VACUETTE PREMIUM SAFETY BLOOD COLLECTION SET

{0}------------------------------------------------ # NOV 1 9 2010 # Kingalo | K162016 | | |----------------------------|----------| | Section 5 - 510(k) Summary | Page 5-1 | Date Prepared: July 13, 2009 Submitter / Contact: H. Carl Jenkins The Wood Burditt Group 10 E. Scranton Avenue, Suite 201 Lake Bluff, IL 60044 (ph) (847) 234-7500 x 205 (fax) (847) 574-0728 (email) hcjenkins@woodburditt.com Applicant / 510(k) Owner: MedPro Safety Products, Inc 817 Winchester Road, Suite 200 Lexington, KY 40505 Phone – (859) 225-5375 Fax - (859) 225-5347 Contact Person - Mrs. Tammy Nichols #### Name of Device | Trade Name: | VACUETTE® PREMIUM Safety Blood Collection Set | |----------------------|-------------------------------------------------------| | Common Name: | Safety device for blood collection | | Classification Name: | Hypodermic Single Lumen Needle with antistick syringe | | Regulations No: | 21 CFR 880.5570 | | Product Code: | FMI | #### Predicate Information | Predicate Device: | VACUETTE SAFETY BLOOD COLLECTION SET | |----------------------|------------------------------------------------| | 510(k) Number: | K011786 | | Date of Concurrence: | 07/12/2001 | | Predicate Device: | BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET | | 510(k) Number: | K011904 | 510(k) Number: K011984 Date of Concurrence: 08/29/2001 {1}------------------------------------------------ | Section 5 - 510(k) Summary | Page 5-2 | |----------------------------|----------| |----------------------------|----------| # Substantial Equivalence Declaration: The term "Substantial Equivalence" as used in this 510(k) Premarket Notification is limited to the definition of Substantial Equivalence found in the Federal Food, Drug, and Cosmetic Act, as amended and as applied under 21 CFR §807, Subpart E, under which a device can be marketed without premarket approval or reclassification. A determination of substantial equivalency under this notification is not intended to have any bearing whatsoever on the resolution of patent infringement suits or any other patent matters. No statements related to, or in support of, substantial equivalence herein shall be construed as an admission against interest under the US Patent Laws or their application by the courts. ## Device Description: Trade or propriety name or model of this device: VACUETTE® PREMIUM Safety Blood Collection Set; | Gauge | Tubing | Accessory | Accessory | Accessory | |-------|--------|-------------|-----------|---------------------------------| | 21 | 10 | Female Luer | | Male Luer | | 23 | 10 | Female Luer | | Male Luer | | 25 | 10 | Female Luer | | Male Luer | | 21 | 19 | Female Luer | | Male Luer | | 23 | 19 | Female Luer | | Male Luer | | 25 | 19 | Female Luer | | Male Luer | | 21 | 30 | Female Luer | | Male Luer | | 23 | 30 | Female Luer | | Male Luer | | 25 | 30 | Female Luer | | Male Luer | | 21 | 10 | Female Luer | Male Luer | Greiner Bio-One Standard Holder | | 23 | 10 | Female Luer | Male Luer | Greiner Bio-One Standard Holder | {2}------------------------------------------------ #### Section 5 - 510(k) Summary | Gauge | Tubing | Accessory | Accessory | Accessory | |-------|--------|-------------|-----------|---------------------------------| | 25 | 10 | Female Luer | Male Luer | Greiner Bio-One Standard Holder | | 21 | 19 | Female Luer | Male Luer | Greiner Bio-One Standard Holder | | 23 | 19 | Female Luer | Male Luer | Greiner Bio-One Standard Holder | | 25 | 19 | Female Luer | Male Luer | Greiner Bio-One Standard Holder | | 21 | 30 | Female Luer | Male Luer | Greiner Bio-One Standard Holder | | 23 | 30 | Female Luer | Male Luer | Greiner Bio-One Standard Holder | | 25 | 30 | Female Luer | Male Luer | Greiner Bio-One Standard Holder | | 21 | 10 | Female Luer | | NA | | 23 | 10 | Female Luer | | NA | | 25 | 10 | Female Luer | | NA | | 21 | 19 | Female Luer | | NA | | 23 | 19 | Female Luer | | NA | | 25 | 19 | Female Luer | | NA | | 21 | 30 | Female Luer | | NA | | 23 | 30 | Female Luer | | NA | | 25 | 30 | Female Luer | | NA | #### Product Description: The Vacuette Premium Safety Blood Collection Set is a single use, individually wrapped, sterile winged blood collection needle with an integrated needle and safety shield bonded to a flexible tubing with a female luer adapter allowing the set to be used with a luer system (e.g. Holdex®). It is available with optional Luer Adapter and / or Luer Adapter + Holder. The device is free of PVC, DEHP, Latex. {3}------------------------------------------------ # Indications for Use: "VACUETTE® PREMIUM Safety Blood Collection Set is used in routine venipuncture procedures. It is used for blood collection. The safety shield is activated automatically to cover the needle immediately