predicate device (K131482) to demonstrate substantial equivalence.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device; there is no training set.
9. How the ground truth for the training set was established
- Not Applicable. This is not an AI/ML device; there is no training set.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized emblem featuring a symbol that resembles a human figure in profile, with flowing lines suggesting movement or connection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 10, 2014
MicroVention, Inc. Ms. Naomi Gong Sr. Regulatory Affairs Project Manager 1311 Valencia Ave Tustin, California 92780
Re: K142014 Trade/Device Name: SOFIA Distal Access Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY, DQO Dated: September 9, 2014 Received: September 10, 2014
Dear Ms. Naomi Gong,
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. 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 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Carlos L. Pena -S
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K142014
Device Name SOFIA Distal Access Catheter
Indications for Use (Describe)
The SOFIA Distal Access Catheter is intended for general intravascular use, including the neuro and peripheral vasculature. It can be used to facilitate the introduction of diagnostic agents. It is not intended for use in coronary arteries.
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
| Trade Name: | SOFIA Distal Access Catheter |
|---|---|
| Generic Name: | Percutaneous Catheter |
| Classification: | Class II, 21 CFR 870.1250 (DQY), 21CFR 870.1200 (DQO) |
| Submitted By: | MicroVention, Inc1311 Valencia AvenueTustin, California U.S.A. |
| Contact: | Naomi GongPhone #: 714-247-8055 |
| Date: | 2014 September 30 |
| Predicate Device: | SOFIA Distal Access Catheter (K131482) |
Device Description:
The SOFIA™ Distal Access Catheter is a single-lumen, flexible catheter designed with coil and braid reinforcement. The distal segment is steam-shapeable and it has a hydrophilic coating for navigation through the vasculature. The radiopaque marker is located at the distal end of the catheter for visualization under fluoroscopy. An introducer sheath and shaping mandrel are also provided.
Indications For Use:
The SOFIA™ Distal Access Catheter is indicated for general intravascular use, including the neuro and peripheral vasculature. It can be used to facilitate introduction of diagnostic and therapeutic agents. It is not intended for use in coronary arteries.
| SOFIA Distal Access Catheter(predicate) | SOFIA Distal AccessCatheter (proposed) | |
|---|---|---|
| Intended Use | Intended for general intravascular use,including the neuro and peripheral vasculature.It can be used to facilitate the introduction ofdiagnostic and therapeutic agents. It is notintended for use in coronary arteries. | Same |
| MaterialCatheter Body | Outer layer of polyurethane elastomer(Polyblend and Pellethane), polyether blockamide (Pebax) and polyamide (Grilamid); innerlayer of stainless steel braid/coil, PTFE andpolyolefin elastomer | Same |
| MarkerHubStrain ReliefIntroducerShaping Mandrel | Platinum/IridiumNylonPolyurethanePebaxStainless steel | Same |
| Catheter size | 5 F | Same |
| ID | 0.055 inch (1.4 mm) | Same |
| OD | 0.068 inch (1.7 mm) | Same |
| Effective Length | 125 cm | 115 cm |
Technological Comparison:
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| SOFIA Distal Access Catheter(predicate) | SOFIA Distal AccessCatheter (proposed) | |
|---|---|---|
| Coating | Hydrophilic coating (Hydak®) | Same |
| Tip Configuration | Steam shapeable by user | Same |
| Guidewire Compatibility | 0.035 inch or 0.038 inch | Same |
| Accessories | Introducer sheath and shaping mandrel | Same |
| Method of Supply | Sterile and single use | Same |
| Sterilization Method | Ethylene Oxide | Same |
| Packaging Configuration | Catheter placed into a HDPE dispenser tube.Dispenser tube, introducer and shaping mandrelplaced on a polyethylene packaging card that isinserted into a Tyvek® pouch. Pouch and IFUplaced in bleached sulfate carton box. | Same |
Verification and Test Summary:
| Bench Testing | ||
