(29 days)
The iBur™ Hubs 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 iBur™ Hubs 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 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.
iBur™ 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 iBur™ Hubs 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. 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 iBur™ Cutting Accessories are designed to fit the corresponding iBur™ Hubs. The cutting accessories when used with a high speed drill and iBur™ Hubs are intended to cut, drill, ream, decorticate, shape, dissect, shave and smooth bone in a variety of surgical procedures.
This document is a 510(k) premarket notification for a medical device, the Stryker iBur™ Hubs and Cutting Accessories. It outlines the modifications to an existing device, compares it to a legally marketed predicate device (K210377), and provides performance data to demonstrate substantial equivalence.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not provide a specific table of acceptance criteria with corresponding numerical performance metrics for the iBur™ device. Instead, it makes a general statement about meeting acceptance criteria and demonstrating sufficiency for intended use.
However, it does indicate the types of performance tests conducted and their qualitative outcomes:
| Acceptance Criteria (Implied) | Reported Device Performance (Qualitative) |
|---|---|
| Functionality is sufficient for intended use | Functionality of the iBur™ Cutting Accessories is sufficient for their intended use. |
| Integrity is sufficient for intended use | Integrity of the iBur™ Cutting Accessories is sufficient for their intended use. |
| Safety is sufficient for intended use | Safety of the iBur™ Cutting Accessories is sufficient for their intended use. |
| Effectiveness is sufficient for intended use | Effectiveness of the iBur™ Cutting Accessories is sufficient for their intended use. |
| Performance of proposed devices as determined by risk analysis | Performance testing was conducted on the proposed devices as determined by the risk analysis, and all acceptance criteria were met. |
| Temperature and Simulated Use Testing | Results demonstrate that the functionality, integrity, and safety and effectiveness of the subject devices are sufficient for their intended use and support a determination of substantial equivalence. |
| Design Validation | Results demonstrate that the functionality, integrity, and safety and effectiveness of the subject devices are sufficient for their intended use and support a determination of substantial equivalence. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample size used for the test set or the data provenance. It mentions "performance testing was conducted on the proposed devices" but does not specify the number of devices or units tested.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable to this document. The device is a surgical cutting accessory, not an AI/diagnostic device that requires expert-established ground truth from a test set. The validation focuses on the device's physical performance characteristics.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods are typically used for establishing ground truth in diagnostic studies, which is not the nature of this submission.
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
This information is not applicable. The device is a surgical tool, not an AI system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a surgical cutting accessory, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not explicitly stated in terms of "ground truth" as it would be for an AI or diagnostic device. For this type of device (surgical cutting accessory), the "ground truth" for performance is established through engineering and material science testing, ensuring the device meets predefined technical specifications for cutting efficacy, safety (e.g., temperature), and structural integrity. This is indicated by the mention of "all acceptance criteria were met for the performance testing."
8. The sample size for the training set
This information is not applicable. The device is a physical product, not an AI model that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable. The device is a physical product, not an AI model.
In summary, the provided document is a 510(k) premarket notification for a modified medical device. It focuses on demonstrating that the device's modifications do not alter its fundamental scientific technology or intended use and that its performance remains substantially equivalent to a predicate device through non-clinical performance testing. The questions regarding AI, expert ground truth, and training data are not relevant to this type of device submission.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 11, 2025
Stryker Instruments Alison Garrad Senior Staff Regulatory Affairs Specialist 1941 Stryker Way Portage, Michigan 49002
Re: K250374
Trade/Device Name: iBur 3.0mm Diamond Match Head, Distal Bend (8431-107-030D); iBur 3.0mm Precision Round, Distal Bend (8431-009-030); iBur 4.0mm Precision Round, Distal Bend (8431-009-040); iBur 2.0mm Diamond Round, Distal Bend (8431-012-020D); iBur 3.0mm Diamond Round. Distal Bend (8431-012-030D); iBur 4.0mm Diamond Round, Distal Bend (8431-012-040D); iBur 3.0mm Coarse Diamond Round, Distal Bend (8431-013-030DC); iBur 4.0mm Coarse Diamond Round, Distal Bend (8431-013-040DC); iBur 5.0mm Coarse Diamond Round, Distal Bend (8431-013-050DC); iBur 3.0mm Precision Match Head, Distal Bend (8431-107-530) Regulation Number: 21 CFR 882.4310 Regulation Name: Powered Simple Cranial Drills, Burrs, Trephines, And Their Accessories Regulatory Class: Class II Product Code: HBE Dated: February 10, 2025 Received: February 10, 2025
Dear Alison Garrad:
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 (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product: and 21 CFR 820.100. Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical
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devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/2/Picture/3 description: The image shows the text "Adam D. Pierce -S" in a large, sans-serif font. The text is arranged in two lines, with "Adam D." on the first line and "Pierce -S" on the second line. The background is a light blue color, with a faint, stylized design element behind the text.
