SHARPS SHUTTLE

{0}------------------------------------------------ Image /page/0/Picture/2 description: The image shows the logo for SAGE PRODUCTS INC. The logo is in black and white, with the word "SAGE" in large, bold letters. Below the word "SAGE" is the phrase "PRODUCTS INC" in smaller letters. The logo is simple and modern. Pre-Market Notification: Sharps Shuttle 510K Summary- K972279 AUG 29 Bar ## Identification of Applicant 1 Sage Products Inc. Company Name ................................................................................................................. A.. Karen Pinto Applicants Name .............................................................................................................................................................. B. Regulatory Affairs Manager 815 Tek Drive Street Address ............................................................................................................................................................... C. Crystal Lake, IL 60014 Address(es) of Manufacturing Site(s) .. Sage Products Inc. D. 815 Tek Drive Crystal Lake, IL 60014 Address(es) of Sterilizing Site(s).......... N/A-Product in non-sterile ய் June 17, 1997 Date of Application .......................................................................................................................................................... r. #### 2 Device | A | Trade or Proprietary Name | Sharps Shuttle/Sharps Shuttle with Locking<br>Mechanism | |----|---------------------------|----------------------------------------------------------------| | B | Common Name | Sharps Container | | C | Classification Name | Accessory to Hypodermic Single Lumen Needle<br>(CFR: 880.5570) | | E. | Classification | II | | F. | Panel | 80 | | G. | Procodes | FMI | Section 10, page 16 of 18 of Submission Revised per 8/20/97 request page 1 of 3 of Summary "Innovative health care products since 1971" {1}------------------------------------------------ Image /page/1/Picture/2 description: The image shows the logo for SAGE PRODUCTS INC. The logo is in black and white, with the word "SAGE" in large, bold letters. Below the word "SAGE" is the phrase "PRODUCTS INC." in smaller letters. The logo is simple and modern. # Pre-Market Notification: Sharps Shuttle 510K Summary- K972279 ### General Description 3 The Sharps Shuttle and Sharps Shuttle with Locking Mechanism are injection or blow molded, single use, non-sterile, disposable, sharps transport containers intended for use in any setting where standard sharps containers are not conveniently accessible, such as EMS, home health care, etc. The Sharps Shuttles may be viewed as a portable sharps containment device that provides an alternative to the procedure of resheathing a needle with its original protective cover which is not a recommended practice or disposing of the sharp in a non-sharps container. The products are designed to hold sharps such as angio-caths, blood needles, lancets and small syringes. The container is cylindrical for rigidness and has a conical taper. The product body is non colored translucent plastic and is approximately 6 inches long by 1 inch in diameter. The cap is red opaque plastic with a hinged cap which when snapped closed contains the biohazardous sharps for safe conveyance. Locking and non locking versions are available. Both versions have a temporary closure which can be reopened for the placement of additional sharps prior to terminal disposal. In addition to the temporary closure, the locking Sharps Shuttle with Locking Mechanism can be permanently locked by engaging the locking tab. Each unit is individually labeled with a biohazard label. Sharps Shuttles are available singly or packaged in a dispenser with an attached carrying handle for easy transport of unused containers. The dispenser is available for the storage of the device prior use. The dispenser does not function as an accessory for use, nor, is it intended to transport containers with biohazardous waste. #### Substantial Equivalence 4 #### Predicate Devices for Sage Products, Inc. Sharps Shuttle A. - > BD Home Sharps Container by Med-Safe Systems, Inc - > One Quart Sharps Container by Sage Products, Inc. - > SHARP-SAFE by Smiths Industries Medical Systems - > STIC-KIT by Emergency Medical Innovations, Inc. #### B. Rationale Discussion In summary, all five products are plastic, non-sterile, disposable, portable, sharps transport containers intended for use in various field situations. All the devices allow for one handed disposal of sharps and offer a means of closure. Section 10, page 17 of 18 of Submission Revised per 8/20/97 request "Innovative health care products since 1911" page 2 of 3 of Summary 815 TEK DRIVE . P.O. BOX 9693 . CRYSTAL LAKE. IL 60039-9693 815-455-4700 ■ 800-323-2220 ■ Fax: 815-455-5599 {2}------------------------------------------------ Image /page/2/Picture/2 description: The image shows the logo for