FRONTLINE MEDICAL SAFETYNET GUIDEWIRE INTRODUCER

K073664 · Injectimed, Inc. · MDM · Aug 8, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K073664
• Device Name: FRONTLINE MEDICAL SAFETYNET GUIDEWIRE INTRODUCER
• Applicant: Injectimed, Inc.
• Product Code: MDM · General, Plastic Surgery
• Decision Date: Aug 8, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4800
• Device Class: Class 1

Intended Use

A percutaneous guidewire introducer for vascular and non-vascular procedures with activating safety shield to reduce needle stick injury during use and disposal.

Device Story

SafetyNET Guidewire Introducer is a manual surgical instrument designed for percutaneous introduction of guidewires in vascular and non-vascular procedures. Device consists of a stainless steel needle and a modified polycarbonate hub/spring assembly. Key feature is an integrated, activating safety shield; allows one-handed activation to cover the needle tip post-use. Used by clinicians in clinical settings to facilitate guidewire placement while reducing risk of accidental needle stick injuries during procedure and subsequent disposal. Device is sterile, single-use, and disposable.

Clinical Evidence

Bench testing only. Product and materials meet all applicable test requirements per ISO 10993-1.

Technological Characteristics

Sterile, single-use, disposable stainless steel needle; modified polycarbonate hub/spring assembly; manual activation mechanism; biocompatibility per ISO 10993-1.

Indications for Use

Indicated for use as a percutaneous guidewire introducer in vascular and non-vascular procedures, incorporating a safety shield to mitigate needle stick injuries during clinical use and disposal.

Regulatory Classification

Identification

A manual surgical instrument for general use is a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892 of this chapter.

Predicate Devices

• SafetyNET Guidewire Introducer (K040029)
• Light Saber Introducer Needle (K013040)

Submission Summary (Full Text)

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K073664

p. (of)

Premarket Notification
SafetyNET Guidewire Introducer

InjectiMed Inc
Ventura, CA

# VIII. Premarket Notification 510(k) Summary

| Submitted by: | InjectiMed Inc<br>2737 Palma Drive<br>Ventura, CA 93003 | AUG - 8 2008 |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Contact person: | Thomas C. Kuracina<br>President | |
| Date prepared: | December 20, 2007 | |
| Device proprietary name: | SafetyNET Guidewire Introducer | |
| Common name: | Percutaneous Guidewire Introducer | |
| Classification name: | Manual surgical instrument for general use<br>21 CFR Sec. 878.4800 | |
| Predicate devices: | SafetyNET Guidewire Introducer (K040029) | |
| | Light Saber Introducer Needle (K013040) | |
| Description of the device: | A needle and hub device for the percutaneous<br>introduction of a guide wire, with a hub modification<br>to allow one-handed activation of a sheath to cover<br>the needle and help prevent accidental needle sticks<br>during use and disposal. | |
| Intended use: | A percutaneous guidewire introducer for vascular<br>and non-vascular procedures with activating safety<br>shield to reduce needle stick injury during use and<br>disposal. | |
| Characteristics: | Sterile, single-use, disposable stainless steel needle<br>with modified polycarbonate hub/spring assembly | |
| Testing | Product and materials meet all applicable test<br>requirement per ISO 10993-1 | |

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

InjectiMed, Inc. % Washington Regulatory Consultants Mr. Richard Hunter, MS, RAC 5616 Mariola Place, NE Albuquerque, New Mexico 87111

AUG - 8 2008

Re: K073664

Trade/Device Name: SafetyNET Guidewire Introducer Regulation Number: 21 CFR 878.4800 Regulation Name: Manual surgical instrument for general use Regulatory Class: II Product Code: MDM Dated: July 7, 2008 Received: July 10, 2008

Dear Mr. Hunter:

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.

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 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.

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#### Page 2 Mr. Richard Hunter, MS, RAC

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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/industry/support/index.html.

Sincerely yours,

Mark M. Milliman

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K073664

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Premarket Notification SafetyNET Guidewire Introducer

InjectiMed Inc Ventura, CA

### V. Indications for Use Statement

510(k) Number:

To be assigned

Device Name:

SafetyNET Guidewire Introducer

Indications for Use:

A percutaneous guide wire introducer for vascular and non-vascular procedures with activating safety shield to reduce needle stick injury during use and disposal.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart )

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Concurrence of CDRH Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number 16073664