Terumo SurGuard 3 Safety Hypodermic Needle

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a group of human profiles. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 October 16, 2015 Terumo (Philippines) Corporation c/o Ms. Phebe Varghese Regulatory Affairs Specialist Terumo Medical Corporation 265 Davidson Avenue, Suite 320 Somerset, New Jersey 08873 Re: K152362 Trade/Device Name: Terumo SurGuard®3 Safety Hypodermic Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: August 19, 2015 Received: August 21, 2015 Dear Ms. Varghese: 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. {1}------------------------------------------------ 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 devicerelated 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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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, Tina Kiang -s for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K152362 Device Name Terumo SurGuard®3 Safety Hypodermic Needle #### Indications for Use (Describe) The Terumo SurGuard®3 Safety Hypodermic Needle is intended for use in the aspiration and injection of fluids for medical purposes. The Terumo Safety Hypodermic Needle is compatible for use with standard luer lock syringes. Additionally, after withdrawal of the needle from the body, the attached needle safety sheath can be manually activated to cover the needle immediately after use to minimize risk of accidental needlestick. Type of Use (Select one or both, as applicable) | <span style="font-family: Arial;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | |-----------------------------------------------------------------------------------------| | <span style="font-family: Arial;">□</span> Over-The-Counter Use (21 CFR 801 Subpart C) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(K) SUMMARY #### A. SUBMITTER INFORMATION (807.92(a)(1)) | Prepared by: | Ma.Cristina Faderagao | |--------------|--------------------------------------| | | Regulatory Affairs Assistant Manager | | | Terumo (Philippines) Corporation | | | Tel. +63 (49) 5412111 | | | Fax +63 (49) 5412121 | Prepared for: Owner/Operator Terumo (Philippines) Corporation 124 East Main Avenue, Laguna Technopark Binan, Laguna, Philippines Owner/Operator Number: 10033966 #### Manufacturer and Sterilization Facility (Applicant) Terumo (Philippines) Corporation 124 East Main Avenue, Laguna Technopark Binan, Laguna, Philippines Registration Number: 3003902955 Contact Person: Phebe Varghese Regulatory Affairs Specialist Terumo Medical Corporation 265 Davidson Avenue, Suite 320 Somerset, NJ 08873 Tel. (732) 412-4166 Fax (732) 302-4905 E-mail: phebe.varghese@terumomedical.com Date prepared: October 14, 2015 {4}------------------------------------------------ #### B. DEVICE NAME (807.92(a)(2)) | Proprietary Name: | Terumo SurGuard®3 Safety Hypodermic Needle | |-----------------------|---------------------------------------------------------------------------------| | Common Name: | Hypodermic needle with safety sheath or needle with<br>needle protection device | | Classification Name: | Hypodermic single lumen needle | | Classification Panel: | General Hospital | | Regulation: | 21 CFR 880.5570 | | Product Code: | FMI | | Classification: | Class II | #### C. PREDICATE DEVICE (807.92(a)(3)) The legally marketed device to which substantial equivalence is claimed is the current device, K122249 - Terumo SurGuard®3 Safety Hypodermic Needle, manufactured by Terumo (Philippines) Corporation. #### D. REFERENCE DEVICE Biocompatibility data from K121607 - Terumo Hypodermic Needle, manufactured by Terumo (Philippines) Corporation, was levered for information regarding hub colorants. ## E. REASON FOR 510(k) SUBMISSION This premarket notification (Special 510(k)) is being submitted for the Terumo SurGuard 3 Safety Hypodermic Needle, manufactured by Terumo (Philippines) Corporation, for the following modifications to the current device: new needle length (19mm), new gauge sizes (18, 19, 20, and 22) for 13 and 16mm needle lengths, cleared under K122249, and a modified safety sheath design for all new gauge and needle length combinations. ## F. DEVICE DESCRIPTION (807.92(a)(4)) #### Principle of Operation Technology The Terumo SurGuard®3 Safety Hypodermic Needle is operated manually or by manual process. {5}------------------------------------------------ ## Design/Construction The Terumo SurGuard®3 Safety Hypodermic