(27 days)
The Pi Drive 2 and Pi Drive 2 Plus Motors are 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 Endoscopic Applications. They are also usable in the placement or cutting of screws, metals, wires, pins, and other fixation devices.
The Pi Drive 2 and Pi Drive 2 Plus Motors are non-patient contact, reusable, electric powered (40 VDC) motors that are supplied non-sterile and intended to be to be sterilized by the user prior to each use. The devices are driven by a three-phase, four-pole, brushless DC motor that is housed in a black anodized aluminum body and directly rotates cutting accessories up to speeds of 75,000 RPM. A 4.6 m long cord is integrated into the proximal end of each motor which is used to connect directly to the CORE 2 Console. The CORE 2 Console is used to supply power to the motors and in conjunction with a foot switch (connected to the console) is used for motor activation and speed control. The Pi Drive 2 Plus contains circuitry that also allows it to be operated using a Stryker handswitch for activation and speed control. Both motors are identical in technology, functionality, indications for use, and are compatible with the same attachments and cutting accessories. The Pi Drive 2 Plus motor is approximately 10.3 mm longer and weighs 85 grams more than the Pi Drive 2 motor, this additional length accommodates use of the Stryker handswitch.
Here's a breakdown of the acceptance criteria and study information for the Stryker Pi Drive 2 Motor and Pi Drive 2 Plus Motor, based on the provided FDA 510(k) submission:
The submission is for a medical device that does not involve AI; it's an electric surgical drill. Therefore, many of the questions related to AI device performance (effect size of human readers with AI vs. without AI, standalone AI performance, ground truth for training set, etc.) are not applicable to this document. The document describes a "Special 510(k)" submission for a line extension of an existing predicate device, focusing on demonstrating substantial equivalence through non-clinical testing.
Acceptance Criteria and Reported Device Performance
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria (Implicitly based on testing) | Reported Device Performance | Study Conducted |
|---|---|---|---|
| Safety and Effectiveness | Meets recognized standards for medical devices | Demonstrated to be sufficient for intended use and indications for use. | Risk Management (ISO 14971) |
| Functionality | Reliable motor operation over its life cycle | Performance is reliable. | Motor Reliability Life Study |
| Electrical Performance | Adheres to electrical safety standards | Compliance met. | Electrical Reliability, IEC 60601-1 Electrical Safety, IEC 60601-1-2 EMC / EMI Testing |
| Packaging | Maintains integrity during handling/storage | Integrity maintained. | Packaging Integrity |
| Design Validation | Overall device performs as intended | Performance validated. | Device Validation Summary |
2. Sample Size for the Test Set and Data Provenance:
The document describes non-clinical testing, which typically refers to laboratory or bench testing rather than studies involving human subjects or real-world data like clinical trials. Therefore, concepts like "test set sample size" and "data provenance" (country of origin, retrospective/prospective) in the context of patient data are not applicable. The testing would have involved a sufficient number of device units to demonstrate statistical confidence in the stated performance characteristics, but specific numbers are not provided in this summary.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This question is not applicable as the device is not an AI diagnostic device requiring expert interpretation for ground truth establishment. The performance is assessed through engineering and functional testing.
4. Adjudication Method for the Test Set:
This question is not applicable for the same reason as above. Adjudication methods are typically for resolving discrepancies in expert interpretations in diagnostic studies.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No. This is not an AI-powered diagnostic device, so an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done:
No. This is not an AI algorithm. Its performance is inherent to its mechanical and electrical design, and its operation is always human-in-the-loop (a surgeon using the drill).
7. The Type of Ground Truth Used:
For the non-clinical testing of this surgical drill, the "ground truth" would be established by:
- Engineering specifications and design requirements: The device is expected to meet predefined performance metrics (e.g., maximum RPM, torque, electrical safety limits).
- Established industry standards: Adherence to standards like ISO 14971 (risk management), IEC 60601-1 (electrical safety), and IEC 60601-1-2 (EMC/EMI) serves as the "ground truth" for compliance.
- Predicate device performance: The performance of the predicate device (Stryker® Pi Drive Plus Motor K152641) acts as a benchmark, with the new device demonstrating "substantial equivalence" in safety and effectiveness.
8. The Sample Size for the Training Set:
This question is not applicable as there is no training set for an AI algorithm here.
9. How the Ground Truth for the Training Set was Established:
This question is not applicable as there is no training set for an AI algorithm here.
