(66 days)
Not Found
No
The summary describes a mechanical attachment for a power tool used in spinal surgery. There is no mention of AI, ML, image processing, or data-driven decision making. The performance studies are focused on mechanical and usability testing.
No
The device is described as an attachment for power tools used to facilitate the placement of pedicle screws. It is a surgical tool, not a device intended to treat or cure a disease or condition.
No
The device is described as an attachment for power tools used to facilitate the placement of pedicle screws. Its function is to rotate screwdrivers for insertion, indicating it is an interventional or surgical device, not one that diagnoses conditions.
No
The device description explicitly states it is an "attachment used with a Stryker battery powered handpiece" and describes its mechanical function (reducing speed, increasing torque), indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "facilitate the placement of the pedicle screws using the power technique." This describes a surgical tool used during a procedure on a patient.
- Device Description: The device is an "attachment used with a Stryker battery powered handpiece that drives accessories to achieve their intended function." This further reinforces its role as a surgical instrument.
- Anatomical Site: The device is used on the "non-cervical spine," indicating a direct interaction with the patient's anatomy.
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform any such tests on samples.
The device described is a surgical instrument used to assist in the placement of implants within the body, which falls under the category of surgical tools or powered surgical instruments, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The intended use is to facilitate the placement of the pedicle screws using the power technique (cordless). When the attachment is attached, the Stryker Power Tools provide power to rotate the screwdrivers for the insertion of pedicle screws.
Pedicle screws from select Stryker Spine implant systems may be implemented in the non-cervical spine using powered instrumentation.
Product codes (comma separated list FDA assigned to the subject device)
NKB, HWE
Device Description
The Stryker POWEReam Xia/Serrato is an attachment used with a Stryker battery powered handpiece that drives accessories to achieve their intended function. The design reduces the speed and increases the torque output from the handpiece by a ratio of 5:1.
The purpose of this premarket notification is to seek clearance for the Stryker POWEReam Xia/Serrato (part number 4405-240-000).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
non-cervical spine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Professional use only in a professional healthcare environment.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A suite of non-clinical testing was executed to demonstrate substantial equivalence to the predicate device. Testing included:
- Performance Design Verification Testing
- Human Factors and Usability Engineering
- Simulated Use Design Validation Testing
All pre-defined acceptance criteria for the above tests have been met. Results from this testing confirm that the subject device performs as intended and supports a determination of substantial equivalence to the predicate device.
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
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.
0
April 29, 2024
Image /page/0/Picture/1 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, which includes the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
Stryker Instruments Kelebogile Moumakwa Staff Regulatory Affairs Specialist 1941 Stryker Way Portage, Michigan 49002
Re: K240526
Trade/Device Name: POWEReam Xia/Serrato Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB, HWE Dated: February 23, 2024 Received: February 23, 2024
Dear Kelebogile Moumakwa:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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,
Eileen
Digitally signed
by Eileen Cadel
Cadel -S Date: 2024.04.29
09:44:20-04'00' for
Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K240526
Device Name POWEReam Xia/Serrato
Indications for Use (Describe)
The intended use is to facilitate the placement of the pedicle screws using the power technique (cordless). When the attachment is attached, the Stryker Power Tools provide power to rotate the screwdrivers for the insertion of pedicle screws.
Pedicle screws from select Stryker Spine implant systems may be implemented in the non-cervical spine using powered instrumentation.
| 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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3
Submitter Information
This Premarket Notification is submitted by:
Stryker Instruments 1941 Stryker Way Portage MI 49002 USA
Contact Information
Kelebogile Moumakwa Staff Regulatory Affairs Specialist Ph: 011-353-86-8617273 Email: kelebogile.moumakwa(@stryker.com Date Prepared: February 2024
Device Name
| Subject Device Information | |
|---|---|
| Trade/ Proprietary Name | POWEReam Xia/Serrato |
| Regulation Names | Thoracolumbosacral pedicle screw system |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor | |
| And Accessory/Attachment | |
| Regulation Numbers | 21 CFR 888.3070 |
| 21 CFR 878.4820 | |
| Review Panel | Orthopedic |
| Product Codes | NKB, HWE |
| Regulatory Class | Class II |
Table 1: Subject Device Information
Predicate Device
The legally marketed predicate for the subject device is detailed in Table 2.
| Primary Predicate Device Name | 510(k) | Product Code | Manufacturer |
|---|---|---|---|
| POWEReam ¼” Drive | K233300 | NKB/HWE | Stryker |
| Instruments |
Table 2: Predicate Device Information
Traditional 510(k) POWEReam Xia/Serrato
4
Indications for Use
The intended use is to facilitate the placement of the pedicle screws using the power technique (cordless). When the attachment is attached, the Stryker Power Tools provide power to rotate the screwdrivers for the insertion of pedicle screws.
Pedicle screws from select Stryker Spine implant systems may be implemented in the noncervical spine using powered instrumentation.
Device Description
The Stryker POWEReam Xia/Serrato is an attachment used with a Stryker battery powered handpiece that drives accessories to achieve their intended function. The design reduces the speed and increases the torque output from the handpiece by a ratio of 5:1.
The purpose of this premarket notification is to seek clearance for the Stryker POWEReam Xia/Serrato (part number 4405-240-000).
