Predicate Devices

Reference Devices

TBA

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a mechanical surgical tool (hubs and cutting accessories) for bone cutting and shaping. There is no mention of AI, ML, image processing, or any software-driven decision-making or analysis. The performance studies focus on mechanical aspects like temperature and simulated use.

Therapeutic

No.
The device is intended to cut bone during surgical procedures and prepare for the placement of fixation devices; it does not treat or cure a disease or condition.

Diagnostic

No

The device is described as an accessory for cutting bone in surgical procedures, not for diagnosing medical conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the iBur™ Hubs and Cutting Accessories are physical devices designed to interface with motors and cutting accessories for bone cutting procedures. It describes physical components like a mount, notch, and cutting edge.

IVD (In Vitro Diagnostic)

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 iBur™ Hubs and Cutting Accessories are used to cut bone in various surgical procedures. This is a direct surgical intervention on the patient's body.
Device Description: The device description reinforces that these are surgical tools designed to interface with motors for cutting bone.
Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or treatment.

IVD devices are used outside the body to analyze samples for diagnostic purposes. This device is used inside the body for surgical procedures.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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 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.

Product codes (comma separated list FDA assigned to the subject device)

HBE, ERL

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Bone (specifically within Neuro, Spine, Ear, Nose, and Throat (ENT)/Otorhinolaryngology, and Endoscopic applications)

Indicated Patient Age Range

General

Intended User / Care Setting

Prescription Use Only

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:

Temperature and Simulated Use Testing
Design Validation

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.

K210377

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.

TBA

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

Regulation Number and Section

§ 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).

Summary

0

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

2

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

3

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 Instruments
1941 Stryker Way,
Portage, MI 49002,
USA
Phone: 269 323 7700
FDA Establishment Registration No.	3015967359
Contact Person	Alison Garrad
Senior Staff Regulatory Affairs Specialist
Phone: +353-21-4533252
mailto: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 to
fundamental scientific technology or
intended use.
Device Modification	1. Update to bend profile of cutting
accessory specifications to alleviate
contact pressure at distal tip.

Introduction of alignment
specification between on cutting
accessory distal bushing and nose
tube. | | |
| Legally Marketed Predicate Device | | | |
| 510(k) Number | Product Code | Trade Name | Manufacturer |
| K210377 | HBE | Stryker iBur™ Hubs
and Cutting
Accessories | 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 | |

5

6

| | demonstrate that the functionality, integrity,
and safety and effectiveness of the iBur™
Cutting Accessories is sufficient for their
intended use and support a determination
of substantial equivalence to the predicate
devices. |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Summary of Performance Testing | Risk Management was conducted in
accordance with ISO 14971. |
| | Performance testing was conducted on
the proposed devices as determined by
the risk analysis for the products. The
following areas were evaluated:
• Temperature and Simulated Use
Testing
• Design Validation |
| | 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 |
| Clinical Tests | No clinical testing was deemed necessary
for 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

7

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 Orthopedic
Spine. | 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. | These devices are also usable in the
preparation for the placement of
screws, metal, wires, pins, and other
fixation devices. | | |
| Classification
of Device | Class II | Class II | Identical | |
| Regulation
Number | 882.4310 | 882.4310 | Identical | |
| Regulation
Name | Powered simple cranial drills, burrs,
trephines, and their accessories | Powered simple cranial drills, burrs,
trephines, and their accessories | Identical | |
| Condition of
Use | Single use | Single use | Identical | |
| Type of Use | Prescription Use Only | Prescription Use Only | Identical | |
| Patient
Population | General | General | Identical | |
| Contra-
indications | None Known | None Known | Identical | |

8

9

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 length
12.5cm	One length
12.5cm	Identical
Description		Stryker iBur™ cutting accessories
[Subject]	Stryker iBur™ cutting accessories
[Predicate K210377]	Explanation of Difference
	No. of flutes on
cutting
accessories	Two	Two	Identical
	Integrated
irrigation	Polytube wrapped in a polyurethane
heat shrink provides irrigation to the
bur head.	Polytube wrapped in a polyurethane
heat shrink provides irrigation to the
bur head.	Identical
	Shelf Life	Diamond Cutting Accessories = 2
year
Fluted Cutting Accessories Tool
Steel = 2 year	Diamond Cutting Accessories = 2
year
Fluted Cutting Accessories Tool Steel
= 2 year	Identical
	Packaging
Configuration	Sealed polybag in a sealed chevron
style pouch sterile barrier system.	Sealed polybag in a sealed chevron
style pouch sterile barrier system.	Identical
	Patient contacting
material - cutting
accessory	Direct cutting bur head - M2, 440B
(Diamond coat).

Indirect - Irrigation tubing
(polyurethane).

Direct - Nose Tube 316L SS and
440C SS, Heat shrink - Polyethylene
Terephthalate.

Direct - Lubricant cutting accessory -
Molykote G-0052FM white bearing
Grease. | Direct cutting bur head - M2, 440B
(Diamond coat).

Indirect - Irrigation tubing
(polyurethane).

Direct - Nose Tube 316L SS and 440C
SS, Heat shrink - Polyethylene
Terephthalate.

10

11

12

| Description | | Stryker iBur™ cutting accessories
[Subject] | Stryker iBur™ cutting accessories
[Predicate K210377] | Explanation of Difference |
|------------------------|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|---------------------------|
| Overall Design Concept | Design
configuration | Cutting Accessories | Cutting Accessories | Identical |
| | Distal Bend
Angle
Accessory | Bend profile updated. Bend
commences more proximally with a
bigger radius of bend creating a
more gradual and less pronounced
curve. | Device bend commences more
distally with smaller radius of bend
creating a more obvious curve. | Similar |
| | Nose Tube
Alignment
Specification | Alignment specification introduced. | Alignment specification not set. | Similar |
| | Line of sight
(of surgical
site) | Narrow nose tube feature enables
line of sight (of surgical site) | Narrow nose tube feature enables
line of sight (of surgical site) | Identical |
| | Shank of
cutting
accessory | 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.