← Product Code [ERL](/submissions/EN/subpart-e%E2%80%94surgical-devices/ERL) · K141935 # STRYKER S2 DRILL (K141935) _Stryker Corporation · ERL · Sep 26, 2014 · Ear, Nose, Throat · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/ERL/K141935 ## Device Facts - **Applicant:** Stryker Corporation - **Product Code:** [ERL](/submissions/EN/subpart-e%E2%80%94surgical-devices/ERL.md) - **Decision Date:** Sep 26, 2014 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 874.4250 - **Device Class:** Class 2 - **Review Panel:** Ear, Nose, Throat - **Attributes:** Therapeutic ## Intended Use The Stryker S2 Drill is intended for use with the Stryker Consolidated Operating Room Equipment (CORE) System. When used with a variety of attachments and cutting accessories, the drill is intended for use in cutting, reaming, decorticating, shaping, and smoothing of bone cement and teeth in a variety of surgical procedures, including but not limited to dental. ENT (ear, nose, and throat), neuro, spine, and endoscopic applications. It is also usable in the placement or cutting of screws, metal, wires, pins, and other fixation devices. ## Device Story Stryker S2 Drill is an electric-powered (40V DC) surgical handpiece designed for use with the Stryker Consolidated Operating Room Equipment (CORE) System. Device rotates various cutting accessories at speeds up to 75,000 RPM to perform bone, bone cement, and tooth manipulation (cutting, reaming, shaping, smoothing) and fixation device placement. Operated by surgeons in clinical settings (OR, dental, etc.) via footswitch control. Device features improved rotor driveshaft compared to predicate. Output is mechanical rotation of surgical attachments; healthcare providers use this to perform precise surgical bone/tissue work. Benefits include enhanced surgical access and efficiency in diverse specialties. ## Clinical Evidence No clinical testing was deemed necessary for this 510(k). Substantial equivalence is supported by bench testing, including verification of the improved rotor driveshaft, simulated use tests, and temperature testing across various torque-speed settings. ## Technological Characteristics Electric-powered (40V DC) surgical drill; 17mm motor diameter; 123.5mm length; 313g weight. Materials: Stainless steel and aluminum. Connectivity: Cable-connected to CORE console. Activation: Footswitch. Speed: 0-75,000 RPM. Attachment retention: Mechanical lock via rotation. ## Regulatory Identification An ear, nose, and throat electric or pneumatic surgical drill is a rotating drilling device, including the handpiece, that is intended to drive various accessories, such as an ear, nose, and throat bur (§ 874.4140), for the controlled incision or removal of bone in the ear, nose, and throat area. ## Predicate Devices - Stryker Consolidated Operating Room Equipment (CORE) Sumex Drill ([K112593](/device/K112593.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three stylized human profiles facing to the right. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 September 26, 2014 Stryker Corporation Mr. Vishal Kanani Sr. Regulatory Affairs Representative 4100 E. Milham Avenue Kalamazoo, MI 49001 Re: K141935 Trade/Device Name: Stryker S2 Drill Regulation Number: 21 CFR 874.4250 Regulation Name: Ear, Nose, and Throat Electric or Pneumatic Surgical Drill Regulatory Class: Class II Product Code: ERL, HBE, DZJ Dated: August 25, 2014 Received: August 27, 2014 Dear Mr. Kanani: 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 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 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/Resourcesfor You/Industry/default.htm. 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 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, Eric A. Mann -S for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) # K141935 Device Name Styker S2 Drill #### Indications for Use (Describe) The Stryker S2 Drill is intended for use with the Stryker Consolidated Operating Room Equipment (CORE) System. When used with a variety of attachments and cutting accessories, the drill is intended for use in cutting, reaming, decorticating, shaping, and smoothing of bone cement and teeth in a variety of surgical procedures, including but not limited to dental. ENT (ear, nose, and throat), neuro, spine, and endoscopic applications. It is also usable in the placement or cutting of screws, metal, wires, pins, and other fixation devices. Type of Use (Select one or both, as applicable) 2 Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. #### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) 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 Druq 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}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the word "Stryker" in a bold, sans-serif font. The letters are all capitalized except for the "t" and "y", which are lowercase. A registered trademark symbol is located to the right of the "r" in "Stryker". The word is in black and the background is white. ## 510(k) Summary | 510(k) Owner: | Stryker Instruments
4100 E. Milham Avenue
Kalamazoo, MI 49001
(p) 269-323-7700
(f) 269-389-5412 | |---------------------------|--------------------------------------------------------------------------------------------------------------| | Contact Person: | Vishal Kanani
Sr. Regulatory Affairs Representative | | Registration Number: | 1811755 | | Date Summary
