(55 days)
Not Found
No
The device description and performance studies focus on mechanical properties and surgical fixation, with no mention of AI/ML terms or functionalities.
Yes
The device is described as an implantable system for anterior cervical fixation, used to treat various spinal conditions, indicating a therapeutic purpose.
No
The device description indicates it is a system of bone plates and screws intended for anterior cervical fixation, which is a treatment, not a diagnostic, function. Its purpose is to fix or stabilize the spine for various conditions, not to detect or identify them.
No
The device description explicitly states that the Admiral ACP System consists of bone plates and screws, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- 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. These tests are performed outside of the body.
- Admiral ACP System Description: The description clearly states that the Admiral ACP System is a system of bone plates and screws intended for anterior cervical fixation. This means it is an implantable device used within the body to stabilize the spine.
- Intended Use: The intended use describes the conditions the device is used to treat (degenerative disc disease, trauma, etc.) by providing structural support to the cervical spine. This is a therapeutic use, not a diagnostic one.
The Admiral ACP System is a surgical implant used for spinal fixation, not a device used for laboratory testing of biological samples.
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
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 bone screws to reduce the potential for screw back-out. The locking pins come preassembled to the Admiral ACP System implant components are made from titanium alloy 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
anterior cervical fixation (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
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
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.
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September 1, 2021
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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
SeaSpine Orthopedics Corporation Ms. Cindy Fong Regulatory Affairs Specialist 5770 Armada Drive Carlsbad, California 92008
Re: K212139
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 7, 2021 Received: July 8, 2021
Dear Ms. Fong:
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
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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,
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
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Indications for Use
510(k) Number (if known)
K212139
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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510(k) Summary
Contact Details
| Applicant Name: | SeaSpine Orthopedics Corporation | ||
|---|---|---|---|
| Address: | |||
| Phone number: | |||
| Fax number: | 5770 Armada Drive, Carlsbad CA | ||
| (949) 855-7175 (Cindy) or (760) 421-2793 (Hong) | |||
| (760) 683-6874 | |||
| Contact Person: | |||
| Additional Contact: | Cindy Fong, Regulatory Affairs Specialist | ||
| Hong Phan, Principal Regulatory Affairs Specialist | |||
| Date Prepared: | July 7, 2021 | ||
| 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: | KWO |
Legally Marketed Predicate Devices
| 510(k) Number | Product Code | Trade Name | Manufacturer |
|---|---|---|---|
| Primary Predicate Device | |||
| K202064 | KWQ | Admiral ACP System | SeaSpine Orthopedics |
| Corporation | |||
| Additional Predicate Device | |||
| K173521 | KWQ | SeaSpine Cabo ACP (Anterior | |
| Cervical Plate) System | SeaSpine Orthopedics | ||
| Corporation |
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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 bone screws to reduce the potential for screw back-out. The locking pins come preassembled to the Admiral ACP System implant components are made from titanium alloy 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),
- . 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 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.