Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. June 9, 2021 Stryker Corporation John Chesney Sr. Principal Regulatory Affairs Specialist 4100 East Milham Avenue Kalamazoo. Michigan 49001 Re: K211490 Trade/Device Name: Pi Drive 2 Motor, Pi Drive 2 Plus Motor Regulation Number: 21 CFR 874.4250 Regulation Name: Ear, nose, and throat electric or pneumatic surgical drill Regulatory Class: Class II Product Code: ERL, DZJ, HBE Dated: May 12, 2021 Received: May 13, 2021 Dear John Chesney: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies.combination product submissions. 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. 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 {1}------------------------------------------------ 801): medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, for Shu-Chen Peng Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K211490 Device Name Stryker Pi Drive 2 Motor Stryker Pi Drive 2 Plus Motor #### Indications for Use (Describe) The Pi Drive 2 and Pi Drive 2 Plus Motors are 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 Endoscopic Applications. They are also usable in the placement or cutting of screws, metals, wires, pins, and other fixation devices. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| | <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | |-------------------------------------------------------------------------------------------------| | <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the word "stryker" in a bold, sans-serif font. The letters are black, and the background is white. There is a black line underneath the word. The word is likely a logo for the Stryker Corporation, a medical technology company. ### Submitter Information #### This Premarket Notification is submitted by: Stryker Instruments 4100 E. Milham Avenue Kalamazoo, Michigan 49001 # Contact Information John Chesney Senior Principal Regulatory Affairs Specialist Ph: (734)673-5624 Fax: (269)389-5412 Email: john.chesney@stryker.com Date Prepared: 12 May 2021 # Device Name | Subject Device Information | | | |----------------------------|-------------------------|-------------------------------------------------------------------------| | | | | | | Trade/ Proprietary Name | Stryker® Pi Drive 2 Motor<br>Stryker® Pi Drive 2 Plus Motor | | Primary | Regulation Name | Ear, nose, and throat electric or pneumatic surgical drill. | | | Review Panel | Ear, Nose, and Throat | | | Product Code | ERL | | | Regulation Number | 21 CFR 874.4250 | | | Regulatory Class | Class II | | Secondary | Regulation Name | Bone cutting instrument and accessories. | | | Review Panel | Dental | | | Product Code | DZJ | | | Regulation Number | 21 CFR 872.4120 | | | Regulatory Class | Class II | | | Regulation Name | Powered simple cranial drills, burrs, trephines, and their accessories. | | | Review Panel | Neurology | | | Product Code | HBE | | | Regulation Number | 21 CFR 882.4310 | | | Regulatory Class | Class II | ### Subject Device Information {4}------------------------------------------------ ### Predicate Device The legally marketed predicate for the subject devices is detailed as follows. | Predicate Device Trade Name | 510(k) | Product Code | Manufacturer | |------------------------------|---------|---------------|---------------------| | Stryker® Pi Drive Plus Motor | K152641 | ERL, HBE, DZJ | Stryker Instruments | # Predicate Device Information ### Indications for Use The Pi Drive 2 and Pi Drive 2 Plus Motors are intended for use with the Stryker Consolidated Operating Room Equipment (CORE) System. When used with a variety of attachments and cutting accessories, the drills are 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. They are also usable in the placement or cutting of screws, metal, wires, pins, and other fixation devices. #### Device Description The Pi Drive 2 and Pi Drive 2 Plus Motors are non-patient contact, reusable, electric powered (40 VDC) motors that are supplied non-sterile and intended to be to be sterilized by the user prior to each use. The devices are driven by a three-phase, four-pole, brushless