|---|---|---|
| Test | Results | Conclusions |
| Simulated Use | Test articles achieved a rating ≥ 3 forpreparation/ease of assembly, introducer sheathinteraction, introducer peel away, tracking withguidewire/microcatheter,microcatheter/guidewire lockup, lubricity anddurability of hydrophilic coating, microcatheter/guidewire removal.Removal/ aspiration of clot, mechanical clotretriever and stent delivery with no particles.(Prior test data from predicate device) | Device performs as intendedunder simulated useconditions |
| Equipment Interface | Test articles compatible with_0.035-inch and0.038-inch guidewires, 6F or larger guidecatheter/guiding sheath, common RHVs usinginsertion tool, stopcocks and ≤ 0.027-inchmicrocatheters(Prior test data from predicate device) | Device compatible withrecommended accessoriescommonly used inintravascular procedures |
| Dimensional and Physical Attributes | Test articles met the specified dimensionalrequirements for catheter OD, catheter ID,overall working length, length of distal section,length of distal tip to marker band and totallength of hub/strain relief | Device met establisheddimensional and physicalspecifications |
| Kink Resistance | No kinks at 1 cm, 4 cm, 12 cm and 25 cm fromdistal tip when wrapped around 0.025-inch and0.030-inch pin gaugesNo kinks noted during simulated use testing(Prior test data from predicate device) | Device resistant to kinkingaround small radii turns |
| Tip Shapeability | Tip angle of test article equivalent to competitivedevices after steam shaping using mandrel withan angle of approximately 90°(Prior test data from predicate device) | Shapeability of distal tipafter steam shapingequivalent to competitivedevices |
| Radio Detectability | Distal marker band visible under fluoroscopy(Prior test data from predicate device) | Device radiopacityequivalent to or better thanpredicate and competitivedevices |
| Bench Testing | ||
| Test | Results | Conclusions |
| Gauging (ISO 594-2) | Gauging pin and hub align in limit planes(Prior test data from predicate device) | Device hub meets therequirements of ISO 594-2 |
| Separation Force (ISO 594-2) | Mating parts separation force greater than 25 N(Prior test data from predicate device) | Device hub meets therequirements of ISO 594-2 |
| Unscrewing Torque (ISO 594-2) | Test article luer remains attached after applyingan unscrewing torque not less than 0.02 Nm for aminimum of 10 seconds(Prior test data from predicate device) | Device hub meets therequirements of ISO 594-2 |
| Stress Cracking (ISO 594-2) | No stress cracks on test article hub(Prior test data from predicate device) | Device hub meets therequirements of ISO 594-2 |
| Ease of Assembly (ISO 594-2) | Components fit together securely with noresistance observed between test article luer andreference fitting(Prior test data from predicate device) | Device hub meets therequirements of ISO 594-2 |
| Resistance to Overriding (ISO 594-2) | Test article luer does not override referencefitting threads(Prior test data from predicate device) | Device hub meets therequirements of ISO 594-2 |
| Durability/Lubricity of HydrophilicCoating | Test article achieved a rating of ≥ 3 duringsimulated use testing for coating durability andlubricity. | Device tracks easily with nocoating cracking orseparation |
| Catheter Stiffness | Device stiffness equivalent to predicate andcompetitive devices(Prior test data from predicate device) | Device tracks in tortuousanatomy while advancing totarget site |
| Torque Strength | No catheter breakage after 50 rotations(Prior test data from predicate device) | Device torque strength sameas predicate device |
| Catheter Flexural Fatigue | No flexural fatigue following repeated bendingduring simulated use testing and repeated hoopstress following pressure and air aspirationtesting(Prior test data from predicate device) | Device integrity suitable forintended clinical use |
| Surface Contamination | Test article free from surface contaminants fromuncured coating surface particulates > 0.02 mm²,embedded particulatesDistal tip smooth and taperedPTFE inner layer not delaminated | Device integrity suitable forintended clinical use |
