(151 days)
Not Found
No
The description focuses on mechanical and material properties of a catheter introducer, with no mention of AI/ML terms or functionalities.
No
The device is a catheter introducer, which facilitates the placement of a catheter. It does not treat a condition or disease itself, but rather aids in a medical procedure.
No
Explanation: The device is a catheter introducer, a tool used to facilitate the placement of other catheters into the body. Its function is to create a pathway, not to diagnose a condition or disease. While it allows for a visual indication (flashback) of vessel penetration, this is a procedural confirmation, not a diagnostic finding.
No
The device description clearly outlines physical components (notched introducer needle, vented fitting, splittable sheath introducer) and the performance studies focus on physical characteristics and biocompatibility, indicating a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to facilitate placing a catheter through the skin into a vein or artery. This is a procedure performed on the patient's body, not on a sample taken from the patient's body.
- Device Description: The description details a physical device (needle, sheath) used for insertion into the body. It does not describe reagents, instruments, or software used to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. The "flashback" mentioned is a visual indication of vessel entry, not a diagnostic test performed on a sample.
- Performance Studies: The performance studies focus on the physical properties and biocompatibility of the device for insertion into the body, not on the accuracy or reliability of a diagnostic test.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a tool for a medical procedure, not for analyzing a biological sample.
N/A
Intended Use / Indications for Use
The catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.
Product codes
DYB
Device Description
The catheter introducer system is a notched introducer needle with a vented fitting and a splittable sheath introducer to facilitate percutaneous placement of a peripherally inserted central catheter (PICC) or midline catheter. The notched needle and clear sheath allow for easy insertion and a quick visual indication (flashback) when the vessel is penetrated. The catheter introducer is available to introduce 26ga/1.9Fr catheter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vein or artery
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)
No performance standards have been established under section 514 of the Food. Drug and Cosmetic Act for these devices. A series of testing was conducted in accordance with protocols based on requirements outlined in the guidance and industry standards and the results were shown to meet the acceptance criteria that were determined to demonstrate substantial equivalence.
The FirstStic™ N Introducer is substantially equivalent to the specified predicate devices based on comparisons of the device functionality, technological characteristics, and Indications for Use. The device design has been qualified through the following tests:
- Dimensional Analysis
- Lie Distance ●
- Needle Penetration Force ●
- Transition Penetration Force
- Sheath Crack Force
- Sheath Peeling Force
- Needle hub retention force
- Sheath hub retention force
- Visual confirmation of flashback ●
- Simulated Use
Biocompatibility testing per ISO 10993-1 was performed, consisting of the following tests:
- Cytotoxicity
- Sensitization
- Irritation/intracutaneous reactivity ●
- Acute Systemic Toxicity/Material Mediated Pyrogen
- Hemocompatibility (Hemolysis Direct and Indirect)
- Thrombogenicity
- Complement Activation Assay (Direct Contact) ●
The results of this testing demonstrates that the FirstStic™ N Introducer, is substantially equivalent to the predicate devices and did not raise new safety or performance questions.