Digitally signed by Adam D. Pierce -S Date: 2025.03.11 16:37:12 -04'00'
Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional, and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K250374
Device Name iBur™ Hubs and Cutting Accessories
Indications for Use (Describe)
The iBur™ Hubs 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 iBur™ Hubs 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 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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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| Contact Details | |||
|---|---|---|---|
| 510(k) Owner | Stryker Instruments1941 Stryker Way,Portage, MI 49002,USAPhone: 269 323 7700 | ||
| FDA Establishment Registration No. | 3015967359 | ||
| Contact Person | Alison GarradSenior Staff Regulatory Affairs SpecialistPhone: +353-21-4533252mailto:alison.garrad@stryker.com | ||
| Date Submitted | March 11, 2025 | ||
| Device Name | |||
| Trade Name | Stryker iBur™ cutting accessories | ||
| Common Name | Powered simple cranial drills, burrs, tre-phines, and their accessories | ||
| Classification | Class II | ||
| Primary Classification | Drills, Burrs, Trephines & Accessories(Simple, Powered)(21 CFR 882.4310, Product code HBE) | ||
| Secondary Classification | Drill, Surgical ENT (Electric or Pneumatic)including Handpiece(21 CFR 874.4250, Product code ERL) | ||
| Reason for 510(k) Submission | Device modifications, no change tofundamental scientific technology orintended use. | ||
| Device Modification | 1. Update to bend profile of cuttingaccessory specifications to alleviatecontact pressure at distal tip.2. Introduction of alignmentspecification between on cuttingaccessory distal bushing and nosetube. | ||
| Legally Marketed Predicate Device | |||
| 510(k) Number | Product Code | Trade Name | Manufacturer |
| K210377 | HBE | Stryker iBur™ Hubsand CuttingAccessories | Stryker Instruments |
| Reference Device | |||
| 510(k) Number | Product Code | Trade Name | Manufacturer |
| TBA | HBE | Stryker iBur™ Cutting Accessories | Stryker Instruments |
| Indications for Use | The iBur™ Hubs 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 iBur™ Hubs 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 | iBur™ 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 iBur™ Hubs 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. 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 iBur™ Cutting Accessories are designed to fit the corresponding iBur™ Hubs. The cutting accessories when used with a high speed drill and iBur™ Hubs are intended to cut, drill, ream, decorticate, shape, dissect, shave and smooth bone in a variety of surgical procedures. | ||
| Performance Data (Non-clinical Tests) | The results of the performance testing |
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| demonstrate that the functionality, integrity,and safety and effectiveness of the iBur™Cutting Accessories is sufficient for theirintended use and support a determinationof substantial equivalence to the predicatedevices. | |
|---|---|
| Summary of Performance Testing | Risk Management was conducted inaccordance with ISO 14971. |
| Performance testing was conducted onthe proposed devices as determined bythe risk analysis for the products. Thefollowing areas were evaluated:• Temperature and Simulated UseTesting• Design Validation | |
| Results of these tests demonstrate thatthe functionality, integrity, and safety andeffectiveness of the subject devices aresufficient for their intended use and supporta determination of substantial equivalence | |
| Clinical Tests | No clinical testing was deemed necessaryfor this 510(k). |
Table 1 Device Numbers and Descriptions
| Device Part Number | Device Description |
|---|---|
| 8431-107-030D | iBur™ 3.0mm Diamond Match Head, Distal Bend |
| 8431-009-030 | iBur™ 3.0mm Precision Round, Distal Bend |
| 8431-009-040 | iBur™ 4.0mm Precision Round, Distal Bend |
| 8431-012-020D | iBur™ 2.0mm Diamond Round, Distal Bend |