Needle [hereinafter referred to as "SurGuard 3 (Short Sheath 2)"] consists of a hypodermic needle with a hinged safety sheath attached to the connector hub which can be attached to either a luer slip or luer lock syringe. This device features a hinged safety sheath attached to the needle hub. The safety sheath contains two locking mechanisms, the tooth-cannula and sheathcollar which are simultaneously activated when manually pressed over the needle immediately after use and just prior to disposal to minimize the possibility of sharps injury. The safety sheath is activated with a one-handed operation, using the finger, thumb, or surface activation. The safety sheath has a finger guide area consisting of a circular dent (for thumb activation; see Figure A) and ramp (for finger activation; see Figure B) which provides tactile confirmation that the user's finger is in the appropriate position for performing the activation. The ramp has steps to provide strong grasp when activating the sheath. There are two stoppers which is located at the end of the circular dent and ramp which prevent the user's finger from going towards the cannula during activation. Another method of activation is by manually pressing the safety sheath over the needle using a firm surface. Image /page/5/Figure/4 description: The image shows a close-up of a mechanical part with a circular dent on its surface. A black arrow points to the dent, labeled as "Circular Dent." A red arrow points to a component on the side of the part, labeled as "Stopper." The image provides a detailed view of the part's features, highlighting the dent and the stopper. Figure A: Circular dent for thumb activation Image /page/5/Figure/6 description: The image shows a close-up of a gray mechanical part with two stoppers. The stoppers are labeled with red arrows pointing to them. The part has a ridged design with multiple horizontal lines. Figure B: Ramp for finger activation The locking mechanisms are positioned within the center and proximal ends of the sheath. The hinge feature allows the medical practitioner to adjust the sheath to its desired position for use. The SurGuard 3 (Short Sheath 2) will have two kinds of needle bevel alignment; zero degree bevel alignment and 90 degree bevel alignment. The SurGuard 3 (Short Sheath 2) will be individually packaged and sterilized by electron beam. {6}------------------------------------------------ #### Materials The materials for all SurGuard 3 (Short Sheath 2) sizes are provided in the table below. | Part Name | Material Name | Manufacturer /<br>Supplier | |-----------------------------|----------------------------------------------------------|--------------------------------------| | Cannula* | Stainless Steel | Kaneko Medix / Terumo<br>Corporation | | Needle Hub* | Polypropylene | Terumo Corporation | | Hub Colorant Base<br>Resin* | Polypropylene + Pigment | Terumo Coporation | | Pink* | Quinacridone Red<br>Perylene Red | Terumo Corporation | | Cream* | Perylene Red<br>Condenzed Azo Yellow | Terumo Corporation | | Yellow* | Perylene Red<br>Condenzed Azo Yellow<br>Titanium Dioxide | Terumo Corporation | | Black* | Carbon Black | Terumo Corporation | | Needle Protector | Polypropylene | Terumo Corporation | | Safety Sheath | Polypropylene | Terumo Corporation | | Collar | Polypropylene | Terumo Corporation | | Glue | Adhesive (Bond 927-T) | Terumo Corporation | | Needle Lubricant* | Reactive Silicone | Terumo Corporation | *Body contacting material #### Specifications The new needle gauge sizes to be added under this 510(k) are: 18G, 19G, 20G, and 22G; additionally, a new needle length of 19mm will be added. This submission also provides new gauge and length combinations for the 13mm and 16mm needle lengths, which were cleared under K122249. Finally, this submission includes a modified design for the short sheath for all new gauge and needle length combinations. The SurGuard 3 (Short Sheath 2) features a modified short sheath designed to allow activation of the safety sheath with larger gauge sizes of short needle lengths. Because the needle is captured and locked inside the tooth cannula part of the safety sheath, the short sheath internal clearances and tooth thicknesses were modified to {7}------------------------------------------------ accommodate these kinds of needles. The following table shows the needle gauge and needle combinations that are new for this submission and those that were cleared