(58 days)
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI/ML or related concepts like image processing or data analysis.
No
The device is an introducer for guide wires and catheters, facilitating their placement in a vein or artery. It does not provide any therapeutic
action itself.
No
The device is described as an introducer to facilitate the insertion of a guide wire and catheter, which is a procedural tool and not used for diagnosis.
No
The device description clearly outlines physical components (plastic housing, wheels, guide wire) and mechanical actions, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- SonoStik Guide Wire Introducer Function: The description clearly states the device is used to "facilitate the introduction of a guide wire and catheter through the skin into a vein or artery." It's a tool used during a medical procedure to access a blood vessel, not to analyze a sample outside the body.
- No Specimen Analysis: There is no mention of the device collecting or analyzing any biological specimens. Its function is purely mechanical, guiding a wire and catheter into the body.
The SonoStik Guide Wire Introducer is a medical device used for vascular access, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The SonoStik Guide Wire Introducer is used to facilitate the introduction of a guide wire and catheter through the skin into a vein or artery of the peripheral vasculature. The SonoStik Guide Wire Introducer is not intended for use in the coronary arteries or neurovasculature.
Product codes (comma separated list FDA assigned to the subject device)
DYB
Device Description
The SonoStik Guide Wire Introducer is intended to facilitate placing a catheter through the skin into a vein or artery of the peripheral vasculature. The device consists of a plastic housing containing an Introducer Wheel, an Advancing Wheel and a guide wire. The mechanism of action of the SonoStik Guide Wire Introducer is accomplished by the Introducer Wheel and the two Advancing Wheels inside the plastic housing. The SonoStik Guide Wire Introducer housing has a "male end" connector capable of mating with the back end of the needle introducer and accurately positions the guide wire through the plastic housing and into the back end of the needle. Once mated, the Introducer and cannula/needle are used to insert the needle into the tissue or vessel. The Introducer Wheel is turned, advancing the guide wire into the vessel lumen. The device has a transparent tube at the proximal end of the device which enables the user to visualize guide wire advancement as he/she engages the introducer wheel.
The SonoStik Guide Wire Introducer is intended to be used with one of two IV catheter and needle sets that have been previously cleared under 510(k) Premarket Notification. The two compatible IV catheter and needle sets are the B Braun Introcan Safety IV Catheter (K020785) and BD Angiocath IV (K950301).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vein or artery of the 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)
The following tests were conducted on the SonoStik Guide Wire Introducer to validate the design, manufacture, assembly, and performance:
- Visual Inspection. This test demonstrated that the device as manufactured meets dimensional specifications and is free of surface defects.
- Cycling Test. This test demonstrated that all moving components of the device can withstand repeated and repetitive use without failure or deterioration of function, with and without mated catheter needle set.
- Simulated Use Test. This test demonstrated that the device can perform the required steps in administering a venous catheter using a rubber arm phantom with simulated blood under average venous blood pressure.
- Guide Wire Tensile Test. This test demonstrated that the guide wire will not fragment or separate during normal operation, as well as quantifying the amount of guide wire travel.
- Corrosion Test. This test demonstrated that the guide wire exhibits corrosion resistance comparable to fully assembled devices over a 1-year shelf-life when tested in accordance with ISO 11070:2014(E).
All devices tested passed all tests. Therefore, data and results from the above tests demonstrate that the SonoStik Guide Wire Introducer meets its performance requirements, and can be found substantially equivalent to the performance of the predicate devices.
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.
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
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 1, 2015
Sonostik, LLC Richard Fogel CEO 14410 Turkey Foot Road North Potomac, Maryland 20878
Re: K152177
Trade/Device Name: Sonostik Guide Wire Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: July 31, 2015 Received: August 4, 2015
Dear Mr. Fogel:
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 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.
1
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,
Kenneth J. Cavanaugh -S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K152177
Device Name SonoStik Guide Wire Introducer
Indications for Use (Describe)
The SonoStik Guide Wire Introducer is used to facilitate the introduction of a guide wire and catheter through the skin into a vein or artery of the peripheral vasculature. The SonoStik Guide Wire Introducer is not intended for use in the coronary arteries or neurovasculature.
| 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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3
510(k) Summary
In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the SonoStik Guide Wire Introducer is provided below.
| Device Common Name: | Catheter Introducer |
|---|---|
| Device Proprietary Name: | SonoStik Guide Wire Introducer |
| Submitter: | SonoStik, LLC |
| 14410 Turkey Foot Road | |
| N. Potomac, MD 20878 | |
| Correspondent: | Richard Fogel |
| CEO, SonoStik, LLC | |
| 14410 Turkey Foot Road | |
| N. Potomac, MD 20878 | |
| 301-219-8552 | |
| dickfogel@gmail.com | |
| Classification Regulation: | 21 CFR 870.1340, Catheter Introducer, Class II |
| Panel: | Cardiovascular |
| Product Code: | DYB – Catheter Introducer |
| Date Prepared: | 09/15/15 |
| Primary Predicate Device: | Pinnacle Precision Access System, Terumo Medical Corp. |
| (K111606) | |
| Additional Predicate Device: | Endologix Guidewire, TechDevice Corporation (K110241) |
Indication for Use:
The SonoStik Guide Wire Introducer is used to facilitate the introduction of a guide wire and catheter through the skin into a vein or artery of the peripheral vasculature. The SonoStik Guide Wire Introducer is not intended for use in the coronary arteries or neurovasculature.
