(183 days)
Not Found
No
The device description and performance studies focus on the physical and mechanical properties of a catheter, with no mention of AI or ML.
No
The device is described as facilitating the introduction of other devices and therapeutic agents, implying it is a delivery tool rather than a therapeutic device itself.
No
The device is a catheter intended to facilitate the introduction of other devices and therapeutic agents, not to diagnose a condition.
No
The device description clearly outlines a physical catheter with various material and structural components, including coil and braid reinforcement, a hydrophilic coating, and a radiopaque marker. The performance studies also focus on physical and material properties, not software validation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "general intravascular use" to "facilitate the introduction of the neuro and therapeutic agents." This describes a device used within the body for delivering substances, not a device used to test samples outside the body to diagnose conditions.
- Device Description: The description details a catheter designed for navigation within blood vessels, which aligns with an in-vivo (within the body) application.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostic testing.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is entirely different.
N/A
Intended Use / 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.
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 and therapeutic agents. It is not intended for use in coronary arteries.
Product codes (comma separated list FDA assigned to the subject device)
DQY, DQO
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
neuro and peripheral vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench Testing:
- Simulated Use: 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. Device performs as intended under simulated use conditions.
- Equipment Interface: 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. Device compatible with recommended accessories commonly used in intravascular procedures.
- Dimensional and Physical Attributes: 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. Device met established dimensional and physical specifications.
- Kink Resistance: 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. Device resistant to kinking around small radii turns.
- Tip Shapeability: Tip angle of test article equivalent to competitive devices after steam shaping using mandrel with an angle of approximately 90°. Shapeability of distal tip after steam shaping equivalent to competitive devices.
- Radio Detectability: Distal marker band visible under fluoroscopy. Device radiopacity equivalent to or better than predicate and competitive devices.
- Gauging (ISO 594-2): Gauging pin and hub align in limit planes. Device hub meets the requirements of ISO 594-2.
- Separation Force (ISO 594-2): Mating parts separation force greater than 25 N. Device hub meets the requirements of ISO 594-2.
- Unscrewing Torque (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. Device hub meets the requirements of ISO 594-2.
- Stress Cracking (ISO 594-2): No stress cracks on test article hub. Device hub meets the requirements of ISO 594-2.
- Ease of Assembly (ISO 594-2): Components fit together securely with no resistance observed between test article luer and reference fitting. Device hub meets the requirements of ISO 594-2.
- Resistance to Overriding (ISO 594-2): Test article luer does not override reference fitting threads. Device hub meets the requirements of ISO 594-2.
- Durability/Lubricity of Hydrophilic Coating: Test article achieved a rating of ≥ 3 during simulated use testing for coating durability and lubricity. Device tracks easily with no coating cracking or separation.
- Catheter Stiffness: Device stiffness equivalent to predicate and competitive devices. Device tracks in tortuous anatomy while advancing to target site.
- Torque Strength: No catheter breakage after 50 rotations. Device torque strength same as predicate device.
- Catheter Flexural Fatigue: No flexural fatigue following repeated bending during simulated use testing and repeated hoop stress following pressure and air aspiration testing. Device integrity suitable for intended clinical use.
- Surface Contamination: 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. Device integrity suitable for intended clinical use.
- Force at Break (Distal and Hub): Catheter force at break ≥2.251bf for distal section and hub/catheter junction. Tensile strength test results equivalent to predicate and competitive devices.
- Flow Rate: Flow rate at 100 psi and 300 psi with diagnostic agents (e.g., saline, contrast media) equivalent to or better than competitive devices. Device meets specified requirements for delivery of diagnostic agents.
- Static Burst Pressure: No damage of pressurized catheter at 46 psi. Device integrity suitable for intended clinical use and met requirements of ISO 10555-1.
- Fluid Leakage at > 46 psi: No liquid leakage from hub and catheter shaft at 46 psi for 30 seconds. Device integrity 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 suitable for intended clinical use and met requirements of ISO 10555-1.