An additional particulate analysis was conducted for FirstSticTM N Introducer and the results did not raise new safety or performance questions.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 seal of the U.S. Department of Health and Human Services. The seal features a stylized image of three human profiles facing right, arranged in a row. The profiles are connected by flowing lines that resemble ribbons or fabric. The seal is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 19, 2014
Argon Medical Devices, Inc. Ms. Suzanne Cheang Regulatory Affairs Manager 1445 Flat Creek Road Athens. TX 75751
Re: K141969
Trade/Device Name: FirstStic™ N Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: December 5, 2014 Received: December 8, 2014
Dear Ms. Cheang:
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
1
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 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/Resourcesfor You/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 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,
Melissa A. Torres -S
For Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
อานาธิเมริกัน (HAQC) เป็นเธอH โรวเมืองเขาเปลี่ยนตรี เดอ รอว่างอินา อุปกราชวนต์ เ
FOR FDA USE ONLY
A BEACH FLASH FLARAGE A NO AUNITHOS - BALL SIHT WOJBS ATTAW TON OG 32A319
(2) นิธุ์ (2) The quinter ประเทศ (2) อรม าคานเทอว์-อน) (2)
Type of Use (Select one or both, as applicable) of the days too been Carter (Free and Support of
Type of Use (Select one or both as applicable)
| Form Approved: OMB No. | 0910-0120 |
|---|---|
| Expiration Date: | December 31, 2013 |
| See PRA Statement on last page. |
| 510(k) Number (if known) | K141969 |
|---|---|
| Device Name | FirstStic™ N Introducer |
| Indications for Use (Describe) | The catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery. |
3
510(k) Summary
| Date Prepared: | December 9, 2014 |
|---|---|
| Company: | Argon Medical Devices, Inc. |
| 1445 Flat Creek Road | |
| Athens, TX 75751 | |
| Facility Registration number: 1625425 | |
| Contact: | Suzanne Cheang |
| Phone: 972-378-6980 | |
| Device trade name: | FirstStic ™ N Introducer |
| Device Common Name: | Catheter Introducer |
| Device classification: | Catheter Introducer |
| Product code, DYB | |
| 21 CFR 870.1340 | |
| Class II | |
| Legally marketed device to which the device is substantially equivalent: | K020834 |
| K093026 | |
| BD Introsyte-NT ™ Precision Introducer | |
| Footprint Medical 1.9Fr PICC Introducer | |
| Description of the device: | The catheter introducer system is a notched introducer needle with a vented fitting and a splittable sheath introducer to facilitate percutaneous placement of a peripherally inserted central catheter (PICC) or midline catheter. The notched needle and clear sheath allow for easy insertion and a quick visual indication (flashback) when the vessel is penetrated. The catheter introducer is available to introduce 26ga/1.9Fr catheter. |
| Indications for Use: | The catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery. |
| Technological Characteristics: | Comparisons of the FirstStic ™ N Introducer and predicate devices show that the technological characteristics such as product performance, design and intended use are substantially equivalent to the current marketed predicate devices. The FirstStic ™ N Introducer is similar in design – device dimensional specifications, and intended use, shelf life and sterilization process of that of the predicate devices. It is equivalent in materials to the predicate devices. |
4
Performance tests No performance standards have been established under section 514 of (Non-Clinical): the Food. Drug and Cosmetic Act for these devices. A series of testing was conducted in accordance with protocols based on requirements outlined in the guidance and industry standards and the results were shown to meet the acceptance criteria that were determined to demonstrate substantial equivalence.
The FirstStic™ N Introducer is substantially equivalent to the specified predicate devices based on comparisons of the device functionality, technological characteristics, and Indications for Use. The device design has been qualified through the following tests:
- Dimensional Analysis
- Lie Distance ●
- Needle Penetration Force ●
- Transition Penetration Force
- Sheath Crack Force
- Sheath Peeling Force
- Needle hub retention force
- Sheath hub retention force
- Visual confirmation of flashback ●
- Simulated Use
Biocompatibility testing per ISO 10993-1 was performed, consisting of the following tests:
- . Cytotoxicity
- Sensitization
- Irritation/intracutaneous reactivity ●
- Acute Systemic Toxicity/Material Mediated Pyrogen
- . Hemocompatibility (Hemolysis Direct and Indirect)
- . Thrombogenicity
- Complement Activation Assay (Direct Contact) ●
The results of this testing demonstrates that the FirstStic™ N Introducer, is substantially equivalent to the predicate devices and did not raise new safety or performance questions.
An additional particulate analysis was conducted for FirstSticTM N Introducer and the results did not raise new safety or performance questions.
Based on the Indications for Use, design safety and performance Substantial testing, the subject FirstStic™ N Introducer meets the requirements Equivalence: that are considered essential for its intended use and is substantially equivalent to the predicate devices.