Precision Thin Reciprocating Blade, 0.010in.

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of two main elements: a circular text element and a symbolic graphic. The text element reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion. The graphic element features a stylized depiction of what appears to be an abstract human form or a symbol representing health and human services. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 January 17, 2017 Stryker Instruments Dr. Joanna McCarthy Senior Regulatory Affairs Specialist Stryker Corporation 4100 E. Milham Ave. Kalamazoo, MI 49009 Re: K161514 Trade/Device Name: Precision Thin Reciprocating Blade, 0.010in Regulation Number: 21 CFR 874.4140 Regulation Name: Ear, Nose, and Throat Bur Regulatory Class: Class I Product Code: EQJ Dated: December 13, 2016 Received: December 15, 2016 Dear Dr. McCarthy: 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 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. Eric A. Mann -S for Malvina Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose, and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health {2}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. | 0910-0120 | |--------------------------|------------------| | Expiration Date: | January 31, 2017 | | See PRA Statement below. | | | 10(k) Number (if known) | 161514 | |-------------------------|--------| |-------------------------|--------| ייעוץ (אוסורפ - Indications for Use (Describe) นาย 1 ค.ศ. 1984 - 1992 - 1992 - 1992 - 1992 - 1992 - 1982 - 1982 - 1992 - 1992 - 1992 - 1997 - 1997 - 1997 - 1997 - 1997 - 1997 - 1997 - 1997 - 1997 - 1997 - 1997 - 1997 - 1 | Type of Use (Select one or both, as applicable) | <span> <span style="text-decoration: underline;"></span>Prescription Use (Part 21 CFR 801 Subpart D) </span> | |-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------| | | <span> <input checked="true" type="checkbox"/> </span> | | | <span> <input type="checkbox"/>Over-The-Counter Use (21 CFR 801 Subpart C) </span> | 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](mailto: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." | FORM FDA 3881 (8/14) | Page 1 of 1 | |----------------------|-------------| |----------------------|-------------| PSC Publishing Services (301) 443-6740 EF r vəzi vəzi qot sudovi ilk və vəzi və qalınmışdır. 0 င - မ ခရမျ นที่010.0 เอชธไช สูติเมื่อวันที่ 1 ที่ปี ที่ต่างๆ สอบอรมันที่มีความ สิ่ง 2012 โรคติดที่มีความ {3}------------------------------------------------ #### 510(k) Number: K161514 #### Section 5.1 Submitter 510(k) Owner: Stryker Instruments, 4100 E. Milham Avenue, Kalamazoo, MI 49001, USA Phone: 269-323-7700 Fax: 269-389-5412 Contact Person: Joanna McCarthy PhD, Senior Regulatory Affairs Specialist Date Prepared: 27th May 2016 #### Section 5.2 Device Information Trade Name: Precision Thin Reciprocating Blade, 0.010in. Device Common Name: ENT Bur Classification Name: Bur, Ear, Nose and Throat | FDA Product Code | Device | Regulation Number | Class | |------------------|----------------------------------|-------------------|-------| | EQJ | <i>Bur, Ear, Nose and Throat</i> | 21 CFR 874.4140 | I | Table 5-1. Classification Data for Precision Thin Reciprocating Blade, 0.010in. {4}------------------------------------------------ ## Section 5.3 Comparison against Regulation Stryker currently markets 31 similar devices within the micro reciprocating saw blade family which are independently listed under the FDA product code EQJ. In this premarket notification all 31 devices covered under the EQJ requlation are compared to the subject device Precision Thin Reciprocating Blade, 0.010in based on their technological characteristics and general ENT indications. It is only the addition of the specific indication for the subject device Precision Thin Reciprocating Blade, 0.010in. that is being compared to the following regulation; Regulation Description: Ear, Nose and Throat Bur Regulation Number: 21 CFR 874.4140 #### Section 5.4 Reference Device | Device Name: | Micro Reciprocating Saw Blade (REF MR-0580) | |----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Type: | Reference Device | | 510(K) Number: | K131053- “ANSPACH XMAX, EMAX2 and EMAX2 Plus<br>System with Otologic Attachment System” cleared under<br>FDA Product Codes ERL and EQJ. | | Description: | The primary comparator device (ENT Regulation 21CFR<br>874.4140) has successfully addressed decision points 1 to 4<br>in the 510(k) Decision Making Flowchart as per FDA)<br>Guidance for Industry and FDA Staff, The 510(k) Program:<br>Evaluating Substantial Equivalence in Premarket<br>Notifications [510(k)], dated July 28, 2014.