(155 days)
Not Found
No
The summary describes mechanical attachments for surgical motors used for cutting bone, bone cement, and teeth. There is no mention of software, algorithms, data processing, or any other components typically associated with AI/ML. The performance studies focus on mechanical and material properties.
Yes
The device is described as an attachment for surgical tools intended to cut bone, bone cement, and teeth for various medical applications, which directly involve diagnosing, treating, or preventing disease, or affecting the structure or function of the body.
No
The Elite and Heavy Duty Attachments are described as surgical tools intended for cutting bone, bone cement, and teeth, and for preparing or cutting fixation devices. They are part of a system that performs a physical action (cutting), rather than diagnosing a condition or disease.
No
The device description explicitly states that the device is a physical attachment made of stainless steel, intended to connect to motors and cutting accessories. It describes physical characteristics, materials, and mechanical functions, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This testing is performed outside of the body (in vitro).
- Device Function: The Elite and Heavy Duty Attachments are surgical tools used within the body (in vivo) to cut bone, bone cement, teeth, and fixation devices during surgical procedures. They are part of a powered surgical system.
- Intended Use: The intended use clearly describes surgical applications and procedures performed directly on the patient's anatomy.
Therefore, the function and intended use of this device fall under the category of surgical instruments, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Elite and Heavy Duty Attachments 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 Elite and Heavy Duty Attachments and Cutting Accessories are intended to cut bone cement in the following manner: drilling, reaming, decorticating, shaping, and smoothing for the following medical applications: Neuro; Spine; Ear, Nose and Throat (ENT)/Otology/Neurotology/Otothinolaryngology; Craniofacial and Maxillofacial; Dental; and Endoscopic applications.
The specific applications include Craniectomy, Laminotomy/Laminectomy, Minimally Invasive Surgery (MIS) Spine. Expanded Endonasal (EEA)/Anterior Skull Base/Endoscopic/Transnasal/Transphenoidal, and Orthopedic Spine.
When used with these motors, the Elite and Heavy Duty Attachments and Cutting Accessories are intended to cut teeth in the following manner: sectioning, splitting, fragmenting, extracting, removing, drilling, and reaming.
When used with these motors, the Elite and Heavy Duty Attachments and Cutting Accessories are also usable in the preparation for the placement of screws, metal, wires, pins, and other fixation devices, or the cutting of screws, metal, wires, pins, and other fixation devices in the following manner: sectioning, smoothing or shaping of metal, and removing/rounding sharp edges.
Product codes (comma separated list FDA assigned to the subject device)
HBE, HBB, ERL, DZI
Device Description
The Stryker® Elite and HD Attachments are used within a system consisting of a variety of devices, including a console, powered motors, and cutting accessories. The attachments connect to the motors and the cutting accessories to complete the system for physician use. The Stryker® Elite and HD Attachments are offered for prescription use only. The Elite and HD Attachments are intended to serve as interfaces between powered motors and cutting accessories for the purposes of:
- Cutting bone, bone cement, and teeth;
- Placing or cutting screws, metal, wires, pins, and other fixation devices; and
- Providing a location for the user to hold and grip the device system.
The Elite and HD Attachments are provided in straight and angled configurations. The subject Elite Attachments are offered in the following lengths: 7cm, 12cm, 14cm, 17cm, and 20cm. The Stryker® HD Attachments are offered in the following lengths: 9cm and 14cm.
The Elite and HD Attachments are powered by, and compatible with, the Stryker electric and pneumatic motors. The attachments are also used with the cutting accessories (burs). All the attachments demonstrate a rotary mode of action by transmitting torque.
The Elite and HD Attachments are made of stainless steel (SST). The attachments display a color band on the outer surface. The color bands serve to enhance the distinction of attachment and cutting accessory compatibility. The Elite and HD Attachment outer profiles feature a sleeker design. The Elite and HD Attachment outer surface textures include laterally grooved and continuous knurling textures for improved user grip.
