(141 days)
The iBur hubs and cutting accessories are intended to be used with the Stryker Core Consolidated Operating Room (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, 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/Transsphenoidal, and Orthopedic Spine.
These devices are also usable in the preparation for the placement of screws, metal, wires, pins, and other fixation devices.
iBur™ Hubs 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 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.
The Stryker iBur™ Hubs are available in straight and angled styles and in one length – 12.5cm.
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.
Here's a breakdown of the acceptance criteria and the study information for the Stryker iBur™ hubs and cutting accessories, based on the provided document:
This document does not include specific quantitative acceptance criteria or detailed study results for performance metrics like accuracy, sensitivity, or specificity. Instead, it describes a non-clinical performance study designed to demonstrate substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document does not provide specific numerical acceptance criteria or performance metrics for the device. The reported performance is a qualitative statement of efficacy in comparison to the predicate device.
| Category | Acceptance Criteria (Not explicitly quantified in document) | Reported Device Performance (as stated in the document) |
|---|---|---|
| Functional / Performance | Device must perform its intended function (cutting bone) comparable to predicate. | "The results of the performance testing demonstrate that the functionality, integrity, and safety and effectiveness of the iBur™ Hubs and Cutting Accessories is sufficient for their intended use and support a determination of substantial equivalence to the predicate device." "Results of these tests 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." |
| Biocompatibility | Device materials must be biocompatible. | Confirmed "Biocompatibility testing" was conducted, and results supported substantial equivalence. No details on specific criteria or results are provided. |
| Sterilization & Packaging | Device must be sterilizable and maintain sterility. | Confirmed "Sterilization and packaging testing" was conducted, and results supported substantial equivalence. No details on specific criteria or results are provided. |
| Shelf Life | Shelf life must be adequate. | Reported shelf lives: Diamond Cutting Accessories = 1 year, Fluted Cutting Accessories Tool Steel = 1 year. (Predicate had 5 years and 3 years respectively, but deemed "Similar"). Hubs are reusable, so not applicable. Deemed "Similar" to predicate. |
| Cleaning Methods | Cleaning methods must be effective. | Reported as "Manual and mechanical (automated)" for both proposed and predicate devices. Deemed "Same". |
| Sterility Assurance Level | Maintain a specified sterility assurance level. | Reported as 10^-6 for both attachments (hubs) and cutting accessories for both proposed and predicate devices. Deemed "Same". |
| Energy Source | Must operate within specified parameters (RPM, pressure). | Reported as 5000-75000 rpm and 120 psi pneumatic pressure for both proposed and predicate devices. Deemed "Same". |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify a numerical sample size for the "performance testing" that was conducted. It generally refers to "the proposed devices" and "the products."
- Data Provenance: The document does not provide information about the country of origin of the data or whether the study was retrospective or prospective. Given it is a non-clinical performance test for a medical device, the data provenance likely refers to in-house laboratory testing at Stryker.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. This was a non-clinical performance test of a surgical tool, not a diagnostic device requiring expert interpretation of results to establish ground truth.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. This was a non-clinical performance test.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, an MRMC comparative effectiveness study was not performed. The document explicitly states: "No clinical testing was deemed necessary for this 510(k)."
- Effect Size: Not applicable.
6. Standalone Performance Study
- Standalone Performance Study: Yes, a standalone (algorithm only without human-in-the-loop performance) non-clinical performance study was done for the device itself, separate from human interaction. This is described as "Functional / Performance Testing, Biocompatibility testing, Sterilization and packaging testing." This type of testing aims to confirm the physical and mechanical properties and safety aspects of the device in isolation, or with simulated use, rather than involving human operators for performance evaluation.
7. Type of Ground Truth Used
- Type of Ground Truth: For the "Performance Data (Non-Clinical Tests)," the ground truth would be based on engineering specifications, material science standards, and established test methodologies to assess functionality, integrity, biocompatibility, and sterilization effectiveness. It's not based on expert consensus, pathology, or outcomes data in the traditional sense, as it's a hardware device rather than a diagnostic or interpretive tool.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This is a mechanical/surgical device, not an AI/Machine Learning algorithm that requires a "training set." The development process for such a device would involve design, prototyping, and iterative testing, not a "training set" in the computational sense.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable, as there is no "training set" for this type of device.