| 8431-012-030D | iBur™ 3.0mm Diamond Round, Distal Bend |
| 8431-012-040D | iBur™ 4.0mm Diamond Round, Distal Bend |
| 8431-013-030DC | iBur™ 3.0mm Coarse Diamond Round, Distal Bend |
| 8431-013-040DC | iBur™ 4.0mm Coarse Diamond Round, Distal Bend |
| 8431-013-050DC | iBur™ 5.0mm Coarse Diamond Round, Distal Bend |
| 8431-107-530 | iBur™ 3.0mm Precision Match Head, Distal Bend |
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| Table 2 Summary of Substantial Equivalence Table - Regulatory Information | |||
|---|---|---|---|
| --------------------------------------------------------------------------- | -- | -- | -- |
| Description | Stryker iBur™ cutting accessories[Subject] | Stryker iBur™ cutting accessories[Predicate K210377] | Explanation of Difference | |
|---|---|---|---|---|
| 510(k) | TBD | K210377 | N/A | |
| Product Code | HBE | HBE | Identical | |
| Secondary Product Code | ERL | ERL | Identical | |
| Regulatory Information | Indications for Use | The iBur™ Hubs 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 iBur™ Hubs 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/ | The iBur™ Hubs 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 iBur™ Hubs 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/ | Identical |
| Description | Stryker iBur™ cutting accessories[Subject] | Stryker iBur™ cutting accessories[Predicate K210377] | Explanation of Difference | |
| Endoscopic/ Transnasal/Transphenoidal, and OrthopedicSpine. | Endoscopic/ Transnasal/Transphenoidal, and OrthopedicSpine. | |||
| These devices are also usable in thepreparation for the placement ofscrews, metal, wires, pins, and otherfixation devices. | These devices are also usable in thepreparation for the placement ofscrews, metal, wires, pins, and otherfixation devices. | |||
| Classificationof Device | Class II | Class II | Identical | |
| RegulationNumber | 882.4310 | 882.4310 | Identical | |
| RegulationName | Powered simple cranial drills, burrs,trephines, and their accessories | Powered simple cranial drills, burrs,trephines, and their accessories | Identical | |
| Condition ofUse | Single use | Single use | Identical | |
| Type of Use | Prescription Use Only | Prescription Use Only | Identical | |
| PatientPopulation | General | General | Identical | |
| Contra-indications | None Known | None Known | Identical |
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| Description | Stryker iBur™ cutting accessories [Subject] | Stryker iBur™ cutting accessories [Predicate K210377] | Explanation of Difference | |
|---|---|---|---|---|
| Technological Characteristics | Attachment to Motor interface | SD/PD style interface | SD/PD style interface | Identical |
| Attachment (Hub) to Motor Locking mechanism | While aligning the dots on the iBur™ hub and motor, slide the iBur™ hub onto the motor until it snaps into place. | While aligning the dots on the iBur™ hub and motor, slide the iBur™ hub onto the motor until it snaps into place. | Identical | |
| Size / length of attachment | Overall device length when cutting accessory assembled into hub 17.1cm. | Overall device length when cutting accessory assembled into hub 17.1cm. | Identical | |
| Nose tube style | Angled | Angled | Identical | |
| Cutting accessory head style offering | Round and Match Head | Round and Match Head | Identical | |
| Cutting accessories diameter head size | 2.0mm -5.0mm | 2.0mm -5.0mm | Identical | |
| Cutting accessory length | One length12.5cm | One length12.5cm | Identical | |
| Description | Stryker iBur™ cutting accessories[Subject] | Stryker iBur™ cutting accessories[Predicate K210377] | Explanation of Difference | |
| No. of flutes oncuttingaccessories | Two | Two | Identical | |
| Integratedirrigation | Polytube wrapped in a polyurethaneheat shrink provides irrigation to thebur head. | Polytube wrapped in a polyurethaneheat shrink provides irrigation to thebur head. | Identical | |
