(161 days)
The Footed 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 Footed Attachments and Cutting Accessories are intended to cut bone in the following manner: drilling, reaming, shaping, dissecting, shaving and smoothing for the following medical applications: Neuro: Spine: Ear, Nose, and Throat (ENT) / Otology /Neurotology/Otorhinolaryngology; Craniofacial (bones of the skull and supraorbital region); and Sternotomy.
Specific applications include Craniectomy, Pterional Craniotomy, Sub Occipital/Retro Sigmoid/Posterior Fossa Craniotomy, Sphenoid Wing Dissection, Laminotomy/Laminectomy, and Orthopedic Spine.
These devices are also usable in the preparation for the placement of screws, metal, wires, pins, and other fixation devices.
Footed Attachments 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 Footed Attachments are intended cut, drill, ream, dissect and shape bone in a variety of surgical procedures including the following specialty areas: Neuro, Spine, ENT, Sternotomy and Orthopedics.
The Stryker Footed Attachments are available in footed and non-footed configurations. The primary difference is the addition of the foot feature at the end of the nose tube.
The footed attachment is offered in two configurations: Fixed Footed Attachments and Rotating Footed Attachments. The primary difference between the Fixed and the Rotating Footed Attachment is the ability to rotate the foot portion of the device independently from the motor.
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 cutting accessories when used with a high speed drill and Footed Attachments are intended to cut, drill, ream, decorticate, shape, dissect, shave and smooth bone in a variety of surgical procedures.
The document provided is a 510(k) Premarket Notification for Stryker Footed Attachments and Cutting Accessories. It outlines the device's indications for use, describes the device, and discusses performance and biocompatibility testing. However, it does not include an acceptance criteria table with reported device performance in the manner typically seen for diagnostic or AI-driven devices (e.g., sensitivity, specificity, AUC).
Instead, the document details a comparative study against predicate and reference devices, focusing on demonstrating substantial equivalence for a medical device that cuts bone. The "acceptance criteria" here are met through various non-clinical performance tests and biocompatibility assessments, and by showing similarity to legally marketed devices.
Therefore, many of the requested items (e.g., sample size for test set, data provenance, number of experts, adjudication method for ground truth, MRMC study, standalone performance, training set sample size and ground truth establishment) are not applicable in the context of this device and the type of information presented in a 510(k) for a surgical tool like this one. This document focuses on demonstrating physical, functional, and material equivalence rather than diagnostic performance metrics.
Here's an attempt to answer the questions based on the provided document, noting where information is not present or not applicable:
Acceptance Criteria and Device Performance Study
The acceptance criteria for the Stryker Footed Attachments and Cutting Accessories are demonstrated through a series of non-clinical performance tests and biocompatibility evaluations, aimed at showing that the device meets its performance requirements and is substantially equivalent to legally marketed predicate devices. The study detailed is primarily a bench-testing and comparative analysis rather than a clinical trial or diagnostic performance study.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Evaluation | Reported Device Performance / Conclusion |
|---|---|---|
| Performance Requirements | Life Testing - Fluted Bur cutting accessories | Meets performance requirements |
| Life Testing – Spiral Routers | Meets performance requirements | |
| Life Testing – Tapered and Straight cutting accessories | Meets performance requirements | |
| Life testing – Diamond bur cutting accessories | Meets performance requirements | |
| Temperature Testing – Bur Cutting Accessory | Meets performance requirements | |
| Temperature Testing - Router Cutting Accessory | Meets performance requirements | |
| Life, Functional and Graphics Testing of Footed Attachments | Sufficient for intended use | |
| Attachment Latch Test | Sufficient for intended use | |
| Biocompatibility | Cytotoxicity | Non-cytotoxic |
| Sensitization | Non-sensitizing | |
| Irritation | Negligible irritant | |
| Acute Systemic Toxicity | Non-toxic | |
| Material Mediated Pyrogenicity (Attachments) | Non-pyrogen | |
| Bacterial Endotoxin Testing (Cutting Accessories) | Requirement met | |
| Colorant Leachables | Pass | |
| Substantial Equivalence | Comparison to Predicate and Reference Devices (K112593, K113476, K081475) | Similar safety and effectiveness profile |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify sample sizes for the individual non-clinical performance and biocompatibility tests. It indicates these were "verification tests" performed to demonstrate performance. The data provenance is internal to Stryker Instruments, as these are non-clinical bench tests. There is no mention of country of origin for data as it's not a clinical study involving patients. The tests are prospective in nature, as they are part of the device development and verification process.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not Applicable (N/A). For this type of device (a surgical cutting tool), "ground truth" as it pertains to diagnostic accuracy (e.g., for an AI algorithm) is not relevant. The "ground truth" for performance is established by engineering specifications, safety standards, and functional requirements for cutting bone, which are verified through the described non-clinical tests.
