SAFETY-MULTIFLY

K032150 · Sarstedt, Inc. · FPA · Sep 12, 2003 · General Hospital

Device Facts

• Record ID: K032150
• Device Name: SAFETY-MULTIFLY
• Applicant: Sarstedt, Inc.
• Product Code: FPA · General Hospital
• Decision Date: Sep 12, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Intended Use

The Safety-Multifly® is a winged blood collection needle set with flexible tubing, an adapter for the S-Monovette® system, and an integral needle protector. The Safety-Multifly® is intended for blood collection via venipuncture. The Safety-Multifly® needle protector, when activated after removal from the patient, covers the used needle until it can be properly disposed; therefore, aiding in the prevention of needle stick injuries. The Safety-Multifly® is individually packaged. sterile, single-use and non-pyrogenic. The Safety-Multifly® is intended to be used in all hospitals and/or practices where S-Monovettes are used.

Device Story

Safety-Multifly is a winged blood collection needle set featuring flexible tubing, an S-Monovette system adapter, and an integrated needle protector. Used by healthcare professionals in hospitals and clinical settings for venipuncture blood collection. After needle withdrawal, the user manually activates the protector to cover the needle, reducing the risk of accidental needle stick injuries. Device is sterile, single-use, and non-pyrogenic. Provides a mechanical safety mechanism to protect clinicians during disposal of used needles.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Winged needle set with flexible tubing and S-Monovette adapter. Features an integrated mechanical needle protector for safety. Single-use, sterile, non-pyrogenic. Class II device (21 CFR 880.5440).

Indications for Use

Indicated for blood collection via venipuncture in patients in hospitals or clinical practices where S-Monovette systems are utilized.

Regulatory Classification

Identification

An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.

Special Controls

*Classification.* Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.

Reference Devices

• S-Monovette® system

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines representing its wings and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle image.

Public Health Service

SEP 1 2 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Peter Rumswinkel VP/ General Manager 1025 Street James Church Road PO Box 468 Newton, North Carolina 28658

Re: K032150

Trade/Device Name: Safety- Multifly Regulation Number: 880.5440, 862.1675 Regulation Name: Intravascular Administration Regulatory Class: II Product Code: FPA. JKA Dated: July 11, 2003 Received: July 14, 2Q03

Dear Mr. Rumswinkel:

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.

{1}------------------------------------------------

Page 2 - Mr. Rumswinkel

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 Runner

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

Enclosure

{2}------------------------------------------------

ATTACHMENT I

Sanstedt, Inc. - P.O. Box 468 . Newton, NC 28658-0468

Image /page/2/Picture/3 description: The image is a black and white logo. The logo is a stylized letter "S" inside of a square. The letter "S" is slanted and has a small horizontal line at the top.

Instruments and Disposables for Medicine and Science

Indications for Use Statement

510(k) Number: K032150

Device Name: Safety-Multifly®

Indications For Use:

The Safety-Multifly® is a winged blood collection needle set with flexible tubing, an adapter for the S-Monovette® system, and an integral needle protector. The Safety-Multifly® is intended for blood collection via venipuncture. The Safety-Multifly® needle protector, when activated after removal from the patient, covers the used needle until it can be properly disposed; therefore, aiding in the prevention of needle stick injuries.

The Safety-Multifly® is individually packaged. sterile, single-use and non-pyrogenic.

The Safety-Multifly® is intended to be used in all hospitals and/or practices where S-Monovettes are used.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) S Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

Patricia Lucente

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

510(k) Number:

Sarstedt Inc. P.O. Box 468 Newton, NC 28658-0468

[phone] Corporate Telefax [phone] Corporate [phone] Sales Phone [phone] Sales Telefax