| Shelf Life | Diamond Cutting Accessories = 2yearFluted Cutting Accessories ToolSteel = 2 year | Diamond Cutting Accessories = 2yearFluted Cutting Accessories Tool Steel= 2 year | Identical | |
| PackagingConfiguration | Sealed polybag in a sealed chevronstyle pouch sterile barrier system. | Sealed polybag in a sealed chevronstyle pouch sterile barrier system. | Identical | |
| Patient contactingmaterial - cuttingaccessory | Direct cutting bur head - M2, 440B(Diamond coat).Indirect - Irrigation tubing(polyurethane).Direct - Nose Tube 316L SS and440C SS, Heat shrink - PolyethyleneTerephthalate.Direct - Lubricant cutting accessory -Molykote G-0052FM white bearingGrease. | Direct cutting bur head - M2, 440B(Diamond coat).Indirect - Irrigation tubing(polyurethane).Direct - Nose Tube 316L SS and 440CSS, Heat shrink - PolyethyleneTerephthalate.Direct - Lubricant cutting accessory -Molykote G-0052FM white bearingGrease. | Identical | |
| Sterilization | Gamma irradiated | Gamma irradiated | Identical | |
| Description | Stryker iBur™ cutting accessories[Subject] | Stryker iBur™ cutting accessories[Predicate K210377] | Explanation of Difference | |
| SterilityAssurance level | Cutting Accessories: 10-6 | Cutting Accessories: 10-6 | Identical | |
| Principle ofoperation /mechanism ofaction | The iBur™ Hubs and cuttingaccessories are usedin conjunction with either an electricor pneumaticmotor, CORE Console and afootswitch. When thesystem is assembled, the surgeoncontrols thefootswitch; this modifies theelectrical signal orpneumatic pressure to the motor,controlling therotational speed of the cuttingaccessory. | The iBur™ Hubs and cuttingaccessories are usedin conjunction with either an electricor pneumaticmotor, CORE Console and afootswitch. When thesystem is assembled, the surgeoncontrols thefootswitch; this modifies theelectrical signal orpneumatic pressure to the motor,controlling therotational speed of the cuttingaccessory. | Identical | |
| Motor powersupply | Electric and Pneumatic | Electric and Pneumatic | Identical | |
| Speed | 5000-75000 rpm | 5000-75000 rpm | Identical | |
| Pneumaticpressurerecommendations | 120 psi (pounds per square inch) | 120 psi (pounds per square inch) | Identical | |
| Source ofactivation | Handswitch and Footswitch | Handswitch and Footswitch | Identical | |
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| Description | Stryker iBur™ cutting accessories[Subject] | Stryker iBur™ cutting accessories[Predicate K210377] | Explanation of Difference | |
|---|---|---|---|---|
| Overall Design Concept | Designconfiguration | Cutting Accessories | Cutting Accessories | Identical |
| Distal BendAngleAccessory | Bend profile updated. Bendcommences more proximally with abigger radius of bend creating amore gradual and less pronouncedcurve. | Device bend commences moredistally with smaller radius of bendcreating a more obvious curve. | Similar | |
| Nose TubeAlignmentSpecification | Alignment specification introduced. | Alignment specification not set. | Similar | |
| Line of sight(of surgicalsite) | Narrow nose tube feature enablesline of sight (of surgical site) | Narrow nose tube feature enablesline of sight (of surgical site) | Identical | |
| Shank ofcuttingaccessory | 0.036" to 0.033" | 0.036" to 0.033" | Identical |
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Conclusion / Substantial Equivalence (SE) Rationale
Verification and Validation activities were performed on all characteristics identified in the risk analysis for the proposed modifications to the subject devices. The modifications to the subject devices do not raise any new questions of safety and effectiveness. Moreover, all acceptance criteria were met for the performance testing including temperature testing, demonstrating that the modifications to the subject devices are safe and effective in accordance with their intended use. This assessment supports a conclusion of substantial equivalence.
§ 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).