(71 days)
Not Found
No
The document describes a standard electric surgical drill and its intended uses. There is no mention of AI or ML capabilities, image processing, or data sets typically associated with AI/ML devices.
No.
The drill is used for cutting, reaming, decorticating, shaping, and smoothing bone, bone cement, and teeth, as well as placing or cutting screws, metal, wires, pins, and other fixation devices. These actions are surgical interventions, not therapeutic treatments.
No
The device description states that the Stryker S2 Drill is an electric-powered motor that rotates cutting accessories for various surgical procedures, indicating it is an operative or therapeutic device rather than one used for diagnosis.
No
The device description explicitly states it is an "electric powered (40V DC) motor" and mentions "cutting accessories," indicating it is a hardware device with mechanical components, not software only.
Based on the provided information, the Stryker S2 Drill is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly describes the device's function as a surgical tool for cutting, reaming, shaping, and smoothing bone, bone cement, and teeth, as well as manipulating fixation devices. This is a direct surgical intervention on the patient's body.
- Device Description: The description confirms it's an electric powered motor that rotates cutting accessories. This aligns with a surgical tool, not a device used to examine specimens outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze biological samples (blood, urine, tissue, etc.) outside of the body to provide information about a patient's health status, diagnosis, or treatment.
IVD devices are used to perform tests on specimens taken from the human body to provide information for diagnostic, monitoring, or screening purposes. The Stryker S2 Drill's function is entirely focused on performing physical actions during surgery.
N/A
Intended Use / Indications for Use
The Stryker S2 Drill is intended for use with the Stryker Consolidated Operating Room Equipment (CORE) System. When used with a variety of attachments and cutting accessories, the drill is intended for use in cutting, reaming, decorticating, shaping, and smoothing of bone cement and teeth in a variety of surgical procedures, including but not limited to dental. ENT (ear, nose, and throat), neuro, spine, and endoscopic applications. It is also usable in the placement or cutting of screws, metal, wires, pins, and other fixation devices.
Product codes
ERL, HBE, DZJ
Device Description
The Stryker S2 Drill is an electric powered (40V DC) motor. When connected to the CORE console, it directly rotates cutting accessories up to speeds of 75,000 RPM.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Following verification tests were performed which demonstrate that the design outputs of the modified device meet the design input requirements:
- Verification of the improved rotor driveshaft
- Simulated use tests
- Temperature testing of different torque-speed setting
Results of these tests demonstrate that the functionality, integrity, and safety and effectiveness of the Stryker S2 Drill is sufficient for their intended use and support a determination of substantial equivalence.
No clinical testing was deemed necessary for this 510(k).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 874.4250 Ear, nose, and throat electric or pneumatic surgical drill.
(a)
Identification. An ear, nose, and throat electric or pneumatic surgical drill is a rotating drilling device, including the handpiece, that is intended to drive various accessories, such as an ear, nose, and throat bur (§ 874.4140), for the controlled incision or removal of bone in the ear, nose, and throat area.(b)
Classification. Class II.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three stylized human profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 26, 2014
Stryker Corporation Mr. Vishal Kanani Sr. Regulatory Affairs Representative 4100 E. Milham Avenue Kalamazoo, MI 49001
Re: K141935
Trade/Device Name: Stryker S2 Drill Regulation Number: 21 CFR 874.4250 Regulation Name: Ear, Nose, and Throat Electric or Pneumatic Surgical Drill Regulatory Class: Class II Product Code: ERL, HBE, DZJ Dated: August 25, 2014 Received: August 27, 2014
Dear Mr. Kanani:
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.
1
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-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/Resourcesfor You/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,
Eric A. Mann -S
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K141935
Device Name Styker S2 Drill
Indications for Use (Describe)
The Stryker S2 Drill is intended for use with the Stryker Consolidated Operating Room Equipment (CORE) System. When used with a variety of attachments and cutting accessories, the drill is intended for use in cutting, reaming, decorticating, shaping, and smoothing of bone cement and teeth in a variety of surgical procedures, including but not limited to dental. ENT (ear, nose, and throat), neuro, spine, and endoscopic applications. It is also usable in the placement or cutting 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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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Image /page/3/Picture/1 description: The image shows the word "Stryker" in a bold, sans-serif font. The letters are all capitalized except for the "t" and "y", which are lowercase. A registered trademark symbol is located to the right of the "r" in "Stryker". The word is in black and the background is white.
