SAFE TIP SYRINGE

K060668 · Devon Safety Products, Inc. · MEG · Jun 12, 2006 · General Hospital

Device Facts

• Record ID: K060668
• Device Name: SAFE TIP SYRINGE
• Applicant: Devon Safety Products, Inc.
• Product Code: MEG · General Hospital
• Decision Date: Jun 12, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Devon SafeTip Safety Syringe is indicated for use in the administration of an intramuscular (IM) injection. The SafeTip Safety Syringe aids in the prevention of accidental needle sticks by passively and automatically deploying a sheath that covers the sharp needle upon completion of the injection

Device Story

SafeTip Safety Syringe is a piston syringe featuring a passive sharp safety mechanism. During injection, the device automatically deploys a plastic sheath over the needle upon completion of the injection, prior to needle removal from tissue. The sheath extends beyond the needle tip, shielding the user and patient from the sharp needle post-removal. Used in clinical settings for intramuscular injections; operated by healthcare professionals. The device benefits patients and clinicians by reducing the risk of accidental needle stick injuries.

Clinical Evidence

No clinical data. Evidence consists of bench testing and simulated clinical use testing to demonstrate performance and reliability of the safety feature per FDA Guidance: Medical Devices with Sharps Injury Prevention Features (August 9, 2005).

Technological Characteristics

Piston syringe with passive needle-sheathing mechanism. Materials consistent with Devon Standard Syringe. Manual operation; no energy source or software. Safety feature is mechanical, deploying a plastic sheath automatically upon injection completion.

Indications for Use

Indicated for intramuscular (IM) injections in patients requiring such administration; aids in preventing accidental needle sticks for healthcare providers.

Regulatory Classification

Identification

A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.

Predicate Devices

• Medisys Tech. CoverTip Safety Syringe
• Becton Dickinson Integra Syringe
• Devon Standard Syringe

Submission Summary (Full Text)

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#### Submitted on behalf of:

Devon Safety Products DBA Devon Medical Supplies 1100 First Avenue, Suite 100 King Of Prussia, PA 19406 Telephone: [phone] Fax:

JUN 12 2006

| Submitted by: | Paladin Medical, Inc. |
|---------------|-----------------------|
| | P.O. Box 560 |
| | Stillwater, MN 55082 |
| Telephone: | 715-549-6035 |
| Fax: | 715-549-5380 |

CONTACT PERSON: Elaine Duncan

DATE PREPARED: March 10, 2006 TRADE NAME: SafeTip Safety Syringe COMMON NAME: Safety Syringe REGULATION: Piston Syringe: 21 CFR 880.5860: Class II General Hospital Product code: MEG and FMI

# SUBSTANTIALLY EQUIVALENT TO:

The Devon Medical Supplies SafeTip Syringe is substantially equivalent to the Medisys Tech. CoverTip Safety Syringe for technological features, the Becton Dickinson Integra Syringe in performance and the Devon Standard Syringe for materials.

# DESCRIPTION of the DEVICE:

The SafeTip Safety Syringe is a piston syringe that features a passive sharp safety feature which covers the needle after injection. The syringe automatically deploys a plastic cover (sheath) over the needle as the injection is completed and prior to the needle's removal from the tissue. The sheath protrudes beyond the end of the needle, shielding the user and patient from the sharp needle after removal.

# INDICATIONS FOR USE:

The SafeTip Syringe is indicated for use in the administration of an intramuscular (IM) injection. The SafeTip Safety Syringe aids in the prevention of accidental needle sticks by passively and automatically deploying a sheath that covers the sharp needle upon completion of the injection

# SUMMARY of TESTING:

The Devon SafeTip Safety Syringe has been shown to meet internationally recognized standards for syringe performance and labeling characteristics. Simulated clinical use testing has demonstrated the performance of the SafeTip syringe and reliability of the safety feature in accordance with the FDA Guidance: Medical Devices with Sharps Injury Prevention Features: August 9, 2005.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, and three parallel lines above it. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

JUN 1 2 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Devon Safety Products, Incorporated C/O Ms. Elaine Duncan President Paladin Medical®, Incorporated PO Box 560 Stillwater, Minnesota 55082

Re: K060668

Trade/Device Name: Devon SafeTip Safety Syringe Regulation Number: 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG, FMI Dated: March 10, 2006 Received: March 14, 2006

Dear Ms. Duncan:

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.

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#### Page 2 - Ms. Duncan

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 (OS) 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/industry/support/index.html.

Sincerely yours.

Senate Y. Michael Onid.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known):

# Device Name: Devon SafeTip Safety Syringe

The Devon SafeTip Safety Syringe is indicated for use in the administration of an The Devon Barely Safety Symge interest Syringe aids in the prevention of accidental meedle sticks by passively and automatically deploying a sheath that covers the needle upon completion of the injection.

Prescription Use X (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)

Catan v.m

Ju Sign-Cit) of Anesthesiology, General Hospital, ction Control, Dental Devices

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