under K122249. "X" demonstrates combinations clearance under K122249, and "New" demonstrates combinations proposed for this submission. | Combination | | Needle Length | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |---------------|-----|---------------|----------------|----------------|----------------|--------------|--|--|-----|--|-----|-----|--|--|-----|--|-----|-----|--|--|-----|--|--|--|--|--|-----|--|-----|--|-----|--|------|-----|--|--|--|--|---|-----|--|--|---|--|---|-----|---|---|--|--|--|-----|--|---|--|--|--|-----|--| | | | 3/8"<br>(9mm) | 1/2"<br>(13mm) | 5/8"<br>(16mm) | 3/4"<br>(19mm) | 1"<br>(25mm) | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Gauge<br>Size | 18G | | New | New | | | 19G | | New | New | | | 20G | | New | New | | | 21G | | | | | | 22G | | New | | New | | Size | 23G | | | | | X | 25G | | | X | | X | 26G | X | X | | | | 27G | | X | | | | 30G | | | Gauge<br>Size | 18G | | | New | New | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 19G | | | New | New | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 20G | | | New | New | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 21G | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 22G | | New | | New | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Size | 23G | | | | | X | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 25G | | | X | | X | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 26G | X | X | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 27G | | X | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 30G | | X | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Table 5.2: Gauge/Needle Length Combination # G. INDICATIONS FOR USE (807.92(a)(5)) The Terumo SurGuard®3 Safety Hypodermic Needle is intended for use in the aspiration and injection of fluids for medical purposes. The Terumo Safety Hypodermic Needle is compatible for use with standard luer slip and luer lock syringes. Additionally, after withdrawal of the needle from the body, the attached needle safety sheath can be manually activated to cover the needle immediately after use to minimize risk of accidental needlestick. Note: The indications for use are identical to the predicate device, Terumo SurGuard 3 Safety Hypodermic Needle (K122249). # H. SUBSTANTIAL EQUIVALENCE COMPARISON (807.92(a)(6)) The SurGuard 3 (Short Sheath 2), the subject of this Special 510(k), is substantially equivalent in its intended use/indications for use, technology/principal of operation, materials, and performance to the Terumo SurGuard®3 Safety Hypodermic Needle, manufactured by Terumo (Philippines) Corporation (K122249). {8}------------------------------------------------ A comparison of the technological characteristics is summarized in the table below. | Device<br>Characteristic | Subject Device:<br>SurGuard 3 (Short Sheath 2) | Predicate Device:<br>SurGuard 3 (K122249) | |------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | Terumo (Philippines) Corporation | Same | | Intended Use /<br>Indications for<br>Use | The Terumo SurGuard3 Safety<br>Hypodermic Needle device is<br>intended for use in the aspiration<br>and injection of fluids for medical<br>purposes. The Terumo SurGuard3<br>Safety Hypodermic Needle is<br>compatible for use with standard<br>luer slip and luer lock syringes. | Same | | Operation<br>Principle | Manual | Same | | Design /<br>Construction | Hypodermic needle with integrated<br>safety feature without syringe<br>attached | Same | | Materials | Stainless steel cannula Polypropylene Hub Polypropylene Needle Protector Polypropylene safety feature | Same | | Package | Blister Shelf box Shipping box | Same | | Specifications | Needle gauges:<br>18G, 19G, 20G, and 22G<br><br>Needle length:<br>13mm, 16mm, and 19mm<br><br>Safety Sheath:<br>Short sheath 2 | Needle gauges:<br>23G, 25G, 26G, and 27G<br><br>Needle length:<br>13mm, 16mm, and 25mm<br><br>Safety Sheath:<br>Short sheath | | Sterilization | E-beam radiation (validated in<br>accordance with ISO 11137-1 to<br>achieve SAI 10-6) | Same | # Table 5.3: Comparison Between Subject and Predicate Device The colorant biocompatibility data from the reference device, Terumo Hypodermic Needle (K121607), were levered for the subject device. A comparison of hub colorant {9}------------------------------------------------ information is summarized in the table below. | Hub Color | Subject Device:<br>SurGuard 3 (Short Sheath 2) | Reference Device:<br>Terumo Hypodermic