(66 days)
Not Found
No
The document describes a mechanical surgical drill and its accessories, with no mention of AI or ML capabilities in its operation, control, or data processing.
Yes
The device is used in various surgical procedures for cutting, drilling, reaming, decorticating, shaping, and smoothing bone, bone cement, and teeth, directly acting on anatomical structures to achieve a therapeutic effect.
No
Explanation: The device description clearly states its intended use is for surgical procedures involving cutting, drilling, reaming, shaping, and smoothing bone, bone cement, and teeth. These are therapeutic and operative actions, not diagnostic ones.
No
The device description clearly outlines physical hardware components including a motor, cable, handswitch, footswitch, and an optional extender, all of which are integral to the device's function.
Based on the provided information, the Stryker Pi Drive Plus Motor is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for cutting, drilling, reaming, etc., of bone, bone cement, and teeth in surgical procedures. This is an in vivo application (within a living organism).
- Device Description: The description details a surgical motor and accessories used for mechanical manipulation of tissue and materials during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) outside of the body to provide information about a patient's health.
IVD devices are specifically designed to be used in vitro (outside the body) for diagnostic purposes. This device is a surgical tool used in vivo.
N/A
Intended Use / Indications for Use
The Stryker Pi Drive Plus Motor 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 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 (comma separated list FDA assigned to the subject device)
ERL, DZJ, HBE
Device Description
The Stryker Pi Drive Plus Motor is a non-sterile, reusable, electric powered (40V DC) motor that rotates cutting accessories up to speeds of 75,000 RPM. It is powered by the CORE console. The cable of the Pi Drive Plus Motor is integrated into the proximal end and connects directly to the CORE console. The subject drill speed is controlled by a foot switch (connected to the CORE Console) or a removable handswitch which triggers a sensor within the handpiece. A variety of attachments and accessories can be used in conjunction with the drill. The motor (drill), cable, handswitch and footswitch are considered non-patient contacting device.
The Extender is an optional direct drive accessory that attaches to the distal end of the drill and transmits torque from the drill to various attachments. The Extender provides an option to add length to the drill, based on the user preference. The Extender is delivered non-sterile, re-usable, constructed of stainless steel material and is considered a non-patient contacting device.
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
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following verification tests were performed on the subject device to demonstrate that device meets performance requirements under its indication for use conditions.
- Reliability Testing- Motor (Drill), Handswitch Functional
- Range Testing and Extender
- Graphic Legibility Testing for Motor (Drill) and Extender
- Temperature Testing
Results of these tests demonstrate that the functionality, integrity, and safety and effectiveness of the subject device are sufficient for their intended use, indications for use and support a determination of the substantial equivalence.
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
§ 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 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 that resembles a stylized eagle or bird with three human profiles incorporated into its design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 20, 2015
Stryker Corporation Ms. Julia Helgeson Staff Regulatory Affairs Specialist, Stryker Instruments 400 E. Milham Avenue Kalamazoo, MI 49001
Re: K152641
Trade/Device Name: Pi Drive Plus Motor, Extender Regulation Number: 21 CFR 874.4250 Regulation Name: Ear, Nose, and Throat Electric or Pneumatic Surgical Drill Regulatory Class: Class II Product Code: ERL, DZJ, HBE Dated: October 23, 2015 Received: October 26, 2015
Dear Ms. Helgeson:
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 devicerelated 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.
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) K152641
Device Name Stryker Pi Drive Plus Motor
Indications for Use (Describe)
The Stryker Pi Drive Plus Motor 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 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) | |
|---|---|
| ☑ 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 Instruments | ||
| 4100 E. Milham Avenue | |||
| Kalamazoo, Michigan 49001 | |||
| US | |||
| FDA Establishment | |||
| Registration Number | 1811755 | ||
| Submitted By | Deval Patel, MS, RAC | ||
| Senior Regulatory Affairs Specialist | |||
| Ph: +1-269-389-5671 | |||
| Fax: +1-269-389-5412 | |||
| E-mail: Deval.Patel@Stryker.com | |||
| Date Submitted | September 14, 2015 | ||
| Device Name | |||
| Trade Name | Stryker® Pi Drive Plus Motor | ||
| Common Name | Ear, Nose, and Throat Electric or Pneumatic Surgical Drill | ||
| Classification | Class II | ||
| Primary | |||
| Classification Name | Drill, Surgical, Ent (Electric or Pneumatic) including Handpiece | ||
| (21 CFR 874.4250, Product code ERL) | |||
| Secondary | |||
| Classification Name | Driver, Wire, and Bone Drill, Manual | ||
| (21 CFR 872.4120, Product code DZJ) | |||
| Drills, Burs, Trephines & Accessories (Simple, Powered) | |||
| (21 CFR 882.4310, Product code HBE) | |||
| Legally Marketed Predicate Device | |||
| 510(k) Number | Product Code | Trade Name | Manufacturer |
| Predicate | |||
| K141935 | ERL, HBE, DZJ | Stryker® S2 Drill | Stryker Instruments |
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Image /page/4/Picture/0 description: The image shows the Stryker logo in black and white. The logo is a stylized wordmark with a unique font. The word "Stryker" is written in all lowercase letters, with the "r" having a distinctive shape. There is a registered trademark symbol to the right of the word.