4. Adjudication Method for the Test Set
Not Applicable (N/A). There is no "adjudication method" in the context of diagnostic agreement, as this is not a diagnostic device or a study involving subjective assessment of output by multiple readers.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. A MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance in diagnostic tasks, which is not the purpose of this submission for a surgical instrument.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not Applicable (N/A). This device is a mechanical surgical tool, not an algorithm or AI system. Therefore, a standalone performance study in that context is not relevant. The device implicitly performs "stand-alone" in its function as a tool, but its performance is measured against engineering and safety criteria, not AI metrics.
7. Type of Ground Truth Used
The "ground truth" in this context refers to the engineering specifications, functional requirements, and safety standards for a device intended to cut bone. For biocompatibility, the ground truth is established by international standards (e.g., AAMI/ANSI/ISO 10993-1) for biological evaluation of medical devices. The assessment of "substantial equivalence" is based on comparing the subject device's features and performance to those of legally marketed predicate devices.
8. Sample Size for the Training Set
Not Applicable (N/A). This device is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not Applicable (N/A). As there is no training set, this question is not applicable.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of the human form. The symbol is composed of three wavy lines that converge to form a head-like shape.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 8, 2015
Stryker Instruments Ms. Jeanne S. Warner Regulatory Affairs Manager 4100 E. Milham Ave. Kalamazoo, Michigan 49001
K143399 Trade/Device Name: Stryker Footed 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 7, 2015 Received: April 8, 2015
Dear Ms. Warner,
Re:
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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device
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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" (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 (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 -50/0
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) K143399
Device Name
Stryker Footed Attachments and Cutting Accessories
Indications for Use (Describe)
The Footed 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 Footed Attachments and Cutting Accessories are intended to cut bone in the following manner: drilling, reaming, shaping, dissecting, shaving and smoothing for the following medical applications: Neuro: Spine: Ear, Nose, and Throat (ENT) / Otology /Neurotology/Otorhinolaryngology; Craniofacial (bones of the skull and supraorbital region); and Sternotomy.
Specific applications include Craniectomy, Pterional Craniotomy, Sub Occipital/Retro Sigmoid/Posterior Fossa Craniotomy, Sphenoid Wing Dissection, Laminotomy/Laminectomy, 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):
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/1 description: The image shows the Stryker logo in black and white. The logo is a stylized wordmark with a distinctive design. The letters are bold and connected, giving the logo a modern and recognizable appearance.