<br><br>However, the technological characteristics (design and<br>material) of the Precision Thin Reciprocating Blade, 0.010in<br>is compared to Anspach Micro Reciprocating Saw Blade,<br>which is cleared through the 510(k) - K131053 | The Anspach Effort, Inc .: Table 5-2. Classification Data for Reference Device. #### Section 5.5 Device Description Stryker's Precision Thin Reciprocating Blade, 0.010in is a sterile, single use cutting accessory which is operated by a surgical drill (handpiece). This handpiece moves the Precision Thin Reciprocating Blade, 0.010in. in a reciprocating manner so that the blade removes bone material on the back stroke of its cut. The Precision Thin Reciprocating Blade, 0.010in. has a thickness of 0.010 inches and therefore can be used in surgical procedures where a narrow kerf width is required when cutting bone. {5}------------------------------------------------ ## Section 5.6 Indications for Use Stryker's Precision Thin Reciprocating Blade, 0.010 inch (REF 5100-437-010) is a sterile, single use cutting accessory intended to cut bone in the posterior canal wall during an Otology procedure. {6}------------------------------------------------ ## Section 5.7 Comparison of Technological Characteristics against Regulation 21 CFR 874.4140 (ENT Burs) and reference device. | Feature | Comparator ENT Bur (21 CFR 874.4140) | Subject Device: Precision Thin Reciprocating Blade,<br>0.010in. | Justification | |---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------| | Product Class | Class I | Class I | Identical | | Regulation | 21 CFR 874.4140 - Bur, ear, nose and throat | 21 CFR 874.4140 - Bur, ear, nose and throat | Identical | | FDA Product Code | EQJ - Bur Ear, Nose and Throat | EQJ - Bur Ear, Nose and Throat | Identical | | Intended Function | Intended to cut bone. | Intended to cut bone. | Identical | | Patient Population | General | General | Identical | | Indications For Use | An ear, nose, and throat bur is a device consisting<br>of an interchangeable drill bit that is intended for<br>use in an ear, nose, and throat electric or<br>pneumatic surgical drill (874.4250) for incising or<br>removing bone in the ear, nose, or throat area.<br>The bur consists of a carbide cutting tip on a<br>metal shank or a coating of diamond on a metal<br>shank. The device is used in mastoid surgery,<br>frontal sinus surgery, and surgery of the facial<br>nerves. | Stryker's Precision Thin Reciprocating Blade, 0.010 inch<br>(REF 5100-437-010) is a sterile, single use cutting accessory<br>intended to cut bone in the posterior canal wall during an<br>Otology procedure. | Similar | | Contraindications | None known | None known | Identical | {7}------------------------------------------------ | Feature | Comparator ENT Bur (21 CFR 874.4140) | Subject Device: Precision Thin Reciprocating<br>Blade, 0.010in. | Justification | |---------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------| | Conditions for Use | Single Use | Single Use | Identical | | Principle of<br>operation<br>/Mechanism of<br>Action | Legally marketed micro reciprocating blades listed<br>under FDA product code EQJ (ENT Bur) are used in<br>conjunction with an electric reciprocating handpiece<br>(CORETM Reciprocating Saws), a CORETM Console<br>and a footswitch or handswitch. When the system is<br>assembled, the surgeon controls the footswitch; this<br>modifies the electrical signal to the motor, controlling<br>the speed of the cutting accessory. | Stryker's Precision Thin Reciprocating Blade, 0.010in.