(137 days)
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 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.
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.
Here's a breakdown of the acceptance criteria and study information for the Stryker MIS Attachments and Cutting Accessories, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes performance tests as "verification tests" and states the "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." Since specific numerical acceptance criteria (e.g., minimum tensile strength, maximum temperature) are not explicitly detailed in the public summary, the "Reported Device Performance" here refers to the device meeting the underlying requirements for each test category.
| Acceptance Criteria Category (Test Performed) | Reported Device Performance |
|---|---|
| Life, Functional, and Graphics Testing of MIS Attachments | Functionality, integrity, safety, and effectiveness are sufficient for intended use. |
| Life Testing of Fluted and Diamond Bur Cutting Accessories | Functionality, integrity, safety, and effectiveness are sufficient for intended use. |
| Temperature Testing of Cutting Accessories | Functionality, integrity, safety, and effectiveness are sufficient for intended use. |
| Slippage Testing of Cutting Accessories | Functionality, integrity, safety, and effectiveness are sufficient for intended use. |
| Whip Testing of Cutting Accessories | Functionality, integrity, safety, and effectiveness are sufficient for intended use. |
| Chatter Testing of Cutting Accessories | Functionality, integrity, safety, and effectiveness are sufficient for intended use. |
| Biocompatibility (Cytotoxicity) | Non-cytotoxic |
| Biocompatibility (Sensitization) | Non-sensitizing |
| Biocompatibility (Irritation) | Negligible irritant |
| Biocompatibility (Acute Systemic Toxicity) | Non-toxic |
| Biocompatibility (Material Mediated Pyrogenicity - Attachments) | Non-pyrogen |
| Biocompatibility (Bacterial Endotoxin Testing - Cutting Accessories) | Requirement met |
| Biocompatibility (Colorant Leachables) | Pass |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes used for each performance test. The nature of these tests (e.g., life testing, temperature testing, slippage testing) suggests these would be controlled laboratory or bench trials using a representative number of devices and components, rather than human subject data.
- Sample Size: Not explicitly stated.
- Data Provenance: The tests are described as "verification tests," implying internal testing conducted by the manufacturer (Stryker Corporation). The document does not specify the country of origin of the data, but since Stryker is based in Kalamazoo, Michigan, USA, it's highly probable the testing was conducted in the USA or by labs commissioned within its network. The studies are prospective in the sense that they were conducted specifically to evaluate the performance of these new devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
For the performance and biocompatibility tests described, the concept of "ground truth established by experts" as typically applies to diagnostic or prognostic AI/medical image analysis is not directly relevant. These are engineering, material science, and biological safety tests. The "ground truth" for these types of tests is defined by established international standards (like ISO 10993 for biocompatibility) and engineering specifications. The results are objective measurements or categorical observations (e.g., "non-toxic," "pass") against these predefined targets or benchmarks.
- Number of Experts: Not applicable in the context of human interpretation of data for ground truth.
- Qualifications of Experts: Not applicable. The "experts" in this context would be the engineers, technicians, and toxicologists conducting the tests with expertise in their respective fields (mechanical engineering, materials science, toxicology, etc.) and knowledge of the relevant standards.
4. Adjudication Method for the Test Set:
Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving human interpretation or subjective assessments where discrepancies need to be resolved. For performance and biocompatibility tests of a physical device, results are generally objective and either meet or do not meet a predefined specification.
- Adjudication Method: Not applicable.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:
The document explicitly states: "No clinical testing was deemed necessary for this 510(k)." Therefore, no MRMC comparative effectiveness study was conducted, and no effect size regarding human readers improving with AI assistance (or any other assistance) is reported.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This device is a surgical instrument (attachments and cutting accessories for powered drills), not an algorithm or an AI-powered diagnostic tool. Therefore, the concept of "standalone algorithm performance" is not applicable. The device's "standalone" performance is evaluated through the physical and biological tests listed (Life, Functional, Temperature, Slippage, Whip, Chatter, Biocompatibility).