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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 30, 2021
Stryker Corporation % Allison Garrad Staff Regulatory Affairs Specialist Stryker Instruments 1941 Stryker Way Portage, Michigan 49002
Re: K210377
Trade/Device Name: Stryker iBur hubs 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, HWE, HSZ Dated: April 4,2021 Received: April 5, 2021
Dear Allison 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 (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 located 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.
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 of medical device-related adverse events) (21 CFR 803) for
{1}------------------------------------------------
devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 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/medicaldevices/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,
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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K210377
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 Core Consolidated Operating Room (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, 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/Transsphenoidal, 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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510(k) Summary
This 510(k) Summary for the Traditional 510(k) Submission for the iBur™ Hubs and Cutting Accessories is prepared in accordance with 21 CFR 807.92.
| Contact Details | |||
|---|---|---|---|
| 510(k) Owner | Stryker Instruments1941 Stryker Way,Portage, MI 49002, USAPhone: 269 323 7700 | ||
| FDA Establishment Registration No. | 3015967359 | ||
| Contact Person | Alison GarradStaff Regulatory Affairs SpecialistPhone: +353-87-6164723mailto:alison.garrad@stryker.com | ||
| Date | June 30, 2021 | ||
| Device Name | |||
| Trade Name | Stryker® iBur™ hubs and cutting accessories | ||
| Common Name | Powered simple cranial drills, burrs, trephines, and their accessories | ||
| Classification | Class II | ||
| Review Panel | Neurology | ||
| 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)Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment(21 CFR 878.4820, Product Code HWE)Surgical instrument motors and accessories/attachments (21CFR 878.4820, Product Code HSZ) | ||
| Reason for 510(k) Submission | Traditional 510(k) – Device modifications and increase in offering with no change to fundamental scientific technology or intended use. | ||
| Device Modification | The product line will be expanded to include the following –Expansion of offeringIntegration of irrigationIntegration of nose tube feature into cutting accessoryThese changes do not change the intended use, indications for use or the fundamental scientific technology of the system. | ||
| Legally Marketed Predicate Device | |||
| 510(k) Number | Product Code | Trade Name | Manufacturer |
| K143540 | HBE | Stryker® MIS Attachments And Cutting Accessories | Stryker Instruments |
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| Reference Device | |||
|---|---|---|---|
| 510(k) Number | Product Code | Trade Name | Manufacturer |
| K191049 | HBE | Stryker® MIS andFooted Attach-ments | Stryker Instruments |
| K143320 | HBE | Stryker® Elite At-tachments | Stryker Instruments |
| These predicate devices have not been the subject of a design related recall. | |||
| Subject Device | |||
| Indications for Use | The iBur™ hubs and cutting accessoriesare intended to be used with the StrykerConsolidated Operating Room EquipmentCORE® Console and electric and pneu-matic motors. When used with these mo-tors, the iBur™ hubs and cutting accesso-ries are intended to cut bone in the follow-ing manner; drilling, reaming, decorticat-ing, shaping, dissecting, shaving, andsmoothing for the following medical appli-cations: Neuro; Spine; Ear, Nose, andThroat (ENT)/Otorhinolaryngology; andEndoscopic applications.Specific applications include Craniot-omy/Craniectomy, Laminotomy/Laminec-tomy, Minimally Invasive Surgery (MIS)Spine, Expanded Endonasal Approach(EEA)/Anterior Skull Base/Endo-scopic/Transnasal/Transsphenoidal, andOrthopedic Spine.These devices are also usable in thepreparation for the placement of screws,metal, wires, pins, and other fixation de-vices. | ||