The Elite and HD Attachments are reusable, provided non-sterile, and end user sterilized. The attachments may be cleaned by manual or mechanical (automated) cleaning procedures. The attachment end user sterilization method is moist heat (steam) and the sterility assurance level (SAL) is 10-6. The Elite and HD Attachments have an expected life of one (1) year. The attachments are individually packaged in a sealed retention insert. The attachment labels contain a label specified part description, quantity, lot number, and contact information. There are no known contraindications for the Elite and HD Attachments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Neuro; Spine; Ear, Nose and Throat (ENT)/Otology/Neurotology/Otorhinolaryngology; Craniofacial and Maxillofacial; Dental; and Endoscopic applications.
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)
Study Type: Performance Testing (Biocompatibility, Functional Life Verification, Bur Whip and Chatter Verification, Packaging Verification)
Key Results:
- Biocompatibility Testing: The subject devices were found to be non-cytotoxic, non-sensitizing, a negligible irritant, non-toxic, and non-pyrogenic. Colorant leachables passed.
- Life Verification Testing: Passed for run time of 1 year, 1 year of Autoclave cycles, 1 year of Automatic wash cycles, 1 year of Locking mechanism actuations (with drill and with bur), and maximum surface temperature on attachment during end of life evaluation less than or equal to 46 degrees C.
- Bur Whip Verification Testing: Mean whip was less than or equal to 0.63mm (Pass) and less than or equal to 0.30mm (Pass).
- Bur Chatter Verification Testing: Mean bur deflection was less than or equal to 1.28mm (Pass).
- Packaging Testing: Package maintained product within confines, labels remained attached and legible, minimal damage exhibited, product aesthetics not compromised, and product fully functional after testing (Pass).
Clinical Testing: No clinical testing was deemed necessary.
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.
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
§ 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling a stylized eagle or bird in flight, composed of three overlapping profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 23, 2015
Stryker Instruments Ms. Brittney M. Larsen, RAC Senior Regulatory Affairs Representative 4100 E. Milham Ave. Kalamazoo, Michigan 49001
Re: K143320 Trade/Device Name: Stryker Elite and Heavy Duty (HD) Attachments Regulation Number: 21 CFR 882.4310 Regulation Name: Powered Simple Cranial Drills, Burrs, Trephines, and Their Accessories Regulatory Class: Class II Product Code: HBE, HBB, ERL, DZI Dated: March 20, 2015 Received: March 24, 2015
Dear Ms. Larsen,
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 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 (reporting of medical device
1
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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Carlos L. Pena -S
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K143320
Device Name Stryker Elite and Heavy Duty (HD) Attachments
Indications for Use (Describe)
The Elite and Heavy Duty Attachments 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 Elite and Heavy Duty Attachments and Cutting Accessories are intended to cut bone cement in the following manner: drilling, reaming, decorticating, shaping, and smoothing for the following medical applications: Neuro; Spine; Ear, Nose and Throat (ENT)/Otology/Neurotology/Otothinolaryngology; Craniofacial and Maxillofacial; Dental; and Endoscopic applications.
The specific applications include Craniectomy, Laminotomy/Laminectomy, Minimally Invasive Surgery (MIS) Spine. Expanded Endonasal (EEA)/Anterior Skull Base/Endoscopic/Transnasal/Transphenoidal, and Orthopedic Spine.
When used with these motors, the Elite and Heavy Duty Attachments and Cutting Accessories are intended to cut teeth in the following manner: sectioning, splitting, fragmenting, extracting, removing, drilling, and reaming.
When used with these motors, the Elite and Heavy Duty Attachments and Cutting Accessories are also usable in the preparation for the placement of screws, metal, wires, pins, and other fixation devices, or the cutting of screws, metal, wires, pins, and other fixation devices in the following manner: sectioning, smoothing or shaping of metal, and removing/rounding sharp edges.
