(60 days)
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, 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.
The Footed 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 Footed Attachments and Cutting Accessories are intended to cut bone in the following manner: drilling, reaming, dissecting, and shaping for the following medical applications: Neuro: Spine; Ear. Nose, and Throat (ENT) /Otology/Neurotology/ Otorhinolaryngology; Craniofacial and Maxillofacial; and Sternotomy.
Specific applications include Craniotomy, Pterional Craniotomy, Sub Occipital/Retro Sigmoid/Posterior Fossa Craniotomy, Sphenoid Wing Dissection, Laminotomy / Laminectomy, and Orthopedic Spine.
These devices are also usable in the preparation for the placement of screws, metal, wires, pins, and other fixation devices. It is also usable in the preparation for the placement of screws, metal, wires, pins, and other fixation devices.
The Stryker MIS and Footed 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 MIS and Footed Attachments are offered for prescription use only. The MIS and Footed 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 Stryker MIS Attachments are available in straight, curved and angled styles.
The Stryker Footed attachments are available as fixed footed, rotating footed, and nonfooted attachments
The MIS and Footed Attachments are made of stainless steel (SST). All MIS and Footed Attachments have a color band on the proximal end of the outer surface to aid the user in correct system assembly. The color band serves to enhance the distinction of attachment and cutting accessory compatibility.
The purpose of this submission is to gain clearance for the color band modifications for the Subject Device Attachments color band that exceeds the threshold as per FDA Guidance, "Deciding When to Submit a 510(k) for a Change to an Existing Device".
The provided text describes a 510(k) premarket notification for a medical device, the Stryker MIS and Footed Attachments. This submission seeks clearance for a modification to an existing device, specifically a change in the color band of the attachments. The FDA's 510(k) clearance process focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving absolute safety and effectiveness through clinical trials for novel devices.
Therefore, the type of "study" described here is primarily verification testing to ensure the modified device (the new color band) does not negatively impact the safety and effectiveness established for the original predicate device.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that "The Subject Device met all pre-defined acceptance criteria." However, the specific quantitative acceptance criteria are not detailed in the provided text. The performance data presented focuses on passing specific tests related to the modification.
| Test Performed | Acceptance Criteria (Not explicitly stated, but implied "pass") | Reported Device Performance |
|---|---|---|
| Colorfastness and Durability test | Implied: No significant degradation or color transfer that would impact safety or function. | Passed |
| Colorfastness Test | Implied: No significant color transfer. | Passed |
| Biocompatibility Evaluation (Chemical Characterization: ICP-MS, Toxicological Risk Assessment) | Implied: No detectable release of harmful substances; acceptable biocompatibility profile. | Performed, adopted from predicate submissions, no new risks identified. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify the exact number of devices or components tested for the Colorfastness and Durability tests or the Chemical Characterization. It generally refers to "the Subject Devices."
- Data Provenance: Not explicitly stated as retrospective or prospective in the context of clinical data, as this was not a clinical study. The tests were performed on the modified devices. There is no information regarding the country of origin for the data generation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable as the clearance is for a modification to an accessory and relies on verification testing and comparison to predicates, not a diagnostic accuracy study requiring expert adjudication of ground truth.
4. Adjudication Method for the Test Set
This section is not applicable as the evaluation did not involve human interpretation or diagnostic assessment that would require adjudication. The testing was objective (e.g., colorfastness, chemical characterization).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically conducted for diagnostic imaging devices to assess the performance of humans with and without AI assistance. The Stryker MIS and Footed Attachments are surgical power tool accessories, not diagnostic devices.
6. If a Standalone Study (i.e. algorithm only without human-in-the loop performance) was done
Yes, in essence, standalone performance testing was done. The "Performance Data" section describes "Verification testing" performed on the Subject Devices in isolation from human operators, focusing on the material properties and safety of the color band modification. These tests (Colorfastness, Durability, Biocompatibility) evaluate the device's characteristics directly.
7. The Type of Ground Truth Used
For the verification testing related to the color band modification, the "ground truth" was based on pre-defined acceptance criteria for material performance and safety standards. For example, "Passed" for colorfastness implies meeting a predefined threshold for acceptable color transfer or degradation. For biocompatibility, the ground truth is adherence to ISO 10993-1 standards and FDA guidance.
