(205 days)
Not Found
No
The summary describes a physical catheter and its intended use for delivering agents. There is no mention of software, algorithms, or any technology that would suggest AI/ML is involved. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is described as a microcatheter intended for the infusion of both diagnostic and therapeutic agents, such as occlusion coils, but the device itself is a delivery mechanism, not the therapeutic agent.
No
The device is described as being for the "infusion of diagnostic agents, such as contrast media, and therapeutic agents". While it infuses diagnostic agents, the device itself is not performing diagnosis.
No
The device description clearly describes a physical catheter, introducer sheath, and shaping mandrel, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "general intravascular use" for the infusion of diagnostic and therapeutic agents within the body. IVDs are used to examine specimens from the body (like blood, urine, tissue) in vitro (outside the body) to provide information about a patient's health.
- Device Description: The description details a catheter designed to be introduced into the vasculature, which is an in vivo (within the body) application.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.
Therefore, the Headway Microcatheter is an in vivo medical device, not an IVD.
N/A
Intended Use / Indications for Use
The Headway Microcatheter is intended for general intravascular use, including the peripheral, coronary and neuro vasculature for the infusion of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils.
Product codes (comma separated list FDA assigned to the subject device)
DQY, DQO
Device Description
The Headway 27 Microcatheter is a single lumen catheter designed to be introduced over a steerable guidewire to access small, tortuous vasculature. The semi-rigid proximal section transitions to a flexible distal tip to facilitate advancement through vessels. Dual radiopaque markers at the distal end facilitate fluoroscopic visualization. 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
peripheral, coronary and neuro 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:
- Surface Contamination: Passed (Free from uncured hydrophilic coating, No surface particulate > .02 mm per tappi chart, Free from surface defect/no sharp edges, Embedded particulate acceptable if OD is in specification, Free from damage)
- Dimensional Attributes: Passed (150 +/- 2 cm effective length, .027" (0.69 mm) lumen, nominal .040"/.034-.028" (1.0/.86--.71 mm) outer diameter, >= 6cm length of distal OD)
- Force at break: Passed (>= 1.12 lbs (5.0 N) for outer diameters from .030" to .045" (.76 to 1.1 mm))
- Freedom from Leakage (Liquid): Passed (No liquid leaking from hub and catheter shaft at 46 psi (317.2 kPa) for 30 second duration)
- Freedom from Leakage (air): Passed (No liquid leaking from hub and catheter shaft at 300 psi/2068 kPa (rated burst pressure) for 10 second duration)
- Burst Pressure of Catheter: Passed (No air leaking into syringe for 15 seconds)
- Dynamic Burst Pressure: Passed (Microcatheter will not burst below 300 psi (2068 kPa))
- Durability and Lubricity of Hydrophilic Coating: Passed (Rated 3 or higher (simulated use))
- Tip Shape and Tip Retention: Passed (Tip retain better than 55% of its original shape)
- Simulated Use: Passed (Rated 3 or higher in tested categories)
- Compatibility with agents: Passed (Rated 3 or higher in tested applicable categories)
- Flow Rate: N/A (Reference data)
- Kink Resistance: Passed (Equivalent to or better kink resistance than competitive)
- Catheter Stiffness: N/A (Document stiffness using Tinius Olsen - reference data only)
- Catheter Flexural Fatigue: Passed (Acceptable results per conditions: Flexural fatigue (simulated use, tip shaping testing) and Hoop stress fatigue (flow rate, dynamic burst, liquid leakage))
- Catheter Particle Testing: Passed (Per USP - less than 25 particles greater than 10 microns and less than 3 particles greater than 25 micron)
- Dead Space: N/A (Reference data)
- Torque Test: Passed (50 rotations without catheter breakage or equivalent to competitive product catheters)
- DMSO Test: Passed (Functional performance and chemical stability)
Biocompatibility:
- Cvtotoxicity ISO 10993-5 MEM Elution Test: Non-toxic (Cell culture tested with test article exhibited slight reactivity (Grade 1))
- Cytotoxicity ISO 10993-5 Cell Culture Agar Overlay: Non-toxic (Grade 2: zone limited to under specimen)
- Sensitization ISO 10993-10 Guinea Pig Maximization Test: Non-irritant (Grade 0: No visible change)
- Irritation ISO 10993-10 Intracutaneous Reactivity Evaluation Test: Non-irritant (Comparative between control and test article 10%, No reaction found)
- Systemic toxicity - Rabbit Pyrogen Test (ISO10993-11): Non-pyrogenic (Temperature increases was 0.0℃ from baseline)
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is placed to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 26, 2015
MicroVention, Inc. Ms. Cynthia Valenzuela Sr. International Regulatory Affairs 1311 Valencia Avenue Tustin, California 92780
Re: K142449 Trade/Device Name: Headway 27 Microcatheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: January 19, 2015 Received: February 27, 2015
Dear Ms. Valenzuela,
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
1
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
2
Indications for Use
510(k) Number (if known) K142449
Device Name Headway 27 Microcatheter
Indications for Use (Describe)
The Headway Microcatheter is intended for general intravascular use, including the peripheral, coronary and neuro vasculature for the infusion of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils.
