(66 days)
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.
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.
The provided document describes the Stryker Pi Drive Plus Motor, an ENT electric or pneumatic surgical drill, and its substantial equivalence to a predicate device (Stryker S2 Drill). However, it does not contain information regarding traditional acceptance criteria and studies typically associated with AI/ML-based medical devices or diagnostic tools. This document focuses on the technical and functional comparison of a surgical drill to its predicate for a 510(k) submission.
Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI/ML are not applicable here. There is no mention of sensitivity, specificity, accuracy, F1-score, AUC, or other metrics typical for diagnostic/AI products.
Here's a breakdown of the available and inapplicable information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
Given this is a physical surgical drill, the "acceptance criteria" are related to its functional performance, integrity, and safety, not statistical diagnostic performance metrics. The document states that the device meets performance requirements.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Functional Performance (cutting, drilling, reaming, etc.) | "Results of these tests demonstrate that the functionality... of the subject device are sufficient for their intended use." |
| Integrity (e.g., structural, material) | "Results of these tests demonstrate that the... integrity... of the subject device are sufficient for their intended use." |
| Safety and Effectiveness (for intended use and indications) | "Results of these tests demonstrate that the... safety and effectiveness of the subject device are sufficient for their intended use." |
| Reliability | "Reliability Testing- Motor (Drill), Handswitch Functional" was performed and results support substantial equivalence. |
| Range Testing (Motor and Extender) | Performed and results support substantial equivalence. |
| Graphic Legibility Testing (Motor and Extender) | Performed and results support substantial equivalence. |
| Temperature Testing | Performed and results support substantial equivalence. |
| Sterility Assurance Level (SAL) | 10-6 (Matches predicate) |
| Power Source | 40 V DC Electric Motor connected via cable to CORE console (Matches predicate) |
| Maximum Speed | 75,000 rpm (Matches predicate) |
| Sterilization Method | Moist Heat (Steam) (Matches predicate) |
| Cleaning Method | Manual and Mechanical (automated) (Matches predicate) |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This is a hardware device. The "test set" would be the manufactured devices undergoing various engineering tests. The document doesn't specify a sample size for these tests, just that "the following verification tests were performed on the subject device." Data provenance (country of origin, retrospective/prospective) is not relevant to testing a physical drill.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. This is a hardware device, not a diagnostic one requiring expert interpretation for ground truth. Ground truth for a drill would be engineering specifications and measurements.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like 2+1 or 3+1 are for reconciling disagreements among human readers/experts in diagnostic studies. This is not relevant for testing a surgical drill.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size of Human Readers Improve with AI vs without AI Assistance
Not applicable. An MRMC study with AI assistance is entirely irrelevant for a surgical drill device.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a surgical drill and does not involve any algorithm or AI/ML. Its performance is always "human-in-the-loop" as it is operated by a surgeon.
7. The Type of Ground Truth Used
For the physical device, the "ground truth" would be established by:
- Engineering Specifications: The design parameters and expected performance characteristics of the motor and extender.
- Physical Measurements and Functional Checks: Verification tests against these specifications (e.g., measuring RPM, checking electrical functionality, assessing material integrity).
- Safety Standards: Compliance with relevant medical device safety standards.
8. The Sample Size for the Training Set
Not applicable. This is a hardware device, not an AI/ML product that would have a "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no training set, there is no ground truth for it.
In summary, the provided document describes a 510(k) premarket notification for a physical medical device (surgical drill) and focuses on demonstrating substantial equivalence through non-clinical performance testing against engineering and safety criteria, rather than clinical performance or AI/ML-related metrics.
{0}------------------------------------------------
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
{2}------------------------------------------------
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) |
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."
{3}------------------------------------------------
510(k) Summary
| Contact Details | |||
|---|---|---|---|
| 510(k) Owner | Stryker Instruments4100 E. Milham AvenueKalamazoo, Michigan 49001US | ||
| FDA EstablishmentRegistration Number | 1811755 | ||
| Submitted By | Deval Patel, MS, RACSenior Regulatory Affairs SpecialistPh: +1-269-389-5671Fax: +1-269-389-5412E-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 | ||
| PrimaryClassification Name | Drill, Surgical, Ent (Electric or Pneumatic) including Handpiece(21 CFR 874.4250, Product code ERL) | ||
| SecondaryClassification 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 |
{4}------------------------------------------------
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 .
{5}------------------------------------------------
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).
{6}------------------------------------------------
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 foruse with the Stryker ConsolidatedOperating Room Equipment (CORE)System. When used with a variety ofattachments 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 ofsurgical procedures, including but notlimited to dental, ENT (ear, nose, andthroat), neuro, spine, and endoscopicapplications. It is also usable in theplacement or cutting of screws,metal, wires, pins, and other fixationdevices. | The Stryker Pi Drive Plus Motor isintended for use with the StrykerConsolidated Operating RoomEquipment (CORE) System. When usedwith a variety of attachments andcutting accessories, the drill is intendedfor use in cutting, drilling, reaming,decorticating, shaping, and smoothing ofbone, bone cement and teeth in avariety of surgical procedures, includingbut not limited to dental, ENT (ear, nose,and throat), neuro, spine, andendoscopic applications. It is also usablein the placement or cutting of screws,metal, wires, pins, and other fixationdevices. |
| Classification ofDevice | Class II | Class II |
| Primary Product Code | ERLDrill, Surgical, ENT (Electric orPneumatic) including Handpiece | ERLDrill, Surgical, ENT (Electric orPneumatic) including Handpiece |
| Primary Regulation | 21 CFR 878.4250Ear, nose and throat electric orpneumatic surgical drill | 21 CFR 878.4250Ear, nose and throat electric orpneumatic 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 viacable to CORE console | 40 V DC Electric Motor connected viacable 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 AccessoriesRetention Method by Drill | Burs: Mechanical Lock | Burs: Mechanical Lock |
| Routers: Routers are not utilizedwith the S2 Drill | Routers: Spring Collar Mechanism | |
| Attachment RetentionMethod by Drill | Attachments (Except FootedAttachment):Mechanical LockFooted Attachment:Footed Attachments are not utilizedwith the S2 Drill | Attachments (Except FootedAttachment):FrictionFooted 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
{8}------------------------------------------------
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.
§ 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.