following blood collection thus preventing accidental needlestick injury." ## Intended Use: The Vacuette Premium Safety Blood Collection Set is used in routine venipuncture procedures. It is used for blood sollection. The winged needle is designed with a safety shield, which is activated automatically to cover the needle immediately following blood eollection to aid in the protection against-accidental-needlestick injury-The product-is-to be-used by appropriately trained healtheare professionals only in accordance with these instructions. # Substantial Equivalence: The VACUETTE® PREMIUM Safety Blood Collection Set is substantially equivalent to the Vacuette Safety Blood Collection Set (K011786) and the BD Pushbutton Butterfly (K011984). ## Simulated Use Testing: Simulated use testing was performed by a panel of health care professionals to evaluate function and performance, ease of use and other functions of the safety feature. # Material Testing: The VACUETTE® PREMIUM Safety Blood Collection Set will meet ISO 10993-1 requirements for material safety and biocompatibility, per product category: - . External Communicating - . Blood Path Indirect - . Contact Duration "A" (Limited) # Conclusions: Summary of Safety and Effectiveness - The device has a release mechanism molded into the needle shield. During the blood collection process, as the user performs the initial puncture, release of the wings causes them to fall open and brings the needle shield into a staged position. When the user is ready to remove the device, they grasp the wings as they would during routine use, and upon closing the needle shield is deployed and covers the needle upon exit. The device is substantially equivalent to the predicate devices (VACUETTE® Safety Blood Collection Set and BD Vacutainer Push Button Set) because it has a plastic safety shield that covers the needle {4}------------------------------------------------ | Section 5 - 510(k) Summary | Page 5-5 | after<br>it<br>has<br>been<br>n<br>cont | |----------------------------|----------|-----------------------------------------| |----------------------------|----------|-----------------------------------------| aminated, protecting the healthcare worker from a potential needlestick. The predicate VACUETTE® Safety Blood Collection Set's safety shield is activated when the user manually slides the shield over the needle after use. The predicate BD Vacutainer Push Button Blood Collection Set's safety shield is activated when the user manually presses the button located on the top of the device, activating the spring mechanism to deploy the safety shield. The VACUETTE® PREMIUM Safety Blood Collection Set's safety shield is automatically activated when the user closes the wings to withdraw the device from the patient. The spring loaded safety shield covers the needle after it has been contaminated, protecting the healthcare worker from a potential needlestick. {5}------------------------------------------------ # DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features the department's emblem, which is a stylized representation of a human figure embracing a globe. The emblem is positioned to the right of the text, which is arranged in a circular pattern around the emblem. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 MedPro Safety Products, Incorporated C/O Mr. H. Carl Jenkins Wood Burditt Group 10 E. Scranton Avenue, Suite 201 · Lake Bluff, Illinois 60044 NOV 1 9 2010 Re: K102010 Trade/Device Name: VACUETTE® PREMIUM Safety Blood Collection Set Regulation Number: 21 CFR 880.5570 Regulation Name: Regulatory Class: II Product Code: JKA, FMI Dated: November 5, 2010 Received: November 8, 2010 Dear Mr. Jenkins: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. {6}------------------------------------------------ #### Page 2- Mr. Jenkins 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {7}------------------------------------------------ | Section 4 - Indications for Use Statement | Page 4-1 | |-------------------------------------------|----------| |-------------------------------------------|----------| #### Indications for Use 510(k) number (if Known): K102010 NOV 1 9 2010 Device Name: VACUETTE® PREMIUM Safety Blood Collection Set Indications for Use: "VACUETTE® PREMIUM Safety Blood Collection Set is used in routine venipuncture procedures. It is used for blood collection. The safety shield is activated automatically to cover the needle immediately following blood collection thus preventing accidental needlestick injury." Prescription Use __ X (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 OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) An Str for RZC (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices Page_1_of_1 K102010 510(k) Number: