(155 days)
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.
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.
The provided text describes the acceptance criteria and study results for the Stryker Elite and Heavy Duty (HD) Attachments. However, it is important to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing a comprehensive detailing of a standalone clinical study for device effectiveness in a clinical setting. The tests described are primarily non-clinical performance and safety tests.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Category | Specific Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | Cytotoxicity | Non-cytotoxic | Non-cytotoxic |
| Sensitization | Non-sensitizing | Non-sensitizing | |
| Irritation | Negligible irritant | Negligible irritant | |
| Acute Systemic Toxicity | Non-toxic | Non-toxic | |
| Material Mediated Pyrogenicity | Non-pyrogen | Non-pyrogen | |
| Colorant Leachables | Pass | Pass | |
| Functional Life Verification | Run time for 1 year | Pass | Pass |
| 1 year of Autoclave cycles | Pass | Pass | |
| 1 year of Automatic wash cycles | Pass | Pass | |
| 1 year of Locking mechanism actuations (with drill) | Pass | Pass | |
| 1 year of Locking mechanism actuations (with bur) | Pass | Pass | |
| Maximum surface temperature on attachment during end of life evaluation | ≤ 46°C | Pass | |
| Bur Performance | Mean bur whip | ≤ 0.63mm | Pass |
| Mean bur whip | ≤ 0.30mm (appears to be a separate or more stringent criterion for a specific aspect of bur whip) | Pass | |
| Mean bur deflection | ≤ 1.28mm | Pass | |
| Packaging | Package integrity | Package must maintain the product within its confines. Labels must remain attached and legible. The packaging may exhibit minimal damage. Product aesthetics should not be compromised and the product must be fully functional after this test procedure. | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "No clinical testing was deemed necessary for this 510(k) premarket notification." Therefore, there is no test set in the sense of patient data. The testing performed was non-clinical (laboratory/bench testing). The provenance of this (non-clinical) data is from Stryker Instruments' testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable, as no clinical testing with a "test set" requiring expert ground truth assessment was conducted. The "ground truth" for the non-clinical tests is established by the specified acceptance criteria for each test (e.g., maximum temperature, whip displacement, material properties).
4. Adjudication Method for the Test Set
Not applicable, as no clinical testing with a "test set" requiring adjudication was conducted.
5. If a Multi-reader Multi-case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a surgical attachment (drill handpiece accessory), not an AI-assisted diagnostic or imaging device used by "human readers." No MRMC study was conducted.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
Not applicable. This is a mechanical surgical device, not an algorithm or AI.
7. The Type of Ground Truth Used
For the non-clinical performance and safety tests, the "ground truth" is defined by established engineering and biocompatibility standards and internal specifications set by Stryker. For example, for biocompatibility, the ground truth is "non-cytotoxic," "non-sensitizing," etc., as defined by the referenced ISO standards. For functional tests like temperature, it's a quantitative limit (≤ 46°C).
8. The Sample Size for the Training Set
Not applicable, as there is no "training set" for this type of mechanical device.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no "training set" for this type of mechanical device.
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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
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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
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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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510(k) Summary
| Contact Details | |||
|---|---|---|---|
| 510(k) Owner | Stryker Instruments4100 E. Milham AvenueKalamazoo, Michigan 49001 USAPh: +1-269-323-5293Fax: +1-269-324-5412 | ||
| FDA EstablishmentRegistration No. | 1811755 | ||
| Contact Person | Brittney M. Larsen, RACPh: +1-269-389-5293Fax: +1-269-389-5412Brittney.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 | ||
| PrimaryClassification Name | Drills, Burs, Trephines & Accessories (Simple, Powered)(21 CFR 882.4310, Product code HBE) | ||
| SecondaryClassification 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® ConsolidatedOperating Room Equipment(CORE) System | StrykerInstruments |
| Secondary Predicate | |||
| K041754 | HBB (primary)ERL, HBE(secondary) | Stryker Maestro PneumaticSystem | StrykerInstruments |
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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.