510(k) Summary
| 510(k) Owner: | Stryker Instruments4100 E. Milham AvenueKalamazoo, MI 49001(p) 269-323-7700(f) 269-389-5299 |
|---|---|
| Contact Person: | Jeanne S. WarnerRegulatory Affairs Manager |
| RegistrationNumber:Date SummaryPrepared: | 1811755May 07, 2015 |
Trade Name(s): Stryker Footed Attachments and Cutting Accessories
Powered simple cranial drills, burrs, trephines, and their accessories. Common Name:
| Product Code | Device | RegulationNumber | Class |
|---|---|---|---|
| HBE(Primary Code) | Drills, burs,trephines, andaccessories(simple, powered) | 21 CFR882.4310 | II |
| ERL(Secondary Code) | Drill, Surgical, ENT(Electric orPneumatic)including | 21 CFR874.4250 | II |
Predicate Device:
Classification
Data:
| 510(k)number | Productcode | Trade name | Manufacturer |
|---|---|---|---|
| K112593 | ERL | Stryker® ConsolidatedOperating RoomEquipment (CORE)System | StrykerInstruments |
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Reference Device-
Anspach:
| TradeName: | Anspach Dissecting Tools |
|---|---|
| Type: | Reference Device |
| 510(k)Number: | K113476 |
| Description: | The primary predicate device has successfullyaddressed decision points 1 to 4 in the 510(k) DecisionMaking Flowchart as per FDA) Guidance for Industryand FDA Staff, The 510(k) Program: EvaluatingSubstantial Equivalence in Premarket Notifications[510(k)], dated July 28, 2014.However, the dimensions, material and technologicalcharacteristics of 2.3mm and 3.0mm spiral routers arecompared to Anspach Dissecting Tools, which arecleared through the 510(k), K113476. |
| Reference Device-Medtronic: | Trade Name: | Medtronic Footed Attachments and Cutting Tools |
|---|---|---|
| Type: | Reference Device | |
| 510(k) Number: | K081475 | |
| Description: | Medtronic Cutting Tools have been used as a reference device since these devices have the same intended use and same technological characteristics as the subject device. Moreover, the dimensions, material and technological characteristics of Stryker 1.5mm spiral routers are compared to the 1.5mm spiral router offered by Medtronic. |
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Stryker®
Indications for Use:
The Footed 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 Footed Attachments and Cutting Accessories are intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving and shaping for the following medical applications: Neuro; Spine; Ear, Nose, and Throat (ENT)/Otology/Neurotology/ Otorhinolaryngology; Craniofacial(bones of the skull and supraorbital region); and Sternotomy.
Specific applications include Craniotomy/Craniectomy, Pterional Craniotomy, Sub Occipital/Retro Sigmoid/Posterior Fossa Craniotomy, Sphenoid Wing Dissection, Laminotomy / Laminectomy, and Orthopedic Spine.
These devices are also usable in the preparation for the placement of screws, metal, wires, pins, and other fixation devices.
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Image /page/6/Picture/0 description: The image shows the word "stryker" in a bold, sans-serif font. The word is all lowercase, and there is a registered trademark symbol to the right of the "r". The word is in black and the background is white.
Device Footed Attachments are prescription medical devices that are designed to Description: provide an interface between a cutting accessory and a high speed motor. When used with a motor and a cutting accessory, the Footed Attachments are intended cut, drill, ream, dissect and shape bone in a variety of surgical procedures including the following specialty areas:
Neuro, Spine, ENT, Sternotomy and Orthopedics.
The Stryker Footed Attachments are available in footed and non-footed configurations. The primary difference is the addition of the foot feature at the end of the nose tube.
The footed attachment is offered in two configurations: Fixed Footed Attachments and Rotating Footed Attachments. The primary difference between the Fixed and the Rotating Footed Attachment is the ability to rotate the foot portion of the device independently from the motor.
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 cutting accessories when used with a high speed drill and Footed Attachments are intended to cut, drill, ream, decorticate, shape, dissect, shave and smooth bone in a variety of surgical procedures.
Performance The following verification tests were performed which demonstrate that the Data (Non device meets the performance requirements under its indications for use Clinical Tests): conditions.
- Life Testing - Fluted Bur cutting accessories
- Life Testing – Spiral Routers
- Life Testing – Tapered and Straight cutting accessories
- Life testing – Diamond bur cutting accessories
- Temperature Testing – Bur Cutting Accessory
- Temperature Testing - Router Cutting Accessory
- Life, Functional and Graphics Testing of Footed Attachments
- Attachment Latch Test
Results of these tests demonstrate that the functionality, integrity, and safety and effectiveness of the Stryker Footed Attachments and Cutting Accessories is sufficient for their intended use and support a determination of substantial equivalence.
