(183 days)
The SOFIA Distal Access Catheter is intended for general intravascular use, including The GOT IA Dicture al vasculature. It can be used to facilitate the introduction of the nours and therapeutic 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 text describes a medical device, the SOFIA™ Distal Access Catheter, and its verification testing for 510(k) clearance. This submission does not include information about AI/ML models, therefore, many of the requested fields related to AI/ML studies cannot be answered. The information pertains to traditional medical device testing.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document presents internal acceptance criteria implicitly through the "Results" and "Conclusions" sections of the verification tests. The "Conclusions" often state that the device "met established specifications" or "performs as intended," implying these were the acceptance criteria.
| Test Category | Specific Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Functional | Simulated Use | Achieves a rating ≥ 3 for various parameters (preparation, tracking, lubricity, etc.) with no particles after procedures like clot aspiration or stent delivery. | 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 | Compatible with 0.035-inch and 0.038-inch guidewires, 6F+ guide catheter/sheath, common RHVs, and ≤ 0.027-inch microcatheters. | 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. | |
| Kink Resistance | No kinks at specified distances (1, 4, 12, 25 cm) when wrapped around pin gauges (0.025-inch, 0.030-inch) and during simulated use. | 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 | Tip angle equivalent to competitive devices after steam shaping with a ~90° mandrel. | Tip angle of test article equivalent to competitive devices after steam shaping using mandrel with an angle of approximately 90°. | |
| Radiodetectability | Distal marker band visible under fluoroscopy, equivalent to or better than predicate/competitive devices. | Distal marker band visible under fluoroscopy. | |
| Durability/Lubricity of Hydrophilic Coating | Achieves a rating of ≥ 3 during simulated use for coating durability and lubricity. | Test article achieved a rating of ≥ 3 during simulated use testing for coating durability and lubricity. | |
| Catheter Stiffness | Stiffness equivalent to predicate and competitive devices to track in tortuous anatomy. | Device stiffness equivalent to predicate and competitive devices. | |
| Torque Strength | No catheter breakage after 50 rotations. | No catheter breakage after 50 rotations. | |
| Catheter Flexural Fatigue | No flexural fatigue during repeated bending in simulated use and hoop stress testing. | No flexural fatigue following repeated bending during simulated use testing and repeated hoop stress following pressure and air aspiration testing. | |
| Flow Rate | Flow rate at 100 psi and 300 psi with diagnostic agents equivalent to or better than competitive devices. | Flow rate at 100 psi and 300 psi with diagnostic agents (e.g., saline, contrast media) equivalent to or better than competitive devices. | |
| Static Burst Pressure | No damage at 46 psi, meeting ISO 10555-1. | No damage of pressurized catheter at 46 psi. | |
| Fluid Leakage at > 46 psi | No liquid leakage from hub and catheter shaft at 46 psi for 30 seconds, meeting ISO 10555-1. | No liquid leakage from hub and catheter shaft at 46 psi for 30 seconds. | |
| Air Leakage | No air leakage at hub into syringe for 15 seconds, meeting ISO 10555-1. | No air leakage at hub into syringe for 15 seconds. | |
| Dynamic Burst | No burst at or below 300 psi, meeting labeled maximum infusion pressure. | Test articles did not burst at or below 300 psi. | |
| Dimensional/Physical | Dimensional and Physical Attributes | Meets specified dimensional requirements for catheter OD, ID, lengths, etc. | 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. |
| Gauging (ISO 594-2) | Gauging pin and hub align in limit planes (meets ISO 594-2). | Gauging pin and hub align in limit planes. | |
| Separation Force (ISO 594-2) | Mating parts separation force greater than 25 N (meets ISO 594-2). | Mating parts separation force greater than 25 N. | |
| Unscrewing Torque (ISO 594-2) | Luer remains attached after applying ≥ 0.02 Nm for ≥ 10 seconds (meets ISO 594-2). | 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) | No stress cracks on test article hub (meets ISO 594-2). | No stress cracks on test article hub. | |
| Ease of Assembly (ISO 594-2) | Components fit securely with no resistance (meets ISO 594-2). | Components fit together securely with no resistance observed between test article luer and reference fitting. | |
| Resistance to Overriding (ISO 594-2) | Luer does not override reference fitting threads (meets ISO 594-2). | Test article luer does not override reference fitting threads. | |