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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 PneumaticSystem(Secondary Predicate -K041754) | Stryker® Elite and HD Attachments(Subject) | Explanationof Differences |
|---|---|---|---|---|
| Classification | Class II | Class II | Class II | Identical |
| PrimaryProduct Code | ERLDrill, Surgical, ENT (Electric orPneumatic) including Handpiece | HBBPneumatic cranial drill motor | HBEDrills, Burs, Trephines & Accessories (Simple,Powered) | Equivalent |
| PrimaryRegulation | 21 CFR 874.4250Ear, nose, and throat electric orpneumatic surgical drill | 21 CFR 882.4370Pneumatic cranial drill motor | 21 CFR 882.4310Powered simple cranial drills, burrs, trephines, andtheir accessories. | Equivalent |
| ProductTypes | Straight and angled attachments | Straight and angled attachments | Straight and angled attachments | Identical |
| Conditionsfor Use | Reusable | Reusable | Reusable | Identical |
| Mechanism ofAction | Powered by electric motors | Powered by pneumatic motors | Powered by electric and pneumatic motors | Equivalent |
| Mode ofAction | 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 cuttingaccessories for the purposes of:• Cutting bone, bone cement, and teeth;• Placing or cutting screws, metal, wires, pins, and otherfixation devices;• Providing a location for the user to hold and grip devicesystem. | 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® CORESystem(Primary Predicate- K112593) | Stryker MaestroPneumatic System(SecondaryPredicate -K041754) | Stryker® Elite and HD Attachments(Subject) | Explanation ofDifferences |
| Indicationsfor Use | The Stryker®ConsolidatedOperating RoomEquipment (CORE)System is intendedfor use in thecutting, drilling,reaming,decorticating,shaping, andsmoothing of bone,bone cement andteeth in a variety ofsurgical procedures,including but notlimited to, dental,ENT (ear, nose,throat), neuro, spine,and endoscopicapplications. It isalso usable in theplacement or cuttingof screws, metal,wires, pins, andother fixationdevices. | The Stryker MaestroPneumatic system isa pneumaticallyoperated surgicalinstrument system.The pneumaticmotor providespower to operateremovable rotatingsurgical cuttingtools and theiraccessories intendedfor use inneurosurgery,includingcraniotomy andspinal surgery; aswell as Ear, Noseand Throat (ENT),orthopedic, andgeneral surgicalapplicationsincludingmaxillofacial,craniofacial andsternotomysurgeries. | The Elite and Heavy Duty Attachments are intended to be used withthe Stryker Consolidated Operating Room Equipment (CORE®)console and electric and pneumatic motors. When used with thesemotors, the Elite and Heavy Duty Attachments and CuttingAccessories are intended to cut bone and bone cement in thefollowing manner: drilling, reaming, decorticating, shaping, andsmoothing 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 SkullBase/Endoscopic/Transnasal/Transphenoidal, and Orthopedic Spine.When used with these motors, the Elite and Heavy Duty Attachmentsand Cutting Accessories are intended to cut teeth in the followingmanner: sectioning, segmenting, splitting, fragmenting, extracting,removing, drilling, and reaming.When used with these motors, the Elite and Heavy Duty Attachmentsand Cutting Accessories are also usable in the preparation for theplacement of screws, metal, wires, pins, and other fixation devices, orthe cutting of screws, metal, wires, pins, and other fixation devices inthe following manner: sectioning, deburring, smoothing or shaping ofmetal, and removing/rounding sharp edges. | The subject devices add thefollowing indications foruse to the existing, clearedindications: Craniectomy,Laminotomy/Laminectomy,Minimally InvasiveSurgery (MIS) Spine,Expanded EndonasalApproach (EEA)/AnteriorSkull Base/Transnasal/Transphenoidal, andOrthopedic Spine. Thesubject indications addverbiage that definescutting for each medium inthe variety of surgicalprocedures listed. Thepurpose of the changesmade to the indications foruse is to list the procedureswithin each generalindication as per currentstandard of care as knownby the medical community.Verification and validationtesting conducted hasdemonstrated that thesubject devices have asimilar safety andeffectiveness profile as thelegally marketed predicatedevices |
