(137 days)
Not Found
No
The summary describes mechanical surgical tools (attachments and cutting accessories) used with a motor for bone cutting. There is no mention of AI, ML, image processing, or any data-driven decision-making or analysis capabilities. The performance studies focus on mechanical and biocompatibility testing.
No
The device is described as cutting accessories used to cut bone in surgical procedures. It is an instrument for surgery, not a therapeutic device.
No
The device is described as surgical cutting and shaping tools for bone (drilling, reaming, decorticating, etc.), not for diagnosing conditions.
No
The device description clearly outlines physical components (attachments and cutting accessories) intended to interface with motors for surgical procedures, indicating it 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 reinforces that the device is used to "cut, drill, ream, decorticate, shape, dissect, shave and smooth bone." This is a mechanical action performed on tissue within the body.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices that are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of specimens.
The device described is a surgical instrument used for bone manipulation during surgery, which falls under the category of surgical devices, not IVDs.
N/A
Intended Use / Indications for Use
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 folling, 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
MIS Attachments 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 MIS Attachments 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 and Orthopedics.
The Stryker MIS Attachments are available in straight, curved and angle styles and in two lengths - 13 cm and 16 cm.
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 MIS Cutting Accessories are designed to fit the corresponding MIS Attachments. The cutting accessories when used with a high speed drill and MIS Attachments 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, teeth (dental), ENT (ear, nose, throat), neuro, spine, and endoscopic applications.
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)
The following verification tests were performed which demonstrate that the device meets the performance requirements under its indications for use conditions:
- Life, Functional and Graphics Testing of MIS Attachments
- Life Testing of Fluted and Diamond Bur Cutting Accessories
- Temperature Testing of Cutting Accessories
- Slippage Testing of Cutting Accessories
- Whip Testing of Cutting Accessories
- Chatter Testing of Cutting Accessories
Results of these tests demonstrate that the functionality, integrity, and safety and effectiveness of the Stryker MIS Attachments and Cutting Accessories is sufficient for their intended use and support a determination of substantial equivalence.
Biocompatibility evaluation was conducted 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.
Tests performed: Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Material Mediated Pyrogenicity (Attachments), Bacterial Endotoxin Testing (Cutting Accessories), Colorant Leachables.
Results showed the devices are non-cytotoxic, non-sensitizing, a negligible irritant, non-toxic, and non-pyrogenic, and passed the colorant leachables test and bacterial endotoxin testing.
No clinical testing was deemed necessary for this 510(k).
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 is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol resembles an abstract caduceus, with a staff and intertwined snakes, but it is rendered in a more fluid and modern design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 6, 2015
Stryker Corporation Ms. Mairead Twomey Sr. Staff Regulatory Affairs Specialist 4100 E. Milham Ave. Kalamazoo, Michigan 49001
Re: K143540 Trade/Device Name: Stryker MIS Attachments 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 Dated: April 2, 2015 Received: April 3, 2015
Dear Ms. Twomey:
This letter corrects our substantially equivalent letter of May 1, 2015.
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
1
Page 2 - Ms. Mairead Twomey
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 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" (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 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) K143540
Device Name
Stryker MIS Attachments and Cutting Accessories
Indications for Use (Describe)
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 folling, 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)
2 Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Section 5
510(k) Summary
. .
Traditional 510(k) Submission
.
1
510(k) Summary, Rev 02
Stryker MIS Attachments and Cutting Accessories
4
510(k) Summary
Classification Data:
| 510(k) Owner: | Stryker Instruments |
|---|---|
| 4100 E. Milham Avenue | |
| Kalamazoo, MI 49001 | |
| (p) 269-323-7700 | |
| (f) 269-389-5412 | |
| Contact Person: | Mairead Twomey |
| Sr. Staff Regulatory Affairs Specialist | |
| Registration | |
| Number: | 1811755 |
| Date Summary | |
| Prepared: | April 29, 2015 |
| Trade Name(s): | Stryker MIS Attachments and Cutting Accessories |
| Common Name: | Surgical Drill Handpieces |
| FDA Product
Code | Device | Regulation
Number | Class |
|----------------------------|---------------------------------------------------------------------------|----------------------|-------|
| HBE
(Primary
Code) | Drills, burs, trephines,
and accessories
(simple, powered) | 21 CFR
882.4310 | II |
| ERL
(Secondary
Code) | Drill, surgical, ENT
(electric or
pneumatic) including
handpiece | 21 CFR
874.4250 | |
| Predicate Device: | 510(k)
number | FDA Product
code | Trade name | Manufacturer |
|-------------------|------------------|---------------------|-----------------------------------------------------------------------|------------------------|
| | K112593 | ERL | Stryker® Consolidated
Operating Room
Equipment (CORE)
System | Stryker
Instruments |
Traditional 510(k) Submission
5
The MIS Attachments and Cutting Accessories are intended to be used with the Stryker Consolidated Operating Room Equipment (CORE®) Console and Indications for Use: 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. These devices are also usable in the preparation for the placement of screws, metal, wires, pins, and other fixation devices.