Type of Use (Select one or both, as applicable)
| Research Use (Part 21 CFR 312) or Screening Purposes |
|---|
| Compassionate Use (21 CFR 312.310) |
Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
1.3. 510(k) Summary
| Trade Name: | Headway 27 Microcatheter |
|---|---|
| Generic Name: | Percutaneous Catheter |
| Classification: | Class II, 21 CFR 870.1250 (DQY), 21CFR 870.1200 (DQO) |
| Submitted By: | MicroVention, Inc. |
| 1311 Valencia Avenue | |
| Tustin, California U.S.A. | |
| Contact: | Cynthia Valenzuela (714) 247 8053 or (949) 413-0071 |
| Date: | 2014 AUG 06 |
| Predicate Device: | Headway 27 Microcatheter (K110813) |
510(k) Summary
Device Description:
The Headway 27 Microcatheter is a single lumen catheter designed to be introduced over a steerable guidewire to access small, tortuous vasculature. The semi-rigid proximal section transitions to a flexible distal tip to facilitate advancement through vessels. Dual radiopaque markers at the distal end facilitate fluoroscopic visualization. An introducer sheath and shaping mandrel are also provided.
Indications For Use:
The Headway Microcatheter is intended for general intravascular use, including the peripheral, coronary and neuro vasculature for the infusion of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils.
| Headway 27 (predicate) | Headway 27 (proposed) | |
|---|---|---|
| Intended Use | The Headway microcatheter is intended | |
| for general intravascular use, including the | ||
| peripheral, coronary and neurovasculature- | ||
| for the infusion of diagnostic and | ||
| therapeutic agents. | Same | |
| Material | Same | |
| Catheter Body | ||
| 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 | ||
| Marker | ||
| Platinum/Iridium | ||
| Hub | ||
| Nylon | ||
| Strain Relief | ||
| Pebax | ||
| Introducer | ||
| Pebax | ||
| Shaping Mandrel | Stainless steel |
Technological Comparison:
4
| Proximal ID/OD | ID = .027" min
OD = .040" | ID = .0278" min
OD = .040" |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|
| Distal ID/OD | ID = .027" min
OD = .034" | ID = .027" min
OD = .035" |
| Effective Length | 150 cm | 156 cm |
| Coating | Hydrophilic coating
(Hydak® - same) | Same |
| Tip Configuration | Straight - Steam Shapeable by physician
prior to use | Same |
| Guidewire Compatibility | 0.018" wires or smaller | 0.014"/0.016"/0.018"/0.021" |
| 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 mandrel
placed on a polyethylene packaging card that is
inserted into a Tyvek® pouch. Pouch and IFU
placed in bleached sulfate carton box. | Same |
Technological Comparison (conti.):
Verification and Test Summary:
| Bench Testing | Acceptance Criteria | Result | |
|---|---|---|---|
| Surface Contamination | • Liquid on surface | ||
| • Particulate on external | |||
| surface | |||
| • Surface defects/sharp | |||
| edges | • Free from uncured | ||
| hydrophilic coating. | |||
| • No surface | |||
| particulate > .02 mm² | |||
| per tappi chart | |||
| • Free from surface | |||
| defect/no sharp edges | |||
| • Embedded particulate | |||
| acceptable if OD is in | |||
| specification | |||
| • Free from damage | Passed | ||
| Dimensional Attributes | • Catheter effective | ||
| length | |||
| • Catheter lumen | |||
| • Catheter outer | |||
| diameter | |||
| • Length of distal OD | |||
| (2.2Fr section) | • 150 ± 2 cm | ||
| • .027" (0.69 mm) | |||
| • nominal .040"/.034- | |||
| .028" (1.0/.86--.71 | |||
| mm) | |||
| • ≥ 6cm | Passed | ||
| Force at break | Device shall not break | ||
| during use | ≥ 1.12 lbs (5.0 N) for | ||
| outer diameters from | |||
| .030" to .045" (.76 to | |||
| 1.1 mm) | Passed |
5
| Bench Testing | Acceptance Criteria | Result | |
|---|---|---|---|
