Stryker 90-S Max SERFAS Energy Probe

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January 26, 2018 Stryker Benjamin Krebs Quality Engineer 5900 Optical Court San Jose, California 95138 Re: K171391 Trade/Device Name: Stryker 90-S Max SERFAS Energy Probe Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: May 9, 2017 Received: May 11, 2017 Dear Benjamin Krebs: 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, 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. 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {1}------------------------------------------------ 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. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Jennifer R. Stevenson -S For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use X171391 510(k) Number (if known) Stryker SERFAS 90-S Max Electrosurgical Probe Device Name hip, ankle, and wrist. super in as into is a your studiose in a first success in a since success and the sizes show. of the for notising to be noticess in the is in is is in it is in the in the more the more of the sett Indications for Use (Describe) | | | Over-The-Counter Use ()Se (Frange | | Subgat C) ( ) the grass ( Use Hart 21 PFR 80 Suppated Type of Use (Select one or both, as applicable) . See to A notisuber drowteds and to stremeritypes of your selligge notices and CONTINUE OF A SEPARATE PAGE IF NEEDED. #### A WOJE SERICA JIAMS FRATS ARA FHT OT MAOR CETTINGS AUOY CHES TON OO* of this information collection, including suggestions for reducting to: to the securities nebrud sint pribrished stremmos bres. notitemori to noitemorini to noitest on the see of the beben a be be niemiem bus not of projects of the projective do really ent PRASItaff@fdda.hhs.gov Paperwork Reduction Act (PRA) Stat Office of Chief Information Officer Food and Drug Administration Destment of Health and Human Services information unless it displays a currently voile OMB number. to noitsellos 6, ot broqzer of beniuper in nozneq s bris 10, 2011 yem van van van van variene and See PRA Statement below. Expiration Date: 06/30/2020 Form Approved: OMB No. 0910-0120 {3}------------------------------------------------ # 1. General Information | 510(k) Sponsor | Stryker Corporation | |-------------------------|------------------------------------------------------------------------------| | Address | 5900 Optical Court<br>San Jose, CA 95138 | | FDA Registration Number | 2936485 | | Correspondence Person | Mr. Benjamin Krebs<br>Quality Engineer<br>Stryker Corporation | | Contact Information | Email: ben.krebs@stryker.com<br>Phone: (408) 754-2897<br>Fax: (408)-754-2969 | | Date Prepared | January 25, 2018 | # 2. Device Identification | Proposed Device: | | |---------------------|----------------------------------------------------------------| | Proprietary Name | Stryker® SERFAS 90-S Max Electrosurgical Probe | | Common Name | RF Probe | | Classification Name | Electrosurgical Cutting and Coagulation Device and Accessories | | Regulation Number | 21 CFR 878.4400 | | Product Code | GEI | | Regulatory Class | II | # Primary Predicate Device: | Proprietary Name | Stryker® SERFAS 90-S Electrosurgical Probe | |------------------------|----------------------------------------------------------------| | Common Name | RF Probe | | Premarket Notification | K160050 | | Classification Name | Electrosurgical Cutting and Coagulation Device and Accessories | | Regulation Number | 21 CFR 878.4400 | | Product Code | GEI | | Regulatory Class | II | {4}------------------------------------------------ | Reference Device: | | |------------------------|----------------------------------------------------------------| | Proprietary Name | SERFAS Energy System | | Common Name | RF Probe | | Premarket Notification | K041810 | | Classification Name | Electrosurgical Cutting and Coagulation Device and Accessories | | Regulation Number | 21 CFR 878.4400 | | Product Code | GEI | | Regulatory Class | II | ### Device Description The Stryker SERFAS 90-S Max electrosurgical probe (hereafter referred to as "Proposed device") is an accessory to the SERFAS Energy System, marketed through K041810 and K160050, and the Crossfire Arthroscopy System, marketed through K071859, which is intended for resection, ablation, and coagulation of soft tissue via radiofrequency (RF) ablation. RF ablation probes are the main tool used in most arthroscopic procedures for the removal of tissue and the coagulation of bleeding vessels. The Proposed device is a disposable single-use electrosurgical device provided sterile via Ethylene Oxide sterilization. # 3. Indications for Use The Stryker SERFAS 90-S Max electrosurgical probe is indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in orthopedic and arthroscopic procedures of joints such as the knee, shoulder, elbow, hip, ankle, and wrist. # 4. Comparison of Technological Characteristics with the Predicate Device The Stryker SERFAS 90-S Max electrosurgical probe is similar to the predicate device with respect to technological characteristics and design. The modifications of the Proposed device, listed below, are minor and testing confirms that these modifications do not raise any new questions of safety or effectiveness, therefore supporting that the SERFAS 90-S Max electrosurgical probe is substantially equivalent to the predicate device currently on the market. The following differences exist between the Proposed device and the predicate device: - Probe Tip (Electrode and Ceramic) Design ● - . Outer Lumen Heat Shrink Material {5}------------------------------------------------ ## 5. Performance Testing The Stryker SERFAS 90-S Max electrosurgical probe was tested for performance in accordance with internal design specifications and with the applicable performance standards, which established the substantial equivalence determination. The following non-clinical tests were conducted and are summarized in the table below: | Test Name | Description | Results | |-------------------|-----------------------------------------------------------------------------------------------------|---------| | Aggressive Use | Determines if a probe can last its full lifetime without<br>failure | Pass | | Tip Cantilever | Determines if the probe tip can withstand the normal and<br>side force | Pass | | Torsion in a Slot | Determines if the probe tip can withstand torsional forces | Pass | | Bending Moment | Verifies failure mode while probe is used in prying<br>manner | Pass | | Impact | Determines a probe can survive an impact of a hard object | Pass | | Electrode Pull | Determines the force at which the electrode is pulled out of<br>the probe tip assembly | Pass | | Heat | Determines if the probe tip can withstand extreme<br>temperatures | Pass | | Captured Tip | Determines strength of probe tip assembly | Pass | | Leak | Determines if probe will allow leakage. | Pass | | Heat Shrink | Determines mechanical strength of heat shrink | Pass | | Mechanical Force | Determines if the probe can withstand representative<br>compressive force on shaft | Pass | | Shaft Compression | Determines if the probe can withstand representative<br>compressive force on shaft | Pass | | Thermal Damage | Determines the thermal effect on tissue of the proposed<br>device compared to the reference device. | Pass | Bench performance testing was conducted to ensure that the device functioned as intended and met design specifications and acceptance criteria. ### 6. Conclusion Based on the intended use, technological characteristics, performance testing, and non-clinical testing in comparison to the predicate device, the Stryker SERFAS 90-S Max electrosurgical probe does not raise any new questions of safety and effectiveness, therefore demonstrating substantial equivalence.