Stryker MIS Attachments and Cutting Accessories

K143540 · Stryker Corporation · HBE · May 1, 2015 · Neurology

Device Facts

• Record ID: K143540
• Device Name: Stryker MIS Attachments and Cutting Accessories
• Applicant: Stryker Corporation
• Product Code: HBE · Neurology
• Decision Date: May 1, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4310
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MIS Attachments and Cutting Accessories are intended to be used with the Stryker Consolidated Operating Room Equipment (CORE®) Console and electric and pneumatic motors. When used with these motors, the MIS Attachments and Cutting Accessories are intended to cut bone in the folling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical applications: Neuro; Spine; Ear, Nose, and Throat (ENT)/ Otorhinolaryngology; and Endoscopic applications. Specific applications include Craniectomy, Laminotomy/Laminectomy, Minimally Invasive Surgery (MIS) Spine, Expanded Endonasal Approach (EEA)/ Anterior Skull Base/ Endoscopic/Transnasal/Transphenoidal, and Orthopedic Spine. These devices are also usable in the preparation for the placement of screws, metal, wires, pins, and other fixation devices.

Device Story

MIS Attachments and Cutting Accessories interface between high-speed electric/pneumatic motors (Stryker CORE Console) and surgical sites. Attachments act as hand-held guides; cutting accessories (fluted/diamond burs) perform bone removal. Used in neuro, spine, ENT, and endoscopic procedures; operated by surgeons in clinical settings. Attachments are reusable; cutting accessories are single-use, sterile. System facilitates bone shaping, drilling, and preparation for fixation hardware (screws, wires, pins). Output is mechanical bone modification; clinical benefit is precise surgical access and site preparation.

Clinical Evidence

No clinical testing was deemed necessary. Evidence consists of bench testing including life, functional, graphics, temperature, slippage, whip, and chatter testing. Biocompatibility testing performed per ISO 10993-1:2009/(R)2013 confirmed devices are non-cytotoxic, non-sensitizing, non-irritating, non-toxic, and non-pyrogenic.

Technological Characteristics

Attachments: 17-4 Stainless Steel (ASTM A564). Cutting Accessories: 440A Stainless Steel (ASTM F899) or M42 Tool Steel (ASTM A600). Energy: Electric/Pneumatic motor-driven. Dimensions: 13 cm and 16 cm lengths. Sterilization: Gamma irradiation (accessories); end-user (attachments). Connectivity: Mechanical interface to CORE console. No software/algorithm.

Indications for Use

Indicated for general patient population requiring bone cutting, drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing in neuro, spine, ENT/otorhinolaryngology, and endoscopic surgical procedures, including preparation for fixation device placement. No known contraindications.

Regulatory Classification

Identification

Powered simple cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments are used with a power source but do not have a clutch mechanism to disengage the tip after penetrating the skull.

Predicate Devices

• Stryker® Consolidated Operating Room Equipment (CORE) System (K112593)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol resembles an abstract caduceus, with a staff and intertwined snakes, but it is rendered in a more fluid and modern design.

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

May 6, 2015

Stryker Corporation Ms. Mairead Twomey Sr. Staff Regulatory Affairs Specialist 4100 E. Milham Ave. Kalamazoo, Michigan 49001

Re: K143540 Trade/Device Name: Stryker MIS Attachments and Cutting Accessories Regulation Number: 21 CFR 882.4310 Regulation Name: Powered Simple Cranial Drills, Burrs, Trephines, and Their Accessories Regulatory Class: Class II Product Code: HBE. ERL Dated: April 2, 2015 Received: April 3, 2015

Dear Ms. Twomey:

This letter corrects our substantially equivalent letter of May 1, 2015.

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.