<br>is used in conjunction with an electric motor (CORETM<br>Reciprocating Saws), a CORETM Console and a<br>footswitch. When the system is assembled, the<br>surgeon controls the footswitch or handswitch; this<br>modifies the electrical signal to the motor, controlling<br>the speed of the cutting accessory. | Identical | | Motor power supply | Powered by Electrical energy. | Electrical energy. | Identical | | For use with a surgical<br>drill (handpiece) per 21<br>CFR 874.4140 | Legally marketed micro reciprocating blades - listed<br>under FDA product code EQJ (ENT Bur) are used with<br>the CORETM Reciprocating Saws. | Used with the CORETM Reciprocating Saws as<br>indicated on the product label. | Identical | | Source of Activation | Footswitch and Handswitch. | Footswitch and Handswitch. | Identical | | Feature | Subject Device: Precision Thin<br>Reciprocating Blade, 0.010in. | Device:<br>Anspach<br>Reference<br>Micro Reciprocating Saw Blade<br>(MR-0580) | Justification | | Cutting Accessory<br>Locking Mechanism | Plug<br>Blade<br>locking<br>Tip<br>and<br>mechanism. | Chuck is tightened around shank. | Similar | | Shank of the Cutting<br>Accessory | 0.125 - 0.124 inches | 0.124 inches | Identical | | Cutting Accessory<br>Geometry | Cut Edge: 0.766 in. (19.5mm)<br>Blade Height: 0.137 in.<br>Cut Thickness: 0.010 in. | Cut Edge: 21.35 mm (0.84 in)<br>Cut Thickness: 0.25 mm (0.010 in) | Similar | | Cutting Accessory<br>Length of exposure | 1.42 in. | 1.37 in. | Similar | | Patient Contacting<br>Material | Blade Arbor - Stainless Steel | Blade Arbor - Stainless Steel. | Similar | | | Blade - Stainless Steel<br>Vacuum Brazing Paste - NICROBRAZ<br>51 S ALLOY. | Blade - Stainless Steel.<br>Vacuum Brazing Paste - Unknown. | | | Sterilization | Supplied sterile, gamma irradiated. | Supplied sterile, gamma irradiated. | Identical | | Sterility Assurance<br>Level (SAL) | SAL of 10-6 | Minimum SAL of 10-6 | Identical | | Shelf-Life | 5 Years | Unknown | Similar | | Packaging<br>Configuration | Individually packaged in foil pouch with<br>Polybag. | Tyvek / Film pouch with the internal<br>packaging being a PETG clamshell<br>blister. | Similar | {8}------------------------------------------------ Table 5-3: Comparative Device Justification Table. {9}------------------------------------------------ ## Section 5.8 Performance Data The following verification tests were performed which demonstrates that the device meets the performance requirements under its indications for use conditions. - Kerf Width Testing ● - Life, Simulated Use Testing ● - Temperature Testing ● Simulated use of a canal wall reconstruction was completed with 3 ENT surgeons for the specific indication in fresh cadaveric Human temporal bone. To supplement this cadaveric study design validation was also completed for the specific indication using PHACON's Temporal Bone Model with 8 ENT surgeons. This model was selected as a suitable cut media for design validation following a technical evaluation along with expert medical opinion. Collectively, the results of these performance tests demonstrate the functionality, integrity, safety and effectiveness of Stryker's Precision Thin Reciprocating Blade, 0.010in. for its intended use and support a determination of substantial equivalence to the regulation 21 CFR 874.4140 (ENT bur). # 5.8.1 Biocompatibility Testing The subject device Precision Thin Reciprocating Blade, 0.010in. is classified as external communicating device: tissue/bone/dentin with limited patient contact (< 24 hours). The Biocompatibility evaluation was conducted in accordance with; - AAMI/ANSI/ISO ISO 10993-1:2009/(R)2013, Biological evaluation of medical . devices - Part 1: Evaluation and testing within a risk management process, and Guidance for Industry and FDA Staff. - Draft Guidance for Industry and FDA Staff, Use of International Standard ISO-● 10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," (Date April 23, 2013). - FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-● 10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," (Dated May 1, 1995). Results of testing validate that the subject device is non-sensitizing, non-irritating and non-toxic (cytotoxic and systemic). #### 5.8.2 Clinical Studies No clinical studies were performed to support substantial equivalence. {10}------------------------------------------------ ## Section 5.9 Conclusions The subject device Precision Thin Reciprocating Blade, 0.010in. is substantially equivalent in intended use, operating principle, fundamental technology, overall design and materials to ENT Burs as described in 21 CFR 874.4140. Risk analysis for the subject device due to the addition of the specific indication reveals no new issues regarding safety or effectiveness.