| Surface Contamination | Free from surface contaminants from uncured coating, particulates > 0.02 mm², embedded particulates. Distal tip smooth and tapered, PTFE 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) | 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. | |
| Particulate Test | < 25 particles > 10 microns/mL, < 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 less than 25 microns per ml volume. No particles greater than 70 microns. | |
| Biocompatibility | Cytotoxicity - MEM Elution Assay (ISO 10993-5) | Cell culture treated with test article exhibits slight reactivity (Grade 1) or less (non-cytotoxic). | Cell culture treated with test article exhibited slight reactivity (Grade 1). |
| Sensitization/Irritation - Kligman Maximization Test (ISO 10993-10) | No reaction at challenge (0% sensitization) (weak allergic potential or sensitizing capacity). | Extracts of the test article elicited no reaction at the challenge (0% sensitization) following the induction phase (Grade 1). | |
| Sensitization/Irritation - Intracutaneous Injection Test (ISO 10993-10) | Extracts do not show significantly greater biological reaction than control sites (non-irritating). | 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) | Hemolysis index low (e.g., < 2%) (non-hemolytic). | The hemolysis index was 0.13% (direct contact) and 0.0% (indirect contact). | |
| Hemocompatibility - Unactivated Partial Thromboplastin Time Assay (ISO 10993-4) | No statistically significant difference between test article exposed plasma and controls (no effect on coagulation). | 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) | C3a and SC5b-9 levels ≤ negative and untreated controls (no effect on complement activation). | C3a and SC5b-9 levels ≤ negative and untreated controls. | |
| Hemocompatibility - Thrombogenicity Study in Dogs (ISO 10993-4) | Minimal thrombosis (e.g., Grade 0 or low) (no significant thrombosis). | 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) | Extracts do not induce significantly greater biological reaction than control extracts (no toxic effects). | 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) | Temperature increases (maximum) low (e.g., < 0.1°C) (non-pyrogenic). | The temperature increases (maximum) was 0.03°C from baseline. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify exact sample sizes for each test in terms of "N" or "number of unique cases/patients." It refers to "test articles," implying a number of device units were subjected to each test. For some tests, it mentions "two out of two test sites" or "test articles."
Data provenance is not provided in terms of country of origin or retrospective/prospective clinical data, as these are bench and biocompatibility tests, not clinical studies involving patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
N/A. This is a medical device performance and safety (bench and biocompatibility) study, not an AI/ML diagnostic accuracy study requiring expert ground truth for interpretation.
4. Adjudication Method for the Test Set
N/A. Not applicable for bench and biocompatibility testing. Ground truth for these tests is based on physical measurements, chemical analyses, and biological responses according to established standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This document does not mention any MRMC comparative effectiveness study, nor does it involve human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No. This document is for a physical medical device, not an algorithm or AI model.
7. The Type of Ground Truth Used
For the bench testing, the "ground truth" is based on:
- Physical measurements: E.g., dimensions (OD, ID, length), force at break, unscrewing torque, flow rates, burst pressures. These are measured objectively against defined specifications.
- Qualitative assessments: E.g., presence/absence of kinks, visibility under fluoroscopy, ease of assembly, presence of stress cracks, evaluation of surface contaminants. These are typically assessed by trained technicians against defined criteria.
- Performance metrics: E.g., successful tracking, minimal resistance, non-overriding threads. These are observed outcomes during simulated use or specific tests.
For biocompatibility testing, the "ground truth" is based on:
- Standardized biological assays: E.g., MEM elution assay for cytotoxicity, Kligman Maximization Test for sensitization, rabbit blood tests for hemocompatibility, rabbit pyrogen test, dog thrombogenicity study. These tests produce quantitative or semi-quantitative results that are interpreted against established acceptance criteria defined in ISO 10993 series of standards.
- Pathology/Histology: For the thrombogenicity study, "minimal thrombosis observed" would be a histological assessment.
8. The Sample Size for the Training Set
N/A. This is not an AI/ML study, so there is no training set.
9. How the Ground Truth for the Training Set Was Established
N/A. This is not an AI/ML study, so there is no training set or ground truth for one.