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
| Contact Details | |||
|---|---|---|---|
| 510(k) Owner | Stryker Instruments | ||
| 4100 E. Milham Avenue | |||
| Kalamazoo, Michigan 49001 USA | |||
| Ph: +1-269-323-5293 | |||
| Fax: +1-269-324-5412 | |||
| FDA Establishment | |||
| Registration No. | 1811755 | ||
| Contact Person | Brittney M. Larsen, RAC | ||
| Ph: +1-269-389-5293 | |||
| Fax: +1-269-389-5412 | |||
| Brittney.Larsen@Stryker.com | |||
| Date Submitted | April 22, 2015 | ||
| Device Name | |||
| Trade Name | Stryker® Elite and Heavy Duty (HD) Attachments | ||
| Common Name | Surgical Drill Handpieces | ||
| Classification | II | ||
| Primary | |||
| Classification Name | Drills, Burs, Trephines & Accessories (Simple, Powered) | ||
| (21 CFR 882.4310, Product code HBE) | |||
| Secondary | |||
| Classification Name | Drill, Surgical ENT (Electric or Pneumatic) including Handpiece | ||
| (21 CFR 874.4250, Product code ERL) |
Pneumatic cranial drill motor
(21 CFR 882.4370, Product code HBB)
Drill, Bone, Powered
(21 CFR 872.4120, Product code DZI) | | |
| Legally Marketed Predicate Device(s) | | | |
| 510(k) Number | Product Code | Trade Name | Manufacturer |
| Primary Predicate | | | |
| K112593 | ERL (primary)
DZI, DZJ, HBE
(secondary) | Stryker® Consolidated
Operating Room Equipment
(CORE) System | Stryker
Instruments |
| Secondary Predicate | | | |
| K041754 | HBB (primary)
ERL, HBE
(secondary) | Stryker Maestro Pneumatic
System | Stryker
Instruments |
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Purpose of this Traditional 510(k) Premarket Notification
Stryker submits this Traditional 510(k), for the Stryker® Elite and HD Attachments, to request clearance for an expansion of indications and addition of color bands to the predicate devices. The predicate devices are currently cleared for a variety of general indications for use. The subject changes include adding the following specific procedures (hereafter referred to as medical applications): Craniectomy, Laminotomy/Laminectomy, Minimally Invasive Surgery (MIS) Spine, Expanded Endonasal Approach (EEA)/Anterior Skull Base/Transnasal/Transphenoidal, and Orthopedic Spine. This expansion of indications does not change the intended use or the fundamental scientific technology of the predicate devices. The subject modifications of this submission also include the addition of color bands to enhance the distinction of attachment and cutting accessory compatibility.
Device Description and Intended Use
The Stryker® Elite and HD Attachments are used within a system consisting of a variety of devices, including a console, powered motors, and cutting accessories. The attachments connect to the motors and the cutting accessories to complete the system for physician use. The Stryker® Elite and HD Attachments are offered for prescription use only. The Elite and HD Attachments are intended to serve as interfaces between powered motors and cutting accessories for the purposes of:
- Cutting bone, bone cement, and teeth; ●
- Placing or cutting screws, metal, wires, pins, and other fixation devices; and ●
- Providing a location for the user to hold and grip the device system. ●
The Elite and HD Attachments are provided in straight and angled configurations. The subject Elite Attachments are offered in the following lengths: 7cm, 12cm, 14cm, 17cm, and 20cm. The Stryker® HD Attachments are offered in the following lengths: 9cm and 14cm.
The Elite and HD Attachments are powered by, and compatible with, the Stryker electric and pneumatic motors. The attachments are also used with the cutting accessories (burs). All the attachments demonstrate a rotary mode of action by transmitting torque.
The Elite and HD Attachments are made of stainless steel (SST). The attachments display a color band on the outer surface. The color bands serve to enhance the distinction of attachment and cutting accessory compatibility. The Elite and HD Attachment outer profiles feature a sleeker design. The Elite and HD Attachment outer surface textures include laterally grooved and continuous knurling textures for improved user grip.
5
Image /page/5/Picture/1 description: The image shows the word "stryker" in a bold, sans-serif font. The word is all lowercase, and there is a registered trademark symbol to the right of the "r". The word is likely a logo for the Stryker Corporation, a medical technology company.
The Elite and HD Attachments are reusable, provided non-sterile, and end user sterilized. The attachments may be cleaned by manual or mechanical (automated) cleaning procedures. The attachment end user sterilization method is moist heat (steam) and the sterility assurance level (SAL) is 10-6. The Elite and HD Attachments have an expected life of one (1) year. The attachments are individually packaged in a sealed retention insert. The attachment labels contain a label specified part description, quantity, lot number, and contact information. There are no known contraindications for the Elite and HD Attachments.
