(30 days)
Not Found
No
The device description and performance studies focus on mechanical properties and surgical implantation, with no mention of AI/ML capabilities or data processing.
Yes
The device is described as an implantable system for anterior cervical fixation to treat various painful and degenerative conditions of the spine, which falls under the definition of a therapeutic device.
No
Explanation: The device description states that the Admiral ACP System is a system of bone plates and screws used for fixation in the cervical spine. It lists indications such as degenerative disc disease, trauma, and tumors, all of which are conditions that the device treats or stabilizes once diagnosed. The system does not mention any function for identifying, analyzing, or interpreting medical conditions or signals.
No
The device description explicitly states that the Admiral ACP System consists of bone plates and screws made from titanium alloy, which are hardware components.
Based on the provided information, the Admiral ACP System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for anterior cervical fixation for various spinal conditions. This involves surgically implanting a device into the body to provide structural support.
- Device Description: The device is described as a system of bone plates and screws made from titanium alloy, designed to be inserted into vertebral bodies. This is a physical implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used outside the body to analyze biological samples. The Admiral ACP System is an implantable surgical device.
N/A
Intended Use / Indications for Use
The Admiral ACP System is intended for anterior cervical fixation (C2-T1) for the following indications:
• 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, kyphosis, and/or lordosis),
·Tumor,
·Pseudoarthrosis,
·and failed previous fusion.
Product codes (comma separated list FDA assigned to the subject device)
KWQ
Device Description
The Admiral ACP System consists of a variety of bone plates and screws. Fixation is achieved by inserting bone screws through the openings in the plate into the vertebral bodies of the cervical spine. The Admiral plates include locking pins that cover the heads of the bone screws to reduce the potential for screw back-out. The locking pins come preassembled to the plate. The Admiral ACP System implant components are made from titanium allov per ASTM F136. Associated instruments are available to facilitate the implantation of the device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine (C2-T1)
Indicated Patient Age Range
Not Found
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)
Non-Clinical Testing: The Admiral ACP System demonstrated equivalent performance to the predicate system through mechanical testing in static axial compression bending and torsion, and dynamic axial compression bending per ASTM F1717.
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
§ 888.3060 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
August 26, 2020
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & 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.
SeaSpine Orthopedics Corporation Aly Alvarez Sr. Regulatory Affairs Specialist 5770 Armada Drive Carlsbad, California 92008
Re: K202064
Trade/Device Name: Admiral ACP System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: July 24, 2020 Received: July 27, 2020
Dear Ms. Alvarez:
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. Acting 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) K202064
Device Name Admiral ACP System
Indications for Use (Describe)
The Admiral ACP System is intended for anterior cervical fixation (C2-T1) for the following indications:
• 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, kyphosis, and/or lordosis),
·Tumor,
·Pseudoarthrosis,
·and failed previous fusion.
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
510(k) Summary
Contact Details
| Applicant Name: | SeaSpine Orthopedics Corporation | ||
|---|---|---|---|
| Address: | |||
| Phone number: | |||
| Fax number: | 5770 Armada Drive, Carlsbad CA | ||
| (619) 884-4342 (Aly) or (949) 855-7175 (Cindy) | |||
| (760) 683-6874 | |||
| Contact Person: | |||
| Additional Contact: | Aly Alvarez, Sr. Regulatory Affairs Specialist | ||
| Cindy Fong, Regulatory Affairs Coordinator | |||
| Date Prepared: | July 24, 2020 | ||
| Device Name | |||
| Trade Name: | Admiral ACP System | ||
| Common Name: | Cervical Plate | Classification Name: Spinal Intervertebral Body Fixation Orthosis (21 CFR 888.3060) | |
| Class: | II | ||
| Product Code: | KWQ |
Legally Marketed Predicate Devices
| 510(k) Number | Product Code | Trade Name | Manufacturer |
|---|---|---|---|
| Primary Predicate Device | |||
| K173521 | KWQ | SeaSpine Cabo ACP (Anterior | |
| Cervical Plate) System | SeaSpine Orthopedics | ||
| Corporation | |||
| Additional Predicate Device | |||
| K112206 | KWQ | Cardiff Anterior Cervical Plate | |
| System | SeaSpine, Inc. | ||
| (formerly known as | |||
| Integra LifeSciences | |||
| Corporation) |
4
Device Description
The Admiral ACP System consists of a variety of bone plates and screws. Fixation is achieved by inserting bone screws through the openings in the plate into the vertebral bodies of the cervical spine. The Admiral plates include locking pins that cover the heads of the bone screws to reduce the potential for screw back-out. The locking pins come preassembled to the plate. The Admiral ACP System implant components are made from titanium allov per ASTM F136. Associated instruments are available to facilitate the implantation of the device.
Indications for Use
The Admiral ACP System is intended for anterior cervical fixation (C2-T1) for the following indications:
- Degenerative Disc Disease (DDD) (defined as neck pain of discogenic origin with . degeneration of the disc confirmed by history and radiographic studies),
- o Spondylolisthesis,
- Trauma (i.e., fracture or dislocation),
- . Spinal Stenosis.
- Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
- Tumor,
- . Pseudoarthrosis,
- . and failed previous fusion.
Summary of Technological Characteristics
The Admiral ACP System is equivalent to the cited predicate devices in regard to components, device description, intended use/indications for use, technological characteristics (operating principle, design, materials, sterility, manufacturing, etc.) and performance (mechanical).
The implants are used to treat the same conditions, have essentially the same precautions and contraindications for use, and represent a basic design concept in terms of safety and effectiveness, and differ only in design details and not functionality.
Non-Clinical Testing
The Admiral ACP System demonstrated equivalent performance to the predicate system through mechanical testing in static axial compression bending and torsion, and dynamic axial compression bending per ASTM F1717.
Conclusions
The submitted data demonstrate that the Admiral ACP System is substantially equivalent to the cited legally marketed predicate device.