| Device Description | iBur™ Hubs and Cutting Accessories areprescription medical devices that are de-signed to provide an interface between acutting accessory and a high speed mo-tor. When used with a motor and a cut-ting accessory, the iBur™ Hubs are in-tended to cut, drill, ream, decorticate,shape, dissect, shave and smooth bone ina variety of surgical procedures includingthe following specialty areas: Neuro,Spine, ENT, Endoscopic.The Stryker iBur™ Hubs are available instraight and angled styles and in onelength – 12.5cm. |
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| Cutting accessories are single use, steriledevices which have a mount or notch ma-chined at their proximal end and a headwith a sharp cutting edge at their distalend. The iBur™ Cutting Accessories aredesigned to fit the corresponding iBur™Hubs. The cutting accessories when usedwith a high speed drill and iBur™ Hubsare intended to cut, drill, ream, decorti-cate, shape, dissect, shave and smoothbone in a variety of surgical procedures. | |
|---|---|
| Performance Data(Non-Clinical Tests) | The results of the performance testingdemonstrate that the functionality, integ-rity, and safety and effectiveness of theiBur™ Hubs and Cutting Accessories issufficient for their intended use and sup-port a determination of substantial equiva-lence to the predicate device. |
| Summary of Performance Testing | Performance testing was conducted onthe proposed devices as determined bythe risk analysis for the products. The fol-lowing areas were evaluated:Functional / Performance Testing Biocompatibility testing Sterilization and packaging testing |
| Results of these tests demonstrate thatthe functionality, integrity, and safety andeffectiveness of the subject devices aresufficient for their intended use and sup-port a determination of substantial equiva-lence. | |
| Clinical Tests | No clinical testing was deemed necessaryfor this 510(k). |
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| Model Numbers | Model Descriptions |
|---|---|
| 8431-107-530 | iBur™ 3.0mm Precision Match Head, Distal Bend |
| 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 |
| 8442-107-525 | iBur™ 2.5mm Precision Match Head, Proximal Bend |
| 8442-107-530 | iBur™ 3.0mm Precision Match Head, Proximal Bend |
| 8442-107-025D | iBur™ 2.5mm Diamond Match Head, Proximal Bend |
| 8442-107-030D | iBur™ 3.0mm Diamond Match Head, Proximal Bend |
| 8442-009-030 | iBur™ 3.0mm Precision Round, Proximal Bend |
| 8442-009-040 | iBur™ 4.0mm Precision Round, Proximal Bend |
| 5407-120-300 | iBur™ Straight Hub |
| 5407-120-300A | iBur™ Angled Hub |
Table 5-1: Model Numbers and Description of proposed devices
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iBur™ Traditional 510(k) K210377
| Table 5-2: Summary of Substantial Equivalence Table | ||
|---|---|---|
| ----------------------------------------------------- | -- | -- |
| Description | Stryker iBur™ hubs and cutting accessories [Proposed], K210377 | Stryker MIS Attachments and Cutting Accessories [Predicate], K143540 | Comparison | |
|---|---|---|---|---|
| Regulatory Information | 510(k) | K210377 | K143540 | N/A |
| Product Code | HBE | HBE | Same | |
| Secondary Product Code | ERL, HWE & HSZ | ERL | Different, the HWE and HSZproduct codes have been added asSecondary product codes for thereview of K210377, the indicationsfor use for the predicate device listOrthopedic indications but theproduct codes HWE and HSZ werenot added as a secondary codesas part of the predicate submission(K143540) |
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iBur™ Traditional 510(k)
K210377