Indications for Use
The Elite and Heavy Duty Attachments 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 Elite and Heavy Duty Attachments and Cutting Accessories are intended to cut bone and bone cement in the following manner: drilling, reaming, decorticating, shaping, and smoothing for the following medical applications: Neuro; Spine; Ear, Nose and Throat (ENT)/Otology/Neurotology/Otorhinolaryngology; Cramiofacial and Maxillofacial; Dental; and Endoscopic applications.
specific applications include Craniotomy/Craniectomy, Laminotomy/ The Laminectomy, Minimally Invasive Surgery (MIS) Spine, Expanded Endonasal Approach (EEA)/Anterior Skull Base/Endoscopic/Transnasal/Transphenoidal, and Orthopedic Spine.
When used with these motors, the Elite and Heavy Duty Attachments and Cutting Accessories are intended to cut teeth in the following manner: sectioning, segmenting, splitting, fragmenting, extracting, removing, drilling, and reaming.
When used with these motors, the Elite and Heavy Duty Attachments and Cutting Accessories are also usable in the preparation for the placement of screws, metal, wires, pins, and other fixation devices, or the cutting of screws, metal, wires, pins, and other fixation devices in the following manner: sectioning, deburring, smoothing or shaping of metal, and removing/rounding sharp edges.
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Table 6-1. Comparison to predicate devices
| Description | Stryker® CORE System
(Primary Predicate - K112593) | Stryker Maestro Pneumatic
System
(Secondary Predicate -
K041754) | Stryker® Elite and HD Attachments
(Subject) | Explanation
of Differences |
|-------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | Class II | Class II | Class II | Identical |
| Primary
Product Code | ERL
Drill, Surgical, ENT (Electric or
Pneumatic) including Handpiece | HBB
Pneumatic cranial drill motor | HBE
Drills, Burs, Trephines & Accessories (Simple,
Powered) | Equivalent |
| Primary
Regulation | 21 CFR 874.4250
Ear, nose, and throat electric or
pneumatic surgical drill | 21 CFR 882.4370
Pneumatic cranial drill motor | 21 CFR 882.4310
Powered simple cranial drills, burrs, trephines, and
their accessories. | Equivalent |
| Product
Types | Straight and angled attachments | Straight and angled attachments | Straight and angled attachments | Identical |
| Conditions
for Use | Reusable | Reusable | Reusable | Identical |
| Mechanism of
Action | Powered by electric motors | Powered by pneumatic motors | Powered by electric and pneumatic motors | Equivalent |
| Mode of
Action | Rotary (transmits torque) | Rotary (transmits torque) | Rotary (transmits torque) | Identical |
| Expected Life | 1 year | 1 year | 1 year | Identical |
| Type of Use | Prescription use only | Prescription use only | Prescription use only | Identical |
| Intended Use | To serve as an interface between powered motors and cutting
accessories for the purposes of:
• Cutting bone, bone cement, and teeth;
• Placing or cutting screws, metal, wires, pins, and other
fixation devices;
• Providing a location for the user to hold and grip device
system. | To serve as an interface between powered motors and cutting accessories for the purposes of:
• Cutting bone, bone cement, and teeth;
• Placing or cutting screws, metal, wires, pins, and other fixation devices;
• Providing a location for the user to hold and grip device system. | To serve as an interface between powered motors and cutting accessories for the purposes of:
• Cutting bone, bone cement, and teeth;
• Placing or cutting screws, metal, wires,
pins, and other fixation devices:
• Providing a location for the user to hold and grip device system. | Identical |
| Descript-
ion | Stryker® CORE
System
(Primary Predicate
- K112593) | Stryker Maestro
Pneumatic System
(Secondary
Predicate -
K041754) | Stryker® Elite and HD Attachments
(Subject) | Explanation of
Differences |
| 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. | The Stryker Maestro
Pneumatic system is
a pneumatically
operated surgical
instrument system.