7. The Type of Ground Truth Used:
For the performance tests: The ground truth implicitly would be the specified engineering performance requirements (e.g., durability under certain loads, maximum temperature reached, absence of slippage/whip/chatter beyond acceptable limits).
For biocompatibility tests: The ground truth is defined by the criteria within the referenced standards (AAMI/ANSI/ISO ISO 10993-1:2009/(R)2013). This includes established biological responses considered "non-cytotoxic," "non-sensitizing," etc.
8. The Sample Size for the Training Set:
This device is not an AI/ML product; therefore, there is no "training set" in the context of algorithm development.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of medical device.
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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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 | |
| RegistrationNumber: | 1811755 |
| Date SummaryPrepared: | April 29, 2015 |
| Trade Name(s): | Stryker MIS Attachments and Cutting Accessories |
| Common Name: | Surgical Drill Handpieces |
| FDA ProductCode | Device | RegulationNumber | Class |
|---|---|---|---|
| HBE(PrimaryCode) | Drills, burs, trephines,and accessories(simple, powered) | 21 CFR882.4310 | II |
| ERL(SecondaryCode) | Drill, surgical, ENT(electric orpneumatic) includinghandpiece | 21 CFR874.4250 |
| Predicate Device: | 510(k)number | FDA Productcode | Trade name | Manufacturer |
|---|---|---|---|---|
| K112593 | ERL | Stryker® ConsolidatedOperating RoomEquipment (CORE)System | StrykerInstruments |
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 |
|---|---|---|
| BiocompatibilityTesting | Cytotoxicity | Non-cytotoxic |
| Sensitization | Non-sensitizing | |
| Irritation | Negligible irritant | |
| Acute Systemic Toxicity | Non-toxic | |
| Material Mediated Pyrogenicity(Attachments) | Non-pyrogen | |
| Bacterial Endotoxin Testing (CuttingAccessories) | 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 & CuttingAccessories) | Justification |
| Product Class | Class II | Class II | Identical |
| Regulation | 21 CFR 874.4250 - Ear, nose, and throatelectric or pneumatic surgical drill21 CFR 882.4310 - Powered simple cranialdrills, burrs, trephines21 CFR 872.4120 - Bone cuttinginstrument and accessories | 21 CFR 882.4310 - Powered simple cranial drills,burrs, trephines | Similar. The regulation of subject device fallswithin predicate cleared device. |
| FDA Product Code | ERL - Drill, Surgical, ENT (Electric orPneumatic) including HandpieceHBE - Drills, Burrs, Trephines & Accessories(Simple, Powered)DZJ - Driver, Wire, and Bone Drill, ManualDZI - Drill, Bone, Powered | Primary: HBE - Drills, Burrs, Trephines &Accessories (Simple, Powered)Secondary: ERL - Drill, Surgical, ENT (Electric orPneumatic) including Handpiece | Similar. The product code of subject device fallswithin predicate cleared device. |
| Intended Function | • The predicate Stryker® MIS Attachmentsact as an interface between the highspeed motors and the cutting accessories• The predicate MIS attachments areintended as a location for the user to holdand grip the device system• MIS Attachments and CuttingAccessories are intended to cut bone andused in the placement of screws, metal,wires, pins, and other fixation devices | • The subject Stryker® MIS Attachments act as aninterface between the high speed motors and thecutting accessories• MIS attachments are intended as a location forthe user to hold and grip the device system• MIS Attachments and Cutting Accessories areintended to cut bone and used in the preparationfor the placement of screws, metal, wires, pins,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 & CuttingAccessories) | Justification |
|---|---|---|---|
| Indications For Use | The Stryker® Consolidated OperatingRoom Equipment (CORE) System isintended for use in the cutting, drilling,reaming, decorticating, shaping, andsmoothing of bone, bone cement andteeth in a variety of surgical procedures,including but not limited to, dental, ENT(ear, nose, throat), neuro, spine, andendoscopic applications. It is also usable inthe placement or cutting of screws, metal,wires, pins, and other fixation devices. | The MIS Attachments and Cutting Accessories areintended to be used with the StrykerConsolidated Operating Room Equipment(CORE®) Console and electric and pneumaticmotors. When used with these motors, the MISAttachments and Cutting Accessories areintended to cut bone in the following manner:drilling, reaming, decorticating, shaping,dissecting, shaving, and smoothing for thefollowing medical applications: Neuro; Spine; Ear,Nose, and Throat (ENT)/Otorhinolaryngology;and Endoscopic applications.Specific applications includeCraniotomy/Craniectomy,Laminotomy/Laminectomy, Minimally InvasiveSurgery (MIS) Spine, Expanded EndonasalApproach (EEA)/Anterior Skull Base/Endoscopic/Transnasal/Transphenoidal, andOrthopedic Spine.These devices are also usable in the preparationfor the placement of screws, metal, wires, pins,and other fixation devices. | Similar.The intended use of all the devices identical; to cutbone.The specific indications that are being proposed foraddition are a subset of already cleared indicationsfor the predicate devices.Verification and Validation testing hasdemonstrated that the subject devices have asimilar safety and effectiveness profile as thelegally 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
.
