Predicate Devices

K040300, K040369, K032303, K043310, K032117, K942956, K943589, K943569, K943540

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a traditional electrically powered surgical system with various handpieces and accessories. There is no mention of AI, ML, image processing, or any data-driven decision-making components. The performance studies focus on software code review and verification/validation of the console's functionality, not on the performance of an AI/ML algorithm.

Therapeutic

No.
The device is used for cutting, drilling, reaming, decorticating, shaping, and smoothing bone, bone cement, and teeth, and for placing or cutting screws, metal, wires, pins, and other fixation devices, which are surgical functions rather than therapeutic.

Diagnostic

No

The device is described for use in surgical procedures for cutting, drilling, reaming, shaping, and smoothing bone, bone cement, and teeth, and for placing or cutting fixation devices. These are operative actions, not actions related to identifying or analyzing a condition.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the system includes a console, irrigation accessories, footswitches, handswitches, and handpiece cords, which are all hardware components. While software is mentioned as undergoing revisions and testing, the device is clearly a hardware system controlled by software, not a software-only device.

IVD (In Vitro Diagnostic)

Based on the provided information, the Stryker® Consolidated Operating Room Equipment (CORE) System is not an IVD (In Vitro Diagnostic) device.

Here's why:

Intended Use: The intended use clearly describes the device's function as a surgical tool for cutting, drilling, shaping, etc., of bone, bone cement, and teeth within the body during surgical procedures.
Device Description: The description details the components of a surgical power tool system (console, handpieces, etc.).
Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) outside the body to provide information for diagnosis, monitoring, or treatment.

IVD devices are specifically designed to perform tests on samples taken from the human body. The Stryker CORE System is a surgical instrument used directly on the patient during surgery.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Stryker ® Consolidated Operating Room Equipment (CORE) System is intended for use in the cutting, drilling, reaming, decorticating, shaping, and smoothing of bone, bone cement and teeth in a variety of surgical procedures, including but not limited to, dental, ENT (ear, nose, throat), neuro, spine, and endoscopic applications. It is also usable in the placement or cutting of screws, metal, wires, pins, and other fixation devices.

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

ERL, DZI, DZJ, HBE

Device Description

The Stryker Consolidated Operating Room Equipment (CORE) System is an electrically powered system. This system includes a console, irrigation accessories, footswitches, handswitches, and handpiece cords which drive a variety of devices including saws, drills, wire drivers, microdebriders, and bone mills.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

bone, bone cement, teeth

Indicated Patient Age Range

Not Found

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)

The clarification of the Stryker® Consolidated Operating Room Equipment (CORE) System indications for use statement is not the result of any design changes that have been made to the console. In addition, the use of this device in orthopedic and spine applications do not present any new risks that would require testing. Therefore, no additional performance testing was performed to evaluate this change.

Each software revision of the Stryker® CORE Console has undergone a code review by a team of internal experts to review source code, evaluate error messaging, and verify adherence to standards. An analysis of new hazards and software requirements emerging as a result of the changes is evaluated for each revision. This is documented in the CORE Console's Software Requirements Specifications (SRS) and risk analysis, which can be found in Section 16. Subsequent verification/ validation testing, including system and Unit box testing, is performed on the console to confirm the continued safety and effectiveness of the Stryker® CORE Console prior to the release of each software revision to the market.

The results of this testing demonstrate that the device is as safe, as effective, and performs as well as or better than the predicate device.

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.

K040300, K040369, K032303, K043310, K032117, K942956, K943589, K943569, K943540

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.

Not Found

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

§ 874.4250 Ear, nose, and throat electric or pneumatic surgical drill.

(a)
Identification. An ear, nose, and throat electric or pneumatic surgical drill is a rotating drilling device, including the handpiece, that is intended to drive various accessories, such as an ear, nose, and throat bur (§ 874.4140), for the controlled incision or removal of bone in the ear, nose, and throat area.(b)
Classification. Class II.