- Dynamic Burst: Test articles did not burst at or below 300 psi. Device met labeled maximum infusion pressure of 300 psi.
- Particulate Test: 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. Device met specifications for maximum allowable particles.
Biocompatibility Studies:
- Cytotoxicity - MEM Elution Assay (ISO 10993-5): Cell culture treated with test article exhibited slight reactivity (Grade 1). Non-cytotoxic.
- Sensitization/Irritation - Kligman Maximization Test (ISO 10993-10): Extracts of the test article elicited no reaction at the challenge (0% sensitization) following the induction phase (Grade 1). Weak allergic potential or sensitizing capacity.
- Sensitization/Irritation - Intracutaneous Injection Test (ISO 10993-10): Extracts of the test article did not show a significantly greater biological reaction than the sites injected with the control article. Non-irritant.
- Hemocompatibility - Rabbit Blood Direct and Indirect Contact (ISO 10993-4): The hemolysis index was 0.13% (direct contact) and 0.0% (indirect contact). Non-hemolytic.
- Hemocompatibility - Unactivated Partial Thromboplastin Time Assay Direct Contact (ISO 10993-4): 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. No effect on coagulation.
- Hemocompatibility - Complement Activation Assay (ISO 10993-4): C3a and SC5b-9 levels $\le$ negative and untreated controls. No effect on complement activation.
- Hemocompatibility - Thrombogenicity Study in Dogs (ISO 10993-4): Minimal thrombosis observed with a Grade 0 in two out of two test sites and two out of two control sites. No significant thrombosis.
- Systemic Toxicity - Systemic Injection Test (ISO 10993-11): Extracts of test article did not induce a significantly greater biological reaction than the control extracts when injected in Swiss Albino mice. No toxic effects.
- Systemic Toxicity - Rabbit Pyrogen Test (ISO 10993-11): The temperature increases (maximum) was 0.03°C from baseline. Non-pyrogenic.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).
0
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, Inc |
| 1311 Valencia Avenue | |
| Tustin, 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.
1
Technological Comparison:
| | Chaperon Guiding
Catheter | SOFIA Distal Access
Catheter | Headway Duo
Microcatheter | | Chaperon Guiding
Catheter | SOFIA Distal Access
Catheter | Headway Duo
Microcatheter |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|-----------------------------------------------------|----------------------------------------|-----------------------------------------|
| Intended Use | Intended for general
intravascular use, including
the neuro and peripheral
vasculature. It can be used
to facilitate the introduction
of diagnostic and
therapeutic agents. It is not
intended for use in coronary
arteries. | Intended for general
intravascular use, including
the neuro and peripheral
vasculature. It can be used
to facilitate the introduction
of diagnostic and
therapeutic agents. It is not
intended for use in coronary
arteries. | Intended for general
intravascular use, including
the peripheral and coronary
vasculature for the infusion
of diagnostic agents, such
as contrast media, and
therapeutic agents, such as
embolization materials.
Intended for neurovascular
use for the infusion of
diagnostic agents, such as
contrast media, and
therapeutic agents that have
been cleared or approved
for use in the
neurovasculature and are
compatible with the inner
diameter of the
microcatheter. | Catheter size | 5 F (outer catheter) | રે દ | 1.6 - 2.1 F. |
| Material
Catheter Body | Outer layer of polyester
elastomer; stainless steel
braid; inner layer of PTFE
(polytetrafluoroehthylene). | Outer layer of polyurethane
elastomer (Polyblend and
Pellethane), polyether block
amide (Pebax) and
polyamide (Grilamid); inner
layer of stainless steel
braid/coil, PTFE and
polyolefin elastomer | Outer layer of polyether
block amide (Pebax) and
polyamide (Grilamid); inner
layer of stainless steel
braid/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 (Terumo
proprietary 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 | Guidewire
Compatibility | 0.035 inch or 0.038 inch | 0.035 inch or 0.038 inch | 0.014 inch or smaller |
| Accessories | N/A | Introducer sheath and
shaping mandre! | Introducer sheath and
shaping mandrel . | | | | |
| Method of Supply | Sterile and single use | Sterile and single use | Sterile and single use | | | | |
| Sterilization
Method | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide | | | | |
| Packaging
Configuration | Catheter placed on
packaging card that is
inserted into Tyvek® pouch.