- Device Description: MIS Attachments 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 MIS Attachments 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 and Orthopedics.
The Stryker MIS Attachments are available in straight, curved and angle styles and in two lengths - 13 cm and 16 cm.
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 MIS Cutting Accessories are designed to fit the corresponding MIS Attachments. The cutting accessories when used with a high speed drill and MIS Attachments are intended to cut, drill, ream, decorticate, shape, dissect, shave and smooth bone in a variety of surgical procedures.
Performance Data The following verification tests were performed which demonstrate that the (Non Clinical Tests): device meets the performance requirements under its indications for use conditions.
- . Life, Functional and Graphics Testing of MIS Attachments
- Life Testing of Fluted and Diamond Bur Cutting Accessories .
- . Temperature Testing of Cutting Accessories
- . Slippage Testing of Cutting Accessories
- Whip Testing of Cutting Accessories
Traditional 510(k) Submission
510(k) Summary, Rev 02
6
Chatter Testing of Cutting Accessories .
Results of these tests demonstrate that the functionality, integrity, and safety and effectiveness of the Stryker MIS Attachments and Cutting Accessories is sufficient for their intended use and support a determination of substantial equivalence.
Biocompatibility Stryker MIS Attachments and Cutting Accessories are classified as external Tests: communicating devices: tissue/bone/dentin with limited patient contact ( The biocompatibility evaluation was conducted 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.
An overview of the Biocompatibility Testing performed is listed in Table 1. Results of testing validate that the subject devices are non-cytotoxic, nonsensitizing, a negligible irritant, non-toxic, and non-pyrogenic.
Table 1: Overview of Biocompatibility Testing
| Tests Performed | Biocompatibility Test | Conclusions |
|---|---|---|
| Biocompatibility | ||
| Testing | Cytotoxicity | Non-cytotoxic |
| Sensitization | Non-sensitizing | |
| Irritation | Negligible irritant | |
| Acute Systemic Toxicity | Non-toxic | |
| Material Mediated Pyrogenicity | ||
| (Attachments) | Non-pyrogen | |
| Bacterial Endotoxin Testing (Cutting | ||
| Accessories) | Requirement met | |
| Colorant Leachables | Pass |
Clinical Tests:
No clinical testing was deemed necessary for this 510(k).
7
| Table 2: Substantial Equivalence Table | |||
|---|---|---|---|
| Feature | Stryker® CORE (Predicate K112593) | Subject MIS (Attachments & Cutting | |
| Accessories) | Justification | ||
| Product Class | Class II | Class II | Identical |
| Regulation | 21 CFR 874.4250 - Ear, nose, and throat | ||
| electric or pneumatic surgical drill | |||
| 21 CFR 882.4310 - Powered simple cranial | |||
| drills, burrs, trephines | |||
| 21 CFR 872.4120 - Bone cutting | |||
| instrument and accessories | 21 CFR 882.4310 - Powered simple cranial drills, | ||
| burrs, trephines | Similar. The regulation of subject device falls | ||
| within predicate cleared device. | |||
| FDA Product Code | ERL - Drill, Surgical, ENT (Electric or | ||
| Pneumatic) including Handpiece | |||
| HBE - Drills, Burrs, Trephines & Accessories | |||
| (Simple, Powered) | |||
| DZJ - Driver, Wire, and Bone Drill, Manual | |||
| DZI - Drill, Bone, Powered | Primary: HBE - Drills, Burrs, Trephines & | ||
| Accessories (Simple, Powered) | |||
| Secondary: ERL - Drill, Surgical, ENT (Electric or | |||
| Pneumatic) including Handpiece | Similar. The product code of subject device falls | ||
| within predicate cleared device. | |||
| Intended Function | • The predicate Stryker® MIS Attachments | ||
| act as an interface between the high | |||
| speed motors and the cutting accessories | |||
| • The predicate MIS attachments are | |||
| intended as a location for the user to hold | |||
| and grip the device system | |||
| • MIS Attachments and Cutting | |||
| Accessories are intended to cut bone and | |||
| used in the placement of screws, metal, | |||
| wires, pins, and other fixation devices | • The subject Stryker® MIS Attachments act as an | ||
| interface between the high speed motors and the | |||
| cutting accessories | |||
| • MIS attachments are intended as a location for | |||
| the user to hold and grip the device system | |||
| • MIS Attachments and Cutting Accessories are | |||
| intended to cut bone and used in the preparation | |||
| for the placement of screws, metal, wires, pins, | |||
| and other fixation devices | Identical | ||
| Patient Population | General | General | Identical |
Table 2: Substantial Equivalence Table
Traditional 510{k) Submission
510(k) Summary, Rev 02
Stryker MIS Attachments and Cutting Accessories
5
:
8
| Feature | Stryker® CORE (Predicate K112593) | Subject MIS (Attachments & Cutting
Accessories) | Justification |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 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.