Summary

0

MAY - 1 2012

stryker

·

**

4100 E. Milham Avenue
Kalamazoo, MI 49001
t: 269 323 7700 f: 269 389 5412
www.stryker.com

Instruments ·

510(k) Summary

| 510(k) Owner: | Stryker Instruments
4100 E. Milham Avenue
Kalamazoo, MI 49001
(p) 269-323-7700
(f) 269-389-5412 | | | | |
|-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|--------------------|-------|--------------------|
| Contact Person: | Michelle Jump | | | | |
| Registration No.: | 1811755 | | | | |
| Trade Name: | Stryker® Consolidated Operating Room Equipment (CORE) System | | | | |
| Common Name: | Console | | | | |
| Classification Name and Regulation Number | Primary Product Code | | | | |
| | PRODUCT CODE | DEVICE | REGULATION NUMBER | CLASS | REVIEW PANEL |
| | ERL | Drill surgical ent
(electric or pneumatic)
including handpiece | 21 CFR
874.4250 | II | EAR NOSE
THROAT |
| | Secondary Product Codes | | | | |
| | PRODUCT CODE | DEVICE | REGULATION NUMBER | CLASS | REVIEW PANEL |
| | DZI | Drill, bone, powered | 21 CFR
872.4120 | II | DENTAL |
| | DZJ | Driver, wire, and bone
drill, manual | 21 CFR
872.4120 | II | DENTAL |
| | HBE | Drills, burs, trephines
& accessories (simple
powered) | 21 CFR
882.4310 | II | NEUROLOGY |
| Predicate Devices: | Stryker® Consolidated Operating Room Equipment (CORE) System
(K040300, K040369, K032303); Synthes Electric Pen Drive (EPD) System (K043310);
and Stryker® Total Performance System (K032117, K942956, K943589, K943569,
K943540) | | | | |
| Device Description: | The Stryker Consolidated Operating Room Equipment (CORE) System is an
electrically powered system. This system includes a console, irrigation accessories,
footswitches, handswitches, and handpiece cords which drive a variety of devices | | | | |

1

including saws, drills, wire drivers, microdebriders, and bone mills.
Indications for Use:	The Stryker ® Consolidated Operating Room Equipment (CORE) System is intended
for use in the cutting, drilling, reaming, decorticating, shaping, and smoothing of bone,
bone cement and teeth in a variety of surgical procedures, including but not limited to
dental, ENT (ear, nose, throat), neuro, spine, and endoscopic applications. It is also
usable in the placement or cutting of screws, metal, wires, pins, and other fixation
devices.
Testing	The clarification of the Stryker® Consolidated Operating Room Equipment (CORE)
System indications for use statement is not the result of any design changes that have
been made to the console. In addition, the use of this device in orthopedic and spine
applications do not present any new risks that would require testing. Therefore, no
additional performance testing was performed to evaluate this change.
Each software revision of the Stryker® CORE Console has undergone a code review
by a team of internal experts to review source code, evaluate error messaging, and
verify adherence to standards. An analysis of new hazards and software requirements
emerging as a result of the changes is evaluated for each revision. This is
documented in the CORE Console's Software Requirements Specifications (SRS) and
risk analysis, which can be found in Section 16. Subsequent verification/ validation
testing, including system and Unit box testing, is performed on the console to confirm
the continued safety and effectiveness of the Stryker® CORE Console prior to the
release of each software revision to the market.
The results of this testing demonstrate that the device is as safe, as effective, and
performs as well as or better than the predicate device.
Biocompatibility	Per ISO 10993-1:2003 and FDA G95-1:1995 guidelines, a biocompatibility
evaluation for the CORE Console is not required due to the non-patient contact
intended use of this medical device.
Substantial
Equivalence
(SE) Rationale:	The Stryker® Consolidated Operating Room Equipment (CORE) System when
compared to its predicates has a similar intended use and technology characteristics
as the predicate devices. Therefore, this device is substantially equivalent to predicate
devices.
Predicate Device Comparison Table
Element of
Comparison	Stryker ® CORE
Console (Under
Review)	Stryker ®
System
(K040300,
K040369,
K032303)	Synthes Electric Pen
Drive (EPD) System
(K043310)	Stryker ® Total
Performance System
(TPS) (K942956,
K943589, K943569,
K943540, K032117)	Substantial
Equivalence
Indications for Use	The Stryker ®
Consolidated Operating
Room Equipment
(CORE) Console is
intended for use in the
cutting, drilling,
reaming,
decorticating, shaping,
and smoothing of bone,
bone cement and teeth
in a variety of surgical
procedures, including
but not limited to
dental, ENT, neuro,
spine, and endoscopic
applications. It is also
usable in the placement
or cutting of screws,	The Stryker®
Consolidated
Operating
Room Equipment
(CORE) System is
intended for use in
the cutting,
drilling, reaming,
decorticating, and
smoothing of
bone, bone
cement and teeth
in a variety of
surgical
procedures,
including but not
limited to dental,
ENT, neuro, and
endoscopic	The Synthes Electric
Pen Drive (EPD)
System is indicated for
screw insertion, pin
and wire placement,
cutting of bone and
metal, drilling,
reaming, decorticating,
shaping, and
smoothing of bones
and teeth in a wide
variety of surgical
procedures, including
but not limited to
general orthopedic
trauma, foot, hand,
maxifacial,
neurosurgical, oral,	The Stryker ® Total
Performance System is
intended for use in the
cutting, drilling,
reaming,
decorticating, and
smoothing of bone,
teeth and other bone
related tissue in a
variety of surgical
procedures,
including but not
limited to dental, ENT,
neuro and endoscopic.
It is
also usable in the
placement or cutting of
screws, wires, pins,	The indications for
use for all three
devices are similar.
	other fixation devices.	applications. It is
also usable in the
placement or
cutting of screws,
metal, wires, pins,
and other fixation
devices.	reconstructive and
spine surgery.	devices. It can also be
used to cut metal.
Handpiece
Connectors	Three connectors allow
handpiece cords to be
connected to the
console. The console is
capable of running two
handpieces
simultaneously.	Three connectors
allow handpiece
cords to be
connected to the
console. The
console is capable
of running two
Handpieces
simultaneously.	Two connectors allow
for two Electric Pen
Drive units to be
connected.	Three connectors allow
handpiece cords to be
connected to the
console.	Similar for all three
devices.
Design feature is
identical to
previously-cleared
Stryker® CORE
Console.
Footswitch
Connectors	Two connectors allow
up to two footswitches
to be run on the
console simultaneously.
The console can also
be controlled by a
wireless footswitch.	Two connectors
allow up to two
footswitches to be
run on the console
simultaneously.	One connector allows
one footswitch to
control one drive unit.	One connector allows
one footswitch to
control one drive unit.	Similar for all three
devices. Stryker®
CORE Console
under review has
the capability of
connecting to a
wireless
footswitch.
Adjustable
Operating
Parameters	The LCD screen allows
the user to set the
desired operating
parameters. Operating
parameters are also
obtained from attached
accessories.	The LCD screen
allows
the user to set the
desired operating
parameters.
Operating
parameters are
also obtained from
attached
accessories.	Max speed may be
controlled using slide
controls provided in the
console for each drive
unit. Torque limiting
feature can be
controlled using an On/
Off/Calibrate knob.
Irrigation can be used
with either Drive Unit 1
or Drive Unit 2 and
knob control is
available to select
between continuous
and variable irrigation
for each drive unit.
Irrigation flow can be
controlled using a flow
rate adjustment knob.
OR
User sets the operating
parameters using the
controls available in
the console or using
the handswitch or
footswitch interface.	The LCD screen allows
the user to set the
desired operating
parameters.	TPS and CORE
Console have
similar software
feature.
Design feature is
identical to
previously-cleared
Stryker® CORE
Console.
Power Output	400 Watts	400 Watts	Information not
available.	400 Watts	TPS and CORE
Console power
output is identical.
Design feature Is
identical to .
previously-cleared
Stryker® CORE
Console.
Wireless Tag
Technology	Accessories are
recognized and
identified on the
console screen.	Accessories are
recognized and
identified on the
console screen.	Information not
available.	Accessories are
recognized and
identified on the
console screen.	TPS and CORE
Console have
similar software
feature. Design
feature is identical
to previously-
cleared Stryker®
CORE Console.
Torque Control	Mechanism to allow the
user to specify the
torque profile to be
used for handpieces.	N/A	Mechanism to allow
the surgeon to implant
and tighten screws
under power. The user
calibrates and sets the
desired torque value
using the control
available in the
console.	N/A	The Stryker®
CORE Console
and Synthes
Electric Pen Drive
System torque
control features
are similar. Both
devices allow the
user to vary torque
settings.

