(75 days)
Not Found
No
The summary describes a mechanical implant system for spinal fusion and does not mention any software, algorithms, or data processing capabilities that would suggest the use of AI/ML.
Yes
Explanation: The device is intended for anterior cervical fixation of the cervical spine as an adjunct to fusion for various conditions like degenerative disc disease, spondylolisthesis, and trauma, which are therapeutic interventions.
No
The device is an Anterior Cervical Plate System intended for fixation of the cervical spine as an adjunct to fusion, which is a therapeutic rather than diagnostic function. It is used to stabilize the spine after a diagnosis has already been made.
No
The device description explicitly states the system consists of physical components like plates, screws, and instruments made from titanium alloy. It is a hardware-based implant system.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- CODA™ Anterior Cervical Plate System Function: The CODA™ system is a surgical implant used to stabilize the cervical spine. It is physically implanted into the patient's body and does not analyze biological specimens.
The provided information clearly describes a surgical implant for spinal fixation, not a device for laboratory testing of biological samples.
N/A
Intended Use / Indications for Use
The CODA™ Anterior Cervical Plate System is intended for anterior cervical fixation of the cervical spine (C2-C7) as an adjunct to fusion in skeletally mature patients. Specific indications include: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
Product codes
KWQ
Device Description
The CODA™ Anterior Cervical Plate (ACP) System is intended for anterior fixation of the cervical spine (C2-C7) as an adjunct to fusion in skeletally mature patients. The system consists of non-sterile and sterile, single use plates and screws that are manufactured from titanium alloy (Ti-6Al-4V ELI). The plates have an integrated active locking mechanism, are offered in various lengths, and accommodate constrained and variable screws. The system includes non-sterile, reusable instruments and sterile, single use instruments designed to facilitate proper implantation of the plate and screws.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine (C2-C7)
Indicated Patient Age Range
skeletally mature patients
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)
Testing was conducted to show that the introduction of a sterile packaged version of the CODA™ Anterior Cervical Plate System does not impact the safety or performance. Clinical data was not necessary for the determination of substantial equivalence. Therefore, the CODA™ Anterior Cervical Plate System is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech Alicia Kaufman Sr. Regulatory Affairs Specialist 375 River Park Circle Marquette, Michigan 49855
Re: K230993
Trade/Device Name: CODA™ Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: May 23, 2023 Received: May 23, 2023
Dear Alicia Kaufman:
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
June 20, 2023
1
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 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.
Image /page/1/Picture/5 description: The image shows the name "Eileen Cadel -S" in large, bold font on the left side. To the right of the name, there is a digital signature block. The signature indicates that the document was digitally signed by Eileen Cadel -S on June 20, 2023, at 13:24:11 -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
Enclosure
2
Indications for Use
Submission Number (if known)
Device Name
CODA™ Anterior Cervical Plate System
Indications for Use (Describe)
The CODA™ Anterior Cervical Plate System is intended for anterior cervical fixation of the cervical spine (C2-C7) as an adjunct to fusion in skeletally mature patients. Specific indications include: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
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
| K230993 - Page 1 of 2 | ||
|---|---|---|
| 510(k) Summary | Prepared on: 2023-05-02 | |
| Contact Details | 21 CFR 807.92(a)(1) | |
| Applicant Name | Pioneer Surgical Technology, Inc. (D.B.A Resolve Surgical Technologies) | |
| Applicant Address | 375 River Park Circle Marquette MI 49855 United States | |
| Applicant Contact Telephone | 763-772-6137 | |
| Applicant Contact | Mrs. Alicia Kaufman | |
| Applicant Contact Email | akaufman@resolvesurg.com | |
| Device Name | 21 CFR 807.92(a)(2) | |
| Device Trade Name | CODA™ Anterior Cervical Plate System | |
| Common Name | Spinal intervertebral body fixation orthosis | |
| Classification Name | Appliance, Fixation, Spinal Intervertebral Body | |
| Regulation Number | 888.3060 | |
| Product Code | KWQ | |
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) | |
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
| K222493 | CODA™ Anterior Cervical Plate System | KWQ |
| Device Description Summary | 21 CFR 807.92(a)(4) | |
| The CODA™ Anterior Cervical Plate (ACP) System is intended for anterior fixation of the cervical spine (C2-C7) as an adjunct to fusion in skeletally mature patients. The system consists of non-sterile and sterile, single use plates and screws that are manufactured from titanium alloy (Ti-6Al-4V ELI). The plates have an integrated active locking mechanism, are offered in various lengths, and accommodate constrained and variable screws. The system includes non-sterile, reusable instruments and sterile, single use instruments designed to facilitate proper implantation of the plate and screws. | ||
| Intended Use/Indications for Use | 21 CFR 807.92(a)(5) |
The CODA™ Anterior Cervical Plate System is interior cervical fixation of the cervical spine (C2-C7) as an adjunct to fusion in skeletally mature patients. Specific indications include: degenerative disc disease (DDD) (defined as neck pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
Indications for Use Comparison
The CODA™ Anterior Cervical Plate System indications included in this Special 510(k) are the same as the CODA™ Anterior Cervical Plate System indications cleared via K222493.
Technological Comparison
The CODA™ Anterior Cervical Plate System was previously cleared via K222493. The purpose of this Special 510(k) is to introduce sterile implants to the CODA™ Anterior Cervical Plate System. Aside from the difference in sterility and packaging configuration, the subject device has the same technological characterice. The summary of verification and validation activities included
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(6)
4
in this submission supports that the sterility and packaging configuration differences do not raise issues of safety and effectiveness as compared to the predicate device.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
Testing was conducted to show that the introduction of a sterile packaged version of the CODA™ Anterior Cervical Plate System does not impact the safety or performance. Clinical data was not necessary for the determination of substantial equivalence. Therefore, the CODA™ Anterior Cervical Plate System is substantially equivalent to the predicate device.