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

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Page 2 - Ms. Mairead Twomey

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 [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" (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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

# Carlos L. Pena -S

Carlos L. Peña, PhD, MS Director Division of Neurological And Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K143540

Device Name

Stryker MIS Attachments and Cutting Accessories

# Indications for Use (Describe)

The MIS Attachments and Cutting Accessories are intended to be used with the Stryker Consolidated Operating Room Equipment (CORE®) Console and electric and pneumatic motors. When used with these motors, the MIS Attachments and Cutting Accessories are intended to cut bone in the folling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical applications: Neuro; Spine; Ear, Nose, and Throat (ENT)/ Otorhinolaryngology; and Endoscopic applications.

Specific applications include Craniectomy, Laminotomy/Laminectomy, Minimally Invasive Surgery (MIS) Spine, Expanded Endonasal Approach (EEA)/ Anterior Skull Base/ Endoscopic/Transnasal/Transphenoidal, and Orthopedic Spine.

These devices are also usable in the preparation for the placement 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)

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# Section 5

# 510(k) Summary

. .

Traditional 510(k) Submission

.

1

510(k) Summary, Rev 02

Stryker MIS Attachments and Cutting Accessories

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# 510(k) Summary

Classification Data:

| 510(k) Owner: | Stryker Instruments |
|---------------------------|-------------------------------------------------|
| | 4100 E. Milham Avenue |
| | Kalamazoo, MI 49001 |
| | (p) 269-323-7700 |
| | (f) 269-389-5412 |
| Contact Person: | Mairead Twomey |
| | Sr. Staff Regulatory Affairs Specialist |
| Registration<br>Number: | 1811755 |
| Date Summary<br>Prepared: | April 29, 2015 |
| Trade Name(s): | Stryker MIS Attachments and Cutting Accessories |
| Common Name: | Surgical Drill Handpieces |

| FDA Product<br>Code | Device | Regulation<br>Number | Class |
|----------------------------|---------------------------------------------------------------------------|----------------------|-------|
| HBE<br>(Primary<br>Code) | Drills, burs, trephines,<br>and accessories<br>(simple, powered) | 21 CFR<br>882.4310 | II |
| ERL<br>(Secondary<br>Code) | Drill, surgical, ENT<br>(electric or<br>pneumatic) including<br>handpiece | 21 CFR<br>874.4250 | |

| Predicate Device: | 510(k)<br>number | FDA Product<br>code | Trade name | Manufacturer |
|-------------------|------------------|---------------------|-----------------------------------------------------------------------|------------------------|
| | K112593 | ERL | Stryker® Consolidated<br>Operating Room<br>Equipment (CORE)<br>System | Stryker<br>Instruments |

Traditional 510(k) Submission

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The MIS Attachments and Cutting Accessories are intended to be used with the Stryker Consolidated Operating Room Equipment (CORE®) Console and Indications for Use: electric and pneumatic motors. When used with these motors, the MIS Attachments and Cutting Accessories are intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical applications: Neuro; Spine; Ear, Nose, and Throat (ENT)/Otorhinolaryngology; and Endoscopic applications.

> Specific applications include Craniotomy/Craniectomy, Laminotomy/Laminectomy, Minimally Invasive Surgery (MIS) Spine, Expanded Endonasal Approach (EEA)/Anterior Skull Base/ Endoscopic/Transnasal/Transphenoidal, and Orthopedic Spine. These devices are also usable in the preparation for the placement of screws, metal, wires, pins, and other fixation devices.

- Device Description: MIS Attachments and Cutting Accessories are prescription medical devices that are designed to provide an interface between a cutting accessory and a high speed motor. When used with a motor and a cutting accessory, the MIS Attachments are intended to cut, drill, ream, decorticate, shape, dissect, shave and smooth bone in a variety of surgical procedures including the following specialty areas: Neuro, Spine, ENT, Endoscopic and Orthopedics.
The Stryker MIS Attachments are available in straight, curved and angle styles and in two lengths - 13 cm and 16 cm.