These devices are also usable in the preparation
for the placement of screws, metal, wires, pins,
and other fixation devices. | Similar.
The intended use of all the devices identical; to cut
bone.
The specific indications that are being proposed for
addition are a subset of already cleared indications
for the predicate devices.
Verification and Validation testing has
demonstrated that the subject devices have a
similar safety and effectiveness profile as the
legally marketed predicate devices. |
| Contraindications | None known | None known | Identical |
| Conditions for Use | Attachments - Reusable | Attachments - Reusable | Identical |
| | Cutting Accessories - Single Use | Cutting Accessories - Single Use | Identical |
Traditional 510(k) Submission
.
510(k) Summary, Rev 02
:
·
Stryker MIS Attachments and Cutting Accessories
6
9
| Feature | Stryker® CORE (Predicate K112593) | Subject MIS (Attachments & Cutting
Accessories) | Justification |
|----------------------------------------------------|---------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Patient Contacting
Material- Attachment | 304 Stainless Steel per ASTM A249 | MIS 13 cm Attachment (Straight and Angled):
17-4 Stainless Steel per ASTM A564 with a color
stripe composed of Uniglaze Epoxy Ink – Lilac
PMS 265U. | Similar. Both the subject and the predicate are
comprised of stainless steel. A color stripe has
been added to the subject devices to aid system
assembly. |
| | 304 Stainless Steel per ASTM A249 | MIS 16cm Attachment (Straight, Curved and
Angled):
17-4 Stainless Steel per ASTM A564 with a color
stripe composed of Uniglaze Epoxy Ink – Brown
UGLZ-7145. | Biocompatibility, Verification and Validation
testing has demonstrated that the subject devices
have a similar safety and effectiveness profile as
the legally marketed predicate devices. |
| Non Patient
Contacting Material -
Attachment | Bearing Lubricant | Bearing Lubricant | Identical |
| | Hub: Kluber Asonic GLY | Hub: Kluber Asonic GLY | Identical |
| | Bearing Lubricant
Rear Nose Tube: Chevron SRI
Front Duplex Bearing: Chevron SRI | Bearing Lubricant
Nose Tube (Front and Rear): Kluber Asonic GLY | Similar. Changed the nose tube bearing lubricant.
The internal lubricant was modified for more
durability during cleaning over device life. The
lubricant is a non-patient contacting material and
therefore out of scope for biocompatibility testing
as per the ISO 10993 standard series. Verification
and validation testing demonstrated that the
subject devices have a similar safety and
effectiveness profile as the legally marketed
predicate devices. |
| | Retainer material | Retainer material: | Identical |
| | Hub: Polyaide-imide | Hub: Polyaide-imide | Identical |
| | Rear Nose Tube: 410 SST | Nose Tube, Front and Rear: 410 SST | Identical |
| | Front Duplex Bearing: 410 SST | | Identical |
Traditional 510{k) Submission
510(k) Summary, Rev 02
:
:
:
:
Stryker MIS Attachments and Cutting Accessories
7
·
10
4100 E. Milham Avonue
Kalamazoo, Mi 49001
Kalamazoo, Mi 49001
t: 269 323 7700 f: 269 324 5412 www.stryker.com
.
| Feature | Stryker® CORE (Predicate K112593) | Subject MIS (Attachments & Cutting
Accessories) | Justification |
|--------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Color Band
Identification | No | Yes
Lilac PMS 265U
Brown UGLZ-7145 | Different. Added color band to aid system
assembly and aid cutting accessory compatibility.
Biocompatibility, Verification and Validation
testing has demonstrated that the subject devices
have a similar safety and effectiveness profile as
the legally marketed predicate devices. |
| Patient Contacting
Material- Cutting
Accessories | Cutting Accessory Diamond Bur - Stainless
Steel EN 10088-3 1.4112 | Cutting Accessory Diamond Bur - Stainless Steel
(440A) per ASTM F899 | Similar. The change in stainless steel has been
made to improve the manufacturability of the
cutting accessories.
