EXEL SECURETOUCH PTP SYRINGE

K011754 · Exelint Intl. Co. · MEG · Jan 22, 2003 · General Hospital

Device Facts

• Record ID: K011754
• Device Name: EXEL SECURETOUCH PTP SYRINGE
• Applicant: Exelint Intl. Co.
• Product Code: MEG · General Hospital
• Decision Date: Jan 22, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

THIS DEVICE IS A SAFETY HYPODERMIC SYRINGE FOR INJECTION OF MEDICATION TO PATIENTS. =THIS DEVICE AIDS IN PREVENTION OF NEEDLE STICK INJURIES=

Device Story

EXEL Secure Touch Safety Syringe; manual hypodermic syringe for medication delivery; incorporates safety mechanism to prevent needle stick injuries; used by clinicians in healthcare settings; device functions as standard piston syringe with integrated safety feature; provides physical barrier or retraction to shield needle after use; reduces risk of accidental percutaneous injury to healthcare personnel.

Clinical Evidence

Bench testing only.

Technological Characteristics

Piston syringe; manual operation; safety mechanism for needle protection; Class II device (880.5860).

Indications for Use

Indicated for patients requiring medication injection via hypodermic syringe; intended to aid in the prevention of needle stick injuries.

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.

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 2 2003

Mr. Armand Hamid Director Medical Products Division P.O. Box 3194 Culver City, California 90231-3194

Re: K011754

Trade/Device Name: EXEL Secure Touch Safety Syringe Regulation Number: 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG, FMF, FMI Dated: October 9, 2002 Received: November 21, 2002

Dear Mr. Hamid:

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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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.

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,

Susan Russer

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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510(k) Number (if known):

Device Name: EXEL SECURE TOUCH SAFETY SYRINGE

Indications For Use:

THIS DEVICE IS A SAFETY HYPODERMIC SYRINGE FOR INJECTION OF MEDICATION TO PATIENTS.

=THIS DEVICE AIDS IN PREVENTION OF NEEDLE STICK INJURIES=

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Retuar Ciccente

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number ________________________________________________________________________________________________________________________________________________________________

Prescription Use / (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)