Pouch and IFU placed in
bleached sulfate carton box. | Catheter placed into a HDPE
dispenser tube. Dispenser
tube, introducer and shaping
mandrel placed on a
polyethylene packaging card
that is inserted into a Tyvek®
pouch. Pouch and IFU
placed in bleached sulfate
carton box. | Catheter placed into a
polyethylene dispenser hoop.
Introducer and shaping '
mandrel placed on
polyethylene packaging card.
Dispenser hoop and
packaging card inserted into
Tyvek® pouch. Pouch and
IFU placed in bleached
sulfate carton box. | | | | |
Page 2 of 7
·
י
2
3
Verification and Test Summary:
| Bench Testing | ||
|---|---|---|
| Test | Results | Conclusions |
| Simulated Use | Test articles achieved a rating $\ge$ 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 | Device performs as intended | |
| under simulated use conditions | ||
| Equipment Interface | 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 $\le$ 0.027-inch | ||
| microcatheters | Device compatible with | |
| recommended accessories | ||
| commonly used in intravascular | ||
| procedures | ||
| Dimensional and Physical Attributes | 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 | Device met established | |
| dimensional and physical | ||
| specifications | ||
| Kink Resistance | 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 | Device resistant to kinking | |
| around small radii turns | ||
| Tip Shapeability | Tip angle of test article equivalent | |
| to competitive devices after steam | ||
| shaping using mandrel with an | ||
| angle of approximately 90° | Shapeability of distal tip after | |
| steam shaping equivalent to | ||
| competitive devices | ||
| Radio Detectability | Distal marker band visible under | |
| fluoroscopy | Device radiopacity equivalent to | |
| or better than predicate and | ||
| competitive devices | ||
| Bench Testing | ||
| Test | Results | Conclusions |
| Gauging (ISO 594-2) | Gauging pin and hub align in limit | |
| planes | Device hub meets the | |
| requirements of ISO 594-2 | ||
| Separation Force (ISO 594-2) | Mating parts separation force | |
| greater than 25 N | Device hub meets the | |
| requirements of ISO 594-2 | ||
| Unscrewing Torque (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 | Device hub meets the | |
| requirements of ISO 594-2 | ||
| Stress Cracking (ISO 594-2) | No stress cracks on test article hub | Device hub meets the |
| requirements of ISO 594-2 | ||
| Ease of Assembly (ISO 594-2) | Components fit together securely | |
| with no resistance observed between | ||
| test article luer and reference fitting | Device hub meets the | |
| requirements of ISO 594-2 | ||
| Resistance to Overriding (ISO 594-2) | Test article luer does not override | |
| reference fitting threads | Device hub meets the | |
| requirements of ISO 594-2 | ||
| Durability/Lubricity of Hydrophilic | ||
| Coating | Test article achieved a rating of ≥ 3 | |
| during simulated use testing for | ||
| coating durability and lubricity. | Device tracks easily with no | |
| coating cracking or separation | ||
| Catheter Stiffness | Device stiffness equivalent to | |
| predicate and competitive devices | Device tracks in tortuous | |
| anatomy while advancing to | ||
| target site | ||
| Torque Strength | No catheter breakage after 50 | |
| rotations | Device torque strength same | |
| as predicate device | ||
| Catheter Flexural Fatigue | No flexural fatigue following | |
| repeated bending during simulated | ||
| use testing and repeated hoop stress | ||
| following pressure and air aspiration | ||
| testing | Device integrity suitable for | |
| intended clinical use | ||
| Surface Contamination | Test article free from surface | |
| contaminants from uncured coating | ||
| surface particulates > 0.02 mm², embedded particulates | Device integrity suitable for | |