Biocompatibility, Verification and Validation
testing has demonstrated that the subject devices
have a similar safety and effectiveness profile as
the legally marketed predicate devices. |
| | Cutting Accessory Fluted Bur - M42 Tool
steel per ASTM A600 | Cutting Accessory Fluted Bur - M42 Tool steel
per ASTM A600 | Identical |
| Sterilization | Cutting accessories - supplied sterile,
gamma irradiated | Cutting accessories - supplied sterile, gamma
irradiated | Identical |
| | Attachment - End-user sterilized
(provided non-sterile)
IFU has instructions on how to sterilize
(ETO, gas plasma, gravity displacement,
moist heat) | Attachment - End-user sterilized (provided non-
sterile)
IFU has instructions on how to sterilize (ETO, gas
plasma, gravity displacement, moist heat) | Identical |
| Sterility Assurance
Level | Attachments: 106 | Attachment: 106 | Identical |
| | Cutting Accessories: 106 | Cutting Accessories: 106 | Identical |
| Shelf Life | Diamond Cutting Accessories = 5 years
Fluted Cutting Accessories Tool Steel = 3
years | Diamond Cutting Accessories = 5 years
Fluted Cutting Accessories Tool Steel = 3 years | Identical |
| | Attachments -Not applicable as these are
reusable devices | Attachments - Not applicable as these are
reusable devices | Identical |
| Traditional 510(k) Submission
8 | | 510(k) Summary, Rev 02 | |
·
Stryker MIS Attachments and Cutting Accessories
510(k) Summary, Rev 02
:
11
| Feature | Stryker® CORE (Predicate K112593) | Subject MIS (Attachments & Cutting
Accessories) | Justification |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Packaging
Configuration | Attachments - Retention Insert in a
corrugated folder carton
MIS Cutting Accessories - tube in a sealed
chevron style pouch sterile barrier system | Attachments - Retention Insert in a corrugated
folder carton
MIS Cutting Accessories - tube in a sealed
chevron style pouch sterile barrier system | Identical |
| Attachment to Motor
Locking Mechanism | SD/PD style interface | SD/PD style interface | Identical |
| Nose Tube Style | Straight, Curved | Straight, Curved, Angled | Different. The addition of the Angled MIS
Attachment to the product line is to provide a
wider range of product offerings.
Verification and Validation testing has
demonstrated that the subject devices have a
similar safety and effectiveness profile as the
legally marketed predicate devices. |
| Cutting Accessory
Locking Mechanism | Friction collet lock | Positive collet locking notch | Different. The change of notch is to improve the
retention of the cutting accessory in the MIS
attachment.
Verification and Validation testing has
demonstrated that the subject devices have a
similar safety and effectiveness profile as the
legally marketed predicate devices. |
| Shank of the Cutting
Accessory | Single shank configuration | Dual shank configuration | Different. The change from a single shank
configuration to a dual shank configuration is to
increase the yield strength of the cutting
accessories.
Verification and Validation testing has
demonstrated that the subject devices have a
similar safety and effectiveness profile as the
legally marketed predicate devices. |
Traditional 510(k) Submission
510(k) Summary, Rev 02
:
Stryker MI5 Attachments and Cutting Accessories
9
12
| Feature | Stryker® CORE (Predicate K112593) | Subject MIS (Attachments & Cutting
Accessories) | Justification |
|-------------------------------------------|-----------------------------------|----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Cutting Accessory
Head Style Offering | Round, Diamond, Match Head | Round, Diamond, Match Head | Identical |
| Cutting Accessories
Diameter Head Size | 1.5 mm - 3.5 mm | 1.5 mm - 5.0 mm | Different. The addition of head sizes to the MIS
Cutting Accessory range is to the product line is to
provide a wider range of product offerings.
Verification and Validation Testing has
demonstrated that the subject devices have a
similar safety and effectiveness profile as the
legally marketed predicate devices. |
| Cutting Accessory
Length | One length
15.69 cm | Two lengths
13 and 16 cm | Similar. The lengths of the Cutting Accessories are
designed to fit the corresponding MIS Nose Tube.
Verification and Validation testing has
demonstrated that the subject devices have a
similar safety and effectiveness profile as the
legally marketed predicate devices. |
| Motor power supply | Electric and Pneumatic | Electric and Pneumatic | Identical |
| Speed | 5000-75000 rpm | 5000-75000 rpm | Identical |
| Pneumatic Pressure
Recommendation | 120 psi (pounds per square inch) | 120 psi (pounds per square inch) | Identical |
| Source of Activation | Handswitch and Footswitch | Handswitch and Footswitch | Identical |
Traditional 510(k) Submission
10
510(k) Summary, Rev 02
:
5tryker MIS Attachments and Cutting Accessories
13
Conclusion / Substantial Equivalence (SE) Rationale
The subject Stryker® MIS Attachments and Cutting Accessories have the same intended use, and similar indications, technologies, characteristics, and principals of operation as the predicate devices. The Stryker® MIS Attachments and Cutting Accessories have a similar safety and effectiveness profile as the legally marketed predicate devices.
Traditional 510(k) Submission