SAGE PRODUCTS INC. The word "SAGE" is in large, bold, sans-serif font. Below the word "SAGE" is the text "PRODUCTS INC" in a smaller, sans-serif font. There is a horizontal line that extends from the left of the word "PRODUCTS" to the right of the word "INC". # Pre-Market Notification: Sharps Shuttle 510K Summary- K972279 ### Design Features 5 | Design Feature | Safety and Effectiveness Basis | |------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Impact Resistance | The impact resistance test will provide information about the containers ability to<br>retain solid contents, following lid closure and locking, in the event it is dropped<br>during handling/transport. | | Puncture<br>Resistance | Contaminated sharps shall be discarded immediately or as soon as feasible in<br>containers that are puncture resistant. Ref: OSHA Bloodborne Pathogens 21<br>CFR 1910.1030, d, 4, iii, A, 1, ii | | Overfill Detection | During use, containers for contaminated sharps shall be replaced routinely and<br>not be allowed to overfill. Ref: OSHA Bloodborne Pathogens 21 CFR<br>1910.1030, d, 4, iii, A, 2, iii | | Leak Resistance | Contaminated sharps shall be discarded immediately or as soon as feasible in<br>containers that are Leak Proof on sides and bottom. Ref: OSHA Bloodborne<br>Pathogens 21 CFR 1910.1030, d, 4, iii, A, 1, iii. | | Sharps Access and<br>Closure | Contaminated sharps shall be discarded immediately or as soon as feasible in<br>containers that are closable. Ref: OSHA Bloodborne Pathogens 21 CFR<br>1910.1030, d, 4, iii, A, 1, i | | Stability | During use, containers for contaminated sharps shall be maintained upright<br>throughout use. Ref: OSHA Bloodborne Pathogens 21 CFR 1910.1030, d, 4, iii,<br>A, 2, ii | | Mounting<br>Accessories | During use, containers for contaminated sharps shall be easily accessible to<br>personnel and located as close as is feasible to the immediate area where sharps<br>are used or can be reasonably anticipated to be found. Ref: OSHA Bloodborne<br>Pathogens 21 CFR 1910.1030, d, 4, iii, A, 2, i | | Handling | Sharps containers should be safe and easy to handle in transport. | | Capacity | This value gives the user an estimate or comparison of volume. | Section 10, page 18 of 18 of Submission Revised per 8/20/97 request page 3 of 3 of Summary "Innovaave health care products since 1971" 815 TEK DRIVE ▪ P.O. Box 9693 ▪ CRY:TAL LAKE. IL 60039-9693 128 - 300-323-2220 = Fax: 815-455-5599 {3}------------------------------------------------ Image /page/3/Picture/2 description: The image shows a logo with text and a stylized graphic. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement around the graphic. The graphic consists of three stylized human profiles facing to the right, stacked on top of each other, creating a sense of depth and unity. The logo is black and white. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 AUG 29 1997 Ms. Karen Pinto Regulatory Affairs Manager Sage Products, Incorporated 815 Tek Drive Crystal Lake, Illinois 60014-9693 K972279 Re: Sharps Shuttle and Sharps Shuttle with Trade Name: Locking Mechanism Regulatory Class: II FMI Product Code: Dated: June 17, 1997 Received: June 18, 1997 Dear Ms. Pinto: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Cood Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, chrough periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 {4}------------------------------------------------ Page 2 - Ms. Pinto through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations. This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, Alidatoust Timot A. Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ Aug. 20. 1997 1 : 42PM SAGE PRODUCTS INC No. 4313 . 3/5 Page_ 1 of 1 510(k) Number (if known): K972279 Sharps Shuttle and Sharps Shuttle with Locking Mechanism Device Name: _________________________________________________________________________________________________________________________________________________________________ Indications For Use: 1 The Sharps Shuttle and Sharp Shuttle with Locking Mechanism are single use, I he Sharps Shutter and Sharps transport containers intended for use in any setting where standard sharps containers are not conveniently accessible, such as EMS, home health care, etc.. [Section 9, Page 15 of 18 of Response to 8/20/97 Request for Additional Information [occaon >> Ret Notification Submission. Sharps Shuttle] (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) | | Concurrence of CDRH, Office of Device Evaluation (ODE) | | |--|--------------------------------------------------------|--| |--|--------------------------------------------------------|--| | (Division Sign-Off) | | |---------------------------------------------------------------------|---------| | Division of Dental, Infection Control, and General Hospital Devices | | | 510(k) Number | K972279 | Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use X (Optional Format 1-2-96)