DC motor that is housed in a black anodized aluminum body and directly rotates cutting accessories up to speeds of 75,000 RPM. A 4.6 m long cord is integrated into the proximal end of each motor which is used to connect directly to the CORE 2 Console. The CORE 2 Console is used to supply power to the motors and in conjunction with a foot switch (connected to the console) is used for motor activation and speed control. The Pi Drive 2 Plus contains circuitry that also allows it to be operated using a Stryker handswitch for activation and speed control. Both motors are identical in technology, functionality, indications for use, and are compatible with the same attachments and cutting accessories. The Pi Drive 2 Plus motor is approximately 10.3 mm longer and weighs 85 grams more than the Pi Drive 2 motor, this additional length accommodates use of the Stryker handswitch. ## Comparison of Technological Characteristics A comparison of the technological characteristics of the subject devices included in the scope of this Special 510(k) with the predicate is included below. {5}------------------------------------------------ # Motor Technological Comparison | | Subject Device | Predicate Device | |-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | DESCRIPTION | Stryker® Pi Drive 2 Motor<br>Stryker® Pi Drive 2 Plus Motor | Stryker® Pi Drive Plus Motor (K152641) | | Indications for Use | The Pi Drive 2 And Pi Drive 2 Plus Motors are intended for use with the<br>Stryker Consolidated Operating Room Equipment (CORE) System.<br>When used with a variety of attachments and cutting accessories, the<br>drill is intended for use in cutting, drilling, reaming, decorticating,<br>shaping, and smoothing of bone, bone cement and teeth in a variety of<br>surgical procedures, including but not limited to Dental, ENT (Ear,<br>Nose, and Throat), Neuro, Spine, and Endoscopic Applications. They<br>are also usable in the placement or cutting of screws, metal, wires, pins,<br>and other fixation devices. | The Stryker Pi Drive Plus Motor is intended for use with the Stryker<br>Consolidated Operating Room Equipment (CORE) System. When used<br>with a variety of attachments and cutting accessories, the drill is<br>intended for use in cutting, drilling, reaming, decorticating, shaping, and<br>smoothing of bone, bone cement and teeth in a variety of surgical<br>procedures, including but not limited to Dental, ENT (Ear, Nose, and<br>Throat), Neuro, Spine, and Endoscopic Applications. It is also usable in<br>the placement or cutting of screws, metal, wires, pins, and other fixation<br>devices. | | Classification of<br>Device | Class II | Class II | | Primary Product<br>Code | ERL<br>Drill, Surgical, ENT (Electric or Pneumatic) including Handpiece | ERL<br>Drill, Surgical, ENT (Electric or Pneumatic) including Handpiece | | Primary Regulation | 21 CFR 874.4250<br>Ear, nose, and throat electric or pneumatic surgical drill | 21 CFR 874.4250<br>Ear, nose, and throat electric or pneumatic surgical drill | | Secondary Product<br>Codes | DZJ<br>Driver, Wire, And Bone Drill, Manual<br>HBE<br>Drills, Burrs, Trephines & Accessories (Simple, Powered) | DZJ<br>Driver, Wire, And Bone Drill, Manual<br>HBE<br>Drills, Burrs, Trephines & Accessories (Simple, Powered) | | Secondary<br>Regulations | 21 CFR 872.4120<br>Bone cutting instrument and accessories<br>21 CFR 882.4310<br>Powered simple cranial drills, burrs, trephines, and their accessories | 21 CFR 872.4120<br>Bone cutting instrument and accessories<br>21 CFR 882.4310<br>Powered simple cranial drills, burrs, trephines, and their accessories | | Condition of Use | Reusable | Reusable | | | Subject Device | Predicate Device | | DESCRIPTION | Stryker® Pi Drive 2 Motor<br>Stryker® Pi Drive 2 Plus Motor | Stryker® Pi Drive Plus Motor (K152641) | | Type of Use | Prescription Use Only | Prescription Use Only | | Patient Population | General | General | | Contraindications | None | None | | Principle of<br>Operation | The cutting, drilling, reaming, decorticating, shaping, and smoothing<br>actions are accomplished through the transfer