5
Image /page/5/Picture/1 description: The image shows the text "K240526 Page 3 of 5" on the left side and the word "stryker" in a stylized font on the right side. The text on the left indicates a document identifier and page number. The word "stryker" is the name of a medical technology company.
| Description | Subject | Predicate | Comparison Assessment |
|---|---|---|---|
| Stryker POWEReam Xia/Serrato | Stryker | ||
| POWEReam ¼" | |||
| Drive (K233300) | |||
| Type of Use | Prescription Use Only | Prescription Use Only | Identical |
| Classification of Device | Class II | Class II | Identical |
| Primary Product Code | NKB, HWE | NKB, HWE | Identical |
| Primary Regulation | 21 CFR 888.3070 | 21 CFR 888.3070 | Identical |
| Regulation Name | Thoracolumbosacral Pedicle Screw System | Thoracolumbosacral | |
| Pedicle Screw System | Identical | ||
| Review Panel | Orthopedic | Orthopedic | Identical |
| Indications for Use | The intended use is to facilitate the | ||
| placement of the pedicle screws using the | |||
| power technique (cordless). When the | |||
| attachment is attached, the Stryker Power | |||
| Tools provide power to rotate the | |||
| screwdrivers for the insertion of pedicle | |||
| screws. | |||
| Pedicle screws from select Stryker Spine | |||
| implant systems may be implemented in the | |||
| non-cervical spine using powered | |||
| instrumentation. | The intended use is for | ||
| drilling, reaming, and | |||
| decorticating of bone and | |||
| other bone-related tissue | |||
| during general surgical | |||
| orthopedic procedures in a | |||
| variety of surgical | |||
| procedures. It is also usable | |||
| in the placement of screws, | |||
| wires, pins, and other | |||
| fixation devices. | |||
| This attachment is designed | |||
| for general surgical use | |||
| where hard tissue and/or | |||
| bone must be cut, reamed, | Identical | ||
| The first two paragraphs of | |||
| the predicate device | |||
| contain the orthopedic | |||
| indications. These | |||
| indications are not in scope | |||
| of this submission. | |||
| The intended use related to | |||
| placement of pedicle | |||
| screws is equivalent. |
Comparison of Regulatory Information
Traditional 510(k) POWEReam Xia/Serrato
6
K240526
Page 4 of 5
Page 4 of 5
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| Description | Subject |
|---|---|
| Stryker POWEReam X |
| Description | Subject | Predicate | Comparison Assessment |
|---|---|---|---|
| Stryker POWEReam Xia/Serrato | Stryker | ||
| POWEReam ¼” | |||
| Drive (K233300) | |||
| drilled, and/or fixated with | |||
| screws, including but not | |||
| limited to, the hand, wrist, | |||
| elbow, sternum, shoulder, | |||
| foot, ankle, knee, and hip. |
The intended use is also to
facilitate the placement of
the pedicle screws using
the power technique
(cordless). When the
attachment is attached, the
Stryker Power Tools
provide power to rotate the
screwdrivers for the
insertion of pedicle screws,
in non-cervical spine
surgical procedures. | |
| Patient Population | General | General | Identical |
| Contraindications | None Known | None Known | Identical |
| Conditions for Use | Professional use only in a professional
healthcare environment. | Professional use only in a
professional healthcare
environment. | Identical |
Traditional 510(k) POWEReam Xia/Serrato
7
Comparison of Technological Characteristics
The subject device has the same intended use as the predicate device as they are both used to facilitate placement of pedicle screws in non-cervical spine procedures. The subject device is indicated to facilitate the placement of pedicle screws using the Stryker Spine Xia and Serrato screwdrivers, while the predicate device is indicated to facilitate the placement of pedicle screws using tools with a 1/4" square fitting.
The design of both the subject and predicate device are similar. Both transmit torque and speed provided from the powered handpiece to associated accessories and both reduce the speed and increase the torque output from the handpiece at a 5:1 gear ratio reduction. The accessory connection end is similar with quick connection design technology; however, the geometries are different as they are designed to connect to different accessories.
Risk evaluation and performance testing have shown that the differences do not introduce new questions of safety and effectiveness and that the subject is at least as safe and effective as the predicate, supporting a determination of substantial equivalence. The evaluation and testing have demonstrated that the subject device is substantially equivalent to the predicate device.
Summary of Non-Clinical Testing
A suite of non-clinical testing was executed to demonstrate substantial equivalence to the predicate device. Testing included:
- Performance Design Verification Testing ●
- Human Factors and Usability Engineering ●
- Simulated Use Design Validation Testing ●
All pre-defined acceptance criteria for the above tests have been met. Results from this testing confirm that the subject device performs as intended and supports a determination of substantial equivalence to the predicate device.
Summary of Clinical Testing
Clinical testing was not required for this Traditional 510(k).
Conclusion
The Stryker POWEReam Xia/Serrato is substantially equivalent to the predicate device currently cleared under K233300 as it has the same intended use, same design, principle of operation and technological characteristics. No new questions of safety or effectiveness have been raised as compared to the predicate. Performance testing has demonstrated that the Stryker POWEReam Xia/Serrato is substantially equivalent to the predicate device.
Traditional 510(k) POWEReam Xia/Serrato