(55 days)
Not Found
No
The summary describes a mechanical instrument (Cannulated Power Driver Attachment) that facilitates the insertion of pedicle screws using powered instrumentation. There is no mention of AI or ML in the device description, intended use, or performance studies.
No.
The device is described as an accessory to spinal implant systems, intended to facilitate the insertion of pedicle screws. It is an instrument used during a medical procedure, not a device that directly provides therapy or treatment to the patient.
No
The device is an accessory to spinal implant systems, specifically a power driver attachment for inserting pedicle screws. Its purpose is to facilitate a surgical procedure (screw insertion), not to diagnose a condition.
No
The device description explicitly states it is a "Cannulated Power Driver Attachment instrument" and an "accessory to the Everest and Range (Mesa and Denali) pedicle screw systems intended to facilitate the insertion of pedicle screws using powered instrumentation." This describes a physical, mechanical device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Description: The description clearly states that the device is a "Cannulated Power Driver Attachment instrument" used to facilitate the insertion of pedicle screws during spinal surgery. It's a mechanical tool used on the patient during a surgical procedure, not for testing samples from the patient.
- Intended Use: The intended use is for "Posterior non-cervical fixation as an adjunct to fusion" for various spinal conditions. This is a surgical intervention, not a diagnostic test.
The device is a surgical instrument used in conjunction with spinal implant systems.
N/A
Intended Use / Indications for Use
The MESA and DENALI Spinal Systems (including ARI Staples) and the EVEREST Spinal System are cleared for the following indications:
Posterior non-cervical fixation as an adjunct to following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies);
spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kydosis); tumor; pseudoarthosis; and/or failed previous fusion.
Except for hooks, when used as an anterolateral thoracic/lumbar system the Range Spinal System may also be used for the same indications as an adjunct to fusion.
Except for the ARI staples, the MESA, DENALI and EVEREST Spinal Systems are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis when used for posterior non-cervical fixation in pediatric patients. The MESA, DENALI and EVEREST Spinal System for pediatric use is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
Product codes
NKB
Device Description
This traditional 510(k) premarket notification is to introduce the Cannulated Power Driver Attachment instrument for use with Stryker Power Systems.
The Cannulated Power Driver Attachment is an accessory to the Everest and Range (Mesa and Denali) pedicle screw systems intended to facilitate the insertion of pedicle screws using powered instrumentation. The Cannulated Power Driver Attachment, also referred to as the power adaptor or subject device, serves as a mechanical interface between the power driver and screwdriver instrument. When the adaptor is attached, the driver (corded and cordless) provides appropriate power to rotate screw drivers for the insertion of pedicle screws. No changes have been made to the indications for use of the associated thoracolumbar spinal implant systems Everest and Range (Mesa and Denali) Spinal Systems. The indications for use of each spinal system remain consistent with their most recent 510(k) clearance.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
non-cervical fixation, non-cervical spine, thoracic/lumbar
Indicated Patient Age Range
pediatric patients, adolescent idiopathic scoliosis
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Cannulated Power Driver Attachment Instrument has demonstrated substantial equivalence to the predicate device. Verification and validation activities demonstrated connection of the Cannulated Power Driver Attachment to various Stryker Power Drivers does not represent a new worst case for powered pedicle screw insertion. The performance of the Cannulated Power Driver Attachment has met all acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K200666, K172724, K170496, K152632, K120434, K122845, K111478
Reference Device(s)
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
October 26, 2020
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo is in blue and reads "FDA U.S. FOOD & DRUG ADMINISTRATION".
K2M Inc. Megan Callanan Senior Regulatory Affairs Specialist 600 Hope Parkway SE Leesburg, Virginia 20175
Re: K202528
Trade/Device Name: Cannulated Power Driver Attachment Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB Dated: August 31, 2020 Received: September 1, 2020
Dear Ms. Callanan:
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
1
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 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,
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
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name Cannulated Power Driver Attachment
Indications for Use (Describe)
The MESA and DENALI Spinal Systems (including ARI Staples) and the EVEREST Spinal System are cleared for the following indications:
Posterior non-cervical fixation as an adjunct to following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies);
spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kydosis); tumor; pseudoarthosis; and/or failed previous fusion.
Except for hooks, when used as an anterolateral thoracic/lumbar system the Range Spinal System may also be used for the same indications as an adjunct to fusion.