Cutting accessories are single use, sterile devices which have a mount or notch machined at their proximal end and a head with a sharp cutting edge at their distal end. The MIS Cutting Accessories are designed to fit the corresponding MIS Attachments. The cutting accessories when used with a high speed drill and MIS Attachments are intended to cut, drill, ream, decorticate, shape, dissect, shave and smooth bone in a variety of surgical procedures.

Performance Data The following verification tests were performed which demonstrate that the (Non Clinical Tests): device meets the performance requirements under its indications for use conditions.

- . Life, Functional and Graphics Testing of MIS Attachments
- Life Testing of Fluted and Diamond Bur Cutting Accessories .
- . Temperature Testing of Cutting Accessories
- . Slippage Testing of Cutting Accessories
- Whip Testing of Cutting Accessories

Traditional 510(k) Submission

#### 510(k) Summary, Rev 02

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#### Chatter Testing of Cutting Accessories .

Results of these tests demonstrate that the functionality, integrity, and safety and effectiveness of the Stryker MIS Attachments and Cutting Accessories is sufficient for their intended use and support a determination of substantial equivalence.

Biocompatibility Stryker MIS Attachments and Cutting Accessories are classified as external Tests: communicating devices: 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, Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," dated April 23, 2013.

> An overview of the Biocompatibility Testing performed is listed in Table 1. Results of testing validate that the subject devices are non-cytotoxic, nonsensitizing, a negligible irritant, non-toxic, and non-pyrogenic.

#### Table 1: Overview of Biocompatibility Testing

| Tests Performed | Biocompatibility Test | Conclusions |
|-----------------------------|------------------------------------------------------|---------------------|
| Biocompatibility<br>Testing | Cytotoxicity | Non-cytotoxic |
| | Sensitization | Non-sensitizing |
| | Irritation | Negligible irritant |
| | Acute Systemic Toxicity | Non-toxic |
| | Material Mediated Pyrogenicity<br>(Attachments) | Non-pyrogen |
| | Bacterial Endotoxin Testing (Cutting<br>Accessories) | Requirement met |
| | Colorant Leachables | Pass |

Clinical Tests:

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

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| Table 2: Substantial Equivalence Table | | | |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| Feature | Stryker® CORE (Predicate K112593) | Subject MIS (Attachments & Cutting<br>Accessories) | Justification |
| Product Class | Class II | Class II | Identical |
| Regulation | 21 CFR 874.4250 - Ear, nose, and throat<br>electric or pneumatic surgical drill<br>21 CFR 882.4310 - Powered simple cranial<br>drills, burrs, trephines<br>21 CFR 872.4120 - Bone cutting<br>instrument and accessories | 21 CFR 882.4310 - Powered simple cranial drills,<br>burrs, trephines | Similar. The regulation of subject device falls<br>within predicate cleared device. |
| FDA Product Code | ERL - Drill, Surgical, ENT (Electric or<br>Pneumatic) including Handpiece<br>HBE - Drills, Burrs, Trephines & Accessories<br>(Simple, Powered)<br>DZJ - Driver, Wire, and Bone Drill, Manual<br>DZI - Drill, Bone, Powered | Primary: HBE - Drills, Burrs, Trephines &<br>Accessories (Simple, Powered)<br>Secondary: ERL - Drill, Surgical, ENT (Electric or<br>Pneumatic) including Handpiece | Similar. The product code of subject device falls<br>within predicate cleared device. |
| Intended Function | • The predicate Stryker® MIS Attachments<br>act as an interface between the high<br>speed motors and the cutting accessories<br>• The predicate MIS attachments are<br>intended as a location for the user to hold<br>and grip the device system<br>• MIS Attachments and Cutting<br>Accessories are intended to cut bone and<br>used in the placement of screws, metal,<br>wires, pins, and other fixation devices | • The subject Stryker® MIS Attachments act as an<br>interface between the high speed motors and the<br>cutting accessories<br>• MIS attachments are intended as a location for<br>the user to hold and grip the device system<br>• MIS Attachments and Cutting Accessories are<br>intended to cut bone and used in the preparation<br>for the placement of screws, metal, wires, pins,<br>and other fixation devices | Identical |
| Patient Population | General | General | Identical |

