EXEL SECURETOUCH SAFETY VACULET BLOOD COLLECTION SET

K022406 · Exelint Intl. Co. · FMI · Sep 30, 2002 · General Hospital

Device Facts

• Record ID: K022406
• Device Name: EXEL SECURETOUCH SAFETY VACULET BLOOD COLLECTION SET
• Applicant: Exelint Intl. Co.
• Product Code: FMI · General Hospital
• Decision Date: Sep 30, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2

Intended Use

This product is intended to be used to collect blood for various blood tests. The EXELINT SecureTouch Vaculet Safety Blood Collection Set aids in the prevention of accidental needle stick injuries.

Device Story

EXEL Secure Touch Safety Vaculet Blood Collection Set is a single-lumen hypodermic needle device used for venipuncture and blood specimen collection. The device incorporates a safety mechanism designed to shield the needle after use, thereby reducing the risk of accidental needle stick injuries to healthcare personnel. It is used in clinical settings by trained medical staff. The device functions as a standard blood collection set with an integrated safety feature; it does not involve electronic processing, software, or automated analysis. The primary benefit is the protection of the clinician from bloodborne pathogens during and after the blood draw procedure.

Clinical Evidence

Bench testing only.

Technological Characteristics

Single-lumen hypodermic needle; manual safety mechanism for needle shielding; sterile; single-use; non-electronic; mechanical design.

Indications for Use

Indicated for use in patients requiring blood collection for diagnostic testing. Intended for use by healthcare professionals to collect blood samples while reducing the risk of accidental needle stick injuries.

Regulatory Classification

Identification

A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## SEP 3 0 2002

Mr. Armand Hamid Director Exclint International Company 5840 West Centinela Avenue Los Angeles, California 90045

Re: K022406

Trade/Device Name: EXEL Secure Touch Safety Vaculet Blood Collection Set Regulation Number: 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: September 19, 2002 Received: September 23, 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.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complics with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.

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Page 2 – Mr. Hamid

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Timothy A. Ullatowski

Timotily A. Ulatowski 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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K022406

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510(k) Number (if known) K022406

Device Name: EXEL Secure Touch Safety Vaculet Blood Collection Set

Indications For Use:

This product is intended to be used to collect blood for various blood tests. The EXELINT SecureTouch Vaculet Safety Blood Collection Set aids in the prevention of accidental needle stick injuries.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over -The-Counter Use ________________________________________________________________________________________________________________________________________________________

Viola Hubbard & Pat Cincotti

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

510(k) Number: Ko2240 6

(Optional Format 1-2-96)