Device Description:
The SonoStik Guide Wire Introducer is intended to facilitate placing a catheter through the skin into a vein or artery of the peripheral vasculature. The device consists of a plastic housing containing an Introducer Wheel, an Advancing Wheel and a guide wire. The mechanism of action of the SonoStik Guide Wire Introducer is accomplished by the Introducer Wheel and the two Advancing Wheels inside the plastic housing. The SonoStik Guide Wire Introducer housing has a "male end" connector capable of mating with the back end of the needle introducer and accurately positions the guide wire through the plastic housing and into the back end of the needle. Once mated, the Introducer and cannula/needle are used to insert the needle into the tissue or vessel. The Introducer Wheel is turned, advancing the guide wire into the vessel lumen. The device has a transparent tube at the proximal end of the device which enables the user to visualize guide wire advancement as he/she engages the introducer wheel.
4
The SonoStik Guide Wire Introducer is intended to be used with one of two IV catheter and needle sets that have been previously cleared under 510(k) Premarket Notification. The two compatible IV catheter and needle sets are the B Braun Introcan Safety IV Catheter (K020785) and BD Angiocath IV (K950301).
Biocompatibility
In accordance with ISO 10993, the contact category of SonoStik Guide Wire Introducer is: Externally Communicating Devices, Circulating Blood, Limited Exposure (>24 hrs). The following biocompatibility testing was conducted on the patient contacting and potentially blood contacting materials:
- Cytotoxicity ISO 10993-5 ●
- Sensitization ISO 10993-10 ●
- Irritation / Intracutaneous Reactivity ISO 10993-10 ●
- Systemic Toxicity ISO 10993-11 ●
- . Pyrogenicity ISO 10993-11
- Thrombogenicity ISO 10993-4 ●
- Hemocompatibility ISO 10993-4 ●
Sterilization
The SonoStik Guide Wire Introducer is provided sterile. It is for single use only. The device is not sold with any additional accessories or components. The device is sterilized using traditional Ethylene Oxide and was validated in accordance with ANSI/AAMI/ISO 11135-1: 2007.
Shelf Life
The shelf life for the SonoStik Guide Wire Introducer is 1 year. Shelf life testing was conducted to demonstrate that the device maintains sterility and functionality throughout its shelf life.
Performance Data
The following tests were conducted on the SonoStik Guide Wire Introducer to validate the design, manufacture, assembly, and performance:
-
- Visual Inspection. This test demonstrated that the device as manufactured meets dimensional specifications and is free of surface defects.
-
- Cycling Test. This test demonstrated that all moving components of the device can withstand repeated and repetitive use without failure or deterioration of function, with and without mated catheter needle set.
-
- Simulated Use Test. This test demonstrated that the device can perform the required steps in administering a venous catheter using a rubber arm phantom with simulated blood under average venous blood pressure.
-
- Guide Wire Tensile Test. This test demonstrated that the guide wire will not fragment or separate during normal operation, as well as quantifying the amount of guide wire travel.
5
-
- Corrosion Test. This test demonstrated that the guide wire exhibits corrosion resistance comparable to fully assembled devices over a 1-year shelf-life when tested in accordance with ISO 11070:2014(E).
All devices tested passed all tests. Therefore, data and results from the above tests demonstrate that the SonoStik Guide Wire Introducer meets its performance requirements, and can be found substantially equivalent to the performance of the predicate devices.
- Corrosion Test. This test demonstrated that the guide wire exhibits corrosion resistance comparable to fully assembled devices over a 1-year shelf-life when tested in accordance with ISO 11070:2014(E).
Substantial Equivalence Discussion
The primary predicate device for the SonoStik Guide Wire Introducer is the Pinnacle Precision Access System (K111606). The guide wire used in the subject device was previously cleared in K110241 and is therefore provided as an additional predicate device to support substantial equivalence. Like the predicate devices, the subject device is indicated for use to facilitate the introduction of a guide wire and catheter through the skin into a vein or artery. Therefore the indication statement of the subject device is substantially equivalent to the predicate devices.
The SonoStik Guide Wire Introducer and the Pinnacle Precision Access System (K111606) have similar components which function in the same manner and similar device specifications. Material differences and specification differences between the devices do not raise different questions of safety and effectiveness. A detailed comparison of the technological characteristics is provided in the following table.
| Proposed Device | Primary Predicate Device | |
|---|---|---|
| Device Name | SonoStik Guide Wire Introducer | Pinnacle Precision Access System |
| 510(k) Number | K152177 | K111606 |
| Submitter | SonoStik, LLC | Terumo Medical Corp. |
| Classification | ||
| Regulation | Catheter Introducer | |
| 870.1340 | Catheter Introducer | |
| 870.1340 | ||
| Product Code | DYB | DYB |
| Panel | Cardiovascular | Cardiovascular |
| Guide Wire Material | Stainless steel | Stainless steel or Nitinol w/Palladium |
| distal coil | ||
| Guide Wire Length | 19.5cm | 45cm |
| Guide Wire OD | .014" | .021" |
| Guide Wire Inserter | Polycarbonate | Polypropylene |
| Plastic Housing | Polycarbonate | NA |
Substantial Equivalence Conclusion:
On the basis of the above comparison of intended use and technological characteristics, the differences between the SonoStik Guide Wire Introducer and the Pinnacle Precision Access System do not raise different questions of safety and effectiveness and the devices can be found substantially equivalent.