8. The Sample Size for the Training Set
This section is not applicable. This submission is for a physical medical device (surgical tool attachment) and its modification, not an AI/machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable as there was no training set for an algorithm.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
June 18, 2019
Stryker Corporation Paminder Khurmi Staff Regulatory Affairs Specialist 4100 E Milham Ave Kalamazoo, Michigan 49001
Re: K191049
Trade/Device Name: Stryker MIS and Footed 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, ERL Dated: April 18, 2019 Received: April 19, 2019
Dear Paminder Khurmi:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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
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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Matthew Krueger, M.S.E. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K191049
Device Name Stryker MIS attachments
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 following manner: drilling, reaming, 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)X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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Indications for Use
510(k) Number (if known) K191049
Device Name Stryker Footed attachments
Indications for Use (Describe)
The Footed 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 Footed Attachments and Cutting Accessories are intended to cut bone in the following manner: drilling, reaming, dissecting, and shaping for the following medical applications: Neuro: Spine; Ear. Nose, and Throat (ENT) /Otology/Neurotology/ Otorhinolaryngology; Craniofacial and Maxillofacial; and Sternotomy.
Specific applications include Craniotomy, Pterional Craniotomy, Sub Occipital/Retro Sigmoid/Posterior Fossa Craniotomy, Sphenoid Wing Dissection, Laminotomy / Laminectomy, and Orthopedic Spine.
These devices are also usable in the preparation for the placement of screws, metal, wires, pins, and other fixation devices. It is 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) |
|---|
| ------------------------------------------------- |
|X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies onlyto requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regardingthis burden estimate or any other as pect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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Stryker Instruments 4100 Milham Ave. Kalamazoo, MI 49001 t: 269 389 7700 f: 269-324-5412 www.stryker.com
510(k)Summary
This section provides a summary of 510(k) information in accordance with the requirements of 21 CFR 807.92.
SUBMITTER l.
| 510(k) Owner: | Stryker Instruments4100 E. Milham AvenueKalamazoo, Michigan 49001 USAPh: +1-269-323-7700Fax: +1-269-324-5412 |
|---|---|
| Submitter/ ContactPerson: | Paminder KhurmiStaff Regulatory Affairs SpecialistPhone: +1-269-389-2264Paminder.Khurmi@Stryker.com |
| FDA EstablishmentRegistration No. | 1811755 |
| Date Submitted: | April 18, 2019 |
DEVICE II.
| Trade Name: | Stryker® MIS and Footed Attachments |
|---|---|
| Common Name: | Surgical Drill Handpieces |
| Primary Classification | Drills, Burs, Trephines & Accessories (Simple, Powered)(21 CFR 882.4310, Product code HBE) |
| Secondary Classification | Drill, Surgical ENT (Electric or Pneumatic) including Handpiece(21 CFR 874.4250, Product code ERL) |
| Classification: | II |
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Stryker Instruments 4100 Milham Ave. Kalamazoo, MI 49001 t: 269 389 7700 f: 269-324-5412 www.stryker.com
lll. PREDICATE DEVICE
| 510 (K) Number | Product code | Trade name | Manufacturer |
|---|---|---|---|
| K143540 | HBE, ERL | Stryker® MISAttachments andcutting accessories | Stryker Instruments |
| K143399 | HBE, ERL | Stryker® FootedAttachments andcutting accessories | Stryker Instruments |
IV. SUBJECT DEVICE DESCRIPTION
The Stryker MIS and Footed 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 MIS and Footed Attachments are offered for prescription use only. The MIS and Footed Attachments are intended to serve as interfaces between powered motors and cutting accessories for the purposes of:
-
Cutting bone, bone cement, and teeth;
- A 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 Stryker MIS Attachments are available in straight, curved and angled styles.
The Stryker Footed attachments are available as fixed footed, rotating footed, and nonfooted attachments
The MIS and Footed Attachments are made of stainless steel (SST). All MIS and Footed Attachments have a color band on the proximal end of the outer surface to aid the user in correct system assembly. The color band serves to enhance the distinction of attachment and cutting accessory compatibility.
The Subject Devices Stryker MIS attachments and Stryker Footed attachments are cleared under two separate 510(k)s. Since the modification to the color band is identical for both attachment types (MIS and Footed), this premarket notification is being submitted as bundled submission in accordance with guidance document issued by FDA on June 22, 2007, "Bundling Multiple Devices or Multiple Indications in a Single Submission".
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Stryker Instruments 4100 Milham Ave. Kalamazoo, MI 49001 t: 269 389 7700 f: 269-324-5412 www.stryker.com
stryker
The purpose of this submission is to gain clearance for the color band modifications for the Subject Device Attachments color band that exceeds the threshold as per FDA Guidance, "Deciding When to Submit a 510(k) for a Change to an Existing Device".