The pneumatic
motor provides
power to operate
removable rotating
surgical cutting
tools and their
accessories intended
for use in
neurosurgery,
including
craniotomy and
spinal surgery; as
well as Ear, Nose
and Throat (ENT),
orthopedic, and
general surgical
applications
including
maxillofacial,
craniofacial and
sternotomy
surgeries. | The Elite and Heavy Duty Attachments 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 Elite and Heavy Duty Attachments and Cutting
Accessories are intended to cut bone and bone cement in the
following manner: drilling, reaming, decorticating, shaping, and
smoothing for the following medical applications: Neuro; Spine; Ear,
Nose and Throat (ENT)/Otology/ Neurotology/Otorhinolaryngology:
Craniofacial and Maxillofacial; Dental; and Endoscopic applications.
The 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.
When used with these motors, the Elite and Heavy Duty Attachments
and Cutting Accessories are intended to cut teeth in the following
manner: sectioning, segmenting, splitting, fragmenting, extracting,
removing, drilling, and reaming.
When used with these motors, the Elite and Heavy Duty Attachments
and Cutting Accessories are also usable in the preparation for the
placement of screws, metal, wires, pins, and other fixation devices, or
the cutting of screws, metal, wires, pins, and other fixation devices in
the following manner: sectioning, deburring, smoothing or shaping of
metal, and removing/rounding sharp edges. | The subject devices add the
following indications for
use to the existing, cleared
indications: Craniectomy,
Laminotomy/Laminectomy,
Minimally Invasive
Surgery (MIS) Spine,
Expanded Endonasal
Approach (EEA)/Anterior
Skull Base/Transnasal/
Transphenoidal, and
Orthopedic Spine. The
subject indications add
verbiage that defines
cutting for each medium in
the variety of surgical
procedures listed. The
purpose of the changes
made to the indications for
use is to list the procedures
within each general
indication as per current
standard of care as known
by the medical community.
Verification and validation
testing conducted has
demonstrated that the
subject devices have a
similar safety and
effectiveness profile as the
legally marketed predicate
devices |
| Description | Stryker® CORE System
(Primary Predicate - K112593); and
Stryker Maestro Pneumatic System
(Secondary Predicate - K041754) | Stryker® Elite and HD
Attachments
(Subject) | Explanation of Differences | |
| Size Information | | | | |
| Straight and Angled
Attachment Length
Offerings | 7cm, 9cm, 12cm, 14cm, 17cm (straight
only), 20cm | 7cm, 9cm, 12cm, 14cm, 17cm,
20cm | Added the Elite 14cm Hooded and the Elite 17cm Angled
Attachment offerings for marketing of a more competitive product
offering. Both of the added attachments are within the cleared
length range. The 14cm hooded attachment includes a built in
hood. Verification and validation testing conducted
has
demonstrated that the subject devices have a similar safety and
effectiveness profile as the legally marketed predicate devices. | |
| Attachment Rear
Housing Outer
Diameters | 0.677in (nominal) | 0.677in (nominal) | Identical | |
| Attachment Nose
Tube Outer
Diameters | 0.234in (nominal)
0.299in (nominal) | 0.234in (nominal)
0.299in (nominal) | Identical | |
| Human Factors Information | | | | |
| Attachment Outer
Profiles | Differences in outer attachment profile
widths are pronounced | Differences in outer attachment
profile widths are not pronounced | Changed the attachment outer profiles to achieve a sleeker design.
These profile changes improve motor system balance. Verification
and validation testing conducted has demonstrated that the subject
devices have a similar safety and effectiveness profile as the
legally marketed predicate devices. | |
| Attachment Outer
Surface Texture | Continuous knurling texture | Continuous and laterally grooved
knurling textures | Added laterally grooved knurling outer surface textures to
attachments. This change improves user grip. Verification and
validation testing conducted has demonstrated that the subject
devices have a similar safety and effectiveness profile as the
legally marketed predicate devices. | |
| Patient Contacting Information | | | | |
| Attachments | Stainless Steel (SST) | SST | Identical | |
| Color band
identification | No color band | Color band | Added color bands to enhance the distinction of attachment and
cutting accessory compatibility. Biocompatibility, verification. | |
| Description | Stryker® CORE System
(Primary Predicate - K112593); and
Stryker Maestro Pneumatic System
(Secondary Predicate - K041754) | Stryker® Elite and HD
Attachments
(Subject) | Explanation of Differences | |
| | | | and validation testing conducted has demonstrated that the subject
devices have a similar safety and effectiveness profile as the
legally marketed predicate devices. | |
| General Information | | | | |
| Packaging | Packaged in a sealed retention insert | Packaged in a sealed retention
insert | Identical | |
| Labeling | Label specified part description, quantity,
lot number, and contact information.
