(141 days)
No
The summary describes a mechanical surgical tool (hubs and cutting accessories) for bone cutting. There is no mention of AI, ML, image processing, or data analysis that would indicate the use of such technologies. The performance studies focus on functional, biocompatibility, sterilization, and packaging testing, consistent with a mechanical device.
No.
The device is described as a cutting tool for bone in surgical procedures, which is a surgical instrument, not a therapeutic device meant for treating or curing a disease or condition.
No
The device is described as an surgical instrument (iBur hubs and cutting accessories) intended for cutting bone, not for diagnosing medical conditions.
No
The device description clearly outlines physical components (hubs and cutting accessories) that are intended to interface with motors and cut bone. This is a hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to "cut bone" in various surgical procedures. This is a direct surgical intervention on the patient's body.
- Device Description: The description details the physical components (hubs and cutting accessories) and their function in mechanically cutting bone.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such specimens.
The device is a surgical tool used for physical manipulation of bone during surgery, which falls under the category of surgical instruments or accessories, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
HBE, ERL, HWE, HSZ
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
General
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing was conducted on the proposed devices as determined by the risk analysis for the products. The following areas were evaluated: Functional / Performance Testing Biocompatibility testing Sterilization and packaging testing
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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
2
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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3
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 Instruments | ||
| 1941 Stryker Way, | |||
| Portage, MI 49002, USA | |||
| Phone: 269 323 7700 | |||
| FDA Establishment Registration No. | 3015967359 | ||
| Contact Person | Alison Garrad | ||
| Staff Regulatory Affairs Specialist | |||
| Phone: +353-87-6164723 | |||
| mailto: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 |
4
| Reference Device | |||
|---|---|---|---|
| 510(k) Number | Product Code | Trade Name | Manufacturer |
| K191049 | HBE | Stryker® MIS and | |
| Footed 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 accessories | ||
| are intended to be used with the Stryker | |||
| Consolidated Operating Room Equipment | |||
| CORE® 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, and | |||
| smoothing for the following medical appli- | |||
| cations: Neuro; Spine; Ear, Nose, and | |||
| Throat (ENT)/Otorhinolaryngology; and | |||
| Endoscopic 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, and
Orthopedic Spine.
These devices are also usable in the
preparation for the placement of screws,
metal, wires, pins, and other fixation de-
vices. | | |
| Device Description | iBur™ Hubs and Cutting Accessories are
prescription medical devices that are de-
signed to provide an interface between a
cutting 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 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. | | |
5
| | Cutting accessories are single use, sterile
devices which have a mount or notch ma-
chined 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, decorti-
cate, shape, dissect, shave and smooth
bone in a variety of surgical procedures. |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance Data
(Non-Clinical Tests) | The results of the performance testing
demonstrate that the functionality, integ-
rity, and safety and effectiveness of the
iBur™ Hubs and Cutting Accessories is
sufficient 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 on
the proposed devices as determined by
the 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 that
the functionality, integrity, and safety and
effectiveness of the subject devices are
sufficient for their intended use and sup-
port a determination of substantial equiva-
lence. |
| Clinical Tests | No clinical testing was deemed necessary
for this 510(k). |
6
| 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
7
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 HSZ | |
| product codes have been added as | ||||
| Secondary product codes for the | ||||
| review of K210377, the indications | ||||
| for use for the predicate device list | ||||
| Orthopedic indications but the | ||||
| product codes HWE and HSZ were | ||||
| not added as a secondary codes | ||||
| as part of the predicate submission | ||||
| (K143540) |
8
iBur™ Traditional 510(k)
K210377
| 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/ | 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. | Same |
| ------------------------ | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------ |
|---|
9
iBur™ Traditional 510(k) K210377
| | | Transnasal/ Transsphenoidal,
andOrthopedic Spine.
