HYPODERMIC NEEDLE-PRO INSULIN SYRINE & NEEDLE WITH NEEDLE PROTECTION DEVICE

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows a handwritten alphanumeric string. The string is "K014073". The characters are written in black ink on a white background. Image /page/0/Picture/1 description: The image shows a logo for "PORTEX". The logo consists of a black rectangle with a white, curved shape in the center. The word "PORTEX" is written in black, bold letters inside the white shape. The white shape is curved on the top and bottom. # FEB 1 3 2002 #### Portex, Inc. 10 Bowman Drive Keene NH 03431-0724 USA Tel: 603 352 3812 www.portexusa.com # K: 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS #### 510(K) SUMMARY: #### COMPANY INFORMATION: Portex, Inc. 10 Bowman Drive Keene, NH 03431 (603) 352-3812 Contact: Brian D. Farias Regulatory Affairs Specialist # PREPARATION DATE OF SUMMARY: December 7, 2001 #### TRADE NAME: Hypodermic Needle-Pro® Insulin Syringe & Needle with Needle Protection Device #### COMMON NAME: Insulin Syringe and Needle with attached needle protection ### PRODUCT CLASS/CLASSIFICATION: Class II, 80 FMF, 21 CFR 880.5860 (Piston Syringe) {1}------------------------------------------------ #### PREDICATE DEVICE(S): K011925 Hypodermic Needle-Pro® Syringe & Needle with Needle Protection Device #### DESCRIPTION: This device is intended for injection of insulin. The needle protection device is an integral I mis device is intended for inforces pre-attached to the needle. Once the needle/needle protection device is attached to a syringe, the collar hoop hinders removal of the needle protection device from the needle. The Needle-Pro® sheath may be adjusted relative to the procedon do roo from are the orange arm to the desired position. After the procedure is completed, the needle is pressed into the sheath using a one-handed technique. As the needle enters the protective sheath, the needle protection device engages and the needle is contained within the sheath. The device should be immediately disposed into a sharps container. The device is supplied with 26G and 27G needles. ### INDICATIONS FOR USE: This device is intended for injection of insulin. The needle protection device covers the needle after use to help prevent needle sticks. ### TECHNICAL CHARACTERISTICS: The proposed device is comprised of identical or similar components and materials as the predicate device. The device is sold sterile. #### NON-CLINICAL DATA: The descriptive characteristics of this device are precise enough to ensure equivalence. {2}------------------------------------------------ # CLINICAL DATA: Not applicable ### CONCLUSION: The comparison to the predicate devices demonstrates that the proposed device is safe and effective and is substantially equivalent to the predicate device. Very truly yours, PORTEX, INC. Brian D. Farias Regulatory Affairs Specialist {3}------------------------------------------------ Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The bird is positioned within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the border of the circle. #### Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 # FEB 1 3 2002 Mr. Brain E. Farias Regulatory Affairs Specialist Portex, Incorporated 10 Bowman Drive Keene, New Hampshire 03431 Re: K014073 Trade/Device Name: Hypodermic Needle-Pro® Insulin Syringe & Needle with Needle Protection Device Regulation Number: 880.5860 Regulation Name: Insulin Syringe and Hypodermic Needle with attached Needle Protection Regulatory Class: II Product Code: FMF Dated: December 7, 2001 Received: December 10, 2001 Dear Mr. Farias: 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 (1 writ), it may of bund 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. {4}------------------------------------------------ Page 2 - Mr. Farias 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. of the Act of all - Four and the Act's requirements, including, but not limited to: registration r ou intilet compry wart 807); labeling (21 CFR Part 801); good manufacturing practice and insting (21 es read on the quality systems (QS) regulation (21 CFR Part 820); and if requirences as bet form 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 11ths letter will and w you've orgine 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 (301) 594-4618 . Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 aller revilla) every at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Timotl Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health {5}------------------------------------------------ # B: INTENDED USE OF DEVICE # PROPOSED INDICATIONS FOR USE: Page 1 of 1 510(k) Number (if known): Unknown Kol 4 073 Device Name: Dories Needle-Pro® Insulin Syringe & Needle with Needle Protection Device Indications For Use: This device is intended for injection of insulin. The needle protection device covers the needle after use to help prevent needle sticks. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use______________________________________________________________________________________________________________________________________________________________ OR Over-The-Counter Use Petrus Ceccarite 'Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices F 1 (k) Number _______________________________________________________________________________________________________________________________________________________________ 1014073