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June 9, 2021
Stryker Corporation John Chesney Sr. Principal Regulatory Affairs Specialist 4100 East Milham Avenue Kalamazoo. Michigan 49001
Re: K211490
Trade/Device Name: Pi Drive 2 Motor, Pi Drive 2 Plus Motor 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: May 12, 2021 Received: May 13, 2021
Dear John Chesney:
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 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
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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 (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,
for Shu-Chen Peng Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K211490
Device Name Stryker Pi Drive 2 Motor Stryker Pi Drive 2 Plus Motor
Indications for Use (Describe)
The Pi Drive 2 and Pi Drive 2 Plus Motors are 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 Endoscopic Applications. They are also usable in the placement or cutting of screws, metals, 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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Submitter Information
This Premarket Notification is submitted by:
Stryker Instruments 4100 E. Milham Avenue Kalamazoo, Michigan 49001
Contact Information
John Chesney Senior Principal Regulatory Affairs Specialist Ph: (734)673-5624 Fax: (269)389-5412 Email: john.chesney@stryker.com Date Prepared: 12 May 2021
Device Name
| Subject Device Information | ||
|---|---|---|
| Trade/ Proprietary Name | Stryker® Pi Drive 2 MotorStryker® Pi Drive 2 Plus Motor | |
| Primary | Regulation Name | Ear, nose, and throat electric or pneumatic surgical drill. |
| Review Panel | Ear, Nose, and Throat | |
| Product Code | ERL | |
| Regulation Number | 21 CFR 874.4250 | |
| Regulatory Class | Class II | |
| Secondary | Regulation Name | Bone cutting instrument and accessories. |
| Review Panel | Dental | |
| Product Code | DZJ | |
| Regulation Number | 21 CFR 872.4120 | |
| Regulatory Class | Class II | |
| Regulation Name | Powered simple cranial drills, burrs, trephines, and their accessories. | |
| Review Panel | Neurology | |
| Product Code | HBE | |
| Regulation Number | 21 CFR 882.4310 | |
| Regulatory Class | Class II |
Subject Device Information
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Predicate Device
The legally marketed predicate for the subject devices is detailed as follows.
| Predicate Device Trade Name | 510(k) | Product Code | Manufacturer |
|---|---|---|---|
| Stryker® Pi Drive Plus Motor | K152641 | ERL, HBE, DZJ | Stryker Instruments |
Predicate Device Information
Indications for Use
The Pi Drive 2 and Pi Drive 2 Plus Motors are intended for use with the Stryker Consolidated Operating Room Equipment (CORE) System. When used with a variety of attachments and cutting accessories, the drills are 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. They are also usable in the placement or cutting of screws, metal, wires, pins, and other fixation devices.
Device Description
The Pi Drive 2 and Pi Drive 2 Plus Motors are non-patient contact, reusable, electric powered (40 VDC) motors that are supplied non-sterile and intended to be to be sterilized by the user prior to each use. The devices are driven by a three-phase, four-pole, brushless DC motor that is housed in a black anodized aluminum body and directly rotates cutting accessories up to speeds of 75,000 RPM. A 4.6 m long cord is integrated into the proximal end of each motor which is used to connect directly to the CORE 2 Console.
The CORE 2 Console is used to supply power to the motors and in conjunction with a foot switch (connected to the console) is used for motor activation and speed control. The Pi Drive 2 Plus contains circuitry that also allows it to be operated using a Stryker handswitch for activation and speed control.
Both motors are identical in technology, functionality, indications for use, and are compatible with the same attachments and cutting accessories. The Pi Drive 2 Plus motor is approximately 10.3 mm longer and weighs 85 grams more than the Pi Drive 2 motor, this additional length accommodates use of the Stryker handswitch.
Comparison of Technological Characteristics
A comparison of the technological characteristics of the subject devices included in the scope of this Special 510(k) with the predicate is included below.
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Motor Technological Comparison
| Subject Device | Predicate Device | |
|---|---|---|
| DESCRIPTION | Stryker® Pi Drive 2 MotorStryker® Pi Drive 2 Plus Motor | Stryker® Pi Drive Plus Motor (K152641) |
| Indications for Use | The Pi Drive 2 And Pi Drive 2 Plus Motors are intended for use with theStryker Consolidated Operating Room Equipment (CORE) System.When used with a variety of attachments and cutting accessories, thedrill 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 not limited to Dental, ENT (Ear,Nose, and Throat), Neuro, Spine, and Endoscopic Applications. Theyare 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 StrykerConsolidated Operating Room Equipment (CORE) System. When usedwith a variety of attachments and cutting accessories, the drill isintended for use in cutting, drilling, reaming, decorticating, shaping, andsmoothing of bone, bone cement and teeth in a variety of surgicalprocedures, including but not limited to Dental, ENT (Ear, Nose, andThroat), Neuro, Spine, and Endoscopic Applications. It is also usable inthe placement or cutting of screws, metal, wires, pins, and other fixationdevices. |
