Pi Drive Plus Motor, Extender

K152641 · Stryker Corporation · ERL · Nov 20, 2015 · Ear, Nose, Throat

Device Facts

• Record ID: K152641
• Device Name: Pi Drive Plus Motor, Extender
• Applicant: Stryker Corporation
• Product Code: ERL · Ear, Nose, Throat
• Decision Date: Nov 20, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 874.4250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Stryker Pi Drive Plus Motor 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 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

The Stryker Pi Drive Plus Motor is a reusable, 40V DC electric surgical drill used with the Stryker CORE System. It functions as a rotary tool to transmit torque to various attachments and cutting accessories (burs, routers). The device is operated by a surgeon in an OR setting, with speed controlled via a foot switch or a hand-integrated sensor. An optional 'Extender' accessory provides additional length. The device facilitates bone and tissue manipulation, screw placement, and hardware cutting. It is non-patient contacting. Clinical benefit is derived from its ability to perform precise surgical tasks in diverse specialties. The device is cleaned and sterilized via moist heat (steam) between uses.

Clinical Evidence

No clinical testing was deemed necessary. Substantial equivalence is supported by non-clinical bench testing, including reliability, functional, graphic legibility, and temperature testing, demonstrating that the device meets performance requirements.

Technological Characteristics

Reusable 40V DC electric motor; stainless steel and aluminum housing; silicone and Slick Sil LSR coated cable. Rotary torque transmission; max speed 75,000 RPM. Connectivity: wired to CORE console. Sterilization: moist heat (steam) to SAL 10^-6. Dimensions: 109mm length, 17mm diameter. Weight: 403g. Features knurled grip and handswitch/footswitch control.

Indications for Use

Indicated for use in general patient populations requiring surgical cutting, drilling, reaming, decorticating, shaping, and smoothing of bone, bone cement, and teeth, or placement/cutting of fixation hardware (screws, wires, pins) during dental, ENT, neuro, spine, and endoscopic procedures. No known contraindications.

Regulatory Classification

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 S2 Drill (K141935)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 20, 2015

Stryker Corporation Ms. Julia Helgeson Staff Regulatory Affairs Specialist, Stryker Instruments 400 E. Milham Avenue Kalamazoo, MI 49001

Re: K152641

Trade/Device Name: Pi Drive Plus Motor, Extender 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: October 23, 2015 Received: October 26, 2015

Dear Ms. Helgeson:

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.

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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 [phone] or [phone] 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 [phone] or [phone] 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

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## Indications for Use

510(k) Number (if known) K152641

Device Name Stryker Pi Drive Plus Motor

### Indications for Use (Describe)

The Stryker Pi Drive Plus Motor 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 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) | |
|----------------------------------------------------------------------------|--|
| <div> <span>☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | |
| <div> <span>☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | |

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## 510(k) Summary

| Contact Details | | | |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|---------------------|
| 510(k) Owner | Stryker Instruments<br>4100 E. Milham Avenue<br>Kalamazoo, Michigan 49001<br>US | | |
| FDA Establishment<br>Registration Number | 1811755 | | |
| Submitted By | Deval Patel, MS, RAC<br>Senior Regulatory Affairs Specialist<br>Ph: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] | | |
| Date Submitted | September 14, 2015 | | |
| Device Name | | | |
| Trade Name | Stryker® Pi Drive Plus Motor | | |
| Common Name | Ear, Nose, and Throat Electric or Pneumatic Surgical Drill | | |
| Classification | Class II | | |
| Primary<br>Classification Name | Drill, Surgical, Ent (Electric or Pneumatic) including Handpiece<br>(21 CFR 874.4250, Product code ERL) | | |
| Secondary<br>Classification Name | Driver, Wire, and Bone Drill, Manual<br>(21 CFR 872.4120, Product code DZJ)<br>Drills, Burs, Trephines & Accessories (Simple, Powered)<br>(21 CFR 882.4310, Product code HBE) | | |
| Legally Marketed Predicate Device | | | |
| 510(k) Number | Product Code | Trade Name | Manufacturer |
| Predicate | | | |
| K141935 | ERL, HBE, DZJ | Stryker® S2 Drill | Stryker Instruments |

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Image /page/4/Picture/0 description: The image shows the Stryker logo in black and white. The logo is a stylized wordmark with a unique font. The word "Stryker" is written in all lowercase letters, with the "r" having a distinctive shape. There is a registered trademark symbol to the right of the word.

| Indication for Use | The Stryker Pi Drive Plus Motor 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 Pi Drive Plus Motor is a non-sterile, reusable, electric powered (40V DC) motor that rotates cutting accessories up to speeds of 75,000 RPM. It is powered by the CORE console. The cable of the Pi Drive Plus Motor is integrated into the proximal end and connects directly to the CORE console. The subject drill speed is controlled by a foot switch (connected to the CORE Console) or a removable handswitch which triggers a sensor within the handpiece. A variety of attachments and accessories can be used in conjunction with the drill. The motor (drill), cable, handswitch and footswitch are considered non-patient contacting device. |
| | The Extender is an optional direct drive accessory that attaches to the distal end of the drill and transmits torque from the drill to various attachments. The Extender provides an option to add length to the drill, based on the user preference. The Extender is delivered non-sterile, re-usable, constructed of stainless steel material and is considered a non-patient contacting device. |
| Performance Data (Non-Clinical Tests) | The results of the performance testing demonstrate that the functionality, integrity, and safety and effectiveness of the Stryker Pi Drive Plus Motor and Extender is sufficient for their intended use and support a determination of substantial equivalence to the predicate device. |
| Summary of Performance Testing | The following verification tests were performed on the subject device to demonstrate that device meets performance requirements under its indication for use conditions. |

- Reliability Testing- Motor (Drill), Handswitch Functional .