| Freedom from Leakage | |||
| (Liquid) | (low pressure - long | ||
| duration) | |||
| Device shall not leak | |||
| fluids | No liquid leaking from | ||
| hub and catheter shaft at | |||
| 46 psi (317.2 kPa) for | |||
| 30 second duration | Passed | ||
| Freedom from Leakage | |||
| (air) | (high pressure - short | ||
| time) | |||
| Device shall not leak | |||
| fluids | No liquid leaking from | ||
| hub and catheter shaft at | |||
| 300 psi/2068 kPa (rated | |||
| burst pressure) for 10 | |||
| second duration | Passed | ||
| Burst Pressure of Catheter | Air shall not leak into | ||
| device | No air leaking into | ||
| syringe for 15 seconds | Passed | ||
| Dynamic Burst Pressure | Microcatheter will not | ||
| burst statically below | |||
| rated burst pressure. | Microcatheter: will not | ||
| burst below 300 psi | |||
| (2068 kPa) | Passed | ||
| Durability and Lubricity of Hydrophilic Coating- | |||
| Verification that hydrophilic coating does not delaminate | |||
| during use | Rated 3 or higher | ||
| (simulated use) | Passed | ||
| Tip Shape and Tip Retention | Tip retain better than | ||
| 55% of its original | |||
| shape | Passed | ||
| Simulated Use | Rated 3 or higher in | ||
| tested categories | Passed | ||
| Compatibility with agents | Rated 3 or higher in | ||
| tested applicable | |||
| categories | Passed | ||
| Flow Rate | Reference data | N/A | |
| Kink Resistance | Equivalent to or better | ||
| kink resistance than | |||
| competitive | Passed | ||
| Catheter Stiffness | Document stiffness | ||
| using Tinius Olsen - | |||
| reference data only | N/A | ||
| Catheter Flexural Fatigue | The catheter must have | ||
| acceptable results per | |||
| the following | |||
| conditions: |
- Flexural fatigue:
simulated use, tip
shaping testing - Hoop stress fatigue:
flow rate, dynamic
burst, liquid leakage, | Passed | |
6
| Bench Testing | Acceptance Criteria | Result |
|---|---|---|
| Catheter Particle Testing | Per USP - less | |
| than 25 particles greater | ||
| than 10 microns and less | ||
| than 3 particles greater | ||
| than 25 micron | Passed | |
| Dead Space | Reference data | N/A |
| Torque Test | 50 rotations without | |
| catheter breakage or | ||
| equivalent to | ||
| competitive product | ||
| catheters. | Passed | |
| DMSO Test | Functional performance | |
| and chemical stability | Passed |
| Biocompatibility | Results | Conclusion |
|---|---|---|
| Cvtotoxicity ISO 10993-5 | ||
| MEM Elution Test | Cell culture tested with test article | |
| exhibited slight reactivity (Grade 1) | Non-toxic | |
| Cytotoxicity ISO 10993-5 | ||
| Cell Culture Agar Overlay | Grade 2: zone limited to under | |
| specimen | Non-toxic | |
| Sensitization ISO 10993-10 | ||
| Guinea Pig Maximization Test | Grade 0: No visible change | Non-irritant |
| Irritation ISO 10993-10 | ||
| Intracutaneous Reactivity Evaluation | ||
| Test | Comparative between control and test | |
| article 10%. | ||
| No reaction found. | Non-toxic effects | |
| Systemic toxicity - Rabbit Pyrogen | ||
| Test (ISO10993-11) | Temperature increases was 0.0℃ from | |
| baseline. | Non-pyrogenic |
7
Summary of Substantial Equivalence:
The data presented in this submission demonstrates the technological similarity and equivalency of the Headway 27 Microcatheter when compared with the predicate device, Headway 27 Microcatheter (K110813).
The devices,
- " Have the same intended use,
- Use the same operating principle,
- Incorporate the same basic design,
- . Are packaged and sterilized using same methods.
In summary, the Headway 27 Microcatheter described in this submission was found to have a safety and effectiveness profile that is similar to the predicate devices.