| Indication for Use | The Stryker Pi Drive Plus Motor 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 Pi Drive Plus Motor is a non-sterile, reusable, electric powered (40V DC) motor that rotates cutting accessories up to speeds of 75,000 RPM. It is powered by the CORE console. The cable of the Pi Drive Plus Motor is integrated into the proximal end and connects directly to the CORE console. The subject drill speed is controlled by a foot switch (connected to the CORE Console) or a removable handswitch which triggers a sensor within the handpiece. A variety of attachments and accessories can be used in conjunction with the drill. The motor (drill), cable, handswitch and footswitch are considered non-patient contacting device. |
| The Extender is an optional direct drive accessory that attaches to the distal end of the drill and transmits torque from the drill to various attachments. The Extender provides an option to add length to the drill, based on the user preference. The Extender is delivered non-sterile, re-usable, constructed of stainless steel material and is considered a non-patient contacting device. | |
| Performance Data (Non-Clinical Tests) | The results of the performance testing demonstrate that the functionality, integrity, and safety and effectiveness of the Stryker Pi Drive Plus Motor and Extender is sufficient for their intended use and support a determination of substantial equivalence to the predicate device. |
| Summary of Performance Testing | The following verification tests were performed on the subject device to demonstrate that device meets performance requirements under its indication for use conditions. |
- Reliability Testing- Motor (Drill), Handswitch Functional .
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Image /page/5/Picture/0 description: The image shows the word "stryker" in a bold, sans-serif font. The word is all lowercase, and there is a small circled "c" symbol to the upper right of the "r". The word is in black and the background is white.
Range Testing and Extender
- Graphic Legibility Testing for Motor (Drill) and Extender ●
- . Temperature Testing
Results of these tests demonstrate that the functionality, integrity, and safety and effectiveness of the subject device are sufficient for their intended use, indications for use and support a determination of the substantial equivalence.
Clinical Tests No clinical testing was deemed necessary for this 510(k).
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Table 6-1: Summary of Predicate Comparison
| DESCRIPTION | STRYKER S2 DRILL [PREDICATE]
K141935 | STRYKER® Pi DRIVE PLUS MOTOR
[SUBJECT] |
|--------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for Use | The Stryker S 2 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. | The Stryker Pi Drive Plus Motor 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. |
| Classification of
Device | Class II | Class II |
| Primary Product Code | ERL
Drill, Surgical, ENT (Electric or
Pneumatic) including Handpiece | ERL
Drill, Surgical, ENT (Electric or
Pneumatic) including Handpiece |
| Primary Regulation | 21 CFR 878.4250
Ear, nose and throat electric or
pneumatic surgical drill | 21 CFR 878.4250
Ear, nose and throat electric or
pneumatic surgical drill |
| Condition of Use | Reusable | Reusable |
| Type of Use | Prescription Use Only | Prescription Use Only |
| Patient Population | General | General |
| Contraindications | None known | None known |
| Mode of Action | Rotary (transmits Torque) | Rotary (transmits Torque) |
| Power source | 40 V DC Electric Motor connected via
cable to CORE console | 40 V DC Electric Motor connected via
cable to CORE console |
| Diameter of Motor | 17mm | 17mm |
| Length of the Motor | 123.5mm | 109mm |
| DESCRIPTION | STRYKER S2 DRILL [PREDICATE]
K141935 | STRYKER® Pi DRIVE PLUS MOTOR
[SUBJECT] |
| Weight of the Motor | 313g | 403g |
| Maximum Speed | 75,000 rpm | 75,000 rpm |
| Accessories | CORE Console Attachments Cutting accessories Irrigation Clips | CORE Console Attachments Cutting accessories Irrigation Clips Extender |
| Means of Speed Control | Footswitch | Handswitch or Footswitch |
| Grip Design | Smooth | Knurled |
| Cutting Accessories
Retention Method by Drill | Burs: Mechanical Lock | Burs: Mechanical Lock |
| | Routers: Routers are not utilized
with the S2 Drill | Routers: Spring Collar Mechanism |
| Attachment Retention
Method by Drill | Attachments (Except Footed
Attachment):
Mechanical Lock
Footed Attachment:
Footed Attachments are not utilized
with the S2 Drill | Attachments (Except Footed
Attachment):
Friction
Footed Attachment:
Mechanical Lock |
| Housing Material of Drill | Stainless Steel and Aluminum | Stainless Steel and Aluminum |
| Cable Material | Silicone | Silicone and Slick Sil LSR coating |
| Method of Sterilization | Moist Heat (Steam) | Moist Heat (Steam) |
| Sterility Assurance Level
(SAL) | 10-6 | 10-6 |
| Cleaning Method | Manual and Mechanical
(automated) | Manual and Mechanical (automated) |
| Packaging | Packaged in a sealed retention insert | Packaged in a sealed retention insert |
Special 510(k) Submission
7
stryker®
Table 6-1: Summary of Predicate Comparison (Continued)
STRYKER® Pi DRIVE PLUS MOTOR
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Image /page/8/Picture/0 description: The image shows the word "stryker" in a bold, sans-serif font. The letters are black and the background is white. There is a small circle with an R inside of it in the upper right corner of the image. The word "stryker" is a registered trademark of Stryker Corporation, a medical technology company.
Conclusion/Substantial Equivalence Rationale
The Stryker Pi Drive Plus Motor is substantially equivalent in indications for use, intended use, technological characteristics, safety and effectiveness to the previously cleared Stryker S2 Drill. The subject device has the same operating principle, functional characteristics and applications as the predicate device. The modifications introduced raise no new issues of safety and effectiveness.
Therefore, the subject device is substantially equivalent to the existing predicate device.