SAFETYNET GUIDEWIRE INTRODUCER

K040029 · Injectimed, Inc. · DYB · Apr 5, 2004 · Cardiovascular

Device Facts

• Record ID: K040029
• Device Name: SAFETYNET GUIDEWIRE INTRODUCER
• Applicant: Injectimed, Inc.
• Product Code: DYB · Cardiovascular
• Decision Date: Apr 5, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

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.

Device Story

Sterile, single-use disposable guidewire introducer; gauge sizes 18G-21G; lengths up to 2.75". Device consists of hypodermic needle with luer hub and integrated spring-loaded plastic safety guard. Used in vascular procedures for percutaneous guidewire placement. After guidewire insertion, user deploys safety guard via one-handed squeeze mechanism; hinged trap locks over needle point; sliding bushing prevents guard removal. Protects clinician from accidental sharps injury post-procedure. Disposed of in sharps container.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993 and FDA Memorandum G95-1 for externally communicating, circulating blood devices with limited contact duration. Functional performance testing confirmed device meets specifications.

Technological Characteristics

Materials: molded plastic luer hub, needle cannula, spring-loaded plastic safety guard. Dimensions: 18G-21G, lengths up to 2.75". Mechanism: spring-loaded guard with hinged trap and sliding bushing. Sterilization: single sterile units or bulk non-sterile. No software or electronics.

Indications for Use

Indicated for percutaneous introduction and placement of guidewires in vascular procedures. For single use. No specific patient population or contraindications defined.

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

• Hart Enterprises Single Wall Introducer Needle (K843719)
• Manan Manufacturing Co. GWI Guide Wire Introducer (K851834)
• Needletech, Inc. Guidewire Introducer Needle (K031173)
• Medamicus Axia RSN™ Guidewire Introducer Safety Needle (K011085, K020563 and K022689)

Submission Summary (Full Text)

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