(119 days)
No
The device description and performance studies focus solely on the mechanical properties and design of a cervical plating system, with no mention of AI or ML technologies.
Yes.
The device is intended for use as an aid in cervical spinal fusion and temporary stabilization of the anterior spine in patients with various medical conditions, indicating a therapeutic purpose.
No
Explanation: The device is an Anterior Cervical Plating System, which is used for temporary stabilization of the anterior spine during cervical spinal fusion. It is a therapy device, not a diagnostic one.
No
The device description clearly outlines physical components such as plates, screws, and surgical instrumentation, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the ACP 1™ Anterior Cervical Plating System is for surgical implantation to aid in cervical spinal fusion. This is a therapeutic and structural device, not a diagnostic one.
- Device Description: The description details the physical components of the system (plates, screws, instrumentation) which are designed for surgical fixation.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide information about a patient's health status based on such analysis. IVDs are specifically designed for these purposes.
Therefore, the ACP 1™ Anterior Cervical Plating System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ACP 1TM Anterior Cervical Plating System is intended for use as an aid in cervical spinal fusion and is intended for unilateral fixation.
The ACP 1TM system is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications:
Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
Trauma (including fractures)
Tumors
Deformities or curvatures (including kyphosis, lordosis, or scoliosis)
Pseudarthrosis
Failed previous fusion
Decompression of the spinal cord following total or partial cervical vertebrectomy
Spondylolisthesis
Spinal stenosis
The associated instrumentation are Class I / 510(k) exempt devices under 21 CFR §888.4540.
Product codes
KWQ
Device Description
The ACP 1TM Anterior Cervical Plating System are one-, two-, three- and four-level plate configurations ranging in lengths 10mm to 22mm for the one-level plates, 24mm to 46mm for the two-level plates, 39mm to 69mm for the three-level plates and 56mm to 96mm for the four-level plates. A locking screw is utilized as an anti-backout mechanism to lock the bone screws in place. The bone screws are provided with either fixed or variable angles available in self-tapping or self-drilling designs. The variable angle bone screws allow the screw to be placed into bone at various degrees of angulation, while the fixed bone screws are inserted at a defined angle. Any combination of bone screws can be used to secure the cervical plate. The bone screws are offered in 4.0mm and 4.5mm diameters in lengths 10mm - 20mm. The implants (bone screws and cervical plates) are provided as single-use, sterile devices manufactured from titanium alloy (Ti6Al4V) per ASTM F136 and ISO 5832-3, as well as associated manual general surgical instrumentation. The implants are available in a variety of sizes to accommodate various patient anatomies.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine at levels C2-T1
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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)
Risk analysis was performed to demonstrate that the ACP 1TM System is substantially equivalent to its predicate devices. The risk analysis determined that the predefined acceptance criteria associated with the following mechanical testing was met: Static and dynamic compression testing per ASTM F1717-14 Static torsion testing per ASTM F1717-14
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Stryker Spine, Aviator® Anterior Cervical Plating (ACP) System, K142237, Synthes Anterior CSLP System, K000742, BioMet MaxAn® Anterior Cervical Plate System, K133518
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.
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" arranged around the perimeter. Inside the circle is an emblem featuring a stylized image of three human profiles facing to the right, stacked one behind the other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 15, 2015
Stryker Corporation Ms. Tina Mornak Regulatory Affairs Specialist 2 Pearl Court Allendale, New Jersey 07401
Re: K150700
Trade/Device Name: ACP 1™ Anterior Cervical Plating System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: June 18, 2015 Received: June 19, 2015
Dear Ms. Mornak:
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.
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
Page 2 - Ms. Tina Mornak
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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
ACP 1TM Anterior Cervical Plating System
Indications for Use (Describe)
The ACP 1™ Anterior Cervical Plating System is intended for use as an aid in cervical spinal fusion and is intended for unilateral fixation.