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Biocompat-Stryker Footed Attachments and Cutting Accessories are classified as ibility Tests: external 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.
Results of testing validate that the subject devices are non-cytotoxic, nonsensitizing, a negligible irritant, non-toxic, and non-pyrogenic.
| 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 | |
| BiocompatibilityTesting | Bacterial Endotoxin Testing (CuttingAccessories) | Requirement met |
| BiocompatibilityTesting | Colorant Leachables | Pass |
Table 1: Overview of Biocompatibility Testing
No clinical testing was deemed necessary for this 510(k). Clinical Tests:
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Table 2: Comparison of Subject, Predicate and Reference Devices
| Feature | Subject Device -Stryker® - FootedAttachments and | Predicate Device -Stryker CORE®(Duraguards, Routers | Reference Device -Anspach DissectingTools (K113476) | Reference Device -Medtronic FootedAttachments and | Justification |
|---|---|---|---|---|---|
| Cutting Accessories | and Burs) ( K112593) | Cutting Tools (K081475) | |||
| Model Name | Footed Attachments | Fixed Duraguards | Not applicable as 510k isfor Cutting Accessories only | Footed Attachments | Similar |
| Rotating Footed Attachments | Steering Duraguards | Not applicable as 510k isfor Cutting Accessories only | Rotating Footed Attachments | Verification andValidationtesting has | |
| Non-Footed Attachments;8cm and 9cm | D-Attachment | Not applicable as 510k isfor Cutting Accessories only | Non-Footed Attachments 8-Band 9-M | Validationtesting has | |
| Tapered, Spiral, Straightrouters | Tapered routers | Tapered, Spiral routers | Tapered, Spiral, Straight routers | demonstratedthat the subject | |
| Match Head and DiamondMatch Head cuttingaccessories | None | Not applicable for thesecutting accessory head types | Match Head and DiamondMatch Head cutting accessories | devices have asimilar safetyand effectivenessprofile as thelegally marketedpredicatedevices. | |
| PatientPopulation | General | General | General | General | Identical |
| Contra-indications | None | None | None | None | Identical |
| Feature | Subject Device - Stryker® –Footed Attachments and CuttingAccessories | PredicateDevice –StrykerCORE®(Duraguards,Routers andBurs)(K112593) | Reference Device -Anspach DissectingTools (K113476) | Reference Device -Medtronic FootedAttachments andCutting Tools(K081475) | Justification |
| Indicationsfor Usestatement | The Footed Attachments andCutting Accessories are intended tobe used with the StrykerConsolidated Operating RoomEquipment (CORE®) Console andelectric and pneumatic motors.When used with these motors, theFooted Attachments and CuttingAccessories are intended to cutbone in the following manner:drilling, reaming, decorticating,shaping, dissecting, shaving andsmoothing for the followingmedical applications: Neuro; Spine;Ear, Nose, and Throat (ENT) /Otology/Neurotology/Otorhinolaryngology;Craniofacial (bones of the skull andsupraorbital region); andSternotomy.Specific applications includeCraniotomy/Craniectomy, PterionalCraniotomy, Sub Occipital/RetroSigmoid/Posterior FossaCraniotomy, Sphenoid WingDissection,Laminotomy/Laminectomy, andOrthopedic Spine.These devices are also usable in thepreparation for the placement ofscrews, metal, wires, pins, and | The Stryker®ConsolidatedOperatingRoomEquipment(CORE) Systemis intended foruse in thecutting, drilling,reaming,decorticating,shaping, andsmoothing ofbone, bonecement andteeth in avariety ofsurgicalprocedures,including butnot limited todental, ENT(ear, nose,throat), neuro,spine, andendoscopicapplications. Itis also usable inthe placementor cutting ofscrews, metal,wires, pins, andother fixationdevices. | Dissection tools areintended for cuttingand shaping boneincluding spine andcranium.7 | The Electric Drill Systemis indicated for theincision / cutting,removal, drilling, andsawing of soft and hardtissue and bone, andbiomaterials in thefollowing applications:• Neurosurgical(Cranial,Craniofacial),• Spinal• Arthroscopic• Orthopedic• Sternotomy• General SurgicalProcedures | Similar.The intendeduse of all thedevicesidentical; to cutbone.The specificindications thatare beingproposed foraddition are asubset ofalready clearedindications forthe predicatedevices.Verification andValidationtesting hasdemonstratedthat the subjectdevices have asimilar safetyandeffectivenessprofile as thelegallymarketedpredicatedevices. |