Except for the ARI staples, the MESA, DENALI and EVEREST Spinal Systems are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis when used for posterior non-cervical fixation in pediatric patients. The MESA, DENALI and EVEREST Spinal System for pediatric use is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
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| 510(k) Summary | |
|---|---|
| 510(k) Summary: Cannulated Power Driver Attachment | |
|---|---|
| Submitter: | K2M, Inc. |
| 600 Hope Pkwy SE | |
| Leesburg, VA 20175 | |
| Contact Person : | Name: Megan Callanan |
| Phone: (551)262-2429 | |
| Email: megan.callanan1@stryker.com | |
| Date Prepared: | 8/31/2020 |
| Trade Name: | Cannulated Power Driver Attachment |
| Common Name: | Spinal Fixation Appliances, Instrument Accessory |
| Proposed Class: | Class II |
| Classification Name: | Thoracolumbosacral Pedicle Screw System |
| Regulation Number: | 888.3070 |
| Product Code: | NKB |
| Predicate Device: | Primary Predicate: K200666 |
| Additional Predicates: K172724, K170496, K152632, K120434, K122845, K111478 | |
| Device Description: | This traditional 510(k) premarket notification is to introduce the Cannulated Power |
| Driver Attachment instrument for use with Stryker Power Systems. |
The Cannulated Power Driver Attachment is an accessory to the Everest and Range
(Mesa and Denali) pedicle screw systems intended to facilitate the insertion of pedicle
screws using powered instrumentation. The Cannulated Power Driver Attachment,
also referred to as the power adaptor or subject device, serves as a mechanical
interface between the power driver and screwdriver instrument. When the adaptor is
attached, the driver (corded and cordless) provides appropriate power to rotate
screw drivers for the insertion of pedicle screws. No changes have been made to the
indications for use of the associated thoracolumbar spinal implant systems Everest
and Range (Mesa and Denali) Spinal Systems. The indications for use of each spinal
system remain consistent with their most recent 510(k) clearance. |
| Intended Use | The intended use for the Cannulated Power Driver Attachment is to facilitate the
placement of pedicle screws using the power technique (corded and cordless). The
Cannulated Power Driver Attachment is intended for exclusive use with the Stryker
Cordless and Corded Power Drivers. When the power adaptors are attached, the
Stryker Power Drivers (corded and cordless) provide power to rotate screwdrivers
for the insertion of pedicle screws.
Pedicle screws from select Stryker Spine implant systems may be implanted in the
non-cervical spine using powered (corded and cordless) instrumentation The |
| | systems included are the family of Everest and Range (Mesa and Denali) Spinal
Systems. |
| Indications for Use: | The MESA and DENALI Spinal Systems (including ARI Staples) and the EVEREST
Spinal System are cleared for the following indications: |
| | Posterior non-cervical fixation as an adjunct to fusion for the following indications:
degenerative disc disease (defined as back pain of discogenic origin with
degeneration of the disc confirmed by history and radiographic studies);
spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e.
scoliosis, kyphosis and/or lordosis); tumor; pseudoarthosis; and/or failed previous
fusion. |
| | Except for hooks, when used as an anterolateral thoracic/lumbar system the Range
Spinal System may also be used for the same indications as an adjunct to fusion. |
| | Except for the ARI staples, the MESA, DENALI and EVEREST Spinal Systems are
indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis when used for
posterior non-cervical fixation in pediatric patients. The MESA, DENALI and EVEREST
Spinal System for pediatric use is intended to be used with autograft and/or allograft.
Pediatric pedicle screw fixation is limited to a posterior approach. |
| Summary of the
Technological | The Cannulated Power Driver Attachment has equivalent materials, fundamental
scientific technologies and design compared with the predicate device. |
| Characteristics | The screws are intended to be inserted manually or with Stryker's corded and
cordless power drivers. The power adaptor accessory instrument assembly aids in
the rotation of the bone screw to facilitate insertion. |
| Non-Clinical
Performance
Evaluation | The Cannulated Power Driver Attachment Instrument has demonstrated substantial
equivalence to the predicate device. Verification and validation activities
demonstrated connection of the Cannulated Power Driver Attachment to various
Stryker Power Drivers does not represent a new worst case for powered pedicle
screw insertion. The performance of the Cannulated Power Driver Attachment has
met all acceptance criteria. |
| Conclusion | Based on the design features, the use of established well known materials, feature
comparisons, and indications for use the subject devices have demonstrated
substantial equivalence to the identified predicate devices. |
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