V. INDICATIONS FOR USE
As the subject premarket notification is a bundled submission, there are 2 proposed indications for use, and are broken in 2 tables for each attachment type for easy navigation. See Table 1 below for Indications for Use for Stryker MIS attachments and Table 2 for Indications for Use for Stryker Footed attachments.
| TABLE 1: COMPARISON OF INDICATIONS FOR USE FOR MIS ATTACHMENTS | |
|---|---|
| Subject Device- Stryker MIS attachments | |
| Indicationsfor Use | The MIS Attachments and Cutting Accessories are intended to be used with theStryker Consolidated Operating Room Equipment (CORE®) Console and electricand pneumatic motors. When used with these motors, the MIS Attachmentsand Cutting Accessories are intended to cut bone in the following manner:drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing forthe 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, ExpandedEndonasal 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. |
TABLE 2: COMPARISON OF INDICATIONS FOR USE FOR FOOTED ATTACHMENTS
| Subject Device- Stryker Footed attachments | |
|---|---|
| Indicationsfor Use | The Footed Attachments and Cutting Accessories are intended to be used withthe Stryker Consolidated Operating Room Equipment (CORE®) Console andelectric and pneumatic motors. When used with these motors, the FootedAttachments and Cutting Accessories are intended to cut bone in the followingmanner: drilling, reaming, decorticating, shaping, dissecting, shaving andsmoothing for the following medical applications: Neuro; Spine; Ear, Nose, andThroat (ENT) /Otology /Neurotology/Otorhinolaryngology; Craniofacial andMaxillofacial; and Sternotomy. |
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Specific applications include Craniotomy/Craniectomy, Pterional Craniotomy, Sub Occipital/Retro Sigmoid/Posterior Fossa Craniotomy, Sphenoid Wing Dissection, Laminotomy / Laminectomy, and Orthopedic Spine. These devices are also usable in the preparation for the placement of screws, metal, wires, pins, and other fixation devices.
The Subject Device Indications for Use remains identical to the Predicate Devices. The modification described to the Subject Device in this 510(k) does not change the Indications for Use.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The Subject Device is compared to the Predicate Device for substantial equivalence of technological characteristics based on the modification described in this submission.
Technological Characteristics
The only change in the Subject and Predicate Devices is the different color band.
The Color Band location, Attachment to Cutting Accessory Locking Mechanism, and Attachment to Motor Locking Mechanism are identical when comparing the Subject and Predicate Device and, all other technological characteristics, remains the same between the Subject and Predicate Devices.
The technological characteristics that are not the same between the Subject and Predicate Devices are the color band material and colorant. However, the Subject Device color band material and colorant are similar to those cleared for the Predicate Device, and the different characteristics do not raise different questions of safety and effectiveness.
VII. PERFORMANCE DATA
The following testing were performed, and the data was provided in support of the substantial equivalence determination:
Verification testing was performed on the Subject Devices as dictated by the results of the Risk Analysis, and no new questions of safety and effectiveness were raised. The Subject Device met all pre-defined acceptance criteria. The results of the tests mention in the Table 3, support the substantial equivalence of the Subject Device to the Predicate Device. Testing data from the following was provided in support of the substantial equivalence determination.
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TABLE 3. LIST IF TESTS PERFORMED
| Tests performed | Results |
|---|---|
| Colorfastness and Durability test | Passed |
| Colorfastness Test | Passed |
Biocompatibility Testing
A biocompatibility evaluation was performed following the recommendations of ISO 10993-1: 2018 and FDA Guidance (Use of International Standard ISO- 10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" June 2016) as appropriate for limited exposure (< 24 hours) externally communicating, tissue/bone/dentin devices. The following assessments were completed to further assess the potential risk of the subject device material and colorant modification impacting color additive release.
- Chemical Characterization: ICP-MS
- . Toxicological Risk Assessment
The Biocompatibility testing was adopted from predicate submissions (K143540, K143399)
Animal Testing
Animal testing was not required as a basis for substantial equivalence.
Clinical Testing
Clinical testing was not required as a basis for substantial equivalence.
The Principle of Operation
The color band modification on the device does not change the Principle of Operation of the Subject Device compared to the Predicate Device.
The Principle of Operation remains: The Subject Device Attachments are combined with a power source, motor, and cutting accessory to achieve their function; the main function of the Subject Device Attachments is to provide a balanced location for the surgeon to hold and grip the device system, and to transmits torque from the motor to a cutting accessory.
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Stryker Instruments 4100 Milham Ave. Kalamazoo, MI 49001 t: 269 389 7700 f: 269-324-5412 www.stryker.com
stryker
VIII. CONCLUSIONS
The subject devices, in comparison with the legally marketed predicates, have the same intended use, indications for use, operating principles, energy source, and functional outputs. Performance testing and risk analysis demonstrate that the devices are as safe and effective as the predicate devices and do not raise different significant questions of safety and effectiveness.
§ 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).