Prepared: | July 07, 2014 | | Trade Name(s): | Stryker S2 Drill | Common Name: Classification Data: Ear, nose, and throat electric or pneumatic surgical drill. | | Product
Code | Device | Regulation
Number | Class | Review
Panel | |--------------------|-----------------|------------------------------------------------------------------------------|----------------------|-------|-------------------------| | Primary
Code | ERL | Drill, Surgical,
ENT (Electric or
Pneumatic)
Including
Handpiece | 21 CFR
874.4250 | II | Ear, Nose
and Throat | | Secondary
Codes | HBE | Drills, burs,
trephines, and
accessories
(simple,
powered) | 21 CFR
872.4120 | II | Neurology | | | DZJ | Driver, wire,
and bone drill,
manual | 21 CFR
872.4120 | II | Dental | ### Predicate Device: | 510(k)
number | Product
code | Trade name | Manufacturer | |------------------|-----------------|--------------------------------------------------------------------------|------------------------| | K112593 | ERL | Stryker®
Consolidated
Operating Room
Equipment
(CORE) System | Stryker
Instruments | {4}------------------------------------------------ 4100 E. Milham Ave. Kalamazoo, MI 49001 t: 269 323 7700 f: 269 389 5412 www.stryker.com Image /page/4/Picture/1 description: The image shows the word "stryker" in a bold, sans-serif font. The word is all lowercase except for the first letter, which is uppercase. There is a registered trademark symbol to the right of the word. The word is in black and the background is white. | Indications for Use: | The Stryker S2 Drill is intended for use with the Stryker Consolidated Operating Room Equipment (CORE) System. When used with a variety of attachments and cutting accessories, the drill is intended for use in cutting, drilling, reaming, decorticating, shaping, and smoothing of bone, bone cement and teeth in a variety of surgical procedures, including but not limited to dental, ENT (ear, nose, and throat), neuro, spine, and endoscopic applications. It is also usable in the placement or cutting of screws, metal, wires, pins, and other fixation devices. | |----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Description: | The Stryker S2 Drill is an electric powered (40V DC) motor. When connected to the CORE console, it directly rotates cutting accessories up to speeds of 75,000 RPM. | | Performance Data (Non Clinical Tests): | Following verification tests were performed which demonstrate that the design outputs of the modified device meet the design input requirements: Results of these tests demonstrate that the functionality, integrity, and safety and effectiveness of the Stryker S2 Drill is sufficient for their intended use and support a determination of substantial equivalence. | | Clinical Tests: | No clinical testing was deemed necessary for this 510(k). | | Conclusion/Substantial Equivalence (SE) Rationale: | The Stryker S2 Drill is substantially equivalent in intended use, technological characteristics, safety, and effectiveness to the previously cleared Stryker CORE Sumex Drill. The products have the same fundamental scientific technology, basic design, functional characteristics and applications. The modifications introduced raise no new issues of safety and effectiveness. Therefore, the Stryker S2 Drill is substantially | equivalent to the existing predicate device. {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the word "Stryker" in a bold, sans-serif font. The letters are all connected, and the word is in black. There is a registered trademark symbol to the right of the letter "r". | Summary of Substantial Equivalence Table | | | |------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Description | Stryker CORE Sumex Drill (Predicate) | Stryker S2 Drill (Subject) | | Intended Use | The Stryker Consolidated Operating
Room Equipment (CORE) System is
intended for use in cutting, drilling,
reaming, decorticating, shaping, and
smoothing of bone, bone cement and
teeth in a variety of surgical
procedures, including but not limited
to, dental, ENT (ear, nose, and
throat), neuro, spine, and endoscopic
applications. It is also usable in the
placement or cutting of screws,
metal, wires, pins, and other fixation
devices. | The S2 Drill is intended for use with
the Stryker Consolidated Operating
Room Equipment (CORE) System.
When used with a variety of
attachments and cutting accessories,
the drill is intended for use in
drilling, cutting, reaming,
decorticating, shaping and
smoothing of bone, bone cement
and teeth in a variety of surgical
procedures, including but not limited
to ENT, neuro, spine and Endoscopic
applications. It is also usable in the
placement or cutting of screws,
metal, wires, pins, and other fixation
devices. | | Housing Material | Stainless Steel | Stainless Steel and Aluminum | | Motor Diameter | 20mm | 17mm | | Length of the drill | 105mm | 123.5mm | | Weight of the drill | 399g | 313g | | Power source | 40V DC Electric Motor connected via
cable to CORE console | 40V DC Electric Motor connected via
cable to CORE console | | Speed | 0-75,000 rpm | 0-75,000 rpm | | Attachment retention
method by drill | Mechanical lock activated by rotation
of attachment onto drill | Mechanical lock activated by
rotation of attachment onto drill | | Mode of activation | Footswitch and Handswitch | Footswitch | --- **Source:** [https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/ERL/K141935](https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/ERL/K141935) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com