No known contraindications. | Label specified part description,
quantity, lot number, and contact
information.
No known contraindications. | Identical | |
| Sterilization Information | | | | |
| Attachments | End-user sterilized (provided non-sterile) | End-user sterilized (provided non-
sterile) | Identical | |
| Sterilization Method | Moist heat (steam) | Moist heat (steam) | Identical | |
| Sterility Assurance
Level (SAL) | 10-6 | 10-6 | Identical | |
| Cleaning Information | | | | |
| Cleaning Methods | Manual and mechanical (automated) | Manual and mechanical
(automated) | Identical | |
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Performance Testing Summary
Biocompatibility testing was performed on the subject devices in accordance with AAMI/ANSI/ISO ISO 10993-1:2009/(R)2013, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process, and Guidance for Industry and FDA Staff, Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," dated April 23, 2013. Results of testing validate that the subject devices are non-cytotoxic, non-sensitizing, a negligible irritant, non-toxic, and non-pyrogenic.
Functional life verification testing was performed to demonstrate the continued device performance during subject attachment life. Bur whip and bur chatter verification testing was conducted to verify the amplitude of bur whip and bur chatter for the subject attachments.
Packaging verification testing was performed as per ASTM D4169, Standard practice for performance testing of shipping containers and systems (sterility). Results of testing validate package integrity during transport.
See Table 6-4, for a summary of the performance testing and acceptance criteria used to evaluate the subject devices. Stryker has determined that the subject devices have a similar safety and effectiveness profile as the legally marketed predicate devices.
| Tests Performed | Biocompatibility Test | Conclusions |
|---|---|---|
| Biocompatibility | ||
| Testing | Cytotoxicity | Non-cytotoxic |
| Sensitization | Non-sensitizing | |
| Irritation | Negligible | |
| irritant | ||
| Acute Systemic Toxicity | Non-toxic | |
| Material Mediated Pyrogenicity | Non-pyrogen | |
| Colorant Leachables | Pass | |
| Life Verification | ||
| Testing | Run time of 1 year | Pass |
| 1 year of Autoclave cycles | Pass | |
| 1 year of Automatic wash cycles | Pass | |
| 1 year of Locking mechanism actuations - | ||
| with drill | Pass | |
| 1 year of Locking mechanism actuations - | ||
| with bur (cutting accessory) | Pass | |
| Maximum surface temperature on | ||
| attachment during end of life evaluation ≤ | ||
| 46°C | Pass |
Table 6-4. Non-clinical testing and Biocompatibility Testing summary
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| Tests Performed | Biocompatibility Test | Conclusions |
|---|---|---|
| Bur Whip | ||
| Verification | ||
| Testing | Mean whip ≤ 0.63mm | Pass |
| Mean whip ≤ 0.30mm | Pass | |
| Bur Chatter | ||
| Verification | ||
| Testing | Mean bur deflection ≤ 1.28mm | Pass |
| Packaging | ||
| Testing | Package must maintain the product within | |
| its confines. Labels must remain attached | ||
| and legible. | Pass | |
| The packaging may exhibit minimal | ||
| damage. | Pass | |
| Product aesthetics should not be | ||
| compromised and the product must be fully | ||
| functional after this test procedure. | Pass |
Clinical Testing
No clinical testing was deemed necessary for this 510(k) premarket notification.
Conclusion / Substantial Equivalence (SE) Rationale
The intended use, basic design, functional characteristics, and fundamental scientific technology are identical between the subject Stryker® Elite and HD Attachments and predicate devices. The Stryker® Elite and HD Attachments have a similar safety and effectiveness profile as the legally marketed predicate devices.