| Indicationsfor Use | The iBur™ Hubs and CuttingAccessories are intended to be usedwith the Stryker ConsolidatedOperating Room Equipment (CORE®)Console and electric and pneumaticmotors. When used with these motors,the iBur™ Hubs and CuttingAccessories are intended to cut bone inthe following manner: drilling, reaming,decorticating, shaping, dissecting,shaving, and smoothing for the followingmedical applications: Neuro; Spine;Ear, Nose, and Throat(ENT)/Otorhinolaryngology; andEndoscopic applications.Specific applications includeCraniotomy/Craniectomy,Laminotomy/Laminectomy, MinimallyInvasive Surgery (MIS) Spine,Expanded Endonasal Approach (EEA)/Anterior Skull Base/ Endoscopic/ | The MIS Attachments and CuttingAccessories are intended to be used withthe Stryker Consolidated Operating RoomEquipment (CORE®) Console andelectric and pneumatic motors. Whenused with these motors, the MISAttachments and Cutting Accessories areintended to cut bone in the followingmanner: drilling, reaming, decorticating,shaping, dissecting, shaving, andsmoothing for the following medicalapplications: Neuro; Spine; Ear, Nose,and Throat (ENT)/Otorhinolaryngology;and Endoscopic applications.Specific applications includeCraniotomy/Craniectomy,Laminotomy/Laminectomy, MinimallyInvasive Surgery (MIS) Spine, ExpandedEndonasal Approach (EEA)/ AnteriorSkull Base/ Endoscopic/ Transnasal/Transphenoidal, and Orthopedic Spine. | Same |
|---|---|---|---|
| ------------------------ | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------ |
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iBur™ Traditional 510(k) K210377
| Transnasal/ Transsphenoidal,andOrthopedic Spine.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 of screws,metal, wires, pins, and other fixationdevices. | |||
|---|---|---|---|---|
| Regulatory Information | Classificationof Device | Class II | Class II | Same |
| RegulationNumber | 882.4310 | 882.4310 | Same | |
| RegulationName | Powered simple cranial drills, burrs,trephines, and their accessories | Powered simple cranial drills, burrs,trephines, and their accessories | Same | |
| Condition ofUse | Hubs – reusableCutting Accessories – single use | Hub – reusableAttachments – reusableCutting Accessories – single use | Same | |
| Type of Use | Prescription Use Only | Prescription Use Only | Same | |
| PatientPopulation | General | General | Same | |
| Contra-indications | None Known | None Known | Same | |
| Usage Hub | Reusable | Reusable | Same | |
| UsageCuttingAccessories | Single Use | Single Use | Same |
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| Description | Stryker iBur™ hubs and cutting accessories [Proposed], K210377 | Stryker MIS Attachments and Cutting Accessories [Predicate], K143540 | Comparison | |
|---|---|---|---|---|
| Overall Design Concept | Design configuration | Separate components:HubCutting accessories | Separate components:HubAttachmentsCutting Accessories | Different |
| Attachment configuration | 1 piece | 2 piece | Different | |
| Attachment to Motor interface | SD/PD style interface | SD/PD style interface | Same | |
| 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. | Align the dot on the attachment with the dot on the handpiece connector.Press the attachment onto the handpiece until it snaps into the connector. | Same | |
| Attachment to Cutting Accessory Locking Mechanism | Align the dot on the cutting accessory with the alignment dot on the iBur™ hub and push the cutting accessory into the iBur™ hub until it snaps into place. | Rotate collar to unlock position, Insert the cutting accessory through the attachment tip, Insert cutting accessory to desired exposure level Rotate lock collar to lock position. | Similar. | |
| Size / length of assembled device | Overall device length when cutting accessory assembled into hub 17.1 cm. | Overall device length when cutting accessory assembled into attachment is 17.7 cm.Overall device length when cutting | Similar | |
| accessory assembled into attachment is 20.7cm. | ||||
| Nose tubestyle | Angled | Straight, Curved, Angled | Same | |
| Colour bandsonattachment | Yes | Yes | Same | |
| Line of sight(of surgicalsite) | Narrow nose tube feature enablesline of sight (of surgical site) | Telescoping feature enables lineof sight (of surgical site) | Similar | |
| Shank ofcuttingaccessory | .036" to 0.033" | 0.046" to 0.058" | Different | |
| Cuttingaccessoryhead styleoffering | Round and Match Head | Round and Match Head | Same | |
| Cuttingaccessoriesdiameterhead size | 2.0mm -5.0mm | 1.5 mm - 5.0 mm | Same | |
| Cuttingaccessorylength | One length12.5cm | Two lengths13 and 16 cm | Different | |
| No. of fluteson cuttingaccessories | Two | Two - Eight | Same | |