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V131482
| 510(k) Summary | |
|---|---|
| Trade Name: | SOFIA™ Distal Access Catheter |
| Generic Name: | Percutaneous Catheter |
| Classification: | Class II, 21 CFR 870.1250 (DQY), 21 CFR 870.1200 (DQO) |
| Submitted By: | MicroVention, Inc1311 Valencia AvenueTustin, California U.S.A. |
| Contact: | Naomi Gong |
| Date: | 2013 November 13 |
| Predicate Device: | Chaperon Guiding Catheter (K082385)Headway Duo Microcatheter (K120917) |
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 devices. It is not intended for use in coronary arteries.
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Technological Comparison:
| Chaperon GuidingCatheter | SOFIA Distal AccessCatheter | Headway DuoMicrocatheter | Chaperon GuidingCatheter | SOFIA Distal AccessCatheter | Headway DuoMicrocatheter | ||
|---|---|---|---|---|---|---|---|
| Intended Use | Intended for generalintravascular use, includingthe neuro and peripheralvasculature. It can be usedto facilitate the introductionof diagnostic andtherapeutic agents. It is notintended for use in coronaryarteries. | Intended for generalintravascular use, includingthe neuro and peripheralvasculature. It can be usedto facilitate the introductionof diagnostic andtherapeutic agents. It is notintended for use in coronaryarteries. | Intended for generalintravascular use, includingthe peripheral and coronaryvasculature for the infusionof diagnostic agents, suchas contrast media, andtherapeutic agents, such asembolization materials.Intended for neurovascularuse for the infusion ofdiagnostic agents, such ascontrast media, andtherapeutic agents that havebeen cleared or approvedfor use in theneurovasculature and arecompatible with the innerdiameter of themicrocatheter. | Catheter size | 5 F (outer catheter) | રે દ | 1.6 - 2.1 F. |
| MaterialCatheter Body | Outer layer of polyesterelastomer; stainless steelbraid; inner layer of PTFE(polytetrafluoroehthylene). | Outer layer of polyurethaneelastomer (Polyblend andPellethane), polyether blockamide (Pebax) andpolyamide (Grilamid); innerlayer of stainless steelbraid/coil, PTFE andpolyolefin elastomer | Outer layer of polyetherblock amide (Pebax) andpolyamide (Grilamid); innerlayer of stainless steelbraid/coil and PTFE | ID | 0.059 inch (1.5 mm) | 0.055 inch (1.4 mm) | 0.0165 inch (0.42 mm) |
| Marker | Tungsten | Platinum/Iridium | Platinum/Iridium | OD | 0.068 inch (1.7 mm) | 0.068 inch (1.7 mm) | 0.023 - 0.0275 inch(0.58 - 0.70 mm) |
| Hub | Nylon | Nylon | Nylon | Effective Length | 95 cm (outer)117 cm (inner) | 125 cm | 157 and 168 cm |
| Strain Relief | Polyester elastomer | Polyurethane | Pebax | Coating | Hydrophilic coating (Terumoproprietary coating) | Hydrophilic coating(Hydak® - same) | Hydrophilic coating(Hydak® - same) |
| Introducer | Not applicable | Pebax | Pebax | Tip Configuration | Preshaped | Steam shapeable by user | Steam shapeable by user |
| Shaping Mandrel | Not applicable | Stainless steel | Stainless steel | GuidewireCompatibility | 0.035 inch or 0.038 inch | 0.035 inch or 0.038 inch | 0.014 inch or smaller |
| Accessories | N/A | Introducer sheath andshaping mandre! | Introducer sheath andshaping mandrel . | ||||
| Method of Supply | Sterile and single use | Sterile and single use | Sterile and single use | ||||
| SterilizationMethod | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide | ||||
| PackagingConfiguration | Catheter placed onpackaging card that isinserted into Tyvek® pouch.Pouch and IFU placed inbleached sulfate carton box. | Catheter placed into a HDPEdispenser tube. Dispensertube, introducer and shapingmandrel placed on apolyethylene packaging cardthat is inserted into a Tyvek®pouch. Pouch and IFUplaced in bleached sulfatecarton box. | Catheter placed into apolyethylene dispenser hoop.Introducer and shaping 'mandrel placed onpolyethylene packaging card.Dispenser hoop andpackaging card inserted intoTyvek® pouch. Pouch andIFU placed in bleachedsulfate carton box. |
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Verification and Test Summary:
| Bench Testing | ||
|---|---|---|
| Test | Results | Conclusions |
| Simulated Use | Test articles achieved a rating $\ge$ 3for preparation/ease of assembly,introducer sheath interaction,introducer peel away, trackingwith guidewire/microcatheter,microcatheter/guidewire lockup,lubricity and durability ofhydrophilic coating, microcatheter/guidewire removal, removal/aspiration of clot, mechanical clotretriever and stent delivery with noparticles | Device performs as intendedunder simulated use conditions |