| Classification ofDevice | Class II | Class II |
| Primary ProductCode | ERLDrill, Surgical, ENT (Electric or Pneumatic) including Handpiece | ERLDrill, Surgical, ENT (Electric or Pneumatic) including Handpiece |
| Primary Regulation | 21 CFR 874.4250Ear, nose, and throat electric or pneumatic surgical drill | 21 CFR 874.4250Ear, nose, and throat electric or pneumatic surgical drill |
| Secondary ProductCodes | DZJDriver, Wire, And Bone Drill, ManualHBEDrills, Burrs, Trephines & Accessories (Simple, Powered) | DZJDriver, Wire, And Bone Drill, ManualHBEDrills, Burrs, Trephines & Accessories (Simple, Powered) |
| SecondaryRegulations | 21 CFR 872.4120Bone cutting instrument and accessories21 CFR 882.4310Powered simple cranial drills, burrs, trephines, and their accessories | 21 CFR 872.4120Bone cutting instrument and accessories21 CFR 882.4310Powered simple cranial drills, burrs, trephines, and their accessories |
| Condition of Use | Reusable | Reusable |
| Subject Device | Predicate Device | |
| DESCRIPTION | Stryker® Pi Drive 2 MotorStryker® Pi Drive 2 Plus Motor | Stryker® Pi Drive Plus Motor (K152641) |
| Type of Use | Prescription Use Only | Prescription Use Only |
| Patient Population | General | General |
| Contraindications | None | None |
| Principle ofOperation | The cutting, drilling, reaming, decorticating, shaping, and smoothingactions are accomplished through the transfer of torque from the motorto the selected attachment mounted on the motor which then transfersthe torque to the intended cutting accessory such as a bur, router, orperforator bit. | The cutting, drilling, reaming, decorticating, shaping, and smoothingactions are accomplished through the transfer of torque from the motorto the selected attachment mounted on the motor which then transfersthe torque to the intended cutting accessory such as a bur, router, orperforator bit. |
| Mode of Action | Rotary (transmits Torque) | Rotary (transmits Torque) |
| Power source | 40 V DC Electric Motor connected via cable to CORE 2 Console | 40 V DC Electric Motor connected via cable to CORE Console |
| Diameter of Motor | 17mm | 17mm |
| Length of the Motor | 98.7mm [Pi Drive 2 Motor]109mm [Pi Drive 2 Plus Motor] | 109mm |
| Weight of the Motor | 315g [Pi Drive 2 Motor]400g [Pi Drive 2 Plus Motor] | 400g |
| Maximum Speed | 75,000 rpm | 75,000 rpm |
| Accessories | CORE 2 Console• Attachments• Cutting accessories• Irrigation Sleeves / Clips• Extender | CORE Console• Attachments• Cutting accessories• Irrigation Sleeves / Clips• Extender |
| Subject Device | Predicate Device | |
| DESCRIPTION | Stryker® Pi Drive 2 MotorStryker® Pi Drive 2 Plus Motor | Stryker® Pi Drive Plus Motor (K152641) |
| Means of SpeedControl | Footswitch [Pi Drive 2 Motor]Hand Switch or Footswitch [Pi Drive 2 Plus Motor] | Hand Switch or Footswitch |
| Grip Design andFinish | Knurled / Black Diamond Like Carbon (DLC) Coated 455 StainlessSteel | Knurled / 455 Stainless Steel |
| Cutting AccessoriesRetention Method | Spring Collar Mechanism in Motor | Spring Collar Mechanism in Motor |
| AttachmentRetention Method | Friction Lock or Mechanical Lock | Friction Lock or Mechanical Lock |
| Motor HousingMaterial | Matte Black Anodized 6061-T6 Aluminum ASTM B210/211 | Black Anodized 6061-T6 Aluminum ASTM B210/211 |
| Cable Material | Gray Silicone with silicone based anti-friction coating [Pi Drive 2Motor]Black Silicone with silicone based anti-friction coating [Pi Drive 2 PlusMotor] | Black Silicone with silicone based anti-friction coating |
| Method ofSterilization | Moist Heat (Steam) | Moist Heat (Steam) |
| Sterility AssuranceLevel (SAL) | 10-6 | 10-6 |
| Cleaning Method | Manual and Mechanical (automated) | Manual and Mechanical (automated) |
| Packaging | Packaged in corrugated box with a retention insert | Packaged in corrugated box with a retention insert |
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Summary of Non-Clinical Testing
The intended use of the subject devices and predicate are identical, and their technological characteristics are similar. The subject devices are a line extension of the predicate and utilize the same design and operating principles. The device modifications do not raise any new or different questions of safety and effectiveness.
Risk management was conducted in accordance with ISO 14971 and did not identify any new or unacceptable risks when compared to the predicate. The following testing was conducted to demonstrate that the modifications to the subject devices are as safe and effective as the predicate.
- Motor Reliability Life ●
- Electrical Reliability ●
- IEC 60601-1 Electrical Safety
- IEC 60601-1-2 EMC / EMI Testing ●
- Packaging Integrity ●
- . Device Validation Summary
Results of these tests demonstrate that the functionality, integrity, and safety and effectiveness of the subject devices are sufficient for their intended use, indications for use and support a determination of substantial equivalence.
Summary of Clinical Testing
Clinical testing was not required for this Special 510(k).
Conclusion
The subject devices have the same indications for use, intended use, principle of operation, functional characteristics, and use applications. The modifications introduced raise no new or different issues of safety and effectiveness and testing has demonstrated substantial equivalence to the 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.