| Integratedirrigation | Polytube wrapped in a polyurethane heatshrink provides irrigation to the bur head. | None (may use the optional irrigationsleeve accessory). | Different | |
| Shelf Life | Diamond Cutting Accessories = 1 yearFluted Cutting Accessories Tool Steel =1 year | Diamond Cutting Accessories = 5yearsFluted Cutting Accessories Tool Steel= 3 years | Similar | |
| Hubs - Not applicable as these are reusable devices | Attachments – Not applicable as these are reusable devices | Same | ||
Table 5-3: Substantial Equivalence Summary Comparison Matrix – Overall Design Concept
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iBur™ Traditional 510(k) K210377
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iBur™ Traditional 510(k) K210377
Table 5-4: Substantial Equivalence Summary Comparison Matrix – Material & Processing
| Feature | Stryker iBur™ hubs and cuttingaccessories [Proposed] | Stryker MIS Attachments andCutting Accessories [Predicate],K143540 | Comparison |
|---|---|---|---|
| Non Patient ContactingMaterial - Hub | Bearing Lubricant Hub | Bearing Lubricant | Similar |
| Bearing LubricantNose Tube | |||
| Patient contactingmaterial - cuttingaccessory | Direct cutting accessory Diamond Bur– Stainless Steel 440B (DiamondCoat). | Direct cutting accessory Diamond Bur– Stainless Steel 440A per ASTMF899. | Similar |
| Direct Cutting accessory Precision andMatch Head Bur – Tool Steel M2. | Direct cutting accessory Flutes Bur –M42 Tool Steel per ASTM A600 | ||
| Colour band material | Ceramic | Ceramic | Similar |
| Colour band colourant | Orange | Light Purple (lilac)Brown | Similar |
| Colour band location | Colour band on the hub | Colour band on the attachment | Same |
| Sterilization | Cutting accessories – supplied sterile,gammairradiated | Cutting accessories – supplied sterile,gammairradiated | Same |
| Hub- End-user sterilized (providednon-sterile). | Attachment - End-user sterilized(providednon-sterile). | Same | |
| Care Instructions has instructions onhow to sterilize (moist heat). | IFU has instructions on how tosterilize (moist heat). | ||
| Sterility Assurance level | Attachments: 10-6 | Attachments: 10-6 | Same |
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iBur™ Traditional 510(k) K210377
| Cutting Accessories: 10-6 | Cutting Accessories: 10-6 | Same | |
|---|---|---|---|
| Cleaning Methods | Manual and mechanical (automated) | Manual and mechanical (automated) | Same |
Table 5-5: Substantial Equivalence Summary Comparison Matrix – Energy Source
| Feature | Stryker iBur™ hubs and cuttingaccessories [Proposed] | Stryker MIS Attachments andCutting Accessories [Predicate].K143540 | Comparison |
|---|---|---|---|
| Principle of operation /mechanism of action | The iBur™ Hubs and cuttingaccessories are used in conjunctionwith either an electric or pneumaticmotor, CORE Console and afootswitch. When the system isassembled, the surgeon controls thefootswitch; this modifies the electricalsignal or pneumatic pressure to themotor, controlling the rotationalspeed of the cutting accessory. | The MIS Attachments and cuttingaccessories are used in conjunctionwith either an electric or pneumaticmotor, CORE Console and afootswitch. When the system isassembled, the surgeon controls thefootswitch; this modifies the electricalsignal or pneumatic pressure to themotor, controlling the rotational speedof the cutting accessory. | Same |
| Motor power supply | Electric and Pneumatic | Electric and Pneumatic | Same |
| Speed | 5000-75000 rpm | 5000-75000 rpm | Same |
| Pneumatic pressurerecommendations | 120 psi (pounds per square inch) | 120 psi (pounds per square inch) | Same |
| Source of activation | Handswitch and Footswitch | Handswitch and Footswitch | Same |
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Conclusion / Substantial Equivalence (SE) Rationale
A review of all similarities and differences, along with the explanation provided to assert that each difference does not raise new questions of safety or effectiveness, demonstrates that the proposed Stryker iBur™ Hubs and Cutting Accessories are as safe and effective as the predicate, and therefore 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).