| Feature | Subject Device -Stryker® - FootedAttachments andCutting Accessories | Predicate Device -– StrykerCORE®(Duraguards,Routers andBurs) ( K112593) | Reference Device -Anspach DissectingTools (K113476) | Reference Device -Medtronic FootedAttachments andCutting Tools(K081475) | Justification |
| AttachmentMaterial | 17-4 Stainless Steel (SST) | 17-4 Stainless Steel(SST) and 13-8MO Stainless Steel(SST) | N/A – Attachments notreferenced | 17-4 Stainless Steel(SST) | Identical |
| AttachmentPackaging | Packaged in a sealedKorrvu retention insert | Packaged in asealed Korrvuretention insert | Not applicable as 510k isfor Cutting Accessoriesonly | Wrapped in a LowDensity Polyethylene bagand placed in a One PieceFolder E-flute corrugatedcarton | Similar |
| SterilizationMethod | Supplied non-sterile.Sterilized at the userfacility by steamsterilization. | Supplied non-sterile. Sterilized atthe user facility bysteam sterilization. | N/A – Attachments notreferenced | Supplied non-sterile.Sterilized at the userfacility by steamsterilization. | Identical |
| Model Name | Footed Attachments | Fixed Duraguards | N/A – Attachments notreferenced | Footed Attachments | Similar |
| Rotating FootedAttachments | SteeringDuraguards | N/A – Attachments notreferenced | Rotating FootedAttachments | Similar | |
| Non-Footed Attachments(8cm and 9cm) | D-Attachment | N/A – Attachments notreferenced | Non-Footed Attachments(8-B and 9-M) | Similar | |
| Tapered, Spiral, StraightRouters | Tapered, StraightRouters | Fluted Spiral, Fluted | Tapered, Spiral, StraightRouters | Identical | |
| Match Head and DiamondMatch Head cuttingaccessories | Match Head andDiamond MatchHead cuttingaccessories | None | Match Head andDiamond Match Headcutting accessories | Identical | |
| Feature | Subject Device -Stryker® - FootedAttachments andCutting Accessories | Predicate Device– StrykerCORE®(Duraguards,Routers andBurs) (K112593) | Reference Device -Anspach DissectingTools (K113476) | Reference Device -Medtronic FootedAttachments andCutting Tools(K081475) | Justification |
| Attachmentconfiguration | • Fixed Footed• Non-Footed• Rotating Footed | • Fixed• Footed• Non-Footed• Rotating• Footed | Not applicable as 510k isfor Cutting Accessoriesonly | • Fixed Footed• Non-Footed• Rotating Footed | Identical |
| Knurling onthe surface ofthe Attachment | Yes | No | Not applicable as 510k isfor Cutting Accessoriesonly | Yes | Similar to predicate.Identical to reference.Verification andValidation testing hasdemonstrated that thesubject devices have asimilar safety andeffectiveness profile asthe legally marketedpredicate devices. |
| FootedAttachmentSize | 12mm-25mm | 12mm-25mm | 12mm-25mm | 12mm-25mm | Identical |
| Type of Router | Tapered, Straight, Spiral | Taper, Straight | Tapered, Spiral | Tapered, Straight, Spiral | Similar |
| Type of Bur | Match Head, DiamondMatch Head | Match Head,Diamond MatchHead | None | Match Head, DiamondMatch Head | Identical |
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Conclusion
The subject Stryker® Footed Attachments and Cutting Accessories have the same fundamental scientific technology, intended use, functional characteristics and applications and therefore have a similar safety and effectiveness profile as the legally marketed predicate devices.
§ 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).