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Console Accessories	Irrigation accessories Handpiece cord Handswitch Footswitch	Irrigation accessories Handpiece cord Handswitch Footswitch	Irrigation accessories Handpiece cord Handswitch Footswitch	Irrigation accessories Handpiece cord Handswitch Footswitch	Similar for all three devices.
---------------------	-------------------------------------------------------------	-------------------------------------------------------------	-------------------------------------------------------------	-------------------------------------------------------------	--------------------------------

Safety and Effectiveness:	Based upon the comparison to the predicate devices, the Stryker® Consolidated Operating Room Equipment (CORE) System does not raise any new issues of safety and effectiveness and is substantially equivalent to legally marketed devices.
Submitted by:	Michelle Jump
Senior Regulatory Affairs Representative

Signature

Date Submitted:	May 1, 2012
-----------------	-------------

and the comments of the comments of

and the country of the country of the country

4

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The text is in all caps and is evenly spaced around the circle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

MAY - 1 2012

Stryker Corporation % Ms. Michelle Jump 4100 E. Milham Avenue Kalamazoo, MI 49001

Re: K112593

Trade/Device Name: Stryker® Consolidated Operating Room Equipment (CORE) System Regulation Number: 21 CFR 874.4250 Regulation Name: Ear, nose, and throat electric or pneumatic surgical drill Regulatory Class: Class II Product Code: ERL Dated: April 24, 2012 Received: May 1, 2012

Dear Ms. Jump:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean 1 read on as made a determination that your device complies with other requirements of the Act

5

or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Edith m.b

Malyina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

6

Indications for Use

510(K) Number: K 112593

Device Name: Stryker® Consolidated Operating Room Equipment (CORE) System

Indications for Use:

The Stryker ® Consolidated Operating Room Equipment (CORE) System is intended for use in the cutting, drilling, reaming, decorticating, shaping, and smoothing of bone, bone cement and teeth in a variety of surgical procedures, including but not limited to, dental, ENT (ear, nose, throat), neuro, spine, and endoscopic applications. It is also usable in the placement or cutting of screws, metal, wires, pins, and other fixation devices.

Prescription Use: X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

D.M.ls

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear,

Nose and Throat Devices

510(k) Number K1125

Section 4 -1

.. 21 CFR 801.109)

otion Use _

Prescription Use (Per 21 CFR 801.109)