of torque from the motor<br>to the selected attachment mounted on the motor which then transfers<br>the torque to the intended cutting accessory such as a bur, router, or<br>perforator bit. | The cutting, drilling, reaming, decorticating, shaping, and smoothing<br>actions are accomplished through the transfer of torque from the motor<br>to the selected attachment mounted on the motor which then transfers<br>the torque to the intended cutting accessory such as a bur, router, or<br>perforator bit. | | Mode of Action | Rotary (transmits Torque) | Rotary (transmits Torque) | | Power source | 40 V DC Electric Motor connected via cable to CORE 2 Console | 40 V DC Electric Motor connected via cable to CORE Console | | Diameter of Motor | 17mm | 17mm | | Length of the Motor | 98.7mm [Pi Drive 2 Motor]<br>109mm [Pi Drive 2 Plus Motor] | 109mm | | Weight of the Motor | 315g [Pi Drive 2 Motor]<br>400g [Pi Drive 2 Plus Motor] | 400g | | Maximum Speed | 75,000 rpm | 75,000 rpm | | Accessories | CORE 2 Console<br>• Attachments<br>• Cutting accessories<br>• Irrigation Sleeves / Clips<br>• Extender | CORE Console<br>• Attachments<br>• Cutting accessories<br>• Irrigation Sleeves / Clips<br>• Extender | | | Subject Device | Predicate Device | | DESCRIPTION | Stryker® Pi Drive 2 Motor<br>Stryker® Pi Drive 2 Plus Motor | Stryker® Pi Drive Plus Motor (K152641) | | Means of Speed<br>Control | Footswitch [Pi Drive 2 Motor]<br>Hand Switch or Footswitch [Pi Drive 2 Plus Motor] | Hand Switch or Footswitch | | Grip Design and<br>Finish | Knurled / Black Diamond Like Carbon (DLC) Coated 455 Stainless<br>Steel | Knurled / 455 Stainless Steel | | Cutting Accessories<br>Retention Method | Spring Collar Mechanism in Motor | Spring Collar Mechanism in Motor | | Attachment<br>Retention Method | Friction Lock or Mechanical Lock | Friction Lock or Mechanical Lock | | Motor Housing<br>Material | Matte Black Anodized 6061-T6 Aluminum ASTM B210/211 | Black Anodized 6061-T6 Aluminum ASTM B210/211 | | Cable Material | Gray Silicone with silicone based anti-friction coating [Pi Drive 2<br>Motor]<br>Black Silicone with silicone based anti-friction coating [Pi Drive 2 Plus<br>Motor] | Black Silicone with silicone based anti-friction coating | | Method of<br>Sterilization | Moist Heat (Steam) | Moist Heat (Steam) | | Sterility Assurance<br>Level (SAL) | 10-6 | 10-6 | | Cleaning Method | Manual and Mechanical (automated) | Manual and Mechanical (automated) | | Packaging | Packaged in corrugated box with a retention insert | Packaged in corrugated box with a retention insert | {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ #### Summary of Non-Clinical Testing The intended use of the subject devices and predicate are identical, and their technological characteristics are similar. The subject devices are a line extension of the predicate and utilize the same design and operating principles. The device modifications do not raise any new or different questions of safety and effectiveness. Risk management was conducted in accordance with ISO 14971 and did not identify any new or unacceptable risks when compared to the predicate. The following testing was conducted to demonstrate that the modifications to the subject devices are as safe and effective as the predicate. - Motor Reliability Life ● - Electrical Reliability ● - IEC 60601-1 Electrical Safety - IEC 60601-1-2 EMC / EMI Testing ● - Packaging Integrity ● - . Device Validation Summary Results of these tests demonstrate that the functionality, integrity, and safety and effectiveness of the subject devices are sufficient for their intended use, indications for use and support a determination of substantial equivalence. #### Summary of Clinical Testing Clinical testing was not required for this Special 510(k). #### Conclusion The subject devices have the same indications for use, intended use, principle of operation, functional characteristics, and use applications. The modifications introduced raise no new or different issues of safety and effectiveness and testing has demonstrated substantial equivalence to the predicate device