| Equipment Interface | Test articles compatible with0.035-inch and 0.038-inchguidewires, 6F or larger guidecatheter/guiding sheath, commonRHVs using insertion tool,stopcocks and $\le$ 0.027-inchmicrocatheters | Device compatible withrecommended accessoriescommonly used in intravascularprocedures |
| Dimensional and Physical Attributes | Test articles met the specifieddimensional requirements forcatheter OD, catheter ID, overallworking length, length of distalsection, length of distal tip tomarker band and total length ofhub/strain relief | Device met establisheddimensional and physicalspecifications |
| Kink Resistance | No kinks at 1 cm, 4 cm, 12 cm and25 cm from distal tip whenwrapped around 0.025-inch and0.030-inch pin gaugesNo kinks noted during simulateduse testing | Device resistant to kinkingaround small radii turns |
| Tip Shapeability | Tip angle of test article equivalentto competitive devices after steamshaping using mandrel with anangle of approximately 90° | Shapeability of distal tip aftersteam shaping equivalent tocompetitive devices |
| Radio Detectability | Distal marker band visible underfluoroscopy | Device radiopacity equivalent toor better than predicate andcompetitive devices |
| Bench Testing | ||
| Test | Results | Conclusions |
| Gauging (ISO 594-2) | Gauging pin and hub align in limitplanes | Device hub meets therequirements of ISO 594-2 |
| Separation Force (ISO 594-2) | Mating parts separation forcegreater than 25 N | Device hub meets therequirements of ISO 594-2 |
| Unscrewing Torque (ISO 594-2) | Test article luer remains attachedafter applying an unscrewing torquenot less than 0.02 Nm for aminimum of 10 seconds | Device hub meets therequirements of ISO 594-2 |
| Stress Cracking (ISO 594-2) | No stress cracks on test article hub | Device hub meets therequirements of ISO 594-2 |
| Ease of Assembly (ISO 594-2) | Components fit together securelywith no resistance observed betweentest article luer and reference fitting | Device hub meets therequirements of ISO 594-2 |
| Resistance to Overriding (ISO 594-2) | Test article luer does not overridereference fitting threads | Device hub meets therequirements of ISO 594-2 |
| Durability/Lubricity of HydrophilicCoating | Test article achieved a rating of ≥ 3during simulated use testing forcoating durability and lubricity. | Device tracks easily with nocoating cracking or separation |
| Catheter Stiffness | Device stiffness equivalent topredicate and competitive devices | Device tracks in tortuousanatomy while advancing totarget site |
| Torque Strength | No catheter breakage after 50rotations | Device torque strength sameas predicate device |
| Catheter Flexural Fatigue | No flexural fatigue followingrepeated bending during simulateduse testing and repeated hoop stressfollowing pressure and air aspirationtesting | Device integrity suitable forintended clinical use |
| Surface Contamination | Test article free from surfacecontaminants from uncured coatingsurface particulates > 0.02 mm², embedded particulates | Device integrity suitable forintended clinical use |
| Distal tip smooth and taperedPTFE inner layer not delaminated | ||
| Force at Break (Distal and Hub) | Catheter force at break ≥2.251bf fordistal section and hub/catheterjunction | Tensile strength test resultsequivalent to predicate andcompetitive devices |
| Bench Testing | ||
| Test | Results | Conclusions |
| Flow Rate | Flow rate at 100 psi and 300 psiwith diagnostic agents (e.g., saline,contrast media) equivalent to orbetter than competitive devices | Device meets specifiedrequirements for delivery ofdiagnostic agents |
| Static Burst Pressure | No damage of pressurized catheterat 46 psi | Device integrity suitable forintended clinical use and metrequirements of ISO 10555-1 |
| Fluid Leakage at > 46 psi | No liquid leakage from hub andcatheter shaft at 46 psi for 30seconds | Device integrity suitable forintended clinical use and metrequirements of ISO 10555-1 |
| Air Leakage | No air leakage at hub into syringefor 15 seconds | Device integrity suitable forintended clinical use and metrequirements of ISO 10555-1 |
| Dynamic Burst | Test articles did not burst at orbelow 300 psi | Device met labeled maximuminfusion pressure of 300 psi |
| Particulate Test | Less than 25 particles greater than10 microns per ml volume and lessthan 3 particles less than 25 micronsper ml volumeNo particles greater than 70 microns | Device met specifications formaximum allowable particles |
.