The ACP 1™ system is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications:
· Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
- · Trauma (including fractures)
- Tumors
- · Deformities or curvatures (including kyphosis, lordosis, or scoliosis)
- Pseudarthrosis
- · Failed previous fusion
- · Decompression of the spinal cord following total or partial cervical vertebrectomy
- · Spondylolisthesis
- · Spinal stenosis
| 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)
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 | |
|---|---|
| Submitter: | Stryker Spine |
| 2 Pearl Court | |
| Allendale, New Jersey 07401 | |
| Contact Person | Tina Mornak |
| Regulatory Affairs Specialist | |
| Phone: 201-760-8193 | |
| Fax: 201-962-4193 | |
| E-mail: tina.mornak@stryker.com | |
| Date Prepared | June 30, 2015 |
| Trade Name | ACP 1TM Anterior Cervical Plating System |
| Common Name | Appliance, fixation, spinal intervertebral body |
| Proposed Class | Class II |
| Classification Name and | |
| Number | Spinal intervertebral body fixation orthosis |
| 21 CFR §888.3060 | |
| Product Code | KWQ |
| Predicate Devices | Primary Predicate: |
| Stryker Spine, Aviator® Anterior Cervical Plating (ACP) System, K142237 | |
| Additional Predicates: | |
| Synthes Anterior CSLP System, K000742 | |
| BioMet MaxAn® Anterior Cervical Plate System, K133518 | |
| Device Description | The ACP 1TM Anterior Cervical Plating System are one-, two-, three- and four-level |
| plate configurations ranging in lengths 10mm to 22mm for the one-level plates, 24mm | |
| to 46mm for the two-level plates, 39mm to 69mm for the three-level plates and 56mm | |
| to 96mm for the four-level plates. A locking screw is utilized as an anti-backout | |
| mechanism to lock the bone screws in place. The bone screws are provided with either | |
| fixed or variable angles available in self-tapping or self-drilling designs. The variable | |
| angle bone screws allow the screw to be placed into bone at various degrees of | |
| angulation, while the fixed bone screws are inserted at a defined angle. Any | |
| combination of bone screws can be used to secure the cervical plate. The bone screws | |
| are offered in 4.0mm and 4.5mm diameters in lengths 10mm - 20mm. The implants | |
| (bone screws and cervical plates) are provided as single-use, sterile devices | |
| manufactured from titanium alloy (Ti6Al4V) per ASTM F136 and ISO 5832-3, as well | |
| as associated manual general surgical instrumentation. The implants are available in a | |
| variety of sizes to accommodate various patient anatomies. | |
| Indications for Use | The ACP 1TM Anterior Cervical Plating System is intended for use as an aid in cervical |
| spinal fusion and is intended for unilateral fixation. | |
| The ACP 1TM system is intended for anterior intervertebral screw fixation of the | |
| cervical spine at levels C2-T1. The system is indicated for temporary stabilization of | |
| the anterior spine during the development of cervical spine fusions in patients with the | |
| following indications: | |
| Degenerative Disc Disease (as defined by neck pain of discogenic origin with | |
| degeneration of the disc confirmed by patient history and radiographic studies)Trauma (including fractures)TumorsDeformities or curvatures (including kyphosis, lordosis, or scoliosis)PseudarthrosisThe associated instrumentation are Class I / 510(k) exempt devices under 21 CFR | |
| §888.4540. | |
| 510(k) Summary | |
| Failed previous fusion Decompression of the spinal cord following total or partial cervical vertebrectomy Spondylolisthesis Spinal stenosis | |
| Summary of the | |
| Technological | |
| Characteristics | The purpose of this Traditional 510(k) is to summarize the design changes and sterile |
| labeling that have been implemented to the Aviator® Anterior Cervical Plating (ACP) | |
| System. These modifications did not alter the fundamental scientific technology or | |
| change/introduce an energy source. The modified devices retained by previously | |
| FDA cleared indications/intended use and mode of operation as presented in 510(k) | |
| #K142237. |
The ACP 1TM System introduces a locking screw as an anti-backout mechanism. The
primary screw locking mechanism is a locking screw, which is designed to lock over
the bone screw heads. Insertion of the locking screw locks the bone screws in place
and allows for additional visual and tactile feedback that the bone screws are locked.
The ACP 1TM System will be provided sterile to the end-user. The implants continue
to be manufactured from surgical grade implantable titanium alloy.
The implemented modifications did not raise new questions of safety or efficacy. |
| Summary of the
Performance Data | Risk analysis was performed to demonstrate that the ACP 1TM System is substantially
equivalent to its predicate devices. The risk analysis determined that the predefined
acceptance criteria associated with the following mechanical testing was met: Static and dynamic compression testing per ASTM F1717-14 Static torsion testing per ASTM F1717-14 |
| Conclusions | The ACP 1TM System has identical indications, technological characteristics, and
principles of operation as its predicates. The risk analysis performed demonstrates
that any minor differences do not impact device performance as compared to the
predicates. The ACP 1TM System was shown to be substantially equivalent to its
predicate devices. |
4