SAFETY NEEDLE

K051019 · Sarstedt, Inc. · JKA · Jul 25, 2005 · Clinical Chemistry

Device Facts

• Record ID: K051019
• Device Name: SAFETY NEEDLE
• Applicant: Sarstedt, Inc.
• Product Code: JKA · Clinical Chemistry
• Decision Date: Jul 25, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1675
• Device Class: Class 2

Intended Use

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

Device Story

Safety-Needle is a single-lumen, sterile, single-use venipuncture needle designed for use with the S-Monovette blood collection system. Device features an integrated needle protector mechanism; activated manually by the clinician after needle withdrawal from the patient. Protector covers the used needle to prevent accidental needle stick injuries during disposal. Used in hospitals and clinical practices by healthcare professionals. Benefits include reduced risk of sharps-related injuries to staff during blood collection procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Single-lumen needle; integrated mechanical needle protector; sterile; non-pyrogenic; single-use; compatible with S-Monovette system.

Indications for Use

Indicated for blood collection via venipuncture in patients requiring blood sampling using the S-Monovette system in hospital or clinical settings.

Regulatory Classification

Identification

A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular emblem with the department's name encircling an abstract symbol in the center. The symbol resembles a stylized caduceus, featuring a staff with three wavy lines representing snakes or ribbons.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 25 2005

Sarstedt, Incorporated c/o Mr. Peter Rumswinkel VP/General Manager 1025 St. James Church Rd. Newton, North Carolina 28658

Re: K051019

Trade/Device Name: Safety Needle Regulation Number: 21 CFR 862.1675 Regulation Name: Blood Collection Needle, Accessory To Tubes, Vials, System Regulatory Class: II Product Code: JKA Dated: July 06, 2005 Received: July 7, 2005

Dear Mr. Rumswinkel:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave rowled your 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 for about in 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 Cosmatic 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 r ou may) aters 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 if your de rise is orabilitional 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 - Mr. Runswinkel

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r toase of acrised alw's termination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any I catal 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 Of It Far 807), and ity systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic for the morely of the provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control 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 premaited predicated on " 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 11 you dosh o specific and 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 other general miormational 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,

Sarette G. Michien Orus.
Chu-Lin, Ph.D.

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

Image /page/2/Picture/22 description: The image shows a logo and a number. The logo is a black square with a white border. Inside the square is a stylized letter 'S' in black. Above the logo is the number 'K051019' written in black ink. The number appears to be handwritten.

Instruments and Disposables for Medicine and Science

Indications for Use

510(k) Number: K051019

Device Name: Safety Needle

Indications For Use:

The Safety-Needle is a single lumen needle for blood collection via venipuncture in conjunction with the S-Monovette® system. The Safety-Needle needle protector, when activated after removal of the needle from the patient, covers the used needle until it can be properly disposed; therefore, aiding in the prevention of needle stick injuries.

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

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

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Chm Vink

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

510(k) Number: L + 51Q 14

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828) 465-4000 Corporate 828) 465-0718 Corporate [phone] Sales [phone] Sales Telefax

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