Needle<br>(K121607) | |-----------|------------------------------------------------|------------------------------------------------------------| | Pink* | Quinacridone Red | Same | | Pink* | Perylene Red | Same | | Cream* | Perylene Red | Same | | Cream* | Condensed Azo Yellow | Same | | Yellow* | Perylene Red | Same | | Yellow* | Condensed Azo Yellow | Same | | Black* | Titanium Dioxide | Same | | Black* | Carbon Black | Same | | | | Table 5.4: Hub Colorant Information Table | | |--|--|-------------------------------------------|--| | | | | | *Body contacting material Colorants present on the subject device and K121607 are supplied by Terumo Corporation. ## I. NON CLINICAL TESTS (807.92(b)(1)) #### Performance Performance testing was conducted to ensure sterility and functionality of the SurGuard 3 (Short Sheath 2) throughout the labeled shelf life, verify conformity to the applicable parts of ISO standards, and demonstrate substantial equivalence to the predicate device. The following performance tests were performed on the SurGuard 3 (Short Sheath 2): | Test | Standard | Result | |----------------------------------------------|-----------|----------------| | Cleanliness | | | | Limits for Acidity or Alkalinity | | N/A | | Conical Fitting | ISO 7864 | | | Bond Between Hub and Needle Tube | | | | Adhesive Hold | | Meets standard | | Exposed cannula length | | | | Needle Access to the Sharp in Safe Mode Test | ISO 23908 | Meets standard | Table 5.5: Performance Testing per ISO Standards {10}------------------------------------------------ No deviations from recognized consensus ISO standards were identified, except where the design of the device resulted in a modified method or acceptance criterion. Additionally, performance testing other than to the above ISO Standards was performed on the device to verify the modified device against the currently cleared device. The device complies with the acceptance criteria established based on the predicate, as shown in the table below: | Performance Test | Results | |--------------------------|---------------------------| | Sheath Activation | Meets acceptance criteria | | Sheath Deactivation | Meets acceptance criteria | | Needle Penetration | Meets acceptance criteria | | Manual Sheath Activation | Meets acceptance criteria | | Measurements | Meets acceptance criteria | | Simulated Use Study | Passed | Table 5.6: Performance Testing per Internal Standards Performance testing demonstrates that the new Terumo SurGuard®3 Safety Hypodermic Needle conforms to the recognized consensus ISO standards (ISO 7864 and ISO 23908) and meets internal standards acceptance criteria. Therefore, it is substantially equivalent to the predicate device and is acceptable for clinical use throughout the shelf life. ## Biocompatibility In accordance with ISO 10993-1, the SurGuard 3 (Short Sheath 2) is classified as: Externally Communicating Device, Circulating Blood, Limited Duration of Contact (<24hr). This classification was the same as the predicate and reference devices (K122249 and K121607). All of the subject device's materials are the same as the predicate and reference devices (K122249 and K121607). These devices have the same intended use, body contact, and contact duration classification based on ISO 10993-1:2009. We conclude, therefore, that the subject device is biocompatible for its intended use. {11}------------------------------------------------ #### Sterilization The sterility of the device is assured using a sterilization method validated in accordance with ISO 11137-1:2006, Sterilization of Health Care Products – Radiation – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices. The Terumo SurGuard® 3 Safety Hypodermic Needle is sterilized to provide a Sterility Assurance Level (SAL) of 10 ° #### Risk Analysis A Product Risk Analysis was conducted in accordance with ISO 14971, taking into account the modifications to the previous device, and it was determined that there were no new issues of safety or effectiveness. ## J. CLINICAL TESTS (807.92(b)(2)) This 510(k) does not include data from clinical tests. ## K. CONCLUSION (807.92(b)(3)) In summary, the SurGuard 3 (Short Sheath 2), subject of this Special 510(k), is substantially equivalent in its intended use, technology/principal of operation, materials, and performance to the current device: K122249 - Terumo SurGuard 3 Safety Hypodermic Needle, manufactured by Terumo (Philippines) Corporation