These devices are also usable in the
preparation for the placement of
screws, metal, wires, pins, and other
fixation devices. | These devices are also usable in the
preparation for the placement of screws,
metal, wires, pins, and other fixation
devices. | |
|------------------------|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|------|
| Regulatory Information | Classification
of Device | Class II | Class II | Same |
| | Regulation
Number | 882.4310 | 882.4310 | Same |
| | Regulation
Name | Powered simple cranial drills, burrs,
trephines, and their accessories | Powered simple cranial drills, burrs,
trephines, and their accessories | Same |
| | Condition of
Use | Hubs – reusable
Cutting Accessories – single use | Hub – reusable
Attachments – reusable
Cutting Accessories – single use | Same |
| | Type of Use | Prescription Use Only | Prescription Use Only | Same |
| | Patient
Population | General | General | Same |
| | Contra-
indications | None Known | None Known | Same |
| | Usage Hub | Reusable | Reusable | Same |
| | Usage
Cutting
Accessories | Single Use | Single Use | Same |
10
| 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: | ||
| Hub | ||||
| Cutting accessories | Separate components: | |||
| Hub | ||||
| Attachments | ||||
| Cutting 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 tube | ||||
| style | Angled | Straight, Curved, Angled | Same | |
| Colour bands | ||||
| on | ||||
| attachment | Yes | Yes | Same | |
| Line of sight | ||||
| (of surgical | ||||
| site) | Narrow nose tube feature enables | |||
| line of sight (of surgical site) | Telescoping feature enables line | |||
| of sight (of surgical site) | Similar | |||
| Shank of | ||||
| cutting | ||||
| accessory | .036" to 0.033" | 0.046" to 0.058" | Different | |
| Cutting | ||||
| accessory | ||||
| head style | ||||
| offering | Round and Match Head | Round and Match Head | Same | |
| Cutting | ||||
| accessories | ||||
| diameter | ||||
| head size | 2.0mm -5.0mm | 1.5 mm - 5.0 mm | Same | |
| Cutting | ||||
| accessory | ||||
| length | One length | |||
| 12.5cm | Two lengths | |||
| 13 and 16 cm | Different | |||
| No. of flutes | ||||
| on cutting | ||||
| accessories | Two | Two - Eight | Same | |
| Integrated | ||||
| irrigation | Polytube wrapped in a polyurethane heat | |||
| shrink provides irrigation to the bur head. | None (may use the optional irrigation | |||
| sleeve accessory). | Different | |||
| Shelf Life | Diamond Cutting Accessories = 1 year | |||
| Fluted Cutting Accessories Tool Steel = | ||||
| 1 year | Diamond Cutting Accessories = 5 | |||
| years | ||||
| Fluted 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
11
iBur™ Traditional 510(k) K210377
12
iBur™ Traditional 510(k) K210377
Table 5-4: Substantial Equivalence Summary Comparison Matrix – Material & Processing
| Feature | Stryker iBur™ hubs and cutting
accessories [Proposed] | Stryker MIS Attachments and
Cutting Accessories [Predicate],
K143540 | Comparison |
|-------------------------------------------------------|-----------------------------------------------------------------------------------|----------------------------------------------------------------------------------|------------|
| Non Patient Contacting
Material - Hub | Bearing Lubricant Hub | Bearing Lubricant | Similar |
| | | Bearing Lubricant
Nose Tube | |
| Patient contacting
material - cutting
accessory | Direct cutting accessory Diamond Bur
– Stainless Steel 440B (Diamond
Coat). | Direct cutting accessory Diamond Bur
– Stainless Steel 440A per ASTM
F899. | Similar |
| | Direct Cutting accessory Precision and
Match 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,
gamma
irradiated | Cutting accessories – supplied sterile,
gamma
irradiated | Same |
| | Hub- End-user sterilized (provided
non-sterile). | Attachment - End-user sterilized
(provided
non-sterile). | Same |
| | Care Instructions has instructions on
how to sterilize (moist heat). | IFU has instructions on how to
sterilize (moist heat). | |
| Sterility Assurance level | Attachments: 10-6 | Attachments: 10-6 | Same |
13
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 cutting
accessories [Proposed] | Stryker MIS Attachments and
Cutting Accessories [Predicate].
K143540 | Comparison |
|-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Principle of operation /
mechanism of action | The iBur™ Hubs and cutting
accessories are used in conjunction
with either an electric or pneumatic
motor, CORE Console and a
footswitch. When the system is
assembled, the surgeon controls the
footswitch; this modifies the electrical
signal or pneumatic pressure to the
motor, controlling the rotational
speed of the cutting accessory. | The MIS Attachments and cutting
accessories are used in conjunction
with either an electric or pneumatic
motor, CORE Console and a
footswitch. When the system is
assembled, the surgeon controls the
footswitch; this modifies the electrical
signal or pneumatic pressure to the
motor, controlling the rotational speed
of the cutting accessory. | Same |
| Motor power supply | Electric and Pneumatic | Electric and Pneumatic | Same |
| Speed | 5000-75000 rpm | 5000-75000 rpm | Same |
| Pneumatic pressure
recommendations | 120 psi (pounds per square inch) | 120 psi (pounds per square inch) | Same |
| Source of activation | Handswitch and Footswitch | Handswitch and Footswitch | Same |
14
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.