### Table 2: Substantial Equivalence Table

Traditional 510{k) Submission

510(k) Summary, Rev 02

Stryker MIS Attachments and Cutting Accessories

5

:

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| Feature | Stryker® CORE (Predicate K112593) | Subject MIS (Attachments & Cutting<br>Accessories) | Justification |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications For Use | The Stryker® Consolidated Operating<br>Room Equipment (CORE) System is<br>intended for use in the cutting, drilling,<br>reaming, decorticating, shaping, and<br>smoothing of bone, bone cement and<br>teeth in a variety of surgical procedures,<br>including but not limited to, dental, ENT<br>(ear, nose, throat), neuro, spine, and<br>endoscopic applications. It is also usable in<br>the placement or cutting of screws, metal,<br>wires, pins, and other fixation devices. | The MIS Attachments and Cutting Accessories are<br>intended to be used with the Stryker<br>Consolidated Operating Room Equipment<br>(CORE®) Console and electric and pneumatic<br>motors. When used with these motors, the MIS<br>Attachments and Cutting Accessories are<br>intended to cut bone in the following manner:<br>drilling, reaming, decorticating, shaping,<br>dissecting, shaving, and smoothing for the<br>following medical applications: Neuro; Spine; Ear,<br>Nose, and Throat (ENT)/Otorhinolaryngology;<br>and Endoscopic applications.<br>Specific applications include<br>Craniotomy/Craniectomy,<br>Laminotomy/Laminectomy, Minimally Invasive<br>Surgery (MIS) Spine, Expanded Endonasal<br>Approach (EEA)/Anterior Skull Base/<br>Endoscopic/Transnasal/Transphenoidal, and<br>Orthopedic Spine.<br>These devices are also usable in the preparation<br>for the placement of screws, metal, wires, pins,<br>and other fixation devices. | Similar.<br>The intended use of all the devices identical; to cut<br>bone.<br>The specific indications that are being proposed for<br>addition are a subset of already cleared indications<br>for the predicate devices.<br>Verification and Validation testing has<br>demonstrated that the subject devices have a<br>similar safety and effectiveness profile as the<br>legally marketed predicate devices. |
| Contraindications | None known | None known | Identical |
| Conditions for Use | Attachments - Reusable | Attachments - Reusable | Identical |
| | Cutting Accessories - Single Use | Cutting Accessories - Single Use | Identical |

Traditional 510(k) Submission

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510(k) Summary, Rev 02

:

·

Stryker MIS Attachments and Cutting Accessories

6

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| Feature | Stryker® CORE (Predicate K112593) | Subject MIS (Attachments & Cutting<br>Accessories) | Justification |
|----------------------------------------------------|---------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Patient Contacting<br>Material- Attachment | 304 Stainless Steel per ASTM A249 | MIS 13 cm Attachment (Straight and Angled):<br>17-4 Stainless Steel per ASTM A564 with a color<br>stripe composed of Uniglaze Epoxy Ink – Lilac<br>PMS 265U. | Similar. Both the subject and the predicate are<br>comprised of stainless steel. A color stripe has<br>been added to the subject devices to aid system<br>assembly. |
| | 304 Stainless Steel per ASTM A249 | MIS 16cm Attachment (Straight, Curved and<br>Angled):<br>17-4 Stainless Steel per ASTM A564 with a color<br>stripe composed of Uniglaze Epoxy Ink – Brown<br>UGLZ-7145. | Biocompatibility, Verification and Validation<br>testing has demonstrated that the subject devices<br>have a similar safety and effectiveness profile as<br>the legally marketed predicate devices. |
| Non Patient<br>Contacting Material -<br>Attachment | Bearing Lubricant | Bearing Lubricant | Identical |
| | Hub: Kluber Asonic GLY | Hub: Kluber Asonic GLY | Identical |
| | Bearing Lubricant<br>Rear Nose Tube: Chevron SRI<br>Front Duplex Bearing: Chevron SRI | Bearing Lubricant<br>Nose Tube (Front and Rear): Kluber Asonic GLY | Similar. Changed the nose tube bearing lubricant.<br>The internal lubricant was modified for more<br>durability during cleaning over device life. The<br>lubricant is a non-patient contacting material and<br>therefore out of scope for biocompatibility testing<br>as per the ISO 10993 standard series. Verification<br>and validation testing demonstrated that the<br>subject devices have a similar safety and<br>effectiveness profile as the legally marketed<br>predicate devices. |
| | Retainer material | Retainer material: | Identical |
| | Hub: Polyaide-imide | Hub: Polyaide-imide | Identical |
| | Rear Nose Tube: 410 SST | Nose Tube, Front and Rear: 410 SST | Identical |
| | Front Duplex Bearing: 410 SST | | Identical |