510(k) Summary, Rev 02
:
·
Stryker MIS Attachments and Cutting Accessories
6
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| Feature | Stryker® CORE (Predicate K112593) | Subject MIS (Attachments & CuttingAccessories) | Justification |
|---|---|---|---|
| Patient ContactingMaterial- Attachment | 304 Stainless Steel per ASTM A249 | MIS 13 cm Attachment (Straight and Angled):17-4 Stainless Steel per ASTM A564 with a colorstripe composed of Uniglaze Epoxy Ink – LilacPMS 265U. | Similar. Both the subject and the predicate arecomprised of stainless steel. A color stripe hasbeen added to the subject devices to aid systemassembly. |
| 304 Stainless Steel per ASTM A249 | MIS 16cm Attachment (Straight, Curved andAngled):17-4 Stainless Steel per ASTM A564 with a colorstripe composed of Uniglaze Epoxy Ink – BrownUGLZ-7145. | Biocompatibility, Verification and Validationtesting has demonstrated that the subject deviceshave a similar safety and effectiveness profile asthe legally marketed predicate devices. | |
| Non PatientContacting Material -Attachment | Bearing Lubricant | Bearing Lubricant | Identical |
| Hub: Kluber Asonic GLY | Hub: Kluber Asonic GLY | Identical | |
| Bearing LubricantRear Nose Tube: Chevron SRIFront Duplex Bearing: Chevron SRI | Bearing LubricantNose Tube (Front and Rear): Kluber Asonic GLY | Similar. Changed the nose tube bearing lubricant.The internal lubricant was modified for moredurability during cleaning over device life. Thelubricant is a non-patient contacting material andtherefore out of scope for biocompatibility testingas per the ISO 10993 standard series. Verificationand validation testing demonstrated that thesubject devices have a similar safety andeffectiveness profile as the legally marketedpredicate 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
:
:
:
:
Stryker MIS Attachments and Cutting Accessories
7
·
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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 & CuttingAccessories) | Justification |
|---|---|---|---|
| Color BandIdentification | No | YesLilac PMS 265UBrown UGLZ-7145 | Different. Added color band to aid systemassembly and aid cutting accessory compatibility.Biocompatibility, Verification and Validationtesting has demonstrated that the subject deviceshave a similar safety and effectiveness profile asthe legally marketed predicate devices. |
| Patient ContactingMaterial- CuttingAccessories | Cutting Accessory Diamond Bur - StainlessSteel EN 10088-3 1.4112 | Cutting Accessory Diamond Bur - Stainless Steel(440A) per ASTM F899 | Similar. The change in stainless steel has beenmade to improve the manufacturability of thecutting accessories.Biocompatibility, Verification and Validationtesting has demonstrated that the subject deviceshave a similar safety and effectiveness profile asthe legally marketed predicate devices. |
| Cutting Accessory Fluted Bur - M42 Toolsteel per ASTM A600 | Cutting Accessory Fluted Bur - M42 Tool steelper ASTM A600 | Identical | |
| Sterilization | Cutting accessories - supplied sterile,gamma irradiated | Cutting accessories - supplied sterile, gammairradiated | Identical |
| Attachment - End-user sterilized(provided non-sterile)IFU has instructions on how to sterilize(ETO, gas plasma, gravity displacement,moist heat) | Attachment - End-user sterilized (provided non-sterile)IFU has instructions on how to sterilize (ETO, gasplasma, gravity displacement, moist heat) | Identical | |
| Sterility AssuranceLevel | Attachments: 106 | Attachment: 106 | Identical |
| Cutting Accessories: 106 | Cutting Accessories: 106 | Identical | |