| Description | Stryker® CORE System(Primary Predicate - K112593); andStryker Maestro Pneumatic System(Secondary Predicate - K041754) | Stryker® Elite and HDAttachments(Subject) | Explanation of Differences | |
| Size Information | ||||
| Straight and AngledAttachment LengthOfferings | 7cm, 9cm, 12cm, 14cm, 17cm (straightonly), 20cm | 7cm, 9cm, 12cm, 14cm, 17cm,20cm | Added the Elite 14cm Hooded and the Elite 17cm AngledAttachment offerings for marketing of a more competitive productoffering. Both of the added attachments are within the clearedlength range. The 14cm hooded attachment includes a built inhood. Verification and validation testing conductedhasdemonstrated that the subject devices have a similar safety andeffectiveness profile as the legally marketed predicate devices. | |
| Attachment RearHousing OuterDiameters | 0.677in (nominal) | 0.677in (nominal) | Identical | |
| Attachment NoseTube OuterDiameters | 0.234in (nominal)0.299in (nominal) | 0.234in (nominal)0.299in (nominal) | Identical | |
| Human Factors Information | ||||
| Attachment OuterProfiles | Differences in outer attachment profilewidths are pronounced | Differences in outer attachmentprofile widths are not pronounced | Changed the attachment outer profiles to achieve a sleeker design.These profile changes improve motor system balance. Verificationand validation testing conducted has demonstrated that the subjectdevices have a similar safety and effectiveness profile as thelegally marketed predicate devices. | |
| Attachment OuterSurface Texture | Continuous knurling texture | Continuous and laterally groovedknurling textures | Added laterally grooved knurling outer surface textures toattachments. This change improves user grip. Verification andvalidation testing conducted has demonstrated that the subjectdevices have a similar safety and effectiveness profile as thelegally marketed predicate devices. | |
| Patient Contacting Information | ||||
| Attachments | Stainless Steel (SST) | SST | Identical | |
| Color bandidentification | No color band | Color band | Added color bands to enhance the distinction of attachment andcutting accessory compatibility. Biocompatibility, verification. | |
| Description | Stryker® CORE System(Primary Predicate - K112593); andStryker Maestro Pneumatic System(Secondary Predicate - K041754) | Stryker® Elite and HDAttachments(Subject) | Explanation of Differences | |
| and validation testing conducted has demonstrated that the subjectdevices have a similar safety and effectiveness profile as thelegally marketed predicate devices. | ||||
| General Information | ||||
| Packaging | Packaged in a sealed retention insert | Packaged in a sealed retentioninsert | Identical | |
| Labeling | Label specified part description, quantity,lot number, and contact information.No known contraindications. | Label specified part description,quantity, lot number, and contactinformation.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 AssuranceLevel (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 |
|---|---|---|
| BiocompatibilityTesting | Cytotoxicity | Non-cytotoxic |
| Sensitization | Non-sensitizing | |
| Irritation | Negligibleirritant | |
| Acute Systemic Toxicity | Non-toxic | |
| Material Mediated Pyrogenicity | Non-pyrogen | |
| Colorant Leachables | Pass | |
| Life VerificationTesting | 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 onattachment during end of life evaluation ≤46°C | Pass |
Table 6-4. Non-clinical testing and Biocompatibility Testing summary
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Image /page/11/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 in black and the background is white.
| Tests Performed | Biocompatibility Test | Conclusions |
|---|---|---|
| Bur WhipVerificationTesting | Mean whip ≤ 0.63mm | Pass |
| Mean whip ≤ 0.30mm | Pass | |
| Bur ChatterVerificationTesting | Mean bur deflection ≤ 1.28mm | Pass |
| PackagingTesting | Package must maintain the product withinits confines. Labels must remain attachedand legible. | Pass |
| The packaging may exhibit minimaldamage. | Pass | |
| Product aesthetics should not becompromised and the product must be fullyfunctional 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.
§ 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).