Traditional 510{k) Submission

510(k) Summary, Rev 02

:

:

:

:

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Stryker MIS Attachments and Cutting Accessories

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4100 E. Milham Avonue
Kalamazoo, Mi 49001
Kalamazoo, Mi 49001
t: 269 323 7700 f: 269 324 5412 www.stryker.com

.

| Feature | Stryker® CORE (Predicate K112593) | Subject MIS (Attachments & Cutting<br>Accessories) | Justification |
|--------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Color Band<br>Identification | No | Yes<br>Lilac PMS 265U<br>Brown UGLZ-7145 | Different. Added color band to aid system<br>assembly and aid cutting accessory compatibility.<br>Biocompatibility, Verification and Validation<br>testing has demonstrated that the subject devices<br>have a similar safety and effectiveness profile as<br>the legally marketed predicate devices. |
| Patient Contacting<br>Material- Cutting<br>Accessories | Cutting Accessory Diamond Bur - Stainless<br>Steel EN 10088-3 1.4112 | Cutting Accessory Diamond Bur - Stainless Steel<br>(440A) per ASTM F899 | Similar. The change in stainless steel has been<br>made to improve the manufacturability of the<br>cutting accessories.<br>Biocompatibility, Verification and Validation<br>testing has demonstrated that the subject devices<br>have a similar safety and effectiveness profile as<br>the legally marketed predicate devices. |
| | Cutting Accessory Fluted Bur - M42 Tool<br>steel per ASTM A600 | Cutting Accessory Fluted Bur - M42 Tool steel<br>per ASTM A600 | Identical |
| Sterilization | Cutting accessories - supplied sterile,<br>gamma irradiated | Cutting accessories - supplied sterile, gamma<br>irradiated | Identical |
| | Attachment - End-user sterilized<br>(provided non-sterile)<br>IFU has instructions on how to sterilize<br>(ETO, gas plasma, gravity displacement,<br>moist heat) | Attachment - End-user sterilized (provided non-<br>sterile)<br>IFU has instructions on how to sterilize (ETO, gas<br>plasma, gravity displacement, moist heat) | Identical |
| Sterility Assurance<br>Level | Attachments: 106 | Attachment: 106 | Identical |
| | Cutting Accessories: 106 | Cutting Accessories: 106 | Identical |
| Shelf Life | Diamond Cutting Accessories = 5 years<br>Fluted Cutting Accessories Tool Steel = 3<br>years | Diamond Cutting Accessories = 5 years<br>Fluted Cutting Accessories Tool Steel = 3 years | Identical |
| | Attachments -Not applicable as these are<br>reusable devices | Attachments - Not applicable as these are<br>reusable devices | Identical |
| Traditional 510(k) Submission<br>8 | | 510(k) Summary, Rev 02 | |