| Shelf Life | Diamond Cutting Accessories = 5 yearsFluted Cutting Accessories Tool Steel = 3years | Diamond Cutting Accessories = 5 yearsFluted Cutting Accessories Tool Steel = 3 years | Identical |
| Attachments -Not applicable as these arereusable devices | Attachments - Not applicable as these arereusable devices | Identical | |
| Traditional 510(k) Submission8 | 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 & CuttingAccessories) | Justification |
|---|---|---|---|
| PackagingConfiguration | Attachments - Retention Insert in acorrugated folder cartonMIS Cutting Accessories - tube in a sealedchevron style pouch sterile barrier system | Attachments - Retention Insert in a corrugatedfolder cartonMIS Cutting Accessories - tube in a sealedchevron style pouch sterile barrier system | Identical |
| Attachment to MotorLocking Mechanism | SD/PD style interface | SD/PD style interface | Identical |
| Nose Tube Style | Straight, Curved | Straight, Curved, Angled | Different. The addition of the Angled MISAttachment to the product line is to provide awider range of product offerings.Verification and Validation testing hasdemonstrated that the subject devices have asimilar safety and effectiveness profile as thelegally marketed predicate devices. |
| Cutting AccessoryLocking Mechanism | Friction collet lock | Positive collet locking notch | Different. The change of notch is to improve theretention of the cutting accessory in the MISattachment.Verification and Validation testing hasdemonstrated that the subject devices have asimilar safety and effectiveness profile as thelegally marketed predicate devices. |
| Shank of the CuttingAccessory | Single shank configuration | Dual shank configuration | Different. The change from a single shankconfiguration to a dual shank configuration is toincrease the yield strength of the cuttingaccessories.Verification and Validation testing hasdemonstrated that the subject devices have asimilar safety and effectiveness profile as thelegally marketed predicate devices. |
Traditional 510(k) Submission
510(k) Summary, Rev 02
:
Stryker MI5 Attachments and Cutting Accessories
9
{12}------------------------------------------------
| Feature | Stryker® CORE (Predicate K112593) | Subject MIS (Attachments & CuttingAccessories) | Justification |
|---|---|---|---|
| Cutting AccessoryHead Style Offering | Round, Diamond, Match Head | Round, Diamond, Match Head | Identical |
| Cutting AccessoriesDiameter Head Size | 1.5 mm - 3.5 mm | 1.5 mm - 5.0 mm | Different. The addition of head sizes to the MISCutting Accessory range is to the product line is toprovide a wider range of product offerings.Verification and Validation Testing hasdemonstrated that the subject devices have asimilar safety and effectiveness profile as thelegally marketed predicate devices. |
| Cutting AccessoryLength | One length15.69 cm | Two lengths13 and 16 cm | Similar. The lengths of the Cutting Accessories aredesigned to fit the corresponding MIS Nose Tube.Verification and Validation testing hasdemonstrated that the subject devices have asimilar safety and effectiveness profile as thelegally marketed predicate devices. |
| Motor power supply | Electric and Pneumatic | Electric and Pneumatic | Identical |
| Speed | 5000-75000 rpm | 5000-75000 rpm | Identical |
| Pneumatic PressureRecommendation | 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
§ 882.4310 Powered simple cranial drills, burrs, trephines, and their accessories.
(a)
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.(b)
Classification. Class II (performance standards).