| intended clinical use | ||
| Distal tip smooth and tapered | ||
| PTFE inner layer not delaminated | ||
| Force at Break (Distal and Hub) | Catheter force at break ≥2.251bf for | |
| distal section and hub/catheter | ||
| junction | Tensile strength test results | |
| equivalent to predicate and | ||
| competitive devices | ||
| Bench Testing | ||
| Test | Results | Conclusions |
| Flow Rate | Flow rate at 100 psi and 300 psi | |
| with diagnostic agents (e.g., saline, | ||
| contrast media) equivalent to or | ||
| better than competitive devices | Device meets specified | |
| requirements for delivery of | ||
| diagnostic agents | ||
| Static Burst Pressure | No damage of pressurized catheter | |
| at 46 psi | Device integrity suitable for | |
| intended clinical use and met | ||
| requirements of ISO 10555-1 | ||
| Fluid Leakage at > 46 psi | No liquid leakage from hub and | |
| catheter shaft at 46 psi for 30 | ||
| seconds | Device integrity 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 suitable for | |
| intended clinical use and met | ||
| requirements of ISO 10555-1 | ||
| Dynamic Burst | Test articles did not burst at or | |
| below 300 psi | Device met labeled maximum | |
| infusion pressure of 300 psi | ||
| Particulate Test | 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 | Device met specifications for
maximum allowable particles |
.
・
4
5
. . . . .
:
:
| Biocompatibility | |||
|---|---|---|---|
| Test | Results | Conclusions | |
| Cytotoxicity - MEM Elution Assay | |||
| (ISO 10993-5) | Cell culture treated with test article | ||
| exhibited slight reactivity (Grade 1) | Non-cytotoxic | ||
| Sensitization/Irritation - Kligman | |||
| Maximization Test (ISO 10993-10) | Extracts of the test article elicited no | ||
| reaction at the challenge (0% | |||
| sensitization) following the | |||
| induction phase (Grade 1). | Weak allergic potential or | ||
| sensitizing capacity | |||
| Sensitization/Irritation - | |||
| Intracutaneous Injection Test (ISO | |||
| 10993-10) | Extracts of the test article did not | ||
| show a significantly greater | |||
| biological reaction than the sites | |||
| injected with the control article | Non-irritant | ||
| Hemocompatibility - Rabbit Blood | |||
| Direct and Indirect Contact (ISO | |||
| 10993-4) | The hemolysis index was 0.13% | ||
| (direct contact) and 0.0% (indirect | |||
| contact) | Non-hemolytic |
6
| Biocompatibility | |||
|---|---|---|---|
| Test | Results | Conclusions | |
| Hemocompatibility - Unactivated | |||
| Partial Thromboplastin Time Assay | |||
| Direct Contact (ISO 10993-4) | 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 | No effect on coagulation | ||
| Hemocompatibility - Complement | |||
| Activation Assay (ISO 10993-4) | C3a and SC5b-9 levels $ \u2264 $ negative | ||
| and untreated controls | No effect on complement | ||
| activation | |||
| Hemocompatibility - | |||
| Thrombogenicity Study in Dogs (ISO | |||
| 10993-4) | Minimal thrombosis observed with | ||
| a Grade 0 in two out of two test sites | |||
| and two out of two control sites | No significant thrombosis | ||
| Systemic Toxicity - Systemic | |||
| Injection Test | |||
| (ISO 10993-11) | Extracts of test article did not | ||
| induce a significantly greater | |||
| biological reaction than the control | |||
| extracts when injected in Swiss | |||
| Albino mice | No toxic effects | ||
| Systemic Toxicity - Rabbit Pyrogen | |||
| Test (ISO 10993-11) | The temperature increases | ||
| (maximum) was 0.03°C from | |||
| baseline | 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.
7
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
9
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
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