·

Stryker MIS Attachments and Cutting Accessories

510(k) Summary, Rev 02

:

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| Feature | Stryker® CORE (Predicate K112593) | Subject MIS (Attachments & Cutting<br>Accessories) | Justification |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Packaging<br>Configuration | Attachments - Retention Insert in a<br>corrugated folder carton<br>MIS Cutting Accessories - tube in a sealed<br>chevron style pouch sterile barrier system | Attachments - Retention Insert in a corrugated<br>folder carton<br>MIS Cutting Accessories - tube in a sealed<br>chevron style pouch sterile barrier system | Identical |
| Attachment to Motor<br>Locking Mechanism | SD/PD style interface | SD/PD style interface | Identical |
| Nose Tube Style | Straight, Curved | Straight, Curved, Angled | Different. The addition of the Angled MIS<br>Attachment to the product line is to provide a<br>wider range of product offerings.<br>Verification and Validation testing has<br>demonstrated that the subject devices have a<br>similar safety and effectiveness profile as the<br>legally marketed predicate devices. |
| Cutting Accessory<br>Locking Mechanism | Friction collet lock | Positive collet locking notch | Different. The change of notch is to improve the<br>retention of the cutting accessory in the MIS<br>attachment.<br>Verification and Validation testing has<br>demonstrated that the subject devices have a<br>similar safety and effectiveness profile as the<br>legally marketed predicate devices. |
| Shank of the Cutting<br>Accessory | Single shank configuration | Dual shank configuration | Different. The change from a single shank<br>configuration to a dual shank configuration is to<br>increase the yield strength of the cutting<br>accessories.<br>Verification and Validation testing has<br>demonstrated that the subject devices have a<br>similar safety and effectiveness profile as the<br>legally marketed predicate devices. |

Traditional 510(k) Submission

510(k) Summary, Rev 02

:

Stryker MI5 Attachments and Cutting Accessories

9

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| Feature | Stryker® CORE (Predicate K112593) | Subject MIS (Attachments & Cutting<br>Accessories) | Justification |
|-------------------------------------------|-----------------------------------|----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Cutting Accessory<br>Head Style Offering | Round, Diamond, Match Head | Round, Diamond, Match Head | Identical |
| Cutting Accessories<br>Diameter Head Size | 1.5 mm - 3.5 mm | 1.5 mm - 5.0 mm | Different. The addition of head sizes to the MIS<br>Cutting Accessory range is to the product line is to<br>provide a wider range of product offerings.<br>Verification and Validation Testing has<br>demonstrated that the subject devices have a<br>similar safety and effectiveness profile as the<br>legally marketed predicate devices. |
| Cutting Accessory<br>Length | One length<br>15.69 cm | Two lengths<br>13 and 16 cm | Similar. The lengths of the Cutting Accessories are<br>designed to fit the corresponding MIS Nose Tube.<br>Verification and Validation testing has<br>demonstrated that the subject devices have a<br>similar safety and effectiveness profile as the<br>legally marketed predicate devices. |
| Motor power supply | Electric and Pneumatic | Electric and Pneumatic | Identical |
| Speed | 5000-75000 rpm | 5000-75000 rpm | Identical |
| Pneumatic Pressure<br>Recommendation | 120 psi (pounds per square inch) | 120 psi (pounds per square inch) | Identical |
| Source of Activation | Handswitch and Footswitch | Handswitch and Footswitch | Identical |

Traditional 510(k) Submission

10

510(k) Summary, Rev 02

:

5tryker MIS Attachments and Cutting Accessories

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### Conclusion / Substantial Equivalence (SE) Rationale

The subject Stryker® MIS Attachments and Cutting Accessories have the same intended use, and similar indications, technologies, characteristics, and principals of operation as the predicate devices. The Stryker® MIS Attachments and Cutting Accessories have a similar safety and effectiveness profile as the legally marketed predicate devices.

Traditional 510(k) Submission