510(k) Summary
| 510(k) Owner: | Stryker Instruments
4100 E. Milham Avenue
Kalamazoo, MI 49001
(p) 269-323-7700
(f) 269-389-5412 |
|---------------------------|--------------------------------------------------------------------------------------------------------------|
| Contact Person: | Vishal Kanani
Sr. Regulatory Affairs Representative |
| Registration Number: | 1811755 |
| Date Summary
Prepared: | July 07, 2014 |
| Trade Name(s): | Stryker S2 Drill |
Common Name:
Classification Data:
Ear, nose, and throat electric or pneumatic surgical drill.
| | Product
Code | Device | Regulation
Number | Class | Review
Panel |
|--------------------|-----------------|------------------------------------------------------------------------------|----------------------|-------|-------------------------|
| Primary
Code | ERL | Drill, Surgical,
ENT (Electric or
Pneumatic)
Including
Handpiece | 21 CFR
874.4250 | II | Ear, Nose
and Throat |
| Secondary
Codes | HBE | Drills, burs,
trephines, and
accessories
(simple,
powered) | 21 CFR
872.4120 | II | Neurology |
| | DZJ | Driver, wire,
and bone drill,
manual | 21 CFR
872.4120 | II | Dental |
Predicate Device:
| 510(k)
number | Product
code | Trade name | Manufacturer |
|------------------|-----------------|--------------------------------------------------------------------------|------------------------|
| K112593 | ERL | Stryker®
Consolidated
Operating Room
Equipment
(CORE) System | Stryker
Instruments |
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4100 E. Milham Ave.
Kalamazoo, MI 49001
t: 269 323 7700 f: 269 389 5412 www.stryker.com
Image /page/4/Picture/1 description: The image shows the word "stryker" in a bold, sans-serif font. The word is all lowercase except for the first letter, which is uppercase. There is a registered trademark symbol to the right of the word. The word is in black and the background is white.
| Indications for Use: | The Stryker S2 Drill is intended for use with the Stryker Consolidated Operating Room Equipment (CORE) System. When used with a variety of attachments and cutting accessories, the drill is intended for use in 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, and throat), neuro, spine, and endoscopic applications. It is also usable in the placement or cutting of screws, metal, wires, pins, and other fixation devices. |
|---|---|
| Device Description: | The Stryker S2 Drill is an electric powered (40V DC) motor. When connected to the CORE console, it directly rotates cutting accessories up to speeds of 75,000 RPM. |
| Performance Data (Non Clinical Tests): | Following verification tests were performed which demonstrate that the design outputs of the modified device meet the design input requirements: Verification of the improved rotor driveshaftSimulated use testsTemperature testing of different torque-speed setting Results of these tests demonstrate that the functionality, integrity, and safety and effectiveness of the Stryker S2 Drill is sufficient for their intended use and support a determination of substantial equivalence. |
| Clinical Tests: | No clinical testing was deemed necessary for this 510(k). |
| Conclusion/Substantial Equivalence (SE) Rationale: | The Stryker S2 Drill is substantially equivalent in intended use, technological characteristics, safety, and effectiveness to the previously cleared Stryker CORE Sumex Drill. The products have the same fundamental scientific technology, basic design, functional characteristics and applications. The modifications introduced raise no new issues of safety and effectiveness. Therefore, the Stryker S2 Drill is substantially |
equivalent to the existing predicate device.
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Image /page/5/Picture/1 description: The image shows the word "Stryker" in a bold, sans-serif font. The letters are all connected, and the word is in black. There is a registered trademark symbol to the right of the letter "r".
| Summary of Substantial Equivalence Table | ||
|---|---|---|
| Description | Stryker CORE Sumex Drill (Predicate) | Stryker S2 Drill (Subject) |
| Intended Use | The Stryker Consolidated Operating | |
| Room Equipment (CORE) System is | ||
| intended for use in 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, and | ||
| 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 S2 Drill is intended for use with | |
| the Stryker Consolidated Operating | ||
| Room Equipment (CORE) System. | ||
| When used with a variety of | ||
| attachments and cutting accessories, | ||
| the drill is intended for use in | ||
| drilling, cutting, reaming, | ||
| decorticating, shaping and | ||
| smoothing of bone, bone cement | ||
| and teeth in a variety of surgical | ||
| procedures, including but not limited | ||
| to ENT, neuro, spine and Endoscopic | ||
| applications. It is also usable in the | ||
| placement or cutting of screws, | ||
| metal, wires, pins, and other fixation | ||
| devices. | ||
| Housing Material | Stainless Steel | Stainless Steel and Aluminum |
| Motor Diameter | 20mm | 17mm |
| Length of the drill | 105mm | 123.5mm |
| Weight of the drill | 399g | 313g |
| Power source | 40V DC Electric Motor connected via | |
| cable to CORE console | 40V DC Electric Motor connected via | |
| cable to CORE console | ||
| Speed | 0-75,000 rpm | 0-75,000 rpm |
| Attachment retention | ||
| method by drill | Mechanical lock activated by rotation | |
| of attachment onto drill | Mechanical lock activated by | |
| rotation of attachment onto drill | ||
| Mode of activation | Footswitch and Handswitch | Footswitch |