(88 days)
Not Found
No
The device description focuses on mechanical components and a safety mechanism, with no mention of AI or ML. The "Mentions AI, DNN, or ML" field is also "Not Found".
No.
The device is a guidewire introducer for vascular procedures and includes a safety feature to reduce sharps injury. It is not described as having any therapeutic effect on a patient.
No
The device is a guidewire introducer designed for percutaneous introduction and placement of guidewires in vascular procedures, with a safety feature to reduce sharps injury. It does not perform any diagnostic function.
No
The device description clearly details a physical, sterile, single-use disposable device made of conventional hypodermic needle-type components and molded plastic parts, designed for percutaneous introduction of guidewires and featuring a mechanical safety guard. It does not describe software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "percutaneous introduction and placement of guidewires in vascular procedures." This is a procedural device used in vivo (within the body) to facilitate a medical procedure.
- Device Description: The description details a needle-type introducer with a safety feature. This aligns with a surgical or procedural tool, not a device used to test samples in vitro (outside the body).
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information based on sample analysis
- Reagents or test kits
The device's function is to physically introduce a guidewire into a blood vessel, which is a direct medical intervention, not a diagnostic test performed on a sample.
N/A
Intended Use / Indications for Use
The Frontline Medical Products SafetyNet™ Guidewire Introducer is intended for single use, for percutaneous introduction and placement of guidewires in vascular procedures, with provision of a feature enabling the user to shield the needle point after use to reduce the risk of accidental sharps injury.
Product codes (comma separated list FDA assigned to the subject device)
DYB
Device Description
The Frontline Medical Products SafetyNet™ Guidewire Introducer is a sterile, single-use disposable device, available in gauge sizes from 18G to 21G and usable lengths up to 2.75." The 18G product is compatible with guidewires up to 0.038" diameter. the 21G is compatible with guidewires up to 0.021" diameter. The product consists of a conventional hypodermic needle-type guidewire introducer with molded plastic luer hub, modified to accept additional components to provide a needle protection feature. The additional components create a spring-loaded molded plastic safety guard assembly that is stored within a semi-rigid housing prior to deployment. After the needle is placed in the blood vessel and the quidewire is introduced, the user deploys the safety guard with a one-handed technique by squeezing two opposing tabs on the housing. This causes the safety quard to move forward to the end of the needle. when a hinged trap within the safety quard drops over the needle point, and is held in place by the spring. The safety guard is restrained from moving off the end of the needle by means of a sliding rigid bushing contained within the safety guard, that stops when reaching a small deformation (bump) that has been created on the distal end of the needle cannula during manufacturing. The used product is then disposed of in a sharps container according to routine policies and procedures. The deployed safety guard provides a reduced risk of accidental needlestick injury. The product will be packaged as single sterile units, or may be provided in bulk non-sterile form to manufacturers of procedure kits for inclusion as an accessory component.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Performance testing has demonstrated that the Frontline Medical Products SafetyNet™ Guidewire Introducer has met the functional requirements and specifications for the device.
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.
K843719, K851834, K031173, K011085, K020563, K022689
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
§ 870.1340 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
APR = 5 2004 510(k) Summary InjectiMed, Inc. Submitter: 2737 Palma Drive Ventura, CA 93003 805-658-1601 Phone: Contact: George C. Brdlik Vice President, Quality Assurance & Regulatory Affairs Phone: 760-390-3298 Proposed Device Identification and Classification: Proprietary Name: Frontline Medical Products SafetyNet™ Guidewire Introducer Common Name: Guidewire Introducer Classification Name and Reference: Catheter Introducer, § 870.1340 Cardiovascular Classification Panel: Product Code: DYB Requiatory Class: Il No performance standards have been Performance Standards:
Predicate Devices
- Hart Enterprises Single Wall Introducer Needle (K843719) ●
- Manan Manufacturing Co. GWI Guide Wire Introducer (K851834) ●
promulgated under Section 514
- Needletech, Inc. Guidewire Introducer Needle (K031173) ●
- Medamicus Axia RSN™ Guidewire Introducer Safety Needle . (K011085, K020563 and K022689)
Intended Use
The Frontline Medical Products SafetyNet™ Guidewire Introducer is intended for single use, for percutaneous introduction and placement of guidewires in vascular procedures, with provision of a feature enabling the user to shield the needle point after use to reduce the risk of accidental sharps injury.
1
Device Description
The Frontline Medical Products SafetyNet™ Guidewire Introducer is a sterile, single-use disposable device, available in gauge sizes from 18G to 21G and usable lengths up to 2.75." The 18G product is compatible with guidewires up to 0.038" diameter. the 21G is compatible with guidewires up to 0.021" diameter. The product consists of a conventional hypodermic needle-type guidewire introducer with molded plastic luer hub, modified to accept additional components to provide a needle protection feature. The additional components create a spring-loaded molded plastic safety guard assembly that is stored within a semi-rigid housing prior to deployment. After the needle is placed in the blood vessel and the quidewire is introduced, the user deploys the safety guard with a one-handed technique by squeezing two opposing tabs on the housing. This causes the safety quard to move forward to the end of the needle. when a hinged trap within the safety quard drops over the needle point, and is held in place by the spring. The safety guard is restrained from moving off the end of the needle by means of a sliding rigid bushing contained within the safety guard, that stops when reaching a small deformation (bump) that has been created on the distal end of the needle cannula during manufacturing. The used product is then disposed of in a sharps container according to routine policies and procedures. The deployed safety guard provides a reduced risk of accidental needlestick injury. The product will be packaged as single sterile units, or may be provided in bulk non-sterile form to manufacturers of procedure kits for inclusion as an accessory component.
Biocompatibility and Performance Testing
Biocompatibility testing on the Frontline Medical Products SafetyNet™ Guidewire Introducer included all tests required to satisfy ISO 10993 and FDA Memorandum G95-1 requirements. The product's fluid path components are considered to be Externally Communicating, Circulating Blood, with limited contact duration.
Performance testing has demonstrated that the Frontline Medical Products SafetyNet™ Guidewire Introducer has met the functional requirements and specifications for the device.
-
-
-
-
- End of 510(k) Summary * * * * *
-
-
-
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, representing medicine and healing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 5 2004
InjectiMed, Inc. c/o Mr. George C. Brdlik GCB Enterprises Vice President, Quality Assurance & Regulatory Affairs 6442 Merlin Drive Carlsbad, CA 92009
Re: K040029
Frontline Medical Products SafetyNet™ Guidewire Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: January 6, 2004 Received: January 8, 2004
Dear Mr. Brdlik:
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). Tourmay, therefore, market the device, subject to the general controls provisions of the Act. Troundly, controls provisions of the Act include requirements for annual registration five. The echnola manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality
3
Page 2 - Mr. George C. Brdlik
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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4648. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Dona R. Vidmer
( Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Statement of Indications for Use
510(k) Number (if known):
Frontline Medical Products SafetyNet Guidewire Introducer Device Name:
Indications for Use:
The Frontline Medical Products SafetyNet™ Guidewire Introducer is intended for single use, for percutaneous introduction and placement of guidewires in vascular procedures, with provision of a feature enabling the user to shield the needle point after use to reduce the risk of accidental sharps injury.
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 CDRH, Office of Device Evaluation (ODE)
Dana R. DeMaret
Sign-Off) : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : Line of Cardiovascular Devices
510(K) Number KO4629