| Force at Break (Distal and Hub) | Catheter force at break ≥2.251bf for distal sectionand hub/catheter junction(Prior test data from predicate device) | Tensile strength test resultsequivalent to predicate andcompetitive devices |
| Flow Rate | Flow rate at 100 psi and 300 psi with diagnosticagents (e.g., saline, contrast media) equivalent topredicate device | Device meets specifiedrequirements for delivery ofdiagnostic agents |
| Static Burst Pressure | No damage of pressurized catheter at 46 psi(Prior test data from predicate device) | Device integrity suitable forintended clinical use and metrequirements of ISO 10555-1 |
| Fluid Leakage at > 46 psi | No liquid leakage from hub and catheter shaft at46 psi for 30 seconds(Prior test data from predicate device) | Device integrity suitable forintended clinical use and metrequirements of ISO 10555-1 |
| Air Leakage | No air leakage at hub into syringe for 15 seconds(Prior test data from predicate device) | Device integrity suitable forintended clinical use and metrequirements of ISO 10555-1 |
| Dynamic Burst | Test articles did not burst at or below 300 psi(Prior test data from predicate device) | Device met labeledmaximum infusion pressureof 300 psi |
| Particulate Test | Less than 25 particles greater than 10 micronsper ml volume and less than 3 particles greaterthan 25 microns per ml volumeNo particles greater than 70 microns(Prior test data from predicate device) | Device met specifications formaximum allowableparticles |
| Biocompatibility | Result | Conclusions |
| Cytotoxcitiy (ISO 10993-5)- MEM elution assay | Cell culture treated with testarticle exhibited slight reactivity(Grade 1) | Non-cytotoxic |
| Sensitization/Irritation (ISO 10993-10)- Guinea pig maximization sensitization | Extracts of the test article elicitedno reaction at the challenge (0%sensitization) following theinduction phase (Grade 1). | Weak allergicpotential orsensitizing capacity |
| Sensitization/Irritation (ISO 10993-10)- Intracutaneous reactivity | Extracts of the test article did notshow a significantly greaterbiological reaction than the sitesinjected with the control article | Non-irritant |
| Hemocompatibility – Rabbit Blood Directand Indirect Contact (ISO 10993-4) | The hemolysis index was 0.13%(direct contact) and 0.0%(indirect contact) | Non-hemolytic |
| Hemocompatibility - Unactivated PartialThromboplastin Time Assay Direct Contact(ISO 10993-4) | No statistically significantdifference found between theUnactivated PartialThromboplastin Time (UPTT) ofthe plasma exposed to the testarticle and that of the plasmaexposed to either the negativecontrol or the untreated control | No effect oncoagulation |
| Hemocompatibility - ComplementActivation Assay (ISO 10993-4) | C3a and SC5b-9 levels < negativeand untreated controls | No effect oncomplementactivation |
| Hemocompatibility - ThrombogenicityStudy in Dogs (ISO 10993-4) | Minimal thrombosis observedwith a Grade 0 in two out of twotest sites and two out of twocontrol sites | No significantthrombosis |
| Systemic Toxicity - Systemic Injection Test(ISO 10993-11) | Extracts of test article did notinduce a significantly greaterbiological reaction than thecontrol extracts when injected inSwiss Albino mice | No toxic effects |
| Systemic Toxicity - Rabbit Pyrogen Test(ISO 10993-11) | The temperature increases(maximum) was 0.03°C frombaseline | Non-pyrogenic |
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Note: Biocompatibility was prior test data from predicate device.
Summary of Substantial Equivalence:
The data presented in this submission demonstrates the technological similarity and equivalency of the SOFIA Distal Access Catheter when compared with the predicate device, SOFIA Distal Access Catheter (K131482).
The devices,
- l Have the same intended use,
- I Use the same operating principle,
- Incorporate the same basic design,
- l Are packaged and sterilized using same methods.
In summary, the SOFIA Distal Access Catheter described in this submission is substantially equivalent to the predicate device.
§ 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).