FIRSTSTIC N INTRODUCER

K141969 · Argon Medical Devices, Inc. · DYB · Dec 19, 2014 · Cardiovascular

Device Facts

• Record ID: K141969
• Device Name: FIRSTSTIC N INTRODUCER
• Applicant: Argon Medical Devices, Inc.
• Product Code: DYB · Cardiovascular
• Decision Date: Dec 19, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.

Device Story

FirstStic™ N Introducer is a catheter introducer system consisting of a notched introducer needle with a vented fitting and a splittable sheath. Used by clinicians to facilitate percutaneous placement of PICC or midline catheters. The notched needle and clear sheath provide visual confirmation (flashback) upon vessel penetration. The device is used in clinical settings to assist in vascular access; it functions as a mechanical guide for catheter insertion. The system is designed for 26ga/1.9Fr catheters.

Clinical Evidence

Bench testing only. No clinical data. Testing included dimensional analysis, needle/transition penetration force, sheath crack/peeling force, hub retention forces, visual flashback confirmation, and simulated use. Biocompatibility testing included cytotoxicity, sensitization, irritation, acute systemic toxicity, hemocompatibility, thrombogenicity, and complement activation. Particulate analysis was also performed.

Technological Characteristics

Catheter introducer system comprising a notched needle with vented fitting and splittable sheath. Materials are equivalent to predicate devices. Sterilization process and shelf life are consistent with predicates. Designed for 26ga/1.9Fr catheters. Mechanical device; no energy source or software.

Indications for Use

Indicated for patients requiring percutaneous placement of a peripherally inserted central catheter (PICC) or midline catheter into a vein or artery.

Regulatory Classification

Identification

A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.

Predicate Devices

• BD Introsyte-NT™ Precision Introducer (K020834)
• Footprint Medical 1.9Fr PICC Introducer (K093026)

Submission Summary (Full Text)

{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 [phone] or [phone] 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 [phone] or [phone] 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: [phone] |
| 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.