・
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. . . . .
:
:
| Biocompatibility | |||
|---|---|---|---|
| Test | Results | Conclusions | |
| Cytotoxicity - MEM Elution Assay(ISO 10993-5) | Cell culture treated with test articleexhibited slight reactivity (Grade 1) | Non-cytotoxic | |
| Sensitization/Irritation - KligmanMaximization Test (ISO 10993-10) | Extracts of the test article elicited noreaction at the challenge (0%sensitization) following theinduction phase (Grade 1). | Weak allergic potential orsensitizing capacity | |
| Sensitization/Irritation -Intracutaneous Injection Test (ISO10993-10) | Extracts of the test article did notshow a significantly greaterbiological reaction than the sitesinjected with the control article | Non-irritant | |
| Hemocompatibility - Rabbit BloodDirect and Indirect Contact (ISO10993-4) | The hemolysis index was 0.13%(direct contact) and 0.0% (indirectcontact) | Non-hemolytic |
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| Biocompatibility | |||
|---|---|---|---|
| Test | Results | Conclusions | |
| Hemocompatibility - UnactivatedPartial Thromboplastin Time AssayDirect Contact (ISO 10993-4) | No statistically significantdifference found between theUnactivated Partial ThromboplastinTime (UPTT) of the plasma exposedto the test article and that of theplasma exposed to either thenegative control or the untreatedcontrol | No effect on coagulation | |
| Hemocompatibility - ComplementActivation Assay (ISO 10993-4) | C3a and SC5b-9 levels $ \u2264 $ negativeand untreated controls | No effect on complementactivation | |
| Hemocompatibility -Thrombogenicity Study in Dogs (ISO10993-4) | Minimal thrombosis observed witha Grade 0 in two out of two test sitesand two out of two control sites | No significant thrombosis | |
| Systemic Toxicity - SystemicInjection Test(ISO 10993-11) | Extracts of test article did notinduce a significantly greaterbiological reaction than the controlextracts when injected in SwissAlbino mice | No toxic effects | |
| Systemic Toxicity - Rabbit PyrogenTest (ISO 10993-11) | The temperature increases(maximum) was 0.03°C frombaseline | Non-pyrogenic |
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 Chaperon Guiding Catheter (K082385) and the HEADWAY DUO Microcatheter (K120917) devices. The devices:
- Have an equivalent intended use, "
- 트 Use the same operating principle,
- . Incorporate the same basic design,
- . Are packaged and sterilized using the same methods.
In summary, the SOFIA Distal Access Catheter described in this substantially equivalent to the predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/7/Picture/1 description: The image shows the seal for the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is a stylized image of a bird.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 22, 2013
Micro Vention. Inc. c/o Ms. Naomi Gong Sr. Regulatory Affairs Project Manager 1311 Valencia Avenue Tustin, CA 92780
Re: K131482
Trade/Device Name: SOFIA Distal Access Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DOY, DQO Dated: October 22, 2013 Received: October 23, 2013
Dear Ms. 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
{8}------------------------------------------------
Page 2 - Ms. Naomi Gong
forth in the quality systems (QS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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,
Joyce M. Whang-S
for Victor Krauthamer, Ph.D. Acting 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): K131482
Device Name: SOFIA Distal Access Catheter
Indications For Use:
The SOFIA Distal Access Catheter is intended for general intravascular use, including The GOT IA Dicture al vasculature. It can be used to facilitate the introduction of the nours and therapeutic agents. It is not intended for use in coronary arteries.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
Joyce M. Whang -S
Page 1 of 1
§ 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).