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Image /page/5/Picture/0 description: The image shows the word "stryker" in a bold, sans-serif font. The word is all lowercase, and there is a small circled "c" symbol to the upper right of the "r". The word is in black and the background is white.

### Range Testing and Extender

- Graphic Legibility Testing for Motor (Drill) and Extender ●
- . Temperature Testing

Results of these tests demonstrate that the functionality, integrity, and safety and effectiveness of the subject device are sufficient for their intended use, indications for use and support a determination of the substantial equivalence.

Clinical Tests No clinical testing was deemed necessary for this 510(k).

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### Table 6-1: Summary of Predicate Comparison

| DESCRIPTION | STRYKER S2 DRILL [PREDICATE]<br>K141935 | STRYKER® Pi DRIVE PLUS MOTOR<br>[SUBJECT] |
|--------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for Use | The Stryker S 2 Drill is intended for<br>use with the Stryker Consolidated<br>Operating Room Equipment (CORE)<br>System. When used with a variety of<br>attachments and cutting accessories,<br>the drill is intended for use in cutting,<br>drilling, reaming, decorticating,<br>shaping, and smoothing of bone,<br>bone cement and teeth in a variety of<br>surgical procedures, including but not<br>limited to dental, ENT (ear, nose, and<br>throat), neuro, spine, and endoscopic<br>applications. It is also usable in the<br>placement or cutting of screws,<br>metal, wires, pins, and other fixation<br>devices. | The Stryker Pi Drive Plus Motor is<br>intended for use with the Stryker<br>Consolidated Operating Room<br>Equipment (CORE) System. When used<br>with a variety of attachments and<br>cutting accessories, the drill is intended<br>for use in cutting, drilling, reaming,<br>decorticating, shaping, and smoothing of<br>bone, bone cement and teeth in a<br>variety of surgical procedures, including<br>but not limited to dental, ENT (ear, nose,<br>and throat), neuro, spine, and<br>endoscopic applications. It is also usable<br>in the placement or cutting of screws,<br>metal, wires, pins, and other fixation<br>devices. |
| Classification of<br>Device | Class II | Class II |
| Primary Product Code | ERL<br>Drill, Surgical, ENT (Electric or<br>Pneumatic) including Handpiece | ERL<br>Drill, Surgical, ENT (Electric or<br>Pneumatic) including Handpiece |
| Primary Regulation | 21 CFR 878.4250<br>Ear, nose and throat electric or<br>pneumatic surgical drill | 21 CFR 878.4250<br>Ear, nose and throat electric or<br>pneumatic surgical drill |
| Condition of Use | Reusable | Reusable |
| Type of Use | Prescription Use Only | Prescription Use Only |
| Patient Population | General | General |
| Contraindications | None known | None known |
| Mode of Action | Rotary (transmits Torque) | Rotary (transmits Torque) |
| Power source | 40 V DC Electric Motor connected via<br>cable to CORE console | 40 V DC Electric Motor connected via<br>cable to CORE console |
| Diameter of Motor | 17mm | 17mm |
| Length of the Motor | 123.5mm | 109mm |
| DESCRIPTION | STRYKER S2 DRILL [PREDICATE]<br>K141935 | STRYKER® Pi DRIVE PLUS MOTOR<br>[SUBJECT] |
| Weight of the Motor | 313g | 403g |
| Maximum Speed | 75,000 rpm | 75,000 rpm |
| Accessories | CORE Console Attachments Cutting accessories Irrigation Clips | CORE Console Attachments Cutting accessories Irrigation Clips Extender |
| Means of Speed Control | Footswitch | Handswitch or Footswitch |
| Grip Design | Smooth | Knurled |
| Cutting Accessories<br>Retention Method by Drill | Burs: Mechanical Lock | Burs: Mechanical Lock |
| | Routers: Routers are not utilized<br>with the S2 Drill | Routers: Spring Collar Mechanism |
| Attachment Retention<br>Method by Drill | Attachments (Except Footed<br>Attachment):<br>Mechanical Lock<br>Footed Attachment:<br>Footed Attachments are not utilized<br>with the S2 Drill | Attachments (Except Footed<br>Attachment):<br>Friction<br>Footed Attachment:<br>Mechanical Lock |
| Housing Material of Drill | Stainless Steel and Aluminum | Stainless Steel and Aluminum |
| Cable Material | Silicone | Silicone and Slick Sil LSR coating |
| Method of Sterilization | Moist Heat (Steam) | Moist Heat (Steam) |
| Sterility Assurance Level<br>(SAL) | 10-6 | 10-6 |
| Cleaning Method | Manual and Mechanical<br>(automated) | Manual and Mechanical (automated) |
| Packaging | Packaged in a sealed retention insert | Packaged in a sealed retention insert |

Special 510(k) Submission

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stryker®

### Table 6-1: Summary of Predicate Comparison (Continued)

STRYKER® Pi DRIVE PLUS MOTOR

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Image /page/8/Picture/0 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 small circle with an R inside of it in the upper right corner of the image. The word "stryker" is a registered trademark of Stryker Corporation, a medical technology company.

### Conclusion/Substantial Equivalence Rationale

The Stryker Pi Drive Plus Motor is substantially equivalent in indications for use, intended use, technological characteristics, safety and effectiveness to the previously cleared Stryker S2 Drill. The subject device has the same operating principle, functional characteristics and applications as the predicate device. The modifications introduced raise no new issues of safety and effectiveness.

Therefore, the subject device is substantially equivalent to the existing predicate device.