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.

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.

AI/ML Overview

The provided text is a 510(k) summary for the Frontline Medical Products SafetyNet™ Guidewire Introducer. It describes the device, its intended use, and states that performance testing has demonstrated it meets functional requirements. However, this document does not contain the detailed acceptance criteria or the specific results of a study that proves the device meets those criteria, nor does it describe an AI/ML device.

Therefore, I cannot fulfill all your requests as the information is not present in the provided text.

Here's a breakdown of what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

Cannot create. The document states "Performance testing has demonstrated that the Frontline Medical Products SafetyNet™ Guidewire Introducer has met the functional requirements and specifications for the device," but it does not list specific acceptance criteria (e.g., tensile strength, flow rate, needle stick protection effectiveness in quantitative terms) or numerical performance results against those criteria.

2. Sample sized used for the test set and the data provenance

Cannot provide. The document mentions "Performance testing" but does not detail the sample size (number of devices tested) or the provenance of the data (e.g., country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This relates to studies involving expert review for AI/ML performance. The provided document describes a medical device, not an AI/ML system.

4. Adjudication method for the test set

Not applicable. This is relevant for AI/ML studies involving multiple expert readers.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This study type is for AI/ML devices.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This study type is for AI/ML devices.

7. The type of ground truth used

Not applicable in the typical sense for AI/ML. For this physical device, "ground truth" would refer to established engineering and biocompatibility standards. The document mentions "Biocompatibility testing on the Frontline Medical Products SafetyNet™ Guidewire Introducer included all tests required to satisfy ISO 10993 and FDA Memorandum G95-1 requirements," which implies adherence to these standards as a form of "ground truth." For performance, general "functional requirements and specifications" were met, but details are not given.

8. The sample size for the training set

Not applicable. This is for AI/ML devices; there is no "training set" for this physical medical device.

9. How the ground truth for the training set was established

Not applicable. This is for AI/ML devices.

In summary, the provided text outlines a regulatory submission for a traditional medical device (a guidewire introducer with a safety feature) and does not contain the detailed study results or AI/ML-specific information requested. The document focuses on regulatory compliance through substantial equivalence to predicate devices and general statements about meeting functional and biocompatibility requirements.

Summary

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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

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Device Description

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 * * * * *

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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

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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

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Statement of Indications for Use

510(k) Number (if known):

Frontline Medical Products SafetyNet Guidewire Introducer Device Name:

Indications for Use:

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

Regulation Number and Section

§ 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).